chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Reported Symptoms: 10022086:INJECTION SITE PAIN; 10053425:INJECTION SITE SWELLING; Narrative: Other Relevant HX: Other: INJECTION SITE PAIN; SWELLING
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Rash, Skin warm
Clinical narrative: Reported Symptoms:  10037844:RASH;   Narrative:  The next day after receiving the vaccination, the patients arm became red, swollen, hot to touch and had a rash. Patient was given Benadryl for this reaction and it resolved after 2 doses.  Other Relevant HX; Other: RASH
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Reported Symptoms:  10019211:HEADACHE;  Narrative:  Other Relevant Hx: HEADACHE
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Reported Symptoms:  10007718: ANAPHYLAXIS;  Narrative:   Other Relevant HX: Other:  ANAPHYLAXIS
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Deep vein thrombosis, Heart rate increased, Pruritus, Swelling
Clinical narrative: Reported Symptoms: 10002424:ANGIOEDEMA; 10014218:EDEMA CONJUCTIVAL; 10037687:PRURITUS; 10037549:PURPURA; 10037844:RASH; 100143071:TACHYCARDIAL 10043642:THORMBOSIS VENOUS DEEP;   Narrative: Patient received 1 does of Jansen COVID 19 Vaccine on 30 Aug 2021.  The patient began experiencing hives, itching, swelling, and rapid heart rate within 1.5 hours of receiving the vaccine. The presented to the Emergency Department and was treated with steroids, antihistamine and epinephrine, but continues to experience swelling, hives, eye swelling, itching for more than 5 months post vaccine. She was diagnosed with chronic urticaria and angioedema. The patient also experience a DVT on 24 December 2021. She continues to take anti-histamine as needed and was started on Xolair. Other relevant HX:  Other: Eye swelling, DVT
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Urticaria chronic
Clinical narrative: Reported Symptoms: 10002424:ANGIOEDEMA; 10014218:EDEMA CONJUCTIVAL; 10037687:PRURITUS; 10037549:PURPURA; 10037844:RASH; 100143071:TACHYCARDIAL 10043642:THORMBOSIS VENOUS DEEP;   Narrative: Patient received 1 does of Jansen COVID 19 Vaccine on 30 Aug 2021.  The patient began experiencing hives, itching, swelling, and rapid heart rate within 1.5 hours of receiving the vaccine. The presented to the Emergency Department and was treated with steroids, antihistamine and epinephrine, but continues to experience swelling, hives, eye swelling, itching for more than 5 months post vaccine. She was diagnosed with chronic urticaria and angioedema. The patient also experience a DVT on 24 December 2021. She continues to take anti-histamine as needed and was started on Xolair. Other relevant HX:  Other: Eye swelling, DVT
Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Autonomic nervous system imbalance, CSF protein increased, Condition aggravated, Feeling cold, Guillain-Barre syndrome
Clinical narrative: Reported Symptoms: 10018767:GUILLAIN-BARRE SYNDROME; Narrative: I answered a telephone call from Dr., ED physician regarding this patient who presented to the ED today with a chief complaint of intermittent tingling and subjective cold sensation in the fingers on both hands. According to Dr., examination revealed no weakness in either upper or lower extremity. Peripheral pulses are intact and there is no palpable coldness or color changes in the distal upper extremities including fingers and hands. Therefore, there is no objective evidence of circulatory insufficiency or motor weakness in the upper and lower extremities. My suspicion is that this patient is experiencing sensory and autonomic symptoms as a result of autonomic dysfunction occurring in the setting of Guillain-Barre syndrome. This all occurred days after influenza vaccination. Other Relevant HX: Other: GUILLAIN BARRE
Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia, Peripheral coldness
Clinical narrative: Reported Symptoms: 10018767:GUILLAIN-BARRE SYNDROME; Narrative: I answered a telephone call from Dr., ED physician regarding this patient who presented to the ED today with a chief complaint of intermittent tingling and subjective cold sensation in the fingers on both hands. According to Dr., examination revealed no weakness in either upper or lower extremity. Peripheral pulses are intact and there is no palpable coldness or color changes in the distal upper extremities including fingers and hands. Therefore, there is no objective evidence of circulatory insufficiency or motor weakness in the upper and lower extremities. My suspicion is that this patient is experiencing sensory and autonomic symptoms as a result of autonomic dysfunction occurring in the setting of Guillain-Barre syndrome. This all occurred days after influenza vaccination. Other Relevant HX: Other: GUILLAIN BARRE
