chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, UNK
Symptoms: Wrong product administered
Clinical narrative: Overdose/pediatric patient receiving an adult dose (0.5 mL dose) instead of pediatric (0.25 mL dose); WRONG PRODUCT ADMINISTERED (pediatric patient receiving an adult dose); Chills; Low-grade fever; MALAISE; NAUSEA; This spontaneous case from United States, initially received on 21-Nov-2024, was reported by a health professional and concerns a patient of unknown age/gender.  Medical history information and concomitant medication was reported as unknown. No allergy information was reported.  No Associated Product Quality Complaint and/or Device Issue.  Administration of company suspect drug: On 02-Nov-2024, the patient received Afluria (TIV) for Not reported., Dos regimen: Not reported, Route of administration: Intramuscular, Lot number: AW1671A (batch number reported as AW1671A, CSL Seqirus Batch number unable to be matched)  Non-company suspect drugs: Spikevax (Elasomeran), Indication: covid-19 prophylaxis. Dose regimen: 0.5 milliliter, Lot number: 3043501.  Adverse reactions/events and outcomes: On 02-Nov-2024, the patient experienced Chills (outcome: Recovered / Resolved, stop date: 04-Nov-2024), Low-grade fever (outcome: Recovered / Resolved, stop date: 04-Nov-2024), MALAISE (outcome: Recovered / Resolved, stop date: 04-Nov-2024), NAUSEA (outcome: Recovered / Resolved, stop date: 04-Nov-2024). On 02-Nov-2024 05:00, the patient experienced Overdose/pediatric patient receiving an adult dose (0.5 mL dose) instead of pediatric (0.25 mL dose) (outcome: Recovered / Resolved, stop date: 20-Nov-2024), WRONG PRODUCT ADMINISTERED (pediatric patient receiving an adult dose) (outcome: Recovered / Resolved, stop date: 20-Nov-2024).  Afluria (TIV) action taken: Not Applicable  Reporter Assessment: The reporter considered all the events as non serious and causality was not reported.; Reporter's Comments: All the events considered related to the administration of Afluria (TIV) except Company causality not related for the events Wrong product administered and overdose.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient had already received a flu vaccine on 09/25/2024.  A second flu shot was given on 12/02/2024.  Patient did not remember getting the flu shot in September.  The patient stated he had no adverse effects.
Age: 37.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea, Pruritus, Rash, Vomiting
Clinical narrative: Diarrhea, vomitting, pruritus/rash on the abdomen
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Wrong product administered
Clinical narrative: Received Hib should have been Hep B.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: patient had red welt on arm around injection site and was hot/warm and tender to the touch for a few days. patient had itchiness around injection site for 2 to 3 week after injection
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: patient had red welt on arm around injection site and was hot/warm and tender to the touch for a few days. patient had itchiness around injection site for 2 to 3 week after injection
Age: 67.0
Sex: F
Vaccine: RSV, UNK
Symptoms: Unevaluable event
Clinical narrative: Appointment is tomorrow
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Syncope
Clinical narrative: Syncope occurred overnight the night she received the vaccine
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: duplicate flu shot given for the 2024 year. patient did not have any reaction to this vaccine.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt developed swelling/redness/itchiness in administration arm (about 3"x3", a few inches below injection site) on 12-5-24. She self-treated with cortisone cream OTC and her symptoms have continued to improve.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: pt received fluzone hd when she signed up for the covid vaccine.  no symptoms.  her md realized she got the flu shot is  when she expected it to be a covid shot
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral
Clinical narrative: PATIENT STATES THAT RIGHT AFTER HOLIDAY (11/28/24), SHE STARTED TO EXPERIENCE TINGLING, NUMBNESS, BUT NO PARALYSIS IN THE MOUTH AND FINGERS ON THE RIGHT SIDE OF HER BODY ONLY.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Pain in extremity
Clinical narrative: GAVE ADULT DOSE OF SPIKEVAX TO 7 YEAR OLD GIRL.  CALLED MOM  ON 12/4/2024 WHEN IT WAS DISCOVERED.  PATIENT HAD NO SIDE EFFECTS AS OF YET.  CALLED MOM AGAIN ON 12 -09-2024 AND SHE STILL WAS DOING FINE BUT DID HAVE A SORE ARM.
