chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: the administration of the liquid component of Menveo without reconstitution of A lyophilized conjugate vaccine component; the administration of the liquid component of Menveo without reconstitution of A lyophilized conjugate vaccine component; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA677A, expiry date 30th April 2023) for prophylaxis.   On 11th October 2022, the patient received Menveo. On 11th October 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-Oct-2022 Reporter's comment: The nurse called and asked for information about the administration of the liquid component of Menveo without reconstitution of A lyophilized conjugate vaccine component. The reporter asked if the patient had to receive an extra properly reconstituted dose. The consent to follow up was granted. Additional Supportive Information: The patient received Menveo without reconstitution of A lyophilized conjugate vaccine component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 31.0
Sex: F
Vaccine: UNK
Symptoms: Dermatitis allergic, Exposure during pregnancy, Hypersensitivity, Rash
Clinical narrative: pregnant patient received a Fluarix vaccine; Allergic rash all over body, went to the ER; Allergic reaction; This prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of allergic rash in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 32P2F, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Additional patient notes included Prior to receiving the Fluarix vaccine, the patient was not allergic to anything.   On 3rd October 2022, the patient received Fluarix Quadrivalent 2022-2023 season (intramuscular) and Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Fluarix Quadrivalent 2022-2023 season at an unknown time during the pregnancy. In October 2022, less than 2 weeks after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced allergic rash and allergic reaction. On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the allergic rash and allergic reaction were recovered/resolved and the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.   It was unknown if the reporter considered the allergic rash and allergic reaction to be related to Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-OCT-2022 Reporter's Comment: The reporter reported an allergic reaction in a patient from a flu clinic that she had conducted. The pregnant patient received Fluarix vaccine in her right deltoid and had an allergic rash all over her body, reporter stated that the patient went to the emergency room on that evening. The reporter stated that the patient was prior to receiving Fluarix vaccine she was not allergic to anything. No information was reported on the pregnancy The reporter did consent to follow up by phone.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administered expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number XK524, expiry date 8th October 2022) for prophylaxis.   On 12th October 2022, the patient received Boostrix. On 12th October 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 12-Oct-2022 Reporter's comment: The licensed practical nurse called to inquired regarding any guidance. The reporter confirmed expired dose was administered at their facility. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Boostrix inadvertently on the day of reporting, which led to expired vaccine used.
Age: 62.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 62-year-old female patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 12th October 2022, the patient received Havrix. On 12th October 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 12-Oct-2022 Reporter's comment: No symptoms were reported. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired Boostrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number XK524, expiry date 8th October 2022) for prophylaxis.   On 12th October 2022, the patient received Boostrix. On 12th October 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 12-Oct-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Boostrix, which led to expired vaccine used.
Age: 73.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: 73 YO received Pedriatric dose of Havrix; 73 YO received Pedriatric dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 73-year-old male patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-Oct-2022 Reporter's comment: The pharmacy student reported that the patient received a pediatric dose of the Havrix.  No reactions was reported.  The reporter consented to follow up via email.  The vaccine administration facility was the same as primary reporter.  Additional Supportive Information: The 73 years old patient received a pediatric dose of the Havrix, which led to underdose and adult use of a child product.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Product preparation error
Clinical narrative: received vaccine reconstituted with water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 2295P, expiry date unknown) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 11th October 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 11th October 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-OCT-2022 Reporter's Comment: The reporter was medical assistant. The reporter reported that, a baby received Rotarix vaccine reconstituted with sterile water. The reporter consented to follow up by email. Additional Supportive Information: The reporter reported that, a baby received Rotarix vaccine reconstituted with sterile water, which led to wrong solution used in drug reconstitution.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 04Oct, 2nd on 12Oct; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 25-year-old male patient who received HBV (Engerix B adult) (batch number 9AX5P, expiry date 23rd November 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B ADULT).   