chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chest discomfort, Cough, Diarrhoea, Headache
Clinical narrative: Extreme headache, nausea, vomiting, diarrhea, sore throat, swollen glands, coughing, a lot of congestion and blowing of the nose, chest congestion and pressure restlessness or sleeplessness. No fever but had an extreme metal taste in mouth once started on PAXLOVID also experienced extreme loss of appetite.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Influenza virus test positive, Insomnia, Lymphadenopathy, Nasal congestion, Nausea
Clinical narrative: Extreme headache, nausea, vomiting, diarrhea, sore throat, swollen glands, coughing, a lot of congestion and blowing of the nose, chest congestion and pressure restlessness or sleeplessness. No fever but had an extreme metal taste in mouth once started on PAXLOVID also experienced extreme loss of appetite.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, Respiratory tract congestion, Restlessness, SARS-CoV-2 test positive, Vomiting
Clinical narrative: Extreme headache, nausea, vomiting, diarrhea, sore throat, swollen glands, coughing, a lot of congestion and blowing of the nose, chest congestion and pressure restlessness or sleeplessness. No fever but had an extreme metal taste in mouth once started on PAXLOVID also experienced extreme loss of appetite.
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient was given Moderna Bivalent vaccine in September 2022 and had another Moderna Bivalent vaccine on December 21, 2022
Sex: M
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: Episodes of Syncope; This case was reported by a consumer via call center representative and described the occurrence of syncope in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced syncope (serious criteria GSK medically significant). On an unknown date, the outcome of the syncope was unknown.   It was unknown if the reporter considered the syncope to be related to Shingrix.     Linked case(s) involving the same patient:  US2022191325   Additional Information: GSK receipt date: 21-DEC-2022 Reporters comment: The reporter was the patient and he stated that he received his first dose of the shingrix vaccine in October of 2021 and the second dose in January of 2022,since received his first dose he had experienced episodes of syncope. No additional details were provided. The reporter consented to follow-up. Additional Supportive information: This case has been linked to the cases US2022191325 reported by the same reporter for second dose. .; Sender's Comments:  US-GSK-US2022191325:Same reporter
Age: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient was given a dose of the undiluted (Gray cap) Pfizer COVID-19 Bivalent booster that was not stored in an ultra-cold temperature freezer and was instead stored in the regular freezer (between -30 to -20 F). It was moved out of the regular freezer to the refrigerator after more than 3 weeks in the regular freezer. The doses were then used after more than 24 hours in the refrigerator. We have contacted Pfizer about this and according to their off-label studies they provided via PDF file, they are not able to support the temperature excursions that occurred. As per CDC guidance, the recommendation is to re-vaccinate the individual with the full authorized dose of any Bivalent vaccine (either Pfizer or Moderna) and we have communicated with the patient for re-vaccination.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, SARS-CoV-2 test positive
Clinical narrative: 11/11/22 presents to ED for "cough, missed HD". PMHx of "hypertension" "end-stage renal disease on hemodialysis and WF, CHF, DM, hypertension, depression"
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray abnormal, Chest pain, Chest tube insertion, Chest tube removal
Clinical narrative: I was given the Covid-19 vaccine as usual. This was my fourth vaccine two being from pfizer and this was the second from Moderna. I had no adverse reaction at the time. 6 days later I was driving and had chest pain. they subsided after 20 minutes but came back later in the afternoon. I went to the hospital, it was determined I had a spontaneous pneumothorax of the left lung.  Numerous Xrays, blood work, and a chest tube were placed for 3 days. I Have no idea if this was a result of an adverse reaction but think it is odd that this would happen when I have no known lung history, am not a smoker,  I run 3 miles a few times a week. I recently graduated from the police academy without any lung issues and now my lung randomly collapses on the same side of the body that I received the vaccine.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pneumothorax, Pneumothorax spontaneous
Clinical narrative: I was given the Covid-19 vaccine as usual. This was my fourth vaccine two being from pfizer and this was the second from Moderna. I had no adverse reaction at the time. 6 days later I was driving and had chest pain. they subsided after 20 minutes but came back later in the afternoon. I went to the hospital, it was determined I had a spontaneous pneumothorax of the left lung.  Numerous Xrays, blood work, and a chest tube were placed for 3 days. I Have no idea if this was a result of an adverse reaction but think it is odd that this would happen when I have no known lung history, am not a smoker,  I run 3 miles a few times a week. I recently graduated from the police academy without any lung issues and now my lung randomly collapses on the same side of the body that I received the vaccine.
