chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUC4, MMR
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Kinrix- 5th DtaP and 4th IPV Mother of patient reported patient started feeling itchy all over her body, her face and ears. Also patients face turned red and then hives appeared all over patients body within the hour of receiving vaccines.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling face
Clinical narrative: Facial swelling over night after vaccine
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Balance disorder, Gait disturbance, Headache, Vertigo
Clinical narrative: Headache, poor balance, inability to walk without assistance, vertigo
Age: 75.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Chills, Pain, Sleep disorder
Clinical narrative: Woke up at 2:30 AM with chills, perhaps a fever, body aches. Took one 200 mg Ibuprofen and fell asleep.  much better now.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: spontaneous abortion on January 1, 2023
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Hypophagia, Mobility decreased, Nausea
Clinical narrative: About 3 hours after receiving pt began experiencing a severe headache. Shortly after she developed nausea and dizziness. Denies vomiting but was not able to drink to eat anything for the nausea. She had to lay down in bed and was unable to get up until it resolved. Pt reports it resolved within 24 hours. She did not tell us about this until she returned today to receive her 2nd dosage. Despite the previous events, she opted to receive the 2nd Shingrix today.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Pain in extremity, Skin warm, Swelling
Clinical narrative: I was diagnosed with Cellulitis on October 13th .    Extreme left foot pain, swelling, hot to touch.   An additional sore spot on lower right leg
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient was given 2 doses of the Fluarix vaccine (influenza vaccine; CPT 90686). Pt was being seen by his PCP, immediately before being seen by pharmacist. Dr. ordered Fluarix and the vaccine was given and documented by MA. The current workflow for administering influenza vaccines is to dispense the vaccine from the stand alone refrigerator and forgo inputting information into the AccuVax machine. The AccuVax removes the alert for an ordered vaccine once the vaccine is removed from the AccuVax or at midnight of that day, whichever occurs first. During pt?s pharmacy appointment, pharmacist ordered pt?s second dose of his Energix-B vaccine (Hepatitis B vaccine; CPT 90746) series. When MA, went to dispense the Energix-B vaccine from the AccuVax machine, an alert showed stating an influenza vaccine was also ordered for the pt. MA acknowledged the alert and also dispensed an influenza vaccine from the vaccine refrigerator. MA then administered both the Fluarix and Energix-B vaccine to the patient then informed another MA, and pharmacist. Patient was informed that he received a second dose of the influenza vaccine by accident and his dose of the Energix-B vaccine. Per website pt unlikely to experience and side effects and the vaccine given is counted as a valid vaccine.
Age: 1.83
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NONE
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Chills, Cough, Dehydration, Fatigue
Clinical narrative: Extreme pain all over muscles of body with focus on joints- jaws, knees, hand and neck the worst. Dry cough. Alternating fever and chills. Nausea and subsequent dehydration. Extreme fatigue and muscle weakness. Symptoms began at 48 hrs from vaccination and are still present 5 days from vaccination. Went to urgent care because couls not afford ER. Missed work.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Full blood count abnormal, Impaired work ability, Influenza virus test negative, Muscular weakness, Myalgia
Clinical narrative: Extreme pain all over muscles of body with focus on joints- jaws, knees, hand and neck the worst. Dry cough. Alternating fever and chills. Nausea and subsequent dehydration. Extreme fatigue and muscle weakness. Symptoms began at 48 hrs from vaccination and are still present 5 days from vaccination. Went to urgent care because couls not afford ER. Missed work.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Nausea, Neck pain, Pain, Pain in extremity, Pain in jaw
Clinical narrative: Extreme pain all over muscles of body with focus on joints- jaws, knees, hand and neck the worst. Dry cough. Alternating fever and chills. Nausea and subsequent dehydration. Extreme fatigue and muscle weakness. Symptoms began at 48 hrs from vaccination and are still present 5 days from vaccination. Went to urgent care because couls not afford ER. Missed work.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Extreme pain all over muscles of body with focus on joints- jaws, knees, hand and neck the worst. Dry cough. Alternating fever and chills. Nausea and subsequent dehydration. Extreme fatigue and muscle weakness. Symptoms began at 48 hrs from vaccination and are still present 5 days from vaccination. Went to urgent care because couls not afford ER. Missed work.
