chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Headache, Influenza like illness, Pyrexia
Clinical narrative: PATIENT RECEIVED 3RD DOSE OF HEPATITIS VACCINE ON 6/27/24, FIRST WAS VAQTA 50 U/ML ON 5/4/23 AT ANOTHER PHARMACY, SECOND HAVRIX FROM OUR PHARMACY ON 11/16/2023 AND THIRD HAVRIX 6/27/24 FROM OUR PHARMACY. PATIENT HAS HAD HEADACHE, RUNNING FEVER 101 DEGREE F, FLU LIKE SYMPTOMS AND RED FACE SINCE.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Extra dose administered, Headache, Influenza like illness, Pyrexia
Clinical narrative: PATIENT RECEIVED FIRST DOSE SHINGRIX AT ANOTHER PHARMACY ON 05/04/2024, 2ND DOSE FROM OUR PHARMACY ON 07/19/2023 AND THIRD DOSE ON 06/27/24. PATIENT STATES SHE'S HAD HEADACH, FEVER 101 DEGREE F, FLU LIKE SYMPTOMS AND RED FACE SINCE THEN.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: Rash. Urticaria multiform
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Employee received the vaccine on 6/28/24 at approximately 1700. Started to feel whole body itchiness, redness & warmth at site the next day in the afternoon. No treatment done at this time.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Conduction disorder
Clinical narrative: I had been under the care of Dr. (Cardiologist) since on or about 2018. I had taken the Sars covid-19 shots by Pfizer. The first shot was done 08/09/2021 and the second one on 08/30/2021. I had NO previous electrical system disturbances previous to taking the COVID shots. This was confirmed by Dr. when I had asked him to note when he first reported 'seeing' the conduction issues. He had looked up on his laptop and told me he had first noted these changes in '2021'
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Blood glucose normal, CSF glucose normal, CSF lymphocyte count increased, CSF monocyte count decreased
Clinical narrative: Diagnosis:  Varicella Zoster meningoencephalitis.  Patient began to exhibit slight vision loss and alteration in mentation sometime between 5/24-5/25.  Worsened, so sought medical care on 5/27.  Had intermittent evaluations between 5/27-6/24 with worsening mentation and vision complaints.  On 6/24 had admission to hospital and work-up revealed: Varicella Zoster positivity from Cerebrospinal fluid.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: CSF neutrophil count negative, CSF protein increased, CSF red blood cell count positive, CSF white blood cell count increased, Cerebral ischaemia
Clinical narrative: Diagnosis:  Varicella Zoster meningoencephalitis.  Patient began to exhibit slight vision loss and alteration in mentation sometime between 5/24-5/25.  Worsened, so sought medical care on 5/27.  Had intermittent evaluations between 5/27-6/24 with worsening mentation and vision complaints.  On 6/24 had admission to hospital and work-up revealed: Varicella Zoster positivity from Cerebrospinal fluid.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster meningoencephalitis, Magnetic resonance imaging head abnormal, Mental status changes, Varicella virus test positive
Clinical narrative: Diagnosis:  Varicella Zoster meningoencephalitis.  Patient began to exhibit slight vision loss and alteration in mentation sometime between 5/24-5/25.  Worsened, so sought medical care on 5/27.  Had intermittent evaluations between 5/27-6/24 with worsening mentation and vision complaints.  On 6/24 had admission to hospital and work-up revealed: Varicella Zoster positivity from Cerebrospinal fluid.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Pain in extremity, Rash, Rash macular
Clinical narrative: Pt stated she was tired and felt run down. her left arm was sore and she developed a blotchy rash on her left leg
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Atrial fibrillation
Clinical narrative: patient rushed to ER 3 days after vaccination diagnosed with afib
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Inflammation, Lymphadenitis
Clinical narrative: inflamation in arm and lymph node
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose fluctuation, Chills, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Fever up to 101.6, chills, fatigue, blood sugar fluctuation, at the site: fever, redness, soreness & swelling
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Fever up to 101.6, chills, fatigue, blood sugar fluctuation, at the site: fever, redness, soreness & swelling
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: Patient reported Blistering at the injection site. Came to Pharmacy and there was a blister at injection site and a couple areas of the left upper arm that were also Blistered. I recommended to visit urgent care to possibly get antivirals prescribed.
