chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiratory arrest, Seizure, Urine analysis
Clinical narrative: Per provider H&P on 11/25/21: "Per dad, PT was at her baseline state of health until early morning of presentation when there was concern for abnormal movements. Per dad, family flew the night prior to presentation to visit family for the holidays and are staying at a hotel. PT was acting normally, watching movies, eating and drinking at her baseline. Had dinner at 10 PM on 11/24 and went to bed at 2 AMish. PT went to sleep that night and on the morning of presentation (at around 9 AM), PT's oldest sister (26 y/o) got up early on morning of presentation to use the bathroom and went to lay back down and noticed PT had upper and lower extremity shaking (bilateral). PT was sharing a hotel room with her sisters and dad was staying in a different hotel room. Sister noticed eyes rolling back of head and neck was stiff. All of her extremities were involved. Sister yelled to other sister to get dad. It was estimated that the time of shaking was less than 1 minute. Dad came to the room and by the time he arrived, the shaking had stopped but, per dad, she "appeared lifeless and blue". Dad thought she may have choked on something so he started to give her the Heimlich maneuver along with several rescue breaths. Dad was not sure if she was breathing spontaneously before giving her rescue breaths but afterwards, he could hear her breathing. After this, she began to open her eyes. In the meantime, the oldest sister was calling 911. Dad estimated that the time she was not breathing was under 1 minute. Paramedics came and PT was out of it and groggy. They did not administer any seizure rescue medications. Per dad, she didn't know how she got to the ED. At the time of history, dad states that she is currently not at baseline and is sleepier than usual when she would normally be very energetic. She had emesis right after the spell and then as dad was carrying her into the ED and then dry-heaved in the ED.    No history of seizures in family. No personal seizure history. Had COVID vaccine 7 days ago (11/18) at PCPs which she seemed to tolerate well - just a sore arm after Two weeks ago had 24 hours of some vomiting, no fever, and had recovered completely.  No current sick symptoms. COVID negative at that time. Mom is visiting her parents. Dad denies any current congestion, rhinorrhea, nausea, vomiting, diarrhea. No sick contacts. " Prescribed rectal diastat for new onset seizure
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cyanosis, Electroencephalogram normal, Eye movement disorder, General physical condition abnormal, Memory impairment
Clinical narrative: Per provider H&P on 11/25/21: "Per dad, PT was at her baseline state of health until early morning of presentation when there was concern for abnormal movements. Per dad, family flew the night prior to presentation to visit family for the holidays and are staying at a hotel. PT was acting normally, watching movies, eating and drinking at her baseline. Had dinner at 10 PM on 11/24 and went to bed at 2 AMish. PT went to sleep that night and on the morning of presentation (at around 9 AM), PT's oldest sister (26 y/o) got up early on morning of presentation to use the bathroom and went to lay back down and noticed PT had upper and lower extremity shaking (bilateral). PT was sharing a hotel room with her sisters and dad was staying in a different hotel room. Sister noticed eyes rolling back of head and neck was stiff. All of her extremities were involved. Sister yelled to other sister to get dad. It was estimated that the time of shaking was less than 1 minute. Dad came to the room and by the time he arrived, the shaking had stopped but, per dad, she "appeared lifeless and blue". Dad thought she may have choked on something so he started to give her the Heimlich maneuver along with several rescue breaths. Dad was not sure if she was breathing spontaneously before giving her rescue breaths but afterwards, he could hear her breathing. After this, she began to open her eyes. In the meantime, the oldest sister was calling 911. Dad estimated that the time she was not breathing was under 1 minute. Paramedics came and PT was out of it and groggy. They did not administer any seizure rescue medications. Per dad, she didn't know how she got to the ED. At the time of history, dad states that she is currently not at baseline and is sleepier than usual when she would normally be very energetic. She had emesis right after the spell and then as dad was carrying her into the ED and then dry-heaved in the ED.    No history of seizures in family. No personal seizure history. Had COVID vaccine 7 days ago (11/18) at PCPs which she seemed to tolerate well - just a sore arm after Two weeks ago had 24 hours of some vomiting, no fever, and had recovered completely.  No current sick symptoms. COVID negative at that time. Mom is visiting her parents. Dad denies any current congestion, rhinorrhea, nausea, vomiting, diarrhea. No sick contacts. " Prescribed rectal diastat for new onset seizure
