chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Decubitus ulcer, Epistaxis, Erectile dysfunction, Executive dysfunction
Clinical narrative: A month after second shot, I woke up in the middle of the night hearing the loud sound of gushing fluid; it was blood pouring out of my nose. I managed to call EMS, and that was all I remember .....until I woke up after 18 days in the hospital.  My 50th birthday passed while I was in the hospital.  I had suffered a massive aneurysm, and was put into a medically induced coma while receiving drug treatment that constricted the blood vessels in my brain to allow it to hopefully heal.  I came out of the experience having constant seizures, and being unable to walk; I had to relearn over the course of six months. In addition to having seizures after that, my forearms began to experience accellerated aging and I cannot even brush against a wall without having tremendous bruising that does not heal, and often decubitus ulcer. My skin on both forearms is crepey, very fragile and always has black and blues and I must wear forearm protectors even inside the house. Since that time, I have had difficulty having and/or maintaining an erection. Additionally, my formerly strong constitution has been very reduced and I feel weak and unsteady all the time.  All these terrible problems have been going on and on for the last four years, and the stress of it has amplified my desire to self-medicate with alcohol, which has become another significant problem, as it is the only thing which has made me able to deal with the symptoms. The medical profession has responded by prescribing a huge list of pharmaceutical products which caused me to have massive mood swings and angry outbursts, as well as increasing the already bad tremors. I've been told that my executive function is also significantly impaired, as I have a hard time being able to anticipate the realistic consequences of actions/choices that I make.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Impaired healing, Medical induction of coma, Premature ageing, Seizure
Clinical narrative: A month after second shot, I woke up in the middle of the night hearing the loud sound of gushing fluid; it was blood pouring out of my nose. I managed to call EMS, and that was all I remember .....until I woke up after 18 days in the hospital.  My 50th birthday passed while I was in the hospital.  I had suffered a massive aneurysm, and was put into a medically induced coma while receiving drug treatment that constricted the blood vessels in my brain to allow it to hopefully heal.  I came out of the experience having constant seizures, and being unable to walk; I had to relearn over the course of six months. In addition to having seizures after that, my forearms began to experience accellerated aging and I cannot even brush against a wall without having tremendous bruising that does not heal, and often decubitus ulcer. My skin on both forearms is crepey, very fragile and always has black and blues and I must wear forearm protectors even inside the house. Since that time, I have had difficulty having and/or maintaining an erection. Additionally, my formerly strong constitution has been very reduced and I feel weak and unsteady all the time.  All these terrible problems have been going on and on for the last four years, and the stress of it has amplified my desire to self-medicate with alcohol, which has become another significant problem, as it is the only thing which has made me able to deal with the symptoms. The medical profession has responded by prescribing a huge list of pharmaceutical products which caused me to have massive mood swings and angry outbursts, as well as increasing the already bad tremors. I've been told that my executive function is also significantly impaired, as I have a hard time being able to anticipate the realistic consequences of actions/choices that I make.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Skin atrophy, Skin discolouration, Skin fragility, Sleep disorder, Stress
Clinical narrative: A month after second shot, I woke up in the middle of the night hearing the loud sound of gushing fluid; it was blood pouring out of my nose. I managed to call EMS, and that was all I remember .....until I woke up after 18 days in the hospital.  My 50th birthday passed while I was in the hospital.  I had suffered a massive aneurysm, and was put into a medically induced coma while receiving drug treatment that constricted the blood vessels in my brain to allow it to hopefully heal.  I came out of the experience having constant seizures, and being unable to walk; I had to relearn over the course of six months. In addition to having seizures after that, my forearms began to experience accellerated aging and I cannot even brush against a wall without having tremendous bruising that does not heal, and often decubitus ulcer. My skin on both forearms is crepey, very fragile and always has black and blues and I must wear forearm protectors even inside the house. Since that time, I have had difficulty having and/or maintaining an erection. Additionally, my formerly strong constitution has been very reduced and I feel weak and unsteady all the time.  