chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: I went to draw up immunization. I had checked date and time. Everything checked out so I drew it up and administered it. It was placed in the right upper arm. I was informed later that the vial had expired. Patient at the time had no reaction.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Ischaemic stroke, Transient ischaemic attack
Clinical narrative: TRANSIENT CEREBRAL ISCHEMIA ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Age: 4.0
Sex: F
Vaccine: COVID19-2, DTAPIPV, MMRV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Wrong covid vaccine preparation given. No adverse outcome.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Pfizer Bivalent vaccine that was given was expired.
Age: 45.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Red area size of softball, swollen, warm to touch, itchy, hard, and painful at site of injection.
Age: 45.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site warmth
Clinical narrative: Red area size of softball, swollen, warm to touch, itchy, hard, and painful at site of injection.
Age: 1.25
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Incorrect dose administered, Wrong product administered
Clinical narrative: Patient received 4th dose of prediarix instead of 1st dose of infarix
Age: 0.5
Sex: M
Vaccine: COVID19-2, DTAPHEPBIP, PNC13, RV5
Symptoms: No adverse event, Product preparation error
Clinical narrative: Wrong covid vaccine preparation given. No adverse outcome.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Metastases to liver, Neoplasm malignant
Clinical narrative: ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 2/23/2023 CANCER METASTATIC TO LIVER ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 2/23/2023 CANCER METASTATIC TO LIVER
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Pfizer Bivalent Booster vaccine was expired.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory failure
Clinical narrative: J96.00 ACUTE RESPIRATORY FAILURE 1/31/2023 NONTRAUMATIC ACUTE KIDNEY INJURY
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Jaundice, Liver function test abnormal, Vena cava thrombosis
Clinical narrative: ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 11/3/2022 ABNL LIVER FUNCTION STUDY ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 11/3/2022 JAUNDICE ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 11/3/2022 ACUTE DVT OF INFERIOR VENA CAVA
Age: 0.75
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product preparation error
Clinical narrative: Wrong covid preparation given. No adverse outcome.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Cardiogenic shock, Cardiomyopathy
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/17/2023 CARDIOMYOPATHY, UNSPECIFIED CARDIOGENIC SHOCK 1/17/2023 CARDIOMYOPATHY, UNSPECIFIED
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Aortic arteriosclerosis, Cerebral artery embolism
Clinical narrative: J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/9/2022 ATHEROSCLEROSIS OF AORTA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/9/2022 CEREBRAL EMBOLISM
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Rash started@ site of injection approximately 24 hours afterward.  Today, 72 hours after injection right upper arm has rash approximately 7cm x 4 cm and feels hot to touch and is painful.   Patient was seen by her PCP Dr. and was prescribed Doxycycline.  She was advised to follow up with urgent care or ER if her symptoms worsened,
Age: 76.0
Sex: F
Vaccine: COVID19-2, HEP, VARZOS
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Diabetic eye disease, Hypogammaglobulinaemia, Hypoxia, Type 2 diabetes mellitus
Clinical narrative: HYPOXIA 12/18/2022 HYPOGAMMAGLOBULINEMIA HYPOXIA 12/18/2022 DM 2 W EYE MANIFESTATION
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, Hypoxia
Clinical narrative: J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/3/2022 NONTRAUMATIC ACUTE KIDNEY INJURY R09.02 HYPOXIA 12/23/2022 NONTRAUMATIC ACUTE KIDNEY INJURY
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Cirrhosis alcoholic, Shock
Clinical narrative: R57.9 SHOCK, UNSPECIFIED 1/19/2023 ALCOHOLIC CIRRHOSIS
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cholangitis, Enterococcal infection, Hypotension, Pancreatic carcinoma
Clinical narrative: I95.9 HYPOTENSION 12/22/2022 ENTEROCOCCUS INFECTION I95.9 HYPOTENSION 12/22/2022 CHOLANGITIS I95.9 HYPOTENSION 12/22/2022 PANCREATIC CANCER, UNSPECIFIED SITE
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Alopecia, Blood thyroid stimulating hormone normal, Diffuse alopecia, Fatigue, Full blood count normal
Clinical narrative: Patient experienced fatigue for 3-4 days post-vaccination.  Approximately one week post-vaccination, parents noticed unusual amounts of hair shedding and thinning of hair. Pediatrician diagnosed telogen effluvium on 2023/04/24.  No treatment has been identified.  Hair loss continues at a steady rate, 42 days post-vaccination.  CBC, TSH and ferratin labs run on May 4th showed no clinically significant findings.  Patient has no known history of hair loss.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Serum ferritin normal
Clinical narrative: Patient experienced fatigue for 3-4 days post-vaccination.  Approximately one week post-vaccination, parents noticed unusual amounts of hair shedding and thinning of hair. Pediatrician diagnosed telogen effluvium on 2023/04/24.  No treatment has been identified.  Hair loss continues at a steady rate, 42 days post-vaccination.  CBC, TSH and ferratin labs run on May 4th showed no clinically significant findings.  Patient has no known history of hair loss.
