chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear swelling, Headache, Herpes zoster, Neck pain, Pain
Clinical narrative: Headache; Sore arm; pain below the crown of head; Shingles; Swelling behind ear/swelling by mastoid gland; Pain right side of neck/turns her neck to the right, it hurts; bumps on right side of scalp; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included pain in arm (barely had a sore arm from the vaccine).   On 27-APR-2023, the patient received the 1st dose of Shingrix (left deltoid). On 29-APR-2023, 2 days after receiving Shingrix, the patient experienced ear swelling (Verbatim: Swelling behind ear/swelling by mastoid gland), neck pain (Verbatim: Pain right side of neck/turns her neck to the right, it hurts) and scalp swelling (Verbatim: bumps on right side of scalp). On 02-MAY-2023, the patient experienced shingles (Verbatim: Shingles). On an unknown date, the patient experienced headache (Verbatim: Headache), pain in arm (Verbatim: Sore arm) and pain (Verbatim: pain below the crown of head). The patient was treated with cefalexin (Keflex). The outcome of the shingles, ear swelling, neck pain, scalp swelling, headache and pain were not resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the shingles, ear swelling, neck pain, scalp swelling, headache, pain in arm and pain to be related to Shingrix.   It was unknown if the company considered the shingles, ear swelling, neck pain, scalp swelling, headache, pain in arm and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-MAY-2023 The reporter was the patient.  The patient received the Shingrix on Thursday. On Saturday afternoon, the patient began experiencing swelling by her mastoid gland, swelling behind her ear, pain on the right side of her neck and bumps on the right side of her scalp.  She was experiencing sharp headaches and sharp pain below the crown of her head.  When she turned her neck to the right, it hurt.  The day before reporting, the patient saw a dermatologist who believed that she might have shingles.  The dermatologist might do a biopsy.  The patient saw an ENT (Ear, Nose, Throat) doctor at the time of reporting, who prescribed Keflex every 8 hours for 7 days.  She might need to get a MRI (Magnetic resonance imaging).  The patient reported that she barely had a sore arm from the vaccine.  The reporter consented to follow up.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Skin swelling
Clinical narrative: Headache; Sore arm; pain below the crown of head; Shingles; Swelling behind ear/swelling by mastoid gland; Pain right side of neck/turns her neck to the right, it hurts; bumps on right side of scalp; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included pain in arm (barely had a sore arm from the vaccine).   On 27-APR-2023, the patient received the 1st dose of Shingrix (left deltoid). On 29-APR-2023, 2 days after receiving Shingrix, the patient experienced ear swelling (Verbatim: Swelling behind ear/swelling by mastoid gland), neck pain (Verbatim: Pain right side of neck/turns her neck to the right, it hurts) and scalp swelling (Verbatim: bumps on right side of scalp). On 02-MAY-2023, the patient experienced shingles (Verbatim: Shingles). On an unknown date, the patient experienced headache (Verbatim: Headache), pain in arm (Verbatim: Sore arm) and pain (Verbatim: pain below the crown of head). The patient was treated with cefalexin (Keflex). The outcome of the shingles, ear swelling, neck pain, scalp swelling, headache and pain were not resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the shingles, ear swelling, neck pain, scalp swelling, headache, pain in arm and pain to be related to Shingrix.   It was unknown if the company considered the shingles, ear swelling, neck pain, scalp swelling, headache, pain in arm and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-MAY-2023 The reporter was the patient.  The patient received the Shingrix on Thursday. On Saturday afternoon, the patient began experiencing swelling by her mastoid gland, swelling behind her ear, pain on the right side of her neck and bumps on the right side of her scalp.  She was experiencing sharp headaches and sharp pain below the crown of her head.  When she turned her neck to the right, it hurt.  The day before reporting, the patient saw a dermatologist who believed that she might have shingles.  The dermatologist might do a biopsy.  The patient saw an ENT (Ear, Nose, Throat) doctor at the time of reporting, who prescribed Keflex every 8 hours for 7 days.  She might need to get a MRI (Magnetic resonance imaging).  The patient reported that she barely had a sore arm from the vaccine.  The reporter consented to follow up.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Tremor
Clinical narrative: Tremors, shacking of hands and face; Teeth chattering; Tiredness and Fatigue; Headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of tremor in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-MAY-2023 10:00, the patient received the 2nd dose of Shingrix (right arm). On 03-MAY-2023, 1 days after receiving Shingrix, the patient experienced teeth chattering (Verbatim: Teeth chattering), fatigue (Verbatim: Tiredness and Fatigue) and headache (Verbatim: Headache). On 03-MAY-2023 14:00, the patient experienced tremor (Verbatim: Tremors, shacking of hands and face). The patient was treated with paracetamol (Tylenol). The outcome of the tremor and fatigue were not resolved and the outcome of the teeth chattering was resolved and the outcome of the headache was unknown.   