Sex: U
Vaccine: COVID19, FLUC4
Symptoms: Chills, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Chills, fever, body ache continuing for 24+ hours. Mild pain and swelling at injection site
Age: 75.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Amnesia, Condition aggravated
Clinical narrative: The patient's wife reported that patient experienced significantly worsening memory loss the evening after receiving the RSV and COVID vaccine.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Single functional kidney
Clinical narrative: Red, warm rash developed on lower part of arm, not where injection occurred and almost 3 days after administration of the vaccine. This was her first Moderna COVID vaccine. She also started Cephalexin the same day. Instructed patient to reach out to her doctor for followup.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Hypoaesthesia, Imperception, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Symptoms after vaccination 3/3/2022.  1. 2 days after the vaccine, I had vertigo. I went to the company's medical service. 2. Then I started having symptoms of a racing heart 3. Tremors in the hands 4. After a week, I went to the emergency room, I couldn't feel my legs from the knee down 5. Spine problem on LL-L5 and L5-S1. 6. Whole body imbalance 7. Rarely filled feet 9. hooked on the body 10. Numbness in the tissues from the knee down 11. dental arch movement 12. biting your tongue 123 does not hold anything in hand light objects 13, symptoms of dementia 14. bump into furniture, notion of space 15. Stuffed legs on the right    Currently: no arlegia medication. With the medication I get muscle pain, knee, stiff nec
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Palpitations, Spinal disorder, Tongue biting, Tooth malformation
Clinical narrative: Symptoms after vaccination 3/3/2022.  1. 2 days after the vaccine, I had vertigo. I went to the company's medical service. 2. Then I started having symptoms of a racing heart 3. Tremors in the hands 4. After a week, I went to the emergency room, I couldn't feel my legs from the knee down 5. Spine problem on LL-L5 and L5-S1. 6. Whole body imbalance 7. Rarely filled feet 9. hooked on the body 10. Numbness in the tissues from the knee down 11. dental arch movement 12. biting your tongue 123 does not hold anything in hand light objects 13, symptoms of dementia 14. bump into furniture, notion of space 15. Stuffed legs on the right    Currently: no arlegia medication. With the medication I get muscle pain, knee, stiff nec
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor, Vertigo
Clinical narrative: Symptoms after vaccination 3/3/2022.  1. 2 days after the vaccine, I had vertigo. I went to the company's medical service. 2. Then I started having symptoms of a racing heart 3. Tremors in the hands 4. After a week, I went to the emergency room, I couldn't feel my legs from the knee down 5. Spine problem on LL-L5 and L5-S1. 6. Whole body imbalance 7. Rarely filled feet 9. hooked on the body 10. Numbness in the tissues from the knee down 11. dental arch movement 12. biting your tongue 123 does not hold anything in hand light objects 13, symptoms of dementia 14. bump into furniture, notion of space 15. Stuffed legs on the right    Currently: no arlegia medication. With the medication I get muscle pain, knee, stiff nec
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: online scheduling tool changed patient age to 65 years old although 64 at the time and turning 65 in < 14 days.
