chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no patients reported any adverse issues or side effects from the administrations; then were subsequently inadvertently administered on 05/28/2024 prior to realizing the products had undergone a TE.; This spontaneous report was received from a Nurse and refers to a 5-year-old male patient.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not reported.   On 26-MAY-2024, varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X023718, expiration date: 26-SEP-2025, and Lot # X026790, expiration date: 14-NOV-2025 (Both captured in MARRS case #2405USA009119), and Lot # X025342, expiration date: 12-MAY-2025 (captured in MARRS case # 2406USA005529) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, Lot #: Y004543 expiration date: 19-AUG-2025 and Lot: Y002100 expiration date: 09-JUL-2025  (captured in MARRS case #2406USA005531 and 2406USA005535) underwent a temperature excursion (TE) at 0.1 C for a time frame of 4 hours and 30 minutes and 0 seconds.   On 28-MAY-2024, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin))(PROQUAD) injection, lot #Y004543, expiration date: 19-AUG-2025, (strength, exact dose and route of administration were not provided) administered for prophylaxis in combination with sterile diluent (exact dose, lot #, expiration date and route of administration were not provided). The patient was vaccinated prior to realizing the product had undergone a TE (Product storage error). There was not previous TE reported. Operator of device was reported as health professional. The reporter state that no patient reported any adverse issues or side effects from the administration. No other information was able to be obtain during the call. No additional adverse event and no product quality complaint reported. No other information provided.  This is one of several reports that were received from the same reporter.; Sender's Comments:  US-009507513-2406USA005531:Original Case : 2405USA009119 US-009507513-2406USA005529:Original Case : 2405USA009119 US-009507513-2405USA009119:Original Case : 2405USA009119 US-009507513-2406USA005535:Original Case : 2405USA009119
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE. No PQC.; was administered during a temperature excursion; This spontaneous report was received from a Medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and historical drugs were not reported. The patient's concomitant therapies included sterile diluent (MERCK STERILE DILUENT).     On 17-JUN-2024, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # X026319, expiration date: 07-NOV-2025 (strength, dose number, route, and anatomical location were not provided) for prophylaxis.  It was reported that the vaccine was administered during a temperature excursión (product storage error). The temperature was -6.7°C and the time frame was 0 Hours 55 Minutes 0 Seconds. There was no previous temperature excursión.  No additional adverse event reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing); "Known Allergies: Onion" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: Jun1991; THYRONINE, start date: 05Jul2023; PROGESTERONE, start date: May2019. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid treatment received from 10Jun2024 to 14Jun2024).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid treatment received from 05Jun2024 to 10Jun2024).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 48.0
Sex: F
Vaccine: PNC20
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: ADVERSE EVENT: Hives on both arms and both hands were swollen. Her feet were starting to swell.   Treatment at ER.  Discharged medications: Famotidine 40mg, Prednisone 20mg, and Claritin 10mg  (loratadine)
Age: 69.0
Sex: M
Vaccine: RSV, TDAP, VARZOS
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: fever, nausea, and vomiting
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chemotherapy, Computerised tomogram neck, Computerised tomogram thorax, Desmoid tumour
Clinical narrative: Received four Pfizer Covid-19 vaccines in left deltoid.  December 2020 - September of 2022.  In October of 2022, started having left shoulder pain with exertion.  Eventually had MRI in March of 2023 revealing 10cm subscapular desmoid tumor around brachial plexus.  Multiple procedures and oral chemo ongoing, but tumor now 14cm as of May 2024.  Tumor causing loss of function, muscle atrophy, chronic pain.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Injection site pain, Laboratory test, Magnetic resonance imaging abnormal
Clinical narrative: Received four Pfizer Covid-19 vaccines in left deltoid.  December 2020 - September of 2022.  In October of 2022, started having left shoulder pain with exertion.  Eventually had MRI in March of 2023 revealing 10cm subscapular desmoid tumor around brachial plexus.  Multiple procedures and oral chemo ongoing, but tumor now 14cm as of May 2024.  Tumor causing loss of function, muscle atrophy, chronic pain.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Medical procedure, Muscle atrophy, Musculoskeletal disorder, Pain
Clinical narrative: Received four Pfizer Covid-19 vaccines in left deltoid.  December 2020 - September of 2022.  In October of 2022, started having left shoulder pain with exertion.  Eventually had MRI in March of 2023 revealing 10cm subscapular desmoid tumor around brachial plexus.  Multiple procedures and oral chemo ongoing, but tumor now 14cm as of May 2024.  Tumor causing loss of function, muscle atrophy, chronic pain.