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Myalgia, Vomiting
Clinical narrative: Reported Symptoms: 10000429:ACHE STOMACH; 10013579:DIZZINES; 10028411:MYALGIA; 10047700:VOMITING; Narrative: Reporter reports on 10/31/23 that pt had stomach pain. No progress notes in system indicating further information. In reports in system no record or administration of 2023-2024 spikevax Other Relevant HX: Other: stomach pain
Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Atrial fibrillation, Back pain, Confusional state, Diplegia, Fatigue
Clinical narrative: Pneumonia, paralysis from the waist down, AFIB, unable to walk, fatigue, muscle aches, confusion, lower back pain. Diagnosed with: Guillian Barre Syndrome
Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Gait inability, Guillain-Barre syndrome, Laboratory test, Myalgia, Paralysis
Clinical narrative: Pneumonia, paralysis from the waist down, AFIB, unable to walk, fatigue, muscle aches, confusion, lower back pain. Diagnosed with: Guillian Barre Syndrome
Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pneumonia
Clinical narrative: Pneumonia, paralysis from the waist down, AFIB, unable to walk, fatigue, muscle aches, confusion, lower back pain. Diagnosed with: Guillian Barre Syndrome
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: Other Relevant Hx: Other: RASH
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Audiogram, Cardiac disorder, Hypotension, Hypovolaemia, Neurological symptom
Clinical narrative: Reported Symptoms: 10021097:HYPOTENSION; 10040527:SHAKINESS; Narrative: 80 yo M presented at hospital for primary care visit and audiogram. Pt received first dose of Shingles series while at PC visit. Shortly after, the pt became hypotensive, started shaking, then had an episode of syncope lasting 8-10 minutes. Pt admitted to ED and was treated with 500mL of NS before being transferred to Gen Med. Etiology was c/f neurologic vs cardiac vs hypovolemic. Medicine team did not attribute syncope to the vaccine, but this seizure-like episode occurred shortly after administration. Other Relevant Hx: Other: Shaking
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Seizure like phenomena, Syncope, Tremor
Clinical narrative: Reported Symptoms: 10021097:HYPOTENSION; 10040527:SHAKINESS; Narrative: 80 yo M presented at hospital for primary care visit and audiogram. Pt received first dose of Shingles series while at PC visit. Shortly after, the pt became hypotensive, started shaking, then had an episode of syncope lasting 8-10 minutes. Pt admitted to ED and was treated with 500mL of NS before being transferred to Gen Med. Etiology was c/f neurologic vs cardiac vs hypovolemic. Medicine team did not attribute syncope to the vaccine, but this seizure-like episode occurred shortly after administration. Other Relevant Hx: Other: Shaking
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Reported Symptoms: 10003239:ARTHRALGIA; 10028411:MYALGIA; 10040617:SHOULDER PAIN; Narrative: Other Relevant HX: Other: pain in rotator cuff
Age: 90.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Rash
Clinical narrative: Reported Symptoms: 10037087:PRURITUS; 00037844:RASH; Narrative: Other Relevant HX: Other: RASH
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Sedation, Somnolence
Clinical narrative: Reported Symptoms: 10013649:DROWSINESS; 10033371:PAIN; 10039897:SEDATION; Narrative: Other Relevant HX: Other: DROWSY; PAIN
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Erythema multiforme, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: Reported Symptoms: 10015150:ERYTHEMA; 10015218:ERYTHEMA MUTIFORNE; 10022086:INJECTION SITE PAIN; 10028411:MYALGIA; 10037844:RASH; 10042600:SWELLING ARM; Narrative: Patient received influenza high-dose vaccination on 09/13/23, patient reported to have redness and soreness near injection site to the PACT nurse. Patient wanted documentation of reaction on patient's chart. Other Relevant HX: Per PACT nursing note on 09/13/23, patient states to have received influenza, high-dose, quadrivalent vaccinations in the past and post-vaccination symptoms have not occurred previously. Other: RASH; SWELLING OF ARM; ERYTHEMA; INJECTION SITE PAIN
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Peripheral swelling, Rash
