chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Wrong product administered
Clinical narrative: The patient was seen for a well child exam and required a Meningitis vaccine for college.  The mom informed the provider that the patient needed Men A.  After discussed to clarify Men B vs. Hep A vs. Meningitis ACYW, and review of the patient's immunization record the provider ordered Meningitis ACYW in the chart.  The medical assistant heard the provider mention the Meningitis vaccine without the powder and grabbed the Bexsero vaccine.  The vial did not scan properly when attempting administration and discussed with another medical assistant.  We had had previous errors with scanning due to the program requiring the brand name of the vaccine.  The order was adjusted to Bexsero and administered.   The patient's mom called later in the day after noticing the immunization record stated Meningitis B.  She was informed that the incorrect vaccine was administered, and the patient was scheduled for the proper vaccine, Menveo.  The patient came into the office on 7/12 and the correct vaccine was administered.  The patient was asked if she had any side effects to the Bexsero vaccine and she states her arm was a little sore.  The incident was discussed with the provider and staff.  A new policy has been put in place that all vaccines that do no scan properly are to be verified by the provider.  The medical assistant has reviewed training and will be monitored for all vaccines.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No reaction; informed PCP
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Cold sweat, Dizziness, Seizure, Syncope
Clinical narrative: PATIENT WAS VACCINATED WITH SECOND DOSE OF HPV VACCINE, A COUPLE MIN LATER, PATIENT STARTED HAVING DIZZINESS, COLD SWEATING, FAINTING, AND SEIZURE. PATIENT DOES NOT HAVE ANY HISTORY OF SEIZURES. SEIZURE LASTED A COUPLE OF SECONDS.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Oropharyngeal pain, Pain, Respiratory tract congestion
Clinical narrative: Sore throat, cough, congestion, body ache, fever. After 2 days tested positive for Covid and am receiving Paxlovid.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: Sore throat, cough, congestion, body ache, fever. After 2 days tested positive for Covid and am receiving Paxlovid.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Hypoaesthesia oral, Lip swelling, Myalgia
Clinical narrative: NAUSEA, DIARRHEA, MUSCLE AND JOINT ACHES, LIP NUMBNESS/SWELLING
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: NAUSEA, DIARRHEA, MUSCLE AND JOINT ACHES, LIP NUMBNESS/SWELLING
Age: 25.0
Sex: F
Vaccine: RAB, TDAP
Symptoms: Cognitive disorder, Headache, Hypoaesthesia, Slow speech, Tinnitus
Clinical narrative: Pt called @ 1332 stating that they had experienced an episode following a 10-mile hike earlier in the day (2-3 hr previous). S/S that were reported included: Vision changes (Pt stated: "vision was splotchy, loss of peripheral vision on the left side, right side was milder"), Mild ringing in ears, Headache, Speech/Cognition were slowed and broken, Loss of feeling in the right hand with milder effect in the left side. Pt stated that S/S were improving by time of call. This nurse advised the Pt go to PCP to be evaluated and requested Pt inform this office of any findings after appointment.
Age: 25.0
Sex: F
Vaccine: RAB, TDAP
Symptoms: Visual field defect, Visual impairment
Clinical narrative: Pt called @ 1332 stating that they had experienced an episode following a 10-mile hike earlier in the day (2-3 hr previous). S/S that were reported included: Vision changes (Pt stated: "vision was splotchy, loss of peripheral vision on the left side, right side was milder"), Mild ringing in ears, Headache, Speech/Cognition were slowed and broken, Loss of feeling in the right hand with milder effect in the left side. Pt stated that S/S were improving by time of call. This nurse advised the Pt go to PCP to be evaluated and requested Pt inform this office of any findings after appointment.
Age: 63.0
Sex: M
Vaccine: HEPAB, PPV, RSV, VARZOS
Symptoms: Neck pain, Pain in extremity, Rash
Clinical narrative: ARM AND NECK PAIN, RASH ON ARMS AND BACK. PATIENT WENT TO ER AND RECEIVED FLUIDS. TIMELINE UNKNOWN.
