chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Insomnia, Loss of personal independence in daily activities
Clinical narrative: Two days after receiving 1 dose of Pfizer vaccine, I was awakened out of my sleep at 5am with rapid heart rate and profuse sweating, tremors/shaking all over, chest pains.  I am now 9 months out from having the one dose and have continued to battle ongoing symptoms since the vaccine.  Most concerning are the continued chest pains (left side heart) that are deep, often accompanied with pain in upper left arm.  In addition to pain, left arm will often go numb/weak like it sometimes does not want to move anymore. In my sleep, both arms often go to sleep which will wake me up with my fingers being completely numb, and it will take several minutes of moving the fingers to regain sensation.   Along with the severe chest pains, I often have swelling that comes and goes in my hands and in my feet/calves.    Abdominal distention has also been an issue, even without eating a meal my stomach is often bloated throughout the day (almost like a pregnant stomach, to help visualize).  I have also had frequent changes in bowel movements between diarrhea and constipation, but mostly diarrhea.    By far the worst experience for me is the chest pains and continued upper body tremors with any movement.  It has been so persistent, and I was finally able to obtain an order for a Cardiac MRI in December (8 months after the vaccine), to which there is finding of myocarditis.  I have never had any heart issues prior to receiving the vaccine, and this has completely altered my ability to function in my day to day life.  It is very difficult to exercise.  It is difficult to complete day to day tasks around the home such as cooking and cleaning, with some days being I am not able to function well enough.  Other symptoms post-vaccine that are on-going: - Left side facial pain/numbness that comes and goes.  Flares frequently with the chest pains. - Eye pains behind both eyes (almost like a crawling sensation).  At times I have floaters - Fatigue, all the time, even when I am able to get rest.  Very low energy  - Insomnia most nights, unable to lay down due to the chest pains - Headaches (they were severe for a while, such as migraines, but lately have been more sensations of pressure) - I have had "stroke like" symptoms in my sleep, where my head hurts very bad on the upper left and I wake up and unable to open my left eye for several minutes, like a paralysis feeling - Shortness of breath; Pulmonary Function tests show almost borderline COPD - Abdominal "shooting pains" that feel like it is attacking my diaphgram - Sharp pains around diaphragm area under heart - POTS like symptoms, Inappropriate Sinus Tachycardia - Lost entire middle toe nail in December with no warning (no fungus, no damage, no discoloration), right foot - occasional Pulsar Tinnitus in left ear to wear I hear my  heartbeat and breathing extremely loudly
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lung opacity, Mitral valve incompetence, Muscular weakness, Myocarditis, Neurological symptom
Clinical narrative: Two days after receiving 1 dose of Pfizer vaccine, I was awakened out of my sleep at 5am with rapid heart rate and profuse sweating, tremors/shaking all over, chest pains.  I am now 9 months out from having the one dose and have continued to battle ongoing symptoms since the vaccine.  Most concerning are the continued chest pains (left side heart) that are deep, often accompanied with pain in upper left arm.  In addition to pain, left arm will often go numb/weak like it sometimes does not want to move anymore. In my sleep, both arms often go to sleep which will wake me up with my fingers being completely numb, and it will take several minutes of moving the fingers to regain sensation.   Along with the severe chest pains, I often have swelling that comes and goes in my hands and in my feet/calves.    Abdominal distention has also been an issue, even without eating a meal my stomach is often bloated throughout the day (almost like a pregnant stomach, to help visualize).  I have also had frequent changes in bowel movements between diarrhea and constipation, but mostly diarrhea.    By far the worst experience for me is the chest pains and continued upper body tremors with any movement.  It has been so persistent, and I was finally able to obtain an order for a Cardiac MRI in December (8 months after the vaccine), to which there is finding of myocarditis.  I have never had any heart issues prior to receiving the vaccine, and this has completely altered my ability to function in my day to day life.  It is very difficult to exercise.  It is difficult to complete day to day tasks around the home such as cooking and cleaning, with some days being I am not able to function well enough.  