chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pharyngeal ulceration, Tongue ulceration, Vocal cord disorder, Vomiting
Clinical narrative: She got her vaccine, she ran 102 temperature around 4 hours after she got the vaccine.  She was really sick to her stomach, throwing up, diarrhea.  She had ulcers that broke out into her mouth and down the left side of her throat and her right side, and kept swopping sides.  The doctors do not what has caused it or why it keeps occuring but she is having them removed next Tuesday, 12/6/23 and going to biopsy them.  She is a former smoker, but had quit and going to biopsy them.  She did not have any of these sores prior to the vaccine.  They come and go, but they always come back, and again did not start until she had the shot.  The day she got the shot about 4 hours after she was at her best friends house who took care of her, she went a few days and does not remember what happened, and her friend told her that she was acting strange and apparently did and said some strange things.  She could not figure out what was happening, and went toENT,  Dr. and he cut them out and then saw the spots on her vocal cords.  She then run out of her insurance visits and did not have the money to pay for any so she did not FU.  She went to her family doctor for check ups and he could not figure out what they were.  He sent her to an ENT, Dr. and then went to Dr. is the one who is going to do the surgery on 12/12/23.  She has sores go down the left side of her throat that are open ulcers that she can feel them, and they can see them with the scope.  There is also one on the left side of her tongue as well.  When they did her blood work they found out that she had an autoimmune disorder and is not on any medicine, and does not know if that is causing these breakouts.  It feels like she has drank gasoline and ate razor blades, and has lost about 40 # as she is not able to eat due to it being painful.    She went to numerous ER's to get some help, and was given antibiotics, magic mouth wash, antifungals, steroids and nothing seemed to help her.    Then she got her 2nd vaccine on 9/15/21 and at that time she did have the 102 fever, not doing things like she did, acting bizaree.  Then it felt like somebody punched her in the arm for a long time, and then the sores come up in her mouth again.  She thinks that they may have gone away and then after the 2nd vaccine they came back, and they have not left completely.  They did clear up some, but is calling them a flare up that has gotten really bad this time.  It has been present at this time for about 8-9 months.   She also has the sores in her ear canal, maybe on her glands and down lower on the vocal cords are.  When Dr. cut them out it was on the right side, and now it's on the left side.  When they did a scope down her throat there was a spot that they found another spot on the left side, and there are 2 spots they are going to remove and biopsy.  She is really really sick and just trying to find out what is causing the problem, and fixing it.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: She got her vaccine, she ran 102 temperature around 4 hours after she got the vaccine.  She was really sick to her stomach, throwing up, diarrhea.  She had ulcers that broke out into her mouth and down the left side of her throat and her right side, and kept swopping sides.  The doctors do not what has caused it or why it keeps occuring but she is having them removed next Tuesday, 12/6/23 and going to biopsy them.  She is a former smoker, but had quit and going to biopsy them.  She did not have any of these sores prior to the vaccine.  They come and go, but they always come back, and again did not start until she had the shot.  The day she got the shot about 4 hours after she was at her best friends house who took care of her, she went a few days and does not remember what happened, and her friend told her that she was acting strange and apparently did and said some strange things.  She could not figure out what was happening, and went toENT,  Dr. and he cut them out and then saw the spots on her vocal cords.  She then run out of her insurance visits and did not have the money to pay for any so she did not FU.  She went to her family doctor for check ups and he could not figure out what they were.  