chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: 10 patients received Moderna vaccine that had thawed out and then refroze; 10 patients received Moderna vaccine that had thawed out and then refroze; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze), PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze), PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze), PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze).    No concomitant medication was reported.  The patients were all adults the patients have not reported other side effects. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743056 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743056:Master case
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Cardiac function test normal, Cardiac imaging procedure normal, Cataplexy, Dyskinesia
Clinical narrative: 1) -Post-COVID vaccine myopericarditis in July 2022, with mildly elevated troponins which was ultimate treated with IVIG, with cardiac function remaining normal throughout the disease course.  Normal cardiac MRI without inflammation/edema/scar in August 2022. 2) Long COVID starting in August/September 2022, fatigue, dysautonomia, postural orthostatic tachycardia syndrome, frequent benign palpitations. 3) Narcolepsy with cataplexy diagnosis, made 9/8/2023
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunoglobulin therapy, Magnetic resonance imaging heart, Myopericarditis, Narcolepsy
Clinical narrative: 1) -Post-COVID vaccine myopericarditis in July 2022, with mildly elevated troponins which was ultimate treated with IVIG, with cardiac function remaining normal throughout the disease course.  Normal cardiac MRI without inflammation/edema/scar in August 2022. 2) Long COVID starting in August/September 2022, fatigue, dysautonomia, postural orthostatic tachycardia syndrome, frequent benign palpitations. 3) Narcolepsy with cataplexy diagnosis, made 9/8/2023
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Post-acute COVID-19 syndrome, Postural orthostatic tachycardia syndrome, Sleep study, Sleep study abnormal
Clinical narrative: 1) -Post-COVID vaccine myopericarditis in July 2022, with mildly elevated troponins which was ultimate treated with IVIG, with cardiac function remaining normal throughout the disease course.  Normal cardiac MRI without inflammation/edema/scar in August 2022. 2) Long COVID starting in August/September 2022, fatigue, dysautonomia, postural orthostatic tachycardia syndrome, frequent benign palpitations. 3) Narcolepsy with cataplexy diagnosis, made 9/8/2023
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin increased
Clinical narrative: 1) -Post-COVID vaccine myopericarditis in July 2022, with mildly elevated troponins which was ultimate treated with IVIG, with cardiac function remaining normal throughout the disease course.  Normal cardiac MRI without inflammation/edema/scar in August 2022. 2) Long COVID starting in August/September 2022, fatigue, dysautonomia, postural orthostatic tachycardia syndrome, frequent benign palpitations. 3) Narcolepsy with cataplexy diagnosis, made 9/8/2023
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Reaction to previous exposure to any vaccine
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 18.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 18.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Expired product administered
Clinical narrative: none
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Unevaluable event
Clinical narrative: none
Age: 50.0
Sex: F
Vaccine: RSV, FLUR4, RSV
Symptoms: Guillain-Barre syndrome, Intensive care, Paraesthesia
Clinical narrative: Per chart note: 50 year old female with no significant PMH who presented from home on 9/22/2023 with acute onset of right sided weakness and right arm tingling that began at 2130 yesterday. She has not had any recent illness or fevers but she did received her influenza and RSV vaccinations 10 days ago. This is the first time she has gotten vaccinated against RSV. There is a strong family history of autoimmune disorders through her family including lupus, rheumatoid arthritis. and sarcoidosis on maternal side of the family. Code stroke called on arrival. Patient 2130 yesterday. NIHSS 5. FSBS 122. BP 132/73,  CT Head was performed showing no acute intracranial hemorrhage.  Pt being treated for Guillane Barre' Syndrome and ultimately transferred to ICU and intubated.  Initial admit to Step down unit. Neuro checks q 4hrs. Transferred to ICU and untimately intubated.  Begin course of IVIG
Age: 50.0
Sex: F
Vaccine: RSV, FLUR4, RSV
Symptoms: Blood glucose normal, Computerised tomogram head normal, Endotracheal intubation, Guillain-Barre syndrome, Hemiparesis
