chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Nausea, Pain, Swelling
Clinical narrative: Pain, swelling, nauseous, fatigue, still feeling terribly ill  6 days after the shot.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Whole body rash starting 15 days after vaccination and worsening in severity over the next 3 days hours.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Altered visual depth perception, Biopsy artery abnormal, Blindness unilateral, Giant cell arteritis, Headache
Clinical narrative: I have GCA from Covid-19 vac. no health issues before the jab. I am legally blind in left eye & partial in right eye. Makes driving an daily chores challenging. I am no longer driving to many near misses due to poor depth perseption for one eye. I got 1st shot at pharmacy on Tues 4/7/21. Two (days) later on Thursday I started a (horrible) neck, head pain. Got worse where I couldn't lay me head on side of pillow. Doctor at time dismissed it as nerves & stress. Told to relax and wait. It kept getting worse, now my jaws were painful. Few weeks later I started losing my vision in upper left of left eye. Next day upper right portion, then lower left and lower right portion. Called eye doc. said to see optomologist ASAP. That was Thursday of same week. Did test and blood work. Sedrate over 100 ASAP get 80mg. prednesone started. On Monday did biopsy of left temple, yes I have GCA. Stayed on 80mg of pred so right eye wont go. for many, many months. That worked, eye doc said I had stoke in eye and dead opticle nerves, sight will never come back. Went on Acterma Acti pen 1xwk, now on tyene inject. Was on methotraxte & folic now 4yr. later no longer on that. To keep treating me doc said to get 2nd shot. No!! but I did. Said no more 'live' vaccines After many months of being on high dose of pred. 80mg. so right eye won't go, it caused my spine to become pithy. Within that 2nd year I had total of 11 comp. fractures which were Kpoplastied, cemented. Last yr. 24 I developed spinal stenosis with facet fractures L4 & L5. Have had 3 epidurals and now '25 waiting for another process to releive pain & sciatic nerves. I hope the worst is over, I have great doctors here locally, as I did in another city. I looked into compensation but because I am retired & insurance takes care of my bills so far, I am denied. I also get state aid. I don't agree because my life is severely reduced, And no independence. But I am thankful, I could have been blind if not for my opthmologist. There are a few other people with same devestation after Covid-19 vac. I hope my problem will help research and study. I guess at early onset of Covid-19 vacc. not much was known abt. side effects. I happened to be one of a few who didn't recover.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Impaired driving ability, Loss of personal independence in daily activities, Lumbar spinal stenosis, Lumbar vertebral fracture, Neck pain
Clinical narrative: I have GCA from Covid-19 vac. no health issues before the jab. I am legally blind in left eye & partial in right eye. Makes driving an daily chores challenging. I am no longer driving to many near misses due to poor depth perseption for one eye. I got 1st shot at pharmacy on Tues 4/7/21. Two (days) later on Thursday I started a (horrible) neck, head pain. Got worse where I couldn't lay me head on side of pillow. Doctor at time dismissed it as nerves & stress. Told to relax and wait. It kept getting worse, now my jaws were painful. Few weeks later I started losing my vision in upper left of left eye. Next day upper right portion, then lower left and lower right portion. Called eye doc. said to see optomologist ASAP. That was Thursday of same week. Did test and blood work. Sedrate over 100 ASAP get 80mg. prednesone started. On Monday did biopsy of left temple, yes I have GCA. Stayed on 80mg of pred so right eye wont go. for many, many months. That worked, eye doc said I had stoke in eye and dead opticle nerves, sight will never come back. Went on Acterma Acti pen 1xwk, now on tyene inject. Was on methotraxte & folic now 4yr. later no longer on that. To keep treating me doc said to get 2nd shot. No!! but I did. Said no more 'live' vaccines After many months of being on high dose of pred. 80mg. so right eye won't go, it caused my spine to become pithy. Within that 2nd year I had total of 11 comp. fractures which were Kpoplastied, cemented. Last yr. 24 I developed spinal stenosis with facet fractures L4 & L5. Have had 3 epidurals and now '25 waiting for another process to releive pain & sciatic nerves. I hope the worst is over, I have great doctors here locally, as I did in another city. I looked into compensation but because I am retired & insurance takes care of my bills so far, I am denied. I also get state aid. I don't agree because my life is severely reduced, And no independence. But I am thankful, I could have been blind if not for my opthmologist. There are a few other people with same devestation after Covid-19 vac. I hope my problem will help research and study. I guess at early onset of Covid-19 vacc. not much was known abt. side effects. I happened to be one of a few who didn't recover.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Optic atrophy, Pain in jaw, Quality of life decreased, Red blood cell sedimentation rate increased, Retinal artery occlusion