Age: 1.25
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer monovalent booster administered to 16mo child with 2 Moderna primary COVID vaccine
Age: 13.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: On 11/18 patient received the bivalent booster instead of the initial dose for Pfizer. Patient was scheduled today for 2nd dose which it is how we found out patient was given the  wrong vaccine. Patient was scheduled with Dr., speaking to mom at patients visit today, mom stated that patient did not get  an adverse reaction after receiving vaccine and patient was fine.  Dr. asked mom that if she would like her son to start the series and mother declined.
Age: 1.25
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer monovalent booster administered to 16 month child with 2 Moderna primary COVID vaccines
Age: 1.08
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt received vaccine at less than recommended minimum interval. No reaction noted.
Age: 27.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient was given a dose of the undiluted (Gray cap) Pfizer COVID-19 Bivalent booster that was not stored in an ultra-cold temperature freezer and was instead stored in the regular freezer (between -30 to -20 F). It was moved out of the regular freezer to the refrigerator after more than 3 weeks in the regular freezer. The doses were then used after more than 24 hours in the refrigerator. We have contacted Pfizer about this and according to their off-label studies they provided via PDF file, they are not able to support the temperature excursions that occurred. As per CDC guidance, the recommendation is to re-vaccinate the individual with the full authorized dose of any Bivalent vaccine (either Pfizer or Moderna) and we have communicated with the patient for re-vaccination.
Age: 39.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Bronchitis, Cough, Influenza virus test negative, Oropharyngeal pain, Respiratory syncytial virus test negative
Clinical narrative: After 1 month of getting my 5th Pfizer Booster shot I came down with Bronchitis on 11/25/2022 in the morning with a sore throat. Later on I had chest congestions and cough. I went to the urgent care on 12/03/2022. In the urgent care I tested negative for COVID-19, FLU, and RSV. They prescribed me with albuterol and promethazine as per needed. I was advised to take the cough syrup at night. I haven't recovered fully yet but my cough has decreased.
Age: 39.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: After 1 month of getting my 5th Pfizer Booster shot I came down with Bronchitis on 11/25/2022 in the morning with a sore throat. Later on I had chest congestions and cough. I went to the urgent care on 12/03/2022. In the urgent care I tested negative for COVID-19, FLU, and RSV. They prescribed me with albuterol and promethazine as per needed. I was advised to take the cough syrup at night. I haven't recovered fully yet but my cough has decreased.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines Pfizer 3/15/21 Lot# En6207;  Pfizer 4/6/21 Lot# Er8733;  12/8/21 Pfizer Lot# FJ8757;  Pfizer 5/19/22 LOt# FM9992
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shot, then shingles twice/ suspected vaccination failure; shingles twice; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got the Shingles shot and was rewarded with shingles twice. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Dose # 3 of primary Pfizer COVID-19 vaccine administered.  No signs or symptoms reported.
Age: 60.0
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea, Haematochezia
Clinical narrative: Diarrhea with blood in stool
Age: 1.08
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt received vaccine at less interval than recommended.
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after three vaccines  Pfizer 3/22/22 Lot# FJ5683;  MOderna 4/6/22 Lot# 057M21A;  Pfizer 10/27/22 Lot# GH9702
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, COVID-19, Cough, Fatigue, Headache
Clinical narrative: I contracted COVID-19 on 12/21/22 with symptoms of sore throat, headache, nausea, cough, joint pain, grogginess, and fatigue. I was prescribed Paxlovid on 12/23/22. My symptoms have begun to resolve today, which is day 7 of illness, but have not fully resolved. The joint pain worsened on day 6 and 7. I am not recovered as of today day 7 of illness.
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Illness, Nausea, Oropharyngeal pain, SARS-CoV-2 test positive, Somnolence
Clinical narrative: I contracted COVID-19 on 12/21/22 with symptoms of sore throat, headache, nausea, cough, joint pain, grogginess, and fatigue. I was prescribed Paxlovid on 12/23/22. My symptoms have begun to resolve today, which is day 7 of illness, but have not fully resolved. The joint pain worsened on day 6 and 7. I am not recovered as of today day 7 of illness.
