chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: SARS-CoV-2 test negative, Somnolence
Clinical narrative: Dizzy immediately after vaccine.  That night, slight fever, fatigue, headache, and sore muscles on left side of neck.  Next day fever went up to 100.5 at night,  fatigue, stomach ache, loss of appetite, ear ache, headache.  Drinking lots of water and herbal tea.  Eating mostly soup and fresh fruit.  Taking Tylenol PM tablet to sleep, both nights. Bed rest and sleeping during the afternoon 1-2  hours.  Today, two days after vaccine, feeling better.  Still tired, still eating bland food and  soup and tea.  Slight nausea.  Temp dropped to 97.8 degrees in am.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Wrong vaccine formulation administered
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Wrong vaccine formulation administered
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, HPV9
Symptoms: Circumstance or information capable of leading to medication error, Wrong product administered
Clinical narrative: PICKED UP THE WRONG BOX OF VACCINES AND ADMINISTERED, DIDN'T REALIZE IT UNTIL, I WENT TO DOCUMENT THE VACCINATION IN THE CHART
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Asthenia, Cough, Respiratory tract congestion
Clinical narrative: 48 hours after my vaccination I developed a fever of around 100 degrees along with coughing and throat congestion and weakness. This has continued for 48 hours now.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, No adverse event, Wrong patient received product
Clinical narrative: Vaccine given to student because parent mistakenly wrote his name (instead of younger brother) on the consent form and he was called into the vaccine clinic. This student had already completed the two-dose series.  Parents were notified. He suffered no ill effects as of this afternoon.
Age: 74.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Gait disturbance, Myalgia, Pain in extremity, Walking aid user
Clinical narrative: Extreme pain in joints, then spreading to muscles from calves up to cranium.  To date, 5 days duration.  I still have not recovered.  I cannot walk without a Walker.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Blood test normal, Disturbance in attention, Fatigue, Hypersomnia
Clinical narrative: Intense , debilitating exhaustion (like the sensation one gets when fighting off an infection): 5 weeks so far since the vaccination. Sleeping 12 hours, waking fatigued, napping, having a hard time focusing, exhausted after a simple activity like walking or doing laundry. The first four weeks I felt a kind of sickness to the fatigue. Week 5 I feel absolutely exhausted but without the zombie yuckiness.  Also, there's still a warm red blotch on my arm at the injection site, 5 weeks later.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site macule, Injection site warmth, Laboratory test normal, Loss of personal independence in daily activities
Clinical narrative: Intense , debilitating exhaustion (like the sensation one gets when fighting off an infection): 5 weeks so far since the vaccination. Sleeping 12 hours, waking fatigued, napping, having a hard time focusing, exhausted after a simple activity like walking or doing laundry. The first four weeks I felt a kind of sickness to the fatigue. Week 5 I feel absolutely exhausted but without the zombie yuckiness.  Also, there's still a warm red blotch on my arm at the injection site, 5 weeks later.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Thyroid function test normal
Clinical narrative: Intense , debilitating exhaustion (like the sensation one gets when fighting off an infection): 5 weeks so far since the vaccination. Sleeping 12 hours, waking fatigued, napping, having a hard time focusing, exhausted after a simple activity like walking or doing laundry. The first four weeks I felt a kind of sickness to the fatigue. Week 5 I feel absolutely exhausted but without the zombie yuckiness.  Also, there's still a warm red blotch on my arm at the injection site, 5 weeks later.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dropped head syndrome, Gait disturbance
Clinical narrative: 1 hour post vaccination patient had episodes of unstable gait, labile level of awareness and responsiveness.  EMT services called when the patient was unable to hold up head and respond to verbal and tactile stimuli.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Bronchospasm, Cough, Dyspnoea
Clinical narrative: Patient with bronchospasm, coughing, shortness of breath. Treated with Epi-pen, Solu-medrol, Benadryl, Pepcid and Duoneb in the clinic. Then transferred to hospital for higher level of care via EMS. Patient stabilized in the clinic. Monitored for a few hours in the ER and release in stable condition.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: pt said her arms is hurting very bad. it is very red and hot to touch
Age: 69.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: No side effects were reported; an adult received a pediatric dose of VAQTA inadvertently; This spontaneous report was received from registered nurse referring to a 69-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-OCT-2023, the elderly (also reported as adult) patient was vaccinated with a pediatric dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection inadvertently, 0.5 milliliter, lot #1971532 (has been verified to be a valid lot number for hepatitis A vaccine, inactivated), expiration date: 13-SEP-2024, as prophylaxis (strength and route of administration were not provided) (Incorrect dose administered). No side effects were reported. No additional information provided.