Clinical narrative: I have GCA from Covid-19 vac. no health issues before the jab. I am legally blind in left eye & partial in right eye. Makes driving an daily chores challenging. I am no longer driving to many near misses due to poor depth perseption for one eye. I got 1st shot at pharmacy on Tues 4/7/21. Two (days) later on Thursday I started a (horrible) neck, head pain. Got worse where I couldn't lay me head on side of pillow. Doctor at time dismissed it as nerves & stress. Told to relax and wait. It kept getting worse, now my jaws were painful. Few weeks later I started losing my vision in upper left of left eye. Next day upper right portion, then lower left and lower right portion. Called eye doc. said to see optomologist ASAP. That was Thursday of same week. Did test and blood work. Sedrate over 100 ASAP get 80mg. prednesone started. On Monday did biopsy of left temple, yes I have GCA. Stayed on 80mg of pred so right eye wont go. for many, many months. That worked, eye doc said I had stoke in eye and dead opticle nerves, sight will never come back. Went on Acterma Acti pen 1xwk, now on tyene inject. Was on methotraxte & folic now 4yr. later no longer on that. To keep treating me doc said to get 2nd shot. No!! but I did. Said no more 'live' vaccines After many months of being on high dose of pred. 80mg. so right eye won't go, it caused my spine to become pithy. Within that 2nd year I had total of 11 comp. fractures which were Kpoplastied, cemented. Last yr. 24 I developed spinal stenosis with facet fractures L4 & L5. Have had 3 epidurals and now '25 waiting for another process to releive pain & sciatic nerves. I hope the worst is over, I have great doctors here locally, as I did in another city. I looked into compensation but because I am retired & insurance takes care of my bills so far, I am denied. I also get state aid. I don't agree because my life is severely reduced, And no independence. But I am thankful, I could have been blind if not for my opthmologist. There are a few other people with same devestation after Covid-19 vac. I hope my problem will help research and study. I guess at early onset of Covid-19 vacc. not much was known abt. side effects. I happened to be one of a few who didn't recover.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sciatica, Spinal compression fracture, Spinal disorder, Vertebroplasty, Visual impairment
Clinical narrative: I have GCA from Covid-19 vac. no health issues before the jab. I am legally blind in left eye & partial in right eye. Makes driving an daily chores challenging. I am no longer driving to many near misses due to poor depth perseption for one eye. I got 1st shot at pharmacy on Tues 4/7/21. Two (days) later on Thursday I started a (horrible) neck, head pain. Got worse where I couldn't lay me head on side of pillow. Doctor at time dismissed it as nerves & stress. Told to relax and wait. It kept getting worse, now my jaws were painful. Few weeks later I started losing my vision in upper left of left eye. Next day upper right portion, then lower left and lower right portion. Called eye doc. said to see optomologist ASAP. That was Thursday of same week. Did test and blood work. Sedrate over 100 ASAP get 80mg. prednesone started. On Monday did biopsy of left temple, yes I have GCA. Stayed on 80mg of pred so right eye wont go. for many, many months. That worked, eye doc said I had stoke in eye and dead opticle nerves, sight will never come back. Went on Acterma Acti pen 1xwk, now on tyene inject. Was on methotraxte & folic now 4yr. later no longer on that. To keep treating me doc said to get 2nd shot. No!! but I did. Said no more 'live' vaccines After many months of being on high dose of pred. 80mg. so right eye won't go, it caused my spine to become pithy. Within that 2nd year I had total of 11 comp. fractures which were Kpoplastied, cemented. Last yr. 24 I developed spinal stenosis with facet fractures L4 & L5. Have had 3 epidurals and now '25 waiting for another process to releive pain & sciatic nerves. I hope the worst is over, I have great doctors here locally, as I did in another city. I looked into compensation but because I am retired & insurance takes care of my bills so far, I am denied. I also get state aid. I don't agree because my life is severely reduced, And no independence. But I am thankful, I could have been blind if not for my opthmologist. There are a few other people with same devestation after Covid-19 vac. I hope my problem will help research and study. I guess at early onset of Covid-19 vacc. not much was known abt. side effects. I happened to be one of a few who didn't recover.