He sent her to an ENT, Dr. and then went to Dr. is the one who is going to do the surgery on 12/12/23.  She has sores go down the left side of her throat that are open ulcers that she can feel them, and they can see them with the scope.  There is also one on the left side of her tongue as well.  When they did her blood work they found out that she had an autoimmune disorder and is not on any medicine, and does not know if that is causing these breakouts.  It feels like she has drank gasoline and ate razor blades, and has lost about 40 # as she is not able to eat due to it being painful.    She went to numerous ER's to get some help, and was given antibiotics, magic mouth wash, antifungals, steroids and nothing seemed to help her.    Then she got her 2nd vaccine on 9/15/21 and at that time she did have the 102 fever, not doing things like she did, acting bizaree.  Then it felt like somebody punched her in the arm for a long time, and then the sores come up in her mouth again.  She thinks that they may have gone away and then after the 2nd vaccine they came back, and they have not left completely.  They did clear up some, but is calling them a flare up that has gotten really bad this time.  It has been present at this time for about 8-9 months.   She also has the sores in her ear canal, maybe on her glands and down lower on the vocal cords are.  When Dr. cut them out it was on the right side, and now it's on the left side.  When they did a scope down her throat there was a spot that they found another spot on the left side, and there are 2 spots they are going to remove and biopsy.  She is really really sick and just trying to find out what is causing the problem, and fixing it.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Electrocardiogram normal, Erythema, Peripheral swelling
Clinical narrative: chest pain reproducible with palpation, R arm redness, and swelling that has been improving. using diclofenac with relief. EKG within normal limits, chest xray pending. normal vital signs.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: swelling to injection site. no pain or itchiness
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site bruising, Injection site reaction
Clinical narrative: Local injection site reaction with bruising on the right upper arm
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Pt received Comirnaty 2023-24 Vial 30mcg/0.3ml Inj 00069-2362 Lot HG7557 EXP 01/10/24 but the RX was typed for Comirnaty 2023-24 30mcg/0.3ml Inj 00069-2377-10 Lot HM7010 Exp 04/10/2024.  The preservative was different that what the patient was expecting.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Blister, Erythema, Oedema, Skin disorder
Clinical narrative: Left deltoid with erythema, edema, blisters causing skin cavitation
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt received Comirnaty 2023-24 Vial 30mcg/0.3ml Inj 00069-2362 Lot HG7557 EXP 01/10/24 but the RX was typed for Comirnaty 2023-24 30mcg/0.3ml Inj 00069-2377-10 Lot HM7010 Exp 04/10/2024.  The preservative was different that what the patient was expecting.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: NO ADVERSE EVENT VACCINE ADMINISTERED BY MISTAKE- 3RD DOSE NOT NEEDED
Age: 30.0
Sex: F
Vaccine: COVID19-2, FLUR4
Symptoms: Exposure during pregnancy, Vaccination site erythema
Clinical narrative: Patient received both Flublok and Spikevax vaccine into the left deltoid around noon on 12/5/2023.  Stated on 12/6/2023 a large oval red tender circle area developed at the vaccination site.  She is currently pregant and was concerned.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: MOC called and stated patient has redness and swelling at injection site. Redness is the size of a nickel but arm is really swollen. I explained to MOC that this is very common with vaccinations. Patient could use tylenol and motrin and alternate between the 2 every 4-6 hours PRN and to also use a cold pack to help swelling.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Vaccination site pain
Clinical narrative: Extreme muscle spasms in arm where vaccinated, beginning approximately 1 minute after vaccination, lasting approximately 2 minutes. After cessation of spasms, 1 - 2 days mild soreness at vaccination site site, in line with typical reaction to influenza vaccination.
