chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Headache, Hypoaesthesia, Influenza virus test negative, Paraesthesia
Clinical narrative: Client has numbness and tingling  in hands started about a week after vaccination, and is still continuing.  11/30/2022 No energy, sinus are sore, all over body weakness, headaches, fever, - S&S are still occurring.  Client reported having COVID in OCT of 2021, and in comparison having COVID was very mild and very easy compared to this reaction.   She has been taking cold medicine, decongest, tylenol.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Sinus pain
Clinical narrative: Client has numbness and tingling  in hands started about a week after vaccination, and is still continuing.  11/30/2022 No energy, sinus are sore, all over body weakness, headaches, fever, - S&S are still occurring.  Client reported having COVID in OCT of 2021, and in comparison having COVID was very mild and very easy compared to this reaction.   She has been taking cold medicine, decongest, tylenol.
Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: I received the Moderna Bivalent booster for COVID-19 on 9/9/2022. On 11/26/2022, I had coughing, sore throat, diarrhea, and a little shortness of breath. I took some DAYQUIL, which reduced some symptoms, but not all. On 11/27/2022, I took a home antigen test and got a positive result. I got a prescription for PAXLOVID that day. I felt better in about two days and rebounded on day 5. I'm currently doing fine, though I still have a little bit of fatigue and cough.
Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: I received the Moderna Bivalent booster for COVID-19 on 9/9/2022. On 11/26/2022, I had coughing, sore throat, diarrhea, and a little shortness of breath. I took some DAYQUIL, which reduced some symptoms, but not all. On 11/27/2022, I took a home antigen test and got a positive result. I got a prescription for PAXLOVID that day. I felt better in about two days and rebounded on day 5. I'm currently doing fine, though I still have a little bit of fatigue and cough.
Age: 74.0
Sex: M
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored, and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inadvertently administered Havrix vaccine sooner than required. I did not see the first dose Hepatitis A vaccine dose date for 12/12/2022.
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Blood test, Decreased appetite, Gastritis, Helicobacter test
Clinical narrative: The adverse event is I developed gastritis. Initially developed GI symptoms that lasted 3-4 days and loss of appetite/ nausea that still persists to today. About 2 weeks after the shot, I started getting severe stomach pains, went to the ER, and was diagnosed with gastritis due to ruling out differential diagnoses with imaging. I have struggled with gastritis symptoms off and on ever since the shot. I have never had issues with gastritis in my life.
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea
Clinical narrative: The adverse event is I developed gastritis. Initially developed GI symptoms that lasted 3-4 days and loss of appetite/ nausea that still persists to today. About 2 weeks after the shot, I started getting severe stomach pains, went to the ER, and was diagnosed with gastritis due to ruling out differential diagnoses with imaging. I have struggled with gastritis symptoms off and on ever since the shot. I have never had issues with gastritis in my life.
Age: 45.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: swelling and pain at injection site, headache, chills, tiredness, severe body aches all over body (same as each previous covid vaccination--see below. Each time the side effects are worse.  moderna 032120A on 1/27/2021 moderna 010A21A on 2/24/2021 Pfizer fH8028 on 11/30/2021
Age: 45.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Pain
Clinical narrative: swelling and pain at injection site, headache, chills, tiredness, severe body aches all over body (same as each previous covid vaccination--see below. Each time the side effects are worse.  moderna 032120A on 1/27/2021 moderna 010A21A on 2/24/2021 Pfizer fH8028 on 11/30/2021
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest pain, Dyspnoea
Clinical narrative: Patient came to ED with shortness of breath and chest pain.  Patient admitted to hospital with Covid.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: The patient called this morning and stated that she woke up with hives all over.  She had gotten a flu shot for the first time and wasn't sure if it was related.  She stated she did not changed soaps, detergents, or had any usual food.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Back pain, COVID-19, Chills, Cough, Fatigue
Clinical narrative: My adverse event started on 12/06/2022. In the morning around 8:00AM. I had a sore throat, chills, cough, fatigue, runny nose, and headaches. On 12/07/2022 I tested positive for COVID-19. I contacted my doctor on 12/08/2022. My doctor prescribed me PAXLOVID for 5 days and TYLENOL as per needed. I developed pain back after COVID-19 infection. As of today 12/16/2022 I still have some symptoms left. I am recovering slowly.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Headache, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: My adverse event started on 12/06/2022. In the morning around 8:00AM. I had a sore throat, chills, cough, fatigue, runny nose, and headaches. On 12/07/2022 I tested positive for COVID-19. I contacted my doctor on 12/08/2022. My doctor prescribed me PAXLOVID for 5 days and TYLENOL as per needed. I developed pain back after COVID-19 infection. As of today 12/16/2022 I still have some symptoms left. I am recovering slowly.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient to be boosted per CDC guidelines.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: Patient reports that RUE began to experience numbness shortly after receiving influenza vaccine in her Right Upper Deltoid. Numbness has improved; however, continues to report numbness to tips of two fingers.