Age: 58.0
Sex: F
Vaccine: PNC20
Symptoms: Cellulitis
Clinical narrative: cellulitis, possible allergic reaction
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Urticaria to neck and chest
Age: 16.0
Sex: M
Vaccine: HEP, HPV9, IPV, MMR, TDAP, VARCEL
Symptoms: Fall, Loss of consciousness
Clinical narrative: Patient received 6 vaccines in total-Tdap, polio, Hep B, MMR, Varicella and HPV. HPV vaccine was given last. Patient remained at administration station for 8-9 minutes after vaccines administered due to volume given. Patient was asked if he was feeling dizzy or lightheaded prior to standing up to return to family. Patient told this RN twice that he was OK. Upon reaching his family, patient passed out and fell to the ground. EMS was called and attended to the patient. Patient had no recollection of  the event and was taken to the hospital for evaluation by the EMS service.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Abdominal pain upper, Arthralgia, Blister, Blood test abnormal
Clinical narrative: 11/21/24 flu shot was given. 11/23/24 low grade fever and not feeling well. 11/24/24 not feeling well and low grade fever. 11/25/24 came home from school and had bruises on back of legs, not feeling well, very fatigued, went to bed at 6pm, stomach pain throughout the night. 11/26/24 didn't go to school, developed dark bruises on back of arms. 11/27/24 extreme swelling on both ankles and feet, bruising on feet, extreme swelling on back of hands, complaints of abdominal pain, took her to walk in clinic, walk in clinic advised we go to ER hospital, ER diagnosed with HSP, purpura noticed on feet and legs, sent home with Ibuprofen. 11/28/24, vomited at noon, extreme belly pain and hard to walk, fatigue, slept through family being over for the holiday 3-6pm, vomited at 845 pm, took back to ER hospital, vomited at 930 pm, ER gave Zofran for nausea and sent home, extreme belly pain for the night. 11/29/24, symptoms all still the same but we kept around the clock alternating tylenol and ibuprofen, no vomiting, crying most of the night in pain from belly. 11/30/24, has not eaten anything in 4 days and is in extreme belly pain crying out and saying her belly is hot, asking to go back to the hospital, we took her back to ER hospital where she was admitted into ICU. 12/1/24 through 12/4/24 remained admitted into ICU on pain meds, diagnostic testing and care team. Finally ate a little bit on 12/2/24 until discharge and pooped after 5 days of not pooping on 12/4/24, prescribed steroids.12/5/24 through todays date 12/9/24, abdominal pain but a little less each day, extreme joint pain, cannot walk at times, purpura is bad and blistering. Follow up appointment with her primary care doctor today showed protein in her urine which could mean kidney issues now. We are being referred to nephrologist.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Blood urine present, Constipation, Contusion, Crying, Decreased appetite
Clinical narrative: 11/21/24 flu shot was given. 11/23/24 low grade fever and not feeling well. 11/24/24 not feeling well and low grade fever. 11/25/24 came home from school and had bruises on back of legs, not feeling well, very fatigued, went to bed at 6pm, stomach pain throughout the night. 11/26/24 didn't go to school, developed dark bruises on back of arms. 11/27/24 extreme swelling on both ankles and feet, bruising on feet, extreme swelling on back of hands, complaints of abdominal pain, took her to walk in clinic, walk in clinic advised we go to ER hospital, ER diagnosed with HSP, purpura noticed on feet and legs, sent home with Ibuprofen. 11/28/24, vomited at noon, extreme belly pain and hard to walk, fatigue, slept through family being over for the holiday 3-6pm, vomited at 845 pm, took back to ER hospital, vomited at 930 pm, ER gave Zofran for nausea and sent home, extreme belly pain for the night. 11/29/24, symptoms all still the same but we kept around the clock alternating tylenol and ibuprofen, no vomiting, crying most of the night in pain from belly. 11/30/24, has not eaten anything in 4 days and is in extreme belly pain crying out and saying her belly is hot, asking to go back to the hospital, we took her back to ER hospital where she was admitted into ICU. 12/1/24 through 12/4/24 remained admitted into ICU on pain meds, diagnostic testing and care team. Finally ate a little bit on 12/2/24 until discharge and pooped after 5 days of not pooping on 12/4/24, prescribed steroids.12/5/24 through todays date 12/9/24, abdominal pain but a little less each day, extreme joint pain, cannot walk at times, purpura is bad and blistering. Follow up appointment with her primary care doctor today showed protein in her urine which could mean kidney issues now. We are being referred to nephrologist.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Feeling hot, Gait disturbance, Gait inability, Gastrointestinal inflammation
Clinical narrative: 11/21/24 flu shot was given. 11/23/24 low grade fever and not feeling well. 11/24/24 not feeling well and low grade fever. 11/25/24 came home from school and had bruises on back of legs, not feeling well, very fatigued, went to bed at 6pm, stomach pain throughout the night. 11/26/24 didn't go to school, developed dark bruises on back of arms. 11/27/24 extreme swelling on both ankles and feet, bruising on feet, extreme swelling on back of hands, complaints of abdominal pain, took her to walk in clinic, walk in clinic advised we go to ER hospital, ER diagnosed with HSP, purpura noticed on feet and legs, sent home with Ibuprofen. 11/28/24, vomited at noon, extreme belly pain and hard to walk, fatigue, slept through family being over for the holiday 3-6pm, vomited at 845 pm, took back to ER hospital, vomited at 930 pm, ER gave Zofran for nausea and sent home, extreme belly pain for the night. 11/29/24, symptoms all still the same but we kept around the clock alternating tylenol and ibuprofen, no vomiting, crying most of the night in pain from belly. 11/30/24, has not eaten anything in 4 days and is in extreme belly pain crying out and saying her belly is hot, asking to go back to the hospital, we took her back to ER hospital where she was admitted into ICU. 12/1/24 through 12/4/24 remained admitted into ICU on pain meds, diagnostic testing and care team. Finally ate a little bit on 12/2/24 until discharge and pooped after 5 days of not pooping on 12/4/24, prescribed steroids.12/5/24 through todays date 12/9/24, abdominal pain but a little less each day, extreme joint pain, cannot walk at times, purpura is bad and blistering. Follow up appointment with her primary care doctor today showed protein in her urine which could mean kidney issues now. We are being referred to nephrologist.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Henoch-Schonlein purpura, Intensive care, Joint swelling, Laboratory test, Loss of personal independence in daily activities
