chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site vesicles
Clinical narrative: produced blisters around the injection site; injection site soreness; experienced chills; muscle soreness; Tiredness; Headache; chicken pox reaction; blisters were itchy; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site blisters in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-MAY-2024, the patient received the 1st dose of Shingrix (intramuscular, right deltoid) .5 ml. On 03-MAY-2024, 2 days after receiving Shingrix, the patient experienced injection site blisters (Verbatim: produced blisters around the injection site), injection site pain (Verbatim: injection site soreness), chills (Verbatim: experienced chills), muscle soreness (Verbatim: muscle soreness), tiredness (Verbatim: Tiredness) and headache (Verbatim: Headache). In MAY-2024, the patient experienced chickenpox (Verbatim: chicken pox reaction) and pruritus (Verbatim: blisters were itchy). On 10-MAY-2024, the outcome of the injection site blisters was resolved (duration 7 days). The outcome of the injection site pain, chills, muscle soreness, tiredness and headache were resolved and the outcome of the chickenpox and pruritus were not reported.   It was unknown if the reporter considered the injection site blisters, injection site pain, chills, muscle soreness, tiredness, headache, chickenpox and pruritus to be related to Shingrix.     It was unknown if the company considered the injection site blisters, injection site pain, chills, muscle soreness, tiredness, headache, chickenpox and pruritus to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-OCT-2024  The patient self-reported this case for herself. The patient received her first Shingrix vaccine in the right arm.  The patient had the usual injection site soreness that started 2 days after the injection.  The patient also experienced chills, muscle soreness, headache and tiredness that all resolved in a couple days.  The patient experienced a chicken pox reaction that produced blisters around the injection site,  The patient did not report this to her health care professional, but they dried up about a week after they appeared.  The patient reported that the  blisters were itchy.  The patient asked now if she should expect the same reaction with the second Shingrix vaccine.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pruritus, Varicella
Clinical narrative: produced blisters around the injection site; injection site soreness; experienced chills; muscle soreness; Tiredness; Headache; chicken pox reaction; blisters were itchy; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site blisters in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-MAY-2024, the patient received the 1st dose of Shingrix (intramuscular, right deltoid) .5 ml. On 03-MAY-2024, 2 days after receiving Shingrix, the patient experienced injection site blisters (Verbatim: produced blisters around the injection site), injection site pain (Verbatim: injection site soreness), chills (Verbatim: experienced chills), muscle soreness (Verbatim: muscle soreness), tiredness (Verbatim: Tiredness) and headache (Verbatim: Headache). In MAY-2024, the patient experienced chickenpox (Verbatim: chicken pox reaction) and pruritus (Verbatim: blisters were itchy). On 10-MAY-2024, the outcome of the injection site blisters was resolved (duration 7 days). The outcome of the injection site pain, chills, muscle soreness, tiredness and headache were resolved and the outcome of the chickenpox and pruritus were not reported.   It was unknown if the reporter considered the injection site blisters, injection site pain, chills, muscle soreness, tiredness, headache, chickenpox and pruritus to be related to Shingrix.     It was unknown if the company considered the injection site blisters, injection site pain, chills, muscle soreness, tiredness, headache, chickenpox and pruritus to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-OCT-2024  The patient self-reported this case for herself. The patient received her first Shingrix vaccine in the right arm.  The patient had the usual injection site soreness that started 2 days after the injection.  The patient also experienced chills, muscle soreness, headache and tiredness that all resolved in a couple days.  The patient experienced a chicken pox reaction that produced blisters around the injection site,  The patient did not report this to her health care professional, but they dried up about a week after they appeared.  The patient reported that the  blisters were itchy.  The patient asked now if she should expect the same reaction with the second Shingrix vaccine.