Age: 11.0
Sex: F
Vaccine: UNK
Symptoms: Presyncope, Seizure like phenomena
Clinical narrative: PATIENT CAME IN TO CLINIC TO GET 2ND DOSE OF HPV VACCINE. PT ADMITS NOT HAVING ANY BREAKFAST PRIOR TO ARRIVING AND FEELING A LITTLE NERVOUS. PATIENT RECEIVED VACCINE AND A COUPLE MINUTES LATER AFTER SEEING SISTER HAVE VASOVAGAL EPISODE SHE ALSO STARTED HAVING SAME EPISODE. AFTER PT WAS PLACED ON CHAIR SHE HAD A SEIZURE LIKE EPISODE. MOTHER DENIES PATIENT HAVING ANY HISTORY OF SEIZURES. PATIENT NEVER LOST CONSCOUSNESS
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Eye discharge, Eye irritation, Skin irritation
Clinical narrative: PT HAD DISCHARGE AND IRRATATED EYE STARTING 24 HOURS POST VACCINATION.  PT STARTED HAVING AN IRRITATED SCALP ON  ONE SIDE OF THE HEAD WITH SMALL RED DOTS.  IRRATATION IS ON SAME SIDE FOR BOTH THE EYE AND SCALP.
Age: 78.0
Sex: M
Vaccine: EBZR
Symptoms: Ammonia, Blood magnesium, Blood phosphorus, Confusional state, Delirium
Clinical narrative: patient experienced recurrent falls and confusion - he was admitted to the hospital and diagnosed with acute encepaholpathy /delirium. MRI brain and EEG were negative. Urine was negative for infection. he experienced hallucination while hospitalized. His symptoms improved slightly, and he was discharged to his assisted living facility.
Age: 78.0
Sex: M
Vaccine: EBZR
Symptoms: Electroencephalogram normal, Encephalopathy, Fall, Full blood count, Hallucination
Clinical narrative: patient experienced recurrent falls and confusion - he was admitted to the hospital and diagnosed with acute encepaholpathy /delirium. MRI brain and EEG were negative. Urine was negative for infection. he experienced hallucination while hospitalized. His symptoms improved slightly, and he was discharged to his assisted living facility.
Age: 78.0
Sex: M
Vaccine: EBZR
Symptoms: Magnetic resonance imaging head normal, Metabolic function test, Scan with contrast normal, Urine analysis normal
Clinical narrative: patient experienced recurrent falls and confusion - he was admitted to the hospital and diagnosed with acute encepaholpathy /delirium. MRI brain and EEG were negative. Urine was negative for infection. he experienced hallucination while hospitalized. His symptoms improved slightly, and he was discharged to his assisted living facility.
Age: 0.25
Sex: M
Vaccine: PNC13, RV1
Symptoms: Confusional state, Decreased appetite, Decreased eye contact, Disorientation, Indifference
Clinical narrative: Low eye contact, aloof, loss of smiling, decrease in human interaction, stimming. It sounds like autism to me. He recovered though because I gave him many antioxidants and turmeric, which are suspected by some people to treat autism. He also got low appetite, disorientation and confusion, which he somehow recovered from. He finally got a very stuffed nose and he hasn't recovered from this yet.
Age: 0.25
Sex: M
Vaccine: PNC13, RV1
Symptoms: Nasal congestion, Reduced facial expression, Social avoidant behaviour, Stereotypy
Clinical narrative: Low eye contact, aloof, loss of smiling, decrease in human interaction, stimming. It sounds like autism to me. He recovered though because I gave him many antioxidants and turmeric, which are suspected by some people to treat autism. He also got low appetite, disorientation and confusion, which he somehow recovered from. He finally got a very stuffed nose and he hasn't recovered from this yet.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Generalized swelling and mild redness left upper arm started within 24 hours of injection; no associated fever, warmth, pain.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered 06/15/2024.