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Patient who is an adult was given 0.25mL of the Moderna Bivalent COVID booster vaccine, which is less than the authorized dose of 0.50mL.  No adverse events were noted at the time of the administration.
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram coronary artery, Echocardiogram, Electrocardiogram, Palpitations
Clinical narrative: 10/3 heart palpitations
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue, Underdose
Clinical narrative: Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient to be boosted per CDC guidelines.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Minor is 11 yrs was given Moderna 12+ indavertently
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Myalgia
Clinical narrative: chills, myalgias, lasting 12 hours
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue, Underdose
Clinical narrative: Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient to be boosted per CDC guidelines.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: I had Covid-19, I got PAXLOVID; I feel better now but I am still recovering from the event.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Fatigue, Oropharyngeal pain, Productive cough, Respiratory tract congestion
Clinical narrative: On 12/10/2022, I started experiencing symptoms of sore throat, which turned into a wet, productive cough, congestion and fatigue. I tested for Covid-19 on 12/10/2022 and it was negative but received a positive result on 12/11/2022. I contacted my physician to inform them of a positive result. I was not eligible for PAXLOVID, but I was prescribed medication for my cough. I tested today, 12/16/2022 and the test was still positive.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: On 12/10/2022, I started experiencing symptoms of sore throat, which turned into a wet, productive cough, congestion and fatigue. I tested for Covid-19 on 12/10/2022 and it was negative but received a positive result on 12/11/2022. I contacted my physician to inform them of a positive result. I was not eligible for PAXLOVID, but I was prescribed medication for my cough. I tested today, 12/16/2022 and the test was still positive.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Administered monovalent vaccine for #3 dose instead of bivalent vaccine.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Administered monovalent vaccine for #3 dose should have administered bivalent vaccine.
Age: 92.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Bacterial test positive, Blood creatine phosphokinase normal, Blood creatinine normal, Blood lactic acid normal
Clinical narrative: Adverse event information provided in this submission, is per a report received by Health Department from a submitting facility. Health Department does not have any further information on this patient remaining hospital course or outcome. Please contact Hospital for any and all additional follow up.   Covid-19 vaccination information is from Immunization Registry.  MODERNA 3/11/2021 LOT # 001B21A  MODERNA 4/8/2021 LOT # 038B21A  MODERNA 12/22/2021 LOT # 013F21A  MODERNA BvlntBstr 10/3/2022 LOT # AS7148B  Admitted TO HOSPTIAL 11/13/2022 Per note submitted: ?Patient was sent to ED from her nursing home because of shortness of breath, cough and generalized weakness. Patient denies any chest pain, palpitations, lightheadedness etc. She is a poor historian and hence much of the information is obtained from previous notes. Review of systems is negative for any the findings. States to be compliant with her medications. Social history is negative for tobacco, alcohol or any recreational drugs. Upon examination of the bedside patient was lying in the bed in no apparent distress. She appeared weak. Her vitals are notable for T-max of 99.8, heart rate in the 70s, respirate r ate of 22 blood pressure was 125/72. She was saturating 100% on 3 L nasal cannula. Of note is the patient's saturation on admission was 85% on room air. Chemistry was notable for creatinine of 1.01 with BUN of 21 and GFR of 40. Troponin and CK within normal limit. CBC unremarkable. UA was positive for leukocyte esterase, nitrites, WBCs and bacteria. Chest x-ray was unremarkable. Patient was given empiric antibiotics, steroids in the E D and is being admitted to hospital for further management.? Health Department does not have any further information on this patient remaining hospital course or outcome. Contact Hospital for any and all additional follow up.