Age: 18.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Peripheral swelling, Product administered at inappropriate site, Swelling
Clinical narrative: Swelling progressed from neck to wrist; SWELLING; Product administered at inappropriate site; This spontaneous case initially received on 05-Nov-2024, from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2794309-1) was reported by a non-health professional and concerns an adult female patient.  At the time of the event the patient had Penicillin allergy.  Administration of company suspect drug(s): On 25-Sep-2024, the patient received Flucelvax (TIV) for indication not reported, Dose regimen: 1 DF, Anatomical site: Right arm; Route of administration: Intramuscular, Lot number: 946608. CSL Seqirus Batch number unable to be matched.   No additional suspect drugs.  Adverse reactions/events and outcomes: On 25-Sep-2024, the patient experienced Swelling progressed from neck to wrist (outcome: Unknown), SWELLING (outcome: Unknown), Product administered at inappropriate site (outcome: Unknown).  Non-drug treatment/Other action taken:  Flucelvax (TIV) action taken: Not Applicable  Reporter assessment:  The reporter assessed the seriousness as nonserious and did not provide causality assessment. ; Reporter's Comments: Causality of Swelling progressed from neck to wrist , swelling was related and Product administered at inappropriate site was not related.
Age: 18.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Peripheral swelling, Product administered at inappropriate site
Clinical narrative: Swelling progressed from neck to wrist; SWELLING; Product administered at inappropriate site; This spontaneous case initially received on 05-Nov-2024, from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2794309-1) was reported by a non-health professional and concerns an adult female patient.  At the time of the event the patient had Penicillin allergy.  Administration of company suspect drug(s): On 25-Sep-2024, the patient received Flucelvax (TIV) for indication not reported, Dose regimen: 1 DF, Anatomical site: Right arm; Route of administration: Intramuscular, Lot number: 946608. CSL Seqirus Batch number unable to be matched.   No additional suspect drugs.  Adverse reactions/events and outcomes: On 25-Sep-2024, the patient experienced Swelling progressed from neck to wrist (outcome: Unknown), SWELLING (outcome: Unknown), Product administered at inappropriate site (outcome: Unknown).  Non-drug treatment/Other action taken:  Flucelvax (TIV) action taken: Not Applicable  Reporter assessment:  The reporter assessed the seriousness as nonserious and did not provide causality assessment. ; Reporter's Comments: Causality of Swelling progressed from neck to wrist , swelling was related and Product administered at inappropriate site was not related.
Age: 9.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Blister rupture, Injection site reaction, Injection site vesicles, Skin wound
Clinical narrative: Blister at injection site; Injection site reaction; Blister at injection site; small wound; This spontaneous case, initially received on 05-Nov-2024, was reported by a non health professional via Vaccine Adverse Event Reporting System (VAERS) (reference number: 2794318-1) concerns an child female patient.   Administration of company suspect drug(s): On 07-Sep-2024, the patient received Flucelvax (TIV) for indication not reported, dosage regimen: not reported, route of administration: not reported, Lot number: Not reported and will not be requested, as received from regulatory authority.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 08-Sep-2024, the patient experienced Blister popped (outcome: Recovered / Resolved, stop date: 2024), Injection site reaction (outcome: Recovered / Resolved, stop date: 2024), Blister at injection site (outcome: Recovered / Resolved, stop date: 2024), small wound (outcome: Recovered / Resolved, stop date: 2024).  The patient's mother reported that patient developed  what looked like a blister at the injection site. The blister popped and at the time of reporting there was a small wound. Despite putting Neosporin for few days events got worse. The patient ultimately saw doctor and received oral antibiotic therapy which resolved the issue.  Flucelvax (TIV) action taken: Not Applicable Treatment medication: Neosporin  Reporter assessment: The reporter assessed the seriousness as non-serious and did not provide causality assessment. ; Reporter's Comments: All events are considered related.
Age: 9.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Injection site reaction, Injection site vesicles, Wound
Clinical narrative: Blister at injection site; Injection site reaction; Blister at injection site; small wound; This spontaneous case, initially received on 05-Nov-2024, was reported by a non health professional via Vaccine Adverse Event Reporting System (VAERS) (reference number: 2794318-1) concerns an child female patient.   Administration of company suspect drug(s): On 07-Sep-2024, the patient received Flucelvax (TIV) for indication not reported, dosage regimen: not reported, route of administration: not reported, Lot number: Not reported and will not be requested, as received from regulatory authority.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 08-Sep-2024, the patient experienced Blister popped (outcome: Recovered / Resolved, stop date: 2024), Injection site reaction (outcome: Recovered / Resolved, stop date: 2024), Blister at injection site (outcome: Recovered / Resolved, stop date: 2024), small wound (outcome: Recovered / Resolved, stop date: 2024).  The patient's mother reported that patient developed  what looked like a blister at the injection site. The blister popped and at the time of reporting there was a small wound. Despite putting Neosporin for few days events got worse. The patient ultimately saw doctor and received oral antibiotic therapy which resolved the issue.  Flucelvax (TIV) action taken: Not Applicable Treatment medication: Neosporin  Reporter assessment: The reporter assessed the seriousness as non-serious and did not provide causality assessment. ; Reporter's Comments: All events are considered related.