Clinical narrative: Reported Symptoms: 10015150:ERYTHEMA; 10015218:ERYTHEMA MUTIFORNE; 10022086:INJECTION SITE PAIN; 10028411:MYALGIA; 10037844:RASH; 10042600:SWELLING ARM; Narrative: Patient received influenza high-dose vaccination on 09/13/23, patient reported to have redness and soreness near injection site to the PACT nurse. Patient wanted documentation of reaction on patient's chart. Other Relevant HX: Per PACT nursing note on 09/13/23, patient states to have received influenza, high-dose, quadrivalent vaccinations in the past and post-vaccination symptoms have not occurred previously. Other: RASH; SWELLING OF ARM; ERYTHEMA; INJECTION SITE PAIN
Sex: M
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Reported Symptoms: 10015150:ERYTEMA; Narrative: On 9/7/23, a reaction of erythema to the COVID Vaccine was entered. No further details documented. No history of COVID vaccination at the medical facility. Other Relevant HX: Other: ERYTHEMA
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Catheterisation cardiac, Syncope
Clinical narrative: Reported Symptoms:  10042772:SYNCOPE;  Narrative:  Per MD note on 9/15/23: pt has syncope and collapsed after second Pfizer COVID booster and was taken to ER and had heart cath. Other Relevant HX:  SYNCOPE
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Reported Symptoms: 10037844:RASH;    Narrative:  Other Relevant HX:  Other:
Age: 84.0
Sex: M
Vaccine: FLUX
Symptoms: Body temperature increased
Clinical narrative: Reported Symptoms: 10005911:BODY TEMPERATURE INCREASED; Narrative: Other Relevant HX: Other: INCREASED BODY TEMPERATURE
Age: 44.0
Sex: M
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Reported Symptoms:  10037844:RASH;   Narrative:  Other Relevant Hx: Other: Rash.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Reported Symptoms: 10042674:SWELLING; Narrative: Other Relevant HX: Other: SWELLING (LOCALIZED)
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Dyspnoea, Nausea, Vomiting
Clinical narrative: Reported Symptoms: 10012727:DIARRHEA; 10028813:NAUSEA; 10047700:VOMITING; Narrative: Patient reported to PCP that they previously experienced diarrhea, nausea, vomiting, and dyspnea with previous influenza vaccine. No data available to corroborate patient's report. Other Relevant HX: Other: NAUSEA AND VOMITING
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Arthralgia, Chest pain, Immediate post-injection reaction, Pain in extremity
Clinical narrative: Reported Symptoms: 10002391:ANGINAL PAIN; 10009479:CHEST PAIN; Narrative: Patient presented to the ED after having his first COVID vaccination earlier that day in his left bicep. Pt stated that immediately after the vaccination he began to have chest pain with intermittent pain in his right arm right wrist, legs, left arm. No nausea, vomiting, numbness, tingling. No headache neck stiffness or pain. Patient has had no recent vaccinations. Other Relevant HX: Other CHEST PAIN
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Reported Symptoms:  10094401:COVID-19 RESPIRATORY INFECTION;  Narrative: Patient contracted during hospitalization. Required isolation and symptom monitoring. Other Relevant HX:  Other: COVID infection
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Imaging procedure, Myalgia, Pain in extremity
Clinical narrative: Reported Symptoms: 10003239:ARTHRALGIA; 10028411:MYALGIA; 10033421:PAIN IN ARM; 10040617:SHOULDER PAIN; Narrative: - Imaging tests performed - ER examination Multiple f/u apts - Patient received previous mRNA moderna covid vaccines without AE Other Relevant HX: Other: PAIN FROM SHOULDER TO ARM
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Respiratory tract infection
Clinical narrative: Reported Systems: 10034401:COVID-19 RESPIRATORY INFECTION; Narrative: Patient admitted for symptom monitoring, but no treatment required. Other Relevant HX: Other: covid infection
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Reported Symptoms: 10384401: COVID-19 RESPIRATORY INFECTION; Narrative: Patient was admitted to hospital and COVID found during stay. Symptomatic treatment required, but no further treatment. Other Relevant HX: Other: COVID  Infection
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, COVID-19, Cough, Dyspnoea, Fibrin D dimer increased
Clinical narrative: Reported Symptoms: 10011232:COUGHING; 10016581:FIBRIN D DIMER INCREASED; 10033556:PALPITATION; 10043088:TACHYPNEA; 10084268:COVID-19; Narrative: Patient received 3 doses Moderna COVID 19 Vaccine (Feb/Mar/Dec 2021) and one dose Pfizer COVID 19 Vaccine (Apr 2022). The patient presented to the ED on 19 June 2023 with cough, runny nose, and difficulty breathing. The patient tested positive on 19 June 2023. The patient admitted to the hospital with elevated d-dimer, hypokalemia, hypoxia, and afib. The patient was treated with dexamethasone, electrolyte replacement, and nebulizers. The patient was discharged on 23 June 23 in stable condition. Reported per EUA. Other Relevant HX: Other: elevated d-dimer, covid