Other symptoms post-vaccine that are on-going: - Left side facial pain/numbness that comes and goes.  Flares frequently with the chest pains. - Eye pains behind both eyes (almost like a crawling sensation).  At times I have floaters - Fatigue, all the time, even when I am able to get rest.  Very low energy  - Insomnia most nights, unable to lay down due to the chest pains - Headaches (they were severe for a while, such as migraines, but lately have been more sensations of pressure) - I have had "stroke like" symptoms in my sleep, where my head hurts very bad on the upper left and I wake up and unable to open my left eye for several minutes, like a paralysis feeling - Shortness of breath; Pulmonary Function tests show almost borderline COPD - Abdominal "shooting pains" that feel like it is attacking my diaphgram - Sharp pains around diaphragm area under heart - POTS like symptoms, Inappropriate Sinus Tachycardia - Lost entire middle toe nail in December with no warning (no fungus, no damage, no discoloration), right foot - occasional Pulsar Tinnitus in left ear to wear I hear my  heartbeat and breathing extremely loudly
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Onychomadesis, Ophthalmoplegia, Pain, Peripheral swelling, Postural orthostatic tachycardia syndrome
Clinical narrative: Two days after receiving 1 dose of Pfizer vaccine, I was awakened out of my sleep at 5am with rapid heart rate and profuse sweating, tremors/shaking all over, chest pains.  I am now 9 months out from having the one dose and have continued to battle ongoing symptoms since the vaccine.  Most concerning are the continued chest pains (left side heart) that are deep, often accompanied with pain in upper left arm.  In addition to pain, left arm will often go numb/weak like it sometimes does not want to move anymore. In my sleep, both arms often go to sleep which will wake me up with my fingers being completely numb, and it will take several minutes of moving the fingers to regain sensation.   Along with the severe chest pains, I often have swelling that comes and goes in my hands and in my feet/calves.    Abdominal distention has also been an issue, even without eating a meal my stomach is often bloated throughout the day (almost like a pregnant stomach, to help visualize).  I have also had frequent changes in bowel movements between diarrhea and constipation, but mostly diarrhea.    By far the worst experience for me is the chest pains and continued upper body tremors with any movement.  It has been so persistent, and I was finally able to obtain an order for a Cardiac MRI in December (8 months after the vaccine), to which there is finding of myocarditis.  I have never had any heart issues prior to receiving the vaccine, and this has completely altered my ability to function in my day to day life.  It is very difficult to exercise.  It is difficult to complete day to day tasks around the home such as cooking and cleaning, with some days being I am not able to function well enough.  Other symptoms post-vaccine that are on-going: - Left side facial pain/numbness that comes and goes.  Flares frequently with the chest pains. - Eye pains behind both eyes (almost like a crawling sensation).  At times I have floaters - Fatigue, all the time, even when I am able to get rest.  Very low energy  - Insomnia most nights, unable to lay down due to the chest pains - Headaches (they were severe for a while, such as migraines, but lately have been more sensations of pressure) - I have had "stroke like" symptoms in my sleep, where my head hurts very bad on the upper left and I wake up and unable to open my left eye for several minutes, like a paralysis feeling - Shortness of breath; Pulmonary Function tests show almost borderline COPD - Abdominal "shooting pains" that feel like it is attacking my diaphgram - Sharp pains around diaphragm area under heart - POTS like symptoms, Inappropriate Sinus Tachycardia - Lost entire middle toe nail in December with no warning (no fungus, no damage, no discoloration), right foot - occasional Pulsar Tinnitus in left ear to wear I hear my  heartbeat and breathing extremely loudly
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary function test abnormal, Sinus tachycardia, Sleep disorder, Supraventricular extrasystoles, Tinnitus