Age: 74.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Diarrhoea, Pruritus, Rash, Urticaria, Vomiting
Clinical narrative: He got his vaccines, he came home and had no issues.  The next night he had diarrhea and vomiting.  Then he got rid of that and then the following day he started getting hives and itching and a rash on his legs and in his groin area, as well as his upper arms.  He went back to the pharmacy when the rash, hives and itching occurred and she gave him butenafine hydrochloride 1% cream.  It is helping a little bit, and if it doesn't go away after he gets done with this tube then he may go to his dermatologist.    He is feeling good otherwise and wants to know if people should be taking both of these together.  He is going to be hesitant regarding taking another vaccine.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Dizziness, Nausea, Pallor
Clinical narrative: doing well except after the vaccination, the patient felt nausea and feels dizziness and the skin color turns pale. Mom concerns about the seizure activities after the vaccine because he had a history of seizure when he had fever and after the vaccinations.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injection site induration, Injection site swelling, Rash, Rash erythematous, Skin warm
Clinical narrative: Day after patient's arm was hot and starting to swell around the injection area.  Two days later she had a softball size (little larger) swollen, hard, hot, area surrounding the injection area.  One week later she began having small red dots with red around them on her lower back.  It spread clear across her back with the red area around the dots going from a pencil size dot to a half dollar size.  Over the sencond week in October she continued to have the rash with more areas appearing.  The area surrounding the red dots has starts turning a light brown as it heals.  As of October 16th they are still visible and trying to heal.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: bruise on leaft breast going all the way into armpit
Age: 91.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Extra dose administered
Clinical narrative: Pt was mistakenly given an additional dose of Fluzone HD QIV (pt had previously received her yearly dose on the week of 9/25/23 from her doctor's office and did not need an additional dose on the date of the event (10/2/23)). Patient had only intended to get the COVID-19 vaccine on 10/2/23,  but the Pharmacy Technician who administered the vaccine accidentally administered the Fluzone HD QIV. The mistake was realized immediately following the vaccination and the patient requested to still have the Moderna COVID--19 vaccine administered. Counselled patient that an additional dose of the flu vaccine would not cause any serious adverse effects, but she should monitor for these and notify us as well as her MD.
Age: 73.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: PATIENT HAS SLIGHT REDNESS AT INJECTION SITE AS WELL AS PALPABLE KNOT AND WARMTH IN THE AREA - PATIENT CONCERNED AND WANTS TO REPORT BECAUSE REACTION HAS PERSISTED FOR FOUR DAYS POST VACCINATION
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Injection site swelling, Nasopharyngitis
Clinical narrative: Pt states that when she first received the vaccine, injection site became swollen. Throughout the day, she massaged the area and swelling went down. Around 8 pm started noticing cold symptoms. Pt complains of chest pain that started today.
Age: 0.08
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given Adult Hep B instead of child one no Adverse reaction
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Rash, Rash maculo-papular, Rash pruritic
Clinical narrative: Pt presents with maculopapular rash on inner arms, stomach, and chest 3 hours after dose given. Pt reports rash is itchy. Benadryl 50mg given in clinic. 1% hydrocortisone cream sent home with patient.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient complained of redness and itching on her arm where vaccine was administered about 5 days after the administration.
Age: 11.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient, age 11, received Pfizer 6 mo to 4 year old preparation of vaccine. Patient received repeat dose same day per CDC recommendations.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: Extreme Soreness in arm started approximately 5 hours after injection; Headache started 7 hours after injection; Body Aches and Chills (chattering teeth) started approx 9 hours after injection and persisted for four hours.  Took Tylenol.  Today (October 16) I am still experiencing some soreness in arm and a slight headache.
Age: 4.0
Sex: F
Vaccine: PNC15
Symptoms: Gait disturbance, Injection site bruising, Injection site pain, Injection site reaction, Injection site scab
Clinical narrative: About 1 hour after immunization, patient complained of significant pain at the injection site and reported difficulty walking/moving her leg. Parent of child noticed a red welt around 6:00 pm that night, with the area of swelling being about the size of a softball. There was warmth at the injection site, which later developed into a bruise that is still persisting. Patient also developed a fever, increased sensitivity/pain at the injection site. Patient had difficulty walking/ moving the leg for about 5 days post injection.  Mother of child tried heat/ice application at the injection site, tried massaging/working out the injection site to disperse pain, patient elevated site with a pillow, pineapple juice to help reduce inflammation.
Age: 4.0
Sex: F
Vaccine: PNC15
Symptoms: Injection site warmth, Mobility decreased, Pyrexia, Sensitive skin
Clinical narrative: About 1 hour after immunization, patient complained of significant pain at the injection site and reported difficulty walking/moving her leg. Parent of child noticed a red welt around 6:00 pm that night, with the area of swelling being about the size of a softball. There was warmth at the injection site, which later developed into a bruise that is still persisting. Patient also developed a fever, increased sensitivity/pain at the injection site. Patient had difficulty walking/ moving the leg for about 5 days post injection.  Mother of child tried heat/ice application at the injection site, tried massaging/working out the injection site to disperse pain, patient elevated site with a pillow, pineapple juice to help reduce inflammation.