Age: 22.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Injection site pain, Injection site swelling, Lymphadenopathy, Pain
Clinical narrative: Fever (100.2-101.1 F) Severe chills Body aches Injection site swelling, soreness Swollen lymph node (right armpit) Treated with acetaminophen and ibuprofen
Age: 22.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: Fever (100.2-101.1 F) Severe chills Body aches Injection site swelling, soreness Swollen lymph node (right armpit) Treated with acetaminophen and ibuprofen
Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient was given a dose of the undiluted (Gray cap) Pfizer COVID-19 Bivalent booster that was not stored in an ultra-cold temperature freezer and was instead stored in the regular freezer (between -30 to -20 F). It was moved out of the regular freezer to the refrigerator after more than 3 weeks in the regular freezer. The doses were then used after more than 24 hours in the refrigerator. We have contacted Pfizer about this and according to their off-label studies they provided via file, they are not able to support the temperature excursions that occurred. As per CDC guidance, the recommendation is to re-vaccinate the individual with the full authorized dose of any Bivalent vaccine (either Pfizer or Moderna) and we have communicated with the patient for re-vaccination.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after three vaccines Pfizer 2/22/21 Lot# EN6200;  Pfizer 3/15/21 Lot# EN6207;  Pfizer 10/1/21 Lot# FC3183
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Headache, Hot flush, Pyrexia
Clinical narrative: I first started having symptoms on 12/24. I had flashes of a headache a little bit of congestion and a slight fever. I was exposed to someone that was COVID-19 positive. After I tested positive all symptoms stayed moderate. I had a headache that was in and out. I can usually take something, and it goes away butalbital. The medication is for migraines, but these heads would go away quick once I take this medication. The fever was just an elevated temp always below 100. My energy levels are good no loss of taste and smell. I had a lingering cough from a cold, so I made an appoint and it lined up with my recovery of COVID-19. The cough went away when I tested positive and I kept my appointment, and she agreed it was a mild case. The appointment was already set for a cough that was lingering and I kept it to get clarity for my COVID-19 case.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I first started having symptoms on 12/24. I had flashes of a headache a little bit of congestion and a slight fever. I was exposed to someone that was COVID-19 positive. After I tested positive all symptoms stayed moderate. I had a headache that was in and out. I can usually take something, and it goes away butalbital. The medication is for migraines, but these heads would go away quick once I take this medication. The fever was just an elevated temp always below 100. My energy levels are good no loss of taste and smell. I had a lingering cough from a cold, so I made an appoint and it lined up with my recovery of COVID-19. The cough went away when I tested positive and I kept my appointment, and she agreed it was a mild case. The appointment was already set for a cough that was lingering and I kept it to get clarity for my COVID-19 case.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 2/9/21 Lot# EL9267;  Pfizer 3/3/21 Lot# EL6202
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood test, Blood urea increased, COVID-19, Death
Clinical narrative: DOSE #3 PFIZER COVID VACCINE GIVEN 10/10/21, LOT # UNKNOWN; pt resides in a Nursing and Rehab Center locally; brough to hospital ( locally) via EMS after blood work drawn at facility the day prior, and BUN > 100; while en route to hospital, the pt's BP dropped requiring a NS bolus with improvement; admitted ; tested positive for COVID; treating providers:   MD and APN,FNP; pt dc'd to SNF where she later passed away
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: DOSE #3 PFIZER COVID VACCINE GIVEN 10/10/21, LOT # UNKNOWN; pt resides in a Nursing and Rehab Center locally; brough to hospital ( locally) via EMS after blood work drawn at facility the day prior, and BUN > 100; while en route to hospital, the pt's BP dropped requiring a NS bolus with improvement; admitted ; tested positive for COVID; treating providers:   MD and APN,FNP; pt dc'd to SNF where she later passed away
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Discomfort, Herpes zoster, Impaired work ability, Pain
Clinical narrative: Got the vaccine, then got shingles/Suspected vaccination failure; Burning pain, living in extreme pain; Can't get comfortable, affected my whole life; I'm on fire all the time; Shingles, cause me I can't go to work; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly 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 vaccination failure (serious criteria GSK medically significant), shingles, pain burning, discomfort and burning sensation. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved and the outcome of the pain burning, discomfort and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain burning, discomfort and burning sensation to be related to Shingles vaccine.     Additional Information: GSK receipt date: 22-Dec-2022 Reporter's comment: The patient had the vaccine and got shingles for almost 4 months cause him/her. The patient could not go to work, had burning pain, could not get comfortable, it had really affected his/her whole life and did not know what to do because he/she was living in pain. The patient did not know the vaccine and should have had a mild this. The patient asked that he/she ever gonna get comfortable again as he/she was on fire all the time and was in extreme pain. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. As it was not clear for which event patient was reporting severity, therefore in worst approach, severity was captured as mild for all events.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: Got the vaccine, then got shingles/Suspected vaccination failure; Burning pain, living in extreme pain; Can't get comfortable, affected my whole life; I'm on fire all the time; Shingles, cause me I can't go to work; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly 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 vaccination failure (serious criteria GSK medically significant), shingles, pain burning, discomfort and burning sensation. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved and the outcome of the pain burning, discomfort and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain burning, discomfort and burning sensation to be related to Shingles vaccine.     Additional Information: GSK receipt date: 22-Dec-2022 Reporter's comment: The patient had the vaccine and got shingles for almost 4 months cause him/her. The patient could not go to work, had burning pain, could not get comfortable, it had really affected his/her whole life and did not know what to do because he/she was living in pain. The patient did not know the vaccine and should have had a mild this. The patient asked that he/she ever gonna get comfortable again as he/she was on fire all the time and was in extreme pain. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. As it was not clear for which event patient was reporting severity, therefore in worst approach, severity was captured as mild for all events.