Clinical narrative: Per chart note: 50 year old female with no significant PMH who presented from home on 9/22/2023 with acute onset of right sided weakness and right arm tingling that began at 2130 yesterday. She has not had any recent illness or fevers but she did received her influenza and RSV vaccinations 10 days ago. This is the first time she has gotten vaccinated against RSV. There is a strong family history of autoimmune disorders through her family including lupus, rheumatoid arthritis. and sarcoidosis on maternal side of the family. Code stroke called on arrival. Patient 2130 yesterday. NIHSS 5. FSBS 122. BP 132/73,  CT Head was performed showing no acute intracranial hemorrhage.  Pt being treated for Guillane Barre' Syndrome and ultimately transferred to ICU and intubated.  Initial admit to Step down unit. Neuro checks q 4hrs. Transferred to ICU and untimately intubated.  Begin course of IVIG
Age: 50.0
Sex: F
Vaccine: RSV, FLUR4, RSV
Symptoms: Immunoglobulin therapy, Intensive care, NIH stroke scale, Neurological symptom, Paraesthesia
Clinical narrative: Per chart note: 50 year old female with no significant PMH who presented from home on 9/22/2023 with acute onset of right sided weakness and right arm tingling that began at 2130 yesterday. She has not had any recent illness or fevers but she did received her influenza and RSV vaccinations 10 days ago. This is the first time she has gotten vaccinated against RSV. There is a strong family history of autoimmune disorders through her family including lupus, rheumatoid arthritis. and sarcoidosis on maternal side of the family. Code stroke called on arrival. Patient 2130 yesterday. NIHSS 5. FSBS 122. BP 132/73,  CT Head was performed showing no acute intracranial hemorrhage.  Pt being treated for Guillane Barre' Syndrome and ultimately transferred to ICU and intubated.  Initial admit to Step down unit. Neuro checks q 4hrs. Transferred to ICU and untimately intubated.  Begin course of IVIG
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Gait disturbance, Pain
Clinical narrative: In my left knee, I know that I have arthritis but it has never bothered me until 3 days or two days after that vaccine; I could hardly walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 as dose 1, single (Lot number: HGL629) at the age of 78 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "Arthritis/In left knee" (ongoing). Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol abnormal. The following information was reported: GAIT DISTURBANCE (non-serious) with onset Sep2023, outcome "unknown", described as "I could hardly walk"; ARTHRITIS (non-serious) with onset Sep2023, outcome "unknown", described as "In my left knee, I know that I have arthritis but it has never bothered me until 3 days or two days after that vaccine". The events "in my left knee, I know that I have arthritis but it has never bothered me until 3 days or two days after that vaccine" and "I could hardly walk" required physician office visit. Therapeutic measures were taken as a result of arthritis, gait disturbance. Additional information: The consumer stated, "In my left knee, I know that I have arthritis, but it has never bothered me until 3 days or two days after that vaccine. I went to the orthopedic plus doctor and he said that they have been studies that shows the COVID 19 vaccine can erupt an arthritic response. I could hardly walk so, I am going on a trip on airplane this coming Saturday 07Oct2023 and I have to get a cortisone shot in that knee so, I can walk, now the problem is I am supposed to wait two weeks after that vaccine to get the Cortisone shot but I do not have enough time because not enough days so, I am going to hope give it to me tomorrow because I can hardly walk. Now I did the research on my own and doctor said, there have been studies that show that the vaccines erupted arthritic response". The consumer further stated, "I think it was little longer that I had the flu shot, Flu vaccination I think it was about a month". The patient was using over the counter Aleve as treatment.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthritis, Gait disturbance
Clinical narrative: In my left knee, I know that I have arthritis but it has never bothered me until 3 days or two days after that vaccine; I could hardly walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 as dose 1, single (Lot number: HGL629) at the age of 78 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "Arthritis/In left knee" (ongoing). Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol abnormal. The following information was reported: GAIT DISTURBANCE (non-serious) with onset Sep2023, outcome "unknown", described as "I could hardly walk"; ARTHRITIS (non-serious) with onset Sep2023, outcome "unknown", described as "In my left knee, I know that I have arthritis but it has never bothered me until 3 days or two days after that vaccine". The events "in my left knee, I know that I have arthritis but it has never bothered me until 3 days or two days after that vaccine" and "I could hardly walk" required physician office visit. Therapeutic measures were taken as a result of arthritis, gait disturbance. Additional information: The consumer stated, "In my left knee, I know that I have arthritis, but it has never bothered me until 3 days or two days after that vaccine. I went to the orthopedic plus doctor and he said