All these terrible problems have been going on and on for the last four years, and the stress of it has amplified my desire to self-medicate with alcohol, which has become another significant problem, as it is the only thing which has made me able to deal with the symptoms. The medical profession has responded by prescribing a huge list of pharmaceutical products which caused me to have massive mood swings and angry outbursts, as well as increasing the already bad tremors. I've been told that my executive function is also significantly impaired, as I have a hard time being able to anticipate the realistic consequences of actions/choices that I make.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: A month after second shot, I woke up in the middle of the night hearing the loud sound of gushing fluid; it was blood pouring out of my nose. I managed to call EMS, and that was all I remember .....until I woke up after 18 days in the hospital.  My 50th birthday passed while I was in the hospital.  I had suffered a massive aneurysm, and was put into a medically induced coma while receiving drug treatment that constricted the blood vessels in my brain to allow it to hopefully heal.  I came out of the experience having constant seizures, and being unable to walk; I had to relearn over the course of six months. In addition to having seizures after that, my forearms began to experience accellerated aging and I cannot even brush against a wall without having tremendous bruising that does not heal, and often decubitus ulcer. My skin on both forearms is crepey, very fragile and always has black and blues and I must wear forearm protectors even inside the house. Since that time, I have had difficulty having and/or maintaining an erection. Additionally, my formerly strong constitution has been very reduced and I feel weak and unsteady all the time.  All these terrible problems have been going on and on for the last four years, and the stress of it has amplified my desire to self-medicate with alcohol, which has become another significant problem, as it is the only thing which has made me able to deal with the symptoms. The medical profession has responded by prescribing a huge list of pharmaceutical products which caused me to have massive mood swings and angry outbursts, as well as increasing the already bad tremors. I've been told that my executive function is also significantly impaired, as I have a hard time being able to anticipate the realistic consequences of actions/choices that I make.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arteriogram coronary normal, Chest pain, Cold sweat, Dizziness, Electrocardiogram abnormal
Clinical narrative: Suffered heart attack (MI) on 4/7/2022 - sudden, sharp pain mid-left side of chest lasting less than 10 seconds, dizziness, light headedness, cold sweats, palpitations. Did not immediately seek medical attention. Saw cardiologist 4/19/2022; Angiogram conducted 4/21/2022 - No blockage detected. Cause of MI is UNKNOWN. Dr. prescribed Metoprolol 50 mg daily.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, Palpitations
Clinical narrative: Suffered heart attack (MI) on 4/7/2022 - sudden, sharp pain mid-left side of chest lasting less than 10 seconds, dizziness, light headedness, cold sweats, palpitations. Did not immediately seek medical attention. Saw cardiologist 4/19/2022; Angiogram conducted 4/21/2022 - No blockage detected. Cause of MI is UNKNOWN. Dr. prescribed Metoprolol 50 mg daily.
Age: 61.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt has slight red bump/know in her vaccine site area from shingles vaccine. She did not get this reaction prior from the first dose. patient has pain and swelling in that area as well since the day of vaccination
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Head injury, Pain, Suture insertion, Syncope
Clinical narrative: Patient said when she came home after the vaccine she felt tired. She reported feeling tired and had  unspecified pain that she treated with Tylenol. She went to sleep. She woke up the next day to open her door for family and she fainted. Pt hit her head and had to report to the ER for stitches. .
Age: 58.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Gait disturbance, Loss of consciousness, Somnolence
Clinical narrative: Patient reports going home within 20 minutes of receiving immunizations. She reported stumbling and extreme sleepiness. She believes that she passed out but is not certain of the duration. Patient states she did not seek medical treatment but felt well again after 24 hours.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Fatigue, Limb discomfort, Mobility decreased, Peripheral swelling
Clinical narrative: Patient called on 6/7/24 5 days after vaccination stating her arm is still very swollen, has been heavy and swollen, hard to lift, hot to the touch and itchy. She has had dizziness and fatigue. Follow up call next day (6/8) she is feeling a little better, still swollen
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Pruritus, Skin warm
Clinical narrative: Patient called on 6/7/24 5 days after vaccination stating her arm is still very swollen, has been heavy and swollen, hard to lift, hot to the touch and itchy. She has had dizziness and fatigue. Follow up call next day (6/8) she is feeling a little better, still swollen
Age: 27.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration
Clinical narrative: PATIENT RECIEVED THE RSVP VACCINATION OUTSIDE OF RECOMMENDATIONS PER PROTOCOL. PATIENT RECIEVED THE ABRYSVO VACCINE IN THE MONTH OF FEBURARY, WHICH  IS OUTSIDE OF THE PROTOCOL FOR SEASONAL ADMNISTRATION ONLY IN MONTHS SEPTEMBER THROUGH JANUARY.