On 12th October 2022, the patient received the 2nd dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 12th October 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-OCT-2022 Reporter's Comment: The operations specialist reported that the patient received second dose of Engerix B on 12th October 2022.  The reporter consented to follow up by mail. Additional Supportive Information: The patient received a dose of Engerix B adult earlier than the recommended interval, which led to shortening of vaccination schedule.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo reconstituted with water; Menveo reconstituted with water; This case was reported by a consumer and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA703A, expiry date 30th April 2023) for prophylaxis.   On 12th October 2022, the patient received Menveo. On 12th October 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 13-OCT-2022 Reporter's Comment: The reporter was patient's mother. The reporter reported that the patient received Menveo vaccine. The reporter stated that the Menveo vaccine was improperly reconstituted with water. No additional details were provided by the reporter. The reporter provided permission to contact healthcare professional. The reporter did consent to follow up. Additional supportive information: Menveo reconstituted with water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix B administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number unknown, expiry date 30th September 2022) for prophylaxis.   On 13th October 2022, the patient received Engerix B. On 13th October 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 13-Oct-2022 Reporter's comment: The pharmacist did not had information about gender, initials or date of birth for the patient, or information about Engerix-B lot number. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Engerix-B, which led to expired vaccine used.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 14Apr2022, 2nd 23Sep2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 26-year-old male patient who received HBV (Engerix B) (batch number 7XY23, expiry date 29th April 2023) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 14th April 2022).   On 23rd September 2022, the patient received the 2nd dose of Engerix B. On 23rd September 2022, unknown after receiving Engerix B, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 13-OCT-2022 Reporter's comment: Pharmacist reported that the patient received a late 2nd dose of Engerix B. The reporter consented to follow-up. Additional supportive information: The patient received 2nd dose of Engerix B later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received 3 doses; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the series was completed in 2018).   On 10th October 2022, the patient received the 3rd dose of Shingrix. On 10th October 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 14-OCT-2022. Reporter's Comments: The reporter stated that a patient who received 3 doses of Shingrix.  Did not consent to follow-up. No other information available. Additional Supportive Information: The patient received 3rd dose of Shingrix which lead to extra dose.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Incomplete course of vaccination, Injection site pain
Clinical narrative: soreness at the injection site; fatigue, tiredness; 1st dose Mar2022, no 2nd dose yet; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received SHINGRIX for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In March 2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain, fatigue and incomplete course of vaccination. On an unknown date, the outcome of the injection site pain and fatigue were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain and fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-OCT-2022. Reporter's Comments: The patient self-reported this case. The reporter stated that the patient received his first dose of Shingrix in March of 2022 and that he not had his second dose.  The patient intends to receive his second dose as soon as possible. The patient received his first dose and experienced soreness at the injection site, tiredness, and fatigue.  The reporter gave consent to follow up. Additional Supportive Information: The patient did not receive 2nd dose which led to incomplete course of vaccination.
Sex: M
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Expired Flulaval administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 7K95C, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 14th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's Comment: The case was reported by nurse. Nurse reported that patient inadvertently administered an expired Flulaval expiry date 30th June 2022 on 14th October 2022. Reporter did not consent to follow. Additional supportive information: As patient administered expired dose which led to expired vaccine used.
Age: 44.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 44-year-old female patient who received HAV (Havrix) (batch number unknown, expiry date 30th September 2022) for prophylaxis.   On 14th October 2022, the patient received Havrix. On 14th October 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's Comment: Reporter reported that a dose of Havrix was given after the expiration date. It was expired on 30th September 2022.  The vaccine administration facility was the same as primary reporter. Reporter consented to follow via email. Additional supportive information: The patient administered expired dose of Havrix, which led to expired vaccine used.