Age: 92.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood urea increased, Chest X-ray normal, Cough, Dyspnoea, Full blood count normal
Clinical narrative: Adverse event information provided in this submission, is per a report received by Health Department from a submitting facility. Health Department does not have any further information on this patient remaining hospital course or outcome. Please contact Hospital for any and all additional follow up.   Covid-19 vaccination information is from Immunization Registry.  MODERNA 3/11/2021 LOT # 001B21A  MODERNA 4/8/2021 LOT # 038B21A  MODERNA 12/22/2021 LOT # 013F21A  MODERNA BvlntBstr 10/3/2022 LOT # AS7148B  Admitted TO HOSPTIAL 11/13/2022 Per note submitted: ?Patient was sent to ED from her nursing home because of shortness of breath, cough and generalized weakness. Patient denies any chest pain, palpitations, lightheadedness etc. She is a poor historian and hence much of the information is obtained from previous notes. Review of systems is negative for any the findings. States to be compliant with her medications. Social history is negative for tobacco, alcohol or any recreational drugs. Upon examination of the bedside patient was lying in the bed in no apparent distress. She appeared weak. Her vitals are notable for T-max of 99.8, heart rate in the 70s, respirate r ate of 22 blood pressure was 125/72. She was saturating 100% on 3 L nasal cannula. Of note is the patient's saturation on admission was 85% on room air. Chemistry was notable for creatinine of 1.01 with BUN of 21 and GFR of 40. Troponin and CK within normal limit. CBC unremarkable. UA was positive for leukocyte esterase, nitrites, WBCs and bacteria. Chest x-ray was unremarkable. Patient was given empiric antibiotics, steroids in the E D and is being admitted to hospital for further management.? Health Department does not have any further information on this patient remaining hospital course or outcome. Contact Hospital for any and all additional follow up.
Age: 92.0
Sex: F
Vaccine: COVID19-2
Symptoms: Glomerular filtration rate decreased, Laboratory test abnormal, Metabolic function test normal, Nitrite urine present, Troponin normal
Clinical narrative: Adverse event information provided in this submission, is per a report received by Health Department from a submitting facility. Health Department does not have any further information on this patient remaining hospital course or outcome. Please contact Hospital for any and all additional follow up.   Covid-19 vaccination information is from Immunization Registry.  MODERNA 3/11/2021 LOT # 001B21A  MODERNA 4/8/2021 LOT # 038B21A  MODERNA 12/22/2021 LOT # 013F21A  MODERNA BvlntBstr 10/3/2022 LOT # AS7148B  Admitted TO HOSPTIAL 11/13/2022 Per note submitted: ?Patient was sent to ED from her nursing home because of shortness of breath, cough and generalized weakness. Patient denies any chest pain, palpitations, lightheadedness etc. She is a poor historian and hence much of the information is obtained from previous notes. Review of systems is negative for any the findings. States to be compliant with her medications. Social history is negative for tobacco, alcohol or any recreational drugs. Upon examination of the bedside patient was lying in the bed in no apparent distress. She appeared weak. Her vitals are notable for T-max of 99.8, heart rate in the 70s, respirate r ate of 22 blood pressure was 125/72. She was saturating 100% on 3 L nasal cannula. Of note is the patient's saturation on admission was 85% on room air. Chemistry was notable for creatinine of 1.01 with BUN of 21 and GFR of 40. Troponin and CK within normal limit. CBC unremarkable. UA was positive for leukocyte esterase, nitrites, WBCs and bacteria. Chest x-ray was unremarkable. Patient was given empiric antibiotics, steroids in the E D and is being admitted to hospital for further management.? Health Department does not have any further information on this patient remaining hospital course or outcome. Contact Hospital for any and all additional follow up.
