chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Urine porphobilinogen normal, Urticaria, Urticaria thermal, Viral titre
Clinical narrative: Full body urticaria with inflammation/swelling which causes severe pain with full body rash, as well as dehydration and fatigue. Caused by any and all UV radiation especially-fluorescent lights.  Long lasting damage to skin caused by fluorescent lights, skin discoloration on face and body. I am 37 year old single female, who has been trapped in my bedroom, at my parents home, in the pitch black, since May. My life has completely been robbed from me and I have not been able to work since 5/19/2023. I was an Operating Room Nurse, I had recently within the last 5 years done a career change, this was my second bachelors degree and had finally started making money in a brutal selfless career. However,  I have now  been on disability, working with staff at facility, I am unable to do any kind of work regardless of accommodation the reaction to the light is to severe.   Diagnosis: L50.1 Idiopathic urticaria, L56.8 blistering due to UV light, L50.2 Urticaria due to cold and heat, L55.9 Sunburn, L50.8 Other urticaria, Photophobia(allergic to fluorescent and halogen lights
Age: 62.0
Sex: M
Vaccine: FLUA4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Multiple patients were being vaccinated with either Fluad or Flucelvax according to age. This was done by Pharmacy at  long term care center. Patients were supposed to be grouped together by vaccine to prevent the administration of the incorrect influenza vaccine, but pt came over and sat down with the Fluad group. The pharmacist had already prepped a Fluad vaccine for the next patient and still had it in her hand when he sat in the vaccination chair. She verified his information but still handed the technician the Fluad instead of the Flucelvax as listed on his paperwork. The patient is 62 years old and should have gotten the Flucelvax because he is under 65 and would not qualify for the Fluad.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproed storage unit
Age: 65.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus
Clinical narrative: Pt states he has "itching" in a line going up and down his arm since the vaccine  sometimes in his shoulder area and sometimes down his inside upper arm and sometimes down his inside lower arm.  Not severe.  Says he thinks he did not have it prior to vaccine and that it feels a little like poison ivy but did not have it prior.  He asked his NP about it while at appointment and she said "oh, maybe they hit a nerve?"   He states the itching started he thinks within a week of the Tdap and has continued on and off moving since.   No increase or decrease in severity.   No rash noticeable.
Age: 91.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Platelet count increased, Rash, Rash erythematous
Clinical narrative: Patient had pain and redness at the site within the first day.  On day 5 she started to develop a painful red rash on her feet.  She went to the ED on October 4 and was found to have elevated platelets and WBC.  She was seen in my office on October 9, platelets and WBC increased.
Age: 91.0
Sex: F
Vaccine: RSV
Symptoms: White blood cell count increased
Clinical narrative: Patient had pain and redness at the site within the first day.  On day 5 she started to develop a painful red rash on her feet.  She went to the ED on October 4 and was found to have elevated platelets and WBC.  She was seen in my office on October 9, platelets and WBC increased.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Ear pain, Eye pain, Facial pain, Malaise
Clinical narrative: One very sharp, shooting pain from shoulder, up my neck about 12 hours after vaccination woke me from sleep. I began to feel generally unwell, as I expected and  had experienced in the past. Followed by severe pain on left side of my face, teeth throbbed like they were all abbessed, pain went to my ear, my eye and left side of my nose.  SEVERE pain.. This lasted about 24 hours then totally disappeared.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Neck pain, Pain, Sleep disorder, Toothache
Clinical narrative: One very sharp, shooting pain from shoulder, up my neck about 12 hours after vaccination woke me from sleep. I began to feel generally unwell, as I expected and  had experienced in the past. Followed by severe pain on left side of my face, teeth throbbed like they were all abbessed, pain went to my ear, my eye and left side of my nose.  SEVERE pain.. This lasted about 24 hours then totally disappeared.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Chills, Dizziness, Headache, Pruritus, Pyrexia
Clinical narrative: HA, Fever, Chills, Dizzy, itching ears and arms, blurry vision, feeling like throat is closing. Treatment Benadryl and steroids. Symptoms improving.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Throat tightness, Vision blurred
Clinical narrative: HA, Fever, Chills, Dizzy, itching ears and arms, blurry vision, feeling like throat is closing. Treatment Benadryl and steroids. Symptoms improving.