Age: 74.0
Sex: F
Vaccine: PNC20, TDAP, VARZOS
Symptoms: Abdominal pain upper, Back pain, Computerised tomogram, Migraine, Peripheral swelling
Clinical narrative: Severe Migraine, back pain and stomach pain, went to hospital and had Xray and CT scan. arm still swollen a week later
Age: 74.0
Sex: F
Vaccine: PNC20, TDAP, VARZOS
Symptoms: X-ray
Clinical narrative: Severe Migraine, back pain and stomach pain, went to hospital and had Xray and CT scan. arm still swollen a week later
Age: 11.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Immediate post-injection reaction, Muscle rigidity, Syncope
Clinical narrative: Vasovagal syncope : patient fainted briefly, then had muscle rigidity immediately following vaccine administration. These symptoms lasted about a minute.  We had her wait 10-15 minutes until she felt better. No medical intervention necessary.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Dizziness, Eye movement disorder, Haemoglobin increased, Loss of consciousness
Clinical narrative: After receiving vaccine & hemoglobin, patient looked at his finger with blood and felt faint.  He started to have shaking of the body and eyes rolled up.  The episode lasted about 1 minute, and he regained consciousness spontaneously.  He admitted that he hadn't drank or eaten anything and was hungry.  He felt better after drinking water and chewing gum in clinic.  He remembers feeling weak & wanting to faint another time when he went for blood draw & saw blood.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Tremor
Clinical narrative: After receiving vaccine & hemoglobin, patient looked at his finger with blood and felt faint.  He started to have shaking of the body and eyes rolled up.  The episode lasted about 1 minute, and he regained consciousness spontaneously.  He admitted that he hadn't drank or eaten anything and was hungry.  He felt better after drinking water and chewing gum in clinic.  He remembers feeling weak & wanting to faint another time when he went for blood draw & saw blood.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis, Headache
Clinical narrative: Onset left facial palsy and right headache 7/14/24. No slurred speech, focal weakness, other symptoms
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Pain in extremity, Pyrexia
Clinical narrative: arm sore, weakness, dizziness, fever
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Medical assistant called and reported ROTATEQ was administered to a patient after being involved in a temperature excursion. Caller stated no patient symptoms have been reported. Caller also reported VAXELIS and ROTATEQ were administered to 1 other p; This spontaneous report was received from medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 01-JUL-2024, the patient was vaccinated with improperly stored 1 dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), formulation: oral liquid, lot # X025246, expiration date: 31-MAR-2025 (exact dose, route of administration and anatomical location were not provided) for prophylaxis.     Administered dose of vaccine was involved in a temperature excursion of 47.48 degrees Fahrenheit (F) for 10 minutes (product storage error). No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event).; Sender's Comments:  US-009507513-2407USA001397:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: No symptoms reported; GARDASIL 9 prefilled syringe leaked while being administered to a patient. Caller states leakage occurred where needle attaches to the syringe hub.; GARDASIL 9 prefilled syringe leaked while being administered to a patient. Caller states leakage occurred where needle attaches to the syringe hub.; GARDASIL 9 prefilled syringe leaked while being administered to a patient. Caller states leakage occurred where needle attaches to the syringe hub.; This spontaneous report was received from a health business professional  concerning to a patient of unspecified age and gender. Their medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On 10-JUL-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter (quantity: 1) (conflicting information), administered as prophylaxis (strength, lot #, expiry date, and route of administration were not provided), using a 30g 1/2 inch needle. However, while injecting the vaccine (conflicting information also reported that the product was not exposed to patient's bodily fluids), leakage occurred where needle attaches to the syringe hub (also reported as between the syringe hub)(accidental underdose) (syringe issue) (poor quality device used). No symptoms reported, but a replacement was requested. Moreover, the reporter stated that there had not been any difficulties attaching the needle (not provided by the company), leakage occurred while the needle was already attached, and that there was nothing visible that could explained why the lacking occured.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Received An Expired Dose of HEPLISAV-B; Initial report received on 04-Jun-2024.  A pharmacist in the reported that a patient (age, gender, race, and ethnicity unknown), received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history or concomitant medications at the time of vaccination were reported. Allergies were unknown.  On 31-May-2024, the patient received an expired dose of HEPLISAV-B (Lot number 939672, expiration date 14-May-2024, NDC number 43528-0003-05; and injection site not reported) intramuscularly. The reporter stated that no adverse effects were reported.  No further information was available.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Received First Dose HEPLISAV-B, and Has Not Received Second Dose Yet; Initial report received on 10-Jun-2024.  A pharmacist reported that a patient (age, gender, race, and ethnicity not provided), received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization more than one year ago but has not received the second dose yet.  Medical history, concomitant medications, and allergies at the time of vaccination were not reported.   On 29-Jun-2023, the patient received the first dose of HEPLISAV-B (Lot number 943241, expiration date 07-Jul-2025; NDC number unknown) intramuscularly in the left deltoid. At the time of the report on 10 Jun-2024, the patient had not received the second dose of HEPLISAV-B yet.  No further information was available.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 19.0