Age: 17.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash, Rash pruritic
Clinical narrative: patient stated approximately 12 hours after vaccination she developed an itch rash all over body
Age: 2.0
Sex: F
Vaccine: YF
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: This event occurred on 05/24/2023 at 11:30 AM. The patient presented to the Health Department with her mother and siblings to receive travel vaccines for an upcoming trip. Once all of the vaccines were prepared and drawn up, myself and a co-worker entered the patient care room to help in administering the vaccines to the family. The patient concerning this VAERS report mistakenly received two doses of the yellow fever vaccine in the right thigh and was only supposed to receive one dose. The patient was meant to receive a meningitis (MCV4) and Typhoid Vi, but the incorrect syringe containing another yellow fever dose for the patient?s sibling was selected accidentally, so the client received the two dose of yellow fever and one dose of Typhoid Vi.  Once this realization was made, I informed my supervisor, of what possibly could have just occurred. The patient did not display any adverse reactions to the vaccines she received while present in the clinic. The patient?s mother was informed of this and advised to watch and observe for any changes in her health. The mother understood this stated that she would seek medical attention if she notices any changes in her daughter?s health.  Contact was made to the patient?s mother the morning of 05/25/2023 by RN to see how the patient?s health was. The mother stated that her daughter and other siblings of the patient were all doing fine, but does observe that her daughter?s legs are sore from the injections. It was relayed to the patient?s mother again to continue to watch for and observe for any changes in her daughter?s health and to seek medical help if she does. The patient?s mother was agreeable to this.
Age: 1.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: wrong vaccination was given
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: I gave the patient their moderna vaccine today (5/25/23). About 20 minutes after they left, I found out that the beyond use date for the vaccine was yesterday (5/24/23). The vaccine is not expired. It has an expiration date of 6/10/23. So it was past the BUD (by one day), but not the expiration date.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: I gave the patient their Moderna vaccine today (5/25/23). About 20 minutes after they left, I found out that the beyond use date for the vaccine was yesterday (5/24/23). The vaccine is not expired. It has an expiration date of 6/10/23. So it was past the BUD (by one day), but not the expiration date.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Pfizer Bivalent Covid-19 vaccine vial was first punctured on 05/23/2023 (unknown exact time) and left overnight at room temperature (up to 30 hours) with 1 dose remaining in the vial. The pharmacist-on-duty withdrew the last dose in that vial on 05/24/2023 and administered to the patient on the left arm. The pharmacy manager already contacted Pfizer manufacturer regarding the stability and safety of the COVID-19 bivalent vaccine and is currently waiting for the manufacturer's decision. The staff pharmacist already contacted patient on the following date regarding the incidence.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Pulmonary embolism, Pulmonary mass, Squamous cell carcinoma of lung, Superior vena cava syndrome
Clinical narrative: Moderna vaccine was administered outside of clinic- reported by patient ? NO LOT NUMBER WERE SUPPLIED ========================================================================= ACUTE PULMONARY EMBOLISM 11/24/2022 SUPERIOR VENA CAVA COMPRESSION SYNDROME ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/26/2022 SUPERIOR VENA CAVA COMPRESSION SYNDROME ACUTE PULMONARY EMBOLISM 11/24/2022 LUNG MASS ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/26/2022 LUNG MASS ACUTE PULMONARY EMBOLISM 11/24/2022 SQUAMOUS CELL CARCINOMA, RIGHT LUNG UPPER LOBE ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/26/2022 SQUAMOUS CELL CARCINOMA, RIGHT LUNG UPPER LOBE
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Overdose
Clinical narrative: no additional AE's were reported; An HCP is reporting an AE on behalf of a patient. The HCP reports that the patient received PROQUAD and VARIVAX on the same day. No additional clarifying statements or AE details were provided and no additional AE's were reported. No PQC.; This spontaneous report was received from an other health professional refers to a patient of unknown age and gender with seasonal allergy. No information on patient's medical history and concomitant medication was provided.   On 25-APR-2023 the patient was vaccinated with 0.5 milliliter of measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (PROQUAD) lot #W035468 and expiration date 06-MAY-2024, subcutaneously for prophylaxis.  On that same day, the patient was vaccinated with 0.5 milliliter of varicella virus vaccine live (oka/merck) (VARIVAX) lot #W031813 and expiration date 05-OCT-2024, subcutaneously for prophylaxis (overdose and no adverse event).