Age: 15.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Immediate post-injection reaction, Loss of consciousness, Movement disorder, Nausea, Pallor
Clinical narrative: After receiving both vaccines, the patient immediately began staring, clenched her fists, and blacked out for approximately 30 seconds. She was extremely pale. Her nurse lifted her legs and she woke and spoke. We moved her to lay down, monitored her vitals signs, gave her water to drink and a cool cloth for her forehead. We gradually sat her back up, her vitals continued to improve until she was able to sit up.  This took approximately 30 minutes and then she walked to the waiting area, where she waited another 15 minutes. Vitals were taken before allowing her to leave. She denied any symptoms of nausea. When given the question, she said she felt like an 8 or 9 out of 10 if 10 was feeling best.  After vaccination, mom then told the nurse that she has had this happen in the past and that it occurs for mom as well.  We notified them that they should tell the healthcare provider prior to receiving a vaccine in the future so that they can be prepared and that the patient could even lay down to prevent this type of episode.  At discharge her vitals were the following:  BP 92/70, Pulse 80, O2sat: 98%
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Injection site swelling, Movement disorder
Clinical narrative: I developed a fever, chills and shaking. I felt fatigued. I also had myoclonus symptoms- shaking badly, head jerking, toes twitching,etc.  I also developed a rash of about 3 inches or so, a big red mark, and some swelling at the injection site.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Myoclonus, Pyrexia, Rash, Tremor
Clinical narrative: I developed a fever, chills and shaking. I felt fatigued. I also had myoclonus symptoms- shaking badly, head jerking, toes twitching,etc.  I also developed a rash of about 3 inches or so, a big red mark, and some swelling at the injection site.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypoaesthesia, Injected limb mobility decreased, Muscle spasms
Clinical narrative: Very painful, visually observable muscle spasms in vaccine arm,  Started a few minutes after vaccination, tapered off after about 10 minutes. Numbness and reduced ability to use arm for several hours. Mild headache, intermittent lightheadedness for about 24 hours.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Very painful, visually observable muscle spasms in vaccine arm,  Started a few minutes after vaccination, tapered off after about 10 minutes. Numbness and reduced ability to use arm for several hours. Mild headache, intermittent lightheadedness for about 24 hours.
Age: 1.5
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product label issue
Clinical narrative: child came in and received 1st dose of new covid 19 vaccine from moderna. She was accidently given the full vial contents of 0.5ml instead of 0.25ml dose, Vial stated single dose vial of .25ml. All staff unaware that the vaccine that is single dose vial comes over filled with more than the single dose. Vaccination was verified by licensed RN and all protocols and policies were followed in the office. This was the first time this office has ever given the covid vaccine.  There was no harm to child after vaccine was given. NO reported side effects. Parents have been in contact with the doctor and RN routinely checking on how patient is doing.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Fatigue, Loss of personal independence in daily activities, Mobility decreased, Muscular weakness
Clinical narrative: Received COVID-19 afternoon Friday, awoke achey & tired Saturday. Later that morning, after watching football game (3 hours), had trouble getting out of my chair. After many toys, I forced the issue and got standing. Did not fall back into my chair as on the previous attempts. I believe I was still achy all over. I attempted to do something (vacuum) and could not keep myself from going to the floor (not hit anything. I called neighbors for help (live alone) and they got me up. My quadriceps were very weak. Had to have assistance. moving around the rest of the night. Next morning I was cautious but it was evident I was back to my normal mobility. Feel it was severe muscle weakness mostly limited to quadriceps lasting for 36 hours.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Received COVID-19 afternoon Friday, awoke achey & tired Saturday. Later that morning, after watching football game (3 hours), had trouble getting out of my chair. After many toys, I forced the issue and got standing. Did not fall back into my chair as on the previous attempts. I believe I was still achy all over. I attempted to do something (vacuum) and could not keep myself from going to the floor (not hit anything. I called neighbors for help (live alone) and they got me up. My quadriceps were very weak. Had to have assistance. moving around the rest of the night. Next morning I was cautious but it was evident I was back to my normal mobility. Feel it was severe muscle weakness mostly limited to quadriceps lasting for 36 hours.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphonia, Arthralgia, Headache, Injection site reaction, Limb discomfort
Clinical narrative: Severe muscle cramping at injection site within 3-3.5h of injection. Within another 2h, fever 100.6, severe headache, joint pain, difficulty lying on right arm- felt like deep Charley horse. Overnight, headache so severe , I was nauseous & vomited. Strained vocal cords & currently do not have a voice back yet.  24h post-injection, no fever. Still have joint pain & cramping, headache (less severe), & very sleepy.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Muscle tension dysphonia, Nausea, Pyrexia, Somnolence