Age: 43.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site pain, Rash erythematous
Clinical narrative: I have had small, painless red spots pop up on my hands, arms, legs, and upper torso. They are not itchy, but they are not attractive in the least (they resemble shingles at first glance). I went to my dermatologist, and she prescribed me a topical steroid. While the steroid makes the spots shrink a little and fade to a pink color, they do not fully subside, and if I stop putting the steroid on, they immediately go back to their same size and bright color. Also, while I no longer have pain at the injection site, it is still fairly prominent and dark in comparison to other people who had the vaccine around the same time that I did.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after three vaccines Moderna 3/3/21 Lot# 010A21A;  Moderna 3/31/21 Lot# 025B21A  Moderna 11/6/21 Lot# 058F21A
Age: 1.33
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Hep A dose administered on 12/27 was administered less than 6 months after the first dose of Hep A, which was administered on 8/22/22. The minimum interval is 6 months, therefor the second dose is considered invalid. This dose will need to be repeated 6 months following the invalid dose, or 6/27/23. There have been no known adverse reactions following immunization on the 27th.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given past 30 day fridge use by date
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case after one dose Janssen
Age: 94.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Atrial fibrillation, Blood test abnormal, Breast disorder female, Chest X-ray abnormal
Clinical narrative: About three days after getting her shot, my mother woke up disoriented and unlike herself. She was lethargic and did not want to eat. She drank some tea and soup, and that's a quarter of what she usually eats. This was on Thursday evening, by that Friday she was not getting any better. I did a COVID-19 test on her. She was negative. It was hard for her to walk or move, I had to carry her to the bathroom. She was unable to get dressed. That Saturday she was worse and had to be physically lifted out of bed to go to the bathroom and she was completely weak and had extreme Flu like symptoms. She was coughing and when she tried to eat, she was having a very hard time swallowing and would choke on it. I called 911 to have the medics transfer to the hospital on that Saturday night around 9:30PM. They found at the ER she had lesions on liver, thyroid and right breast, Her X-Ray show her left lung was a third to a half clouded and the right lung a quarter to a third cloudy, and they diagnosed her with pneumonia. She was given medication at the hospital and an antibiotic regime for 5 to 6 days and it was not making any improvement. They changed the antibiotic and that was seemed to be making slight improvement, but then she developed sepsis. Then they made the choice to have a cardiologist change her meds due to her AFIB. The cardiologist changed the meds at 5 PM in the afternoon and didn't get more AFIB medication until 9AM the next morning.