Clinical narrative: 11/21/24 flu shot was given. 11/23/24 low grade fever and not feeling well. 11/24/24 not feeling well and low grade fever. 11/25/24 came home from school and had bruises on back of legs, not feeling well, very fatigued, went to bed at 6pm, stomach pain throughout the night. 11/26/24 didn't go to school, developed dark bruises on back of arms. 11/27/24 extreme swelling on both ankles and feet, bruising on feet, extreme swelling on back of hands, complaints of abdominal pain, took her to walk in clinic, walk in clinic advised we go to ER hospital, ER diagnosed with HSP, purpura noticed on feet and legs, sent home with Ibuprofen. 11/28/24, vomited at noon, extreme belly pain and hard to walk, fatigue, slept through family being over for the holiday 3-6pm, vomited at 845 pm, took back to ER hospital, vomited at 930 pm, ER gave Zofran for nausea and sent home, extreme belly pain for the night. 11/29/24, symptoms all still the same but we kept around the clock alternating tylenol and ibuprofen, no vomiting, crying most of the night in pain from belly. 11/30/24, has not eaten anything in 4 days and is in extreme belly pain crying out and saying her belly is hot, asking to go back to the hospital, we took her back to ER hospital where she was admitted into ICU. 12/1/24 through 12/4/24 remained admitted into ICU on pain meds, diagnostic testing and care team. Finally ate a little bit on 12/2/24 until discharge and pooped after 5 days of not pooping on 12/4/24, prescribed steroids.12/5/24 through todays date 12/9/24, abdominal pain but a little less each day, extreme joint pain, cannot walk at times, purpura is bad and blistering. Follow up appointment with her primary care doctor today showed protein in her urine which could mean kidney issues now. We are being referred to nephrologist.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Nausea, Occult blood positive, Peripheral swelling, Protein urine present
Clinical narrative: 11/21/24 flu shot was given. 11/23/24 low grade fever and not feeling well. 11/24/24 not feeling well and low grade fever. 11/25/24 came home from school and had bruises on back of legs, not feeling well, very fatigued, went to bed at 6pm, stomach pain throughout the night. 11/26/24 didn't go to school, developed dark bruises on back of arms. 11/27/24 extreme swelling on both ankles and feet, bruising on feet, extreme swelling on back of hands, complaints of abdominal pain, took her to walk in clinic, walk in clinic advised we go to ER hospital, ER diagnosed with HSP, purpura noticed on feet and legs, sent home with Ibuprofen. 11/28/24, vomited at noon, extreme belly pain and hard to walk, fatigue, slept through family being over for the holiday 3-6pm, vomited at 845 pm, took back to ER hospital, vomited at 930 pm, ER gave Zofran for nausea and sent home, extreme belly pain for the night. 11/29/24, symptoms all still the same but we kept around the clock alternating tylenol and ibuprofen, no vomiting, crying most of the night in pain from belly. 11/30/24, has not eaten anything in 4 days and is in extreme belly pain crying out and saying her belly is hot, asking to go back to the hospital, we took her back to ER hospital where she was admitted into ICU. 12/1/24 through 12/4/24 remained admitted into ICU on pain meds, diagnostic testing and care team. Finally ate a little bit on 12/2/24 until discharge and pooped after 5 days of not pooping on 12/4/24, prescribed steroids.12/5/24 through todays date 12/9/24, abdominal pain but a little less each day, extreme joint pain, cannot walk at times, purpura is bad and blistering. Follow up appointment with her primary care doctor today showed protein in her urine which could mean kidney issues now. We are being referred to nephrologist.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Purpura, Pyrexia, Somnolence, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: 11/21/24 flu shot was given. 11/23/24 low grade fever and not feeling well. 11/24/24 not feeling well and low grade fever. 11/25/24 came home from school and had bruises on back of legs, not feeling well, very fatigued, went to bed at 6pm, stomach pain throughout the night. 11/26/24 didn't go to school, developed dark bruises on back of arms. 11/27/24 extreme swelling on both ankles and feet, bruising on feet, extreme swelling on back of hands, complaints of abdominal pain, took her to walk in clinic, walk in clinic advised we go to ER hospital, ER diagnosed with HSP, purpura noticed on feet and legs, sent home with Ibuprofen. 11/28/24, vomited at noon, extreme belly pain and hard to walk, fatigue, slept through family being over for the holiday 3-6pm, vomited at 845 pm, took back to ER hospital, vomited at 930 pm, ER gave Zofran for nausea and sent home, extreme belly pain for the night. 11/29/24, symptoms all still the same but we kept around the clock alternating tylenol and ibuprofen, no vomiting, crying most of the night in pain from belly. 11/30/24, has not eaten anything in 4 days and is in extreme belly pain crying out and saying her belly is hot, asking to go back to the hospital, we took her back to ER hospital where she was admitted into ICU. 12/1/24 through 12/4/24 remained admitted into ICU on pain meds, diagnostic testing and care team. Finally ate a little bit on 12/2/24 until discharge and pooped after 5 days of not pooping on 12/4/24, prescribed steroids.12/5/24 through todays date 12/9/24, abdominal pain but a little less each day, extreme joint pain, cannot walk at times, purpura is bad and blistering. Follow up appointment with her primary care doctor today showed protein in her urine which could mean kidney issues now. We are being referred to nephrologist.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray gastrointestinal tract abnormal