Age: 7.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient, age 7, received Pfizer 6 month to 4 year old vaccination instead of age specific 5 to 11. Patient received repeat dose same day per recommendation from CDC.  No adverse reaction
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: fatigue, lightheded, dizziness
Age: 85.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects were reported; HCP called to report a TE with MMR II. MMR II has been improperly stored at room temp since 9/13/2023 at 10:09AM (22C) Was never returned to its recommended range because the refrigerator was not operational.  Administered to a patient on 9/18/2023 (; This spontaneous report was received from other health professional and refers to an 85-year-old.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 18-SEP-2023 and 20-SEP-2023, the patient was vaccinated with 0.5 ml improperly stored  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 ml, lot #U039664, expiration date: 15-DEC-2023, administered for prophylaxis (strength, and route of administration were not provided).(incorrect product storage).  Measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) has been improperly stored at room temp since 13-SEP-2023 at 10:09AM (22C). It was never returned to its recommended range because the refrigerator was not operational. No adverse effects were reported.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report a TE with VARIVAX. Improperly stored; This spontaneous report was received from a medical assistant referring to a 4-year-old patient of unknown 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 (0.5 mL, lot #W018825, expiration date 14-JUN-2024, route of administration and anatomical location were not provided) for prophylaxis (Product storage error). No adverse effects reported. No additional adverse events (AEs) or product quality complaints (PQC) were reported (No adverse event).
Age: 20.0
Sex: U
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No other AE; the date of first vaccination was on 13-JUN-2022 (therefore the child was 20 months), and per the label: The first dose is administered at 12 to 15 months of age; This spontaneous report was received from a health business partner (HBP) and refers to a 20-month-old patient of unknown gender. No information on patient's medical history, concurrent conditions and concomitant medications was provided.  On 13-JUN-2022, the patient was vaccinated with first dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) injection (exact dose, lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis (Inappropriate age at vaccine administration). On 12-OCT-2023, the patient was vaccinated with second dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) injection rHA (lot #W029538, expiration date 15-SEP-2024, exact dose, route of administration and anatomical location were not provided) for prophylaxis.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; HCP called to report a TE with VARIVAX.  Improperly stored.; This spontaneous report has been received from a medical assistant, regarding a 4-years-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 19-SEP-2023, the patient was vaccinated with improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, at a dose of 0.5 milliliters as prophylaxis (lot number: W018825, which was determined to be valid, with an expiration date on 14-JUN-2024) (strengths, scheme, route and anatomical location of administration were not reported).  The administered dose underwent a temperature excursion of unreported temperature during an unspecified period time. Previous temperature excursion was not reported.    No additional adverse event was provided.  This is one of several reports from the same reporter.
Sex: U
Vaccine: RSV
Symptoms: Syncope
Clinical narrative: Fainting; This serious case was reported by a consumer via interactive digital media and described the occurrence of fainting 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 fainting (Verbatim: Fainting) (serious criteria GSK medically significant). The outcome of the fainting was not reported.   It was unknown if the reporter considered the fainting to be related to Arexvy.     It was unknown if the company considered the fainting to be related to Arexvy.  Additional Information: GSK Receipt Date: 09-OCT-2023 This case was reported via interactive digital media. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: RSV