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient did not received 0.5 ml of vaccine instead of 1 cc of Engerix vaccine
Sex: U
Vaccine: COVID19, FLUC4
Symptoms: Lymphadenopathy
Clinical narrative: My partner has covid, and I almost definitely have it too. My lymph nodes are swollen, but no other symptoms as of yet. My partner did not get a booster and does have flu-like symptoms.
Age: 53.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: swelling and redness at the site
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylacic reaction 4 hours
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bone contusion, Complication associated with device, Condition aggravated, Contusion, Fall
Clinical narrative: I began to notice that I was having an inability to move my arms when I woke up and there was a nerve tingling sensation unlike that which you experience when your arm Falls asleep. It happens even when I'm laying flat on my back. That is the only way I can sleep now. In October 2021 I noticed it getting worse. There were days I could not use my arms to get dressed or hold anything for 30 minutes or more. This still continues and I have intermittent paralysis to the point where I cannot even answer the phone by swiping when I first get up in the morning. I've never had anything like this before in my life. It happens sometimes when I'm walking around. If I carry anything, it makes it significantly worse. I have had to quit my job due to my inability to carry my work of supplies around and due to pain and excessive bleeding lasting up to 5 weeks, from the Essure  implants. I have fallen quite a bit because of the paralysis. It has affected my right leg at times. But not with any noticeable symptoms. So when I have gotten up to walk, my leg feels normal but then it's like it's not there. I cracked or bruised my tailbone, elbow and broke my right toe over this. I am not sure the leg thing is part of it but they are all related to neurological systems so it could be a progression.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Foot fracture, Fractured coccyx, Haemorrhage, Impaired work ability, Loss of personal independence in daily activities
Clinical narrative: I began to notice that I was having an inability to move my arms when I woke up and there was a nerve tingling sensation unlike that which you experience when your arm Falls asleep. It happens even when I'm laying flat on my back. That is the only way I can sleep now. In October 2021 I noticed it getting worse. There were days I could not use my arms to get dressed or hold anything for 30 minutes or more. This still continues and I have intermittent paralysis to the point where I cannot even answer the phone by swiping when I first get up in the morning. I've never had anything like this before in my life. It happens sometimes when I'm walking around. If I carry anything, it makes it significantly worse. I have had to quit my job due to my inability to carry my work of supplies around and due to pain and excessive bleeding lasting up to 5 weeks, from the Essure  implants. I have fallen quite a bit because of the paralysis. It has affected my right leg at times. But not with any noticeable symptoms. So when I have gotten up to walk, my leg feels normal but then it's like it's not there. I cracked or bruised my tailbone, elbow and broke my right toe over this. I am not sure the leg thing is part of it but they are all related to neurological systems so it could be a progression.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Medical device pain, Mobility decreased, Monoplegia, Paraesthesia, Paralysis
Clinical narrative: I began to notice that I was having an inability to move my arms when I woke up and there was a nerve tingling sensation unlike that which you experience when your arm Falls asleep. It happens even when I'm laying flat on my back. That is the only way I can sleep now. In October 2021 I noticed it getting worse. There were days I could not use my arms to get dressed or hold anything for 30 minutes or more. This still continues and I have intermittent paralysis to the point where I cannot even answer the phone by swiping when I first get up in the morning. I've never had anything like this before in my life. It happens sometimes when I'm walking around. If I carry anything, it makes it significantly worse. I have had to quit my job due to my inability to carry my work of supplies around and due to pain and excessive bleeding lasting up to 5 weeks, from the Essure  implants. I have fallen quite a bit because of the paralysis. It has affected my right leg at times. But not with any noticeable symptoms. So when I have gotten up to walk, my leg feels normal but then it's like it's not there. I cracked or bruised my tailbone, elbow and broke my right toe over this. I am not sure the leg thing is part of it but they are all related to neurological systems so it could be a progression.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder, Upper limb fracture, Weight bearing difficulty