that they have been studies that shows the COVID 19 vaccine can erupt an arthritic response. I could hardly walk so, I am going on a trip on airplane this coming Saturday 07Oct2023 and I have to get a cortisone shot in that knee so, I can walk, now the problem is I am supposed to wait two weeks after that vaccine to get the Cortisone shot but I do not have enough time because not enough days so, I am going to hope give it to me tomorrow because I can hardly walk. Now I did the research on my own and doctor said, there have been studies that show that the vaccines erupted arthritic response". The consumer further stated, "I think it was little longer that I had the flu shot, Flu vaccination I think it was about a month". The patient was using over the counter Aleve as treatment.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no side effects; Improperly stored vaccine was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 12-JUL-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) injection, administered for prophylaxis (lot# W012730, expiration date: 16-OCT-2023; strength and route of administration were not provided). The vaccine was improperly stored at 6 degrees Celsius for 7 hours. There was no previous temperature excursion (Product storage error). No side effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2309USA008482: US-009507513-2309USA008465: US-009507513-2309USA008212: US-009507513-2309USA008121:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no side effects; Improperly stored vaccine was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 16-AUG-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) injection, administered for prophylaxis (lot# W012730, expiration date: 16-OCT-2023; strength and route of administration were not provided). The vaccine was improperly stored at 6 degrees Celsius for 7 hours. There was no previous temperature excursion (product storage error). No side effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2309USA008121: US-009507513-2309USA008458: US-009507513-2309USA008482: US-009507513-2309USA008212:
Age: 1.17
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered, No adverse event
Clinical narrative: No symptoms were reported by the HBP; HBP called to report that a dose of PROQUAD and an inadvertently given additional dose of VARIVAX were given today, 9/25/2023, to a 15-month-old patient. HBP reports that the medications were pulled for the Medical Assistant, by a brand-new employee,; PROQUAD and an inadvertently given additional dose of VARIVAX were given today, 9/25/2023, to a 15-month-old patient. HBP reports that the medications were pulled for the Medical Assistant, by a brand-new employee,; This spontaneous report was received from a nurse practitioner and refers to a 14 (also reported as 15) month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 25-SEP-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # W039688, expiration date not provided but upon internal review established as 13-DEC-2024), and inadvertently on the same date, with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # X007355, expiration date not provided but upon internal review established as 08-SEP-2024, therapy type rHA) (inappropriate schedule of product administration, overdose), as the vaccines were pulled to the medical assistant by a brand new employee, but the medical assistant did not check the doses prior administration. No symptoms were reported, but it was informed to the patient's family to be on the lookout for fever and febrile seizures.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called regarding VARIVAX. Product had undergone TE and it was administered after the TE. No reported adverse reactions.; No reported adverse reactions; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (valid lot number W039294 [expiration date 11-DEC-2024]) (dose, dose number, frequency, route of administration, vaccination scheme, and anatomical location was not provided), after temperature excursion (product storage error).  No additional adverse event (AE).
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Dizzy; headache; achy; red, painful and swollen at injection site (this one lasted 3 days); tired
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site swelling, Pain
Clinical narrative: Dizzy; headache; achy; red, painful and swollen at injection site (this one lasted 3 days); tired
Age: 22.0
Sex: M
Vaccine: ANTH, MNQ, TYP, YF
Symptoms: Headache, Inappropriate schedule of product administration, Myalgia
Clinical narrative: Patient was given a premature anthrax booster, given 2 weeks early. He developed headache and muscle aches for 2 days, otherwise no symptoms.
Age: 27.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Arthralgia, Back pain, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Swelling, pain, itching, hot to touch, and redness at site of COVID vaccine injection (left deltoid). No treatment, cold compress used once. Aches in lower back and hips lasting one day after vaccine administration.