Age: 92.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urine analysis abnormal, Urine leukocyte esterase positive, White blood cells urine positive
Clinical narrative: Adverse event information provided in this submission, is per a report received by Health Department from a submitting facility. Health Department does not have any further information on this patient remaining hospital course or outcome. Please contact Hospital for any and all additional follow up.   Covid-19 vaccination information is from Immunization Registry.  MODERNA 3/11/2021 LOT # 001B21A  MODERNA 4/8/2021 LOT # 038B21A  MODERNA 12/22/2021 LOT # 013F21A  MODERNA BvlntBstr 10/3/2022 LOT # AS7148B  Admitted TO HOSPTIAL 11/13/2022 Per note submitted: ?Patient was sent to ED from her nursing home because of shortness of breath, cough and generalized weakness. Patient denies any chest pain, palpitations, lightheadedness etc. She is a poor historian and hence much of the information is obtained from previous notes. Review of systems is negative for any the findings. States to be compliant with her medications. Social history is negative for tobacco, alcohol or any recreational drugs. Upon examination of the bedside patient was lying in the bed in no apparent distress. She appeared weak. Her vitals are notable for T-max of 99.8, heart rate in the 70s, respirate r ate of 22 blood pressure was 125/72. She was saturating 100% on 3 L nasal cannula. Of note is the patient's saturation on admission was 85% on room air. Chemistry was notable for creatinine of 1.01 with BUN of 21 and GFR of 40. Troponin and CK within normal limit. CBC unremarkable. UA was positive for leukocyte esterase, nitrites, WBCs and bacteria. Chest x-ray was unremarkable. Patient was given empiric antibiotics, steroids in the E D and is being admitted to hospital for further management.? Health Department does not have any further information on this patient remaining hospital course or outcome. Contact Hospital for any and all additional follow up.
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, Tachycardia
Clinical narrative: One incident of a-fib eight days after. Tachycardia.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Decreased appetite
Clinical narrative: I had a head cold, lots of mucus, chest infection, chest congestion, coughing, muscle weakness, extreme fatigue, headache, low grade fever, loss of appetite, and loss taste and smell for a couple of months. I work for a medical center, and they tested me there. I was positive for COVID-19. I talked to my doctor and told him I had COVID-19. He did not prescribe me anything, I just took over the counter medications.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Muscular weakness, Nasopharyngitis, Pyrexia
Clinical narrative: I had a head cold, lots of mucus, chest infection, chest congestion, coughing, muscle weakness, extreme fatigue, headache, low grade fever, loss of appetite, and loss taste and smell for a couple of months. I work for a medical center, and they tested me there. I was positive for COVID-19. I talked to my doctor and told him I had COVID-19. He did not prescribe me anything, I just took over the counter medications.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I had a head cold, lots of mucus, chest infection, chest congestion, coughing, muscle weakness, extreme fatigue, headache, low grade fever, loss of appetite, and loss taste and smell for a couple of months. I work for a medical center, and they tested me there. I was positive for COVID-19. I talked to my doctor and told him I had COVID-19. He did not prescribe me anything, I just took over the counter medications.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Headache, Pyrexia
Clinical narrative: Headache, chest and head congestion; coughing; fatigue and low grade fever 99.7 x 3 days.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Headache, chest and head congestion; coughing; fatigue and low grade fever 99.7 x 3 days.
Age: 24.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient presented to the health clinic. The patient stated he had wanted the flu and COVID Bivalent booster. He had proof of a primary series of Pfizer given by Pharmacy. He showed me a COVID vaccine card photo from his phone -that had one of the doses on it. The other dose was the only vaccine on immunization record. I proceeded and gave this patient a Pfizer Bivalent booster dose. I later found out that the second primary series dose given by the pharmacy was given too soon- only 14 days apart. It was then invalidated by immunization information system after an admin person here at our department entered his vaccine history based on the records he provided me to enter into the immunization information system. However, the immunization information system validated the Bivalent dose I gave him.  The patient was informed of this and instructed that revaccination was not indicated per CDC guidelines.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood glucose normal, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: A few minutes after administering the vaccine, patient began sweating and became very dizzy and nauseous. She was monitored and given a drink of water (Epi-pen brought but deemed not necessary). She began improving after given water. 911 was called and patient evaluated by EMTs; BP and blood sugar within normal limits. Patient improved enough to go home without going to hospital.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dizziness, Fatigue, Infection
Clinical narrative: I was lightheaded with a cough, exhaustion and congestion. On the 24th I started feeling ill and tested positive on the 26th and negative on the 28th and wasn't feeling better. I went to my doctor and he said I had a secondary respiratory infection and I was given antibiotics.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Respiratory tract congestion, Respiratory tract infection, SARS-CoV-2 test positive
Clinical narrative: I was lightheaded with a cough, exhaustion and congestion. On the 24th I started feeling ill and tested positive on the 26th and negative on the 28th and wasn't feeling better. I went to my doctor and he said I had a secondary respiratory infection and I was given antibiotics.