Age: 31.0
Sex: F
Vaccine: COVID19, HEPA
Symptoms: Chills, Decreased appetite, Dehydration, Fatigue, Lymphadenopathy
Clinical narrative: Fever lasting more than 24 hours starting 12 hours after injection, chills, sore arm in injection arm, swollen armpit lymph nodes, fatigue, loss of appetite, dehydration, general muscle soreness
Age: 31.0
Sex: F
Vaccine: COVID19, HEPA
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Fever lasting more than 24 hours starting 12 hours after injection, chills, sore arm in injection arm, swollen armpit lymph nodes, fatigue, loss of appetite, dehydration, general muscle soreness
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Oropharyngeal pain, Pain
Clinical narrative: Nausea, sore throat, headache, fatigue, body aches and pains. Lasted three days.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Nausea, sore throat, headache, fatigue, body aches and pains. Lasted three days.
Age: 34.0
Sex: M
Vaccine: UNK
Symptoms: Acupuncture, Arthralgia, Asthenia, Carpal tunnel syndrome, Dupuytren's contracture
Clinical narrative: 1. Dyshidrotic eczema- started 2 days after vaccine. Skin started peeling off fingers. Treatment included topical creams and steroid cream. Still ongoing. 2. Joint soreness. 2 weeks after vaccine, joint soreness started in ankles and worked up through knees, hips, shoulders, elbows, neck, and hands. Treatment has included physical therapy and chiropractic care. Still ongoing. 3. Muscle tightness/tendon tightness/hand numbness. Tightening of arm and leg muscles. Arm tightness has lead to carpal tunnel, Hand  tightness in tendons, dupytrens in both hands, de quervains in both thumbs. Physical therapy, chiropractic care, movement specialist, hand specialist, acupuncture and massage. Still ongoing. 4. Fatigue. Tiredness more than usual. Started within a couple months of vaccine. Extra tired and run down. Still on going.
Age: 34.0
Sex: M
Vaccine: UNK
Symptoms: Dyshidrotic eczema, Fatigue, Hypoaesthesia, Muscle tightness, Neck pain
Clinical narrative: 1. Dyshidrotic eczema- started 2 days after vaccine. Skin started peeling off fingers. Treatment included topical creams and steroid cream. Still ongoing. 2. Joint soreness. 2 weeks after vaccine, joint soreness started in ankles and worked up through knees, hips, shoulders, elbows, neck, and hands. Treatment has included physical therapy and chiropractic care. Still ongoing. 3. Muscle tightness/tendon tightness/hand numbness. Tightening of arm and leg muscles. Arm tightness has lead to carpal tunnel, Hand  tightness in tendons, dupytrens in both hands, de quervains in both thumbs. Physical therapy, chiropractic care, movement specialist, hand specialist, acupuncture and massage. Still ongoing. 4. Fatigue. Tiredness more than usual. Started within a couple months of vaccine. Extra tired and run down. Still on going.
Age: 34.0
Sex: M
Vaccine: UNK
Symptoms: Pain in extremity, Skin exfoliation, Tendon disorder, Tenosynovitis stenosans
Clinical narrative: 1. Dyshidrotic eczema- started 2 days after vaccine. Skin started peeling off fingers. Treatment included topical creams and steroid cream. Still ongoing. 2. Joint soreness. 2 weeks after vaccine, joint soreness started in ankles and worked up through knees, hips, shoulders, elbows, neck, and hands. Treatment has included physical therapy and chiropractic care. Still ongoing. 3. Muscle tightness/tendon tightness/hand numbness. Tightening of arm and leg muscles. Arm tightness has lead to carpal tunnel, Hand  tightness in tendons, dupytrens in both hands, de quervains in both thumbs. Physical therapy, chiropractic care, movement specialist, hand specialist, acupuncture and massage. Still ongoing. 4. Fatigue. Tiredness more than usual. Started within a couple months of vaccine. Extra tired and run down. Still on going.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Rash, Urticaria
Clinical narrative: Rash/hives followed vaccination from 5/28/24
Age: 60.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Fatigue, Pruritus, Rash
Clinical narrative: On Saturday pt developed itchy rash on trunk and saturday night had about 30 minutes of stratchy throat which self resolved. Rash improving but waxes and wanes. Pt also endorse fatigue and polyarthralgias. Overall syndrome c/f serum sickness vs delayed mild anaphylactoid reaction.