Age: 82.0
Sex: M
Vaccine: YF
Symptoms: Unevaluable event
Clinical narrative: Patient reported hospitalization
Age: 12.0
Sex: M
Vaccine: MMRV, UNK
Symptoms: Product storage error
Clinical narrative: no additional AE; received improperly stored PROQUAD since it "was stored in the refrigerator for months" instead of the freezer; This spontaneous report was received from a nurse on 19-Feb-2025, and refers to a 12-year-old male patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 13-Jan-2025, the patient was vaccinated with the second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y017208, expiration date 13-Apr-2026), administered by Subcutaneous route in Right Arm (expiration date was not reported) as prophylaxis with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported).  It was assumed that Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) could be stored in both the freezer and refrigerator and both State and Private Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were moved to the refrigerators where they remained within normal refrigerated temperature range until administration. Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was improperly stored since it "was stored in the refrigerator for months" instead of the freezer until administration (Product storage error). No additional AE (no adverse event).   .
Age: 12.0
Sex: M
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; received improperly stored PROQUAD since it "was stored in the refrigerator for months" instead of the freezer; This spontaneous report was received from a nurse on 19-Feb-2025, and refers to a 12-year-old male patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 13-Jan-2025, the patient was vaccinated with the second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y017208, expiration date 13-Apr-2026), administered by Subcutaneous route in Right Arm (expiration date was not reported) as prophylaxis with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported).  It was assumed that Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) could be stored in both the freezer and refrigerator and both State and Private Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were moved to the refrigerators where they remained within normal refrigerated temperature range until administration. Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was improperly stored since it "was stored in the refrigerator for months" instead of the freezer until administration (Product storage error). No additional AE (no adverse event).   .
Age: 10.0
Sex: F
Vaccine: HEP, IPV, MMRV, TDAP, MMRV, UNK
Symptoms: Product storage error
Clinical narrative: No adverse event; patient may have received improperly stored PROQUAD; This spontaneous report was received from a Registered Nurse and refers to a 10-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Hepatitis b vaccine rHBsAg (yeast) (ENGERIX B), Diphtheria vaccine toxoid; Pertussis vaccine acellular 3-component; Tetanus vaccine toxoid (BOOSTRIX), Polio vaccine inact 3v (Vero () IPOL) .  On 01-OCT-2024, the facility received a shipment of COVID vaccines that needed to be stored in the freeze. There was no room in the freezer to accommodate the shipment. A document was found on the FDA website and it was assumed that Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) could be stored in both the freezer and refrigerator and both State and private Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were moved to the refrigerators where they remained within normal refrigerated temperature range until administration.   The dose administered was moved from freezer to refrigerator an 01-OCT-2024 and on 19-NOV-2024, the patient was vaccinated with an improperly stored second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y008284, expiration date: 21-OCT-2025), dose number 2, administered by Subcutaneous route in Right Arm (Product storage error) and diluent (MERCK STERILE DILUENT), administered by Subcutaneous route in Right Arm (lot # and expiration date were not reported), for prophylaxis.  Lot # is being requested and will be submitted if received.; Sender's Comments: Priority : 5 , Is case serious : No , Index user :  , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 12/04/2013 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Age: 10.0
Sex: F
Vaccine: HEP, IPV, MMRV, TDAP, MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; patient may have received improperly stored PROQUAD; This spontaneous report was received from a Registered Nurse and refers to a 10-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Hepatitis b vaccine rHBsAg (yeast) (ENGERIX B), Diphtheria vaccine toxoid; Pertussis vaccine acellular 3-component; Tetanus vaccine toxoid (BOOSTRIX), Polio vaccine inact 3v (Vero () IPOL) .  On 01-OCT-2024, the facility received a shipment of COVID vaccines that needed to be stored in the freeze. There was no room in the freezer to accommodate the shipment. A document was found on the FDA website and it was assumed that Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) could be stored in both the freezer and refrigerator and both State and private Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were moved to the refrigerators where they remained within normal refrigerated temperature range until administration.   The dose administered was moved from freezer to refrigerator an 01-OCT-2024 and on 19-NOV-2024, the patient was vaccinated with an improperly stored second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y008284, expiration date: 21-OCT-2025), dose number 2, administered by Subcutaneous route in Right Arm (Product storage error) and diluent (MERCK STERILE DILUENT), administered by Subcutaneous route in Right Arm (lot # and expiration date were not reported), for prophylaxis.  Lot # is being requested and will be submitted if received.; Sender's Comments: Priority : 5 , Is case serious : No , Index user :  , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 12/04/2013 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Age: 11.0