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Noticed redness around the site and you can feel a lump under the skin.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Injection site reaction - large red, itchy area at injection site. Pt says area is about the size of her hand and is wrapping around her arm.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Torticollis, Tremor
Clinical narrative: At night in bed, I have the covers over my ear (lay on side).  Notice noise and just thought because it seemed I was pushing head hard into pillow.  Gotten a little worse and realized about a month later that my head was shaking.  Told my Dr. around middle of February and he said wait to see if gets worse.  Called for appointment in March and said I now have slight headaches.  Got appointment May 15, 2024 with neurologist.  Said I had cervical dystonia.  See Dr. again at end of July.  Was reading up on this disease and talked to another person and found it could be caused by the vaccine but there is no proof.  I believe it said could be cause by mono which I had at the age of 20.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: patient reported symptoms on 6/30/24, light circular red mark on patient's right arm around the site of injection, patient stated it was itching.  the symptoms started on 6/29/24 and immunization was administered on 6/21/24.  She stated it was much better on 6/30/24 than it was on 6/29/24, it was improving.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Dyspnoea, Headache, Heart rate increased
Clinical narrative: Rapid heartbeat, difficulty breathing, fever, headache, body aches, then a day later: nausea, stomach pain, diarrhea. No action taken and difficulty breathing subsided after 24 hours.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Rapid heartbeat, difficulty breathing, fever, headache, body aches, then a day later: nausea, stomach pain, diarrhea. No action taken and difficulty breathing subsided after 24 hours.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Brain fog, Disturbance in attention, Dysgeusia, Fatigue
Clinical narrative: Metal taste on sides of toung. Days after 2nd dose there was the brain fog and focus issues. months later fatigue and muscle pain and joint pain. About a year after I have numbness and sensation issues in lower legs. I have severe muscle pain in right arm with joint pain.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Myalgia, Pain in extremity, Sensory disturbance
Clinical narrative: Metal taste on sides of toung. Days after 2nd dose there was the brain fog and focus issues. months later fatigue and muscle pain and joint pain. About a year after I have numbness and sensation issues in lower legs. I have severe muscle pain in right arm with joint pain.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Cough, Decreased appetite, Dyspnoea, Headache
Clinical narrative: Headache, cough, congestion , SOA, decreased appetite
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza virus test negative, Respiratory syncytial virus test negative, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: Headache, cough, congestion , SOA, decreased appetite
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac assistance device user, Cytogenetic analysis, Laboratory test, Magnetic resonance imaging heart, Resuscitation
Clinical narrative: While flying I experienced sudden cardiac death and was resuscitated with an AED. The plane diverted to Hospital where I was treated.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sudden cardiac death
Clinical narrative: While flying I experienced sudden cardiac death and was resuscitated with an AED. The plane diverted to Hospital where I was treated.
Age: 76.0
Sex: M
Vaccine: RSV, RSV, RSV, VARCEL
Symptoms: Arthritis, Condition aggravated, Eyelid function disorder, Fatigue, Hypoaesthesia oral
Clinical narrative: Symptoms started within 12 hours. Woke up with fingers curled and stiff followed by sharp, jabbing pain in both feet. As day went on numbness started to move up to knees.  Saw PCP 5 days later as soon as I could get apt. She filed report and advised I see my neurologist who consequently did a EMG and it showed peripheral nerve damage.  Was admitted to hospital for infusions of IVIG for GBS. My symptoms continue to be very bad with now numb fingertips that make it hard to grip and drop things.  Severe pain and numbness mostly in feet but numbness from knees down. Bad muscle weakness and debilitation fatigue and this is four months out.