Sex: M
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This spontaneous report was received from a lawyer regarding a case in litigation and referred to male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 24-JUN-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the routine health maintenance prevention of shingles (herpes zoster) (strength, dose, route, lot number and expiration date were not provided). On an unspecified date in 2016 (reported as shortly after vaccination), the patient experienced bell's palsy. The outcome of the event was not recovered. The lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX). Upon internal review, the event bell's palsy was determined to be medically significant. The reporter considered the event bell's palsy to be disability.
Sex: U
Vaccine: HPV9
Symptoms: Dizziness, Headache
Clinical narrative: severe headache and dizziness; severe headache and dizziness; This spontaneous report was received from a nurse referring to an adolescent patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On unknown date, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection 0.5 mL/dose as prophylaxis (lot#, expiration date, route of administration and anatomical location not provided).  On an unknown date, the patient experienced severe headache and dizziness, of which it was recommended to discontinue the series. It was unknown whether the patient received treatment for severe headache and dizziness. Additional adverse event details were unknown. At the reporting time, the outcome of severe headache and dizziness was not reported. The action taken with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was withdrawn.  The causal relationship between severe headache and dizziness and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No other AE; HBP calling to report the administration of an expired dose of ROTATEQ and PEDVAXHIB to a patient on 11/03/2023.  Caller confirmed no previous temperature excursions for these products and stored in the recommended range until the time of administrat; This spontaneous report was received from medical assistant and refers to a patient to unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-NOV-2023, the patient was vaccinated with expirienced dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #W010331, expiration date: 01-NOV-2023, administered orally for prophylaxis (strength was not provided); and  haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #U024090, expiration date: 28-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse event was reported.
Sex: M
Vaccine: PPV, RSV
Symptoms: Syncope
Clinical narrative: Syncope; This serious case was reported by a consumer via sales rep and described the occurrence of syncope in a 75-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE for prophylaxis.   On 20-OCT-2023, the patient received Arexvy and PNEUMOCOCCAL VACCINE. On 21-OCT-2023, 1 days after receiving Arexvy, the patient experienced syncope (Verbatim: Syncope) (serious criteria GSK medically significant). The outcome of the syncope was not reported.   It was unknown if the reporter considered the syncope to be related to Arexvy.     It was unknown if the company considered the syncope to be related to Arexvy.   Additional Information: GSK Receipt Date: 02-NOV-2023 The reporter stated the patient was given both the Arexvy and pneumococcal vaccine on the same time. The patient experienced syncope. It was unknown if the reporter considered the syncope to be related to pneumococcal vaccine.  The reporter did not consented to follow up.
Sex: M
Vaccine: RSV
Symptoms: Fatigue, Malaise, Pain
Clinical narrative: tiredness; achiness; ill for 4 days; This non-serious case was reported by a physician via interactive digital media and described the occurrence of tiredness in a elderly male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received the 1st dose of Arexvy (unknown arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced tiredness (Verbatim: tiredness), pain (Verbatim: achiness) and unwell (Verbatim: ill for 4 days). The outcome of the tiredness, pain and unwell were resolved (duration 4 days).   The reporter considered the tiredness and pain to be related to Arexvy. It was unknown if the reporter considered the unwell to be related to Arexvy.     The company considered the tiredness and pain to be related to Arexvy. It was unknown if the company considered the unwell to be related to Arexvy.  Additional Information: GSK Receipt Date: 29-OCT-2023 This case was reported by a patient via interactive digital media. The patient, who claims to be a physician, wrote on the social medial platform that they received the RSV vaccine (brand unspecified) and was ill for 4 days with tiredness and achiness. They also stated, it was not as bad as the shingles vaccine. The reporter did not consent to follow-up.