Clinical narrative: Severe muscle cramping at injection site within 3-3.5h of injection. Within another 2h, fever 100.6, severe headache, joint pain, difficulty lying on right arm- felt like deep Charley horse. Overnight, headache so severe , I was nauseous & vomited. Strained vocal cords & currently do not have a voice back yet.  24h post-injection, no fever. Still have joint pain & cramping, headache (less severe), & very sleepy.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Severe muscle cramping at injection site within 3-3.5h of injection. Within another 2h, fever 100.6, severe headache, joint pain, difficulty lying on right arm- felt like deep Charley horse. Overnight, headache so severe , I was nauseous & vomited. Strained vocal cords & currently do not have a voice back yet.  24h post-injection, no fever. Still have joint pain & cramping, headache (less severe), & very sleepy.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Seizure
Clinical narrative: Had a seizure within minutes. Not sure which influenza I got
Age: 77.0
Sex: F
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: MenQuadfi dose was supposed to be administered on 7/13. Pt was never administered this dose and will need to be rescheduled
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Patient experienced soreness, pain, weakness , chills, sweats, fever
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Injection site rash
Clinical narrative: Rash developed at injection site within few minutes of receiving vaccines. One small round red area on back and one small round area on chest noted.  Patient was given 25mg of Benadryl per NP orders at 12:28PM and was monitored for one hour after start of reaction. Patient denied any shortness of breath, trouble breathing, wheezing, or swelling. When patient left office at 1:30PM, no redness or rash noted at injection site or on chest or back
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Burning sensation, Dysuria, Urine analysis normal
Clinical narrative: I have very bad burning when I urinate.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Gait inability, Headache, Immediate post-injection reaction
Clinical narrative: immediately after pt got vaccien she states she felt headache and dizziness such that she could not walk - she stayed at the facility for 2 hour and  did go home she continued to feel worse and went to er 10 days later - she still feel porrly even now 12/6/23 she feels that the  vial was warm and not sored properly at the pharmacy where she got the vaccine
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test
Clinical narrative: immediately after pt got vaccien she states she felt headache and dizziness such that she could not walk - she stayed at the facility for 2 hour and  did go home she continued to feel worse and went to er 10 days later - she still feel porrly even now 12/6/23 she feels that the  vial was warm and not sored properly at the pharmacy where she got the vaccine
Age: 64.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Axillary pain, Lymphadenopathy, Pain
Clinical narrative: Shooting pain flashes in right shoulder and arm pit. Lymph node/arm pit slightly swollen. Needed tylenol to reduce pain in order to sleep. No pain at touch but sustained pain with flashes of sharper pain in armpit and shoulder, front and back. Flashes of pain disappeared after a week. Pain decreased over time. Today, day #8, still feel armpit and shoulder are not back to normal but doing much better. No need of pain killer anymore. At this rate, shoulder should be back to normal after 2 weeks.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Injection site erythema, Pain in extremity
Clinical narrative: PATITENT INADVERTANTLY WAS ADMINISTERED TWO DOSES OF MODERNA COVID VACCINE; ONE EACH R & L DELTOID.  PT WAS MADE AWARE OF THIS.  PROVIDER FOLLOWED UP WITH PATIENT ON FRIDAY12/1/23 AND NO ADVERSE SYSTEMIC  EVENTS WERE REPORTED. PT DID HAVE SITE REDNESS AND SORE ARMS.  PT ALSO RECEIVED HER RSV AND HIGH DOSE FLU VACCINE AT THE SAME TIME
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia
Clinical narrative: Severe knee join pain.  Onset 24 hours after injection.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient was given Shingrix but originally requested for RSV. No signs of any symptoms or adverse event from the patient. Spoke to the patient about an hour after the vaccine, patient did not complain about anything. Patient did said they got the Shingrix vaccine about 5 years ago.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: MA-C administered Spikevax for 12 years and older instead of Moderna mRNA 6 months to 11 years.  No adverse symptoms. Reviewed with PCP/Clinic Chief, Assistant Director of Nursing, and Pharmacy. No additional treatment and/or follow up required. Parental review completed.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient requested an RSV vaccination and Fluarix was administered indadvertently. Patient had received Flucelvax on 11/2/23.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient  requested RSV but was given Shingrix. I contacted the patient an hour after vaccination to let him know what had happened. Spoke to the wife. She did not state any side effects or any adverse event. Wife said they both got Shingrix about 5 years ago.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: MA-C administered Spikevax for 12 years and older instead of Moderna mRNA 6 months to 11 years.  No adverse symptoms. Reviewed with PCP/Clinic Chief, Assistant Director of Nursing, and Pharmacy. No additional treatment and/or follow up required. Parental review completed.