Age: 50.0
Sex: F
Vaccine: FLU4, HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was inadvertently given a high dose influenza vaccine intended for pts 65+
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 5.0
Sex: F
Vaccine: DTAPIPV, IPV
Symptoms: Extra dose administered
Clinical narrative: Gave an additional IPV.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: Day 1, slight pain in long bones (1-2 days) . Sore right arm persists. Day 3 -present -raised, red sore with scabbing. soreness, warmth and red at injection site 2mm diam.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Scab
Clinical narrative: Day 1, slight pain in long bones (1-2 days) . Sore right arm persists. Day 3 -present -raised, red sore with scabbing. soreness, warmth and red at injection site 2mm diam.
Age: 9.0
Sex: M
Vaccine: FLUN4
Symptoms: Asthma, Wheezing
Clinical narrative: The patient has been hospitalized for wheezing and has asthma, FluMist was given at 410pm and patient was kept for monitoring till 540pm
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Injection site rash, Rash pruritic
Clinical narrative: Patient has developed an itchy rash around one of the vaccines place on right arm (had influenza and MCV) on that arm. Not sure which one. Mother place cool towels and used benadryl cream, but still itchy. No getting worse. No systemic reactions
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Pain
Clinical narrative: Fever, body aches for 1-2 days with light sensitivity, headache. Light sensitivity and headaches, fatigue, muscle pain, joint pain for months following.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, Pyrexia
Clinical narrative: Fever, body aches for 1-2 days with light sensitivity, headache. Light sensitivity and headaches, fatigue, muscle pain, joint pain for months following.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Bell's palsy
Clinical narrative: R sided Bell's Palsy. Onset upon awakening 10/10/23
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: Headache leading to migraine
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Blepharitis, Headache, Keratitis, Myalgia
Clinical narrative: Severe headache, body aches, fever, severe light sensitivity, joint pain, muscle pain, blepharitis, keratoconjunctivitis, nausea, vision disturbance. Fever lasted 4-5 days, other symptoms persisted for over 2 months.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Pain, Photophobia, Pyrexia, Visual impairment
Clinical narrative: Severe headache, body aches, fever, severe light sensitivity, joint pain, muscle pain, blepharitis, keratoconjunctivitis, nausea, vision disturbance. Fever lasted 4-5 days, other symptoms persisted for over 2 months.
Age: 17.0
Sex: F
Vaccine: HEP, IPV, MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: MMRV vaccine administered on a 17 year old patient
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administration error, Underdose
Clinical narrative: The patient came in for their COVID vaccine. The adult and pediatric dose boxes were in the same drawer in the refrigerator and the pediatric box was opened. The pediatric dose was administered and the error was discovered when processing another vaccine. Pfizer was contacted and the recommendation from ACIP was to re-administer the age appropriate vaccine as soon as possible. The patient was contacted and came in and received the correct vaccine (Comirnaty). He was encouraged to call with any future questions or concerns.
Age: 71.0
Sex: M
Vaccine: PNC20
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Sore arm. Pt. feels like he can't lift his arm. He saw his doctor today about it and the dr gave him a muscle relaxer.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 60 years old and received Fluzone HD
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Area noted to have large redness throughout whole leg with rock hard spot near injection spot, with warmness to touch
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth and swelling at injection site. Patient has experienced this with previous covid immunizations
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: The patient came in for their COVID vaccine. The adult and pediatric dose boxes were in the same drawer in the refrigerator and the pediatric box was opened. The pediatric dose was administered and the error was discovered when processing another vaccine. Pfizer was contacted and the recommendation was to re-administer the age appropriate vaccine as soon as possible. The patient was contacted and will return tomorrow for the correct vaccine (Comirnaty). He was encouraged to call with any future questions or concerns.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose, Wrong product administered
Clinical narrative: The patient came in for their COVID vaccine. The adult and pediatric dose boxes were in the same drawer in the refrigerator and the pediatric box was opened. The pediatric dose was administered and the error was discovered when processing another vaccine. Pfizer was contacted and the recommendation was to re-administer the age appropriate vaccine as soon as possible. The patient was contacted and a voicemail was left. Once he is reached we will recommend we re-vaccinate with the appropriate vaccine.