Age: 76.0
Sex: M
Vaccine: RSV, RSV, RSV, VARCEL
Symptoms: Muscular weakness, Neuropathy peripheral, Pain in extremity
Clinical narrative: Symptoms started within 12 hours. Woke up with fingers curled and stiff followed by sharp, jabbing pain in both feet. As day went on numbness started to move up to knees.  Saw PCP 5 days later as soon as I could get apt. She filed report and advised I see my neurologist who consequently did a EMG and it showed peripheral nerve damage.  Was admitted to hospital for infusions of IVIG for GBS. My symptoms continue to be very bad with now numb fingertips that make it hard to grip and drop things.  Severe pain and numbness mostly in feet but numbness from knees down. Bad muscle weakness and debilitation fatigue and this is four months out.
Age: 76.0
Sex: M
Vaccine: RSV, RSV, RSV, VARCEL
Symptoms: Arteriospasm coronary, Arthralgia, Electromyogram abnormal, Extremity contracture, Fatigue
Clinical narrative: Symptoms started within 12 hours. Woke up with fingers curled and stiff followed by sharp, jabbing pain in both feet. As day went on numbness started to move up to knees.  Saw PCP 5 days later as soon as I could get apt. She filed report and advised I see my neurologist who consequently did a EMG and it showed peripheral nerve damage.  Was admitted to hospital for infusions of IVIG for GBS. My symptoms continue to be very bad with now numb fingertips that make it hard to grip and drop things.  Severe pain and numbness mostly in feet but numbness from knees down. Bad muscle weakness and debilitation fatigue and this is four months out.
Age: 76.0
Sex: M
Vaccine: RSV, RSV, RSV, VARCEL
Symptoms: Guillain-Barre syndrome, Immediate post-injection reaction, Immunoglobulin therapy, Injection site pain, Pain
Clinical narrative: Symptoms started within 12 hours. Woke up with fingers curled and stiff followed by sharp, jabbing pain in both feet. As day went on numbness started to move up to knees.  Saw PCP 5 days later as soon as I could get apt. She filed report and advised I see my neurologist who consequently did a EMG and it showed peripheral nerve damage.  Was admitted to hospital for infusions of IVIG for GBS. My symptoms continue to be very bad with now numb fingertips that make it hard to grip and drop things.  Severe pain and numbness mostly in feet but numbness from knees down. Bad muscle weakness and debilitation fatigue and this is four months out.
Age: 76.0
Sex: M
Vaccine: RSV, RSV, RSV, VARCEL
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Symptoms started within 12 hours. Woke up with fingers curled and stiff followed by sharp, jabbing pain in both feet. As day went on numbness started to move up to knees.  Saw PCP 5 days later as soon as I could get apt. She filed report and advised I see my neurologist who consequently did a EMG and it showed peripheral nerve damage.  Was admitted to hospital for infusions of IVIG for GBS. My symptoms continue to be very bad with now numb fingertips that make it hard to grip and drop things.  Severe pain and numbness mostly in feet but numbness from knees down. Bad muscle weakness and debilitation fatigue and this is four months out.
Age: 76.0
Sex: M
Vaccine: RSV, RSV, RSV, VARCEL
Symptoms: Asthenia, Guillain-Barre syndrome, Hypoaesthesia, Neuropathy peripheral, Pain
Clinical narrative: Symptoms started within 12 hours. Woke up with fingers curled and stiff followed by sharp, jabbing pain in both feet. As day went on numbness started to move up to knees.  Saw PCP 5 days later as soon as I could get apt. She filed report and advised I see my neurologist who consequently did a EMG and it showed peripheral nerve damage.  Was admitted to hospital for infusions of IVIG for GBS. My symptoms continue to be very bad with now numb fingertips that make it hard to grip and drop things.  Severe pain and numbness mostly in feet but numbness from knees down. Bad muscle weakness and debilitation fatigue and this is four months out.