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Received HEPLISAV-B when Pregnant (26 Weeks); Initial report received on 18-Jun-2024.  The report was initially received from the DV2-HBV-27 HEPLISAV-B Pregnancy Registry.  A patient reported that she, a 19-year-old female (race and ethnicity not provided), received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while 26 weeks pregnant.  Medical history, allergies, and concomitant medications were not reported.   The last menstrual period date, pregnancy history, and pregnancy risk factors were not reported.  Estimated date of delivery was 24-Sep-2024.  On 18-Jun-2024, the patient received dose 1 of HEPLISAV-B (Lot number 944915, expiration date 19-Sep-2026, and NDC number 43528-003-05) intramuscularly in the right deltoid when she was 26 weeks pregnant with a female baby. Initially, the patient was informed by the nurse at the clinic that HEPLISAV-B was safe to receive, but she received a call back a few hours later and was informed it was not recommended in pregnant women.    No additional information was provided.  Company Comment: The company assessed the event as non-serious; Sender's Comments: The company assessed the event as non-serious
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Received First Dose of Heplisav-B, and Second Dose 7 Days Apart; Initial report received on 20-Jun-2024.  A physician reported that a female patient in her 40's (race and ethnicity not provided), inadvertently received the first dose and second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization one week apart.  Medical history, concomitant medications, and allergies were not reported.   On 13-Jun-2024, the patient received the first dose of HEPLISAV-B (Lot number 943888, expiration date 14-May-2026; and NDC number, route of administration, and injection site not reported).  On 20-Jun-2024, seven days after having been vaccinated with the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot number 943888, expiration date 14-May-2026; and NDC number, route of administration, and injection site not reported).   The reporter stated that the doses were inadvertently given one week apart.  No adverse reactions were reported.  No additional information was provided.  Company Comment:
Age: 55.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: Received First Dose of Heplisav, and Received Second Dose of Engerix B; Received First Dose of HEPLISAV-B on Jun 6, 2023, and dose of Engerix on December 20, 2023; Initial report received on 24-Jun-2024.  A medical assistant reported that a 55-year-old male patient (race and ethnicity not provided), received the first dose of a hepatitis B vaccine with HEPLISAV-B (hepatitis B vaccine) and received a second dose with ENGERIX-B more than six months later.  Medical history and concomitant medications were not reported. The patient had no known drug allergies.  On 06-Jun-2023, the patient received the first dose of HEPLISAV-B (Lot number 941591, expiration date 31-Aug-2025, and NDC 43528-003-05) intramuscularly in the left deltoid. On 20-Dec-2023, 198 days after having been vaccinated with HEPLISAV-B, the patient received the second dose of a hepatitis B vaccine with ENGERIX-B (no details provided). The patient had no other side effects.  No further information was available.  Company Comment: The company assessed the events as non-serious; Sender's Comments: The company assessed the events as non-serious
Age: 26.0
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: Received "wrong" Hepatitis-B Shot While Pregnant; Initial report received on 27-Jun-2024.  The report was initially received from the DV2-HBV-27 HEPLISAV-B Pregnancy Registry.  A consumer reported that she, a 26-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while pregnant.  No relevant medical history was reported.  No relevant concomitant medications were reported.  The patient's expected delivery date (EDD) is 02-Feb-2025.  On 27-Jun-2024, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and site not reported).  The patient was pregnant at the time of vaccination.  She was informed that she received the "wrong" hepatitis-B shot.  She received "the one you aren't supposed to give pregnant people."    No additional information was provided.   Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Received First Dose, and Have Not Received Second Dose; Initial report received on 28-Jun-2024.  A pharmacist in the country reported that a 59-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and has not received the second scheduled dose.  No relevant medical history was reported.  No relevant concomitant medications were reported.    On 04-May-2024, the patient received the first dose of HEPLISAV-B (Lot #943009, expiration date 31-Oct-2025, NDC # 43528-003-05, route and site not reported).  As of date of reporting, 28-Jun-2024, the patient has not received the second dose. No adverse reactions were reported.   No additional information was reported.   Company Comment: The company assessed the event as non-serious; Sender's Comments: The company assessed the event as non-serious