Age: 20.0
Sex: M
Vaccine: FLUN4
Symptoms: Syncope
Clinical narrative: Vagal syncope shortly after immunization
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; LPN calls to report that a patient was administered Pneumovax 23 lot# w015900 exp 10/20/2023 today 11/30/2023.  No side effects reported.  No further AE.  No PQC.; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-NOV-2023, the patient was vaccinated one time with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot# w015900, expiration date: 20-OCT-2023 (exact dose, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse event reported (no adverse event).
Sex: M
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: he felt it was about to faint; This spontaneous report was received from a male patient of unknown age, who was referring to himself. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On an unknown date in 2004, the patient received his first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (dose, lot #, expiry date, site and route of administration were not provided) for prophylaxis.  On that day, after minutes from receiving the vaccine, he felt as he was about to faint. So the medical team made sure he lied down for few minutes and that he was okay before leaving premises. This only happened with the first dose. On an unknown date, the patient recovered from the event. He completed his full regimen.  The causal relationship between feeling he was about to faint and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Nurse calling to report adverse event regarding the administration of an expired dose of PNEUMOVAX 23.  Nurse stated that the PNEUMOVAX 23 dose had a labeled expiration date of 10/20/2023 and the product was administered on 11/21/2023.  Nurse confirm; This spontaneous report was received from a nurse refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 21-NOV-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # W007035, expiration date: 20-OCT-2023, 0.5 milliliter (once) (route of administration and anatomical location were not reported) for prophylaxis (expired product administered). Nurse confirmed no report of medical concerns or symptoms from patient involved (no adverse event).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No additional AEs; expired dose of PNEUMOVAX 23 was administered; Information has been received from medical assistant and refers to a patient of unknown age and gender.   The patient's current conditions, medical history and concomitant medications were not reported.  On 29-NOV-2023, the patient was vaccinated with expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) injection 0.5 mL, intramuscularly, lot# W021636 (valid), expiration date 01-OCT-2023 (strength and anatomical location were not provided) as prophylaxis (Expired product administered). No other information provided. No additional AEs (No adverse event) or PQC reported.
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No side effects reported / No additional AE; MMRII concomitantly with PROQUAD on 28NOV2023.; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient.  Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.  On 28-NOV-2023, the patient was administered with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) injection, lot #W035197, expiration date: 24-MAY-2024, albumin status recombinant human albumin (rHA) (strength, and route of administration were not provided) concomitantly with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) injection, lot #W032508, expiration date: 09-APR-2024 (strength, and route of administration were not provided) (Overdose), both administered as prophylaxis. Vaccine operator was a healthcare professional. No other medical information known. No side effects or additional adverse event (AE) reported (No adverse event).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired dose was potentially administered to a patient; No additional AE reported; This spontaneous report was received from a pharmacist concerning an adult patient of unknown age and gender. The patient's concurrent condition, medical history, and concomitant medications were not provided.  On an unknown date, the patient was potentially vaccinated with expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection as prophylaxis (dose, lot#, expiry date, route of administration and anatomical location not provided), which was 3 months past its expiration (expired product administered). No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No AE; accidentally administered an expired PNEUMOVAX 23 vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 01-DEC-2023, the patient was accidentally vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot #W007035 was valid for formulation pre-filled syringe, expiration date: 20-OCT-2023, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used). No additional adverse event (AE)/ product quality complaint (PQC).
Sex: U
Vaccine: RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse event; HBP calling to report the administration of a ROTATEQ and VAXELIS to the same patient following a temperature excursion.; This spontaneous report was received from a office manager and refers to a unspecified age and gender patient. No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided  On 01-DEC-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1965644, expiration date: 02-OCT-2024 (reported as 20-OCT-2024) who had been verified to be a valid number (strength and dose were not provided); and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection, lot #U7536AA, expiration date: 30-SEP-2025 who had been verified to be a valid number (strength, and route of administration were not provided) administered for prophylaxis. Both vaccines were administered following a temperature excursion (Product storage error). No additional adverse event.