Age: 27.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swelling, pain, itching, hot to touch, and redness at site of COVID vaccine injection (left deltoid). No treatment, cold compress used once. Aches in lower back and hips lasting one day after vaccine administration.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Cough, Eye discharge, Fatigue, Hypersensitivity
Clinical narrative: Flu vaccine, unknown type. Cause fatigue,  body aches, chills, sneezing,  coughing, runny nose/eyes, allergic reaction around left eye (swelled close)
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Rhinorrhoea, Sneezing, Swelling of eyelid
Clinical narrative: Flu vaccine, unknown type. Cause fatigue,  body aches, chills, sneezing,  coughing, runny nose/eyes, allergic reaction around left eye (swelled close)
Age: 16.0
Sex: M
Vaccine: UNK
Symptoms: Eye swelling, Swollen tongue
Clinical narrative: Swollen eyes  Swollen tongue
Sex: U
Vaccine: RVX
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: my right leg has been hurting bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of leg pain in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   In SEP-2023, the patient received RSV vaccine. In SEP-2023, immediately after receiving RSV vaccine, the patient experienced leg pain (Verbatim: my right leg has been hurting bad).The outcome of the leg pain was not reported.   It was unknown if the reporter considered the leg pain to be related to RSV vaccine.   It was unknown if the company considered the leg pain to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 25-SEP-2023 This case was reported by a patient via interactive digital media. The reporter wanted to know what side effects you had. The patient got his/her RSV vaccine a week ago from the day of reporting and his/her right leg had been hurting bad immediately after the shot. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Erythema, Injection site mass
Clinical narrative: Lumps developed under skin at injection site; Arm still shows redness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site lump in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site lump (Verbatim: Lumps developed under skin at injection site) and erythema of extremities (Verbatim: Arm still shows redness).The outcome of the injection site lump and erythema of extremities were not resolved.   It was unknown if the reporter considered the injection site lump and erythema of extremities to be related to Arexvy.     It was unknown if the company considered the injection site lump and erythema of extremities to be related to Arexvy.   Additional Information: GSK Receipt Date: 28-SEP-2023 This case was reported by a patient via interactive digital media. The reporter stated that arm still showed redness and lump developed under skin at the injection site.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: nurse called to inform that a 2-year-old patient received a dose of Kinrix back in 7/Sep/2023. It was the first dTap and IPV dose for the patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5AY2J) for prophylaxis.   On 07-SEP-2023, the patient received the 1st dose of Kinrix. On 07-SEP-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: nurse called to inform that a 2-year-old patient received a dose of Kinrix back in 7/Sep/2023. It was the first dTap and IPV dose for the patient).The outcome of the inappropriate age at vaccine administration 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: 25-SEP-2023 The reporter called to inform that a 2-year-old patient received a dose of Kinrix, which led to inappropriate age at vaccine administration. It was the first dTap and IPV dose for the patient. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Age: 0.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Hiberix expired on 7/27/2023 and was administered today; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 3-month-old female patient who received Hib (Hiberix) (batch number 5Y9N9, expiry date 27-JUL-2023) for prophylaxis.   On 26-SEP-2023, the patient received the 1st dose of Hiberix. On 26-SEP-2023, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: Hiberix expired on 7/27/2023 and was administered today).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 26-SEP-2023 The reporter reported that the patient received Hiberix vaccine which was already expired, which led to expired vaccine used. The vaccine administration facility was the same as primary reporter The reporter consented to follow up via postal.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo was reconstituted with sterile water and administered to a patient; Menveo was reconstituted with sterile water and administered to a patient; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA957A, expiry date 30-SEP-2024) for prophylaxis.   On 26-SEP-2023, the patient received Menveo. On 26-SEP-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo was reconstituted with sterile water and administered to a patient) and inappropriate dose of vaccine administered (Verbatim: Menveo was reconstituted with sterile water and administered to a patient).The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 26-SEP-2023 The reporter called to report that Menveo was reconstituted with sterile water and administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up via email.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Achy sore painful arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number EP5FD, expiry date 07-DEC-2024) for prophylaxis.   On 01-SEP-2023, the patient received Arexvy (left arm). In SEP-2023, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: Achy sore painful arm).The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Arexvy.  It was unknown if the company considered the pain in arm to be related to Arexvy.   Additional Information: GSK Receipt Date: 27-SEP-2023 The reporter stated that a patient received Arexvy in her left arm and developed achy sore and painful arm that had not resolved yet.  The reporter consented to follow up. The case had been linked to US2023133483, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023133483:2nd report