Age: 84.0
Sex: M
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored, and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Age: 78.0
Sex: F
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored, and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Imaging procedure, Joint range of motion decreased, Joint range of motion measurement, Loss of personal independence in daily activities, Musculoskeletal stiffness
Clinical narrative: About the 20th of June, I was visiting family, and in the morning at a hotel, I woke up with a terrible stiffness in primarily my left shoulder and left arm. I attributed it to maybe sleeping in a bad position because it was a weird bed. It didn't do go away. Gradually over the month of July, it faded. I noticed it was hard to wash my back with my left arm in the shower. It didn't bother me too much and I just ignored it. It continued to be an inconvenience and I attributed it to age. I got my 5th dose on 9/9/2022 and it was no big deal. I felt nothing out of the usual for the first 24 hours and everything seemed fine. Towards the end of September and beginning of October, my shoulder became much stiffer. I could not put on my suit jackets and shirts on well. I thought it was just age and just tried to work it out. I thought it would go away with time, but it didn't go away. I saw my primary care doctor, and she recommended I see PT or Orthopedic. At my regular check up, I told her that my shoulder was getting stiff and interfering with some activities so she recommended to see PT. A week later, I suddenly came down with a sinus infection and it was a weekend. I went to the local clinic and while getting checked out, he noticed when I was leaving that I was putting on my jacket on a weird way. He looked at me and said not to go to PT but to go to Orthopedic right away. 11/1/2022 was when I had an appointment with orthro and went through the range of motion, took images of my shoulder and x-rays. It was in that conversation that he told me that I have adhesive capsulitis of the left shoulder. He asked some questions and asked about the COVID-19 vaccines and I noted that they were all in my left arm and that's when he showed me some research that could be in relation to the vaccines. He said I'll have to go through physical therapy and it'll take probably a year to recover the motion. I'm more than a month into PT currently. I'm not sure if this is in relation the vaccine.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Periarthritis, Sinusitis, Ultrasound scan abnormal, X-ray limb
Clinical narrative: About the 20th of June, I was visiting family, and in the morning at a hotel, I woke up with a terrible stiffness in primarily my left shoulder and left arm. I attributed it to maybe sleeping in a bad position because it was a weird bed. It didn't do go away. Gradually over the month of July, it faded. I noticed it was hard to wash my back with my left arm in the shower. It didn't bother me too much and I just ignored it. It continued to be an inconvenience and I attributed it to age. I got my 5th dose on 9/9/2022 and it was no big deal. I felt nothing out of the usual for the first 24 hours and everything seemed fine. Towards the end of September and beginning of October, my shoulder became much stiffer. I could not put on my suit jackets and shirts on well. I thought it was just age and just tried to work it out. I thought it would go away with time, but it didn't go away. I saw my primary care doctor, and she recommended I see PT or Orthopedic. At my regular check up, I told her that my shoulder was getting stiff and interfering with some activities so she recommended to see PT. A week later, I suddenly came down with a sinus infection and it was a weekend. I went to the local clinic and while getting checked out, he noticed when I was leaving that I was putting on my jacket on a weird way. He looked at me and said not to go to PT but to go to Orthopedic right away. 11/1/2022 was when I had an appointment with orthro and went through the range of motion, took images of my shoulder and x-rays. It was in that conversation that he told me that I have adhesive capsulitis of the left shoulder. He asked some questions and asked about the COVID-19 vaccines and I noted that they were all in my left arm and that's when he showed me some research that could be in relation to the vaccines. He said I'll have to go through physical therapy and it'll take probably a year to recover the motion. I'm more than a month into PT currently. I'm not sure if this is in relation the vaccine.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: booster was given to a child less than 18 without them meeting criteria.  (not immunocompromised).  Vaccine given at mothers request.  No adverse reaction to vaccine.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Device connection issue, Syringe issue
Clinical narrative: RN injected patient's right deltoid until needle fully in muscle, pushed plunger and noticed 1-2 drops of vaccine leak from faulty connection between syringe and needle, continued to push plunger (no vaccine leakage) until syringe contents emptied, and attempted to withdraw syringe from patient's arm. While pulling on syringe, syringe separated from needle (syringe in RN's hand, needle in patient's arm). RN immediately removed needle from patient's arm with no incident and applied Band-Aid (no blood present). No complaints from patient regarding pain. RN later (same day) informed patient and patient's daughter (authorized representative) who agreed for patient to be revaccinated on 1/18/23 based on CDC guidelines to revaccinate immediately (no minimum interval) if patient received dose that is less than recommended per manufacturer.