Clinical narrative: 11/21/24 flu shot was given. 11/23/24 low grade fever and not feeling well. 11/24/24 not feeling well and low grade fever. 11/25/24 came home from school and had bruises on back of legs, not feeling well, very fatigued, went to bed at 6pm, stomach pain throughout the night. 11/26/24 didn't go to school, developed dark bruises on back of arms. 11/27/24 extreme swelling on both ankles and feet, bruising on feet, extreme swelling on back of hands, complaints of abdominal pain, took her to walk in clinic, walk in clinic advised we go to ER hospital, ER diagnosed with HSP, purpura noticed on feet and legs, sent home with Ibuprofen. 11/28/24, vomited at noon, extreme belly pain and hard to walk, fatigue, slept through family being over for the holiday 3-6pm, vomited at 845 pm, took back to ER hospital, vomited at 930 pm, ER gave Zofran for nausea and sent home, extreme belly pain for the night. 11/29/24, symptoms all still the same but we kept around the clock alternating tylenol and ibuprofen, no vomiting, crying most of the night in pain from belly. 11/30/24, has not eaten anything in 4 days and is in extreme belly pain crying out and saying her belly is hot, asking to go back to the hospital, we took her back to ER hospital where she was admitted into ICU. 12/1/24 through 12/4/24 remained admitted into ICU on pain meds, diagnostic testing and care team. Finally ate a little bit on 12/2/24 until discharge and pooped after 5 days of not pooping on 12/4/24, prescribed steroids.12/5/24 through todays date 12/9/24, abdominal pain but a little less each day, extreme joint pain, cannot walk at times, purpura is bad and blistering. Follow up appointment with her primary care doctor today showed protein in her urine which could mean kidney issues now. We are being referred to nephrologist.
Age: 37.0
Sex: F
Vaccine: VARZOS
Symptoms: Product use issue, Wrong product administered
Clinical narrative: On 12/3/2024, I went to Pharmacy to receive the FLU vaccine. I was told, and it was documented, that I was given the FLU vaccine: Flucelvax Trival 2024-2025 SYR Manufacturer SEQIRUS, LOT #391416. After returning home, I received a phone call that I was not given the FLU vaccine and that the pharmacist made an error and administered the SHINGRIX vaccine for shingles in error. I am postpartum and breastfeeding a 2-month-old infant. While this vaccine is FDA-approved for those 18 and older, I do not represent the intended population for this vaccine, and there is no research available on receipt of this vaccine and breastfeeding.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Rash macular, Urticaria
Clinical narrative: Hives, red blotches, itching
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Condition aggravated, Neuralgia, Pain in extremity, Pyrexia
Clinical narrative: Excessive neuropathy pain in arms and legs, fever,
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Skin laceration
Clinical narrative: patient passed out and cut his eyebrow; cut his eyebrow; This spontaneous report was received from Consumer via company representative and refers to a 9-year-old male.  The patient's medical history, and concurrent conditions  were not reported.  On an unknown date, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASILand indication were not provided) for prophylaxis and it was reported that the patient was vaccinated with another vaccine that the patient did not specify to the reporter.   On an unknown date, after receiving his dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) the patient passed out and cut his eyebrow on the table in the examination room (Loss of consciousness, Face injury). The outcome of loss of consciousness and face injury was unknown.   The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.   Upon internal review patient passed out (Loss of consciousness) was considered to be medically significant.  Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Underdose
Clinical narrative: No additional AE details; Inbound call from prescriber who reports due to a patient moving during administration of VARIVAX only about half of the dose was received. AE is being filed for invalid dose due to only receiving a partial dose as well as potential exposure of patie; as well as potential exposure of patient's skin; as well as potential exposure of patient's skin; This spontaneous report was received from a physician regarding a patient of unspecified age and gender. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported.  On 04-DEC-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, as prophylaxis along with sterile diluent solution for injection/infusion (strengths, lot numbers, expiry dates, routes of administration were not provided [no indication given for this last product]). However, due to patient moving during administration, only about half of the dose (also reported as partial dose) was received. Moreover, there was potential exposure of the vaccine to patient's skin (Accidental underdose; Exposure via skin contact; Accidental exposure to product). Prescriber did not have complete information available at time of call. No additional adverse events or product quality complaints were reported.  Lot# is being requested and will be submitted if received.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives, torso, started overnight. Spread throughout torso two days later
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, CSF test, Computerised tomogram head normal, Electroencephalogram normal, Epilepsy
Clinical narrative: Seizures/epilepsy, treatment as of now is medicinal. Testing for future treatment options. First seizure was tonic/clonic in September of 2023, followed by November 2023, and having focal seizures ever since even with medication. Now undergoing mri's, ct scan, pet scan, emu stays, all with no answers to cause.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure, Magnetic resonance imaging head normal, Partial seizures, Positron emission tomogram normal
Clinical narrative: Seizures/epilepsy, treatment as of now is medicinal. Testing for future treatment options. First seizure was tonic/clonic in September of 2023, followed by November 2023, and having focal seizures ever since even with medication. Now undergoing mri's, ct scan, pet scan, emu stays, all with no answers to cause.