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: received a dose of Boostrix on 26Sep2023 that was exposed to a temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a adult male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7C75N, expiry date 06-DEC-2025) for prophylaxis.   On 26-SEP-2023, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: received a dose of Boostrix on 26Sep2023 that was exposed to a temperature excursion).The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 28-SEP-2023 The reporter reported that a patient received a dose of Boostrix that was exposed to a temperature excursion, which led to incorrect storage of vaccine.  No symptoms were reported. The reporter consented to follow up via email. This was 1 of 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023133818:same reporter different pateint,different drug US-GSK-US2023133819:samereporter different pateint,different drug US-GSK-US2023133819:same reporter different patient
Age: 63.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The booster dose was administered today September 28, 2023. This is being reported as a possible late dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old female patient who received HAB (Twinrix) (batch number 797F9, expiry date 30-DEC-2025) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 8th September 2022), Twinrix (received 2nd dose on 15th September 2022) and Twinrix (received 3rd dose on 29th September 2022).   On 28-SEP-2023, the patient received Twinrix. On 28-SEP-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: The booster dose was administered today September 28, 2023. This is being reported as a possible late dose).The outcome of the drug dose administration interval too long 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-SEP-2023 The reporter stated that patient received the first dose of the Twinrix accelerated dosing schedule last year.  This was being reported as a possible late dose. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. The patient received 4th dose of Twnrix later than the recommended schedule, which led to lengthening of vaccination schedule. The case had been linked to US2023133823, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023133823:Same reporter, different patient
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: patient who received expired dose the vaccine was expired on September 7th 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 25-year-old male patient who received HBV (Engerix B) (expiry date 07-SEP-2023) for prophylaxis.   On 25-SEP-2023, the patient received Engerix B. On 25-SEP-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: patient who received expired dose the vaccine was expired on September 7th 2023).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 26-SEP-2023 The pharmacist had patient who received Engirix-B which was expired, which led to expired vaccine used The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received a Shingrix vaccine in Sept, 2020 and has not received the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix in September 2020).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received a Shingrix vaccine in Sept, 2020 and has not received the 2nd dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-SEP-2023 Till date the patient had not received the 2nd dose of Shingrix which led to incomplete course of vaccination. The reporter was not sure if patient needs to start over again or she could only administer 2nd dose. This case is linked with US2021019660, US2021019656 and US2021001321, reported by same reporter. The reporter consented to follow up. No further information was available.; Sender's Comments:  US-GSK-US2021019660:Same reporter US-GSK-US2021019656:Same reporter US-GSK-US2021001321:Same reporter
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Chills, Injection site pain, Lethargy
Clinical narrative: Injection site pain and soreness  Chills  Lethargy  Joint pain
Age: 88.0
Sex: F
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: a day after patient received the fluzone high-dose quad vaccine she came into the pharmacy and said she had requested the covid vaccine instead of the flu vaccine and that she had already received the flu vaccine at a hospital several weeks before.  she said she had no ill effects from the vaccine she had received the previous day.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Lip swelling, Mouth swelling, Oedema peripheral, Peripheral swelling
Clinical narrative: swelling in throat and mouth and lips  and then in left hand all the way up left arm to armpit over course of seven days
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: swelling in throat and mouth and lips  and then in left hand all the way up left arm to armpit over course of seven days
Age: 16.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Chills, Erythema, Fatigue, Headache, Pain
Clinical narrative: arm pain, redness and swelling 2-3hrs later then severe headache, chills, fatigue + body aches - started 4-6 hrs later + lasted 24 hrs
Age: 16.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Pain in extremity, Peripheral swelling, SARS-CoV-2 test negative