Sex: F
Vaccine: CHIK, CHIK
Symptoms: Flushing, Throat clearing
Clinical narrative: Patient continued reporting of possible airway impairment; Feeling of needing to "clear her throat" along with feeling "flushed"; Feeling of needing to "clear her throat" along with feeling "flushed"; The following information was received from nurse on 10 Oct 2024.  A female of unknown age received one dose of IXCHIQ (prevention of disease caused by Chikungunya virus (CHIKV), batch number 24B011) on 10 Oct 2024.  Within 10 minutes post administration of IXCHIQ she experienced feeling of needing to 'clear her throat' along with feeling 'flushed'. Patient continued reporting of possible airway impairment. She was treated with 50 mg oral Diphenhydramine. Oral mucosa was inspected and no swelling, inflammation, or signs of acute vaccine reaction were noticed. The nurse was able to see back of the throat. Patient was able to ingest diphenhydramine without issue. No hives, nor swelling of face, throat, eyes, lips nor itching, GI symptoms, wheezing, vomiting, or tachycardia was observed.  Outcome was reported as improving.  Relevant laboratory values of 10 Oct 2024 included blood presserure (120/78), heart rate (78, between 68-80) and oxygen saturation (above 98pct).; Sender's Comments: Causality assessed as possibly related for all reported events, as time to onset is plausible (within 10 minutes past vaccination) and as at least the reported symptoms hoarseness and respiratory symptoms are known and the events can be seen in the context of an allergic reaction which is also labelled.
Sex: F
Vaccine: CHIK, CHIK
Symptoms: Dysphonia, Flushing, Respiratory symptom, Throat clearing
Clinical narrative: Patient continued reporting of possible airway impairment; Feeling of needing to "clear her throat" along with feeling "flushed"; Feeling of needing to "clear her throat" along with feeling "flushed"; The following information was received from nurse on 10 Oct 2024.  A female of unknown age received one dose of IXCHIQ (prevention of disease caused by Chikungunya virus (CHIKV), batch number 24B011) on 10 Oct 2024.  Within 10 minutes post administration of IXCHIQ she experienced feeling of needing to 'clear her throat' along with feeling 'flushed'. Patient continued reporting of possible airway impairment. She was treated with 50 mg oral Diphenhydramine. Oral mucosa was inspected and no swelling, inflammation, or signs of acute vaccine reaction were noticed. The nurse was able to see back of the throat. Patient was able to ingest diphenhydramine without issue. No hives, nor swelling of face, throat, eyes, lips nor itching, GI symptoms, wheezing, vomiting, or tachycardia was observed.  Outcome was reported as improving.  Relevant laboratory values of 10 Oct 2024 included blood presserure (120/78), heart rate (78, between 68-80) and oxygen saturation (above 98pct).; Sender's Comments: Causality assessed as possibly related for all reported events, as time to onset is plausible (within 10 minutes past vaccination) and as at least the reported symptoms hoarseness and respiratory symptoms are known and the events can be seen in the context of an allergic reaction which is also labelled.