Sex: F
Vaccine: HEP, IPV, MMRV, MNQ, TDAP, UNK
Symptoms: Product storage error
Clinical narrative: No adverse effects reported; improperly stored PROQUAD; This spontaneous report was received from an Other health professional and refers to an 11-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Hbhepb (Hepatitis b vaccine;HIB vaccine), Ipol (Polio vaccine inact 3v (Vero)), Men (Meningococcal vaccine), Boostrix (Diphtheria vaccine toxoid;Pertussis vaccine acellular 3-component;Tetanus vaccine toxoid) .  The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live lyophilisate and solvent for solution for injection (PROQUAD) was moved to the refrigerators on 01-OCT-2024 where it remained within normal refrigerated temperature (36 to 46 degrees Fahrenheit) until administration. The patient received the first dose of improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live lyophilisate and solvent for solution for injection (PROQUAD) subcutaneously at right arm on 04-DEC-2024 for prophylaxis since it "was stored in the refrigerator for months" instead of the freezer (lot # Y008284, expiry date: 21-OCT-2025) (Product storage error). No adverse effects reported (no adverse event).  This is one of many reports from the same reporter.
Age: 11.0
Sex: F
Vaccine: HEP, IPV, MMRV, MNQ, TDAP, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; improperly stored PROQUAD; This spontaneous report was received from an Other health professional and refers to an 11-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Hbhepb (Hepatitis b vaccine;HIB vaccine), Ipol (Polio vaccine inact 3v (Vero)), Men (Meningococcal vaccine), Boostrix (Diphtheria vaccine toxoid;Pertussis vaccine acellular 3-component;Tetanus vaccine toxoid) .  The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live lyophilisate and solvent for solution for injection (PROQUAD) was moved to the refrigerators on 01-OCT-2024 where it remained within normal refrigerated temperature (36 to 46 degrees Fahrenheit) until administration. The patient received the first dose of improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live lyophilisate and solvent for solution for injection (PROQUAD) subcutaneously at right arm on 04-DEC-2024 for prophylaxis since it "was stored in the refrigerator for months" instead of the freezer (lot # Y008284, expiry date: 21-OCT-2025) (Product storage error). No adverse effects reported (no adverse event).  This is one of many reports from the same reporter.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Faeces discoloured, No adverse event, Product dose omission issue
Clinical narrative: patient missed their second dose of ROTATEQ; green poop; This spontaneous report was received from a consumer referring her son as a 2-month-old male patient.   His medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.   On 11-NOV-2024, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), Oral liquid, dose number 1, 1 dosage form administered by Oral route (po) (lot # and expiration date were not reported) as prophylaxis (reported as "rotavirus.")  On unspecified date in November 2024, the patient had "green poop" (faeces discoloured) following first vaccination, which lasted for "about a week or two". Then on an unspecified date in November 2024, he recovered from the event. Patient's mother reported that the patient missed his second dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) on 11-JAN-2025 (product dose omission issue). No symptoms or side effects were reported by the patient's mother for the patient missing the second dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ). No further information reported by the patient's mother.  The causal relationship between faeces discoloured and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was unknown as patient's mother was unsure if that was because of the Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ.)  Additional information was not expected.
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong patient
Clinical narrative: No additional AE; infant patient was inadvertently administered an adolescent dose of GARDASIL 9 today, 3/3/2025, that was meant for their older sibling; Medical Assistant calling with a report of an adverse event regarding GARDASIL 9.  Medical assistant stated that an infant patient was inadvertently administered an adolescent dose of GARDASIL 9 today, 3/3/2025, that was meant for their older sibling; This spontaneous report was received from a Physician Assistant (reported as medical assistant) and refers to an infant patient of unknown age and gender.   The patient's medical history, concurrent conditions, concomitant therapies were not reported, past drug reactions and allergies were not reported.    On 03-MAR-2025, the infant patient was inadvertently vaccinated with an adolescent dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), 0.5 mL, Two or Three dose series, indicated as prophylaxis (lot number Y010656 has been verified to be a valid number for Human Papillomavirus 9-valent Vaccine, Recombinant [GARDASIL 9], expiration date: 29-Nov-2026; formulation route of administration and anatomical site of injection were not provided) that was meant for their older sibling who was of age to received their first dose (Product administered to patient of inappropriate age, Wrong patient received product). The reporter confirmed the patient involved has not experienced any medical concerns or symptoms after the administration (No adverse event).