Clinical narrative: arm pain, redness and swelling 2-3hrs later then severe headache, chills, fatigue + body aches - started 4-6 hrs later + lasted 24 hrs
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; improperly stored VAQTA might had been administered; Information has been received from a registered nurse referring to an unknown number of patients of an unknown age and gender.  The patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unspecified dates in April 2016, (reported as since 16-APR-2016), the patients might have been vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # M003011, expiration date: 15-NOV-2017; dose and route of administration were not provided).  The vaccine was exposed to temperature of 6 degrees Fahrenheit for 7 hours. No previous temperature excursion was reported. No adverse effects were reported. There was no product quality complaint.  On 16- MAY- 2016, a call was placed to the registered nurse. The call was received by another nurse. No additional information including patient identifiers, lot number and expiration date and date of vaccination were available at time of call. This is one of several reports received from the same reporter.  Additional information has been requested. Narrative was updated.; Sender's Comments:  US-009507513-1604USA013742: US-009507513-1604USA014684: US-009507513-1604USA014683:, MERCK1604USA014682:Mfr number
Age: 0.33
Sex: M
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: the patient has not had any symptoms/ no additional AE; PEDVAXHIB and ROTATEQ were administered to 1 patient after the excursion; This spontaneous report was received from an office manager (in charge of vaccine storage) referred to a 4-month-old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  The haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) had temperature excursion on 11-SEP-2023. The temperature was 47.5 F with time frame: 1 Hour 45 Minutes 0 Seconds. There was no previous temperature excursion. On an unknown date in September 2023, after the excursion, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 1 dose, lot #X003664, expiration date: 10-NOV-2025, administered as prophylaxis (strength, and route of administration were not provided); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, lot #1965641, expiration date: 19-SEP-2024, administered as prophylaxis (strength, and route of administration were not provided) (Product storage error). The patient has not had any symptoms. The reporter stated we did not have permission to contact the patient's physician but did provide permission to follow up with her (the reporter). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/; HCP reported a 2-month 2-day old patient received GARDASIL 9. The operator of the device was a nurse. No additional AE/no PQC.; Information has been received from a licensed practical nurse, referring to a 2 month- old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 25-SEP-2023, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, lot #W026152, expiration date: 29-JAN-2025 (also reported on 09-JAN-2025), administered for prophylaxis (strength, and route of administration were not provided) (Inappropriate age at vaccine administration).  the reporter stated that the 2-month 2-day old patient received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the operator of the vaccine was a nurse. No additional adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella virus test negative
Clinical narrative: serologically tested negative for varicella immunology; This spontaneous report was received from a health care professional referring to an adult patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with two dose series of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 mL, administered intramuscularly for varicella immunization (strength, lot #, and expiry date were not provided).  On an unknown date, the patient experienced serologically tested negative for varicella immunology (antibody test negative). The outcome of the event was not known.  The causal relationship between the event and varicella virus vaccine live (oka/merck) (VARIVAX) was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE details; HCP called to report a TE. 3 Administered doses. Dose was administered on 9/9/2023, excursion occurred on 9/7/2023.; This spontaneous report was received from a healthcare professional (HCP) and referred to a patient of unknown age or gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  The excursion of varicella virus vaccine live (oka/merck) (VARIVAX) injection occurred on 07-SEP-2023, and it was vaccinated to the patient on 09-SEP-2023 (lot #W039293, expiration date: 11-DEC-2024; strength, dose and route were not reported) for prophylaxis (Product storage error).   The excursion temperature was 0.2 degrees Celsius (C) with time frame from minus 14 C up to minus 10 C for 30 minutes, and from minus 10 C up to 8 C for 30 minutes. There was no previous temperature excursion. No further adverse event (AE) details were reported (No adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2309USA009213:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Product had undergone TE and it was administered after the TE; 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, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #w039294, expiration date: 11-DEC-2024, administered for prophylaxis (anatomical location, strength, and route of administration were not provided) and before administration the product undergone temperature excursion (TE) (product storage error). No additional adverse events (AE).