Age: 94.0
Sex: F
Vaccine: COVID19-2
Symptoms: Choking, Computerised tomogram abnormal, Computerised tomogram breast abnormal, Computerised tomogram liver abnormal, Cough
Clinical narrative: About three days after getting her shot, my mother woke up disoriented and unlike herself. She was lethargic and did not want to eat. She drank some tea and soup, and that's a quarter of what she usually eats. This was on Thursday evening, by that Friday she was not getting any better. I did a COVID-19 test on her. She was negative. It was hard for her to walk or move, I had to carry her to the bathroom. She was unable to get dressed. That Saturday she was worse and had to be physically lifted out of bed to go to the bathroom and she was completely weak and had extreme Flu like symptoms. She was coughing and when she tried to eat, she was having a very hard time swallowing and would choke on it. I called 911 to have the medics transfer to the hospital on that Saturday night around 9:30PM. They found at the ER she had lesions on liver, thyroid and right breast, Her X-Ray show her left lung was a third to a half clouded and the right lung a quarter to a third cloudy, and they diagnosed her with pneumonia. She was given medication at the hospital and an antibiotic regime for 5 to 6 days and it was not making any improvement. They changed the antibiotic and that was seemed to be making slight improvement, but then she developed sepsis. Then they made the choice to have a cardiologist change her meds due to her AFIB. The cardiologist changed the meds at 5 PM in the afternoon and didn't get more AFIB medication until 9AM the next morning.
Age: 94.0
Sex: F
Vaccine: COVID19-2
Symptoms: Decreased appetite, Disorientation, Dysphagia, Feeling abnormal, Gait disturbance
Clinical narrative: About three days after getting her shot, my mother woke up disoriented and unlike herself. She was lethargic and did not want to eat. She drank some tea and soup, and that's a quarter of what she usually eats. This was on Thursday evening, by that Friday she was not getting any better. I did a COVID-19 test on her. She was negative. It was hard for her to walk or move, I had to carry her to the bathroom. She was unable to get dressed. That Saturday she was worse and had to be physically lifted out of bed to go to the bathroom and she was completely weak and had extreme Flu like symptoms. She was coughing and when she tried to eat, she was having a very hard time swallowing and would choke on it. I called 911 to have the medics transfer to the hospital on that Saturday night around 9:30PM. They found at the ER she had lesions on liver, thyroid and right breast, Her X-Ray show her left lung was a third to a half clouded and the right lung a quarter to a third cloudy, and they diagnosed her with pneumonia. She was given medication at the hospital and an antibiotic regime for 5 to 6 days and it was not making any improvement. They changed the antibiotic and that was seemed to be making slight improvement, but then she developed sepsis. Then they made the choice to have a cardiologist change her meds due to her AFIB. The cardiologist changed the meds at 5 PM in the afternoon and didn't get more AFIB medication until 9AM the next morning.
Age: 94.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hepatic lesion, Hypophagia, Infection, Influenza like illness, Lethargy
Clinical narrative: About three days after getting her shot, my mother woke up disoriented and unlike herself. She was lethargic and did not want to eat. She drank some tea and soup, and that's a quarter of what she usually eats. This was on Thursday evening, by that Friday she was not getting any better. I did a COVID-19 test on her. She was negative. It was hard for her to walk or move, I had to carry her to the bathroom. She was unable to get dressed. That Saturday she was worse and had to be physically lifted out of bed to go to the bathroom and she was completely weak and had extreme Flu like symptoms. She was coughing and when she tried to eat, she was having a very hard time swallowing and would choke on it. I called 911 to have the medics transfer to the hospital on that Saturday night around 9:30PM. They found at the ER she had lesions on liver, thyroid and right breast, Her X-Ray show her left lung was a third to a half clouded and the right lung a quarter to a third cloudy, and they diagnosed her with pneumonia. She was given medication at the hospital and an antibiotic regime for 5 to 6 days and it was not making any improvement. They changed the antibiotic and that was seemed to be making slight improvement, but then she developed sepsis. Then they made the choice to have a cardiologist change her meds due to her AFIB. The cardiologist changed the meds at 5 PM in the afternoon and didn't get more AFIB medication until 9AM the next morning.
Age: 94.0
Sex: F
Vaccine: COVID19-2
Symptoms: Loss of personal independence in daily activities, Lung disorder, Mobility decreased, Pneumonia, SARS-CoV-2 test negative
Clinical narrative: About three days after getting her shot, my mother woke up disoriented and unlike herself. She was lethargic and did not want to eat. She drank some tea and soup, and that's a quarter of what she usually eats. This was on Thursday evening, by that Friday she was not getting any better. I did a COVID-19 test on her. She was negative. It was hard for her to walk or move, I had to carry her to the bathroom. She was unable to get dressed. That Saturday she was worse and had to be physically lifted out of bed to go to the bathroom and she was completely weak and had extreme Flu like symptoms. She was coughing and when she tried to eat, she was having a very hard time swallowing and would choke on it. I called 911 to have the medics transfer to the hospital on that Saturday night around 9:30PM. They found at the ER she had lesions on liver, thyroid and right breast, Her X-Ray show her left lung was a third to a half clouded and the right lung a quarter to a third cloudy, and they diagnosed her with pneumonia. She was given medication at the hospital and an antibiotic regime for 5 to 6 days and it was not making any improvement. They changed the antibiotic and that was seemed to be making slight improvement, but then she developed sepsis. Then they made the choice to have a cardiologist change her meds due to her AFIB. The cardiologist changed the meds at 5 PM in the afternoon and didn't get more AFIB medication until 9AM the next morning.