Age: 57.0
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Fatigue, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Rash on left arm appeared 22 hours after injection and persists 56 hours after injection. Injection site pain and swelling appeared 4 hours after injection and began to resolve 48 hours after injection. Fatigue, dizziness, and nausea appeared 22 hours after injection and resolved 48 hours after injection.
Age: 57.0
Sex: F
Vaccine: PNC20
Symptoms: Rash
Clinical narrative: Rash on left arm appeared 22 hours after injection and persists 56 hours after injection. Injection site pain and swelling appeared 4 hours after injection and began to resolve 48 hours after injection. Fatigue, dizziness, and nausea appeared 22 hours after injection and resolved 48 hours after injection.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Vaccine given on a Friday afternoon. At about 12 hrs after vaccination we noted some redness around injection site. At 18 hours it increased in redness and was swollen.. At 24 hours injection site increased in redness. It became raised, itchy, painful to touch and hot to touch.  It became hard for the child to move her arm. By 36 hours redness spread to cover whole upper extremity wrapping around arm . It continued to be painful, hot to touch, raised and itchy. Child given oral Benadryl.  Completed a Video visit where provider believed it was cellulite and recommended antibiotics. Delayed giving antibiotics. Gave one dose of abx before seeing pediatrician. Pediatrician advised to stop abx as likely was not antibiotics and a localized reaction to the vaccine
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Vaccine given on a Friday afternoon. At about 12 hrs after vaccination we noted some redness around injection site. At 18 hours it increased in redness and was swollen.. At 24 hours injection site increased in redness. It became raised, itchy, painful to touch and hot to touch.  It became hard for the child to move her arm. By 36 hours redness spread to cover whole upper extremity wrapping around arm . It continued to be painful, hot to touch, raised and itchy. Child given oral Benadryl.  Completed a Video visit where provider believed it was cellulite and recommended antibiotics. Delayed giving antibiotics. Gave one dose of abx before seeing pediatrician. Pediatrician advised to stop abx as likely was not antibiotics and a localized reaction to the vaccine
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: The patient states that her arm (Right Arm) is sore at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 05-MAR-2025, the patient received the 1st dose of Shingles vaccine (right arm). In MAR-2025, an unknown time after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: The patient states that her arm (Right Arm) is sore at the injection site). The outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date : 06-MAR-2025 The patient received the Shingles vaccine the day before reporting at a local pharmacy.  The patient stated that her arm (right Arm) was sore at the injection site.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Emotional distress, Feeling hot, Laboratory test, Magnetic resonance imaging, Pain
Clinical narrative: Turn rotator cuff; Frozen shoulder; warm rush sensation through her chest; agony; pain; she could not raise her arm; This spontaneous report has been received from a consumer regarding a 62-year-old female patient.  The patient's medical history and concurrent conditions were not reported. Concomitant medications included Dexmethylphenidate hydrochloride (FOCALIN), Tramadol hydrochloride, and anti depressant.  On 06-JAN-2022 at about 10:00, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), administered as prophylaxis (strength, dose, vaccination scheme, route of administration, anatomical site of injection, lot number, and expiration date were not reported).  On that same date at around 11:30, the patient was standing and experienced a warm rush sensation through her chest (Feeling hot). That night, the patient went to raise her arms to put a shirt on and she could not raise her arm (Vaccination site movement impairment). The reporter stated that she had been dealing with this pain ever since (Pain), and she was in agony for the first 18 months (Emotional distress). On an unknown date in 2023, the patient recovered from the event of emotional distress. On an unknown date, the patient experienced frozen shoulder (Periarthritis) and turn rotator cuff (Rotator cuff syndrome). She stated that she had been to many different healthcare professionals (HCP) including neurologists, pain management, physical therapists, orthopedics, and a psychiatrist, and that all the HCPs want to do is ''cut''. Also, it was reported that some of the treatments have included physical therapy and pain management injections but that the pain persists, and that the patient has gotten ''every test in the book'' including magnetic resonance imaging (MRI). She mentioned that the vaccine di work because she has not gotten sick since she got it back in 2022. At the time of the reporting, the patient had not recovered from the events of pain, rotator cuff syndrome, and periarthritis. The outcome of the events of vaccination site movement impairment and feeling hot was unknown.   The causal relationship between the events and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was not reported.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Periarthritis, Rotator cuff syndrome