Age: 51.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Persistent right shoulder pain with limited range of motion that is worsening; Persistent right shoulder pain with limited range of motion that is worsening; This spontaneous case, initially received on 05-Nov-2024, was reported by a health authority, Vaccine Adverse Event Reporting System (VAERS) (Reference number: 2799701-1), and concerns an adult female patient.  Administration of company suspect drug(s): On 01-Oct-2024, the patient received Afluria (TIV) for unknown indication., Dose regimen: 1 DF, Route of administration: Intramuscular, Anatomical site: Right Arm, Batch number reported as AW1669A. CSL Seqirus Batch number unable to be matched  No additional suspect drugs.  Adverse reactions/events and outcomes: On 01-Oct-2024, the patient experienced Persistent right shoulder pain with limited range of motion that is worsening (outcome: Not recovered / Not resolved), Persistent right shoulder pain with limited range of motion that is worsening (outcome: Not recovered / Not resolved).  Afluria (TIV) action taken: Not Applicable  Reporter's assessment: The reporter assessed the events as non-serious and did not provide the causality assessment.; Reporter's Comments: The events were considered related to the administration of Afluria (TIV).
Age: 51.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Arthritis, Mobility decreased
Clinical narrative: Persistent right shoulder pain with limited range of motion that is worsening; Persistent right shoulder pain with limited range of motion that is worsening; This spontaneous case, initially received on 05-Nov-2024, was reported by a health authority, Vaccine Adverse Event Reporting System (VAERS) (Reference number: 2799701-1), and concerns an adult female patient.  Administration of company suspect drug(s): On 01-Oct-2024, the patient received Afluria (TIV) for unknown indication., Dose regimen: 1 DF, Route of administration: Intramuscular, Anatomical site: Right Arm, Batch number reported as AW1669A. CSL Seqirus Batch number unable to be matched  No additional suspect drugs.  Adverse reactions/events and outcomes: On 01-Oct-2024, the patient experienced Persistent right shoulder pain with limited range of motion that is worsening (outcome: Not recovered / Not resolved), Persistent right shoulder pain with limited range of motion that is worsening (outcome: Not recovered / Not resolved).  Afluria (TIV) action taken: Not Applicable  Reporter's assessment: The reporter assessed the events as non-serious and did not provide the causality assessment.; Reporter's Comments: The events were considered related to the administration of Afluria (TIV).
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Balance disorder, Deafness unilateral, Impaired driving ability, Muscular weakness, Vertigo
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Temporary lost of hearing, could not walk 2 days after-Severe, Systemic: Weakness-Severe, Additional Details: lost of hearing day after, then could not walk 2 days after. hospital stay for 2 weeks, now doing at home rehab, Other Vaccines:  VaccineTypeBrand: Fluzone High-Dose; Manufacturer: Sanofi; LotNumber: ut8163aa; Route: IM; BodySite: LD; Dose: 1; VaxDate: 09/20/2024
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vision blurred, Vomiting, Walking aid user
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Temporary lost of hearing, could not walk 2 days after-Severe, Systemic: Weakness-Severe, Additional Details: lost of hearing day after, then could not walk 2 days after. hospital stay for 2 weeks, now doing at home rehab, Other Vaccines:  VaccineTypeBrand: Fluzone High-Dose; Manufacturer: Sanofi; LotNumber: ut8163aa; Route: IM; BodySite: LD; Dose: 1; VaxDate: 09/20/2024
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Deafness, Gait inability, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Temporary lost of hearing, could not walk 2 days after-Severe, Systemic: Weakness-Severe, Additional Details: lost of hearing day after, then could not walk 2 days after. hospital stay for 2 weeks, now doing at home rehab, Other Vaccines:  VaccineTypeBrand: Fluzone High-Dose; Manufacturer: Sanofi; LotNumber: ut8163aa; Route: IM; BodySite: LD; Dose: 1; VaxDate: 09/20/2024
Age: 41.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy
Clinical narrative: Systemic: Fever-Medium
Age: 41.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Pyrexia
Clinical narrative: Systemic: Fever-Medium
Age: 78.0
Sex: F
Vaccine: FLUA4, FLUA4
Symptoms: Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Site: Swelling at Injection Site-Severe
Age: 78.0
Sex: F
Vaccine: FLUA4, FLUA4
Symptoms: Injection site swelling
Clinical narrative: Site: Swelling at Injection Site-Severe
Age: 64.0
Sex: F
Vaccine: FLU3, FLUC4
Symptoms: Arthritis, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Severe
Age: 64.0
Sex: F
Vaccine: FLU3, FLUC4
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe
Age: 64.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: pt states cant move arm. whole arm is in pain from shoulder to hand. pt states not swollen but painful to the point that the arm is unusable
Age: 64.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: pt states cant move arm. whole arm is in pain from shoulder to hand. pt states not swollen but painful to the point that the arm is unusable
Age: 62.0
Sex: F
Vaccine: PNC21, COVID19
Symptoms: Dysphonia, Feeling abnormal, Paraesthesia
Clinical narrative: Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: tingling right side jaw area
Age: 62.0
Sex: F
Vaccine: PNC21, COVID19
Symptoms: Paraesthesia
Clinical narrative: Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: tingling right side jaw area
Age: 33.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Injection site reaction, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient reports experiencing numbness in index and ring finger of left arm which received the Flulaval vaccine.