Sex: M
Vaccine: RSV
Symptoms: Injection site pain
Clinical narrative: sting; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of stinging in a male 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 stinging (Verbatim: sting). The outcome of the stinging was unknown.   It was unknown if the reporter considered the stinging to be related to Arexvy.     It was unknown if the company considered the stinging to be related to Arexvy.   Additional Information: GSK Receipt Date: 31-OCT-2023 A GSK Field Representative reported that a pharmacist stated that of 169 patients that received the vaccine Arexvy at a local pharmacy, the most common comment from the patients was that the vaccine stings. The pharmacist stated that the ratio was 50/50 for male and female patients. No additional information was provided. The reporter consented to follow up. This case is linked to US2023AMR152513, same reporter.; Sender's Comments:  US-GSK-US2023AMR152513:Female Patients case
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Product administration error
Clinical narrative: 35 years old was given vaccine in error; This non-serious case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 35-year-old female patient who received Herpes zoster (Shingrix) (batch number CRSXF, expiry date 23-AUG-2025) for prophylaxis.   Concurrent medical conditions included anxiety. Concomitant products included escitalopram.   On 14-JUL-2023, the patient received Shingrix .5 ml. On 14-JUL-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 35 years old was given vaccine in error). The outcome of the inappropriate age at vaccine administration was resolved.   Additional Information: GSK Receipt Date: 02-NOV-2023 35 year old patient was given the vaccine in error when it was not indicated which led to inappropriate age at vaccine administration. The patient had not reported any side effects at the time of reporting. The reporter enquired was there anything patient should be watching out for at this time.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: unable to get the second shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (In 2021, received first dose).   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: unable to get the second shot). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-OCT-2023 The case was received from the patient via interactive digital media. The patient received a Shingrix shot during the COVID pandemic (in 2021) but was unable to get the second shot. The reporter asked if he should start over now and get two shots (as though he never received any shots), or do he get his second and final shot now. The follow-up could not be possible as no contact details were available. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: RSV
Symptoms: Malaise
Clinical narrative: Sick; This non-serious case was reported by a physician via sales rep and described the occurrence of sickness in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 1 day after receiving Arexvy, the patient experienced sickness (Verbatim: Sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Arexvy.   It was unknown if the company considered the sickness to be related to Arexvy.   Additional Information: GSK Receipt Date: 30-OCT-2023 A healthcare professional (Hcp) reported that a patient got sick 1 day following rsv vaccine.  The hcp reported that the patient was positive for mono and it was a coincidence. The reporter did not consent to follow up.
Sex: U
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Very sore arm and not getting better; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm (Verbatim: Very sore arm and not getting better). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Arexvy.     It was unknown if the company considered the pain in arm to be related to Arexvy.   Additional Information: GSK Receipt Date: 28-OCT-2023 The case was received from the consumer via interactive digital media The patient received Arexvy and had very sore arm and not getting better. The follow-up could not be possible as no contact details were available. This case was linked with US2023AMR151220 and US2023AMR151221, reported by the same reporter for different patients.; Sender's Comments:  US-GSK-US2023AMR151221:Sme reporter US-GSK-US2023AMR151220:Same reporter
Age: 0.33
Sex: F
Vaccine: FLU4
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: accidentally given/accidentally given outside of label, to a 4 month old; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 2YA52, expiry date 30-JUN-2024) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent .5 ml. On an unknown date, an unknown time after receiving FluLaval Quadrivalent, the patient experienced inappropriate age at vaccine administration (Verbatim: accidentally given/accidentally given outside of label, to a 4 month old). 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: 30-OCT-2023 The reporter stated the vaccine was accidentally given outside of label to 4-month-old patient which led to Inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Drug dose administration interval too long; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 3rd November 2022).   