Clinical narrative: Two days after receiving 1 dose of Pfizer vaccine, I was awakened out of my sleep at 5am with rapid heart rate and profuse sweating, tremors/shaking all over, chest pains.  I am now 9 months out from having the one dose and have continued to battle ongoing symptoms since the vaccine.  Most concerning are the continued chest pains (left side heart) that are deep, often accompanied with pain in upper left arm.  In addition to pain, left arm will often go numb/weak like it sometimes does not want to move anymore. In my sleep, both arms often go to sleep which will wake me up with my fingers being completely numb, and it will take several minutes of moving the fingers to regain sensation.   Along with the severe chest pains, I often have swelling that comes and goes in my hands and in my feet/calves.    Abdominal distention has also been an issue, even without eating a meal my stomach is often bloated throughout the day (almost like a pregnant stomach, to help visualize).  I have also had frequent changes in bowel movements between diarrhea and constipation, but mostly diarrhea.    By far the worst experience for me is the chest pains and continued upper body tremors with any movement.  It has been so persistent, and I was finally able to obtain an order for a Cardiac MRI in December (8 months after the vaccine), to which there is finding of myocarditis.  I have never had any heart issues prior to receiving the vaccine, and this has completely altered my ability to function in my day to day life.  It is very difficult to exercise.  It is difficult to complete day to day tasks around the home such as cooking and cleaning, with some days being I am not able to function well enough.  Other symptoms post-vaccine that are on-going: - Left side facial pain/numbness that comes and goes.  Flares frequently with the chest pains. - Eye pains behind both eyes (almost like a crawling sensation).  At times I have floaters - Fatigue, all the time, even when I am able to get rest.  Very low energy  - Insomnia most nights, unable to lay down due to the chest pains - Headaches (they were severe for a while, such as migraines, but lately have been more sensations of pressure) - I have had "stroke like" symptoms in my sleep, where my head hurts very bad on the upper left and I wake up and unable to open my left eye for several minutes, like a paralysis feeling - Shortness of breath; Pulmonary Function tests show almost borderline COPD - Abdominal "shooting pains" that feel like it is attacking my diaphgram - Sharp pains around diaphragm area under heart - POTS like symptoms, Inappropriate Sinus Tachycardia - Lost entire middle toe nail in December with no warning (no fungus, no damage, no discoloration), right foot - occasional Pulsar Tinnitus in left ear to wear I hear my  heartbeat and breathing extremely loudly
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor, Tricuspid valve incompetence, Ventricular extrasystoles, Vitreous floaters, Walking distance test abnormal
Clinical narrative: Two days after receiving 1 dose of Pfizer vaccine, I was awakened out of my sleep at 5am with rapid heart rate and profuse sweating, tremors/shaking all over, chest pains.  I am now 9 months out from having the one dose and have continued to battle ongoing symptoms since the vaccine.  Most concerning are the continued chest pains (left side heart) that are deep, often accompanied with pain in upper left arm.  In addition to pain, left arm will often go numb/weak like it sometimes does not want to move anymore. In my sleep, both arms often go to sleep which will wake me up with my fingers being completely numb, and it will take several minutes of moving the fingers to regain sensation.   Along with the severe chest pains, I often have swelling that comes and goes in my hands and in my feet/calves.    Abdominal distention has also been an issue, even without eating a meal my stomach is often bloated throughout the day (almost like a pregnant stomach, to help visualize).  I have also had frequent changes in bowel movements between diarrhea and constipation, but mostly diarrhea.    By far the worst experience for me is the chest pains and continued upper body tremors with any movement.  It has been so persistent, and I was finally able to obtain an order for a Cardiac MRI in December (8 months after the vaccine), to which there is finding of myocarditis.  I have never had any heart issues prior to receiving the vaccine, and this has completely altered my ability to function in my day to day life.  It is very difficult to exercise.  It is difficult to complete day to day tasks around the home such as cooking and cleaning, with some days being I am not able to function well enough.  Other symptoms post-vaccine that are on-going: - Left side facial pain/numbness that comes and goes.  Flares frequently with the chest pains. - Eye pains behind both eyes (almost like a crawling sensation).  At times I have floaters - Fatigue, all the time, even when I am able to get rest.  Very low energy  - Insomnia most nights, unable to lay down due to the chest pains - Headaches (they were severe for a while, such as migraines, but lately have been more sensations of pressure) - I have had "stroke like" symptoms in my sleep, where my head hurts very bad on the upper left and I wake up and unable to open my left eye for several minutes, like a paralysis feeling - Shortness of breath; Pulmonary Function tests show almost borderline COPD - Abdominal "shooting pains" that feel like it is attacking my diaphgram - Sharp pains around diaphragm area under heart - POTS like symptoms, Inappropriate Sinus Tachycardia - Lost entire middle toe nail in December with no warning (no fungus, no damage, no discoloration), right foot - occasional Pulsar Tinnitus in left ear to wear I hear my  heartbeat and breathing extremely loudly