Age: 60.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Arthralgia, Fatigue, Rash pruritic, Throat irritation
Clinical narrative: On Saturday pt developed itchy rash on trunk and saturday night had about 30 minutes of stratchy throat which self resolved. Rash improving but waxes and wanes. Pt also endorse fatigue and polyarthralgias. Overall syndrome c/f serum sickness vs delayed mild anaphylactoid reaction.
Age: 38.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Rash
Clinical narrative: VCR calling on behalf Medical Assistant to report an adverse event for GARDASIL 9. HCP reported patient received first dose of GARDASIL 9 on 2/21/2024 and developed a rash on the face on 2/22/2024. Caller stated rash went away on the same day. Patien; This spontaneous report was received from a medical assistant concerning to a 38-year-old female. Her medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On 21-FEB-2024, was vaccinated with the firs dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, one dose, lot #1965045, expiration date: 19-JAN-2026, administered intramuscularly (IM) for prophylaxis (strength and anatomical location were not provided).  On 22-FEB-2024, the patient developed a rash on the face on. However, it was stated that the rash went away on the same day (recovered).   On 22-MAY-2024, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, one dose, administered IM for prophylaxis (strength, lot #, expiry date, and anatomical location were not provided).  The causal relationship between rash and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Lot# was being requested and would be updated upon review.
Sex: F
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Injection site discomfort, Injection site pain, Underdose
Clinical narrative: slightly sore injection site; not sure she got the full amount even on the 1st dose; Injection site discomfort; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: slightly sore injection site), injection site discomfort (Verbatim: Injection site discomfort) and incomplete dose administered (Verbatim: not sure she got the full amount even on the 1st dose). The outcome of the injection site pain was not reported and the outcome of the injection site discomfort was resolved (duration 1 day) and the outcome of the incomplete dose administered was unknown.   It was unknown if the reporter considered the injection site pain and injection site discomfort to be related to Shingrix.   It was unknown if the company considered the injection site pain and injection site discomfort to be related to Shingrix.   Linked case(s) involving the same patient:US2024AMR069736   Additional Information: GSK receipt date: 29-MAY-2024 and 30-MAY-2024 The reporter reported that a patient received Shingrix vaccine and experienced injection site discomfort which was lasted a day following the vaccination. No lot or expiration date were available. The pharmacist when mixing the fluid, the vial flew out of his hand and fluid spilled so they were not sure if she got full amount of Shingrix dose, which led to incomplete dose administered. There had been no other side effects other than a slightly sore injection site. The case had been linked to US2024067180, reported by the same reporter, for a different patient. For tolerance of 2nd dose of Shingrix, refer case US2024AMR069736.; Sender's Comments:  US-GSK-US2024067180: US-GSK-US2024AMR069736:Wife CASE
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: First dose was given in October 2023 and second dose given on 25May2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 62-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number PK74B, expiry date 22-FEB-2025) for prophylaxis.   Previously administered products included Arexvy (received 1st dose in October 2023).   On 25-MAY-2024, the patient received the 2nd dose of Arexvy. On 25-MAY-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: First dose was given in October 2023 and second dose given on 25May2024). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 29-MAY-2024 The patient received a second dose of Arexvy, which led to extra dose administered.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: baby only got the liquid DTaP-IPV portion with no reported adverse event; Initial information was received on 30-May-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient who only got the liquid dtap-ipv portion of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine inact (VAQTA) for Prophylactic vaccination.  On 23-May-2024, the patient received 0.5 ml, total (once) (dose 4) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot UK003AA, expiry date: 15-Mar-2025, strength: unknown) via unknown route in unknown administration site for Immunisation and only got the liquid dtap-ipv portion with no reported adverse event (single component of a two-component product administered) (Latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Module of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: she did not have the booster; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 51-year-old female patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (received 1st dose of Havrix in year 2002).   On an unknown date, the patient did not receive the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incomplete course of vaccination (Verbatim: she did not have the booster). 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: 29-MAY-2024. The reporter reported that he/she just had a quick question, he/she had been looking on the internet and had not got the right answer. The patient was an adult, she had a Havrix in 2002 and she did not have the booster.  She would be traveling, so now reporter wanted to know if she should start the series again or if she just get the booster.  The vaccine administration facility was the same as primary reporter. Caller did not have the specific date of the vaccine, she only mention that the 1st dose was on 2002, reporter set it as 01-JAN-2002 because the format did not allow only the year.  