Age: 64.0
Sex: M
Vaccine: FLUA4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received Fluad instead of a standard dose flu as indicated by age.  Patient does not have any side effects noted.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 50.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Cellulitis, Migraine
Clinical narrative: Patient reported getting cellulitis and having a migraine since receiving both vaccines.  Patient has reported that she went to both urgent care and the hospital, but dates of visits are currently unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 27.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Chest pain, Lymphadenopathy
Clinical narrative: Patient received the annual flu shot and new Spikevax covid vaccine on 10/11/23.  Patient called the pharmacy on 10/12/23 and asked to speak to someone about the vaccines she had received.  The patient asked the pharmacist if having chest pain and swelling of the lymph nodes the day after getting vaccines was normal.  The pharmacist told her we sometimes see flu-like symptoms for a day or two after getting these vaccines but if she is having chest pain we would recommend getting medical attention.  Pharmacist enquired if there  were any other factors that could have caused this,  such as physical exertion, exercise or other illness.  Patient said nothing out of the ordinary.  Pharmacist reaffirmed getting medical attention.  Patient did not seem very concerned and said that was all the info she needed for now.
Age: 63.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Fluad Quad 65+ given to a 63 year old.
Age: 21.0
Sex: M
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Really bad Urticaria
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bursitis, Pain in extremity
Clinical narrative: PATIENT EXPERIENCED PAIN IN HER ARM THAT STARTED AFTER RECEIVING THE VACCINE AND CONTINUED. PATIENT WENT TO MD ON 10/12/23 AND WAS DIAGNOSED WITH BURSITIS.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details provided; Medical assistant reports improperly stored vaccine was administered to a patient. Reported excursions occurred 8/3/2023, 8/4/2023 and 8/8/2023. Product was administered to one patient 8/24/2023.  Include in the Description (cut and paste with respon; This spontaneous report was received from medical assistant and referred to a patient of unknown age and gender. The patient's medical history, concurrent condition, and concomitant therapy were not reported.  On 03-AUG-2023, the vaccine hepatitis A vaccine, inactivated (VAQTA) injection had improperly stored temperature excursion with temperature from 36 Fahrenheit degrees ('also reported as '35.6F') to 46 Fahrenheit degrees for 2 hours 30 minutes and 0 seconds. On 04-AUG-2023, this vaccine had below 36 Fahrenheit degrees ('also reported as '35.4F') for 3 hours 0 minutes and 0 seconds. On 08-AUG-2023, this vaccine had temperature excursion from 36 Fahrenheit degrees ('also reported as '35.7F') to 46 Fahrenheit degrees for 9 hours 0 minutes and 0 seconds. On 24-AUG-2023, the patient vaccinated with hepatitis A vaccine, inactivated (VAQTA) injection (valid lot # 1971534 with reported expiry date 06-OCT-2024) (strength, dose description, route of administration were not provided) as prophylaxis (Product storage error). There was no additional adverse event details provided (No adverse event).
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea
Clinical narrative: a little harder to breathe afterwards (dyspnoea); Information has been received from an other company on 14-SEP-2023.  This spontaneous report was received from a consumer referring to a 75 years old female patient. The patient's concurrent condition included primary pulmonary arterial hypertension. The patient's medical history and concomitant therapy were not reported.  On an unknown date in 2023 (reported as "a couple weeks ago"), the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) for immunization (strength, dose and route of administration were unknown; lot number and expiration date were not reported).  After the vaccination, the patient found a little harder to breathe (dyspnoea). At the reporting time, the outcome of the event was unknown.  The causal relationship between zoster vaccine live (ZOSTAVAX) and the event of dyspnoea was reported as possibly related.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Caller reported vaccine administered after temperature excursion.  No other information provided.  No additional AEs or PQC reported.          ?    Names of vaccines involved (including lot/exp) VARIVAX X010534  4/11/2025        ?    Temperature; This spontaneous report was received from a nurse and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapies were not provided.    On 30-SEP-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 ml intramuscularly, lot # X010534, expiration date 11-APR-2025 (anatomical location was not provided), for prophylaxis. The vaccine was incorrectly stored for 1 hour 2 minutes (-1.1 degrees Celsius). There was also a previous excursion (no details reported). No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE/no PQCs.; Nurse reported PROQUAD was administered after TE; see TE case 02487539. See full details below. No additional AE/no PQCs.    ?    Names of vaccines involved PROQUAD X007537 09/08/2024        ?    Temperature 8.1°F        ?    