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Respiratory arrest, Resuscitation, Retching
Clinical narrative: Per provider H&P on 11/25/21: "Per dad, PT was at her baseline state of health until early morning of presentation when there was concern for abnormal movements. Per dad, family flew the night prior to presentation to visit family for the holidays and are staying at a hotel. PT was acting normally, watching movies, eating and drinking at her baseline. Had dinner at 10 PM on 11/24 and went to bed at 2 AMish. PT went to sleep that night and on the morning of presentation (at around 9 AM), PT's oldest sister (26 y/o) got up early on morning of presentation to use the bathroom and went to lay back down and noticed PT had upper and lower extremity shaking (bilateral). PT was sharing a hotel room with her sisters and dad was staying in a different hotel room. Sister noticed eyes rolling back of head and neck was stiff. All of her extremities were involved. Sister yelled to other sister to get dad. It was estimated that the time of shaking was less than 1 minute. Dad came to the room and by the time he arrived, the shaking had stopped but, per dad, she "appeared lifeless and blue". Dad thought she may have choked on something so he started to give her the Heimlich maneuver along with several rescue breaths. Dad was not sure if she was breathing spontaneously before giving her rescue breaths but afterwards, he could hear her breathing. After this, she began to open her eyes. In the meantime, the oldest sister was calling 911. Dad estimated that the time she was not breathing was under 1 minute. Paramedics came and PT was out of it and groggy. They did not administer any seizure rescue medications. Per dad, she didn't know how she got to the ED. At the time of history, dad states that she is currently not at baseline and is sleepier than usual when she would normally be very energetic. She had emesis right after the spell and then as dad was carrying her into the ED and then dry-heaved in the ED.    No history of seizures in family. No personal seizure history. Had COVID vaccine 7 days ago (11/18) at PCPs which she seemed to tolerate well - just a sore arm after Two weeks ago had 24 hours of some vomiting, no fever, and had recovered completely.  No current sick symptoms. COVID negative at that time. Mom is visiting her parents. Dad denies any current congestion, rhinorrhea, nausea, vomiting, diarrhea. No sick contacts. " Prescribed rectal diastat for new onset seizure
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Somnolence, Tremor, Vomiting
Clinical narrative: Per provider H&P on 11/25/21: "Per dad, PT was at her baseline state of health until early morning of presentation when there was concern for abnormal movements. Per dad, family flew the night prior to presentation to visit family for the holidays and are staying at a hotel. PT was acting normally, watching movies, eating and drinking at her baseline. Had dinner at 10 PM on 11/24 and went to bed at 2 AMish. PT went to sleep that night and on the morning of presentation (at around 9 AM), PT's oldest sister (26 y/o) got up early on morning of presentation to use the bathroom and went to lay back down and noticed PT had upper and lower extremity shaking (bilateral). PT was sharing a hotel room with her sisters and dad was staying in a different hotel room. Sister noticed eyes rolling back of head and neck was stiff. All of her extremities were involved. Sister yelled to other sister to get dad. It was estimated that the time of shaking was less than 1 minute. Dad came to the room and by the time he arrived, the shaking had stopped but, per dad, she "appeared lifeless and blue". Dad thought she may have choked on something so he started to give her the Heimlich maneuver along with several rescue breaths. Dad was not sure if she was breathing spontaneously before giving her rescue breaths but afterwards, he could hear her breathing. After this, she began to open her eyes. In the meantime, the oldest sister was calling 911. Dad estimated that the time she was not breathing was under 1 minute. Paramedics came and PT was out of it and groggy. They did not administer any seizure rescue medications. Per dad, she didn't know how she got to the ED. At the time of history, dad states that she is currently not at baseline and is sleepier than usual when she would normally be very energetic. She had emesis right after the spell and then as dad was carrying her into the ED and then dry-heaved in the ED.    No history of seizures in family. No personal seizure history. Had COVID vaccine 7 days ago (11/18) at PCPs which she seemed to tolerate well - just a sore arm after Two weeks ago had 24 hours of some vomiting, no fever, and had recovered completely.  No current sick symptoms. COVID negative at that time. Mom is visiting her parents. Dad denies any current congestion, rhinorrhea, nausea, vomiting, diarrhea. No sick contacts. " Prescribed rectal diastat for new onset seizure