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 13-year-old female patient. The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 14-NOV-2022, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events or issues reported in the patient (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Sex: U
Vaccine: HEPA, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; Caller reported an AE for VAQTA and MMRII. The caller said the patient received both VAQTA and MMRII on 5/19/2023 and the vaccines were expired. Confirmed with caller no other AE occurred. AE letter sent to prescriber. No other AE. No PQC.; 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 reported.  On 19-MAY-2023, the patient was vaccinated with one expired dose of hepatitis a vaccine, inactivated (VAQTA) lot #W002894, expiration date: 06-MAR-2023, (exact dose, route of administration and anatomical location were not reported) for prophylaxis. On the same day, the patient was vaccinated with one expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin) (M-M-R II) lot# u009511, expiration date: 25-MAR-2023, (exact dose, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse event reported (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Additional AE; HCP called to report patient received expired dose of GARDASIL 9.; This spontaneous report was received from  a licensed vocational nurse and refers to a 12-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-MAY-2023, the patient was vaccinated with expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #U008897, expiration date: 16-MAY-2023, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; HCP reported VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications was not provided.  On 22-MAY-2023, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (0.5 mL, lot #W032370, expiration date 10-OCT-2024, route of administration and anatomical location were not provided) for prophylaxis (Improper storage of product in use).  On unknown day, the suspect vaccine experienced a temperature excursion of 19.2 degrees Fahrenheit for 8 hours and 20 minutes. There was no reported previous temperature excursion. No additional adverse events (AEs) or product quality complaints (PQC) were reported (No adverse event). No additional information provided.; Sender's Comments:  US-009507513-2305USA007880:MSD
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reported VARIVAX was administered after a temperature excursion. Temperature: 19.2F; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 22-MAY-2023, the patient was vaccinated with one dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection 0.5 ml (lot#: W032370, expiration date: 10-OCT-2024; strength, route of administration, and anatomical location were not provided) as prophylaxis. The vaccine administered experienced a temperature excursion of 19.2 F for 8 hours 20 minutes (product storage error). Moreover, it was stated that there were no previous temperature excursions. No additional adverse events (AE) (no adverse event) were reported.; Sender's Comments:  US-009507513-2305USA007766:
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash, Rash vesicular, Vaccination failure
Clinical narrative: herpes zoster about 5 years after completing the 2 dose series / Suspected vaccination failure; herpes zoster about 5 years after completing the 2 dose series; neuropathic pain for the past 4 months/ The neuropathic pain has not resolved, but is manageable by reporter; vesicular rash on a dermatome in his back; This serious case was reported by a pharmacist via sales rep and described the occurrence of vaccination failure in a adult male 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 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 5 years after receiving Shingrix and more than 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: herpes zoster about 5 years after completing the 2 dose series / Suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster (Verbatim: herpes zoster about 5 years after completing the 2 dose series), vesicular rash (Verbatim: vesicular rash on a dermatome in his back) and post herpetic neuralgia (Verbatim: neuropathic pain for the past 4 months/ The neuropathic pain has not resolved, but is manageable by reporter). The outcome of the vaccination failure was unknown and the outcome of the herpes zoster was not reported and the outcome of the vesicular rash was resolved (duration 4 weeks) and the outcome of the post herpetic neuralgia was not resolved.  It was unknown if the reporter considered the vaccination failure, herpes zoster, vesicular rash and post herpetic neuralgia to be related to Shingrix and Shingrix.  It was unknown if the company considered the vaccination failure, herpes zoster, vesicular rash and post herpetic neuralgia to be related to Shingrix and Shingrix.  