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: The vaccine was given to multiple patients subcutaneously; This non-serious case was reported by a nurse via sales rep and described the occurrence of intramuscular formulation administered by other route in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: The vaccine was given to multiple patients subcutaneously). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 08-JUL-2024 The vaccine was given to multiple patients subcutaneously, which led to intramuscular formulation administered by other route. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Culture urine negative, Laboratory test normal, Urinary hesitation
Clinical narrative: Difficulty starting urination; This non-serious case was reported by a consumer and described the occurrence of difficulty initiating urine stream in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11-JUN-2024, the patient received the 1st dose of Shingrix. On 15-JUN-2024, 4 days after receiving Shingrix, the patient experienced difficulty initiating urine stream (Verbatim: Difficulty starting urination). The outcome of the difficulty initiating urine stream was not resolved.   It was unknown if the reporter considered the difficulty initiating urine stream to be related to Shingrix.     It was unknown if the company considered the difficulty initiating urine stream to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-JUL-2024 The patient self-reported this case. The patient had difficulty starting urination. The patient went to gynecologist thinking it was a urinary tract infection but all tests were negative, she went to primary care provider and her urine culture was normal and her labs were perfect.  The patient reported that, she was getting an ultrasound but this all started after she got the 1st dose of her Shingrix vaccine.  The patient was concerned about the 2nd dose and she was hesitant to get 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: nerve pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of post herpetic neuralgia in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included electric shock, blister, pain, rash, pruritus and burning sensation. Concurrent medical conditions included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced post herpetic neuralgia (Verbatim: nerve pain). The outcome of the post herpetic neuralgia was not reported.   It was unknown if the reporter considered the post herpetic neuralgia to be related to Shingles vaccine.     It was unknown if the company considered the post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-JUL-2024 The patient had electric shocks like this for 4 months. The reporter reported when first get Shingles they had blisters. After the blisters goes away (usually 2 weeks or more) no longer contagious, but keep the pain, the rash, itching and burning (like the electric shocks of pain. The patient had one shingles vaccine but never got the other because had other health problem. The shingles were still in hair on one side down neck, around the back of ear and neck . The reporter reported, the patient going to see a specialist for nerve pain.
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: had extreme injection site pain; had extreme injection site redness; had extreme injection site swelling; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   On 19-MAR-2024, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced injection site pain (Verbatim: had extreme injection site pain), injection site erythema (Verbatim: had extreme injection site redness) and injection site swelling (Verbatim: had extreme injection site swelling). The outcome of the injection site pain, injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to Kinrix and Kinrix Pre-Filled Syringe Device.     It was unknown if the company considered the injection site pain, injection site erythema and injection site swelling to be related to Kinrix and Kinrix 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: 06-MAY-2024 The nurse had concerns about Kinrix lot number 34MF9. The nurse had noticed patients receiving this Kinrix vaccine had extreme injection site redness, swelling, and pain. The vaccine was administered to a patient who experienced these symptoms. The reporter did not know injection site location, or duration of symptoms. The vaccine administration facility was the same as primary reporter. This was 1 of 4 cases reported by same reporter.   Upon internal review the case was updated on 21-MAY-2024. Medwatch form updated with product problem. Summary of Changes: Suspect product device details updated and narrative updated.   Upon internal review case was updated on 06-JUL-2024 The event pharmaceutical product complaint was deleted. Summary of changes: Event tab and narrative was updated.; Sender's Comments:  US-GSK-US2024057404:Same reporter/Diffrent patient US-GSK-US2024057403:Same reporter/Diffrent patient US-GSK-US2024057401:Same reporter/Diffrent patient US-GSK-US2024057400:Same reporter/Diffrent patient US-GSK-US2024057396:Same reporter/Diffrent patient
Sex: F
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a female patient who received MMR (Priorix) (batch number JR94T, expiry date 21-JUN-2024) for prophylaxis.   On 01-JUN-2024, the patient received Priorix. On 01-JUN-2024, an unknown time after receiving Priorix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). 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: 05-JUL-2024 The patient received Priorix vaccine at inappropriate age, which led to inappropriate age at vaccine administration.            The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: Hiberix reconstituted incorrectly with sterile water; it was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 6-month-old female patient who received Hib (Hiberix) (batch number TL3KP, expiry date 15-MAR-2026) for prophylaxis.   