Age: 76.0
Sex: M
Vaccine: RSV, RSV, RSV, VARCEL
Symptoms: Paraesthesia
Clinical narrative: Symptoms started within 12 hours. Woke up with fingers curled and stiff followed by sharp, jabbing pain in both feet. As day went on numbness started to move up to knees.  Saw PCP 5 days later as soon as I could get apt. She filed report and advised I see my neurologist who consequently did a EMG and it showed peripheral nerve damage.  Was admitted to hospital for infusions of IVIG for GBS. My symptoms continue to be very bad with now numb fingertips that make it hard to grip and drop things.  Severe pain and numbness mostly in feet but numbness from knees down. Bad muscle weakness and debilitation fatigue and this is four months out.
Age: 76.0
Sex: M
Vaccine: RSV, RSV, RSV, VARCEL
Symptoms: Asthenia, Electromyogram abnormal, Fatigue, Finger deformity, Guillain-Barre syndrome
Clinical narrative: Symptoms started within 12 hours. Woke up with fingers curled and stiff followed by sharp, jabbing pain in both feet. As day went on numbness started to move up to knees.  Saw PCP 5 days later as soon as I could get apt. She filed report and advised I see my neurologist who consequently did a EMG and it showed peripheral nerve damage.  Was admitted to hospital for infusions of IVIG for GBS. My symptoms continue to be very bad with now numb fingertips that make it hard to grip and drop things.  Severe pain and numbness mostly in feet but numbness from knees down. Bad muscle weakness and debilitation fatigue and this is four months out.
Age: 76.0
Sex: M
Vaccine: RSV, RSV, RSV, VARCEL
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Muscular weakness, Musculoskeletal disorder, Musculoskeletal stiffness
Clinical narrative: Symptoms started within 12 hours. Woke up with fingers curled and stiff followed by sharp, jabbing pain in both feet. As day went on numbness started to move up to knees.  Saw PCP 5 days later as soon as I could get apt. She filed report and advised I see my neurologist who consequently did a EMG and it showed peripheral nerve damage.  Was admitted to hospital for infusions of IVIG for GBS. My symptoms continue to be very bad with now numb fingertips that make it hard to grip and drop things.  Severe pain and numbness mostly in feet but numbness from knees down. Bad muscle weakness and debilitation fatigue and this is four months out.
Age: 76.0
Sex: M
Vaccine: RSV, RSV, RSV, VARCEL
Symptoms: Pain in extremity, Peripheral nerve injury
Clinical narrative: Symptoms started within 12 hours. Woke up with fingers curled and stiff followed by sharp, jabbing pain in both feet. As day went on numbness started to move up to knees.  Saw PCP 5 days later as soon as I could get apt. She filed report and advised I see my neurologist who consequently did a EMG and it showed peripheral nerve damage.  Was admitted to hospital for infusions of IVIG for GBS. My symptoms continue to be very bad with now numb fingertips that make it hard to grip and drop things.  Severe pain and numbness mostly in feet but numbness from knees down. Bad muscle weakness and debilitation fatigue and this is four months out.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion 12 F; no additional AE; This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (recombinant Human albumin), 1 dose, lot #X011981, expiration date: 19-JUL-2024, administered for prophylaxis (anatomical location, strength, and route of administration were not provided); and sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion was used: 1 dose (strength, lot #, expiry date, route of administration, and indication were not provided). Measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection was administered to a patient on an unspecified date during a temperature excursion (Product storage error); temperature 12 degrees (F) for 1 hour. There was no previous temperature excursion. No additional adverse events.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptomatic adverse events; Temperature Excursion -12.4 C; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided.  On 03-JUN-2024, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 ml/ series, lot #y000202, expiration date: 03-JAN-2026, administered for prophylaxis (strength, frequency, route of administration, and anatomical location were not provided) (product storage error). The varicella virus vaccine live (oka/merck) (VARIVAX) vaccine underwent a temperature excursion at a temperature of -12.4 degrees Celsius, for the time frame of 42 minutes. There was a previous temperature excursion of -14 degrees Celsius to -10 degrees Celsius (-11.6 C) for 29 minutes. No additional adverse event (AE) (no adverse event).  This is one of two cases from the same reporter.; Sender's Comments:  US-009507513-2406USA001263:MSD
Age: 0.42
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE information; a single dose of VAQTA was administered to a 5 month old patient on 6/7/2024; This spontaneous report was received from medical assistant and refers to a 5-month-old of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-JUN-2024, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter once, valid lot #X023974, expiration date: 18-APR-2025, administered for prophylaxis (strength, and route of administration were not provided) (product administered to patient of inappropriate age). No symptoms or side effects were reported. No additional adverse event (AE) information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles; hurt like a lot; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: hurt a lot). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine. It was unknown if the company considered the shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 21-JUN-2024 This case was reported the patient via interactive digital media. The patient had third incidence of shingles and had the shingles vaccine (had after 2nd time).  The patient hurt a lot.  The patient was taking Valtrex. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK Shingles vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Oedema peripheral, Tenderness