Age: 33.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event- vaccine was expired as of 9/7/2022 and was administered on 10/27/2022
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: OFF LABEL DOSING FREQUENCY; This spontaneous report received from a consumer concerned a male of race (other), unspecified age, and ethnic origin. The patient's height, and weight were not reported. The patient was a naturopathic doctor. The patient was previously vaccinated with covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, 01 total administered on 01-MAY-2021 for covid-19 prophylaxis.  It was unknown whether the patient experienced any adverse events following vaccination with covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient received first booster dose of covid-19 vaccine ad26. cov2. s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194 expiry: UNKNOWN) dose was not reported, 01 total administered on 05-NOV-2021 for covid-19 prophylaxis.  It was unknown whether the patient experienced any adverse events following vaccination with covid-19 vaccine ad26. cov2. s (Dose number in series 2). The patient additionally received second booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin not reported, batch number: 213D21A expiry: UNKNOWN) dose was not reported, 01 total administered on 13-MAY-2022 for covid-19 prophylaxis which was an off label dosing frequency (Off label use) (Dose number in series 3). The consumer reported as they believe that the JANSSEN COVID-19 VACCINE is excellent and the patient has been covid free. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was non-serious. This case, from the same reporter is linked to 20230138182.
Sex: U
Vaccine: DT, TDAP
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: patient received TD vaccine in error; the patient was supposed to receive ADACEL with no  reported adverse event; Initial information received on 17-Jan-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who received DIPHTHERIA AND TETANUS TOXOIDS vaccine in error; the patient was supposed to receive DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] with no  reported adverse event.   The patient's past medical history, medical treatment(s),concomitant medication,  vaccination(s) and family history were not provided.   On an unknown date the patient developed a non-serious  event of received td vaccine (strength, formulation, administration site, route, batch and expiry date was unknown for Immunization) in error; the patient was supposed to receive adacel with no  reported adverse event (wrong product administered) (latency: Same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and DIPHTHERIA AND TETANUS TOXOIDS.  Action taken with DIPHTHERIA AND TETANUS TOXOIDS (DIPHTHERIA AND TETANUS TOXOIDS) and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest discomfort, Chest pain, Injection site erythema, Pain, Pain in extremity
Clinical narrative: Fever of 101.7- normal 96.8, extreme body aches,  arm pain, redness at injection site all lasted 2 days, chest pain and pressure
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: Fever of 101.7- normal 96.8, extreme body aches,  arm pain, redness at injection site all lasted 2 days, chest pain and pressure
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Myocarditis
Clinical narrative: In January 2020, I retired and had a complete physical, head to toe. At 72 years old, I was 100% perfectly healthy. no chronic illnesses, no cancer, diabetes, NOTHING (except an enlarged prostrate). In 2020, I took the two Pfizer vaccinations, and then later had the Booster. Now (in August of 2022) at 74, after the 2 covid shots and a booster, I have been diagnosed with Myocarditis, which I NEVER had before.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Insomnia, Myalgia, Pyrexia
Clinical narrative: Fever, achy joints and muscles throughout body, difficulty sleeping due to those aches and pain...diarrhea
Age: 33.0
Sex: M
Vaccine: ANTH, FLU4
Symptoms: Hypersensitivity
Clinical narrative: 7 days after vaccination he developed sensitivity to the right flank extending to the anterior chest and never crossing midline at dermatome distribution T6 and 7.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Premature menopause