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Flulaval had temperature excursion, then administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 13th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's comment: Medical assistant reported that Flulaval had a temperature excursion during shipping from GlaxoSmithKline. The vaccines were put in the fridge at arrival. However a patient was administered a dose on the 13th October 2022. The reporter declined to provide additional information. The reporter did not consent to follow-up. Additional Supportive Information: The patient received dose of Flulaval which had a temperature excursion during shipping from GlaxoSmithKline, which led to Incorrect storage of drug.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2019, 2nd never received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's comment: Pharmacist reported that a patient received 1st dose of Shingrix in 2019 and never got the 2nd dose. The vaccine administration facility was the same as primary reporter. No other information was available. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix vaccine, which led to Incomplete course of vaccination.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Asthenia, Atrial fibrillation, Basedow's disease, Cerebrovascular accident
Clinical narrative: Stroke; Graves' disease; AFIB; Shingles on her finger/underneath her nail; Shivers; Muscle pain; Felt sick to her stomach; Became very ill; Weakness; first dose of SHINGRIX about 5 years ago, and she has not yet received her second dose; This case was reported by a consumer via call center representative and described the occurrence of stroke in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the patient did not receive 2nd dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced stroke (serious criteria GSK medically significant), graves' disease (serious criteria GSK medically significant), atrial fibrillation (serious criteria GSK medically significant), shingles, shivers, muscle pain, upset stomach, illness, weakness and incomplete course of vaccination. On an unknown date, the outcome of the stroke, graves' disease, atrial fibrillation, shingles and incomplete course of vaccination were unknown and the outcome of the shivers, muscle pain, upset stomach, illness and weakness were recovered/resolved.   It was unknown if the reporter considered the stroke, graves' disease, atrial fibrillation, shingles, shivers, muscle pain, upset stomach, illness and weakness to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-Oct-2022 Reporter's comment: The reporter was the patient. The patient stated that she received her first dose of Shingrix about 5 years prior to the reporting, and she had not yet received her second dose. The patient stated she became very ill after receiving the first dose, which included shivers, muscle pain, weakness, and felt sick to her stomach. Since receiving her first dose of Shingrix, the patient had a stroke, graves' disease, diagnosed with atrial fibrillation, and had Shingles on her finger/underneath her nail. The reporter did not consent to follow-up. The patient did not wish to consent to follow up with Health-care professional. The patient did not wish to provide date of birth. This case was linked with case US2022148323, reported by the same reporter. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2022148323:Same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Herpes zoster, Illness, Incomplete course of vaccination, Myalgia
Clinical narrative: Stroke; Graves' disease; AFIB; Shingles on her finger/underneath her nail; Shivers; Muscle pain; Felt sick to her stomach; Became very ill; Weakness; first dose of SHINGRIX about 5 years ago, and she has not yet received her second dose; This case was reported by a consumer via call center representative and described the occurrence of stroke in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the patient did not receive 2nd dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced stroke (serious criteria GSK medically significant), graves' disease (serious criteria GSK medically significant), atrial fibrillation (serious criteria GSK medically significant), shingles, shivers, muscle pain, upset stomach, illness, weakness and incomplete course of vaccination. On an unknown date, the outcome of the stroke, graves' disease, atrial fibrillation, shingles and incomplete course of vaccination were unknown and the outcome of the shivers, muscle pain, upset stomach, illness and weakness were recovered/resolved.   It was unknown if the reporter considered the stroke, graves' disease, atrial fibrillation, shingles, shivers, muscle pain, upset stomach, illness and weakness to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-Oct-2022 Reporter's comment: The reporter was the patient. The patient stated that she received her first dose of Shingrix about 5 years prior to the reporting, and she had not yet received her second dose. The patient stated she became very ill after receiving the first dose, which included shivers, muscle pain, weakness, and felt sick to her stomach. Since receiving her first dose of Shingrix, the patient had a stroke, graves' disease, diagnosed with atrial fibrillation, and had Shingles on her finger/underneath her nail. The reporter did not consent to follow-up. The patient did not wish to consent to follow up with Health-care professional. The patient did not wish to provide date of birth. This case was linked with case US2022148323, reported by the same reporter. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2022148323:Same reporter