Time frame 3 hour; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 18-SEP-2023, nurse reported PROQUAD was administered after TE; see TE case 02487539 (Temperature 8.1°F for 3 hours). See full details below. No additional AE/no PQCs.  Lot Number X007537 is not valid for V221.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse reported VARIVAX was administered after TE; 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 and concomitant medications was not provided.  On 28-SEP-2023, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (1 dosage form, lot #X000532, expiration date 04-JAN-2025, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Product storage error).   The suspect vaccine experienced a temperature excursion of 8.1 degrees Fahrenheit for 3 hours. No additional adverse events (AEs) or product quality complaints (PQC) were reported (No adverse event). No previous temperature excursion.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Nurse reported PROQUAD was administered after TE; see TE case 02487539. See full details below. No additional AE/no PQCs.    ?    Names of vaccines involved PROQUAD X007537 09/08/2024        ?    Temperature 8.1°F        ?    Time frame 3 hour; This spontaneous report as received from a nurse refers to a patient of unknown age and gender.     The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 21-SEP-2023, the patient was vaccinated with an improperly stored 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), lot# X007537, expiration date: 08-SEP-2023 (exact dose, route of administration and anatomical location were not reported) for prophylaxis.        Administered dose of vaccine was exposed to the temperature excursion of 8.1 degrees Fahrenheit for 3 hours (product storage error). No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event).  Lot number X007537 has been verified to be a non-valid lot number for V221.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Nurse reported VARIVAX  was administered after TE; see TE case 02487539. See full details below. No additional AE/no PQCs.    ?    Names of vaccines involved VARIVAX X000532 1/4/2025        ?    Temperature 8.1°F        ?    Time frame 3 hours; This spontaneous report was received from Other Health Professional and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 25-SEP-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose, lot #X000532, expiration date: 04-JAN-2025 (strength, route of administration, and indication were not provided).   The nurse reported varicella virus vaccine live (oka/merck) (VARIVAX) was administered after temperature excursion (TE) of  8.4 degrees F during a time frame of 3 hours. No Previous temperature excursion was reported. No additional adverse events (AE) were reported.    ?
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Nurse reported PROQUAD was administered after TE; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 26-SEP-2023, the patient was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, as prophylaxis (lot number: X009129, which was determined to be valid, with an expiration date on 24-SEP-2024) (strength, dose, scheme, route and anatomical location of administration were not reported).  The administered dose underwent a temperature excursion of 81 degrees Fahrenheit for 3 hours. No previous temperature excursion was reported.   No additional adverse event was provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE; Nurse reported PROQUAD was administered after TE; see TE case 02487539. See full details below. No additional AE/no PQCs.    ?    Names of vaccines involved PROQUAD X013909 11/10/2024        ?    Temperature 8.1°F        ?    Time frame 3 hour; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 28-SEP-2023, the patient was vaccinated with first dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection,  (lot #X013909 has been verified to be valid, expiration date: 10-NOV-2024), administered for prophylaxis (strength, and route of administration were not provided) after temperature excursion (product storage error). No adverse events reported.    Moreover it was reported, temperature 8.1°F, time frame 3 hours 0 minutes 0 seconds, with no previous temperature excursion
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No adverse effects reported. No additional AE.; HBP calling to report post expiry dose of MMR II.  No adverse effects reported.  No additional AE.  No PQC. LOT U031359  Exp. 10/7/2023; This spontaneous report was received from offiece manager and refers to a 12-month-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-OCT-2023, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, single dose, lot #U031359, expiration date: 07-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Nurse reported that a patient received 2 doses of PROQUAD shorter than recommended.  The first dose of PROQUAD was given on 8/7/2023 and second dose was given on 8/22/2023.  No additional AEs were reported. No further information provided.  No PQC.; No additional AEs were reported.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 07-AUG-2023, the patient was vaccinated with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # w035472 and expiration date 06-MAY-2024 for prophylaxis (exact dose, route and site of administration were not provided). On 22-AUG-2023, the patient was vaccinated with second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # w035472 and expiration date 06-MAY-2024 for prophylaxis (exact dose, route and site of administration were not provided) (inappropriate schedule of product administration and no adverse event).