Clinical narrative: Early menopause, no history of this in my family.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: 3rd dose was administered/extra dos on April 12th 2020; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 79-year-old male patient who received Herpes zoster (Shingrix) (batch number t79d7, expiry date 1st October 2022) for prophylaxis.   Previously administered products included Shingrix (patient had got 2 doses of Shingrix in 2019).   On 12th April 2020, the patient received the 3rd dose of Shingrix. On 12th April 2020, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.       Additional Information: GSK receipt date: 13-JAN-2023 Reporter's comment: The pharmacist had reported on 13 January 2023 that they realized after verifying records that patient got two doses of Shingrix on 2019 and 1 extra dose on 12 April 2020. The patient had never reported adverse event (AE) after the administration of a third dose. The pharmacist wanted to verify about safety data in case of possible questions after letting the patient know. The vaccine administration facility was the same as primary reporter. The reporter had consented to follow-up. Additional supportive information: At the time of reporting, the patient had received the third dose of Shingrix vaccine, which had led to extra dose administered.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    This case was created for 10th out of 40 patients reported. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    No Concomitant medication was reported.  Pharmacy intern reporting that correctional facility administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients. No patient information or product information available. Consent provided for safety follow-up.  No treatment medication was reported   This case was linked to MODERNATX, INC.-MOD-2023-698650 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-698650:Master case
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasal congestion, Pain, Rhinorrhoea, Wrong product administered
Clinical narrative: Runny nose; Achy; A stuffed nose; Patient felt run down, Tired; Received a bivalent booster dose instead of a Moderna monovalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of RHINORRHOEA (Runny nose), PAIN (Achy), NASAL CONGESTION (A stuffed nose), FATIGUE (Patient felt run down, Tired) and WRONG PRODUCT ADMINISTERED (Received a bivalent booster dose instead of a Moderna monovalent vaccine) in a 29-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose), PAIN (Achy), NASAL CONGESTION (A stuffed nose), FATIGUE (Patient felt run down, Tired) and WRONG PRODUCT ADMINISTERED (Received a bivalent booster dose instead of a Moderna monovalent vaccine). At the time of the report, RHINORRHOEA (Runny nose), PAIN (Achy), NASAL CONGESTION (A stuffed nose), FATIGUE (Patient felt run down, Tired) and WRONG PRODUCT ADMINISTERED (Received a bivalent booster dose instead of a Moderna monovalent vaccine) was resolving.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient received a bivalent booster dose instead of Moderna monovalent vaccine. Patient had not received any other vaccines and no previous vaccine received within 4 weeks prior to COVID-19 Vaccine.  Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    This case was created for  29th out of 40 patients reported. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    This case was created for 10th out of 40 patients reported. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    This case was created for 35th out of 40 patients reported. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    This case was created for 10th out of 40 patients reported. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master case
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Vaccination site swelling
Clinical narrative: Vaccine injection site on leg had Swelling 4 inches x 4 inches,  redness 6 inches x 6 inches, warm and tender to the touch.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose Dec2020, 2nd shot this week; This case was reported by a consumer and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received in December 2020) and Covid vaccine (received in January 2021).   In January 2023, the patient received the 2nd dose of Shingles vaccine. In January 2023, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 13-JAN-2023 Reporter's Comments: The reporter was a patient. The reporter asked, what happened if the second shot was not given in the 2 to 6 month window. The patient failed to get his/her second shot in that window. The doctor just gave patient 2nd shot this week (from the reporting date). The patient was doubting the effectiveness after such a long period and asked for a advise. Additional Supportive Information: The patient received the 2nd dose of Shingles vaccine delayed than the recommended schedule, which led to lengthening of the vaccination schedule. Note: The suspect vaccine captured as Shingles vaccine instead of Shingrix, based upon clarification received from intake hub.