It was unknown if the reporter considered the tremor, teeth chattering, fatigue and headache to be related to Shingrix.     It was unknown if the company considered the tremor, teeth chattering, fatigue and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-MAY-2023. The reporter was the spouse of a patient.  Patient also reported some information during the call.  Patient received the 2nd shot of Shingrix vaccine at a local pharmacy in the right arm.  Patient reported he had the vaccine around 10 am and at 2 am the next day, he reported having tremors in his entire body up to the head.  Patient reported having shacking hands, shacking face, Teeth chattering, tiredness, fatigue and headache.  Patient reported that his symptoms had improved.  Reporter stated that even though he was shaking, patient did not have chills, fever or felt cold.  Patient stated that he had less tremors on the day of reporting, but he still felt tired.  Patient reported of taking 2 Tylenol tablets.  Not all information was available. Lot and expiry were unknown. Consent to follow up with HCP was not provided.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric dose given to adult; Pediatric dose given to adult; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a adult female patient who received HBV (Engerix B pediatric) (batch number A9349) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Pediatric dose given to adult) and adult use of a child product (Verbatim: Pediatric dose given to adult). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 04-MAY-2023 The reporter reported that one of their employees gave another of their employees (patient) a pediatric dose of Engerix B, instead of an adult dose The reporter consented to follow up. A pediatric dose of Engerix B was administered instead of an adult dose which led to underdose and adult use of child product.
Sex: M
Vaccine: DTAPHEPBIP, HEP
Symptoms: Expired product administered, Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Expired Engerix administered/ which had an expiration date of 24Apr2023; 4th Hep b dose administered; Pediarix 1st dose on 20Dec2021, 2nd dose on 17Mar2022; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 19-month-old male patient who received HBV (Engerix B) (batch number K329E, expiry date 24-APR-2023) for prophylaxis.  Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis.  Previously administered products included Pediarix (1st dose was received as Pediarix pre-filled syringe on 20-DEC-2021).  On 03-MAY-2023, the patient received Engerix B. On 17-MAR-2022, the patient received the 2nd dose of Pediarix. On 17-MAR-2022, not applicable after receiving Engerix B and an unknown time after receiving Pediarix, the patient experienced drug dose administration interval too long (Verbatim: Pediarix 1st dose on 20Dec2021, 2nd dose on 17Mar2022). On 03-MAY-2023, the patient experienced expired vaccine used (Verbatim: Expired Engerix administered/ which had an expiration date of 24Apr2023) and extra dose administered (Verbatim: 4th Hep b dose administered). The outcome of the expired vaccine used, extra dose administered and drug dose administration interval too long 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: 04-MAY-2023 Nurse reported that the patient was administered a dose of Engerix-B on 03 May 2023, which had an expiration date of 24 April 2023, which had led to expired vaccine used. The patient had received the third dose of Pediarix as pre filled syringe on 06 MAY 2022. The nurse stated this dose was the patient's fourth hepatitis b dose, and that it was given because the patient's third hepatitis b dose was administered too soon which had led to extra dose administered. The patient had previously been dosed with Pediarix vaccine. At the time of reporting, the expired dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter had consented to follow-up. On 17th March 2022, the patient received the 2nd dose of Pediarix, vaccine later than the recommended interval, which had led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Tenderness, Vaccination failure
Clinical narrative: Got both Vx 1-2 yrs ago, now maybe shingles / Suspected vaccination failure; The beginning of shingles; her left buttock became sore to the touch; black and blue; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular, unknown arm) .5 ml and the 1st dose of Shingrix (unknown arm). On 03-MAY-2023, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Got both Vx 1-2 yrs ago, now maybe shingles / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: The beginning of shingles), tenderness (Verbatim: her left buttock became sore to the touch) and skin discoloration (Verbatim: black and blue). The outcome of the vaccination failure was unknown and the outcome of the shingles and skin discoloration were not reported and the outcome of the tenderness was not resolved.  It was unknown if the reporter considered the vaccination failure, shingles, tenderness and skin discoloration to be related to Shingrix and Shingrix.  It was unknown if the company considered the vaccination failure, shingles, tenderness and skin discoloration to be related to Shingrix and Shingrix.  Additional Information: GSK Receipt Date: 05-MAY-2023 The reporter was the patient herself and reported that, she received both vaccines of her Shingrix vaccine one or two years ago, in an unknown arm. She reported that, two days ago her left buttock became sore to the touch. She stated that, it felt like it is black and blue, but it was not discolored. The reporter thought that, maybe the Shingrix vaccine was wearing off and this was the beginning of shingles. The reporter had denied consent to follow-up. This case was considered as suspected vaccination failure as details regarding, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain
Clinical narrative: Achiness; Headache; Nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-MAY-2023, the patient received the 2nd dose of Shingrix (injection, left arm). In MAY-2023, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: Achiness), headache (Verbatim: Headache) and nausea (Verbatim: Nausea). The outcome of the pain, headache and nausea were not resolved.   It was unknown if the reporter considered the pain, headache and nausea to be related to Shingrix.     It was unknown if the company considered the pain, headache and nausea to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-MAY-2023 On the day of reporting, the patient was still experiencing achiness, headache, and nausea. The reporter consented to follow up with healthcare professional.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: 3rd dose of Havrix given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 2-year-old male patient who received HAV (Havrix) (batch number 9R5LC, expiry date 02-NOV-2024) for prophylaxis.   On 04-MAY-2023, the patient received the 3rd dose of Havrix. On 04-MAY-2023, an unknown time after receiving Havrix, the patient experienced extra dose administered (Verbatim: 3rd dose of Havrix given). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 05-MAY-2023 The healthcare proportional asked for safety information regarding this situation. The reporter consented to follow up. The reporter stated that the patient received a third dose of Havrix, which led to extra dose administered.
Sex: M
Vaccine: HEPAB
Symptoms: Hepatitis A antigen positive, Hepatitis B antigen, Incomplete course of vaccination
Clinical narrative: 1st dose on 2013, 2nd never; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (first dose of Twinrix back in 2013).   On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose on 2013, 2nd never). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-MAY-2023 The doctor of medicine reported that the patient never completed the scheme up to the reporting date. The health care professional reported that the serological test was performed which showed that the patient was reactive to hepatitis A but not to Hepatitis B. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Dysphonia, Ear pain, Nasal congestion, Sneezing
Clinical narrative: earache; stuffy nose; sneezing; hoarseness; This non-serious case was reported by a consumer via call center representative and described the occurrence of ear pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-MAY-2023, the patient received the 1st dose of Shingrix. On 05-MAY-2023, 4 days after receiving Shingrix, the patient experienced ear pain (Verbatim: earache), nasal stuffiness (Verbatim: stuffy nose), sneezing (Verbatim: sneezing) and hoarseness (Verbatim: hoarseness). The outcome of the ear pain, nasal stuffiness, sneezing and hoarseness were unknown.   It was unknown if the reporter considered the ear pain, nasal stuffiness, sneezing and hoarseness to be related to Shingrix.     It was unknown if the company considered the ear pain, nasal stuffiness, sneezing and hoarseness to be related to Shingrix.   Additional Information: GSK receipt date: 05-MAY-2023 The reporter reported that on the day of reporting, the patient woke up with an earache, stuffy nose, sneezing and hoarseness. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose May2022, no 2nd dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on May 2022 by intramuscular route in an unknown arm).   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: 1st dose May2022, no 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 05-MAY-2023 The patient was self-reported this case. The patient reported that he received first dose of Shingrix vaccine about 1 year ago. The patient stated that he will contact healthcare professional for second dose of Shingrix vaccine. The reporter did not consent to follow up. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered to a 4mo; 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 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix administered to a 4mo). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-MAY-2023 The nurse reported that the 4 months old patient had received a doses of kinrix, who was 9 months old at the time of reporting and the nurse mentioned that the vaccine was administered 5 months . The health care professional asked about the effectiveness of the dose. The 4 months old patient received the dose of kinrix which lead inappropriate age of vaccine administered. The permission for follow up was not requested during the call.
Sex: U
Vaccine: VARZOS
Symptoms: Wrong product administered
Clinical narrative: Got the Shingrix vaccine instead of Varivax; This non-serious case was reported by a physician via sales rep and described the occurrence of wrong vaccine administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-MAY-2023, the patient received Shingrix. On 05-MAY-2023, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: Got the Shingrix vaccine instead of Varivax). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 05-MAY-2023 The reporter reported that physician stated we would give Varivax instead of Shingrix however the patient, in the meantime, went to a pharmacy and got the Shingrix vaccine. The patient received Shingrix vaccine instead of Varivax which led to wrong vaccine administered.