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Hypokalaemia, Hypoxia, Palpitations, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10011232:COUGHING; 10016581:FIBRIN D DIMER INCREASED; 10033556:PALPITATION; 10043088:TACHYPNEA; 10084268:COVID-19; Narrative: Patient received 3 doses Moderna COVID 19 Vaccine (Feb/Mar/Dec 2021) and one dose Pfizer COVID 19 Vaccine (Apr 2022). The patient presented to the ED on 19 June 2023 with cough, runny nose, and difficulty breathing. The patient tested positive on 19 June 2023. The patient admitted to the hospital with elevated d-dimer, hypokalemia, hypoxia, and afib. The patient was treated with dexamethasone, electrolyte replacement, and nebulizers. The patient was discharged on 23 June 23 in stable condition. Reported per EUA. Other Relevant HX: Other: elevated d-dimer, covid
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Tachypnoea
Clinical narrative: Reported Symptoms: 10011232:COUGHING; 10016581:FIBRIN D DIMER INCREASED; 10033556:PALPITATION; 10043088:TACHYPNEA; 10084268:COVID-19; Narrative: Patient received 3 doses Moderna COVID 19 Vaccine (Feb/Mar/Dec 2021) and one dose Pfizer COVID 19 Vaccine (Apr 2022). The patient presented to the ED on 19 June 2023 with cough, runny nose, and difficulty breathing. The patient tested positive on 19 June 2023. The patient admitted to the hospital with elevated d-dimer, hypokalemia, hypoxia, and afib. The patient was treated with dexamethasone, electrolyte replacement, and nebulizers. The patient was discharged on 23 June 23 in stable condition. Reported per EUA. Other Relevant HX: Other: elevated d-dimer, covid
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Pneumonia streptococcal
Clinical narrative: Reported Symptoms: 10084401:COVID-19 RESPIRATORY INFECTION; Narrative: Patient with dual infection of COVID and streptococcal pneumonia. Required hospitalization for treatment. Other Relevant HX: Other: COVID infection
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: Reported Symptoms:  10064401:COVID-19 RESPIRATORY INFECTION;  Narrative: COVID infection required hospitalization and treatment with remdesivir Other Relevant HX:  Other: COVID infection
Age: 14.0
Sex: F
Vaccine: HEP, HPV9, MMRV, TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted, arousable on/off; vital signs stable 104/68, HR 95, 96% R/A. @ 10:15 pt fully awake. A/O x 4, neuro checks by MD no deficit. @ 10:20 Pt. fully ambulated and oral fluids & snack tolerated.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: severe case of urticaria/hives/large welts; This is a spontaneous report and received from Consumer or other non HCPs. Other Case identifier(s): 2024NVX-US-000000183 (Novavax).  A 79-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 3 (booster), single (Lot number: GH9694) at the age of 79 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1; at AM, Anatomical site: arm left., Lot number: 301308a), administration date: 27Sep2021, for COVID-19 Immunization, reaction(s): "no reaction"; bnt162b2 (DOSE 2; at AM, Anatomical site: arm left., Lot number: FM553), administration date: 24May2022, for COVID-19 Immunization, reaction(s): "no reaction". The following information was reported: URTICARIA (non-serious) with onset 15Sep2022, outcome "recovered" (16Sep2022), described as "severe case of urticaria/hives/large welts". Therapeutic measures were taken as a result of urticaria. Additional information: It was reported that the patient had a severe case of urticaria for 2 days. Upon follow-up of 29Feb2024, it is reported that within 6 hours of Pfizer CovidBiVac vaccination, entire body has an adverse reaction: hives and severe urticaria (large welts), lasted 2 days, started Benadryl 50mg immediately but hives persisted. Patient received Benadryl from 15Sep2022 to 18Sep2022. Event was considered as non-serious. Patient had no reactions to the previous Pfizer covid vaccines but they were not BiVal. Patient also wanted to know What Covid booster would recommend after the September 2022 adverse reaction.  The lot number for BNT162b2, BNT162b2 omi ba.4-5, was not provided and will be requested during follow up.  Follow-up (29Feb2024 and 29Feb2024): These are follow-up spontaneous reports received from a Consumer (patient). Updated information included: new reporter added, patient's gender updated to female, patient's age and age at vaccination provided, historic vaccine information updated, product data (vaccine date updated, Anatomical Location and lot number provided, Vaccine Facility Information provided), event data (event details and treatment information added, event seriousness).