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; The patient then came down with shingles a few weeks ago; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In FEB-2021, the patient received the 2nd dose of Shingrix. In OCT-2020, the patient received the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: The patient then came down with shingles a few weeks ago).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 22-MAR-2023 The patient received Shingrix 1st dose and then 2nd dose.  The patient then came down with shingles a few weeks ago per the health care professional (hcp). This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up.
Sex: U
Vaccine: UNK, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: outbreak of shingles occurred on the left side of my torso/suspected vaccination failure; outbreak of shingles occurred on the left side of my torso; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (INFLUENZA SHOT) for prophylaxis.   The patient's past medical history included shingles (had shingles twice before (in 1981 in my 20s and then later on)).   On 12-JAN-2021, the patient received Shingrix. On 29-SEP-2023, the patient received INFLUENZA SHOT. On 01-OCT-2023, 992 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: outbreak of shingles occurred on the left side of my torso/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: outbreak of shingles occurred on the left side of my torso).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK receipt date: 6-Oct-2023 The patient received a Shingrix vaccination and on 29th September 2023,  received his or her annual flu shot vaccination.  Two days later after Flu shot, the patient had an outbreak of shingles occurred on the left side of his or her torso. The patient was very disappointed to be suffering the effects of shingles now at age 65 after receiving the Shingrix medication. The physician said that no vaccine was 100 percent effective but come on man. The patient really did not want a callback. It was unknown if the reporter considered the shingles to be related to Flu shot. This case was considered as suspected vaccination failure as details regarding completion of primary schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: RSV
Symptoms: Nausea
Clinical narrative: Nauseous; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nausea in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced nausea (Verbatim: Nauseous).  The outcome of the nausea was not reported.   It was unknown if the reporter considered the nausea to be related to Arexvy.     It was unknown if the company considered the nausea to be related to Arexvy.   Additional Information: GSK Receipt date: 03-OCT-2023 This case was reported via interactive digital media. Follow up was not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Mobility decreased, Pain
Clinical narrative: Put me in bed; Broken out in very active shingles; Very painful; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date, refer linked case US2023AMR136019).   On 27-SEP-2023, the patient received the 2nd dose of Shingrix. In SEP-2023, 4 hrs after receiving Shingrix, the patient experienced shingles (Verbatim: Broken out in very active shingles) and pain (Verbatim: Very painful). On an unknown date, the patient experienced mobility decreased (Verbatim: Put me in bed). The outcome of the shingles, pain and mobility decreased were not reported.   It was unknown if the reporter considered the shingles, pain and mobility decreased to be related to Shingrix.     It was unknown if the company considered the shingles, pain and mobility decreased to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR136019   Additional Information: GSK Receipt Date: 02-OCT-2023 The reporter reported that the on Thursday and within 4 hours she experienced broken out in very active shingles in eleven locations on her body. The reporter stated that they were very painful and put her in bed. The reporter asked is this normal or do she need to be concerned.; Sender's Comments:  US-GSK-US2023AMR136019:same patient different dose
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose of Shingrix on 27Oct2021 and is late for 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 27-OCT-2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose of Shingrix on 27Oct2021 and is late for 2nd dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 02-OCT-2023 The reporter did not have lot/expiry date. The reporter consented to follow-up via postal mail. Till the time of vaccination, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: the use of FluLaval in patients over 65 and wanted to know if there was an issue; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 65-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 7ASC3) for prophylaxis.   On 29-SEP-2023, the patient received FluLaval Quadrivalent. On 29-SEP-2023, an unknown time after receiving FluLaval Quadrivalent, the patient experienced inappropriate age at vaccine administration (Verbatim: the use of FluLaval in patients over 65 and wanted to know if there was an issue).  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: 02-OCT-2023 The vaccine administration facility was the same as primary reporter The physician called in to request information about the use of FluLaval in patients over 65, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: RSV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: right arm is still in a lot of pain/Arexvy site still painful; could not lift her right arm; This non-serious case was reported by a nurse via call center representative and described the occurrence of pain in arm in a adult female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number JC7Z5, expiry date 01-FEB-2025) for prophylaxis.   Concomitant products included COVID-19 VACCINE (COVID VACCINE).   On 18-SEP-2023, the patient received Arexvy (right arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: right arm is still in a lot of pain/Arexvy site still painful) and injected limb mobility decreased (Verbatim: could not lift her right arm).The patient was treated with paracetamol (Tylenol), ibuprofen, non-drug therapy (Ice Pack (No Medication)) and non-drug therapy (Heat (Non-Drug Therapy)).The outcome of the pain in arm was not resolved and the outcome of the injected limb mobility decreased was unknown.   It was unknown if the reporter considered the pain in arm and injected limb mobility decreased to be related to Arexvy.   It was unknown if the company considered the pain in arm and injected limb mobility decreased to be related to Arexvy.   Additional Information: GSK Receipt Date: 02-OCT-2023 The case was reported by the patient.  She stated that she received Arexvy in right arm and Covid vaccine in left arm.  She stated that her left arm was fine but her right arm was still in a lot of pain.  She could not lift her arm.  She was tried, ice, heat, salon pas patches, Tylenol and Ibuprofen without success.  She stated that Arexvy injection site still painful.  The reporter consented to follow up.