Age: 33.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Skin tightness
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient reports experiencing numbness in index and ring finger of left arm which received the Flulaval vaccine.
Age: 33.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient reports experiencing numbness in index and ring finger of left arm which received the Flulaval vaccine.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse side effects were reported; HCP called regarding VARIVAX that was expired and administered to patients.  VARIVAX Lot and expiration date are W018830 and 6/14/2024, STERILE DILUENT Lot and expiration date 1973262  3/10/2026. Expired product was supported. HCP provided patient in; This spontaneous report has been received from a Nurse referring a 12-month-old patient of an unknown gender.  The patient's pertinent medical history, previous drug reactions and allergies were not provided. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On 30-OCT-2024, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, dose administered, route and anatomical location of administration were not provided; lot # reported as W018830, which has been verified to be a valid lot # for this vaccine, expiration date provided and validated to be on 14-JUN-2024) (expired product administered). No adverse side effects were reported. No additional AE (no adverse event).  This is one of several reports received from the same reporter.
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Occupational exposure to product, Syringe issue
Clinical narrative: no additional adverse event; multi-vial carton of MMRII that contained 1 broken vial. Caller states the vial is broken at the neck and at the bottom.; her finger did come in contact with the product powder; This spontaneous report was received from medical assistant and refers to a female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter, lot #Y008289, expiration date: 24-APR-2026, administered for prophylaxis (strength, and route of administration were not provided). On 06-NOV-2024, the reporter received a shipment of a multi-vial carton of the vaccines contined 1 broken vial. She noticed the broken vial upon opening box. Caller states that the vial was broken at the neck and at the bottom (Product container issue). It was also reported that the patient finger did come in contact with the product powder (Occupational exposure to product). No additional adverse event was reported.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Extra dose administered, Infantile spitting up, Somnolence
Clinical narrative: she spit up and threw everythin in her stomach within a minute or two of being given the full dose; she spit up and threw everythin in her stomach within a minute or two of being given the full dose; doctor re-administered the vaccine but read online it said the vaccine should not be re-aministered; just been a bit sleepy afterwards; This spontaneous report was received from nurse and refers to an 8-week-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 07-NOV-2024, the patient was vaccinated with two doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, unk, administered orally for prophylaxis (strength, lot #, and expiry date were not provided).  On 07-NOV-2024, the patient experienced she spit up and threw everythin in her stomach within a minute or two of being given the full dose. Doctor readministered the vaccine but he read online it said the vaccine shouldn't be re-administered (Extra dose administered). Said that the child has just been a bit sleepy afterwards but no other symptoms. At the time of reporting, the outcome of the events was unknown.  The causal relationship between all adverse events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was unknown.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: no symptomatic adverse events.; Inbound call from agent who had a nurse on the line.  Nurse warm transferred.  Nurse reporting administration of VAQTA PFS to a patient past expiration.  Caller states the VAQTA expired on 1-OCT-2024 and administered on 5-NOV-2024.  Nurse did not; This spontaneous report as received from a nurse refers to a patient of unknown age and gender.   No medical history, concurrent conditions or concomitant therapies were reported.  On an unknown date the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) lot # X006702, 0.5 milligram (route of administration was not reported) for prophylaxis.  The reporter stated the hepatitis a vaccine, inactivated(VAQTA) expired on 01-OCT-2024 and administered on 05-NOV-2024  No adverse event reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Customer calling to report that a dose of VARIVAX was administered to a patient on 8/2/2024 and expired on 8/1/2024. Product has not undergone a temperature excursion. No additional AE, no PQC. No additional information.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 02-AUG-2024, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # W024332, expiration date 01-AUG-2024, 0.5 milliliter (route of administration not reported) for prophylaxis (expired product administered). No adverse event was reported.