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccines was frozen instead of refrigerated.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine frozen instead of refrigerator.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Off label use
Clinical narrative: HOSPITALIZED; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced hospitalized (Dose number in series 1) (date unspecified). Patient said was he was hesitant to take TREMFYA (guselkumab) because it was made by Johnson and Johnson who made the COVID vaccine that the patient had taken and ended up hospitalized for 3 days as a result. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hospitalized was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: Hospitalisation; The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hospitalisation
Clinical narrative: HOSPITALIZED; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced hospitalized (Dose number in series 1) (date unspecified). Patient said was he was hesitant to take TREMFYA (guselkumab) because it was made by Johnson and Johnson who made the COVID vaccine that the patient had taken and ended up hospitalized for 3 days as a result. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hospitalized was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: Hospitalisation; The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 41.0
Sex: F
Vaccine: COVID19, HPV9, HPV9
Symptoms: Injection site warmth, Throat irritation
Clinical narrative: Patient starting feeling an itchy feeling in her throat at check out, followed by coughing. The scratchy/itchy feeling intensified and she was brought back into the treatment area. It was noted that the patients left arm was warm to the touch. Patient was given 25mg diphenhydramine orally and vitals were obtained. Patient was monitored closely for approximately 30 minutes. Patient did not go into distress but did have the feeling of a lump her in throat, which decreased as the time lapsed.  Shortly after returning home (approximately 2-3 hours post injection), patient started having increased feeling of scratching in her throat and took another 50mg of diphenhydramine at home. Patient also took 10mg of prednisone orally that she happened to have at home (previously prescribed to the family dog). The itching/scratching resolved, and the feeling of the "lump" in her throat diminished, but did not resolve completely. Around noon the next day, the patient had an increased feeling of itchy/scratchy throat and the "lump" in the throat was more pronounced. Patient took 50mg of diphrenhydramine. Around 4pm, patient started feeling very ill and left work. Patient complained of achiness, and chills. Patient went immediately to bed with multiple blanket to try and get warm. The patients husband noted that she did not feel cold to the touch. Around 8pm, patient started feeling better and was able to get out of bed. Patient took another 25mg of diphrenhydramine and 20mg of prednisone around 10pm. Today, March 1, patient has not taken any prednisone or diphrenhydamine but the "lump" feeling is still present in her throat. Patient was prescribed an epi-pen that was picked up at the pharmacy on 2/29/2024. Patient has been referred to immunologist.
Age: 41.0
Sex: F
Vaccine: COVID19, HPV9, HPV9
Symptoms: Feeling cold, Impaired work ability, Malaise, Pain, Sensation of foreign body
Clinical narrative: Patient starting feeling an itchy feeling in her throat at check out, followed by coughing. The scratchy/itchy feeling intensified and she was brought back into the treatment area. It was noted that the patients left arm was warm to the touch. Patient was given 25mg diphenhydramine orally and vitals were obtained. Patient was monitored closely for approximately 30 minutes. Patient did not go into distress but did have the feeling of a lump her in throat, which decreased as the time lapsed.  Shortly after returning home (approximately 2-3 hours post injection), patient started having increased feeling of scratching in her throat and took another 50mg of diphenhydramine at home. Patient also took 10mg of prednisone orally that she happened to have at home (previously prescribed to the family dog). The itching/scratching resolved, and the feeling of the "lump" in her throat diminished, but did not resolve completely. Around noon the next day, the patient had an increased feeling of itchy/scratchy throat and the "lump" in the throat was more pronounced. Patient took 50mg of diphrenhydramine. Around 4pm, patient started feeling very ill and left work. Patient complained of achiness, and chills. Patient went immediately to bed with multiple blanket to try and get warm. The patients husband noted that she did not feel cold to the touch. Around 8pm, patient started feeling better and was able to get out of bed. Patient took another 25mg of diphrenhydramine and 20mg of prednisone around 10pm. Today, March 1, patient has not taken any prednisone or diphrenhydamine but the "lump" feeling is still present in her throat. Patient was prescribed an epi-pen that was picked up at the pharmacy on 2/29/2024. Patient has been referred to immunologist.