Clinical narrative: Pain at the site of injection; swelling under arm on side of body; fatigue; tenderness; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-JUN-2024, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain at the site of injection), injection site swelling (Verbatim: swelling under arm on side of body), fatigue (Verbatim: fatigue) and tenderness (Verbatim: tenderness). The outcome of the injection site pain, injection site swelling, fatigue and tenderness were not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, fatigue and tenderness to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site swelling, fatigue and tenderness to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-JUN-2024 The patient has concerned about the pain, pain and swelling under my arm or lymph nodes. The patient experienced pain at the site of injection, fatigue, tenderness, and swelling under arm on side of body where injection was given.
Sex: U
Vaccine: RVX
Symptoms: Erythema, Injection site swelling, Pain in extremity, Respiratory tract congestion
Clinical narrative: arm swelled at the injection site; arm was red; arm sore; little congested; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a 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 injection site swelling (Verbatim: arm swelled at the injection site), erythema of extremities (Verbatim: arm was red), pain in arm (Verbatim: arm sore) and nasal congestion (Verbatim: little congested). The outcome of the injection site swelling, erythema of extremities and pain in arm were resolved and the outcome of the nasal congestion was not reported.   It was unknown if the reporter considered the injection site swelling, erythema of extremities, pain in arm and nasal congestion to be related to RSV vaccine.     It was unknown if the company considered the injection site swelling, erythema of extremities, pain in arm and nasal congestion to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 22-JUN-2024 This case was reported by patient itself. The patient's arm swelled at the injection site, was red and sore for days and got a little congested.
Age: 13.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient 13 years of age received Infanrix; 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 13-year-old female patient who received DTPa (Infanrix) for prophylaxis.   On 01-APR-2024, the patient received Infanrix. On 01-APR-2024, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: patient 13 years of age received Infanrix ). 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: 18-JUN-2024 Nurse reported that patient 13 years of age received Infanrix instead of Tdap-Boostrix, which led to inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter. Consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Nausea, Pain
Clinical narrative: Body Aches; Nausea; Inappropriate Schedule of Vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced general body pain (Verbatim: Body Aches), nausea (Verbatim: Nausea) and incomplete course of vaccination (Verbatim: Inappropriate Schedule of Vaccine). The outcome of the general body pain and nausea were resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the general body pain and nausea to be related to Shingrix.     It was unknown if the company considered the general body pain and nausea to be related to Shingrix.   Additional Information: GSK receipt date: 20-JUN-2024 The patient received first dose of Shingrix in 2019 and afterward experience nausea and body aches so she never received the second dose.   The patient was now (at the time of reporting) in pharmacy asking if she would need to restart the series.   At the time of reporting, the pharmacist did not have the exact date of administration, product lot number, duration of the nausea and body aches. Till the time of reporting the patient did not receive 2nd dose, which led to incomplete course of vaccination. Consented to follow up.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: received a Hiberix vaccine on 19-JUN-2024 that expired on 15-JUN-2024; 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-month-old patient who received Hib (Hiberix) (expiry date 15-JUN-2024) for prophylaxis.   On 19-JUN-2024, the patient received Hiberix. On 19-JUN-2024, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: received a Hiberix vaccine on 19-JUN-2024 that expired on 15-JUN-2024). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 20-JUN-2024 The healthcare professional reported that the patient received an expired dose of Hiberix vaccine yesterday (prior to the reporting day), which led to an expired vaccine used. The reporter was reaching to see if this dose was considered valid or what the recommended wait time was to repeat if needed. The reporter was also wondering if there were any potential adverse reactions, they should be aware of.