The caller did not have the batch number of this 1st dose.  Also, reporter set 51 years old as the age of the patient, however, she received the 1st dose when she was 29 years old. Till the time of reporting, the patient did not receive 2nd dose of Havrix, which led to incomplete course of vaccination.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: a patient was given an extra dose of DAPTACEL with no reported adverse event; Initial information received on 31-May-2024 regarding an unsolicited valid non-serious case received from an Other health professional.  This case involves a 1 years old male patient who was given an extra dose of diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 20v (crm197) (Prevnar 20); hepatitis a vaccine for Prophylactic vaccination and HIB vaccine conj (tet tox) (Acthib) for Immunisation.  On 15-Sep-2023, the patient received 0.5 ml (TOTAL) dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection (lot- C60413AA and expiration date- 06-Jul-2024) via intramuscular route in the left thigh (strength: not provided) for Immunisation (extra dose administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Extra dose administered, No adverse event
Clinical narrative: had administered an extra dose of Menquadfi to a patient with no reported adverse event; Initial information received on 05-Jun-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 17 years old female patient who was administered an extra dose of meningococcal a-c-y-w135 (t conj) vaccine [menquadfi] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Jun-2024, the patient received 0.4 ml  dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine  Solution for injection (lot number: U7996AA) (Expiry date: 30-Apr-2026) (Strength: standard) (Frequency: once) via intramuscular route in the right deltoid for immunization.  On 03-Jun-2024, the patient was administered an extra dose of meningococcal a-c-y-w135 (t conj) vaccine [menquadfi] to a patient with no reported adverse event (extra dose administered) (latency: same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Module of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site discolouration, Local reaction
Clinical narrative: Left lateral thigh 5 cm diameter discoloration places brownish cafe color
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; that patient received inappropriately stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender.  There was no information about the patient's pertinent medical history, concomitant medications or drug reactions and allergies provided.  On 13-MAY-2024, the patient was vaccinated with an inappropriately stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, single dose, lot #Y003143, expiration date: 27-JUL-2025, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). Temperature excursion of 19.8 degrees Fahrenheit for 20 hours and 15 minutes was reported. No previous temperature excursion reported.   No adverse effects reported (No adverse event).  This is one of 34 reports received from the same reporter.; Sender's Comments:  US-009507513-2405USA007588: US-009507513-2405USA007600: US-009507513-2405USA007488: US-009507513-2405USA007924:2405USA007454 US-009507513-2405USA007905: US-009507513-2405USA007573: US-009507513-2405USA007578: US-009507513-2405USA007617: US-009507513-2405USA007648: US-009507513-2405USA007667: US-009507513-2405USA007684: US-009507513-2405USA007692: US-009507513-2405USA007713: US-009507513-2405USA007720: US-009507513-2405USA007722: US-009507513-2405USA007724: US-009507513-2405USA007727: US-009507513-2405USA007728: US-009507513-2405USA007731: US-009507513-2405USA007761: US-009507513-2405USA007763: US-009507513-2405USA007771: US-009507513-2405USA007791: US-009507513-2405USA007833: US-009507513-2405USA007841: US-009507513-2405USA007901: US-009507513-2405USA007909: US-009507513-2405USA007911: US-009507513-2405USA007912: US-009507513-2405USA007935: US-009507513-2405USA008015: US-009507513-2405USA007700: US-009507513-2405USA007916: US-009507513-2405USA007924:2405USA007454 US-009507513-2405USA007722: US-009507513-2405USA007912:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP reported PROQUAD was administered to a patient on an unspecified date during a temperature excursion (case 02613440). No additional AE. No PQC.  Names of vaccines involved (including lot/exp) PROQUAD X011981 07/19/2024 Temperature 12°F Time fram; No additional AE; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. Information regarding the patient's concurrent conditions, and was not provided. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On an unspecified date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, for prophylaxis (route of administration, vaccination scheme frequency, and anatomical location, were not provided; valid lot number x011981 with an expiration date of 19-JUL-2024; albumin status: rHA). The administered dose of the vaccine experienced a temperature excursion 12 degrees Fahrenheit for 1 hour. There was no previous temperature excursions. I was not reported if the temperature was recorded by a data logger or not. There was no adverse effect reported.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no side effects being reported; expired ROTATEQ was given inadvertently to a patient on 6/4/2024.; This spontaneous report has been received from a medical assistant, referring to an 8-week-old patient of an unknown gender. The information regarding the patient's concurrent conditions, concomitant therapies or medical history was not reported.  On 04-JUN-2024, the patient was inadvertently vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 millilter oral liquid, lot# 1968385, expiry date 22-MAY-2024, administered for prophylaxis (dose, route of administration and anatomical location were not reported) (expired product administered). No side effects reported (no adverse event).