Age: 65.0
Sex: M
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored, and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Asthenia, COVID-19, Death, Pneumonia aspiration
Clinical narrative: hospitalized for weakness secondary to COVID-19 infection and acute hypoxemic respiratory failure. Patient was known to be a high risk for aspiration. Symptomatic treatment for COVID was provided throughout admission.  Video swallow study with recommendations for extremely thick liquids and minced/moist solids. Diet was liberalized per patient preference after discussing risks of aspiration. Oxygen needs increased from 5 L to 15 L after that. Care team met with patient 11/22/2022 and discussed goals of care. Patient and spouse understood the risks of aspiration with an unrestricted diet. Initial goal was to improve patient's swallowing and eventually go to rehab. Patient's respiratory status continued to decline on his unrestricted diet. On 11/25 patient verbalized his desire to stop active care. Situation reviewed with wife and patient ultimately elected for comfort care. He was admitted to hospice 11/25. Died 11/30/2022 - immediate cause: aspiration pneumonia, due to consequence of COVID-19.  Submitter does not have access to further medical records. If more information is needed, please contact Hospital
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory disorder, SARS-CoV-2 test positive, Swallow study abnormal
Clinical narrative: hospitalized for weakness secondary to COVID-19 infection and acute hypoxemic respiratory failure. Patient was known to be a high risk for aspiration. Symptomatic treatment for COVID was provided throughout admission.  Video swallow study with recommendations for extremely thick liquids and minced/moist solids. Diet was liberalized per patient preference after discussing risks of aspiration. Oxygen needs increased from 5 L to 15 L after that. Care team met with patient 11/22/2022 and discussed goals of care. Patient and spouse understood the risks of aspiration with an unrestricted diet. Initial goal was to improve patient's swallowing and eventually go to rehab. Patient's respiratory status continued to decline on his unrestricted diet. On 11/25 patient verbalized his desire to stop active care. Situation reviewed with wife and patient ultimately elected for comfort care. He was admitted to hospice 11/25. Died 11/30/2022 - immediate cause: aspiration pneumonia, due to consequence of COVID-19.  Submitter does not have access to further medical records. If more information is needed, please contact Hospital
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient given Pfizer Bivalent for their 1st dose instead of Monovalent. Provider notified and she notified the parents before they left the office.
Age: 51.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: COVID-19, Chills, Cough, Fatigue, Feeling cold
Clinical narrative: On 12/12/2022, I felt cold and had a bit of a cough and fatigue. Tuesday night, I woke up at 2 AM with chills and took my temperature which was 101. Took an at home COVID-19 test on 12/14/2022 and it was positive. I still have a little bit of a cough and very congested. My fever hung around until 12/15/2022 but it seems to be gone for today. I am still feeling very tired with general body aches.
Age: 51.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Pain, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: On 12/12/2022, I felt cold and had a bit of a cough and fatigue. Tuesday night, I woke up at 2 AM with chills and took my temperature which was 101. Took an at home COVID-19 test on 12/14/2022 and it was positive. I still have a little bit of a cough and very congested. My fever hung around until 12/15/2022 but it seems to be gone for today. I am still feeling very tired with general body aches.