On 30-OCT-2023, the patient received the 2nd dose of Twinrix. On 30-OCT-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Drug dose administration interval too long). 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:30-OCT-2023 The patient received the Hepatitis A B Twinrix vaccine on 3rd November 2022.  They did not give him/her any information that he/she would need two more shots and that he/she needed to follow up in six months for the 2nd dose.  The patient learned that within the past week when he/she googled to see if the Twinrix vaccine was an annual thing. So, he/she got the second dose on 30th October 2023.  He/she notified the pharmacist about his/her previous one and how he/she wonder did he/she had to start over because of the time gap.  The pharmacist told him/her that no he/she did not need to start over and gave him/her the second dose.  The patient was wondering that accurate advice because when he/she asked them how long did the last they did not know and it was the same organization but different city who did not advise me properly the first time. The patient received 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: RSV
Symptoms: Body temperature increased, Influenza like illness, Peripheral swelling, Tenderness
Clinical narrative: Swollen arm; Arm sore to touch; flu type feeling; Elevated Temperature; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 23-OCT-2023, the patient received Arexvy. On 24-OCT-2023, 1 days after receiving Arexvy, the patient experienced influenza (Verbatim: flu type feeling) and body temperature increased (Verbatim: Elevated Temperature). On 28-OCT-2023, the patient experienced swelling arm (Verbatim: Swollen arm) and pain in arm (Verbatim: Arm sore to touch). The outcome of the influenza, body temperature increased, swelling arm and pain in arm were not reported.   It was unknown if the reporter considered the influenza, body temperature increased, swelling arm and pain in arm to be related to Arexvy.   It was unknown if the company considered the influenza, body temperature increased, swelling arm and pain in arm to be related to Arexvy.   Additional Information: GSK Receipt Date: 30-OCT-2023 The reporter reported that experiencing flu type feeling with an elevated temperature and her arm was swollen and sore to touch after getting Arexvy. The reporter did not provide lot number, expiration date or date of birth. No additional information was provided.
Sex: U
Vaccine: RSV
Symptoms: Pain
Clinical narrative: is aching after rsv shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain 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 pain (Verbatim: is aching after rsv shot). The outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Arexvy.  It was unknown if the company considered the pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 31-OCT-2023 The case was received from the patient via (Open field AE monitoring) interactive digital media. The patient stated that it was aching after the RSV shot. Follow-up would not be possible, as no contact details were available.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Coordination abnormal, Illness, Lip swelling, Mouth swelling
Clinical narrative: felt weak particularly in legs and felt overall uncoordinated; felt weak particularly in legs and felt overall uncoordinated; extreme swelling in lips and mouth area; extreme swelling in lips and mouth area; became ill; This non-serious case was reported by a consumer via sales rep and described the occurrence of coordination abnormal in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28-OCT-2023 12:00, the patient received the 1st dose of Shingrix. On 29-OCT-2023, 1 days after receiving Shingrix, the patient experienced coordination abnormal (Verbatim: felt weak particularly in legs and felt overall uncoordinated), lower extremities weakness of (Verbatim: felt weak particularly in legs and felt overall uncoordinated), swollen mouth (Verbatim: extreme swelling in lips and mouth area), lip swelling (Verbatim: extreme swelling in lips and mouth area) and illness (Verbatim: became ill). The patient was treated with steroids nos (Steroids) and benadryl (nos) (Benadryl). The outcome of the coordination abnormal, lower extremities weakness of, swollen mouth, lip swelling and illness were not reported.   It was unknown if the reporter considered the coordination abnormal, lower extremities weakness of, swollen mouth, lip swelling and illness to be related to Shingrix.   It was unknown if the company considered the coordination abnormal, lower extremities weakness of, swollen mouth, lip swelling and illness to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-OCT-2023 The patient stated that she received the vaccine and became ill the next day as she woke up on Sunday and felt weak particularly in legs and felt overall uncoordinated.  Later that evening she had extreme swelling in lips and mouth area.  She called a doctor who advised to take an allergy pill and get to an emergency room (ER) as soon as possible. She immediately went to the ER where she was given IV 125 mg steroid and 50 mg Benadryl and was prescribed oral steroids for 6 days. She saw another doctor on Tuesday at urgent care to get checked out because she needed to travel for work routing within the state. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Muscular weakness