Sex: F
Vaccine: HPV9
Symptoms: Ill-defined disorder, Neurological symptom
Clinical narrative: a female high school age patient reported ascending Guillain-Barre like symptoms after receiving a dose of Gardasil-9; The patient later was diagnosed with something else (she could not remember exactly what); This spontaneous report was received from a healthcare professional (HCP) at an "FFM" referring to a non-pregnant female patient at high school age (exact age was not reported). The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.  On an unknown date, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, lot#, and expiration date were not reported) by a healthcare professional for prophylaxis.  On an unknown date after the vaccination, the patient developed Guillain-Barre like symptoms. Later, on an unknown date, the patient was diagnosed with something else rather than Guillain-Barre (ill-defined disorder).  Upon internal review, the event of Guillain Barre syndrome was determined to be medically significant.  Additional information is not expected.
Sex: U
Vaccine: RSV
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: pain at injection site; itching at injection site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a 80-year-old patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: pain at injection site) and injection site itching (Verbatim: itching at injection site). The outcome of the injection site pain and injection site itching were not resolved.   It was unknown if the reporter considered the injection site pain and injection site itching to be related to Arexvy.     It was unknown if the company considered the injection site pain and injection site itching to be related to Arexvy.   Additional Information: GSK receipt date: 10-NOV-2024 The case was received from the patient via (Open field AE monitoring) interactive digital media. The patient wants to know how long the pain and itching at the injection site would last and how could he/she eliminate the itching or at least relieve it.
Sex: M
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: Death-Unknown cause; This serious case was reported by a consumer via call center representative and described the occurrence of unknown cause of death in a male 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 unknown cause of death (Verbatim: Death-Unknown cause) (serious criteria death and GSK medically significant). The reported cause of death was unknown.   It was unknown if the reporter considered the unknown cause of death to be related to Shingrix.     The company considered the unknown cause of death to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 05-DEC-2024 The patient was deceased. Reporter called to request patient name be removed from the GlaxoSmithKline mailing lists. She knows that the patient at least had 1 dose of Shingrix in order to be placed on the mailing list. The reporter did not consent to follow-up.; Sender's Comments: Death is an unlisted event which is considered unrelated to GSK vaccine Shingrix.; Reported Cause(s) of Death: Unknown cause of death
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Pruritus, Swelling, Tenderness
Clinical narrative: Nearly 3 inch wide swollen and tender area (hard in the center).  Itchy around the edges later on.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Hemiparesis, Hypoaesthesia, Influenza virus test negative, Pain, SARS-CoV-2 test negative
Clinical narrative: 3hrs after vaccine administered pt w/ full body hives, numbness on left side of body and throat tightness. Seen in ER. Given tylenol for additional body aches. Given Benadryl. seen at office next day. Hives mostly resolved. left sided numbness/weakness improved but still present. Plan for recheck in 2 wks.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Streptococcus test negative, Throat tightness, Urticaria
Clinical narrative: 3hrs after vaccine administered pt w/ full body hives, numbness on left side of body and throat tightness. Seen in ER. Given tylenol for additional body aches. Given Benadryl. seen at office next day. Hives mostly resolved. left sided numbness/weakness improved but still present. Plan for recheck in 2 wks.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Deep vein thrombosis, Injection site swelling
Clinical narrative: 11/14/24 started with R upper arm swelling was seen 11/17/24 at an urgent care and found to have right upper extremity DVT
Age: 65.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Itching, rash, hives
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: NEXT DAY SYMPTOMS HEADACHE, FEVER, GENERALIZED PAIN, ITCHING AND REDNESS INJECTION SITE/ ON 12/09/24 PRESCRIBER GAVE CLINDAMYCIN 300 EVERY 8 HOURS HAS TAKEN 2 DOSES AND AREA IS STILL HOT AND PAINFULL.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: NEXT DAY SYMPTOMS HEADACHE, FEVER, GENERALIZED PAIN, ITCHING AND REDNESS INJECTION SITE/ ON 12/09/24 PRESCRIBER GAVE CLINDAMYCIN 300 EVERY 8 HOURS HAS TAKEN 2 DOSES AND AREA IS STILL HOT AND PAINFULL.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: I administered the incorrect vaccine. I gave the child this vaccine instead of the flu shot by accident.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Rash
Clinical narrative: Rash on head and abdomen
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Cerebrovascular accident, Computerised tomogram head abnormal, Dysmenorrhoea