Age: 7.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Boostrix administered to 7 year old; This non-serious case was reported by a nurse via patient support programs and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 21-OCT-2024, the patient received Boostrix. On 21-OCT-2024, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix administered to 7 year old). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-OCT-2024 Boostrix administered to 7 year old which led to inappropriate age at vaccine administration. Patient came from other country and there was no vaccination history available at all and patient needs to start the school that was why they were starting over vaccination.
Sex: U
Vaccine: FLUX, RVX
Symptoms: Malaise
Clinical narrative: Been sick for a week; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   On an unknown date, the patient received RSV vaccine (unknown arm) and Influenza vaccine (unknown arm). On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: Been sick for a week). The outcome of the sickness was resolved (duration 1 week).   It was unknown if the reporter considered the sickness to be related to RSV vaccine.     It was unknown if the company considered the sickness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 18-OCT-2024 The case was received from the patient via interactive digital media. The patient was reporter. The reported that the patient got Flu and RSV vaccine same day same arm and patient has been developed sick for a week. It was unknown if the reporter considered the sickness to be related to Influenza vaccine.
Sex: F
Vaccine: RVX
Symptoms: Cough, Nasal congestion, Rhinorrhoea
Clinical narrative: Wife and I got this. Most miserable 3 weeks of cough and snot we have ever day; Wife and I got this. Most miserable 3 weeks of cough and snot we have ever day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced cough (Verbatim: Wife and I got this. Most miserable 3 weeks of cough and snot we have ever day) and nasal congestion (Verbatim: Wife and I got this. Most miserable 3 weeks of cough and snot we have ever day). The outcome of the cough and nasal congestion were resolved (duration 3 weeks).   It was unknown if the reporter considered the cough and nasal congestion to be related to RSV vaccine.     It was unknown if the company considered the cough and nasal congestion to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 18-OCT-2024 This case was reported by a consumer via interactive digital media. The patient received RSV vaccine. Most miserable 3 weeks of cough and snot we have ever day. This case has been linked to the case US2024AMR131479 reported by the same reporter.  ; Sender's Comments:  US-GSK-US2024AMR131479:same reporter, female
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Drug dose interval too long; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 52-year-old female patient who received HAB (Twinrix) (batch number 7X224, expiry date 30-DEC-2025) and (batch number 797F9, expiry date 30-DEC-2025) for prophylaxis.   Previously administered products included Hepatitis B. Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On 16-MAY-2024, the patient received the 2nd dose of Twinrix. On 16-MAY-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Drug dose interval too long). The outcome of the drug dose administration interval too long 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: 18-OCT-2024 Physician Assistant reported that a patient received a first dose of Hepatitis B vaccine (unknown brand, lot number or expiration date) on June 19th 2017. The patient received the first dose of Twinrix on April 3th 2024 and a second dose of Twinrix on May 16th 2024. Patient did not receive any Hepatitis A vaccines so far. The patient received second dose of Twinrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: recive 3rd dose of Menveo vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 3443E, expiry date 30-SEP-2025) for prophylaxis.   Previously administered products included Menactra (received 1st dose in 2019) and Meningococcal vaccine A/C/Y/W (received 2nd dose of Meningococcal vaccine A/C/Y/W (Meningitis Quadri vaccine) in 2023).   On 18-OCT-2024, the patient received the 3rd dose of Menveo (intramuscular, left deltoid). On 18-OCT-2024, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: recive 3rd dose of Menveo vaccine). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 18-OCT-2024 The reporter reported that a patient had received 1st dose of Menactra vaccine in 2019, and 2nd dose of Meningitis Quadri vaccine in 2023. The reporter reported that it was not provided a brand name or the manufacturing company name for the 2nd dose. The healthcare professional reported that the patient received a 3rd dose of Menveo vaccine that was not needed which led to, extra dose administered.  The reporter reported that the patient received the injection in her left deltoid.