Age: 80.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored, and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthma, COVID-19, Condition aggravated, Cough, Feeling abnormal
Clinical narrative: I had a sore throat on 11/01/2022, I took a home COVID-19 test that came back negative. On Wednesday I awoke with a fever of 101F, coughing, sore throat. I called the doctor to see if they wanted me to retest for COVID-19. I woke up Thursday still feeling bad, my fever was still up, so I chose to test again as I had not heard back from the doctor's office yet. The COVID-19 test came back positive. Later that day I did hear back and had a telehealth with a nurse practioner who prescribed molnupiravir and advised that I also take Delsym. Three days taking the molnupiravir, in the evening I noticed a rash in my groin area was bright red and under my arm. I had an asthma attack, and my albuterol inhaler would not help. My husband took me to the emergency room. The emergency room doctor said it looked as if I was having an allergic reaction to the molnupiravir and to stop taking it immediately. He gave me a steroid and told me to see my PCP immediately the next day. I started having asthma attacks regularly, my PCP told me to see my pulmonologist. He changed my inhaler to Spiriva and gave me a round of prednisone. I am feeling much more like myself, slowing getting back to my Spring training.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, Pyrexia, Rash, Rash erythematous, SARS-CoV-2 test positive
Clinical narrative: I had a sore throat on 11/01/2022, I took a home COVID-19 test that came back negative. On Wednesday I awoke with a fever of 101F, coughing, sore throat. I called the doctor to see if they wanted me to retest for COVID-19. I woke up Thursday still feeling bad, my fever was still up, so I chose to test again as I had not heard back from the doctor's office yet. The COVID-19 test came back positive. Later that day I did hear back and had a telehealth with a nurse practioner who prescribed molnupiravir and advised that I also take Delsym. Three days taking the molnupiravir, in the evening I noticed a rash in my groin area was bright red and under my arm. I had an asthma attack, and my albuterol inhaler would not help. My husband took me to the emergency room. The emergency room doctor said it looked as if I was having an allergic reaction to the molnupiravir and to stop taking it immediately. He gave me a steroid and told me to see my PCP immediately the next day. I started having asthma attacks regularly, my PCP told me to see my pulmonologist. He changed my inhaler to Spiriva and gave me a round of prednisone. I am feeling much more like myself, slowing getting back to my Spring training.
Age: 1.08
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, MMRV, PNC13
Symptoms: Febrile convulsion, Influenza virus test negative, SARS-CoV-2 test negative
Clinical narrative: Febrile seizure that lasted 1 minute
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Bradycardia, Death, Device dependence, Haemodialysis, Hypotension
Clinical narrative: He remained BiPAP dependent and unable to manage secretions.  Hemodialysis was continued.  He declined required intubation and then initiation of pressor support.  He was covered for sepsis without significant improvement.  He was not stable enough to consider tracheostomy and that procedure was delayed.  Information was obtained from the outside hospital indicating that he had metastatic adenocarcinoma in the left pleural effusion.  Discussions were then held with his family regarding appropriate levels of care.  As they were considering he developed a brief arrest from which he was resuscitated.  After resuscitation the family did make him DNR active.  They agreed to discontinue hemodialysis with plans to withdraw the ventilator later this week.  However the patient became progressively hypotensive and bradycardic and expired at 7:05 a.m. on 12/14.  I notified his wife.
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Increased bronchial secretion, Lung adenocarcinoma, Mechanical ventilation, Pleural effusion, Positive airway pressure therapy
Clinical narrative: He remained BiPAP dependent and unable to manage secretions.  Hemodialysis was continued.  He declined required intubation and then initiation of pressor support.  He was covered for sepsis without significant improvement.  He was not stable enough to consider tracheostomy and that procedure was delayed.  Information was obtained from the outside hospital indicating that he had metastatic adenocarcinoma in the left pleural effusion.  Discussions were then held with his family regarding appropriate levels of care.  As they were considering he developed a brief arrest from which he was resuscitated.  After resuscitation the family did make him DNR active.  They agreed to discontinue hemodialysis with plans to withdraw the ventilator later this week.  However the patient became progressively hypotensive and bradycardic and expired at 7:05 a.m. on 12/14.  I notified his wife.