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Electroencephalogram, Loss of consciousness, Respiratory arrest
Clinical narrative: Per provider H&P on 11/25/21: "Per dad, PT was at her baseline state of health until early morning of presentation when there was concern for abnormal movements. Per dad, family flew the night prior to presentation to visit family for the holidays and are staying at a hotel. PT was acting normally, watching movies, eating and drinking at her baseline. Had dinner at 10 PM on 11/24 and went to bed at 2 AMish. PT went to sleep that night and on the morning of presentation (at around 9 AM), PT's oldest sister (26 y/o) got up early on morning of presentation to use the bathroom and went to lay back down and noticed PT had upper and lower extremity shaking (bilateral). PT was sharing a hotel room with her sisters and dad was staying in a different hotel room. Sister noticed eyes rolling back of head and neck was stiff. All of her extremities were involved. Sister yelled to other sister to get dad. It was estimated that the time of shaking was less than 1 minute. Dad came to the room and by the time he arrived, the shaking had stopped but, per dad, she "appeared lifeless and blue". Dad thought she may have choked on something so he started to give her the Heimlich maneuver along with several rescue breaths. Dad was not sure if she was breathing spontaneously before giving her rescue breaths but afterwards, he could hear her breathing. After this, she began to open her eyes. In the meantime, the oldest sister was calling 911. Dad estimated that the time she was not breathing was under 1 minute. Paramedics came and PT was out of it and groggy. They did not administer any seizure rescue medications. Per dad, she didn't know how she got to the ED. At the time of history, dad states that she is currently not at baseline and is sleepier than usual when she would normally be very energetic. She had emesis right after the spell and then as dad was carrying her into the ED and then dry-heaved in the ED.    No history of seizures in family. No personal seizure history. Had COVID vaccine 7 days ago (11/18) at PCPs which she seemed to tolerate well - just a sore arm after Two weeks ago had 24 hours of some vomiting, no fever, and had recovered completely.  No current sick symptoms. COVID negative at that time. Mom is visiting her parents. Dad denies any current congestion, rhinorrhea, nausea, vomiting, diarrhea. No sick contacts. " Prescribed rectal diastat for new onset seizure
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test, Seizure, Urine analysis
Clinical narrative: Per provider H&P on 11/25/21: "Per dad, PT was at her baseline state of health until early morning of presentation when there was concern for abnormal movements. Per dad, family flew the night prior to presentation to visit family for the holidays and are staying at a hotel. PT was acting normally, watching movies, eating and drinking at her baseline. Had dinner at 10 PM on 11/24 and went to bed at 2 AMish. PT went to sleep that night and on the morning of presentation (at around 9 AM), PT's oldest sister (26 y/o) got up early on morning of presentation to use the bathroom and went to lay back down and noticed PT had upper and lower extremity shaking (bilateral). PT was sharing a hotel room with her sisters and dad was staying in a different hotel room. Sister noticed eyes rolling back of head and neck was stiff. All of her extremities were involved. Sister yelled to other sister to get dad. It was estimated that the time of shaking was less than 1 minute. Dad came to the room and by the time he arrived, the shaking had stopped but, per dad, she "appeared lifeless and blue". Dad thought she may have choked on something so he started to give her the Heimlich maneuver along with several rescue breaths. Dad was not sure if she was breathing spontaneously before giving her rescue breaths but afterwards, he could hear her breathing. After this, she began to open her eyes. In the meantime, the oldest sister was calling 911. Dad estimated that the time she was not breathing was under 1 minute. Paramedics came and PT was out of it and groggy. They did not administer any seizure rescue medications. Per dad, she didn't know how she got to the ED. At the time of history, dad states that she is currently not at baseline and is sleepier than usual when she would normally be very energetic. She had emesis right after the spell and then as dad was carrying her into the ED and then dry-heaved in the ED.    