Clinical narrative: I began to notice that I was having an inability to move my arms when I woke up and there was a nerve tingling sensation unlike that which you experience when your arm Falls asleep. It happens even when I'm laying flat on my back. That is the only way I can sleep now. In October 2021 I noticed it getting worse. There were days I could not use my arms to get dressed or hold anything for 30 minutes or more. This still continues and I have intermittent paralysis to the point where I cannot even answer the phone by swiping when I first get up in the morning. I've never had anything like this before in my life. It happens sometimes when I'm walking around. If I carry anything, it makes it significantly worse. I have had to quit my job due to my inability to carry my work of supplies around and due to pain and excessive bleeding lasting up to 5 weeks, from the Essure  implants. I have fallen quite a bit because of the paralysis. It has affected my right leg at times. But not with any noticeable symptoms. So when I have gotten up to walk, my leg feels normal but then it's like it's not there. I cracked or bruised my tailbone, elbow and broke my right toe over this. I am not sure the leg thing is part of it but they are all related to neurological systems so it could be a progression.
Age: 35.0
Sex: F
Vaccine: FLUC4, TD
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: Patient received Flu vaccine and Td vaccine on 3/27/24 on the left arm. After Td vaccine administration (which patient felt was too close to the left shoulder cap), patient felt shooting pain down from arm to fingers. Patient experienced continuous pain that resulted in limited use of her left arm. She was eventually seen by orthopedic and was diagnosed with SIRVA (shoulder injury related to vaccine administration) on 5/13/24 requiring formal physical therapy.
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: patient reports having inflammation and redness on the arm of the vaccine injection site that started the day after the shot. Patient reports still having some redness and inflammation since the shot
Age: 1.17
Sex: F
Vaccine: HEPA, HEPA, MMR, MMR, PNC20, PNC20, VARCEL, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Per mother patient had fevers on 6/17/24 in the PM. Slight rash on 6/18/24 morning and it spread thru out the day to a full body rash.                                                                                                                             Provider prescribed                diphenhydrAMINE 12.5 mg/5 mL oral elixir (Benadryl)  3 ml po  q  12 hours prn for itching and follow up appoinment was made for 6/21/24 at 1:45pm
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Diarrhea, abdominal pain
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Cardiac tamponade, Chest pain, Computerised tomogram thorax abnormal, Echocardiogram abnormal
Clinical narrative: MD at 10/4/2022 11:10 AM  I have reviewed the key components of the history and physical exam as performed by the examining resident.  We discussed the differential and assessment as listed and I am in agreement with the treatment and follow up plan as outlined in the progress note. I will review the final documentation prior to signing the note. 10/4/2022 11:10 AM  Subjective      CONSENT   - Called and spoke wth patient. The patient agreed to conduct the visit via their personal audio  device. - I have verified the patient's name and DOB - I have verified the patient's location.    