Additional Information: GSK Receipt Date: 22-MAY-2023 The reporter was a PharmD. The reporter thought that the patient received the Shingrix about 5 years ago (2017-2018). The pharmacist had reported that, the patient was getting a herpes zoster about 5 years after completing the 2 doses series. He reported a vesicular rash on a dermatome in his back. He did not seek care for the rash from his Primary care physician (PCP). The rash had resolved after 4 weeks. He reported neuropathic pain for the past 4 months.  He had taken over the counter (OTC) pain medicine but did not seek further care.  He reported not being on any immunosuppressive meds or any awareness of compromising conditions.  The neuropathic pain had not resolved but was manageable by reporter. He said it did not stop him from his normal activities. The reporter had denied consent to follow-up.  This case was considered as suspected vaccination failure as detail regarding laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Wrong technique in product usage process
Clinical narrative: Administration of 2 720 unit Havrix as a single dose instead of 1440 unit Havrix to an adult age patient; Administration of 2 720 unit Havrix as a single dose instead of 1440 unit Havrix; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of adult use of a child product in a adult patient who received HAV (Havrix 720 Junior) for prophylaxis.   On an unknown date, the patient received Havrix 720 Junior. On an unknown date, an unknown time after receiving Havrix 720 Junior, the patient experienced adult use of a child product (Verbatim: Administration of 2 720 unit Havrix as a single dose instead of 1440 unit Havrix to an adult age patient) and wrong technique in product usage process (Verbatim: Administration of 2 720 unit Havrix as a single dose instead of 1440 unit Havrix). The outcome of the adult use of a child product and wrong technique in product usage process were unknown.   Additional Information: GSK receipt date: 18-May-2023 The reporter was a PharmD. The reporter did not consent to follow up. The adult patient was administered with 2 doses of Havrix 720 instead of Havrix 1440 unit, which led to adult use of a child product and wrong technique in product usage process.
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Hypersensitivity
Clinical narrative: ALLERGIC REACTION TO SHINGRIX; This non-serious case was reported by a consumer via call center representative and described the occurrence of allergy to vaccine in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced allergy to vaccine (Verbatim: ALLERGIC REACTION TO SHINGRIX). The outcome of the allergy to vaccine was not reported.   The reporter considered the allergy to vaccine to be possibly related to Shingrix.     The company considered the allergy to vaccine to be possibly related to Shingrix.   Additional Information: GSK Receipt Date: 23-MAY-2023 The reporter stated his or her mother was currently being sent to the emergency room and they thought it might be the reaction of shingrix vaccine. The patient administered the shingrix vaccine a few days ago. The patient was having an allergic reaction to the vaccine and wanted to know what would be don't to counter act that. The reporter denied the consent to follow up.
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPV
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Overdose
Clinical narrative: administered a patient both Kinrix and Pediarix on 16/05/2023; Extra dose administered; patient received kinrix as 2nd dose; This non-serious case was reported by a physician via call center representative and described the occurrence of overdose in a 4-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number M7HL3) for prophylaxis.   Co-suspect products included DTPa-IPV (Kinrix) (batch number N7HL3) for prophylaxis.   Previously administered products included hepatitis B vaccine (the patient receive at birth), hepatitis B vaccine (received at 25 months of age), IPV (received at 25 months of age) and DTAP (received at 25 months of age).   On 16-MAY-2023, the patient received the 2nd dose of Pediarix and the 2nd dose of Kinrix. On 16-MAY-2023, an unknown time after receiving Pediarix and Kinrix, the patient experienced overdose (Verbatim: administered a patient both Kinrix and Pediarix on 16/05/2023), extra dose administered (Verbatim: Extra dose administered) and inappropriate schedule of vaccine administered (Verbatim: patient received kinrix as 2nd dose). The outcome of the overdose, extra dose administered and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-MAY-2023 The vaccine, patient and event information was provided. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The reporter called and stated that a nurse administered a patient both Kinrix and Pediarix at the time of reporting, which led to overdose and inappropriate schedule of vaccine administered. The patient 2nd dose of Kinrix, which led to extra dose administered.