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No side effects reported; he received the first dose in 2018, the second dose in 2022, and he is wanting to get his third dose next week, in June 2024; This spontaneous report has been received from a medical assistant, referring to a 24-year-old male patient. The information regarding the patient's concurrent conditions, concomitant therapies or medical history was not reported.  On an unknown date in 2018, the patient was vaccinated with 1st dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot# and expiry date were not reported) for prophylaxis. On an unknown date in 2022, he was vaccinated with 2nd dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot# and expiry date were not reported) for prophylaxis (inappropriate schedule of product administration). He wanted to get his 3rd dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) to be administered the following week, in June 2024. No side effects reported (no adverse event).  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Nurse called and reported that an expired dose of MMR II was administered to a patient. Caller stated the dose expired 5/25/2024 and was administered 6/5/2024. Caller stated no patient symptoms have been reported. Caller stated products has not been; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 05-JUN-2024 the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status: rHA) lot # W039699 and expiration date25-MAY-2024 for prophylaxis (exact dose, dose number, route and site of administration were not provided) (expired product administered and no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no patient symptoms have been reported; Nurse called and reported that an expired dose of MMR II was administered to a patient.; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 05-JUN-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) injection, 1 dose, administered as  prophylaxis (lot #W039699 has been verified to be valid, expiration date reported and established as: 25-MAY-2024) (strength, dose, anatomical location, and route of administration were not provided) (expired vaccine used). No patient symptoms have been reported.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient is not experiencing any symptoms; HBP called  on behalf of HCP (not on line)  to report that a 12-month-old received VARIVAX and PROQUAD. Caller states the patient is not experiencing any symptoms. Lot information for VARIVAX was provided but information was unknown for PROQUAD. Perm; This spontaneous report was received from an office manager and refers to a 12-month-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 06-JUN-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, at a dose of 0.5 milliliter, administered as prophylaxis (lot #x006980 has been verified to be valid, expiration date reported and established as 07-MAR-2025) (strength, anatomical location, and route of administration were not provided); and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical location and route of administration were not provided) (overdose). The patient was not experiencing any symptoms.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms reported and no additional details provided; Nurse calling to report the inadvertent administration of an expired dose of the MMR II Vaccine to a patient on 06/06/2024.  No symptoms reported and no additional details provided.  No other AE and no PQC; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 06-JUN-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) injection, administered as prophylaxis (lot #W022640 has been verified to be valid, expiration date  reported and established as 15-APR-2024) (strength, and route of administration were not provided) (expired product administered). No symptoms reported and no additional details provided
Age: 9.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: About 30 minutes after receiving G9, 9 year old walked out of office and fainted.; This spontaneous report has been received from a nurse, regarding a 9-year-old male. The patient's pertinent medical history, concurrent conditions, drug allergies or concomitant medications 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, frequency 1, administered for prophylaxis (dose, vaccination scheme, route of administration, anatomical site of injection, lot number, and expiration date were not provided).  On that same date, 30 minutes after receiving vaccine, the patient walked out of the office and fainted (syncope). On an unknown date, the patient recovered from the event.   The causal relationship between fainted and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Upon internal review, the event syncope was determined to be medically significant.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: COVID-19, Incomplete course of vaccination
Clinical narrative: Covid; never got the 2nd one because of Covid, then forgot all about it until now; This non-serious case was reported by a consumer via call center representative and described the occurrence of covid-19 in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In FEB-2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced covid-19 (Verbatim: Covid) and incomplete course of vaccination (Verbatim: never got the 2nd one because of Covid, then forgot all about it until now). The outcome of the covid-19 was not reported and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     It was unknown if the company considered the covid-19 to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-MAY-2024 The patient self reported this case. The patient received first Shingrix vaccine and never got the 2nd one because of Covid, then forgot all about it until now (till the time of reporting). The reporter asked, what she need to do, get the 2nd vaccine now or start over or was it too late for either. The reporter already asked her doctor who was clueless and gave no indication he planned on educating himself. The patient already know what the CDC (Centers for Disease Control and Prevention) recommends, she was hoping GSK would have the most up to date info. Never mind, this how everything was anymore. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discharge, Injection site discomfort, Injection site pain