Pt. is a 48 y.o. female seen today via video visit for: hospital follow up   Went to hospital 9/27 for CP that started late August   CT chest found pericardial effusion   Echo with tamponade physiology and pt transferred to main campus   Admitted to ICU, had pericardiocentesis   500 cc liters removed   Discharged last Friday   Discharged on 3 months of colchicine, ibuprofen, pantoprazole   Breathing better today but chest is sore   Has follow up scheduled with cardiology in 1 month - to schedule repeat echo at that time   Note, pt had COVID in June, preceding the symptoms that brought her to the hospital   Review of Systems  See HPI. All other systems reviewed and are negative.      Objective          'Hands on' exam was not performed since this encounter was done via a video call. Any pertinent visual findings are noted as follows.    Pt sounds well in NAD     Assessment / Plan     Pt doing well s/p short ICU stay for pericardial effusion with tamponade and pericardiocentesis that tapped 500 cc.   Has appropriate follow up scheduled with cards   Continue colchicine, motrin, pantoprazole as prescribed   ETC precautions   Get health maintenance labs and return for PE   1. Pericardial effusion (Primary) 2. Screening for hyperlipidemia -     Lipid Panel; Future; Expected date: 10/10/2022 3. Screening for diabetes mellitus (DM) -     Comprehensive Metabolic Panel (CMP); Future; Expected date: 10/10/2022 4. Encounter for HCV screening test for low risk patient -     Hepatitis C Virus (HCV) Antibody with Reflex to Quan RT PCR; Future; Expected date: 10/10/2022     Follow-up  Return if symptoms worsen or fail to improve, for Annual physical.   Subjective Objective Assessment / Plan
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Intensive care, Pericardial drainage, Pericardial effusion
Clinical narrative: MD at 10/4/2022 11:10 AM  I have reviewed the key components of the history and physical exam as performed by the examining resident.  We discussed the differential and assessment as listed and I am in agreement with the treatment and follow up plan as outlined in the progress note. I will review the final documentation prior to signing the note. 10/4/2022 11:10 AM  Subjective      CONSENT   - Called and spoke wth patient. The patient agreed to conduct the visit via their personal audio  device. - I have verified the patient's name and DOB - I have verified the patient's location.    Pt. is a 48 y.o. female seen today via video visit for: hospital follow up   Went to hospital 9/27 for CP that started late August   CT chest found pericardial effusion   Echo with tamponade physiology and pt transferred to main campus   Admitted to ICU, had pericardiocentesis   500 cc liters removed   Discharged last Friday   Discharged on 3 months of colchicine, ibuprofen, pantoprazole   Breathing better today but chest is sore   Has follow up scheduled with cardiology in 1 month - to schedule repeat echo at that time   Note, pt had COVID in June, preceding the symptoms that brought her to the hospital   Review of Systems  See HPI. All other systems reviewed and are negative.      Objective          'Hands on' exam was not performed since this encounter was done via a video call. Any pertinent visual findings are noted as follows.    Pt sounds well in NAD     Assessment / Plan     Pt doing well s/p short ICU stay for pericardial effusion with tamponade and pericardiocentesis that tapped 500 cc.   Has appropriate follow up scheduled with cards   Continue colchicine, motrin, pantoprazole as prescribed   ETC precautions   Get health maintenance labs and return for PE   1. Pericardial effusion (Primary) 2. Screening for hyperlipidemia -     Lipid Panel; Future; Expected date: 10/10/2022 3. Screening for diabetes mellitus (DM) -     Comprehensive Metabolic Panel (CMP); Future; Expected date: 10/10/2022 4. Encounter for HCV screening test for low risk patient -     Hepatitis C Virus (HCV) Antibody with Reflex to Quan RT PCR; Future; Expected date: 10/10/2022     Follow-up  Return if symptoms worsen or fail to improve, for Annual physical.   Subjective Objective Assessment / Plan
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sudden death
Clinical narrative: Online report of sudden death of 41-year-old EUA medical countermeasure recipient. Dose#1 Date 03/10/21 LOT#EN6200, DOSE#2 Date 03/29/21 LOT#ER8732 DOSE#3 Date 11/04/21 LOT# FF2593. Social media posts indicate no post inoculation adverse events nor any subsequent inoculations. Victim posted on social media the day of his death, 06/03/24. No information about hospitalization prior to sudden death available. Victim received medical care through the facility. It's likely his medical records are there.