Age: 28.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: Expired dose administered to patient; 28 years old patient got Bexsero; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 28-year-old female patient who received Men B NVS (Bexsero) (batch number M7455, expiry date 31-DEC-2022) for prophylaxis.   On 05-MAY-2023, the patient received Bexsero. On 05-MAY-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired dose administered to patient) and inappropriate age at vaccine administration (Verbatim: 28 years old patient got Bexsero). The outcome of the expired vaccine used and inappropriate age at vaccine administration 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: 05-MAY-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email. An expired dose of Bexsero was administered to a 28 years old patient, which led to expired vaccine used and inappropriate age at vaccine administration.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19
Clinical narrative: Contracted covid; This non-serious case was reported by a consumer via call center representative and described the occurrence of covid-19 in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-APR-2023, the patient received the 2nd dose of Shingrix. On 04-MAY-2023, 22 days after receiving Shingrix, the patient experienced covid-19 (Verbatim: Contracted covid). The patient was treated with nirmatrelvir + ritonavir (Paxlovid). The outcome of the covid-19 was not resolved.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  It was unknown if the company considered the covid-19 to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-MAY-2023 The reporter was the patient. The patient was contracted covid. The patient stated that she was started on Paxlovid by her healthcare professional for treatment. The reporter did not consent to follow up.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix administered; 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 patient who received HBV (Engerix B) (batch number K329E, expiry date 24-APR-2023) for prophylaxis.   On 05-MAY-2023, the patient received Engerix B. On 05-MAY-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired Engerix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 05-MAY-2023 The health care professionals reported that the patient received Engerix B on 5 May 2023 which was expired on 24 April 2023.  Patient received a dose of Engerix B on 4 May 2023 which was expired on April 08, 2023, which led to expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 5 yrs ago, 2nd not yet; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received first dose 5 years ago).   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: 1st dose 5 yrs ago, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 08-MAY-2023 The reporter wanted to know if they can restart the series. The reporter did not had any additional information or patient demographics to provide at time of call.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 31-year-old male patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 08-MAY-2023, the patient received Havrix. On 08-MAY-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). 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: 8-May-2023 The reporter consented to follow-up via email. The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; 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 18-year-old female patient who received Men B NVS (Bexsero) (batch number 59M3M, expiry date 28-FEB-2023) for prophylaxis.   On 05-MAY-2023, the patient received the 2nd dose of Bexsero. On 05-MAY-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-MAY-2023 At the time of reporting, the dose had not been repeated.  The vaccine administration facility was the same as primary reporter. The reporter gave permission to consent follow-up. The patient received an expired dose of Bexsero, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate increased, Myalgia, Pyrexia
Clinical narrative: Muscle aches; Fever 100-99 degrees; Resting heart rate is usually in the 60's but is now in mid to high 80-'s; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included atrial fibrillation. Concomitant products included metoprolol and apixaban (Eliquis).   On 07-MAY-2023, the patient received the 2nd dose of Shingrix (intramuscular, left arm). On 08-MAY-2023, 1 days after receiving Shingrix, the patient experienced muscle pain (Verbatim: Muscle aches), fever (Verbatim: Fever 100-99 degrees) and heart rate increased (Verbatim: Resting heart rate is usually in the 60's but is now in mid to high 80-'s). The patient was treated with ibuprofen (Advil). The outcome of the muscle pain, fever and heart rate increased were not resolved.   It was unknown if the reporter considered the muscle pain, fever and heart rate increased to be related to Shingrix.     It was unknown if the company considered the muscle pain, fever and heart rate increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-MAY-2023 The patient received 2nd dose of Shingrix. The reporter stated that the next day of vaccination, he woke up with muscle aches, fever of 100 now went to 99 degrees (been taking ADVIL).  Reporter also mentioned that his resting heart rate was usually in the 60's but was now in mid to high 80's. The reporter consented to follow up.