Clinical narrative: Turn rotator cuff; Frozen shoulder; warm rush sensation through her chest; agony; pain; she could not raise her arm; This spontaneous report has been received from a consumer regarding a 62-year-old female patient.  The patient's medical history and concurrent conditions were not reported. Concomitant medications included Dexmethylphenidate hydrochloride (FOCALIN), Tramadol hydrochloride, and anti depressant.  On 06-JAN-2022 at about 10:00, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), administered as prophylaxis (strength, dose, vaccination scheme, route of administration, anatomical site of injection, lot number, and expiration date were not reported).  On that same date at around 11:30, the patient was standing and experienced a warm rush sensation through her chest (Feeling hot). That night, the patient went to raise her arms to put a shirt on and she could not raise her arm (Vaccination site movement impairment). The reporter stated that she had been dealing with this pain ever since (Pain), and she was in agony for the first 18 months (Emotional distress). On an unknown date in 2023, the patient recovered from the event of emotional distress. On an unknown date, the patient experienced frozen shoulder (Periarthritis) and turn rotator cuff (Rotator cuff syndrome). She stated that she had been to many different healthcare professionals (HCP) including neurologists, pain management, physical therapists, orthopedics, and a psychiatrist, and that all the HCPs want to do is ''cut''. Also, it was reported that some of the treatments have included physical therapy and pain management injections but that the pain persists, and that the patient has gotten ''every test in the book'' including magnetic resonance imaging (MRI). She mentioned that the vaccine di work because she has not gotten sick since she got it back in 2022. At the time of the reporting, the patient had not recovered from the events of pain, rotator cuff syndrome, and periarthritis. The outcome of the events of vaccination site movement impairment and feeling hot was unknown.   The causal relationship between the events and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was not reported.
Sex: M
Vaccine: MMRV
Symptoms: Device connection issue, Underdose
Clinical narrative: the PFS leaked from around the leurlock during administration; Initial caller was medical assistant who then placed MD on phone.  HCP reported PQC for Sterile Diluent PFS.  Caller states the PFS leaked from around the leurlock during administration and then the needle and leurlock broke off when engaging the saf; syringe leak; This spontaneous report was received from a physician referring to a 4-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live lyophilisate and solvent for solution for injection (PROQUAD), injection for prophylaxis, 0.5 milliliter, intramuscularly, lot number Y009348 which has been verified to be valid, expiration date reported and validated as 11-NOV-2025 (anatomical location, scheme and strength not provided) with sterile diluent solution for injection, lot number 1973529 which is an invalid lot number, expiration date 03-MAR-2026. On 20-FEB-2025, the prefilled syringe leaked from around the leurlock during administration. The reporter stated that the prefilled syringe leaked from around the leurlock during administration and then the needle and leurlock broke off when engaging the safety cap (poor quality deice used) (accidental underdose).  Follow-up was received from reporter on 24-FEB-2025. The needle and leur lock broke off from the syringe. The louer lock itself was still inact and attached to the needle. The reporter confirmed needle detached from louer lock while engaging safety cap. It was not difficult to attach the needle but she could not get a good seal.
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Caller reported VARIVAX administered after temperature excursion. No other information provided.; This spontaneous report has been received from a nurse, regarding to a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported. On 07-FEB-2025, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka-merck) lyophilisate and solvent for solution for injection (VARIVAX) 0.5 milliliter (mL) administered as prophylaxis Lot No. Y015108 has been verified to be a valid lot number for [varicella virus vaccine live (oka-merck) lyophilisate and solvent for solution for injection], expiration date reported  and upon internal validation established as 06-SEP-2026 (strength, dose number, route and anatomical location of administration and vaccination scheme frequency were not provided) that was reconstituted with an sterile diluent solution for injection (BAXTER STERILE DILUENT) (Lot number, expiration date and route of administration was not provided (product storage error), after a temperature excursion of -2.1 degree Celsius (C) (-2.1C) during a time frame of 6 hours 45 minutes and 0 seconds. No previous temperature excursion was reported.  This is one of several reports received from the same reporter.