Clinical narrative: 2021- December-  Painful menstral cycles-bad migraines-put on mini-pill to help ease pain. was later diagnosed with endometriosis.    2022-Backache so severe I had to get MRI. Found Tumor in Spine.   2024- January, during a bad case of COVID, I started to develop a rash on my fingers and toes. Not long after, my nails began bruising and falling off. Diagnosed with "covid toe". This took about 8 months to grow back healthy.   November 2024- bad migraines continue, esp before my period. Periods have been irregular and very painful. Thursday, Nov 7th, I was at work and started having kaleidoscope vision, followed by a blackout. I went to the ER and CT Scan determined I had a stroke.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Endometriosis, Immunisation reaction, Kaleidoscope vision, Loss of consciousness, Magnetic resonance imaging spinal abnormal
Clinical narrative: 2021- December-  Painful menstral cycles-bad migraines-put on mini-pill to help ease pain. was later diagnosed with endometriosis.    2022-Backache so severe I had to get MRI. Found Tumor in Spine.   2024- January, during a bad case of COVID, I started to develop a rash on my fingers and toes. Not long after, my nails began bruising and falling off. Diagnosed with "covid toe". This took about 8 months to grow back healthy.   November 2024- bad migraines continue, esp before my period. Periods have been irregular and very painful. Thursday, Nov 7th, I was at work and started having kaleidoscope vision, followed by a blackout. I went to the ER and CT Scan determined I had a stroke.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Migraine, Nail bed bleeding, Onychomadesis, Rash
Clinical narrative: 2021- December-  Painful menstral cycles-bad migraines-put on mini-pill to help ease pain. was later diagnosed with endometriosis.    2022-Backache so severe I had to get MRI. Found Tumor in Spine.   2024- January, during a bad case of COVID, I started to develop a rash on my fingers and toes. Not long after, my nails began bruising and falling off. Diagnosed with "covid toe". This took about 8 months to grow back healthy.   November 2024- bad migraines continue, esp before my period. Periods have been irregular and very painful. Thursday, Nov 7th, I was at work and started having kaleidoscope vision, followed by a blackout. I went to the ER and CT Scan determined I had a stroke.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal cord neoplasm
Clinical narrative: 2021- December-  Painful menstral cycles-bad migraines-put on mini-pill to help ease pain. was later diagnosed with endometriosis.    2022-Backache so severe I had to get MRI. Found Tumor in Spine.   2024- January, during a bad case of COVID, I started to develop a rash on my fingers and toes. Not long after, my nails began bruising and falling off. Diagnosed with "covid toe". This took about 8 months to grow back healthy.   November 2024- bad migraines continue, esp before my period. Periods have been irregular and very painful. Thursday, Nov 7th, I was at work and started having kaleidoscope vision, followed by a blackout. I went to the ER and CT Scan determined I had a stroke.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Chills, Pyrexia, Stomatitis, Vaccination site mass
Clinical narrative: fever and chills onset later in day of vaccine, vaccine site lump about golf-ball sized. sores to tongue/mouth/upper lip. No rash to body nor hives. Symptoms had cleared naturally.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient came stating that the hospital where she works at Optical store stated she hadn't gotten the flu vaccine and needed to get one ASAP.  Received a communication stating that patient had received the same flu vaccine in August 2024.  I called patient and asked her and she confirmed that she had received it but that her employer was requesting it.  I asked patient how she was feeling and she said fine.  No symptoms or side effects from it.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pain in extremity, Pyrexia
Clinical narrative: Patient called and stating that she had fever that night of vaccination and her arm is painful. And she  developed rash below the site of injection.  Next day I called her to follow up with her reaction and she stating that she has excruciating pain in her arm and she is heading to MD.
Age: 41.0
Sex: F
Vaccine: TYP
Symptoms: Constipation
Clinical narrative: Unusual constipation started 36 hours after the first dose and continued through all three remaining doses and for two days after the last dose.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site discharge, Injection site erythema, Injection site pruritus, Injection site scab, Skin exfoliation
Clinical narrative: 12/2/24 Removed band aid and noticed redness, skin pealing off and clear fluid leaking from injection site, with itchiness. 12/6/24 Site still itchy and scab over.
Age: 53.0
Sex: F
Vaccine: PNC20
Symptoms: Rash
Clinical narrative: Patient said she got a rash soon after she got the vaccine.  It doesn't hurt but it is red and it has grown a bit.  It has been 5 days and has not gone down.  She has tried to put ice on it and has contacted her dr.  Mentioned using hydrocortisone cream and if painful take Ibuprofen or Acetaminophen.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Child given expired vaccine. No adverse reactions.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Myocarditis
Clinical narrative: pt developed chest pain on dec 7 and was hospitalized at hospital from dec 7 - 9th with myocarditis.