No history of seizures in family. No personal seizure history. Had COVID vaccine 7 days ago (11/18) at PCPs which she seemed to tolerate well - just a sore arm after Two weeks ago had 24 hours of some vomiting, no fever, and had recovered completely.  No current sick symptoms. COVID negative at that time. Mom is visiting her parents. Dad denies any current congestion, rhinorrhea, nausea, vomiting, diarrhea. No sick contacts. " Prescribed rectal diastat for new onset seizure
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ecchymosis, Haemoglobin decreased, Immune thrombocytopenia, Petechiae, Platelet count decreased
Clinical narrative: Received 2nd covid vaccine on 11/23, on 11/25 my daughter showed my red pin point dots (rash) all over her lower legs.  Research of the symptom showed that it was an immune response to the vaccine and no immediate cause for alarm.  On 11/26 she brought my attention 6 bruises on her lower legs, in addition to pin point dots, that appeared out of nowhere.  The bruises started at her feet and went to her knees.  We were advised by the dr on call through her local office to go to the Emergency room.  The Emergency room doctor took blood samples, and they diagnosed her with Idiopathic thrombocytopenia directly related to the COVID vaccine.  She has never had a reaction to any other vaccine, and is current on all her other vaccines.  We are currently treating the condition with steroids to increase her platelet count, and will be doing repeat labs in the next couple of days.  She is not allowed any rough physical activity due to a serious risk of internal bleeding with the extremely low platelet levels, and we won't know what her long term prognosis is for years to come.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: White blood cell count normal
Clinical narrative: Received 2nd covid vaccine on 11/23, on 11/25 my daughter showed my red pin point dots (rash) all over her lower legs.  Research of the symptom showed that it was an immune response to the vaccine and no immediate cause for alarm.  On 11/26 she brought my attention 6 bruises on her lower legs, in addition to pin point dots, that appeared out of nowhere.  The bruises started at her feet and went to her knees.  We were advised by the dr on call through her local office to go to the Emergency room.  The Emergency room doctor took blood samples, and they diagnosed her with Idiopathic thrombocytopenia directly related to the COVID vaccine.  She has never had a reaction to any other vaccine, and is current on all her other vaccines.  We are currently treating the condition with steroids to increase her platelet count, and will be doing repeat labs in the next couple of days.  She is not allowed any rough physical activity due to a serious risk of internal bleeding with the extremely low platelet levels, and we won't know what her long term prognosis is for years to come.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test abnormal, Contusion, Full blood count abnormal, Immune thrombocytopenia, Platelet count decreased
Clinical narrative: Received 2nd covid vaccine on 11/23, on 11/25 my daughter showed my red pin point dots (rash) all over her lower legs.  Research of the symptom showed that it was an immune response to the vaccine and no immediate cause for alarm.  On 11/26 she brought my attention 6 bruises on her lower legs, in addition to pin point dots, that appeared out of nowhere.  The bruises started at her feet and went to her knees.  We were advised by the dr on call through her local office to go to the Emergency room.  The Emergency room doctor took blood samples, and they diagnosed her with Idiopathic thrombocytopenia directly related to the COVID vaccine.  She has never had a reaction to any other vaccine, and is current on all her other vaccines.  We are currently treating the condition with steroids to increase her platelet count, and will be doing repeat labs in the next couple of days.  She is not allowed any rough physical activity due to a serious risk of internal bleeding with the extremely low platelet levels, and we won't know what her long term prognosis is for years to come.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash macular, Vaccination complication