Symptoms: Atypical pneumonia, Condition aggravated, Cough, Wheezing
Clinical narrative: Walking pneumonia; Cough worse; Wheezing; This serious case was reported by a nurse via sales rep and described the occurrence of pneumonia in a female 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 pneumonia (Verbatim: Walking pneumonia) (serious criteria GSK medically significant), cough aggravated (Verbatim: Cough worse) and wheezing (Verbatim: Wheezing). The patient was treated with azithromycin (Z-Pak). The outcome of the pneumonia, cough aggravated and wheezing were not resolved.   It was unknown if the reporter considered the pneumonia, cough aggravated and wheezing to be related to Arexvy.     It was unknown if the company considered the pneumonia, cough aggravated and wheezing to be related to Arexvy.   Additional Information: GSK Receipt Date: 10-OCT-2023 The reporter reported that the rheumatologist's mother received the RSV vaccine but not sure if it was GSK or Pfizer vaccine and subsequently developed walking pneumonia.  The patient experienced cough 1 to 3 days prior to receiving the vaccine, then after receiving the vaccine the patient became worse. Patient was prescribed a Z-pack but symptoms did not improve so she presented to her PCP and PCP diagnosed her with walking pneumonia due to wheezing on exam and no CXR was performed. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Hyperhidrosis, Vomiting
Clinical narrative: Sweats; Chills; Vomiting; Headache; Generally feel like crap; This non-serious case was reported by a consumer and described the occurrence of sweating in a 68-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included lisinopril and sildenafil citrate (Viagra).   On 04-OCT-2023, the patient received Shingles vaccine. On 04-OCT-2023, less than a day after receiving Shingles vaccine, the patient experienced sweating (Verbatim: Sweats), chills (Verbatim: Chills), vomiting (Verbatim: Vomiting), headache (Verbatim: Headache) and feeling abnormal (Verbatim: Generally feel like crap). The outcome of the sweating, chills, vomiting, headache and feeling abnormal were not resolved.   It was unknown if the reporter considered the sweating, chills, vomiting, headache and feeling abnormal to be related to Shingles vaccine.  It was unknown if the company considered the sweating, chills, vomiting, headache and feeling abnormal to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 6-OCT-2023 The reporter after receiving shingles vaccine experienced sweats, chills, vomiting, headache and generally felt like crap for the last two days since he got the shot. The symptoms were not treated. The reporter consented to follow up.
Sex: M
Vaccine: COVID19, FLUX, RSV
Symptoms: Fatigue, Injection site pain, Pyrexia
Clinical narrative: pain at the injection site; Temperature elevation; fever; fatigue; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 4-day-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis and COVID-19 VACCINE (COVID 19 VACCINE) for prophylaxis.   On 05-OCT-2023, the patient received the 1st dose of Arexvy (left arm), Flu vaccine and COVID 19 VACCINE. On 06-OCT-2023, 1 days after receiving Arexvy and Flu vaccine, the patient experienced injection site pain (Verbatim: pain at the injection site), temperature elevation (Verbatim: Temperature elevation), fever (Verbatim: fever) and fatigue (Verbatim: fatigue). The outcome of the injection site pain and fatigue were not reported and the outcome of the temperature elevation and fever were resolved.   It was unknown if the reporter considered the injection site pain, temperature elevation, fever and fatigue to be related to Arexvy and Flu vaccine.     It was unknown if the company considered the injection site pain, temperature elevation, fever and fatigue to be related to Arexvy and Flu vaccine.   Additional Information: GSK Receipt Date: 6-OCT-2023 The reporter stated that the patient received the COVID, RSV and Flu vaccines at the same time and woke up the next morning with pain at the injection site.   Later that day she had a fever and fatigue.