Age: 18.0
Sex: M
Vaccine: PNC15
Symptoms: Wrong product administered
Clinical narrative: Patient was given a PCV 15 in error when patient should have received a pneumovax 23 vaccine  based on patients diagnosis of Type 1 diabetes. Patient will be following up in 8 weeks to receive pnuemovax 23
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: DTAP VACCINE GIVEN IN ERROR TO CHILD OVER THE AGE OF 7; SHOULD HAVE BEEN TDAP
Age: 0.25
Sex: M
Vaccine: HEP, IPV
Symptoms: Rash
Clinical narrative: whole body rash within 2 hours of administration
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Angiopathy, Cardiac disorder, Cerebrovascular accident, Coronary artery occlusion
Clinical narrative: Emergent significant Cardiac and vascular disease (including RCA blockage and Stroke)
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Attempt to contact patient was unsuccessful
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: FLUAD GIVEN IN ERROR TO MALE AGE 44; NOT ELIGIBLE FOR SENIOR DOSE
Age: 35.0
Sex: M
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Underdose
Clinical narrative: Doses of pediatric Hep A and Hep B were given in error. 2nd pediatric dose given to complete dose
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Patient stated that her arm was a little sore the night of the injection.  The following morning she noticed a red area around the injection site. The red area around the injection area grew to an oblong , red  circular area that was 3 inches long on 12/8/24 when she presented it to the pharmacy and stated she was going to go to urgent care .  I felt her arm and agreed that she should go have the urgent care examine her arm.  The patient returned to the pharmacy after the urgent care visit.  She stated that the MD had sent an rx to our pharmacy for an antibiotic- Doxycycline 100mg 1 capsule twice daily for 10 days- just in case it was cellulitis.
Age: 82.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Erythema, Pruritus, Tenderness
Clinical narrative: Patient stated that the arm where he received the vaccines became tender, itching, and the skin is slightly red and the effects presented after receiving the vaccines and continued for 2 weeks now.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Headache, Loss of consciousness
Clinical narrative: right after receiving the vaccine pt "passed out" we laid pt down & put her feet up.  she was "out of it" for a few minutes. Dr. came into the room & did a sternal rub- pt awakened but was drowsy, complained of a headache & feeling tired. pt eventually was able to sit up, drank some water. the first attempt to get pt to stand she said she couldn't feel her legs, she sat back down & we tried again a couple of minutes later. pt was eventually able to walk to their car with the assistance of RN, encouraged to rest at home today & drink lots of water.
Age: 68.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Computerised tomogram thorax abnormal, Deep vein thrombosis, Dyspnoea exertional, Pulmonary embolism, Ultrasound Doppler abnormal
Clinical narrative: DVT noticed in right calf on 11/2 after 5 h flight. Patient initially believed it due to calf strain from exercise. Patient noticed shortness of breath after exercise upon returning home the following week. Presented to urgent care, Dx as PVT and PE, placed on generic Lovenox.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: PATIENT RECEIVED MODERNA COVID-19 VACCINE , AFTER NURSE ADMINISTERED AND WENT TO GIVE THE FLU VACCINE, HE STATED THAT HE HAD RECEIVED COVID VACCINE ALREADY LAST MONTH AND ONLY WANTED THE FLU SHOT. COVID-19 DOSE WAS GIVEN IN ERROR.