Age: 94.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sepsis, Thyroid disorder
Clinical narrative: About three days after getting her shot, my mother woke up disoriented and unlike herself. She was lethargic and did not want to eat. She drank some tea and soup, and that's a quarter of what she usually eats. This was on Thursday evening, by that Friday she was not getting any better. I did a COVID-19 test on her. She was negative. It was hard for her to walk or move, I had to carry her to the bathroom. She was unable to get dressed. That Saturday she was worse and had to be physically lifted out of bed to go to the bathroom and she was completely weak and had extreme Flu like symptoms. She was coughing and when she tried to eat, she was having a very hard time swallowing and would choke on it. I called 911 to have the medics transfer to the hospital on that Saturday night around 9:30PM. They found at the ER she had lesions on liver, thyroid and right breast, Her X-Ray show her left lung was a third to a half clouded and the right lung a quarter to a third cloudy, and they diagnosed her with pneumonia. She was given medication at the hospital and an antibiotic regime for 5 to 6 days and it was not making any improvement. They changed the antibiotic and that was seemed to be making slight improvement, but then she developed sepsis. Then they made the choice to have a cardiologist change her meds due to her AFIB. The cardiologist changed the meds at 5 PM in the afternoon and didn't get more AFIB medication until 9AM the next morning.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Arthritis, Fall, Magnetic resonance imaging abnormal, Musculoskeletal stiffness
Clinical narrative: It was arthritis pain. I am going to a pain management doctor now. After about a week I noticed that I was stiffer, but I did not think much of it. It progressively got more noticeable where before it was an annoyance. The last couple of months the right side has been extremely painful. The pain in more in my right hip. I am doing physical therapy, but I am unable to determine whether I am improving. I use a TENS unit at home, and I was hoping that what I was taking for the left hip, which is hydrocodone, but it is not helping with the issue of my right leg. I take physical therapy 3 times a week for a month, and I do have the option of extending it. I suffered a fall on a Friday December 02, 2022, so they completed an x-ray and an MRI on December 07, 2022. I returned to the doctor on December 15, 2022.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, X-ray normal
Clinical narrative: It was arthritis pain. I am going to a pain management doctor now. After about a week I noticed that I was stiffer, but I did not think much of it. It progressively got more noticeable where before it was an annoyance. The last couple of months the right side has been extremely painful. The pain in more in my right hip. I am doing physical therapy, but I am unable to determine whether I am improving. I use a TENS unit at home, and I was hoping that what I was taking for the left hip, which is hydrocodone, but it is not helping with the issue of my right leg. I take physical therapy 3 times a week for a month, and I do have the option of extending it. I suffered a fall on a Friday December 02, 2022, so they completed an x-ray and an MRI on December 07, 2022. I returned to the doctor on December 15, 2022.
Age: 32.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient was given a dose of the undiluted (Gray cap) Pfizer COVID-19 Bivalent booster that was not stored in an ultra-cold temperature freezer and was instead stored in the regular freezer (between -30 to -20 F). It was moved out of the regular freezer to the refrigerator after more than 3 weeks in the regular freezer. The doses were then used after more than 24 hours in the refrigerator. We have contacted Pfizer about this and according to their studies they provided, they are not able to support the temperature excursions that occurred. As per CDC guidance, the recommendation is to re-vaccinate the individual with the full authorized dose of any Bivalent vaccine (either Pfizer or Moderna) and we have communicated with the patient for re-vaccination.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after three vaccines  Moderna 2/26/21 Lot# 025A21A;  Moderna 3/26/21 Lot# 008B21A;  Moderna 11/26/21 Lot# 034F21A
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered an expired vaccine; vaccine had expired on 12/16/2022. No adverse reaction to vaccine.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given past 30 day fridge use by date
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient was given a dose of the undiluted (Gray cap) Pfizer COVID-19 Bivalent booster that was not stored in an ultra-cold temperature freezer and was instead stored in the regular freezer (between -30 to -20 F). It was moved out of the regular freezer to the refrigerator after more than 3 weeks in the regular freezer. The doses were then used after more than 24 hours in the refrigerator. We have contacted Pfizer about this and according to their off-label studies they provided via PDF file, they are not able to support the temperature excursions that occurred. As per CDC guidance, the recommendation is to re-vaccinate the individual with the full authorized dose of any Bivalent vaccine (either Pfizer or Moderna) and we have communicated with the patient for re-vaccination.