On 08-JUL-2024, the patient received Hiberix. On 08-JUL-2024, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Hiberix reconstituted incorrectly with sterile water) and inappropriate dose of vaccine administered (Verbatim: it was administered to a patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 08-JUL-2024 The nurse had Hiberix reconstituted incorrectly with sterile water, and it was administered to a patient, which led wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 42.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: received Kinrix instead of Adacel; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 42-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 08-JUL-2024, the patient received Kinrix. On 08-JUL-2024, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: received Kinrix instead of Adacel). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-JUL-2024 Nurse stated a 42 year old patient received Kinrix instead of Adacel on July 8th 2024 which led to wrong vaccine administered. The reporter did not have lot number or expiration date Kinrix on hand.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Kinrix Administration of expiration dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 5AY2J, expiry date 10-JUN-2024) for prophylaxis.   On 08-JUL-2024, the patient received Kinrix. On 08-JUL-2024, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Kinrix Administration of expiration dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 08-JUL-2024 A reporter reported that one of his/her staff member administrated a dose of Kinrix that expired on June 10th 2024 which led to expired vaccine used. The reporter wanted to know did you have information about this situation. The vaccine administration facility was the same as primary reporter.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Skin lesion, Vaccination failure
Clinical narrative: patient received his first dose of Shingrix in 2018 and his 2nd dose in 2020; Shingles; Suspected vaccination failure; shingles outbreak 2 times; lesions appearing on his lift shoulder/left front of chest; lesion behind ear; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included peripheral neuropathy.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In JUN-2022, more than a year after receiving Shingrix and more than 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles outbreak 2 times) and skin lesion (Verbatim: lesions appearing on his lift shoulder/left front of chest). In JUN-2024, the patient experienced shingles (Verbatim: Shingles) and skin lesion (Verbatim: lesion behind ear). On an unknown date, the patient experienced drug dose administration interval too long (Verbatim: patient received his first dose of Shingrix in 2018 and his 2nd dose in 2020). The outcome of the vaccination failure and drug dose administration interval too long were unknown and the outcome of the shingles, skin lesion and skin lesion were resolved (duration 10 days) and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure, shingles, skin lesion, shingles and skin lesion to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles, skin lesion, shingles and skin lesion to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 10-JUL-2024 The reporter was the wife of the patient. She stated that the patient received his first dose of Shingrix in 2018 and his 2nd dose in 2020. the patient received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule. In June of 2022, he suffered an outbreak of shingles, with lesions appearing on his left shoulder, left front of chest half-way down. They delayed treatment for several days not realizing it was shingles. It was treated and lasted about 10 days. In June of 2024 he suffered another outbreak beginning with one lesion behind his ear. They accessed treatment immediately and the lesions did not spread. The one lesion lasted about ten days.; Sender's Comments: Vaccination failure  is a listed event which is considered related to GSK vaccine Shingrix.
Sex: U
Vaccine: COVID19
Symptoms: Cutaneous vasculitis
Clinical narrative: Leukocytoclastic vasculitis; This literature-non-study case was reported in a literature article and describes the occurrence of CUTANEOUS VASCULITIS (Leukocytoclastic vasculitis) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.   LITERATURE REFERENCE:  Previously administered products included for COVID-19 prophylaxis: Moderna vaccine (Dose 2 of Two previous doses) and Moderna vaccine (Dose 1 of Two previous doses). Past adverse reactions to the above products included No adverse effect with Moderna vaccine and Moderna vaccine.    On an unknown date, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced CUTANEOUS VASCULITIS (Leukocytoclastic vasculitis) (seriousness criterion medically significant). At the time of the report, CUTANEOUS VASCULITIS (Leukocytoclastic vasculitis) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered CUTANEOUS VASCULITIS (Leukocytoclastic vasculitis) to be related.    Concomitant medications were not reported.  Patient was treated with unspecified systemic high dose corticosteroids.  It has been hypothesized that COVID-19 induces cytokine storm and/or immune complex formation, triggering autoimmune diseases including vasculitis. This study aimed to evaluate this relationship, focusing on cutaneous vasculitis's clinical presentation and specifically immunoglobulin A (IgA) vasculitis, given the latter's association with infection and potential systemic ramifications.  COVID-19-associated vasculitis" was defined as vasculitis attributed to COVID-19 infection/vaccination by the treating physician.  This study identified 184 potential patients. Seven COVID-19-associated vasculitis cases (5 from infection and 2 from vaccination) and 43 non-COVID-19-associated vasculitis cases. Of the 2 vaccination-associated cases, one patient was exposed to the Pfizer vaccine with no prior doses, and one to the Moderna vaccine with two previous doses.  