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any adverse events; A HCP called to report that his data logger in his vaccine refrigerator quit working on 03/08/2024 but was not realized and reset until 05/31/2024, which resulted in unknown temperature condition exposure to the vaccines.; This spontaneous report was received from registered nurse and refers to a 12-month-old of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  The reported stated that his data logger in his vaccine refrigerator quit working on 08-MAR-2024. On 14-MAY-2024, the patient was inadvertently vaccinated with an improperly stored dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5ml once, lot #X019624, expiration date reported as 07-NOV-2025 (strength, and route of administration were not provided) administered for prophylaxis. The reported was not realized and reset until 31-MAY-2024, which resulted in unknown temperature condition exposure to the vaccines (Product storage error). The patient did not experience any adverse events.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2406USA001829: US-009507513-2406USA001983: US-009507513-2406USA001816: US-009507513-2406USA001974: US-009507513-2406USA001859: US-009507513-2406USA001795:
Age: 0.75
Sex: U
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional AE/ no PQC.; HCP called to report that the patient was administered MMR II at 9 months of age instead of 12 months due to the patient traveling; This spontaneous report was received from a Medical Assistant (M.A) concerning a 9-month-old patient (instead of 12 months due to the patient traveling) of unknown gender. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.      On 06-MAR-2024, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 ml (dose, route, lot# and the expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). The diluent used to reconstitute the MMR II, sterile diluent (MERCK STERILE DILUENT) lot# and expiration date was unknown.  Lot # is being requested and will be submitted if received.
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AE/No PQC.; HCP calling. Caller stated that they accidentally administered an adult dose of VAQTA to a 17 year old on 05/17/2024. The caller stated that they just realized the error upon reviewing the records. Caller was asking about revaccination data. Conferen; patient received first dose of VAQTA on 9/18/2017. This patient received an adult dose of VAQTA 5/17/2024; This spontaneous report was received from a medical assistant concerning a 17-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-SEP-2017, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical location and route of administration were not provided).  On 17-MAY-2024, the patient was accidentally vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (Accidental overdose, Inappropriate schedule of product administration) (strength, exact dose, lot #, expiry date, anatomical location and route of administration were not provided). No adverse events were reported.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no patients reported any adverse issues or side effects from the administrations; then were subsequently inadvertently administered on 05/28/2024 prior to realizing the products had undergone a TE.; This spontaneous report was received from a Nurse and refers to a 5-year-old male patient.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not reported.   On 26-MAY-2024, varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X023718, expiration date: 26-SEP-2025, and Lot # X026790, expiration date: 14-NOV-2025 (Both captured in MARRS case #2405USA009119), and Lot # X025342, expiration date: 12-MAY-2025 (captured in MARRS case # 2406USA005529) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, Lot #: Y004543 expiration date: 19-AUG-2025 (captured in MARRS case # 2406USA005530) and Lot: Y002100 expiration date: 09-JUL-2025  (captured in MARRS case # 2406USA005535) underwent a temperature excursion (TE) at 0.1 C for a time frame of 4 hours and 30 minutes and 0 seconds.   On 28-MAY-2024, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) injection, lot #Y002100, expiration date: 09-JUL-2025 (strength, exact dose and route of administration were not provided) administered for prophylaxis in combination with sterile diluent (exact dose, lot #, expiration date and route of administration were not provided). The patient was vaccinated prior to realizing the product had undergone a TE (Product storage error). There was not previous TE reported. Operator of device was reported as health professional. The reporter state that no patient reported any adverse issues or side effects from the administration. No other information was able to be obtain during the call. No additional adverse event and no product quality complaint reported. No other information provided.  This is one of several reports that were received from the same reporter.; Sender's Comments:  US-009507513-2405USA009119:Original Case : 2405USA009119 US-009507513-2406USA005529:Original Case : 2405USA009119 US-009507513-2406USA005530:Original Case : 2405USA009119 US-009507513-2406USA005535:Original Case : 2405USA009119