Age: 80.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 24Oct2022, 2nd dose 08May2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 80-year-old female patient who received HAB (Twinrix) (batch number 2PG39) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 24th October 2022).   On 08-MAY-2023, the patient received the 2nd dose of Twinrix. On 08-MAY-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose 24Oct2022, 2nd dose 08May2023). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 08-May-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal mail. The patient received 2nd dose of Twinrix later than recommended interval, which led to lengthening of vaccine schedule.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Adult dose to a 4 day-old patient; Adult dose to a 4 day-old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 4-day-old female patient who received HBV (Engerix B) (batch number NT9X3, expiry date 09-SEP-2024) for prophylaxis.   On 08-MAY-2023, the patient received Engerix B. On 08-MAY-2023, an unknown time after receiving Engerix B, the patient experienced adult product administered to child (Verbatim: Adult dose to a 4 day-old patient) and overdose (Verbatim: Adult dose to a 4 day-old patient). The outcome of the adult product administered to child and overdose were unknown.   Additional Information: GSK Receipt Date: 8-MAY-2023. A nurse called in to report the administration of an Engerix adult dose to a 4 day-old patient. The health care professional asked for safety information about  this situation. The reporter consented to follow up. Engerix adult dose administered to a 4 day-old patient which led to adult product administered to child and and overdose.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: patient was administered (8-May-2023) an expired (8-April-2023) dose of the pediarix vaccine; 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 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 7P2Y3, expiry date 08-APR-2023) for prophylaxis.   On 08-MAY-2023, the patient received the 1st dose of Pediarix (left thigh). On 08-MAY-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: patient was administered (8-May-2023) an expired (8-April-2023) dose of the pediarix vaccine). 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: 09-MAY-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  The patient received an expired dose of Pediarix, which led to expired vaccine used.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Neoplasm malignant
Clinical narrative: Cancer; This serious case was reported by a consumer via call center representative and described the occurrence of cancer in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In SEP-2021, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced cancer (Verbatim: Cancer) (serious criteria GSK medically significant). The outcome of the cancer was not reported.   It was unknown if the reporter considered the cancer to be related to Shingrix.     It was unknown if the company considered the cancer to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-MAY-2023 The patient reported that she received a dose of Shingrix and was diagnosed with cancer and was not able to get dose 2 yet.  The reporter had an appointment on 11th May 2023 to get Shingrix dose 2. The reporter did not wanted to provide any additional information.  The reporter did not consent to follow-up.
Age: 0.17
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 and half months old patient was administered a dose of Kinrix.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30-SEP-2022) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 2 and half months old patient was administered a dose of Kinrix.). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-MAY-2023 The reporter informed that a patient was administered a dose of Kinrix. 2 and a half months patient was administered with a dose of Kinrix which led to inappropriate age at vaccine administration. The Vaccine Administration Facility is the same as Primary Reporter. HCP didn't mention administration date. The reporter consented to follow up.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Received an expired dose of Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-year-old male patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29-APR-2023) for prophylaxis.   On 05-MAY-2023, the patient received Infanrix. On 05-MAY-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Received an expired dose of Infanrix). 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.   Linked case(s) involving the same patient:  US2023066934   Additional Information: GSK Receipt Date: 09-MAY-2023 The reporter at a health department reported that patient received an expired dose of Infanrix. The reporter consented to follow up. The patient had received an expired dose of Infanrix vaccine, which had led to expired vaccine used. This case is linked to the case US2023066934, reported by the same reporter.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19 immunisation, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 76 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, penicillin allergy, and erythromycin allergy. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered at left arm on 13-MAR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 74 years old. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received second dose of non-company suspect vaccine Moderna (elasomeran)  (Dose number in series 2) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered at left arm on 27-OCT-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with second dose of vaccine Moderna (elasomeran) (Dose number in series 2). The patient received additional third dose of non-company suspect vaccine Moderna (elasomeran) (Dose number in series 3)(form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered at left arm on 15-APR-2022 for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with third dose of vaccine Moderna (elasomeran) (Dose number in series 3).  The patient received additional fourth dose of non-company suspect vaccine Moderna (elasomeran) (Dose number in series 4) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered at left arm on 16-SEP-2022 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 4). Concomitant medications included finasteride, krill oil, and metoprolol succinate. On an unspecified date in 2023, the patient experienced suspected covid-19 infection (Dose number in series 4) and was treated with drug nirmatrelvir/ritonavir (form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from 28-APR-2023 to 02-MAY-2023 for covid-19 treatment.  On 7-MAY-2023, patient experienced paxlovid rebound with cough, runny nose, low grade fever, congestion (Dose number in series 4). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, elasomeran, and elasomeran was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose, Wrong product administered
Clinical narrative: Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box), UNDERDOSE (patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box), UNDERDOSE (patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box), UNDERDOSE (patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and UNDERDOSE (patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box).    Concomitant medication details not reported by the reporter. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment details was not reported by the reporter. This case contains information about patient 3rd out of 18 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-723704 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723704:Patient 1(Master Case)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box).    Concomitant drugs were not reported.  It was reported that there was a dark blue cap vial with a dose of 25 mcg for age group 6 months to 5 years instead patient was administered with 10 mcg dosage from the dark pink cap and a label with a yellow box.  Treatment medications were not provided.  This case was reported for patient 4 Out of 18(12 Patients-Initial Dose).   This case was linked to US-MODERNATX, INC.-MOD-2023-723704 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723704:Patient 1(Master Case)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box).    Concomitant medication was not provided.  Treatment information was not provided.  This case contains information for the 5th patient out of 18 child patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723704 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723704:Patient 1(Master Case)