Clinical narrative: felt weak particularly in legs and felt overall uncoordinated; felt weak particularly in legs and felt overall uncoordinated; extreme swelling in lips and mouth area; extreme swelling in lips and mouth area; became ill; This non-serious case was reported by a consumer via sales rep and described the occurrence of coordination abnormal in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28-OCT-2023 12:00, the patient received the 1st dose of Shingrix. On 29-OCT-2023, 1 days after receiving Shingrix, the patient experienced coordination abnormal (Verbatim: felt weak particularly in legs and felt overall uncoordinated), lower extremities weakness of (Verbatim: felt weak particularly in legs and felt overall uncoordinated), swollen mouth (Verbatim: extreme swelling in lips and mouth area), lip swelling (Verbatim: extreme swelling in lips and mouth area) and illness (Verbatim: became ill). The patient was treated with steroids nos (Steroids) and benadryl (nos) (Benadryl). The outcome of the coordination abnormal, lower extremities weakness of, swollen mouth, lip swelling and illness were not reported.   It was unknown if the reporter considered the coordination abnormal, lower extremities weakness of, swollen mouth, lip swelling and illness to be related to Shingrix.   It was unknown if the company considered the coordination abnormal, lower extremities weakness of, swollen mouth, lip swelling and illness to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-OCT-2023 The patient stated that she received the vaccine and became ill the next day as she woke up on Sunday and felt weak particularly in legs and felt overall uncoordinated.  Later that evening she had extreme swelling in lips and mouth area.  She called a doctor who advised to take an allergy pill and get to an emergency room (ER) as soon as possible. She immediately went to the ER where she was given IV 125 mg steroid and 50 mg Benadryl and was prescribed oral steroids for 6 days. She saw another doctor on Tuesday at urgent care to get checked out because she needed to travel for work routing within the state. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lip swelling
Clinical narrative: felt weak particularly in legs and felt overall uncoordinated; felt weak particularly in legs and felt overall uncoordinated; extreme swelling in lips and mouth area; extreme swelling in lips and mouth area; became ill; This non-serious case was reported by a consumer via sales rep and described the occurrence of coordination abnormal in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28-OCT-2023 12:00, the patient received the 1st dose of Shingrix. On 29-OCT-2023, 1 days after receiving Shingrix, the patient experienced coordination abnormal (Verbatim: felt weak particularly in legs and felt overall uncoordinated), lower extremities weakness of (Verbatim: felt weak particularly in legs and felt overall uncoordinated), swollen mouth (Verbatim: extreme swelling in lips and mouth area), lip swelling (Verbatim: extreme swelling in lips and mouth area) and illness (Verbatim: became ill). The patient was treated with steroids nos (Steroids) and benadryl (nos) (Benadryl). The outcome of the coordination abnormal, lower extremities weakness of, swollen mouth, lip swelling and illness were not reported.   It was unknown if the reporter considered the coordination abnormal, lower extremities weakness of, swollen mouth, lip swelling and illness to be related to Shingrix.   It was unknown if the company considered the coordination abnormal, lower extremities weakness of, swollen mouth, lip swelling and illness to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-OCT-2023 The patient stated that she received the vaccine and became ill the next day as she woke up on Sunday and felt weak particularly in legs and felt overall uncoordinated.  Later that evening she had extreme swelling in lips and mouth area.  She called a doctor who advised to take an allergy pill and get to an emergency room (ER) as soon as possible. She immediately went to the ER where she was given IV 125 mg steroid and 50 mg Benadryl and was prescribed oral steroids for 6 days. She saw another doctor on Tuesday at urgent care to get checked out because she needed to travel for work routing within the state. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, No adverse event, Product use issue
Clinical narrative: Arexvy was administered to a pregnant patient 36 weeks and 2 days gestation; This non-serious prospective pregnancy case was reported by a pharmacist via sales rep and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 19-OCT-2023, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy was administered to a pregnant patient 36 weeks and 2 days gestation). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 36 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 30-OCT-2023 The reporter stated that, the Arexvy vaccine was administered by an NP (nurse practitioner) to a pregnant patient at 36 weeks and 2 days gestation, which led to vaccine exposure during pregnancy. The patient had not reported any ADE's (adverse events) since that time. The reporter did not agree to follow up from GSK.