Finally, all COVID-19-associated vasculitis cases required systemic corticosteroids (100%), compared to 35% (15/43) of non-COVID-19 vasculitis cases. No differences were noted in median time to clearance. Overall, no notable differences were noted between COVID-19-associated infection vs. vaccination cases.  Company comment-This is a literature non-study case concerning a patient of unknown age and gender with no reported medical history, who experienced the unexpected and serious (medically significant) AESI cutaneous vasculitis after a third dose of SPIKEVAX COVID-19 VACCINE NOS was administered on an unknown exact date, hence latency cannot be assessed. Systemic corticosteroids were required. No further details were provided for medical review. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: He got this box of Paxlovid at the end of Feb, because he had received the vaccine but it causes reactions in him.; He got this box of Paxlovid at the end of Feb, because he had received the vaccine but it causes reactions in him.; This is a spontaneous report received from a Physician from medical information team.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "He got this box of Paxlovid at the end of Feb, because he had received the vaccine but it causes reactions in him.". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: He got this box of Paxlovid at the end of Feb, because he had received the vaccine but it causes reactions in him.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 omi xbb.1.5  in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she took paxlovid/she was fully vaccinated; she took paxlovid/she was fully vaccinated; This is a spontaneous report received from a Physician from medical information team.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she took paxlovid/she was fully vaccinated". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  Additional information: The caller had a relative in (city name), she took Paxlovid, it didn't had the same effect as the first time she had Covid and she was fully vaccinated. He later mentioned that it was her niece and the fever went away pretty quickly but she was still exhausted.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 omi xbb.1.5  in this patient cannot be completely excluded.  ,Linked Report(s) : US-PFIZER INC-202400216133 same reporter/product/events; different patient;
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: So okay I've had Covid once before, I'm vaccinated, I've got all of my vaccinations; So okay I've had Covid once before, I'm vaccinated, I've got all of my vaccinations; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 68-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "So okay I've had Covid once before, I'm vaccinated, I've got all of my vaccinations". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: inadvertently administering an expired daptacel with no reported adverse event; Initial information received on 09-Jul-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old male patient to whom inadvertently administering an expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and HIB VACCINE CONJ (TET TOX) (ACT HIB) for Immunisation.  On 08-Jul-2024, the patient was inadvertently administered an expired 0.5 ml (dose 4) of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, Suspension for injection (lot C6013AA; expiry date: 05-Jul-2024) via intramuscular route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency: on same day).  Reportedly vaccination will be repeated   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: vaccine was administered by error, it was an extra dose with no reported Adverse Event; Initial information received on 11-Jul-2024 regarding an unsolicited valid non-serious case received from a health professional.  This case involves an unknown age and gender patient who was administered with Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] by error and it was an extra dose, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Powder and suspension for suspension for injection administered by error, and it was an extra dose with no reported adverse event (extra dose administered) (latency: same day) (strength: not reported) (lot number, expiry date: not reported) via unknown route in unknown administration site for immunization. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired daptacel was administered to a patient with no reported adverse event; Initial information received on 12-Jul-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 years old female patient who was administered expired Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis A Vaccine for Immunisation.  On 12-Jul-2024 at 10:23, the patient received 0.5 ml dose 2 of expired suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine (Suspension for injection) with no reported adverse event (expired product administered) (latency: same day) (lot C6013AA, strength: standard, frequency: once) (expiry date: 05-Jul-2024) via intramuscular route in the Right Upper Thigh for Immunisation.  Reportedly, Nurse reports that Daptacel expired last Friday.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE. No PQC.; expired dose of VARIVAX was administered to one patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. Concomitant therapies included sterile diluent(MERCK STERILE DILUENT).    On 10-JUL-2024, the patient was vaccinated with one expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # w018831, expiration date: 14-JUN-2024 (expired product administered) (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis.    No adverse event reported as patient was asymptomatic. It was mentioned that the product had no history of a temperature excursion.