Sex: F
Vaccine: RSV
Symptoms: Injection site pain, Myalgia
Clinical narrative: injection site pain; said had myalgia; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female 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 injection site pain (Verbatim: injection site pain) and myalgia (Verbatim: said had myalgia).The outcome of the injection site pain and myalgia were not reported.   It was unknown if the reporter considered the injection site pain and myalgia to be related to Arexvy.  It was unknown if the company considered the injection site pain and myalgia to be related to Arexvy.   Additional Information: GSK Receipt Date: 06-OCT-2023 The reporter mentioned that another healthcare professional (patient) got Arexvy shot and experienced myalgia and injection site pain. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Longer than Recommended Interval; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient received one dose of Shingrix 5 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Longer than Recommended Interval).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 06-OCT-2023 The physician reported that the patient was wondering if he got one dose of Shingrix 5 years ago. The reporter asked if patient should restart the series or just get one more dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 86.0
Sex: M
Vaccine: RSV
Symptoms: Injection site rash, Rash
Clinical narrative: Skin rash / all over body rash; This non-serious case was reported by a nurse via sales rep and described the occurrence of generalized rash in a 86-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 274P2) and (batch number 574P2) for prophylaxis.   On 03-OCT-2023, the patient received Arexvy (left deltoid). On 04-OCT-2023, 1 days after receiving Arexvy, the patient experienced generalized rash (Verbatim: Skin rash / all over body rash).  The patient was treated with benadryl (nos) (Benadryl). The outcome of the generalized rash was resolved.   It was unknown if the reporter considered the generalized rash to be related to Arexvy.     It was unknown if the company considered the generalized rash to be related to Arexvy.   Additional Information: GSK Receipt Date: 06-OCT-2023 The reporter was a nurse at a long-term care facility. Following day of vaccination, the patient developed a skin rash on the left arm and the peri area, next day the rash spread to his head and feet.  First day it was just a general rash around the injection site but the next day it was a head-to-toe rash. According to the reporter the rash appears to be improving today. Treating physician was aware of this event. The patient was given Benadryl by mouth and the rash resolved. Lot number from antigen vial 574P2. No other lots provided. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: FLUX, TDAP, VARZOS
Symptoms: Heart rate increased, Pain, Pyrexia
Clinical narrative: Fever; Increase heart rate; Body ache; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis and DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On 21-SEP-2023, the patient received Shingrix, Flu vaccine and Tdap Vaccine. On an unknown date, an unknown time after receiving Shingrix, Flu vaccine and Tdap Vaccine, the patient experienced fever (Verbatim: Fever), heart rate increased (Verbatim: Increase heart rate) and general body pain (Verbatim: Body ache). The outcome of the fever and general body pain were resolved and the outcome of the heart rate increased was not resolved.   It was unknown if the reporter considered the fever, heart rate increased and general body pain to be related to Shingrix, Flu vaccine and Tdap Vaccine.   It was unknown if the company considered the fever, heart rate increased and general body pain to be related to Shingrix, Flu vaccine and Tdap Vaccine.   Additional Information: GSK Receipt Date: 6-OCT-2023 The reporter was the patient who received Shingrix and was having an increase in her heart rate since then.  According to reporter she also had fever and body ache that went away.  Reporter stated that she received 2 other vaccines the same day Flu and Tdap booster, she did not know the names of the vaccines.  Reporter went to the doctor, had an EKG and was okay. The reporter did not consent to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: warm to touch of her upper arm where the shot was received; She experienced pain/Pain in upper arm; She experienced swelling/swelling of upper arm; She experienced redness/redness at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On 17-AUG-2023, less than a day after receiving Shingrix, the patient experienced injection site warmth (Verbatim: warm to touch of her upper arm where the shot was received), injection site pain (Verbatim: She experienced pain/Pain in upper arm), injection site swelling (Verbatim: She experienced swelling/swelling of upper arm) and injection site erythema (Verbatim: She experienced redness/redness at injection site).  The outcome of the injection site warmth, injection site pain, injection site swelling and injection site erythema were unknown.   It was unknown if the reporter considered the injection site warmth, injection site pain, injection site swelling and injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site warmth, injection site pain, injection site swelling and injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-OCT-2023 The patient reported that she received first dose of Shingrix injection and experienced pain, redness, swelling and warm to touch of her upper arm where the shot was received.  Two physicians advised her not to receive the 2nd shot due to this experience. They provided the telephone number to provide to the physicians. The reporter did not consent to follow up. The patient did not want her doctor to feel singled out.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: second dose has not yet been given; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (In 2022 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: second dose has not yet been given).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 06-OCT-2023 The reporter stated that a patient received his first dose of Shingrix at another facility a year ago. The second dose of Shingrix had not yet been given, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: received a dose of Shingrix that was reconstituted with sterile non approved diluent.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number FD47S, expiry date 09-FEB-2024) for prophylaxis.   On 05-OCT-2023, the patient received the 2nd dose of Shingrix. On 05-OCT-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: received a dose of Shingrix that was reconstituted with sterile non approved diluent.). The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 06-SEP-2023 A pharmacy technician reported that a patient received a dose of Shingrix that was reconstituted with sterile non approved diluent, which led to wrong solution used in drug reconstitution. No symptoms reported. The reporter consented to follow up.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: sterile water was used to reconstitute Menveo; sterile water was used to reconstitute Menveo and administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number M23G5, expiry date 30-NOV-2024) for prophylaxis.   On 06-OCT-2023, the patient received Menveo. On 06-OCT-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: sterile water was used to reconstitute Menveo) and inappropriate dose of vaccine administered (Verbatim: sterile water was used to reconstitute Menveo and administered).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-OCT-2023 The medical assistant called to report sterile water was used to reconstitute Menveo and it was administered to a patient. Menveo reconstituted with sterile water instead of the supplied CYW-135 liquid conjugate, which led to Wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. The reporter consented to follow up via email.