Clinical narrative: Received 2nd covid vaccine on 11/23, on 11/25 my daughter showed my red pin point dots (rash) all over her lower legs.  Research of the symptom showed that it was an immune response to the vaccine and no immediate cause for alarm.  On 11/26 she brought my attention 6 bruises on her lower legs, in addition to pin point dots, that appeared out of nowhere.  The bruises started at her feet and went to her knees.  We were advised by the dr on call through her local office to go to the Emergency room.  The Emergency room doctor took blood samples, and they diagnosed her with Idiopathic thrombocytopenia directly related to the COVID vaccine.  She has never had a reaction to any other vaccine, and is current on all her other vaccines.  We are currently treating the condition with steroids to increase her platelet count, and will be doing repeat labs in the next couple of days.  She is not allowed any rough physical activity due to a serious risk of internal bleeding with the extremely low platelet levels, and we won't know what her long term prognosis is for years to come.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Dizziness, Feeling cold, Feeling hot, Paraesthesia
Clinical narrative: Within the same minute that the vaccine was given  I got an all over body feeling that went from my head to my feet then I got the cold chills with sweaty , I felt tricking in my throat and tightening.. I was dizzy , spacey and nauseous and I could tell my blood pressure bottomed out just like as if I was having an imetrex allergic reaction! The staff provided me with water and an ice pack and wanted to give Benadryl or a snack and made me sit for an hr ! I got home and I would say a few hrs later I got hives and had to give myself Benadryl!  Today 11/29 my left arm is in excruciating pain that has been all day and even through the evening
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thirst
Clinical narrative: Within the same minute that the vaccine was given  I got an all over body feeling that went from my head to my feet then I got the cold chills with sweaty , I felt tricking in my throat and tightening.. I was dizzy , spacey and nauseous and I could tell my blood pressure bottomed out just like as if I was having an imetrex allergic reaction! The staff provided me with water and an ice pack and wanted to give Benadryl or a snack and made me sit for an hr ! I got home and I would say a few hrs later I got hives and had to give myself Benadryl!  Today 11/29 my left arm is in excruciating pain that has been all day and even through the evening
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Feeling cold, Hyperhidrosis
Clinical narrative: Within the same minute that the vaccine was given  I got an all over body feeling that went from my head to my feet then I got the cold chills with sweaty , I felt tricking in my throat and tightening.. I was dizzy , spacey and nauseous and I could tell my blood pressure bottomed out just like as if I was having an imetrex allergic reaction! The staff provided me with water and an ice pack and wanted to give Benadryl or a snack and made me sit for an hr ! I got home and I would say a few hrs later I got hives and had to give myself Benadryl!  Today 11/29 my left arm is in excruciating pain that has been all day and even through the evening
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain in extremity, Throat irritation, Throat tightness, Urticaria
Clinical narrative: Within the same minute that the vaccine was given  I got an all over body feeling that went from my head to my feet then I got the cold chills with sweaty , I felt tricking in my throat and tightening.. I was dizzy , spacey and nauseous and I could tell my blood pressure bottomed out just like as if I was having an imetrex allergic reaction! The staff provided me with water and an ice pack and wanted to give Benadryl or a snack and made me sit for an hr ! I got home and I would say a few hrs later I got hives and had to give myself Benadryl!  Today 11/29 my left arm is in excruciating pain that has been all day and even through the evening
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: [After first two doses] sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA ([After first two doses] sore arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A, 013M20A and 014F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced MYALGIA ([After first two doses] sore arm). At the time of the report, MYALGIA ([After first two doses] sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. The patient reported that he did not take any medications to treat his symptoms.   This case was linked to MOD-2021-395653, MOD-2021-395666 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: Had Moderna booster yesterday. Today I feel weak; This spontaneous case was reported by an other health care professional and describes the occurrence of ASTHENIA (Had Moderna booster yesterday. Today I feel weak) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced ASTHENIA (Had Moderna booster yesterday. Today I feel weak). At the time of the report, ASTHENIA (Had Moderna booster yesterday. Today I feel weak) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were reported.   This case was linked to MOD-2021-393117, MOD-2021-393118 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Non-Significant Follow up received on 24-Nov-2021 which contains updated contact information