Sex: U
Vaccine: RSV
Symptoms: Cough, Dysphonia
Clinical narrative: Raspy cough; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough 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 cough (Verbatim: Raspy cough). The outcome of the cough was not reported.   It was unknown if the reporter considered the cough to be related to Arexvy.     It was unknown if the company considered the cough to be related to Arexvy.   Additional Information: GSK receipt date: 29-Nov-2023 The case was received from the patient via (Open field AE monitoring) interactive digital media. After getting the RSV, the patient had developed a raspy cough.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, No adverse event, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: Arexvy given to a 33 week pregnant woman; Arexvy was mistakenly given to a 35 years old women; This non-serious prospective pregnancy 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 RSVPreF3 adjuvanted (Arexvy) (batch number 2Cy74, expiry date 30-MAR-2025) for prophylaxis.   On 25-NOV-2023, the patient received Arexvy (intramuscular) .5 ml. On 25-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Arexvy was mistakenly given to a 35 years old women). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy given to a 33 week pregnant woman). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 33 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 27-Nov-2023 The reporter reported that the 33 weeks pregnant patient received Arexvy vaccine on Saturday, which led to vaccine exposure during pregnancy. The patient received Arexvy who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter reported that there was no known side effects or adverse reactions noted or reported. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Arexvy was given to a pregnant woman; This non-serious prospective pregnancy case was reported by a nurse via sales rep and described the occurrence of vaccine exposure during pregnancy in a adult 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 vaccine exposure during pregnancy (Verbatim: Arexvy was given to a pregnant woman). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 23-OCT-2023 Arexvy was given to a pregnant patient, which led to vaccine exposure during pregnancy. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Oral herpes zoster, Pain
Clinical narrative: severe case of shingles; Painful; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of oral herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced oral herpes zoster (Verbatim: severe case of shingles) and pain (Verbatim: Painful). The outcome of the oral herpes zoster and pain were not reported.   It was unknown if the reporter considered the oral herpes zoster and pain to be related to Shingles vaccine.     It was unknown if the company considered the oral herpes zoster and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 28-NOV-2023 The reporter received a shingles shot a few years ago and a week later got a severe case of Shingles inside the mouth, was most painful thing had ever experienced. Follow-up not possible as no contact details provided. The physician said dangerous because so close to the brain.
Sex: M
Vaccine: RSV
Symptoms: Exposure via skin contact, Underdose
Clinical narrative: witnessed clear fluid (not blood) running down his arm; he did not receive the full 0.5 ml dose.; This non-serious case was reported by a consumer via call center representative and described the occurrence of exposure via skin contact in a 78-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In NOV-2023, the patient received Arexvy (intramuscular, unknown arm) .5 ml. In NOV-2023, an unknown time after receiving Arexvy, the patient experienced exposure via skin contact (Verbatim: witnessed clear fluid (not blood) running down his arm) and accidental underdose (Verbatim: he did not receive the full 0.5 ml dose.). The outcome of the exposure via skin contact and accidental underdose were unknown.   Additional Information: GSK Receipt Date: 27-NOV-2023 The reporter was the wife, and her husband had received an Arexvy shot. She provided limited information.  She said that the date of immunization was within the past week. She did not have the paperwork in front of her thus she did not know the lot number.  She seemed willing to provide the lot number if she found it. During administration the reporter indicated that they witnessed clear fluid (not blood) running down his arm and therefore they are concerned that he did not receive the full 0.5 ml dose, which led to exposure via skin contact and accidental under dose. The reporter did not consent to follow-up.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: dose of BOOSTRIX was given 11/27/2023 and the medication was expired; 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 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7mh39, expiry date 18-NOV-2023) for prophylaxis.   On 27-NOV-2023, the patient received Boostrix. On 27-NOV-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: dose of BOOSTRIX was given 11/27/2023 and the medication was expired). 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: 27-NOV-2023  The health care professional was the reporter.  Calls today to report a dose of Boostrix was given 27th November 2023 and the medication was expired on 18th November 2023 which led to expired vaccine used. No further information was known. The reporter consented to follow up.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: 12 year old patient received Boostrix as a booster dose but the vaccines was expired; 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 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7MH39, expiry date 18-NOV-2023) for prophylaxis.   In NOV-2023, the patient received Boostrix. In NOV-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: 12 year old patient received Boostrix as a booster dose but the vaccines was expired). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date 27 Nov 2023: The HCP reported that a 12 year old patient received Boostrix as a booster dose but the vaccines was expired, which led to expired vaccine used. The reporter consented to follow up via email.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Medical Assistant reported on Nov 27th 2023 that today a patient was vaccinated with an expired Boostrix dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7MH39, expiry date 18-NOV-2023) for prophylaxis.   On 27-NOV-2023, the patient received Boostrix. On 27-NOV-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Medical Assistant reported on Nov 27th 2023 that today a patient was vaccinated with an expired Boostrix dose). 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 27 Nov 2023: Medical Assistant reported that on the day of reporting a patient was vaccinated with an expired Boostrix dose, which led to expired vaccine used. No Patient´s details when asked. The reporter consented to follow up via email.
Age: 74.0
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Pharmacist states a patient received the 1st dose of Engerix-B on 9/30/2023 but did not come in until now to get the 2nd dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Previously administered products included Engerix b adult (received 1st dose on 30th September 2023).   On an unknown date, the patient received the 2nd dose of Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced incomplete course of vaccination (Verbatim: Pharmacist states a patient received the 1st dose of Engerix-B on 9/30/2023 but did not come in until now to get the 2nd dose.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date 27 Nov 2023 The pharmacist stated a patient received the 1st dose of Engerix-B but did not come in until now to get the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. The VAERS details reported for 1st dose.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Pharmacist states a pregnant patient was given Arexvy.; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy 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 vaccine exposure during pregnancy (Verbatim: Pharmacist states a pregnant patient was given Arexvy.). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt date: 28-NOV-2023 Reporter stated that a pregnant patient was given Arexvy. No further details were provided. Reporter was in the car during the call, and it was very difficult to had a conversation due to background noise and difficult hearing and understanding the reporter. The reporter consented to follow up via mail.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Dyspnoea, Laboratory test normal
Clinical narrative: Two days after receiving the vaccine, consumer was walking and could not breathe for 10-15 seconds.The following day, consumer was in shower and could not breathe for 10-15 seconds.; This non-serious case was reported by a consumer via call center representative and described the occurrence of difficulty breathing in a 72-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 20-OCT-2023, the patient received Arexvy (left arm). On 22-OCT-2023, 2 days after receiving Arexvy, the patient experienced difficulty breathing (Verbatim: Two days after receiving the vaccine, consumer was walking and could not breathe for 10-15 seconds.The following day, consumer was in shower and could not breathe for 10-15 seconds.). The outcome of the difficulty breathing was resolved.   It was unknown if the reporter considered the difficulty breathing to be related to Arexvy.   It was unknown if the company considered the difficulty breathing to be related to Arexvy.   Additional Information: GSK Receipt Date: 28-NOV-2023 The reporter stated that 2 days after receiving the Arexvy vaccine, he was walking and suddenly could not breathe for 10-15 seconds.  He was breathing normally the rest of the day.  The following day, 3 days after the vaccine, consumer was in shower and could not breathe again for 10-15 seconds.  He had been breathing normally since then.  Five days after receiving the vaccine, he had an appointment with his doctor at the clinic.  The doctor ordered some medical tests at the hospital and the results all came back as clear or normal.  The reporter recommended that he called and reported to GlaxoSmithKline. The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient received a third dose of such vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 7TA92) for prophylaxis.   Previously administered products included Shingrix (the patient had finished the Shingrix series back in 2019).   On 17-NOV-2023, the patient received the 3rd dose of Shingrix. On 17-NOV-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: patient received a third dose of such vaccine). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date:28-NOV-2023 The pharmacist called to inform that a patient had received a third dose of such vaccine, which led to extra dose administered. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 0.17
Sex: U
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Inappropriate reconstitution Technique; Inappropriate reconstitution Technique; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 10-week-old patient who received Rota (Rotarix lyophilized formulation) (batch number 5279E, expiry date 25-FEB-2024) for prophylaxis.   On 14-AUG-2023, the patient received Rotarix lyophilized formulation. On 14-AUG-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate reconstitution Technique) and inappropriate dose of vaccine administered (Verbatim: Inappropriate reconstitution Technique). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-NOV-2023 The health care professional had reported that Rotarix diluent was administered without reconstitution with lyophilized portion of the vaccine to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow-up. This case had been linked with US2023166468, reported by the same reporter.; Sender's Comments:  US-GSK-US2023166468:Same Reporter , same Product .