Age: 8.0
Sex: M
Vaccine: HEP, UNK, UNK, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; patients may have received improperly stored PROQUAD; This spontaneous report was received from a Nurse and refers to an 8-year-old male patient.   The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 01-Oct-2024 FCPH received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accommodate the shipment. A document was found on the FDA website. It was assumed that Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) could be stored in both the freezer and refrigerator and both State and Private Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were moved to the refrigerators where they remained within normal refrigerated temperature range until administration.   On 05-Dec-2024, the patient was vaccinated with the improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y008284, expiration date: 21-Oct-2025) administered by Subcutaneous route in Left Arm for prophylaxis with sterile diluent (MERCK STERILE DILUENT) (Product storage error). On the same day, the patient also received Engerix b (Hepatitis b vaccine rHBsAg (yeast)) (lot #95BJ9) (Left arm), administered by Intramuscular route and Flucelvax quadrivalent (Influenza vaccine inact sAg 4v) (lot #946595) (Right Arm), administered by Intramuscular route. No additional AE.   This is one of the several reports received from the same reporter.
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: "The HCP sttated she did not experienced any other adverse issues ir side effects form the administered or missed dose"; No adverse event; Information has been received from Business Partner/CRO on 28-Feb-2025.  This spontaneous report was received from a/an Other health professional and refers to a(n) 51-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On Sep-1978, the patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot # and expiration date were not reported). On an unknown date, the patient started therapy with sterile diluent (BAXTER STERILE DILUENT), (indication, expiration date, and lot # were not reported). The patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), for the treatment of Prophylaxis.  On an unknown date, the patient experienced No adverse event. On an unknown date, the patient experienced "The HCP sttated she did not experienced any other adverse issues ir side effects form the administered or missed dose".   At the reporting time, the outcome of No adverse event and "The HCP sttated she did not experienced any other adverse issues ir side effects form the administered or missed dose" was unknown.   The action taken with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live and sterile diluent was reported as not applicable.
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Rash
Clinical narrative: broke up with rash a month later up the torso like ringworms; has not received a second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of rash in a 49-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) (batch number 797F9, expiry date 30-DEC-2025) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Twinrix. On 19-NOV-2024, the patient received the 1st dose of Twinrix. On an unknown date, not applicable after receiving Twinrix and 1 month after receiving Twinrix, the patient experienced rash (Verbatim: broke up with rash a month later up the torso like ringworms) and incomplete course of vaccination (Verbatim: has not received a second dose yet). The outcome of the rash was unknown and the outcome of the incomplete course of vaccination was not applicable.   It was unknown if the reporter considered the rash to be related to Twinrix and Twinrix Pre-Filled Syringe Device.     It was unknown if the company considered the rash to be related to Twinrix and Twinrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date : 26-FEB-2025 Pharmacist called on February 26, 2025 to report a patient received the first dose for Twinrix on November 19, 2024 and broke up with rash a month later up the torso like ringworms and and had not received a second dose yet. Till the time of reporting, the patient did not receive 2nd dose of twinrix, which led to incomplete course of vaccination.
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Priorix was administered intramuscularly instead of subcutaneously.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix was administered intramuscularly instead of subcutaneously.). The outcome of the subcutaneous injection formulation administered by other route was not applicable.   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-MAR-2025 Pharmacist reports Priorix was administered intramuscularly instead of subcutaneously, which led to subcutaneous injection formulation administered by other route The reporter consented to follow up. No details at time of call were available.