Age: 16.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP
Symptoms: Blood pressure decreased, Pallor, Posture abnormal
Clinical narrative: Patient received vaccines at 9:37am. Patient appeared normal immediately after administration. Nurse was called into patient's room at 9:47am to the patient slumped in his chair, laid over on the desk, and pale. Patient was conscious when nurse entered room. Patient is unsure if he ever fully lost consciousness. Patient was moved to the exam table and vitals were monitored. BP was initially low but gradually increased to normal after approximately 5 minutes.  Patient drank soda and stated he was feeling back to normal. Patient was monitored for 45 minutes after the event and examined by in house provider prior to leaving the clinic.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Laryngitis, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Severe cold, laryngitis, sore throat, cough.  OTC cough medicine, Advil, Amoxicillin-clav.   I am not sure that any of this is related to either Covid or flu vaccines, but the timing is just 3 weeks from dates of vaccinations.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Husband came to the pharmacy on 12-05-24 to fill wife's Rx for pain and stated that his wife has been in pain ever since the date she's received a flu shot. She went to see an NP who prescribed her tramadol and lidocaine patches to control her pain. The NP stated that the vaccination had been given to high that might effected her axillary nerve. Patient is going to have a follow up appointment on Dec. 17th to see her doctor again.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I have had left ear tinnitus that started two weeks after receiving my third COVID vaccine
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Diarrhoea, Dysphagia, Dysuria
Clinical narrative: pt says he started feeling sick to his stomach and having trouble swallowing. His scalp started itching. He was having itching traveling up and down his body like it was in his blood system. His eyes was itching. Then he developed a terrible headache and had trouble urinating. He feels like his stomach was closed off and couldn't eat. When he did eat he would vomit everything back up. He went to the ER. He was given a steroid shot. It seemed to help very little. He went to the ER and was supposed to prescription but it was never called in. He doesn't remember what it was. Then he went to the another facility. He was given more steroids that made him sicker. He called them back to let them know he is not getting better and he is supposed to be seen on Dec 12th.  He continues to feel nausated, weak, has bouts of diarrhea, is hot and has a terrible headache.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye pruritus, Feeling hot, Headache, Nausea, Pruritus
Clinical narrative: pt says he started feeling sick to his stomach and having trouble swallowing. His scalp started itching. He was having itching traveling up and down his body like it was in his blood system. His eyes was itching. Then he developed a terrible headache and had trouble urinating. He feels like his stomach was closed off and couldn't eat. When he did eat he would vomit everything back up. He went to the ER. He was given a steroid shot. It seemed to help very little. He went to the ER and was supposed to prescription but it was never called in. He doesn't remember what it was. Then he went to the another facility. He was given more steroids that made him sicker. He called them back to let them know he is not getting better and he is supposed to be seen on Dec 12th.  He continues to feel nausated, weak, has bouts of diarrhea, is hot and has a terrible headache.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: pt says he started feeling sick to his stomach and having trouble swallowing. His scalp started itching. He was having itching traveling up and down his body like it was in his blood system. His eyes was itching. Then he developed a terrible headache and had trouble urinating. He feels like his stomach was closed off and couldn't eat. When he did eat he would vomit everything back up. He went to the ER. He was given a steroid shot. It seemed to help very little. He went to the ER and was supposed to prescription but it was never called in. He doesn't remember what it was. Then he went to the another facility. He was given more steroids that made him sicker. He called them back to let them know he is not getting better and he is supposed to be seen on Dec 12th.  He continues to feel nausated, weak, has bouts of diarrhea, is hot and has a terrible headache.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash erythematous
Clinical narrative: Red abrased area appeared approximately, 9-20-24, 1 week after vaccine given in left arm.  To date the red rashy area is still visable.  Arm soreness from the vaccine on 9-13-24 still continues.
Age: 77.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness around the injection area. Patient said the symptoms are getting better.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Erythema, swelling, and localized warmth in upper left arm.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient had come in requesting a flu shot, when the provider said she was ready I administered the flu shot. When I went to document, I noticed the patient had already been giving a flu shot one month prior.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Felt pain during the flu shot. Soreness and pain continued. It hurts lifting the arm and during rotation. Now feeling sharp pain through whole arm.
Age: 13.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Fatigue, Hyperacusis, Joint swelling, Photophobia
Clinical narrative: Fatigue, light and sound sensitivity, knee joint swelling, arthralgia
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Speech disorder
Clinical narrative: Child speaks out of the side of his mouth.  From what was gathered, it sounded like it comes and goes.  Dad stated this had also happened the last time the child received Dtap.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Pt reported having pruritis and raised erythematous patches two weeks after receiving 2nd dose of Shingrix.  Sites affected included arms, torso, back and scalp.  Pt was on Enbrel for rheumatoid arthritis treatment for 5-6 months.  No history of allergies, no recent use of lotions or fragrances
Age: 25.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site rash, Rash, Rash pruritic
Clinical narrative: Pt with hx of recurrent shingles presents today with generalized rash.  Received shingles vaccine on 11/4/24. Developed redness and inflammation at the injection site the following day  Rash slowly has spread down her bilateral arms, chest, torso, and both legs. It is linear. Worse on right side.  Rash is itchy  Worse after showering  Has been trying oils to keep skin moisturized  Denies fevers, recent illness  No hx of autoimmune  No similar rash in the past
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: duplicate vaccine
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired on 11/12/2024 and didnt notice until after administering vaccine. Manufacture was called and ruled that no harm done and pt will need to be revaccinated for hib. Advised parent and parent stated it was ok and she will vaccinate at next well child check.
Age: 78.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: duplicate vaccine
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: DISCOVERED AT INVENTORY THAT LOT # GIVEN WAS FOR MODERNA SPIKEVAX FOR 12+ YEARS, PATIENT SHOULD HAVE RECEIVED .25 DOSE FOR THOSE AGE 6 MOS-11 YRS
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Brain fog, Dehydration, Diarrhoea
Clinical narrative: Severe watery diarrhea, >20x day, stomach pain, cramping, headache, loss of appetite, nausea, leading to dehydration and weakness. Did not seek formal treatment because I couldn't get out of bed from 12/3-12/5. Slowly rehydrated with pedialyte and sports drinks. Did not eat from 12/2-12/6. Currently able to eat, however diarrhea-3-5x day, nausea and stomach cramping/pain continues. Ongoing brain fog. Continuing to focus on hydration and rest.