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; temperautre excursion; This spontaneous report was received from a medical assistant concerning a patient of unknown age. No concurrent condition, medical history, or concomitant therapy was reported.  On 01-NOV-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength and route were unknown; 0.5 ml, recombinant Human albumin; lot # T016198 has been verified to be a valid lot number, expiration date reported and confirm upon internal validation as 11-MAY-2022) and hepatitis a vaccine, inactivated(VAQTA) (strength and route were unknown; 0.5 ml; lot # T037788 has been verified to be a valid lot number, expiration date reported and confirm upon internal validation as 30-APR-2022) for prophylaxis following a temperature excursion (product storage error). There was no previous temperature excursion. There was no adverse event.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2111USA009348:
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; an expired pediatric dose of RECOMBIVAX HB was administered to an adult patient; an expired pediatric dose of RECOMBIVAX HB was administered to an adult patient; Incorrect dosage administered; This spontaneous report was received from a nurse referring to an adult patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 05-NOV-2021, the patient was vaccinated with an expired pediatric dose of hepatitis b vaccine (recombinant) thimerosal-free (RECOMBIVAX HB) (lot # S022583, expiration date 31-OCT-2021, 0.5 milliliter) for prophylaxis (product administered to patient of inappropriate age, incorrect dosage administered and expired product administered). No prior temperature excursions had occurred to the dose of Hepatitis B Vaccine (Recombinant)(RECOMBIVAX HB) that was administered. No additional AE reported.
Sex: F
Vaccine: VARZOS
Symptoms: Sudden hearing loss
Clinical narrative: sudden loss of hearing; Information has been received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. Information about the patient's concurrent condition, concomitant medication and medical history was not provided. On or around 09-JUL-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine (unspecified date), the patient suffered from sudden loss of hearing. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the product. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The causality was assessed as related by the lawyer.   The event of loss of hearing was considered as disabled by the lawyer.  Upon internal review, loss of hearing was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: soreness at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were reported as follows: The age at the vaccination was not reported. The patient reported that received Shingles vaccine. Patient informed had soreness at the injection site for a few days. The reporter reported his/her friend got shingles and was not going to get the shots after they finally went away but after dealing with all the severe pain he ended up getting the shots, he decided he wasn't as tough as he thought he was. The case had been linked with US2021AMR241060 reported for the same patient for another dose of Shingles vaccine.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR241060:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: 2nd one knocked me on my ass for a few days; This case was reported by a consumer via interactive digital media and described the occurrence of malaise in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced malaise. On an unknown date, the outcome of the malaise was recovered/resolved.   It was unknown if the reporter considered the malaise to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient got both his/her Shingles vaccine shots this fall. The patient stated 2nd shot knocked him/her on his/her ass for a few days. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Hypoacusis
Clinical narrative: 50% hearing loss from having shot; This case was reported by a consumer via interactive digital media and described the occurrence of partial hearing loss in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced partial hearing loss. On an unknown date, the outcome of the partial hearing loss was unknown.   The reporter considered the partial hearing loss to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingle shot and 50% hearing loss from having shot.