Age: 41.0
Sex: F
Vaccine: COVID19, HPV9, HPV9
Symptoms: Throat irritation
Clinical narrative: Patient starting feeling an itchy feeling in her throat at check out, followed by coughing. The scratchy/itchy feeling intensified and she was brought back into the treatment area. It was noted that the patients left arm was warm to the touch. Patient was given 25mg diphenhydramine orally and vitals were obtained. Patient was monitored closely for approximately 30 minutes. Patient did not go into distress but did have the feeling of a lump her in throat, which decreased as the time lapsed.  Shortly after returning home (approximately 2-3 hours post injection), patient started having increased feeling of scratching in her throat and took another 50mg of diphenhydramine at home. Patient also took 10mg of prednisone orally that she happened to have at home (previously prescribed to the family dog). The itching/scratching resolved, and the feeling of the "lump" in her throat diminished, but did not resolve completely. Around noon the next day, the patient had an increased feeling of itchy/scratchy throat and the "lump" in the throat was more pronounced. Patient took 50mg of diphrenhydramine. Around 4pm, patient started feeling very ill and left work. Patient complained of achiness, and chills. Patient went immediately to bed with multiple blanket to try and get warm. The patients husband noted that she did not feel cold to the touch. Around 8pm, patient started feeling better and was able to get out of bed. Patient took another 25mg of diphrenhydramine and 20mg of prednisone around 10pm. Today, March 1, patient has not taken any prednisone or diphrenhydamine but the "lump" feeling is still present in her throat. Patient was prescribed an epi-pen that was picked up at the pharmacy on 2/29/2024. Patient has been referred to immunologist.
Age: 0.58
Sex: M
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: other vaccines may have been administered after TE; This non-valid, spontaneous report was received from a Medical Assistant and refers to an unspecified patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis (strength, lot #, and expiry date were not provided), which was administered after temperature excursion (TE) (product storage error).  Follow up information was received on 23-FEB-2024, from the registered medical assistant concerning a 7-month-old male patient.  On 27-NOV-2023, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot number 1965567, which had been verified to be a valid lot number, expiry date reported and validated as 30-AUG-2024. The operator of vaccine was a healthcare professional. It was mentioned that the medication error occurred in the process of storage in clinical practice. Moreover, the vaccine was available for return/evaluation.  This is one of the five cases received from the same reporter.; Sender's Comments:  US-009507513-2402USA008732: US-009507513-2402USA008737: US-009507513-2402USA008738: US-009507513-2402USA008740:
Age: 1.0
Sex: U
Vaccine: HIBV, VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: The patient did not experience any adverse issues or side effects from the dose of VARIVAX administered outside PI; A HBP called to report an AE in which a medical assistant (MA) administered a dose of VARIVAX using the incorrect DILUENT on 01/30/2024.  Instead of using MERCK DILUENT, the VARIVAX vaccine was reconstituted using 0.4% NaCl DILUENT supplied for ACTHI; This spontaneous report was received from an unspecified reporter (reporter type reported as "other" but not specified), referring to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.     On 30-JAN-2024, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection, lot # X021283 with expiration date 20-AUG-2025, for prophylaxis (strength, dose, route of administration and anatomical location were not reported), using the incorrect diluent. Instead of using the product sterile diluent, the varicella virus vaccine live (oka/merck)(VARIVAX) vaccine was reconstituted using 0.4% sodium chloride (NaCl) diluent supplied for hib vaccine conj (tet tox) (ACTHIB) vaccine lot # UJ854AA with expiration date reported as "15-MAR-2024" (formulation, strength, dose, route of administration and indication were not reported)(product preparation error). It was stated that the patient did not experience any adverse issues or side effects from the dose of varicella virus vaccine live (oka/merck)(VARIVAX). No additional adverse event (AE) was reported.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: product storage error; This spontaneous report was received from a registered medical assistant and refers to a 6-months-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 21-NOV-2023, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot number 1932235, which had been verified to be a valid lot number, expiry date reported and confirmed as 12-APR-2024, administered orally for prophylaxis (strength not provided) (product storage error). It was mentioned that the medication error occurred in the process of storage in clinical practice.  This is one of the five cases received from the same reporter.; Sender's Comments:  US-009507513-2312USA000790: US-009507513-2402USA008732: US-009507513-2402USA008738: US-009507513-2402USA008740:
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: product storage error; This spontaneous report was received from a registered medical assistant and refers to a 2-months-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 22-NOV-2023, the patient was vaccinated with the first dose of an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot number 1932235, which had been verified to be a valid lot number, expiry date reported and confirmed as 12-APR-2024, administered orally for prophylaxis (strength not provided) (product storage error). It was mentioned that the medication error occurred in the process of storage in clinical practice.  This is one of the five cases received from the same reporter.; Sender's Comments:  US-009507513-2312USA000790: US-009507513-2402USA008737: US-009507513-2402USA008740: US-009507513-2402USA008732:
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: product storage error; This spontaneous report was received from a registered medical assistant and refers to a 4-months-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 03-JAN-2024, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot number 1932235, which had been verified to be a valid lot number, expiry date reported and confirmed as 12-APR-2024, administered orally for prophylaxis (strength not provided) (product storage error). It was mentioned that the medication error occurred in the process of storage in clinical practice.  This is one of the five cases received from the same reporter.; Sender's Comments:  US-009507513-2402USA008737: US-009507513-2312USA000790: US-009507513-2402USA008738: US-009507513-2402USA008732:
Age: 9.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: a 9 year old patient received a 3rd dose of Boostrix too early; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number NR5DX, expiry date 02-FEB-2026) for prophylaxis.   Previously administered products included Td (received on 11-JAN-2023) and Dtap (received on 23-SEP-2023).   On 10-JAN-2024, the patient received Boostrix. On 10-JAN-2024, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a 9 year old patient received a 3rd dose of Boostrix too early). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 19-FEB-2024 The healthcare professional (HCP) wanted to know the guidance if a patient received a 3rd dose of Boostrix too early, which led to inappropriate age at vaccine administration. The patient received Td and DtP vaccines from other unknown manufacturers.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: patient  received a Tdap dose in 2020 at 11 years of age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 15-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 35S2S, expiry date 06-FEB-2026) for prophylaxis.   Previously administered products included Tdap (In 2020, received vaccine at the age of 11 years).   On 19-FEB-2024, the patient received Boostrix. On 19-FEB-2024, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: patient  received a Tdap dose in 2020 at 11 years of age). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 20-FEB-2024 Medical assistant called to stated that a patient received a dose of Boostrix day before of reporting and only afterwards did they find out that patient received a Tdap dose in 2020 at 11 years of age, which led to extra dose administered. The reporter consented to follow-up.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Pharmacist stated they have a patient who received the 1st dose of Twinrix on 18OCT2024 and now they wanted to get the 2nd dose, but it was out of the usual schedule.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 18th October 2023.).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Pharmacist stated they have a patient who received the 1st dose of Twinrix on 18OCT2024 and now they wanted to get the 2nd dose, but it was out of the usual schedule.). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-FEB-2024 The pharmacist stated that the patient now they wanted to get the 2nd dose, but it was out of the usual schedule. Till the time of reporting, the patient did not receive the 2nd dose of Twinrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administration at less than the recommended interval; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 51-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 35S2S, expiry date 06-FEB-2026) for prophylaxis.   Previously administered products included Boostrix (had received Boostrix vaccine on an unknown date).   On 19-FEB-2024, the patient received the 2nd dose of Boostrix. On 19-FEB-2024, an unknown time after receiving Boostrix, the patient experienced drug dose administration interval too short (Verbatim: Administration at less than the recommended interval). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-feb-2024 The nurse contacted inquiring about Boostrix. The administration of Boostrix before the recommended interval, which led to shortening of vaccine schedule. The reporter provided information about vaccine, patient and event.  The vaccine administration facility is the same as primary reporter. The reporter consented to follow up.
Age: 89.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea, Fatigue, Headache, Injection site pruritus, Injection site reaction
Clinical narrative: red skin rash at the injection site that has spread around the area; Red and itchy skin rash at the injection site; Injection site itching; Diarrhea; Body aches; Fatigue; she had headaches; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 89-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 14-FEB-2024, the patient received Arexvy (left arm). In FEB-2024, less than a week after receiving Arexvy, the patient experienced injection site rash (Verbatim: red skin rash at the injection site that has spread around the area), injection site erythema (Verbatim: Red and itchy skin rash at the injection site), injection site itching (Verbatim: Injection site itching), diarrhea (Verbatim: Diarrhea), general body pain (Verbatim: Body aches), fatigue (Verbatim: Fatigue) and headache (Verbatim: she had headaches). The patient was treated with hydrocortisone. The outcome of the injection site rash, injection site erythema, injection site itching and diarrhea were not resolved and the outcome of the general body pain, fatigue and headache were resolved.   It was unknown if the reporter considered the injection site rash, injection site erythema, injection site itching, diarrhea, general body pain, fatigue and headache to be related to Arexvy.     It was unknown if the company considered the injection site rash, injection site erythema, injection site itching, diarrhea, general body pain, fatigue and headache to be related to Arexvy.   Additional Information: GSK Receipt Date: 21-FEB-2024 The patient self reported this case. The patient received Arexvy vaccine and she had headaches, fatigue and body aches for the following 2 days after the vaccination. Then, 2 to 3 day ago (from the reporting date) developed diarrhea, which was not usual in her, and a red skin rash at the injection site that has spread around the area.  The rash was very itchy. The patient put some Hydrocortisone today (on the day of reporting) to relieve to itchiness.