Age: 9.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Infanrix administered to patient over 7; Infanrix administered, supposed to receive Tdap; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-year-old male patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 7th October 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's comment: Interim Practice Manager stated that the Infanrix was administered to a over 7 years old patient. The patient was supposed to receive a Tdap vaccine. Lot number and expiration date was not available at time of call. The reporter consented to follow-up via mail. Additional Supportive Information: The patient received Infanrix instead of Tdap,which led to inappropriate age at vaccine administration and wrong vaccine administered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient concerned a 70 year old female of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient had previously received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose and start therapy date were not reported, 1 total administered for covid-19 prophylaxis. No adverse events were reported following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series: 1). The patient had previously received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose and start therapy date were not reported, 1 total (first booster) administered for covid-19 prophylaxis. No adverse events were reported following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series: 2). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 3) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total (second booster) administered on 04-MAY-2022 for covid-19 prophylaxis which was off label dosing frequency (Dose number in series: 3), associated with an Off label use. Age at time of vaccination 70 years old. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Asthma
Clinical narrative: HAIR LOSS (AROUND 3 INCH DIAMETER PATCHES OF HAIR LOSS); ASTHMA/WHEEZING; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user (very rare possible social occasions), non smoker, and asthma (Patient had asthma in elementary school which he had outgrown and lately since receiving the vaccine, he had to take an inhaler even when he was not exercising), and other pre-existing medical conditions included: Patient had no known allergies and had no drug abuse or illicit drug usage. Patient was pretty healthy and hardly ever get sick. Patient never had hair loss before and didn't have any history of hair loss in the family and never had covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 15-SEP-2021 for covid-19 prophylaxis. Age at time of vaccination 41 years old. No concomitant medications were reported. On 2022, the patient experienced hair loss (around 3 inch diameter patches of hair loss), and asthma/wheezing. Treatment medications (dates unspecified) included: salbutamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hair loss (around 3 inch diameter patches of hair loss), and asthma/wheezing. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea
Clinical narrative: nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous) in a 25-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57164B) for COVID-19 prophylaxis.     Crohn's - on Humira.  Previously administered products included for Product used for unknown indication: Influenza vaccine on 04-Oct-2022. Past adverse reactions to the above products included No adverse reaction with Influenza vaccine. Concurrent medical conditions included Crohn's (on Humira). Concomitant products included ADALIMUMAB (HUMIRA) for Crohn's.    On 04-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 04-Oct-2022, the patient experienced NAUSEA (nauseous). On 05-Oct-2022, NAUSEA (nauseous) had resolved.            It was reported that the patient was nauseous for hours after the shot. It started maybe 3 hours after the patient got it. After that the patient felt asleep and was fine the next day It is unknown if the patient experienced any additional symptoms/events. No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: She also knows of a woman who was having issues with blood clot. She is not sure which vaccine she took also.; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (She also knows of a woman who was having issues with blood clot. She is not sure which vaccine she took also.) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (She also knows of a woman who was having issues with blood clot. She is not sure which vaccine she took also.) (seriousness criteria hospitalization and medically significant). At the time of the report, THROMBOSIS (She also knows of a woman who was having issues with blood clot. She is not sure which vaccine she took also.) outcome was unknown.            No concomitant medications was reported.  Patient could not provide the vaccination information because could not find the vaccination card. Patient did not knowhowmany doses of the Moderna vaccine she had.  No treatment medications was reported.  Company comment: This is a spontaneous case concerning a female patient with no reported relevant medical history, who experienced the unexpected and serious (due to medically significant and hospitalization) event of thrombosis. The event occurred after of a dose of Covid-19 vaccine with mRNA-1273.222 vaccine. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a female patient with no reported relevant medical history, who experienced the unexpected and serious (due to medically significant and hospitalization) event of thrombosis. The event occurred after of a dose of Covid-19 vaccine with mRNA-1273.222 vaccine. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Gait disturbance, Impaired driving ability, Nausea