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 7554T, expiry date 30-JUN-2025) for prophylaxis.   On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). 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: 18-OCT-2024 The pharmacist reported that they had a refrigerator that went out of temperature range and, it did not get super hot before they set it, but a number of these Fluarix were given after the temperature excursion which led to incorrect product storage error. The vaccine was stored at 56 degree Fahrenheit for 135 hours. The pharmacist reported that the vaccine was given to patient.  The pharmacist reported that the vaccines were given to 17 patients but he gave the initials of 20 patients. The pharmacist was not sure which patients got the doses before the maximum cumulative time of the extended stability data was reached. This was 1 of 20 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024128760:same reporter/different patient US-GSK-US2024128727:same reporter/different patient US-GSK-US2024128730:same reporter/different patient US-GSK-US2024128758:same reporter/different patient US-GSK-US2024128763:same reporter/different patient US-GSK-US2024128754:same reporter/different patient US-GSK-US2024128771:same reporter/different patient US-GSK-US2024128736:same reporter/different patient US-GSK-US2024128739:same reporter/different patient US-GSK-US2024128724:same reporter/different patient US-GSK-US2024128734:same reporter/different patient US-GSK-US2024128756:same reporter/different patient US-GSK-US2024128719:same reporter/different patient US-GSK-US2024128767:same reporter/different patient US-GSK-US2024128741:same reporter/different patient US-GSK-US2024128716:same reporter/different patient
Sex: F
Vaccine: FLU3
Symptoms: Accidental exposure to product, Injury associated with device
Clinical narrative: Accidental occupational exposure to product; Needle stick of nurse; Product Complaint; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental occupational exposure to product in a female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number XG9AF) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received FluLaval 2024-2025 season. On an unknown date, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced accidental occupational exposure to product (Verbatim: Accidental occupational exposure to product), accidental needle stick (Verbatim: Needle stick of nurse) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the accidental occupational exposure to product, accidental needle stick and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the accidental needle stick to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.     It was unknown if the company considered the accidental needle stick to be related to FluLaval 2024-2025 season and Flulaval 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: 18-OCT-2024 and 22-OCT-2024 The nurse reported that the hub of the syringe, for the Flulaval vaccine, was coming off; and mentioned to have this same issue for 4 different lot numbers: XG9AF, 4795R, J4349 and 33G3M. The reporter was aware of 4 total vaccines at 4 different locations. She was not the one preparing the injection.  She indicated that the LLA (luer lok adaptors) are breaking off. The HCPs who was preparing the doses experienced. There was no suspect syringes available. They have all been discarded. The suspect product has been administered one only and other three she believes were not. Regarding the one that was administered, the patient received the full dose. hen after the injection was complete and the syringe/needle were removed from the patient and the nurse went to put the safety guard on and in doing so the needle popped off stuck the hand of the nurse. Reporter was not seeking credit but she wanted to report this and was seeking tips to how to prevent it from happening again. The defect was discovered at during preparation and one was discovered after injection. The leur lok adaptors are compatible (She believes they are BD 23 gauge, one inch). Some of the Luer Lok adaptors are loose and spinning before they  put the needle on.
Age: 45.0
Sex: M
Vaccine: UNK
Symptoms: Product complaint, Syringe issue, Underdose
Clinical narrative: Product Complaint; Less than the recommended dose given; fluid leak; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 45-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2024-2025 season) (batch number 2257N, expiry date 03-JUN-2025) for prophylaxis. This case was associated with a product complaint.   On 21-OCT-2024, the patient received FluLaval Quadrivalent 2024-2025 season. On 21-OCT-2024, an unknown time after receiving FluLaval Quadrivalent 2024-2025 season, the patient experienced incomplete dose administered (Verbatim: Less than the recommended dose given) and syringe leak (Verbatim: fluid leak). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the incomplete dose administered, syringe leak and pharmaceutical product complaint 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: 21-OCT-2024 A pharmacist contacted GlaxoSmithKline to request information about how to proceed after a dose of FluLaval had partially been administered because the fluid leaked when being administered which led to incomplete dose administered, syringe leak and pharmaceutical product complaint. They provided information about the adverse event and the vaccine, but the call dropped as it was being transferred to the general response center for the product quality complaints. The pharmcy said that the reporter was a floater pharmacist and had not worked in their store in over a month. They said they did not had any product quality issues with Flulaval.