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Hypersensitivity, Throat tightness
Clinical narrative: allergic reaction to a Tdap vaccine (probably an Boostrix) after giving birth; She had troubles to breath; patient´s throat closed out; This non-serious case was reported by a nurse via call center representative and described the occurrence of allergic reaction in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   The patient's past medical history included delivery.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced allergic reaction (Verbatim: allergic reaction to a Tdap vaccine (probably an Boostrix) after giving birth), difficulty breathing (Verbatim: She had troubles to breath) and throat constriction (Verbatim: patient´s throat closed out). The outcome of the allergic reaction, difficulty breathing and throat constriction were unknown.   It was unknown if the reporter considered the allergic reaction, difficulty breathing and throat constriction to be related to Boostrix.     It was unknown if the company considered the allergic reaction, difficulty breathing and throat constriction to be related to Boostrix.   Additional Information: GSK receipt date: 19-MAY-2023 The nurse from a pediatric office reported that a patient delivered her baby and after that she received on the hospital, a Tdap vaccine (probably a Boostrix) and suffered an allergic reaction.  She had troubles to breath and her throat closed out.  Nurse and patient were concern about the newborn child and wanted to know more safety data about Pediarix first dose on infants whose mothers had allergic reactions to Boostrix. No other information was available at the moment of the reporting because health care professional (HCP) worked from a pediatric office. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Dental paraesthesia, Injection site pain, Pain, Paraesthesia, Paraesthesia oral
Clinical narrative: Tingling in his mouth that also affected his gums and teeth on the right of the face; Sluggishness; Severe pain, deep pain; Tingling in his mouth that also affected his gums and teeth on the right of the face; Tingling right of the face; Pain in the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-MAY-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). In MAY-2023, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain in the injection site). On 17-MAY-2023, the patient experienced tingling mouth (Verbatim: Tingling in his mouth that also affected his gums and teeth on the right of the face), sluggishness (Verbatim: Sluggishness), pain (Verbatim: Severe pain, deep pain), tingling teeth (Verbatim: Tingling in his mouth that also affected his gums and teeth on the right of the face) and tingling (Verbatim: Tingling right of the face). The patient was treated with paracetamol (Tylenol) and ibuprofen. The outcome of the injection site pain was not reported and the outcome of the tingling mouth, sluggishness, pain, tingling teeth and tingling were unknown.   It was unknown if the reporter considered the injection site pain, tingling mouth, sluggishness, pain, tingling teeth and tingling to be related to Shingrix.     It was unknown if the company considered the injection site pain, tingling mouth, sluggishness, pain, tingling teeth and tingling to be related to Shingrix.   Additional Information: GSK receipt date: 22-May-2023 This case was self reported by the patient.  The patient received first dose of Shingrix on and had sluggishness the day after vaccination.  The patient also described tingling in his mouth that also affected his gums and teeth on the right of the face affecting the lower jaw up to the right cheek bone. The patient described this tingling and severe pain, deep pain, as like being at a dentist getting a deep cleaning. The patient also stated that has had pain in the injection site.  The patient said he went to the dentist, had x-rays and nothing was found.  The patient also stated that he has been taking Tylenol and Ibuprofen for pain. The adverse event was filed.  The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Sluggishness
Clinical narrative: Tingling in his mouth that also affected his gums and teeth on the right of the face; Sluggishness; Severe pain, deep pain; Tingling in his mouth that also affected his gums and teeth on the right of the face; Tingling right of the face; Pain in the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-MAY-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). In MAY-2023, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain in the injection site). On 17-MAY-2023, the patient experienced tingling mouth (Verbatim: Tingling in his mouth that also affected his gums and teeth on the right of the face), sluggishness (Verbatim: Sluggishness), pain (Verbatim: Severe pain, deep pain), tingling teeth (Verbatim: Tingling in his mouth that also affected his gums and teeth on the right of the face) and tingling (Verbatim: Tingling right of the face). The patient was treated with paracetamol (Tylenol) and ibuprofen. The outcome of the injection site pain was not reported and the outcome of the tingling mouth, sluggishness, pain, tingling teeth and tingling were unknown.   It was unknown if the reporter considered the injection site pain, tingling mouth, sluggishness, pain, tingling teeth and tingling to be related to Shingrix.     It was unknown if the company considered the injection site pain, tingling mouth, sluggishness, pain, tingling teeth and tingling to be related to Shingrix.   Additional Information: GSK receipt date: 22-May-2023 This case was self reported by the patient.  The patient received first dose of Shingrix on and had sluggishness the day after vaccination.  The patient also described tingling in his mouth that also affected his gums and teeth on the right of the face affecting the lower jaw up to the right cheek bone. The patient described this tingling and severe pain, deep pain, as like being at a dentist getting a deep cleaning. The patient also stated that has had pain in the injection site.  The patient said he went to the dentist, had x-rays and nothing was found.  The patient also stated that he has been taking Tylenol and Ibuprofen for pain. The adverse event was filed.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Pain, Pain in extremity