Sex: U
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: They were dosing Bexsero like Trumenba; This non-serious case was reported by a physician via sales rep and described the occurrence of interchange of vaccine products in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On an unknown date, the patient received Bexsero and TRUMENBA. On an unknown date, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: They were dosing Bexsero like Trumenba). The outcome of the interchange of vaccine products 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: 27-JUL-2023 It was reported that they were dosing Bexsero like Trumenba which led to interchange of vaccine products.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness unilateral, Condition aggravated, Keratitis, Oral herpes, Pharyngeal swelling
Clinical narrative: blindness left eye; exacerbation of stromal keratitis; fever; cold sores; throat swollen; This serious case was reported by a consumer via call center representative and described the occurrence of blind left eye in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included keratitis (Stromal Keratitis).   On 17-OCT-2023, the patient received the 2nd dose of Shingrix. On 17-OCT-2023, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: fever), cold sores (Verbatim: cold sores) and throat swelling (Verbatim: throat swollen). On 18-OCT-2023, the patient experienced blind left eye (Verbatim: blindness left eye) (serious criteria GSK medically significant) and condition aggravated (Verbatim: exacerbation of stromal keratitis). The outcome of the blind left eye, fever, cold sores, throat swelling and condition aggravated were unknown.   It was unknown if the reporter considered the blind left eye, fever, cold sores, throat swelling and condition aggravated to be related to Shingrix.     It was unknown if the company considered the blind left eye, fever, cold sores, throat swelling and condition aggravated to be related to Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: blindness left eye; exacerbation of stromal keratitis; fever; cold sores; throat swollen; This serious case was reported by a consumer via call center representative and described the occurrence of blind left eye in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included keratitis (Stromal Keratitis).   On 17-OCT-2023, the patient received the 2nd dose of Shingrix. On 17-OCT-2023, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: fever), cold sores (Verbatim: cold sores) and throat swelling (Verbatim: throat swollen). On 18-OCT-2023, the patient experienced blind left eye (Verbatim: blindness left eye) (serious criteria GSK medically significant) and condition aggravated (Verbatim: exacerbation of stromal keratitis). The outcome of the blind left eye, fever, cold sores, throat swelling and condition aggravated were unknown.   It was unknown if the reporter considered the blind left eye, fever, cold sores, throat swelling and condition aggravated to be related to Shingrix.     It was unknown if the company considered the blind left eye, fever, cold sores, throat swelling and condition aggravated to be related to Shingrix.
Age: 29.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: inadvertently administered an expired Havrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 29-year-old male patient who received HAV (Havrix) (batch number NZ7GR, expiry date 17-JUN-2023) for prophylaxis.   On 21-JUN-2023, the patient received Havrix. On 21-JUN-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: inadvertently administered an expired Havrix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 30-Oct-2023 The registered nurse called to inquired that it was still good or they should revaccinate. The reporter did not consent to follow-up. The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Movement disorder, Peripheral swelling, Pyrexia
Clinical narrative: hard to move arm; redness of left arm; Swellingof left arm; slight fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of movement disorder in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27-OCT-2023, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On 27-OCT-2023, less than a day after receiving Shingrix, the patient experienced swelling arm (Verbatim: Swellingof left arm) and fever (Verbatim: slight fever). On 28-OCT-2023, the patient experienced movement disorder (Verbatim: hard to move arm) and erythema of extremities (Verbatim: redness of left arm). On 28-OCT-2023, the outcome of the fever was resolved. The outcome of the movement disorder, erythema of extremities and swelling arm were not resolved.   It was unknown if the reporter considered the movement disorder, erythema of extremities, swelling arm and fever to be related to Shingrix.     It was unknown if the company considered the movement disorder, erythema of extremities, swelling arm and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-OCT-2023 The reporter was the patient who received her second Shingrix Vaccine and stated that she did not had this reaction after the first vaccine, however it was not at the same pharmacy. The reporter stated that she had hardness to move arm, redness, swelling and a slight fever since receiving this second vaccine. The reporter asked questions about what to do for these issues and was advised to speak to her pharmacist of for medical advice.  The reporter consented to follow up.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 40 years old received Pediarix; administered Pediarix instead a Tdap vaccine; 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 40-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number ZK4XF, expiry date 11-APR-2025) for prophylaxis.   On 30-OCT-2023, the patient received Pediarix. On 30-OCT-2023, an unknown time after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: 40 years old received Pediarix) and wrong vaccine administered (Verbatim: administered Pediarix instead a Tdap vaccine). The outcome of the inappropriate age at vaccine administration and wrong 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: 30-OCT-2023 The nurse reported 40 year old male was supposed to receive a Tdap vaccine but a Medical Assistant administered Pediarix instead which led to inappropriate age at vaccine administered and wrong vaccine administered. At the time of reporting, no additional dosing had occurred. The reporter consented to follow up. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of vaccine/cannot confirm that she ever received her 2nd dose of Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose in July 2018 probably in her left 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: Inappropriate schedule of vaccine/cannot confirm that she ever received her 2nd dose of Shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 26-Jul-2023 The reporter was reported that she received her 1st dose of Shingrix in July 2018 probably in her left arm (no further information provided about this vaccine), and cannot confirm that she ever received her 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter was not ask for consent to follow up with HCP.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Mobility decreased
Clinical narrative: Reporter states she had no energy and was actually lying in the bathroom floor due to no energy; This non-serious case was reported by a consumer via call center representative and described the occurrence of loss of energy in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced loss of energy (Verbatim: Reporter states she had no energy and was actually lying in the bathroom floor due to no energy). The outcome of the loss of energy was resolved (duration 24 hrs).   It was unknown if the reporter considered the loss of energy to be related to Shingrix.    It was unknown if the company considered the loss of energy to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-OCT-2023 The reporter was the patient who stated the night she received her Shingrix vaccine was 5.5 months ago.  The reporter stated that she had no energy and was actually lying in the bathroom floor due to no energy, this had since resolved and only lasted 24 hours.