Age: 63.0
Sex: M
Vaccine: RSV
Symptoms: Incorrect dose administered, Product preparation issue, Wrong technique in product usage process
Clinical narrative: pharmacist pulled back the label and noticed that the lyophilized tablet was not dissolved; the lyophilized tablet was not dissolved; the lyophilized tablet was not dissolved; Wrong technique in drug usage process; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 63-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3EX93, expiry date 24-FEB-2025) for prophylaxis. This case was associated with a product complaint.   On 29-SEP-2023, the patient received Arexvy (injection, right arm). On 29-SEP-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: the lyophilized tablet was not dissolved), inappropriate dose of vaccine administered (Verbatim: the lyophilized tablet was not dissolved) and wrong technique in drug usage process (Verbatim: Wrong technique in drug usage process). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: pharmacist pulled back the label and noticed that the lyophilized tablet was not dissolved).The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered, wrong technique in drug usage process and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 02-OCT-2023 and 05-OCT-2023 The reporter reported that another pharmacist at facility gave an Arexvy injection to a patient.  After injecting the Arexvy into the patient's right arm, the pharmacist pulled back the label and noticed that the lyophilized tablet was not dissolved and administering pharmacist then called patient back, reconstituted the same undissolved antigen vial with another new adjuvant vial and re-administered the dose of Arexvy, which led to inappropriate preparation of medication, inappropriate dose of vaccine administered and wrong technique in drug usage process. Both injections were given in the same arm on the same day. The reporter reviewed video of administering pharmacist reconstituting Arexvy dose both times and stated that he prepared the dose correctly according to the PI instructions.  No harm to patient had been reported by facility staff at this time. The reported defect was classified as vaccine appearance.
Sex: M
Vaccine: MENB, MENB, MENB
Symptoms: Interchange of vaccine products, Product supply issue
Clinical narrative: administration of Trumenba; facility not having Bexsero; This non-serious case was reported by a physician via call center representative and described the occurrence of interchange of vaccine products in a 19-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 13-OCT-2021, the patient received the 1st dose of Bexsero. On an unknown date, the patient received the 2nd dose of Bexsero. On 08-JUN-2022, the patient received TRUMENBA. On an unknown date, an unknown time after receiving Bexsero and not applicable after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: administration of Trumenba) and product supply issue (Verbatim: facility not having Bexsero).  The outcome of the interchange of vaccine products and product supply issue 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 2 Oct 2023: The physician stated that a patient received his first dose of Bexsero on 13-OCT-2021. At another facility, the patient received Trumenba on 8-JUN-2022 and 10-OCT-2022 due to the facility not having Bexsero, which led to interchange of vaccine products and product supply issue. The patient was scheduled to received second dose of Bexsero on 9th October 2023. Follow-up via email was accepted.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Injection site erythema, Injection site swelling, Malaise, Nausea
Clinical narrative: Feeling unwell; Nausea; Headaches; Significant redness and swelling at the injection site; Significant redness and swelling at the injection site; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number PX7E2, expiry date 30-SEP-2026) for prophylaxis.   On 22-SEP-2023, the patient received Bexsero (right deltoid). In SEP-2023, an unknown time after receiving Bexsero, the patient experienced injection site swelling (Verbatim: Significant redness and swelling at the injection site) and injection site erythema (Verbatim: Significant redness and swelling at the injection site). On an unknown date, the patient experienced feeling unwell (Verbatim: Feeling unwell), nausea (Verbatim: Nausea) and headache (Verbatim: Headaches).The outcome of the injection site swelling, injection site erythema, feeling unwell, nausea and headache were unknown.   The reporter considered the injection site swelling, injection site erythema, feeling unwell, nausea and headache to be possibly related to Bexsero and Bexsero Pre-Filled Syringe Device.  The company considered the injection site swelling, injection site erythema, feeling unwell, nausea and headache to be possibly related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-OCT-2023 The reporter was a nurse form a clinic who stated a patient received Bexsero in her right deltoid and a day later the patient noticed swelling and redness at the injection site but the clinic was not notified until days later.  The patient was seen the day before reporting at the clinic and had a significant swelling and redness at the injection site, patient was feeling unwell with headache and nauseas.  The treating physician believed that the patient was having an adverse event related to the vaccine.  The reporter consented to follow up.