Age: 0.17
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: given Fluarix Quadravalent to a then 2 month old patient; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number 4XY5D, expiry date 30-JUN-2024) for prophylaxis.   On 10-JAN-2024, the patient received the 1st dose of Fluarix Quadrivalent 2023-2024 season. On 10-JAN-2024, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced inappropriate age at vaccine administration (Verbatim: given Fluarix Quadravalent to a then 2 month old patient). 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: 20-JUN-2024 The caller was the GSK rep stating that an AE was reported to her today.  She stated a Nursing supervisor reported that an MA ,who no longer works there, may have given Fluarix Quadrivalent to a then 2 month old patient, which led to inappropriate age at vaccine administration. She reported that the infant was in the office to get her routine vaccines and Fluarix was not ordered by the HCP.  The office paper work showed that Fluarix was given.  No other information on the other vaccines given.  The patient was 7 months old (at the time of reporting).  No other information provided. Consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Somnolence
Clinical narrative: soreness at the injection site; feeling very sleepy; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In JUN-2024, the patient received Shingrix. In JUN-2024, less than a week after receiving Shingrix, the patient experienced injection site pain (Verbatim: soreness at the injection site) and sleepiness (Verbatim: feeling very sleepy). The outcome of the injection site pain and sleepiness were unknown.   It was unknown if the reporter considered the injection site pain and sleepiness to be related to Shingrix.     It was unknown if the company considered the injection site pain and sleepiness to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-JUN-2024 Patient reported receiving Shingrix 4 days ago. Patient reported soreness at the injection site and feeling very sleepy.
Age: 0.17
Sex: M
Vaccine: DTAPIPV
Symptoms: Cough, Feeling hot, Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: had a respiratory distress; severe cough; Fever; started throwing flames; Kinrix instead of a dose of Pediarix; gave a pediatric patient of 2 months old a dose of kinrix; This was first Dtap vaccine; This serious case was reported by a other health professional via call center representative and described the occurrence of respiratory distress in a 3-month-old male patient who received DTPa-IPV (Kinrix) (batch number F5492, expiry date 27-OCT-2024) for prophylaxis.   On 30-APR-2024, the patient received the 1st dose of Kinrix. On 30-APR-2024, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Kinrix instead of a dose of Pediarix), inappropriate age at vaccine administration (Verbatim: gave a pediatric patient of 2 months old a dose of kinrix) and inappropriate schedule of vaccine administered (Verbatim: This was first Dtap vaccine). On 01-MAY-2024, the patient experienced respiratory distress (Verbatim: had a respiratory distress) (serious criteria GSK medically significant), cough (Verbatim: severe cough), fever (Verbatim: Fever) and feeling hot (Verbatim: started throwing flames). The outcome of the respiratory distress, cough, fever, feeling hot, wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   It was unknown if the reporter considered the respiratory distress, fever and feeling hot to be related to Kinrix and Kinrix Pre-Filled Syringe Device. The reporter considered the cough to be possibly related to Kinrix and Kinrix Pre-Filled Syringe Device.     The company considered the respiratory distress to be unrelated to Kinrix and Kinrix Pre-Filled Syringe Device. The company considered the cough to be possibly related to Kinrix and Kinrix Pre-Filled Syringe Device. It was unknown if the company considered the fever and feeling hot 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: 21-JUN-2024 The Health Care Professional reported that the patient who was 2 years old receieved Kinrix instead of a dose of Pediarix on 30th April 2024 which led to Wrong vaccine administered and Inappropriate age at vaccine administration. This was the first Dtap vaccine which led to Inappropriate schedule of vaccine administered. On 1st May 2024 the patient had the respiratory distress, he had coughing, he started throwing flames, he had fever. On 1st May 2024 the patient started with severe cough that may be could be related with Kinrix. The reporter consented to follow up.; Sender's Comments: Respiratory distress is an unlisted event which is considered unrelated to GSK vaccine Kinrix and Kinrix PRE-FILLED SYRINGE DEVICE.