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: MYOCARDITIS; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced myocarditis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of myocarditis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211157170-COVID-19 VACCINE AD26.COV2.S-Myocarditis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Rash
Clinical narrative: RASH ON STOMACH TO BACK WHICH LOOKED LIKE PRICKLY HEAT; VERY TIRED; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine for prophylactic vaccination. The patient received macitentan (tablet, route of admin not reported, batch number: Unknown) 10 mg, every 1 day, from 2019, frequency was not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-NOV-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 20-NOV-2021, the patient experienced very tired. On 21-NOV-2021, the patient experienced rash on stomach to back which looked like prickly heat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of macitentan was not changed. The patient recovered from very tired on 20-NOV-2021, and was recovering from rash on stomach to back which looked like prickly heat. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: INAPPROPRIATE AGE AT VACCINE ADMINISTRATION (ADMINISTERED TO UNDER THE AGE OF 18); OFF LABEL USE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: 11-APR-2022) dose was not reported, administered on 26-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-NOV-2021, the patient experienced inappropriate age at vaccine administration (administered to under the age of 18). On 26-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate age at vaccine administration (administered to under the age of 18) and off label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I HAD SHOT AND STILL GOT THE VIRUS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced i had shot and still got the virus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of i had shot and still got the virus was not reported. This report was non-serious. This report was associated with a regulatory authority: 90000204289.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: INJURY FROM VACCINE; This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced injury from vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injury from vaccine was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site induration, Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: sort of feels like there's a little bump there; and the skin color looks like color pink; hardness; it was sore a little bit/tenderness; swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (sort of feels like there's a little bump there), VACCINATION SITE DISCOLOURATION (and the skin color looks like color pink), VACCINATION SITE INDURATION (hardness), VACCINATION SITE PAIN (it was sore a little bit/tenderness) and VACCINATION SITE SWELLING (swelling) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 038A21A and 047A21A.) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (sort of feels like there's a little bump there), VACCINATION SITE DISCOLOURATION (and the skin color looks like color pink), VACCINATION SITE INDURATION (hardness), VACCINATION SITE PAIN (it was sore a little bit/tenderness) and VACCINATION SITE SWELLING (swelling). At the time of the report, VACCINATION SITE MASS (sort of feels like there's a little bump there), VACCINATION SITE DISCOLOURATION (and the skin color looks like color pink), VACCINATION SITE INDURATION (hardness), VACCINATION SITE PAIN (it was sore a little bit/tenderness) and VACCINATION SITE SWELLING (swelling) outcome was unknown.            No Concomitant Medications were Reported. No Treatments were Reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Myalgia, Pyrexia
Clinical narrative: feeling "blah"; headache/headache pain at bottom left side of head; a fever; sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling "blah"), HEADACHE (headache/headache pain at bottom left side of head), PYREXIA (a fever) and MYALGIA (sore left arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 025B21A and 030A21A) for COVID-19 vaccination. The patient's past medical history included Colon cancer on 04-May-2021, Cancer surgery (Colon Cancer surgery.) on 08-Jun-2021 and Colonoscopy on 04-May-2021. Concurrent medical conditions included Arthritis.Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]) for Arthritis.On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced FEELING ABNORMAL (feeling "blah"), HEADACHE (headache/headache pain at bottom left side of head), PYREXIA (a fever) and MYALGIA (sore left arm). At the time of the report, FEELING ABNORMAL (feeling "blah"), HEADACHE (headache/headache pain at bottom left side of head), PYREXIA (a fever) and MYALGIA (sore left arm) outcome was unknown. Treatment medications were not provided.This case was linked to MOD-2021-392014 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: intense side effects/reactions more intense than with the second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (intense side effects/reactions more intense than with the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination. Previously administered products included for Vaccination: flu shot (high dose flu shot) in 2020.Past adverse reactions to the above products included Vaccination adverse reaction with flu shot.On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced VACCINATION COMPLICATION (intense side effects/reactions more intense than with the second dose). At the time of the report, VACCINATION COMPLICATION (intense side effects/reactions more intense than with the second dose) outcome was unknown. Reporter informed that at pharmacy patient was given one shot but when the state showed her records the facility submitted says that patient had got a flu shot, so that raised questions for her. Patient is unsure if she got the Moderna or a flu shot. Reporter asked whether patient can get an antibody test to know if she got the booster and Is there any way she can know if she got the booster.No Concomitant medication were reported.No treatment medication were reported.This case was linked to MOD-2021-392098 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow up received includes no new information.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Little bit of soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little bit of soreness in her arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. No medical history was provided by the reporter.Concomitant products included VITAMINS NOS for an unknown indication.On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (Little bit of soreness in her arm). The patient was treated with LYSINE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Little bit of soreness in her arm) outcome was unknown. Treatment drug include OTC Lysine.This case was linked to MOD-2021-392152, MOD-2021-391952 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Oct-2021, PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant information was not reported.Treatment information was not reported.Most recent FOLLOW-UP information incorporated above includes:On 22-Nov-2021: Follow-up received includes updated patient identifier.