Age: 0.5
Sex: M
Vaccine: UNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 06Jan2023, 2nd on 10Jan2023; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 6-month-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 7TP53, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT).   On 10th January 2023, the patient received the 2nd dose of Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 10th January 2023, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:13-JAN-2023 Reporter's Comment: The reporter was a nurse coordinator. The reporter reported that the 6 month old infant patient received Fluarix QIV dose on 06th January 2023 and instead of coming back in 28 days for second dose, the parents misunderstood and brought the patient back on 10th January 2023 and received second dose. The vaccine administration facility was the same as primary reporter The reporter did consent to follow up. Additional supportive information: The patient received 2nd dose of Fluarix Quadrivalent early than recommended time frame, which led to shortening of vaccinations schedule.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-interferon antibody, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report was received from literature: This report concerned a 36 year old female of an unspecified race and ethnicity. The objective of the study is to present in-depth characterization of transmission and immunity among vaccinated individuals in a household, revealing complex dynamics and unappreciated comorbidities, including autoimmunity to type 1 interferon in the presumptive index case. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on 10-APR-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow up will be requested for this case. Age at time of vaccination 4 decade old. No concomitant medications were reported. The 5 individuals were live together in the same residence, where they ate, slept and socialized with one another in an un-masked setting. The individual number 6 lived separately but frequented the home of individuals of 5. Together, these individuals also attended weekly community events, such as religious services, together as 1 large group. Each individual was thus exposed to one another either through co-residence or frequent visitation. On 16-MAY-2021, the patient (individual number 2) had fever, cough, rhinorrhea and headache. On 19-MAY-2021, a covid-19 PCR test was performed which was positive (confirmed covid-19 infection) which leads to confirmed clinical vaccination failure. On 23-MAY-2021, a rapid antigen test was performed which was came as positive. On an unspecified date, anti-interferon (IFN)-a2 autoantibodies test was performed from the serum which was negative. The patient did not required care at a health facility and improved with self-monitoring at home. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. The authors emphasized that with household exposure to COVID-19, even fully vaccinated individuals with typical levels of neutralizing antibodies are at risk of infection. The data support the urgency for continued vaccination, boosters, and next generation vaccines that contain mutations known to confer immune escape potential. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000267919; Sender's Comments: V0: 20230136345- confirmed clinical vaccination failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding, No adverse event
Clinical narrative: No adverse reaction; I am breastfeeding and I recently received a COVID vaccine and I know that antibodies pass into breast milk as well; This spontaneous case was reported by a consumer and describes the occurrence of NO ADVERSE EVENT (No adverse reaction) and MATERNAL EXPOSURE DURING BREAST FEEDING (I am breastfeeding and I recently received a COVID vaccine and I know that antibodies pass into breast milk as well) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Breast feeding.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction) and MATERNAL EXPOSURE DURING BREAST FEEDING (I am breastfeeding and I recently received a COVID vaccine and I know that antibodies pass into breast milk as well). At the time of the report, NO ADVERSE EVENT (No adverse reaction) outcome was unknown and MATERNAL EXPOSURE DURING BREAST FEEDING (I am breastfeeding and I recently received a COVID vaccine and I know that antibodies pass into breast milk as well) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for MATERNAL EXPOSURE DURING BREAST FEEDING (I am breastfeeding and I recently received a COVID vaccine and I know that antibodies pass into breast milk as well).    No concomitant and treatment medications were reported.  Patient reported that she took the third booster dose (fourth from the beginning vaccination) Spikevax. She knew that antibodies could appear in milk. She had frozen extra servings that she intended to give to her baby in the future when she would return to work (in about 6 months, temperature -21 degrees Celsius). Patient was asking if she could still freeze. She asked if it would rather let go off freezing. Patient was asking how she could check if there were antibodies in the milk. If necessary, she would gladly make the milk available for research.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jan-2023: Live follow up received by safety on 04-Jan-2023 contains significant information: Suspect details was updated. On 18-Jan-2023: Follow up received by safety on 18-Jan-2023 included an Email received and contains significant information: Reporter information, event(verbatim) information were updated.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master