Age: 0.17
Sex: M
Vaccine: DTAPIPV
Symptoms: Respiratory distress, Wrong product administered
Clinical narrative: had a respiratory distress; severe cough; Fever; started throwing flames; Kinrix instead of a dose of Pediarix; gave a pediatric patient of 2 months old a dose of kinrix; This was first Dtap vaccine; This serious case was reported by a other health professional via call center representative and described the occurrence of respiratory distress in a 3-month-old male patient who received DTPa-IPV (Kinrix) (batch number F5492, expiry date 27-OCT-2024) for prophylaxis.   On 30-APR-2024, the patient received the 1st dose of Kinrix. On 30-APR-2024, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Kinrix instead of a dose of Pediarix), inappropriate age at vaccine administration (Verbatim: gave a pediatric patient of 2 months old a dose of kinrix) and inappropriate schedule of vaccine administered (Verbatim: This was first Dtap vaccine). On 01-MAY-2024, the patient experienced respiratory distress (Verbatim: had a respiratory distress) (serious criteria GSK medically significant), cough (Verbatim: severe cough), fever (Verbatim: Fever) and feeling hot (Verbatim: started throwing flames). The outcome of the respiratory distress, cough, fever, feeling hot, wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   It was unknown if the reporter considered the respiratory distress, fever and feeling hot to be related to Kinrix and Kinrix Pre-Filled Syringe Device. The reporter considered the cough to be possibly related to Kinrix and Kinrix Pre-Filled Syringe Device.     The company considered the respiratory distress to be unrelated to Kinrix and Kinrix Pre-Filled Syringe Device. The company considered the cough to be possibly related to Kinrix and Kinrix Pre-Filled Syringe Device. It was unknown if the company considered the fever and feeling hot 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: 21-JUN-2024 The Health Care Professional reported that the patient who was 2 years old receieved Kinrix instead of a dose of Pediarix on 30th April 2024 which led to Wrong vaccine administered and Inappropriate age at vaccine administration. This was the first Dtap vaccine which led to Inappropriate schedule of vaccine administered. On 1st May 2024 the patient had the respiratory distress, he had coughing, he started throwing flames, he had fever. On 1st May 2024 the patient started with severe cough that may be could be related with Kinrix. The reporter consented to follow up.; Sender's Comments: Respiratory distress is an unlisted event which is considered unrelated to GSK vaccine Kinrix and Kinrix PRE-FILLED SYRINGE DEVICE.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: vaccine that was administered 12 days past the expiration date; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (expiry date MAY-2024) for prophylaxis.   On 03-JUN-2024, the patient received Engerix B. On 03-JUN-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: A vaccine that was administered 12 days past the expiration date," reporter confirmed it was the Engerix-B). 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: 24-Jun-2024 A pharmacist called to inform about a vaccine that was administered 12 days past the expiration date, reporter confirmed it was the Engerix-B, which led to expired vaccine used. The reporter did not know the age of the patient, only that it was a pediatric patient.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Accidentally given expire dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 12-month-old female patient who received MMR (Priorix) (batch number EP99Z, expiry date 13-MAY-2024) for prophylaxis.   On 21-MAY-2024, the patient received Priorix. On 21-MAY-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: Accidentally given expire 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: 24-JUN-2024 The practice nurse was wondering about when Priorix actually expired if accidentally given after the expiration date which led to expired vaccine used. If it was given 1 day after expiration did the patient need to had another dose or was it still good. Yes, a few patients received expired doses ranging from being expired for 1 day to 1 week. The case is linked with US2024078700, same reporter, different patient.; Sender's Comments:  US-GSK-US2024078700:Same reporter/Different patient
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not received yet; 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 Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose receive don 30th October 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-JUN-2024 Pharmacist requested data on administration of a late 2nd dose of Shingrix. Patient received 1st Shingrix dose on October 30, 2021 and was back to receive 2nd dose today. At the time of call, it was unknown if patient received 2nd dose of Shingrix. As per Pharmacist, patient didn't receive 1st dose of Shingrix at their pharmacy so lot and expiration date of Shingrix received was unknown. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Ear discomfort, SARS-CoV-2 test, Visual impairment