Sex: M
Vaccine: RSV
Symptoms: Bronchitis, Cough, Malaise, Respiratory symptom, Rhinorrhoea
Clinical narrative: he was very sick; experienced upper respiratory symptoms; cough; sneezing; runny nose; bronchitis; This non-serious case was reported by a consumer via call center representative and described the occurrence of upper respiratory symptom in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concomitant products included doxycycline.   On 08-NOV-2023, the patient received Arexvy (left arm). In NOV-2023, an unknown time after receiving Arexvy, the patient experienced upper respiratory symptom (Verbatim: experienced upper respiratory symptoms), cough (Verbatim: cough), sneezing (Verbatim: sneezing), runny nose (Verbatim: runny nose), bronchitis (Verbatim: bronchitis) and sickness (Verbatim: he was very sick). The patient was treated with prednisone. In NOV-2023, the outcome of the sickness was resolved. The outcome of the upper respiratory symptom, cough, sneezing, runny nose and bronchitis were unknown.   It was unknown if the reporter considered the upper respiratory symptom, cough, sneezing, runny nose, bronchitis and sickness to be related to Arexvy.     It was unknown if the company considered the upper respiratory symptom, cough, sneezing, runny nose, bronchitis and sickness to be related to Arexvy.   Additional Information: GSK receipt date: 29-NOV-2023 The reporter was the patient's wife who states that the patient received Arexvy and stated that after getting a dose, the patient experienced upper respiratory symptoms, cough, sneezing, runny nose, and bronchitis.  The reporter's physician gave him prednisone and bronchitis for his symptoms.  She stated he was very sick for 3 weeks. The reporter did not consent to follow-up.
Sex: M
Vaccine: RSV
Symptoms: Sneezing
Clinical narrative: he was very sick; experienced upper respiratory symptoms; cough; sneezing; runny nose; bronchitis; This non-serious case was reported by a consumer via call center representative and described the occurrence of upper respiratory symptom in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concomitant products included doxycycline.   On 08-NOV-2023, the patient received Arexvy (left arm). In NOV-2023, an unknown time after receiving Arexvy, the patient experienced upper respiratory symptom (Verbatim: experienced upper respiratory symptoms), cough (Verbatim: cough), sneezing (Verbatim: sneezing), runny nose (Verbatim: runny nose), bronchitis (Verbatim: bronchitis) and sickness (Verbatim: he was very sick). The patient was treated with prednisone. In NOV-2023, the outcome of the sickness was resolved. The outcome of the upper respiratory symptom, cough, sneezing, runny nose and bronchitis were unknown.   It was unknown if the reporter considered the upper respiratory symptom, cough, sneezing, runny nose, bronchitis and sickness to be related to Arexvy.     It was unknown if the company considered the upper respiratory symptom, cough, sneezing, runny nose, bronchitis and sickness to be related to Arexvy.   Additional Information: GSK receipt date: 29-NOV-2023 The reporter was the patient's wife who states that the patient received Arexvy and stated that after getting a dose, the patient experienced upper respiratory symptoms, cough, sneezing, runny nose, and bronchitis.  The reporter's physician gave him prednisone and bronchitis for his symptoms.  She stated he was very sick for 3 weeks. The reporter did not consent to follow-up.