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no patients reported any adverse issues or side effects from the administrations; then were subsequently inadvertently administered on 05/28/2024 prior to realizing the products had undergone a TE.; This spontaneous report was received from a Nurse and refers to a 5-year-old male patient.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not reported.   On 26-MAY-2024, varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X023718, expiration date: 26-SEP-2025, and Lot # X026790, expiration date: 14-NOV-2025 (Both captured in MARRS case #2405USA009119), and Lot # X025342, expiration date: 12-MAY-2025 (captured in MARRS case # 2406USA005529) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, Lot #: Y004543 expiration date: 19-AUG-2025 (captured in MARRS case # 2406USA005530) and Lot: Y002100 expiration date: 09-JUL-2025  (captured in MARRS case # 2406USA005531) underwent a temperature excursion (TE) at 0.1 C for a time frame of 4 hours and 30 minutes and 0 seconds.  On 28-MAY-2024, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) injection, lot #Y002100, expiration date: 09-JUL-2025 (strength, exact dose and route of administration were not provided) administered for prophylaxis in combination with sterile diluent (exact dose, lot #, expiration date and route of administration were not provided). The patient was vaccinated prior to realizing the product had undergone a TE (Product storage error). There was not previous TE reported. Operator of device was reported as health professional. The reporter state that no patient reported any adverse issues or side effects from the administration. No other information was able to be obtain during the call. No additional adverse event and no product quality complaint reported.  No other information provided.  This is one of several reports that were received from the same reporter.; Sender's Comments:  US-009507513-2406USA005530:Original Case : 2405USA009119 US-009507513-2406USA005529:Original Case : 2405USA009119 US-009507513-2406USA005531:Original Case : 2405USA009119 US-009507513-2405USA009119:Original Case : 2405USA009119
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This non-serious case was reported by a consumer and described the occurrence of expired vaccine used 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 expired vaccine used (Verbatim: Expired vaccine used). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 17-MAY-2024 Patient given Shingrix expired for more than 1 month.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administered a dose of Kinrix to a 5 year old male patient that had not had any prior vaccines; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number 25ZH4, expiry date 28-OCT-2024) for prophylaxis.   On 09-MAY-2024, the patient received the 1st dose of Kinrix. On 09-MAY-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: administered a dose of Kinrix to a 5 year old male patient that had not had any prior vaccines). The outcome of the inappropriate schedule of vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 18-JUN-2024 The physician reported a nurse administered a dose of Kinrix to a 5 year old male patient that had not had any prior vaccines, which led to inappropriate schedule of vaccine administration. Consented to follow up.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Rash, Rash erythematous
Clinical narrative: Red bumps on arm.; This non-serious case was reported by a consumer via sales rep and described the occurrence of local swelling in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Menveo and Bexsero. On an unknown date, an unknown time after receiving Menveo and Bexsero, the patient experienced local swelling (Verbatim: Red bumps on arm.). The outcome of the local swelling was unknown.   It was unknown if the reporter considered the local swelling to be related to Menveo, Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the local swelling to be related to Menveo, Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 18-JUN-2024 The consumer stated her sons girlfriend developed red bumps on her arm after receiving Bexsero and Menveo. There was no further information given by the GSP Rep.  Did not consent to follow-up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient developed cellulitis after shingles vaccine administration. She required treatment at urgent care and was given antibiotics to treat cellulitis.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Next day my ear starte with noise
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Trigger finger
Clinical narrative: Developed severe trigger finger - R ring finger about 2 days after first covid vac 03/01/2021 - Moderna lot 011A21A.   Developed severe trigger finger Right index finger about 2 days after second vac - 03/29/2021 - Moderna lot 020B21A . Symptoms slowly resolved over next 2 years.  Developed swelling and pain with flexion right long finger about 2 days after covid Vac -04/12/2024 - Moderna  - lot 3031664      -   all vaccinations  were given in Left arm
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Amnesia, Confusional state
Clinical narrative: The following morning after receiving vaccine the patient experienced a 3 hour window with complete memory loss/confusion.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain
Clinical narrative: pt had 'significant shoulder and back pain on side the vaccine was given.' pain was unrelieved with tylenol 1000mg, massage and heat. the pain had not improved since 6/21/24. patient denied any signs of rash, fever, fatigue, malaise, swelling.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, COVID-19, Gait inability, Vertigo
Clinical narrative: Had neurologic symptoms for 3 months; couldn't walk or stand; had vertigo and brain fog
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Nausea, Pain
Clinical narrative: Very tired,  nauseous, diarrhea, chills, fever, body hurts, labored thoughts.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Thinking abnormal
Clinical narrative: Very tired,  nauseous, diarrhea, chills, fever, body hurts, labored thoughts.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Neck pain, Pain
Clinical narrative: Gradual onset to current persistence of chest pain/pressure radiating to arm and neck with shortness of breath. No history of medical condition. Life has been considered healthy for decades: strict diet and exercise, normal BMI and regular doctor visits with no abnormality identified.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Fatigue, Influenza like illness
Clinical narrative: Fatigue, flu-like aches, weakness
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Cyanosis, Hypersomnia, Hypotonia, Hypotonic-hyporesponsive episode, Pallor
Clinical narrative: By the rime the mother and the baby got home from the clinic, the baby was asleep and would not wake up unless woken up to feed. At around 3-4 o'clock in the afternoon, mom was reading a book and the baby was laying on her chest. She noticed that the baby was very pale, almost bluish in color. The baby was also very flaccid and still sleeping. Mom called arounf 4:39 p.m.and was advised to wake the baby up and feed her,stimulate her and swaddle her. I had mom count her heart rate and she got 36 beats in 15 seconds. The baby was breathing fine and was not apneic nor tachypneic. She did wake up and finished her bottle of expressed breastmilk, which improved her color. Continued...... After feeding, the baby's muscle tone was still low. Concerns for HHE (Hypotonic-Hyporesponsive Episode) prompted me to advise the parents to take her to the Emergency Room. Consultaion with the ER physician and the Hospitalists were done and the consensus was to admit her overnight for observation.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Eye swelling, Hypoaesthesia, Paraesthesia, Pyrexia
Clinical narrative: patient reported rash, hives, swollen eyes, skin warm to the touch, tingling, burning sensation, and numbness. Patient reported fever, and swelling as well.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm, Swelling, Urticaria
Clinical narrative: patient reported rash, hives, swollen eyes, skin warm to the touch, tingling, burning sensation, and numbness. Patient reported fever, and swelling as well.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site warmth, Product administered at inappropriate site
Clinical narrative: Vaccine not given in deltoid but given 4 inches below it.  It was given IM.  Sight is red, hot and painful and redeems area is growing.  It is currently 4x4 inches.  Patient having difficulty moving arm.  It has been 2 days.   May need to take her to the hospital.
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient came to pharmacy on 6/23/24 to report redness, swelling, itching in left arm at the injection site. Patient does not have any other symptoms. no fever, no itchiness or swelling in throat. no rash
Age: 64.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Hypoaesthesia, Pyrexia
Clinical narrative: Patient experience numbness and fever ater receiving  Shingrix and Arexvy shots a couple hours after . She was taken by ambulence to hospital and was admitted for 5 days.
Age: 69.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Myalgia
Clinical narrative: muscle pains in all my joints that i had injuries.   This is the first time I am reporting this when getting a vaccine or flu, but this typical of my getting a shot.   It lasted a bit of 24 hours.
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: injection site redness and swelling, swollen lymph node under sore arm
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash pruritic
Clinical narrative: Vaccine received Friday June 14, 2024. Mild rash appeared on face on day 5-6 after receiving vaccine. Today, 6/23/24, rash spreads all throughout body. Rash appears to be small itchy bumps all over the body but predominantly on face and trunk. No fever. No new foods ingested (rule out due to food allergies), no new skin products used.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: When giving dose 2, some of the vaccine leaked out of the side of the syringe and down his arm. It's unclear exactly how much came out of the syringe but he probably received approx. 50-75% of the dose. I offered to re-dose, but he did not want another shot and was fine with what he received. No adverse reaction occurred from this; he just most likely did not receive his full dose.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Burning sensation, Papilloma excision, Precancerous skin lesion, Rash