Clinical narrative: covid 19; she started experiencing ear pressure; her eyesight deteriorated; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19), EAR DISCOMFORT (she started experiencing ear pressure) and VISUAL IMPAIRMENT (her eyesight deteriorated) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In January 2024, the patient experienced COVID-19 (covid 19). In 2024, the patient experienced EAR DISCOMFORT (she started experiencing ear pressure) and VISUAL IMPAIRMENT (her eyesight deteriorated). At the time of the report, COVID-19 (covid 19), EAR DISCOMFORT (she started experiencing ear pressure) and VISUAL IMPAIRMENT (her eyesight deteriorated) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2024, SARS-CoV-2 test: Positive.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient mentioned that she received her last vaccine in September 2023 and tested positive for COVID-19 in January. She was unable to get tested at a hospital but confirmed it through a home test. She reported experiencing 36 hours of fever and cold symptoms during her COVID-19 illness. After recovering, she noticed that her eyesight deteriorated, and she started experiencing ear pressure. No treatment medication was reported.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event, Product label confusion
Clinical narrative: stated that they thought the expiration date was 3/24/2025 and verified with Pasteur that it was 3/25/2024 has been administered with no reported adverse event; Initial information received on 24-Jun-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 3 patients and it was reported that the reporter thought that expiration date of HIB (PRP/T) VACCINE [Act-Hib] was 24-Mar-2025 and verified with pasteur that it was 24-Mar-2024 and had been administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Ona n unknown date in 2024, it was reported that they thought the expiration date of HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (lot; strength unknown) was 24-Mar-2025 and verified with pasteur that it was 24-Mar-2024 and had been administered to 3 patients with no reported adverse event (expired product administered) (latency: same day). Information regarding batch number 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: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Eczema, Psoriasis
Clinical narrative: Eczema / psoriasis on scalp developed in December 2022 and now has developed on other parts of body
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC reported.; HCP called to report VARIVAX was administered to a patient after experiencing a T/E.  No symptoms reported.  HCP provided consent to contact.  No additional AE/PQC reported.; This spontaneous report was received from a registered nurse referring to a 23-month-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 11-MAR-2024, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (0.5ML, lot number: X021930, expiration date: 29-AUG-2025; strength and route of administration were not provided) for prophylaxis. The administered vaccine experienced temperature excursion (TE) before on an unknown date (product storage error). No symptoms were reported. No additional adverse events (AE) were reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC reported; HCP called to report PROQUAD was administered to a patient after experiencing a T/E.  No symptoms reported.  HCP provided consent to contact.  No additional AE/PQC reported.; This spontaneous report was received from a registered nurse referring to a 4-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 11-MAR-2024, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) injection (0.5ML, lot number: X022920, expiration date: 12-MAR-2025; strength and route of administration were not provided) for prophylaxis. The administered vaccine experienced temperature excursion (TE) before on an unknown date (product storage error). No symptoms were reported. No additional adverse events (AE) were reported (no adverse event).
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: experienced redness at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-JUN-2024, the patient received the 1st dose of Shingrix (right arm). In JUN-2024, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: experienced redness at the injection site). In JUN-2024, the outcome of the injection site erythema was resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt date: 21-JUN-2024 The reporter was the wife of patient, she reported that on behalf of her husband, who was received his first dose of Shingrix in his right arm on 12 June 2024, and experienced redness at the injection site.  The reporter states that this redness went away after a couple of days.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: I received an incoming call from Dr. informing me that my daughter had received the Hep A vaccination instead of the scheduled Hep B vaccination. The staff member provided information on Hep B but administered the incorrect vaccine to my child. she received Hep A vaccination 7/6/2023 and another 6/28/2024