Clinical narrative: injection site discomfort; injection site soreness; do not know if the full dose was administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site discomfort in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site discomfort (received first dose of Shingrix on unknown date, for tolerance refer case US2024AMR069586).   On 28-MAY-2024 19:00, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On 28-MAY-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: do not know if the full dose was administered). On 28-MAY-2024 23:00, the patient experienced injection site discomfort (Verbatim: injection site discomfort) and injection site pain (Verbatim: injection site soreness). Rechallenge with Shingrix was positive. The outcome of the injection site discomfort and injection site pain were not resolved and the outcome of the inappropriate dose of vaccine administered was unknown.   It was unknown if the reporter considered the injection site discomfort and injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site discomfort and injection site pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR069586   Additional Information: GSK Receipt Date: 29-MAY-2024 and 30-MAY-2024 The reporter stated his wife received the second dose of Shingrix yesterday (day before reporting) around 7 pm and she felt fluid coming down her arm. The patient felt injection site discomfort and soreness which started probably 4 hours post injection and she was still experiencing it. The pharmacist stated it was negative pressure still in the needle that was the fluid but it was enough fluid to form a bead and drip.  They basically did not know if the full dose was administered, she clearly got some of the dose but how much cannot be quantified.  The patient got some of the dose but how much cannot be quantified which led to inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2024067180:HUSBAND CASE US-GSK-US2024AMR069586:Same patient, 1st dose US-GSK-US2024AMR069586:Wife CASE
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Injection site discomfort
Clinical narrative: Injection site discomfort; fatigue/felt very tired/rest needed; need to rest a didn't have alot of energy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site discomfort in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site discomfort (received 1st dose on an unknown date, For tolerance to 1st dose, refer case US2024067180.).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On an unknown date, 12 hrs after receiving Shingrix, the patient experienced injection site discomfort (Verbatim: Injection site discomfort), fatigue (Verbatim: fatigue/felt very tired/rest needed) and loss of energy (Verbatim: need to rest a didn't have alot of energy). Rechallenge with Shingrix was positive. The outcome of the injection site discomfort, fatigue and loss of energy were resolved (duration 2 days).   It was unknown if the reporter considered the injection site discomfort, fatigue and loss of energy to be related to Shingrix.     It was unknown if the company considered the injection site discomfort, fatigue and loss of energy to be related to Shingrix.   Linked case(s) involving the same patient:  US2024067180   Additional Information: GSK receipt date: 29-MAY-2024 The pharmacist reported that a patient received Shingrix vaccine and experienced fatigue, injection site discomfort, he felt tired and need to rest and did not had a lot of energy. The dates of administration, lot and expiration date of each dose unknown. The fatigue was significant. This case is linked with US2024067180, reported by same reporter.; Sender's Comments:  US-GSK-US2024067180:1st dose male pt
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: patient received her first dose of Bexsero on April 16th 2024, and by accident they switched brands and administered Trumenba on May 28th 2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number 5P2P7, expiry date 31-JAN-2026) for prophylaxis.   Co-suspect products included Meningococcal vaccine B rfHbpA/fHbpB (Trumenba) for prophylaxis.   On 16-APR-2024, the patient received the 1st dose of Bexsero. On 28-MAY-2024, the patient received Trumenba. On 28-MAY-2024, 42 days after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: patient received her first dose of Bexsero on April 16th 2024, and by accident they switched brands and administered Trumenba on May 28th 2024). The outcome of the interchange of vaccine products 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: 28-MAY-2024 The pharmacist reported that, the patient received her 1st dose of Bexsero and by accident they switched brands and administered Trumenba which led to interchange of vaccine products.  The reporter consented to follow up
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Inappropriate Reconstitution Technique; patient was given the adjuvant portion of Shingrix vaccine only; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 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 inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique) and inappropriate dose of vaccine administered (Verbatim: patient was given the adjuvant portion of Shingrix vaccine only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 29-MAY-2024 The nurse reported that the patient was given the adjuvant portion of Shingrix vaccine only, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. Unfortunately he did not had any information on the vaccination date, patient or details on vaccine, he informed he was just told this happened. The nurse stated that he will also report this to the CDC and that he consented for follow up by email to give more details. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.