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate Dose Administered (adult dose maladministered on a pediatric patient); Inappropriate Dose Administered (adult dose maladministered on a pediatric patient); This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a patient who received HAV (Havrix 1440 adult) for prophylaxis.   On an unknown date, the patient received Havrix 1440 adult. On an unknown date, an unknown time after receiving Havrix 1440 adult, the patient experienced accidental overdose (Verbatim: Inappropriate Dose Administered (adult dose maladministered on a pediatric patient)) and adult product administered to child (Verbatim: Inappropriate Dose Administered (adult dose maladministered on a pediatric patient)). The outcome of the accidental overdose and adult product administered to child were not applicable.   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-MAR-2025 The reporter called to ask any medical concerns about the maladministration of an adult dose in a pediatric patient on one of their clinics, which led to accidental overdose and adult product administered to child. No vaccination date, nor vaccine detail or patient´s demographics were obtained (Anonymous Healthcare provider did not consent follow-up from Safety Department).  No further information was obtained in this call. Did not consent to follow-up.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Sleep disorder
Clinical narrative: awoke 3 times at night completely drenched in sweat; awoke 3 times at night completely drenched in sweat; This spontaneous case was reported by a patient and describes the occurrence of NIGHT SWEATS (awoke 3 times at night completely drenched in sweat) and SLEEP DISORDER (awoke 3 times at night completely drenched in sweat) in a 63-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043159) for COVID-19 prophylaxis.     No Medical History information was reported.   On 24-Feb-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 26-Feb-2025,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced NIGHT SWEATS (awoke 3 times at night completely drenched in sweat). On an unknown date, the patient experienced SLEEP DISORDER (awoke 3 times at night completely drenched in sweat). At the time of the report, NIGHT SWEATS (awoke 3 times at night completely drenched in sweat) and SLEEP DISORDER (awoke 3 times at night completely drenched in sweat) outcome was unknown.      No concomitant medications were reported. It was reported that he has awoken 3 times at night completely drenched in sweat and never experienced this before. No treatment medications were reported.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, MNQ, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Menquadfi vaccine administered instead of Prevnar vaccine  no adverse reaction
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP called to report a child was administered an expired VAQTA vaccine. Lot/Expiration X017083  12/13/2024, administered 2/19/2025.  Consent to contact is yes. No adverse side effects were reported. No additional information available at this time. N; This spontaneous report was received from a physician and refers to a 3-year-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 19-FEB-2025, the patient was vaccinated with an expired dose of with Hepatitis A Vaccine, Inactivated (VAQTA) (lot #X017083, who had been verified to be a valid lot number, expiration date reported and assessed as 13-DEC-2024) administered for prophylaxis (strength, exact dose, anatomical route of administration were not provided) (expired product administered).   No adverse event.
Age: 43.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: pediatric immunizaton was given to an adult; pediatric immunizaton was given to an adult; This non-serious case was reported by a other health professional and described the occurrence of underdose in a 43-year-old male patient who received HBV (Engerix B pediatric) (batch number 4ZN3H, expiry date 01-DEC-2026) for prophylaxis.   On 02-OCT-2024, the patient received Engerix B pediatric (intramuscular) 1 ml. On 02-OCT-2024, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: pediatric immunizaton was given to an adult) and adult use of a child product (Verbatim: pediatric immunizaton was given to an adult). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 13-NOV-2024 The other health professional reported that the pediatric immunization was given to an adult which led to underdose and adult use of a child product.
Vaccine: RSV
Symptoms: Fatigue, Myalgia
Clinical narrative: Fatigue; experienced myalgia; This non-serious case was reported by a physician via sales rep and described the occurrence of fatigue in a elderly patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced fatigue (Verbatim: Fatigue) and myalgia (Verbatim: experienced myalgia). The outcome of the fatigue was resolved and the outcome of the myalgia was not reported.   The reporter considered the fatigue to be related to Arexvy. It was unknown if the reporter considered the myalgia to be related to Arexvy.     The company considered the fatigue to be related to Arexvy. It was unknown if the company considered the myalgia to be related to Arexvy.   Additional Information: GSK Receipt Date: 05-MAR-2025 Physician reported that patient took Arexvy vaccine and experienced fatigue and myalgia.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: I was down for 2 days and it was rough; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling miserable in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling miserable (Verbatim: I was down for 2 days and it was rough). The outcome of the feeling miserable was resolved (duration 2 days).   The reporter considered the feeling miserable to be related to Shingrix.     The company considered the feeling miserable to be related to Shingrix.   Additional Information: GSK receipt date: 02-MAR-2025 This case was reported by a patient via interactive digital media.  Patient reported that he/she was down for 2 days. Patient stated it was rough, but would rather than face shingles.