Clinical narrative: quarter size round red spot at injection site; painful to touch; she can't sleep on that side due to pain; pain when raising arm; red glob; experiencing painful injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-MAY-2023, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). In MAY-2023, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: experiencing painful injection site). On 20-MAY-2023, the patient experienced injection site erythema (Verbatim: quarter size round red spot at injection site), tenderness (Verbatim: painful to touch), pain in arm (Verbatim: she can't sleep on that side due to pain), pain upon movement (Verbatim: pain when raising arm) and erythema (Verbatim: red glob). The outcome of the injection site pain, injection site erythema, tenderness, pain in arm, pain upon movement and erythema were not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, tenderness, pain in arm, pain upon movement and erythema to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site erythema, tenderness, pain in arm, pain upon movement and erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-MAY-2023 The patient reported that received 2nd dose of Shingrix and experienced painful injection site with a red spot the size of a quarter at the injection site and also reported a larger area below the injection site as a big red glob which was painful to touch.  The patient said it was painful to raise arm and that she could not sleep on that side due to pain. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder, Tenderness
Clinical narrative: quarter size round red spot at injection site; painful to touch; she can't sleep on that side due to pain; pain when raising arm; red glob; experiencing painful injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-MAY-2023, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). In MAY-2023, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: experiencing painful injection site). On 20-MAY-2023, the patient experienced injection site erythema (Verbatim: quarter size round red spot at injection site), tenderness (Verbatim: painful to touch), pain in arm (Verbatim: she can't sleep on that side due to pain), pain upon movement (Verbatim: pain when raising arm) and erythema (Verbatim: red glob). The outcome of the injection site pain, injection site erythema, tenderness, pain in arm, pain upon movement and erythema were not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, tenderness, pain in arm, pain upon movement and erythema to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site erythema, tenderness, pain in arm, pain upon movement and erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-MAY-2023 The patient reported that received 2nd dose of Shingrix and experienced painful injection site with a red spot the size of a quarter at the injection site and also reported a larger area below the injection site as a big red glob which was painful to touch.  The patient said it was painful to raise arm and that she could not sleep on that side due to pain. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect dose administered
Clinical narrative: incomplete dose of Boostrix due to a leakage of the vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 75-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number LP2G2, expiry date 19-SEP-2025) for prophylaxis.   On 22-MAY-2023, the patient received Boostrix. On 22-MAY-2023, an unknown time after receiving Boostrix, the patient experienced incomplete dose administered (Verbatim: incomplete dose of Boostrix due to a leakage of the vaccine). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 22-MAY-2023 The vaccine administration facility was the same as Primary Reporter. The reporter consented to follow up.  The reporter informed that earlier that day a patient received an incomplete dose of Boostrix due to a leakage of the vaccine, which led to incomplete dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness
Clinical narrative: flu like symptoms after receiving her Shingrix vaccine; stated having a headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: flu like symptoms after receiving her Shingrix vaccine) and headache (Verbatim: stated having a headache). The outcome of the influenza-like symptoms and headache were resolved.   It was unknown if the reporter considered the influenza-like symptoms and headache to be related to Shingrix.   It was unknown if the company considered the influenza-like symptoms and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-MAY-2023 The patient had having a headache and flu like symptoms after receiving her Shingrix vaccine. The reporter did not consent to follow-up due to limited information.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: stored Priorix in the freezer and it was exposed to -22.4 F; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 16-month-old male patient who received MMR (Priorix) (batch number 2AR75, expiry date 11-MAY-2024) for prophylaxis.   On 03-MAY-2023, the patient received Priorix. On 03-MAY-2023, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: stored Priorix in the freezer and it was exposed to -22.4 F). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-May-2023  LPN states they stored Priorix in the freezer and it was exposed to minus 22.4 F.  It was administered to a patient.  Consented to follow up via postal. The vaccine administration facility was the same as primary reporter.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Use of a Non-approved Diluent to Reconstitute and Administer the Lyophylized Meningococcal Group A Component of the 2-vial Presentation of Menveo; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA911A, expiry date 31-MAR-2024) for prophylaxis.   On 13-MAY-2023, the patient received Menveo. On 13-MAY-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Use of a Non-approved Diluent to Reconstitute and Administer the Lyophylized Meningococcal Group A Component of the 2-vial Presentation of Menveo). The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 22-May-2023  Pharmacist has a female patient who on 13th May 2023, received by error Menveo reconstituted with sterile saline water, which led to wrong solution used in drug reconstitution. The reporter consented to follow up.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Overdose; Adult product administered to child; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 2-year-old patient who received HAV (Havrix 1440) for prophylaxis.   On 19-MAY-2023, the patient received Havrix 1440. On 19-MAY-2023, an unknown time after receiving Havrix 1440, the patient experienced overdose (Verbatim: Overdose) and adult product administered to child (Verbatim: Adult product administered to child). The outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-May-2023  Vaccine coordinator stated that an adult dose of Havrix was administered to a 2 year old patient last Friday, which led to overdose and adult product administered to child. The reporter consented to follow up via email. The reporter did not verify the date of admin.  HCP did not have any additional patient identifiers, nor did she have details surrounding the event.