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Second dose administered 2 weeks after; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On an unknown date, the patient received the 2nd dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Second dose administered 2 weeks after).  The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 06-OCT-2023 The vaccine administration facility was the same as primary reporter, The reporter wished to knew how to proceed as the wrong dose was administered and partial information provided. The pharmacist called in to report that a patient received a dose of Arexvy and 1 prior doses being administered, which led to extra dose administered. The reporter consented to follow up.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Expired Product Used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 7-year-old female patient who received DTPa (Infanrix) (batch number LS444, expiry date 22-SEP-2023) for prophylaxis.   On 05-OCT-2023, the patient received Infanrix. On 05-OCT-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Expired Product Used).  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: 6th Oct 2023 The practice manager called to inquire how to proceed, as the patient was inadvertently administered an expired Infanrix yesterday on 5th Oct 2023. The reporter did not consent to follow-up. The patient received expired dose of infanrix which led to expired vaccine used.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Vertigo, dizziness, nauseous.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient was administered rota virus after 16wks of birth.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Pain, Pyrexia, Rash, Rash pruritic
Clinical narrative: pt received rsv vaccine on 10/05/23 at 10 am next day she had bodyache and low grade fever.. on 10/07/23 upon waking up she saw the bad rash over her shoulder and neck which the next day the rash progressed to other site..... for the next 2 days rash was very itching and worsend. on 10/11/23 the rash was gone and disappeared
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Skin discolouration
Clinical narrative: A patient took Comirnaty 12+ SDV 23-2 vaccine today on Right Arm and returned to pharmacy few minutes later as he noticed discoloration (bluish-purple color skin) on the back of his palm on his right arm. Pharmacist who gave the vaccine checked the spot where it was discolored/bruised and the patient said it wasn't painful to touch, injection site was to painful to touch either, patient was able to lift his arm normally. Patient was not dizzy or had no other symptoms. Patient said he did not notice/remember having this bruise/discoloration before coming to the pharmacy, he noticed this on the back of his palm while we was shopping after getting the vaccine. Patient was asked to report at pharmacy/ get emergency help if symptoms worsens or experiences any other side effect. Patient also got RSV vaccine on Left Arm and upon checking by pharmacist everything seemed normal on left arm
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse.  Expired Vaccine 6/30/2023
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Cardiac flutter, Chest discomfort, Chest pain, Dyspepsia
Clinical narrative: Heart palpitations, instant racing heart when bending down. Chest pressure, chest pain, excessive heart burn that is intermittent after palpitation/heart flutter and episodes.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram normal, Electrocardiogram normal, Palpitations
Clinical narrative: Heart palpitations, instant racing heart when bending down. Chest pressure, chest pain, excessive heart burn that is intermittent after palpitation/heart flutter and episodes.
Age: 69.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product administration error
Clinical narrative: pt signed vaccine form and confirmed with 2 employees she wanted polio vaccine and checked box that she was requesting vaccine , however she did not want an immunization, just reporting to be safe, no bad vaccine reaction , she wanted prolia medicine to be injected no vaccination
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Confusional state, Dizziness, Musculoskeletal stiffness, Mydriasis, Pallor
Clinical narrative: 4 shots.  Two in each arm.  He slumped over, was pale, pupils big as saucers, legs stiffened and arm flexed with a little shake.  It lasted about 20-30 seconds.  When he came to he was so confused.  He then continued getting pale and woozy for about 30 minutes.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Posture abnormal, Tremor
Clinical narrative: 4 shots.  Two in each arm.  He slumped over, was pale, pupils big as saucers, legs stiffened and arm flexed with a little shake.  It lasted about 20-30 seconds.  When he came to he was so confused.  He then continued getting pale and woozy for about 30 minutes.