Age: 5.0
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Boostrix administered instead of Infanrix to 5 year old; Boostrix administered instead of Infanrix to 5 year old; Boostrix administered instead of Infanrix to 5 year old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 5-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis.   On an unknown date, the patient received Boostrix and Infanrix. On an unknown date, an unknown time after receiving Boostrix and not applicable after receiving Infanrix, the patient experienced adult use of a child product (Verbatim: Boostrix administered instead of Infanrix to 5 year old), wrong vaccine administered (Verbatim: Boostrix administered instead of Infanrix to 5 year old) and underdose (Verbatim: Boostrix administered instead of Infanrix to 5 year old). The outcome of the adult use of a child product, wrong vaccine administered and underdose 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: 21-OCT-2024 Office Manager reported a Medical Assistant accidentally administered a five year old patient a Tetanus, Diphtheria, Pertussis Vaccine (Boostrix) instead of a Diphtheria-Tetanus-Pertussis Vaccine (Infanrix) which led to adult use of a child product, wrong vaccine administered and underdose.  The rpeorter enquired to provide some advise on these situation.
Age: 77.0
Sex: F
Vaccine: HIBV
Symptoms: Intercepted product prescribing error
Clinical narrative: Hiberix prescribed to a 77 year old; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted product prescribing error in a 77-year-old female patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient did not receive Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced intercepted product prescribing error (Verbatim: Hiberix prescribed to a 77 year old). The outcome of the intercepted product prescribing error was unknown.   Additional Information: GSK Receipt Date: 21-OCT-2024 Healthcare professional called to ask if Hiberix could be administered to a 77 year old adult that wants to get it. HCP mentioned that physician prescribed it to this patient however, there is no further information available which led to intercepted product prescribing error.
Age: 8.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 8 year old received Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old male patient who received DTPa-IPV (Kinrix) (batch number 42Y93, expiry date 06-MAY-2026) for prophylaxis.   Previously administered products included DTpa (first dose was administered at week 13), DTpa (second dose was administered at week 22), DTpa (third dose was administered at 7 month) and DTpa (Fourth dose was administered at 20th month).   On 21-OCT-2024, the patient received the 5th dose of Kinrix. On 21-OCT-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 8 year old received Kinrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-OCT-2024 A registered nurse called in to report that a patient accidentally received a dose of Kinrix instead of their TDaP dose and wanted to know how to proceed.  8 year old received Kinrix which led to inappropriate age at vaccine administration
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient received 2 doses of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number GK2AZ, expiry date 21-APR-2006) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On 21-OCT-2024, the patient received the 1st dose of Shingrix. On 21-OCT-2024, an unknown time after receiving Shingrix, the patient experienced overdose (Verbatim: patient received 2 doses of Shingrix). The outcome of the overdose was unknown.   Additional Information: GSK Receipt Date: 21-OCT-2024 Pharmacist reported that on October 21st 2024 a male patient received 2 doses of Shingrix whch led to overdose. Both vaccines same lot number and expiration date. This suppose to be the first dose administered to the patient.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 20th May 2023).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Late 2nd dose). The outcome of the incomplete course of vaccination 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: 21-OCT-2024 A pharmacist called to inform that a patient has only received 1 dose (of Twinrix) back in January 2023, she wants to complete her vaccination for Hepatitis A and B. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: maladministration of a 3th dose of MENVEO; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (1st dose received on 24th July 2018). Concomitant products included Meningococcal vaccine A/C/Y/W conj (CRM197) (Menveo).   On 21-OCT-2024, the patient received the 3rd dose of Menveo. On 21-OCT-2024, an unknown time after receiving Menveo, the patient experienced wrong vaccine administered (Verbatim: maladministration of a 3th dose of MENVEO). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 21-OCT-2024 Pharmacist (Third party reporter) asked about the maladministration of a 3th dose of Menveo for a seventeen year old male patient (somebody called about a grandson case), instead of a Meningococcal B vaccine which led to wrong vaccine administered. No further information was provided from the pharmacist's end in this call.