Sex: F
Vaccine: HEP
Symptoms: Accidental underdose
Clinical narrative: adult patient was accidentally given a pediatric dose of Engerix-b; adult patient was accidentally given a pediatric dose of Engerix-b; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 33-year-old female patient who received HBV (Engerix B pediatric) (batch number EP724, expiry date 14-MAR-2025) for prophylaxis.   On 16-MAY-2023, the patient received Engerix B pediatric. On 16-MAY-2023, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: adult patient was accidentally given a pediatric dose of Engerix-b) and adult use of a child product (Verbatim: adult patient was accidentally given a pediatric dose of Engerix-b). The outcome of the accidental underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 22-MAY-2023 The reporter wished to know how to proceed. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Urticaria
Clinical narrative: inappropriate dosing schedule; red welts on leg; This non-serious case was reported by a consumer via call center representative and described the occurrence of erythema urticarial in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   In DEC-2018, the patient received the 2nd dose of Shingrix (left arm). In DEC-2018, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: inappropriate dosing schedule). On an unknown date, the patient experienced erythema urticarial (Verbatim: red welts on leg). The outcome of the erythema urticarial was resolved (duration 1 day) and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the erythema urticarial to be related to Shingrix.     It was unknown if the company considered the erythema urticarial to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-MAY-2023 The patient did not want to supply any demographics. The patient stated after receiving first dose he received second dose of shingrix vaccine after 6 weeks. The patient also reported that after administration of second dose he had red welts on one of his legs, which were gone following day. The reporter did not consent to follow-up with HCP. The patient received 2nd dose of Shingrix earlier than recommended interval, which led to shortening of vaccination schedule.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reconstituted with a sterile diluent and not the supplied liquid; reconstituted with a sterile diluent and not the supplied liquid; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 18-MAY-2023, the patient received Menveo. On 18-MAY-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstituted with a sterile diluent and not the supplied liquid) and inappropriate dose of vaccine administered (Verbatim: reconstituted with a sterile diluent and not the supplied liquid). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 23-May-2023 The reporter was a nursing supervisor. The reporter did not have dose lot number or expiration date and she did not had any patient information. The vaccine administration facility was the same as primary reporter. The reporter gave permission for follow-up. A nurse administered a dose of Menveo which was reconstituted with a sterile diluent and not with the supplied liquid CYW-135 conjugate, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received third dose of shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 82-year-old male patient who received Herpes zoster (Shingrix) (batch number 27224, expiry date 08-MAR-2024) for prophylaxis.   Previously administered products included Shingrix (completed Shingrix series back in December 2020).   In NOV-2022, the patient received the 3rd dose of Shingrix. In NOV-2022, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: received third dose of shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 24-May-2023 A pharmacist asked for safety information.  During the call permission for follow up was not requested. The patient received the third dose of Shingrix, which led to extra dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Extended vaccination interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received a dose on 6th December 2021 of batch number 4C493).   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: Extended vaccination interval). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 24-May-2023 A pharmacist wanted to know if the second dose could be given or if the series needed to be restarted.  Information about vaccine, patient and event was collected. The reporter consented to follow-up. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.