Age: 89.0
Sex: F
Vaccine: RSV
Symptoms: Pain, Rash erythematous
Clinical narrative: red skin rash at the injection site that has spread around the area; Red and itchy skin rash at the injection site; Injection site itching; Diarrhea; Body aches; Fatigue; she had headaches; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 89-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 14-FEB-2024, the patient received Arexvy (left arm). In FEB-2024, less than a week after receiving Arexvy, the patient experienced injection site rash (Verbatim: red skin rash at the injection site that has spread around the area), injection site erythema (Verbatim: Red and itchy skin rash at the injection site), injection site itching (Verbatim: Injection site itching), diarrhea (Verbatim: Diarrhea), general body pain (Verbatim: Body aches), fatigue (Verbatim: Fatigue) and headache (Verbatim: she had headaches). The patient was treated with hydrocortisone. The outcome of the injection site rash, injection site erythema, injection site itching and diarrhea were not resolved and the outcome of the general body pain, fatigue and headache were resolved.   It was unknown if the reporter considered the injection site rash, injection site erythema, injection site itching, diarrhea, general body pain, fatigue and headache to be related to Arexvy.     It was unknown if the company considered the injection site rash, injection site erythema, injection site itching, diarrhea, general body pain, fatigue and headache to be related to Arexvy.   Additional Information: GSK Receipt Date: 21-FEB-2024 The patient self reported this case. The patient received Arexvy vaccine and she had headaches, fatigue and body aches for the following 2 days after the vaccination. Then, 2 to 3 day ago (from the reporting date) developed diarrhea, which was not usual in her, and a red skin rash at the injection site that has spread around the area.  The rash was very itchy. The patient put some Hydrocortisone today (on the day of reporting) to relieve to itchiness.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received the 1st dose of Shingrix on 06 October 2023 and received the 2nd dose on 20 October 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number L227A) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 20-OCT-2023, the patient received the 2nd dose of Shingrix. On 20-OCT-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: patient received the 1st dose of Shingrix on 06 October 2023 and received the 2nd dose on 20 October 2023). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 21-FEB-2024 The pharmacist reported that a patient that received the 1st dose of Shingrix on 06 October 2023, received the 2nd dose of Shingrix earlier than the recommended interval, which led to shortening of the vaccine schedule.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site muscle weakness, Injection site pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: muscle weakness at injection site; arm pain which has worsened; pain at injection site; fever; she experienced body aches; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site muscle weakness in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-FEB-2024, the patient received the 1st dose of Shingrix. On 07-FEB-2024, 1 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site), fever (Verbatim: fever) and general body pain (Verbatim: she experienced body aches). On an unknown date, the patient experienced injection site muscle weakness (Verbatim: muscle weakness at injection site) and pain in arm (Verbatim: arm pain which has worsened). The outcome of the injection site muscle weakness, injection site pain and pain in arm were not resolved and the outcome of the fever and general body pain were resolved.   It was unknown if the reporter considered the injection site muscle weakness, injection site pain, fever, general body pain and pain in arm to be related to Shingrix.     It was unknown if the company considered the injection site muscle weakness, injection site pain, fever, general body pain and pain in arm to be related to Shingrix.   Additional Information: GSK receipt date: 22-FEB-2024 The patient reported that she received her first Shingrix dose and experienced body aches and fever, which are recovered, and arm pain which has worsened and not recovered.  She also reported progressive weakening of the injection site muscle, which was not recovering, but continued to get worse. The Vaccine Administration Facility was the same as Primary Reporter The reporter consented to follow up.
Sex: U
Vaccine: MEN, MNQ
Symptoms: Extra dose administered
Clinical narrative: Double dose of men b or menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Menveo and Meningococcal B vaccine. On an unknown date, an unknown time after receiving Menveo and Meningococcal B vaccine, the patient experienced overdose (Verbatim: Double dose of men b or menveo). The outcome of the overdose was unknown.   Additional Information: GSK Receipt Date: 20-Feb-2024 The reporter reported that one of our medical assistants gave a patient possibly a double dose of men b or menveo as the medical assistant did not remember, which led to overdose The reporter wanted to know as there are any studies on possible harmful side effects. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.