Clinical narrative: Dizziness/feel like I'm falling; not able to drive; almost fell several times; hard time walking; feel nauseated; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizziness/feel like I'm falling), IMPAIRED DRIVING ABILITY (not able to drive), FALL (almost fell several times), GAIT DISTURBANCE (hard time walking) and NAUSEA (feel nauseated) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057f22a) for COVID-19 prophylaxis.     Patient had allergic to penicillium.  Previously administered products included for Product used for unknown indication: flu vaccine (for two days, 2 weeks before receiving the vaccine) in September 2022, flu vaccine (for two days and 2 weeks before receiving the vaccine) in September 2022. Past adverse reactions to the above products included Cold with flu vaccine; and Sore throat with flu vaccine. Concurrent medical conditions included Drug allergy (sulfa). Concomitant products included GABAPENTIN, METFORMIN, ATORVASTATIN and CALCIUM for an unknown indication.    On 09-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Oct-2022, the patient experienced DIZZINESS (Dizziness/feel like I'm falling), IMPAIRED DRIVING ABILITY (not able to drive), FALL (almost fell several times), GAIT DISTURBANCE (hard time walking) and NAUSEA (feel nauseated). The patient was treated with DIAZEPAM (VALIUM) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness/feel like I'm falling), IMPAIRED DRIVING ABILITY (not able to drive), FALL (almost fell several times), GAIT DISTURBANCE (hard time walking) and NAUSEA (feel nauseated) was resolving.            On 29-Jan-2021, the patient received first dose of Moderna Covid-19 Vaccine, batch number 012l20a.  On 26-Feb-2021, received second dose of Moderna Covid-19 Vaccine, batch number 013m20a.  On 07-Nov-2021, received third dose (1st booster) of Moderna Covid-19 Vaccine, batch number 014f21a.  Patient had not been diagnosed nor tested positive for COVID-19.  The event does not cause the patient to seek medical care and patient had not experienced similar adverse event in the past.  The patient had not both acute and chronic illnesses at the time of vaccination.  At the time of reporting patient symptoms improving.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received first dose on 22-Apr-2021 and second dose on 05-May-2022; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 22-Apr-2021 and second dose on 05-May-2022) and NO ADVERSE EVENT (No adverse event) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 002c1A) for COVID-19 prophylaxis.     Concurrent medical conditions included Type 2 diabetes mellitus, BPH, Hypertension and Drug allergy (Unknown historical drug).   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 22-Apr-2021 and second dose on 05-May-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 22-Apr-2021 and second dose on 05-May-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Patient received third dose as Moderna booster on 04-Jan-2022, batch number (041JZ1A) and anatomical location was reported as left arm.  Patient started to had Pfizer paxlovid drug (300-100 mg) on 03-Oct-2022 and stopped at 07-Oct-2022, Batch/lot number (1918538A) and indication used as (Treatment of COVID-19/COVID-19 Treatment)  Patient was taking a lot of Contact for a list as a concomitant medication.  Patient had body temperature and result were provided as 97.2 Fahrenheit and had BP with result as 140/79  On 11-Oct-2022 Patient had Paxlovid Rebound and tested positive (line extremely dark and immediate). It's back feeling cold like symptoms  runny nose, sneezing, stifles, nasal congestion and run down, no headache, no achiness. Chest and breathing good, no coughing and outcome for this was reported as recovering/resolving.  No treatment medication were provided.  Device Date : 12-Oct-2022
Age: 59.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine / instead of receiving Moderna COVID-19 Vaccine, Bivalent, they got Moderna COVID-19 vaccine with Blue Capped Purple-Bordered; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine / instead of receiving Moderna COVID-19 Vaccine, Bivalent, they got Moderna COVID-19 vaccine with Blue Capped Purple-Bordered) and NO ADVERSE EVENT (no adverse event) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine / instead of receiving Moderna COVID-19 Vaccine, Bivalent, they got Moderna COVID-19 vaccine with Blue Capped Purple-Bordered). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine / instead of receiving Moderna COVID-19 Vaccine, Bivalent, they got Moderna COVID-19 vaccine with Blue Capped Purple-Bordered) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine / instead of receiving Moderna COVID-19 Vaccine, Bivalent, they got Moderna COVID-19 vaccine with Blue Capped Purple-Bordered).    No concomitant product reported by reporter.  Seven patient received Moderna COVID-19 vaccine with Blue Capped Purple-Bordered (Ages 6-11 years Monovalent) instead of receiving Moderna COVID-19 Vaccine Bivalent.  No treatment medication reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Live Significant follow up included batch number and expiry date. On 17-Oct-2022: Live Significant Follow-up added. Patient identifiers updated.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: quite a reaction for a day or two, typical symptoms; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (quite a reaction for a day or two, typical symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (quite a reaction for a day or two, typical symptoms). At the time of the report, IMMUNISATION REACTION (quite a reaction for a day or two, typical symptoms) had resolved.            Concomitant product use was not provided by the reporter.  Normally, the patient would get quite a reaction for a day or two, like the typical symptoms. The patient had the bivalent booster shot for COVID last Monday, which would be the fifth shot overall that the patient received. However, this time the patient had no symptoms or reactions. The patient did not even feel it while receiving the vaccine. The patient's arm was not sore.   Treatment information was not provided.