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Agonal respiration, COVID-19, Cardiac arrest, Death
Clinical narrative: pt brought to ED earlier in the day with abnormal labs which included acute on chronic renal failure and positive for COVID; admission to hosp recommended by pt refused and was dc'd to home; later in the day, pt brought back to ED with nausea and inability to urinate; pt began agonal breathing with a drop in heart rate; asystole on the monitor; family informed and stated she is DNR/DNI; pt passed away in the hospital
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate decreased, Laboratory test abnormal, Nausea, SARS-CoV-2 test positive, Urinary retention
Clinical narrative: pt brought to ED earlier in the day with abnormal labs which included acute on chronic renal failure and positive for COVID; admission to hosp recommended by pt refused and was dc'd to home; later in the day, pt brought back to ED with nausea and inability to urinate; pt began agonal breathing with a drop in heart rate; asystole on the monitor; family informed and stated she is DNR/DNI; pt passed away in the hospital
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 3/23/21 Lot# 044A21A;  Moderna 4/20/21 Lot# 043B21A
Age: 73.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, Chest discomfort, Cough, Exposure to SARS-CoV-2, Feeling abnormal
Clinical narrative: My wife tested positive previously and I kept with my normal activity because I wasn't showing any symptoms. I ended up testing positive 5 days later, on 12/23/22. I woke up on 12/23/22, with a tight chest, cough, congestion, body aches, and runny nose. I just felt bad, I contacted my doctor and was prescribed 5 days worth of PAXLOVID. My symptoms started to improve after taking PAXLOVID.
Age: 73.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Pain, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: My wife tested positive previously and I kept with my normal activity because I wasn't showing any symptoms. I ended up testing positive 5 days later, on 12/23/22. I woke up on 12/23/22, with a tight chest, cough, congestion, body aches, and runny nose. I just felt bad, I contacted my doctor and was prescribed 5 days worth of PAXLOVID. My symptoms started to improve after taking PAXLOVID.
Age: 4.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient completed her 3 doses of Pfizer vaccine 10/2022.  I misunderstood the bivalent dose as a 4 year old and she got a 4th covid vaccine which was the pfizer bivalent.
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given Bivalent booster instead of number one primary
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: weakness; fatigue; server dizziness; This case was reported by a consumer via interactive digital media and described the occurrence of weakness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included pneumococcal vaccine (Pneumonia Vaccine) for prophylaxis.   On 15th October 2022, the patient received Shingles vaccine and Pneumonia Vaccine at an unknown dose and frequency. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced weakness, fatigue and dizziness. On an unknown date, the outcome of the weakness, fatigue and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the weakness, fatigue and dizziness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-DEC-2022 Reporter's Comment: This case was received from consumer via interactive digital media. The reporter stated that on 15th October 2022 the patient got a shingle shot and a pneumonia shot and had been going through weakness fatigue, server dizziness. The patient stated physician would not listen they keep ordering test. The reporter believes it's from the shingles shot. Additional supportive information: The follow up would not possible, as no contact details were available. It was unknown if the reporter considered the weakness, fatigue and dizziness to be related to Pneumonia vaccine.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Influenza A virus test negative, Influenza virus test negative, Pain, Respiratory symptom
Clinical narrative: I was having some upper respiratory issues and slight chills and body aches. I went to urgent care the next day and they tested me for COVID-19, Influenza A and B, and SARS and the Influenza A came back positive. I was given TAMIFLU and was on that for five days which helped after a couple days.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test negative
Clinical narrative: I was having some upper respiratory issues and slight chills and body aches. I went to urgent care the next day and they tested me for COVID-19, Influenza A and B, and SARS and the Influenza A came back positive. I was given TAMIFLU and was on that for five days which helped after a couple days.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 6/24/2 Lot# 011D21A;  Moderna 7/22/21 Lot# 007D21A