Age: 29.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Immunisation reaction, Injection site rash
Clinical narrative: Covid arm. Rash appeared underneath spot where injection was given 2 days after shot.
Age: 3.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Incomplete course of vaccination, Product administered to patient of inappropriate age, Underdose, Wrong product administered
Clinical narrative: states this should have been the 4th dose of Infanrix; received Boostrix instead of Infanrix; pediatric patient (3 years old) received Boostrix; patient (3 years old) received Boostrix instead of Infanrix; 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 3-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number M4E4A, expiry date 05-OCT-2025) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis.   On 16-AUG-2023, the patient received Boostrix. On an unknown date, the patient did not receive the 4th dose of Infanrix. On 16-AUG-2023, an unknown time after receiving Boostrix and not applicable after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: received Boostrix instead of Infanrix), inappropriate age at vaccine administration (Verbatim: pediatric patient (3 years old) received Boostrix) and underdose (Verbatim: patient (3 years old) received Boostrix instead of Infanrix). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: states this should have been the 4th dose of Infanrix ).  The outcome of the wrong vaccine administered, inappropriate age at vaccine administration, underdose and incomplete course of vaccination 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: 06-OCT-2023 The reporter reported that patient received Boostrix instead of Infanrix. The reporter stated that this should had been the 4th dose of Infanrix (which appears that it would be a late dose if going by recommended schedule). The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The reporter reported that patient received Boostrix instead of Infanrix, which led to wrong vaccine administration. The reporter reported that 3 year old patient received Boostrix, which led to inappropriate age at vaccine administration and under dose. The reporter reported that till the time of reporting the patient had not received the 4th dose of Infanrix vaccine, which lead to incomplete course of vaccination.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Chills, 100.8 fever, body aches, headache, fatigue
Age: 67.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Pruritus, Sleep disorder, Urticaria
Clinical narrative: Spikevax 2023-2024 & Fluzone HD 2023-2024 were received 10/6/23.  Patient woke up itching during the night.  Discovered hives in the morning of 10/7/23 which began on the right side of hip/buttocks.  Hives then developed on left hip & inner thigh. Visible hives & itching were only symptoms. Pt was seen by a provider at her Dr's office on Monday morning 10/9/23. Hives were fading at that point.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Ear pain, Ear swelling, Fatigue
Clinical narrative: Muscle pain , swollen face, teeth hurting ,  jaw hurting, back of my ears are swollen and in pain, weakness,tiredness,Fever, chills, knees shaking when i try to walk
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in jaw, Pyrexia, Swelling face, Toothache
Clinical narrative: Muscle pain , swollen face, teeth hurting ,  jaw hurting, back of my ears are swollen and in pain, weakness,tiredness,Fever, chills, knees shaking when i try to walk
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Muscle pain , swollen face, teeth hurting ,  jaw hurting, back of my ears are swollen and in pain, weakness,tiredness,Fever, chills, knees shaking when i try to walk
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Ecchymosis, Injection site bruising
Clinical narrative: quarter size bruise at the injection site; ecchymosis; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of injection site bruising in a 67-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 93PD7, expiry date 22-OCT-2024) for prophylaxis.   On 29-SEP-2023, the patient received Arexvy (intramuscular, left deltoid). On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site bruising (Verbatim: quarter size bruise at the injection site) and ecchymosis (Verbatim: ecchymosis).  The outcome of the injection site bruising was not reported and the outcome of the ecchymosis was unknown.   It was unknown if the reporter considered the injection site bruising and ecchymosis to be related to Arexvy.     It was unknown if the company considered the injection site bruising and ecchymosis to be related to Arexvy.   Additional Information: GSK Receipt Date: 06-OCT-2023 The reporter reported the event to a field representative. Field representative did not have complete information. The agent directly called to reporter and reporter stated that after giving a patient an Arexvy vaccine, she developed a quarter size bruise at the injection site. The reporter consented to follow up.