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a  7 year, 11 month old male child was given a Kinrix vaccine in his left thigh on 7/18/2023.; 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 7-year-old male patient who received DTPa-IPV (Kinrix) (batch number 25ZH4, expiry date 27-OCT-2024) for prophylaxis.   On 18-JUL-2023, the patient received Kinrix (intramuscular, left thigh) .5 mg. On 18-JUL-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a  7 year, 11 month old male child was given a Kinrix vaccine in his left thigh on 7/18/2023.). 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: 30-OCT-2023 The caller was a medical assistant calling to report an adverse event for one of their patients.  The caller reported a  7 year, 11 month old male child was given a Kinrix vaccine in his left thigh, which led to inappropriate age at vaccine administration  Warm transferred for next steps. The reporter consented to follow up by GSK
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received 2nd 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 female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 19 January 2023).   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: not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-OCT-2023 The pharmacist was calling to report that a husband and wife had dose 1 of Shingrix given on January 19, 2023. She stated they picked up dose 2 in May 2023 from the pharmacy but dose 2 was not administered. The Shingrix vials that the patient brought in on the day reporting to be given had an expiration date of October 12, 2023, batch number 5592T, so they were not administered. They did not get dose 2 yet and pharmacy was asking for replacement of expired Shingrix (2 full doses).  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023150326:2 of 2 report
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: She states they picked up dose 2 in May 2023 from the pharmacy but dose 2 was not administered.; 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 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on January 19, 2023).   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: She states they picked up dose 2 in May 2023 from the pharmacy but dose 2 was not administered.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 30-OCT-2023 The pharmacist was calling to report that a patient had dose 1 Shingrix.  She stated they picked up dose 2 in May 2023 from the pharmacy but dose 2 was not administered.  The Shingrix vials that the patient brought in today to be given have an expiration date of October 12, 2023, so they were not administered.  They did not get dose 2 yet and pharmacy is asking for replacement of expired Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up. The case is linked US2023150323, by same reporter.; Sender's Comments:  US-GSK-US2023150323:1 of 2 report
Age: 25.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: the vaccines was expired on 9/22/2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 25-year-old male patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 30-OCT-2023, the patient received the 1st dose of Twinrix. On 30-OCT-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: the vaccines was expired on 9/22/2023). 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: 30-OCT-2023 The pharmacist reported that a male patient received Twinrix 1st dose today on the standar schedule, but she did not realized that the vaccines was expired on 22nd September 2023, which led expired vaccine used. The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Hiberix mixed with saline water rather than diluent; Hiberix mixed with saline water rather than diluent and administered to patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-month-old male patient who received Hib (Hiberix) (batch number 595R2, expiry date 09-JAN-2025) for prophylaxis.   On 30-OCT-2023, the patient received the 4th dose of Hiberix. On 30-OCT-2023, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Hiberix mixed with saline water rather than diluent) and inappropriate dose of vaccine administered (Verbatim: Hiberix mixed with saline water rather than diluent and administered to patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 30-OCT-2023 The nurse reported a patient was administered with Hiberix that was mixed with saline water and not the accompanied diluent, which led to Wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. The reporter consented to follow up.