Clinical narrative: I was vaccinated with the Janssen on February 11, 2022. I had a dermatologist appointment on March 29. The PA saw four precancerous spots on my face. She froze them then did a skin cancer check. She removed a suspicious looking wart. The pathologist report came back and the PA wanted to remove the wart. I made an appointment for the morning of April 11. On April 8th I got a burning sensation in my left forearm and the sensation was all the way to the tips of my fingers. I started rubbing and scratching the area. A rash developed. I showed the area to the PA. She asked if I was diabetic and I said no. She prescribed Triamcinolone Acetonide Ointment and the rash cleared leaving a scaly spot. On June 12, 2024 I had a skin cancer check. The PA did a biopsy of the area and the pathology report came back as a squamous-cell carcinoma.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation, Squamous cell carcinoma of skin
Clinical narrative: I was vaccinated with the Janssen on February 11, 2022. I had a dermatologist appointment on March 29. The PA saw four precancerous spots on my face. She froze them then did a skin cancer check. She removed a suspicious looking wart. The pathologist report came back and the PA wanted to remove the wart. I made an appointment for the morning of April 11. On April 8th I got a burning sensation in my left forearm and the sensation was all the way to the tips of my fingers. I started rubbing and scratching the area. A rash developed. I showed the area to the PA. She asked if I was diabetic and I said no. She prescribed Triamcinolone Acetonide Ointment and the rash cleared leaving a scaly spot. On June 12, 2024 I had a skin cancer check. The PA did a biopsy of the area and the pathology report came back as a squamous-cell carcinoma.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: 1 day after vaccine given patient developed a local reaction with redness and swelling of the left thigh. The area of redness and induration continued to grow. The area was painful.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Pyrexia
Clinical narrative: Fever of 100.2, normal temp is 97.7
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient called to inform us that her left arm  has swollen ,turn red  and a little warm  after 3 days of getting Shingrix.  She said, it does not itch or bothering her at the moment.  I advised her to take ibuprofen or Tylenol to help with the pain and inflammation.  The patient was also advised to use cold compress on the area to decrease swelling.  We will follow up with her in couple of days on her status.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dermal cyst, Ear pain, Erythema, Induration
Clinical narrative: Left side inner ear pain, swelling, ear redness that lasted more than 1-week.  Dr. Prescribed ear infection drop.  It helped ease the pain.   Am existing  skin cyst on left side of my back developed pain, swelling, hardening.  Seeing Dr. on 6/26.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: Left side inner ear pain, swelling, ear redness that lasted more than 1-week.  Dr. Prescribed ear infection drop.  It helped ease the pain.   Am existing  skin cyst on left side of my back developed pain, swelling, hardening.  Seeing Dr. on 6/26.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Myopericarditis, Pericardial effusion, Pericardial rub, SARS-CoV-2 test
Clinical narrative: myo/pericarditis; pericardial effusion; pericardial rub; This is a spontaneous report received from a Consumer or other non HCP.  A 23-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 at 13:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 23 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: NEXPLANON taken for contraception. Vaccination history included: j&j (DOSE 1, SINGLE, Batch/Lot No: 201A211A, Anatomical location: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 07Apr2021, when the patient was 21-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2 (BOOSTER), SINGLE, Batch/Lot No: FE3594, Anatomical location: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: 15Dec2021, when the patient was 22-year-old, for COVID-19 immunization; influenza (DOSE NUMBER UNKNOWN, SINGLE, influenza quadrivalent Pfizer, vaccine location: arm), administration date: 06Oct2022, when the patient was 23-year-old, for Influenza immunisation. The following information was reported: MYOPERICARDITIS (hospitalization, medically significant) with onset 11Nov2022 at 17:30, outcome "recovered with sequelae", described as "myo/pericarditis"; PERICARDIAL EFFUSION (hospitalization, medically significant) with onset 11Nov2022 at 17:30, outcome "recovered with sequelae"; PERICARDIAL RUB (hospitalization) with onset 11Nov2022 at 17:30, outcome "recovered with sequelae". The patient was hospitalized for myopericarditis, pericardial effusion, pericardial rub (start date: 11Nov2022, discharge date: Nov2022, hospitalization duration: 1 day(s)). The events "myo/pericarditis", "pericardial effusion" and "pericardial rub" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Electrocardiogram: (11Nov2022) myo/pericarditis, notes: pericardial effusion, abnormal ECG and pericardial rub; SARS-CoV-2 test: (11Nov2022) Negative, notes: Nasal Swab; Troponin: (11Nov2022) elevated. Therapeutic measures were taken as a result of myopericarditis, pericardial effusion, pericardial rub. Clinical course: Patient had no signs of infection or illness other than chest pain and tachycardia. Treatment included: Colchicine, ibuprofen, and 1 year of Arcalyst. Patient had no known allergies.