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given past 30 day fridge use by date
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Moderna 4/21/21 Lot# 002C21A;  Moderna 5/19/21 Lot# 043L20A;  Moderna 12/10/21 Lot# 031H21A
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dyspepsia, Fatigue, Incorrect product formulation administered, Lethargy, Pain
Clinical narrative: PATIENT WAS INFORMED OF THE ERROR MADE ON 12/27 ON 12/28. I ASKED THE PATIENT IF SHE WAS HAVING ANY SYMPTOMS, SHE STATED: TIRED, BODY ACHES, HEART BURN AND LATHARGIC. WHEN I ASKED IF SHE HAD ANY SYMPTOMS WITH THE FIRST COVID INJECTION SHE STATED THEY WERE PRETTY MUCH THE SAME JUST THE HEART BURN WAS DIFFERENT.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given past 30 day fridge use by date
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient was given a dose of the undiluted (Gray cap) Pfizer COVID-19 Bivalent booster that was not stored in an ultra-cold temperature freezer and was instead stored in the regular freezer (between -30 to -20 F). It was moved out of the regular freezer to the refrigerator after more than 3 weeks in the regular freezer. The doses were then used after more than 24 hours in the refrigerator. We have contacted Pfizer about this and according to their off-label studies they provided via PDF file, they are not able to support the temperature excursions that occurred. As per CDC guidance, the recommendation is to re-vaccinate the individual with the full authorized dose of any Bivalent vaccine (either Pfizer or Moderna) and we have communicated with the patient for re-vaccination.
Age: 88.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Malaise, Oropharyngeal pain
Clinical narrative: I contracted COVID-19 with symptoms of fever of 100.0, sore throat, cough, congestion, runny nose, and fatigue. I was prescribed PAXLOVID 12/17/22. I was ill for 3 days before my symptoms began to resolve. I am still experiencing a tickle in my throat and runny nose. I am not fully recovered yet.
Age: 88.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pyrexia, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: I contracted COVID-19 with symptoms of fever of 100.0, sore throat, cough, congestion, runny nose, and fatigue. I was prescribed PAXLOVID 12/17/22. I was ill for 3 days before my symptoms began to resolve. I am still experiencing a tickle in my throat and runny nose. I am not fully recovered yet.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chronic obstructive pulmonary disease, Condition aggravated, Death, Diuretic therapy
Clinical narrative: 3RD DOSE OF PFIZER COVID VACCINE GIVEN 9/1/21, LOT #FF2588; pt brought to hospital with COPD exacerbation and found to be positive for COVID; despite aggressive treatments (O2 supplementation, steroids, Remdesivir, diuretics, IV magnesium) pt made no improvements; was dc'd to a Hospice facility locally with comfort measures only; pt passed away in hospice
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: 3RD DOSE OF PFIZER COVID VACCINE GIVEN 9/1/21, LOT #FF2588; pt brought to hospital with COPD exacerbation and found to be positive for COVID; despite aggressive treatments (O2 supplementation, steroids, Remdesivir, diuretics, IV magnesium) pt made no improvements; was dc'd to a Hospice facility locally with comfort measures only; pt passed away in hospice
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given past 30 day fridge use by date
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Intensive care, Laboratory test, Mechanical ventilation, Oxygen saturation decreased
Clinical narrative: My smart watch alerted me to my oxygen levels had been lower for the last two months, a nursing student in my home helped me with an oxygen machine which I begin to use. My doctor hospitalized me where I stayed in ICU after 28 hours in the ER, I stayed hospitalized for seven days and recovered well with a ventilator I now use at night. Things are now back to relatively normal.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Musculoskeletal chest pain, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: Sunday, November 13, 2022, I had a scratchy throat and then it became sore.  It continued to get worse.  On Tuesday I began having a cough and it became so severe it felt like I was cracking my ribs.  I tested positive for COVID-19 on my home test.  I had a video visit with my doctor.  I was prescribed liquid cough syrup in the beginning but later Tessalon Perles for my cough.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Throat irritation
Clinical narrative: Sunday, November 13, 2022, I had a scratchy throat and then it became sore.  It continued to get worse.  On Tuesday I began having a cough and it became so severe it felt like I was cracking my ribs.  I tested positive for COVID-19 on my home test.  I had a video visit with my doctor.  I was prescribed liquid cough syrup in the beginning but later Tessalon Perles for my cough.