Age: 5.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: pts 5th dose where Boostrix was admin instead of Infanrix; pts 5th dose where Boostrix was admin instead of Infanrix; 5 year old male received a dose of Boostrix on 20Sep2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 5-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2B723, expiry date 17-OCT-2025) for prophylaxis.   On 20-SEP-2023, the patient received Boostrix. On 20-SEP-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: pts 5th dose where Boostrix was admin instead of Infanrix), inappropriate schedule of vaccine administered (Verbatim: pts 5th dose where Boostrix was admin instead of Infanrix) and inappropriate age at vaccine administration (Verbatim: 5 year old male received a dose of Boostrix on 20Sep2023).  The outcome of the wrong vaccine administered, inappropriate schedule of vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 3-Oct-2023 The medical assistant reported no symptoms. The reporter consented to follow-up via email. The patient received a dose of Boostrix as 5th dose instead of Infanrix at an inappropriate age, which led to wrong vaccine administered, inappropriate schedule of vaccine administered and inappropriate age at vaccine administration.
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: has not received another dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received first dose in February 2023).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: has not received another dose yet).  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: 3-Oct-2023 The pharmacist reported that the patient had not receive another dose yet. The reporter declined follow up, did not have any patient information. Did not consent to follow-up. Till the time of reporting, the patient did not receive second dose of Twinrix, which led to incomplete course of vaccination.
Age: 38.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Lymphadenopathy, Product administered to patient of inappropriate age
Clinical narrative: swelling lymph node in right armpit; below 50 years old patient received shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of axillary lymph nodes enlarged in a 38-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   On 28-SEP-2023, the patient received Shingrix (right arm) and INFLUENZA VACCINE (right arm). On 28-SEP-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: below 50 years old patient received shingrix). On an unknown date, the patient experienced axillary lymph nodes enlarged (Verbatim: swelling lymph node in right armpit).  The outcome of the axillary lymph nodes enlarged was not resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the axillary lymph nodes enlarged to be related to Shingrix.     It was unknown if the company considered the axillary lymph nodes enlarged to be related to Shingrix.   Additional Information: GSK Receipt date: 03-OCT-2023 The patient was self-reported.  The patient stated she received Shingrix and Flu vaccine (from Sanofi-pasteur manufacturer) on 28 September 2023 in her right arm and since them she noticed swelling lymph nodes in her right armpit. It was unknown if the reporter considered the axillary lymph nodes enlarged to be related to Flu vaccine.   38 years old patient received Shingrix which led to inappropriate age at vaccine administration. The reporter did not consent to follow-up.
Sex: U
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the diluent component of rotarix; received only the diluent component of rotarix; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate preparation of medication (Verbatim: received only the diluent component of rotarix) and inappropriate dose of vaccine administered (Verbatim: received only the diluent component of rotarix).  The outcome of the inappropriate preparation of medication and inappropriate dose 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: 3-Oct-2023 The GlaxoSmithKline field representative provided limited information. The reporter consented to follow-up. The patient received only diluent of Rotarix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.