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Resuscitation, Sepsis
Clinical narrative: He remained BiPAP dependent and unable to manage secretions.  Hemodialysis was continued.  He declined required intubation and then initiation of pressor support.  He was covered for sepsis without significant improvement.  He was not stable enough to consider tracheostomy and that procedure was delayed.  Information was obtained from the outside hospital indicating that he had metastatic adenocarcinoma in the left pleural effusion.  Discussions were then held with his family regarding appropriate levels of care.  As they were considering he developed a brief arrest from which he was resuscitated.  After resuscitation the family did make him DNR active.  They agreed to discontinue hemodialysis with plans to withdraw the ventilator later this week.  However the patient became progressively hypotensive and bradycardic and expired at 7:05 a.m. on 12/14.  I notified his wife.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Feeling abnormal
Clinical narrative: 14 days after shot developed irregular A-Fib heartbeat for the first time in my life. 170 BPM heartbeat for over 4 hours. Thought I was going to die. Admitted to Hospital Emergency 2/4/2021 - 2/5/2021.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Musculoskeletal discomfort, Musculoskeletal stiffness, Nasal congestion
Clinical narrative: I DON'T THINK THIS IS ACTUALLY AN "ADVERSE EVENT" BUT I'M REPORTING IT SO IT CAN BE EVALUATED BY SOMEONE MORE INFORMED THAN ME. On about Dec. 1 I started to have some nose and throat congestion, mostly coughing, and increasing stiffness and and discomfort at the base of my neck. I thought is was a cold but at the suggestion of family took an at home Covid test on Dec. 2 which was negative, then another on Dec. 4, which was positive. I went to an immediate care clinic and discussed my condition and treatment options. The NP I talked to agreed that I was likely a little late to get the most out of treatment with Paxlovid, and said my vital signs were quite good, indicating I was pretty unlikely to get much worse and would likely get better pretty quickly. She gave me a prescription for Paxlovid with directions about other medications if I decided to use it, but told me it was my decision to take Paxlovid or not. I decided not to and I got better pretty quickly and was back pretty much to normal by Dec. 9-10. Negative at home Covid tests Dec. 5 and 6.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I DON'T THINK THIS IS ACTUALLY AN "ADVERSE EVENT" BUT I'M REPORTING IT SO IT CAN BE EVALUATED BY SOMEONE MORE INFORMED THAN ME. On about Dec. 1 I started to have some nose and throat congestion, mostly coughing, and increasing stiffness and and discomfort at the base of my neck. I thought is was a cold but at the suggestion of family took an at home Covid test on Dec. 2 which was negative, then another on Dec. 4, which was positive. I went to an immediate care clinic and discussed my condition and treatment options. The NP I talked to agreed that I was likely a little late to get the most out of treatment with Paxlovid, and said my vital signs were quite good, indicating I was pretty unlikely to get much worse and would likely get better pretty quickly. She gave me a prescription for Paxlovid with directions about other medications if I decided to use it, but told me it was my decision to take Paxlovid or not. I decided not to and I got better pretty quickly and was back pretty much to normal by Dec. 9-10. Negative at home Covid tests Dec. 5 and 6.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza A virus test negative, Influenza B virus test, Pyrexia, Streptococcus test negative, Vaccination site erythema
Clinical narrative: Patient began with a fever yesterday night of 101.0. Two occasions of vomiting without coughing. Also has swelling, and redness with local warmth around the site of the new season influenza vaccine.  Pt was given ibuprofen here in the office. Dr. examine patient and prescribed her Ibuprofen, Pedialyte, cetirizine, Albuterol. Pt has a follow-up on  12/20/2022 to see how she is doing.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site swelling, Vaccination site warmth, Vomiting
Clinical narrative: Patient began with a fever yesterday night of 101.0. Two occasions of vomiting without coughing. Also has swelling, and redness with local warmth around the site of the new season influenza vaccine.  Pt was given ibuprofen here in the office. Dr. examine patient and prescribed her Ibuprofen, Pedialyte, cetirizine, Albuterol. Pt has a follow-up on  12/20/2022 to see how she is doing.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Improperly stored vaccine involved in a temperature excursion was administered to a patient.; No additional AE reported; This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender.  No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions, or concomitant medications.  On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, which was improperly stored and involved in a temperature excursion (Product storage error). The patient received 1 unspecified dose, lot # W006595, with an expiration date on 10-OCT-2024, administered for prophylaxis (exact dose, anatomical location, and route of administration were not provided).  The dose of b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was exposed to a temperature excursion of 57.49 degrees Fahrenheit (°F) during a time frame of for 1 hour 45 minutes. No adverse events were reported.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Fatigue, Overdose, Pain
Clinical narrative: Pain and soroness; Fatigue; 2 doses on the same day; This case was reported by a other health professional via call center representative and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 20th November 2022, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On 20th November 2022, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced overdose. On an unknown date, the patient experienced pain and fatigue. On an unknown date, the outcome of the pain and fatigue were not recovered/not resolved and the outcome of the overdose was unknown.   It was unknown if the reporter considered the pain and fatigue to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 07-DEC-2022 Reporter's Comment: The reporter was a medical liaison for redacted with limited details. The reporter stated that a patient was administered with 2 doses of Shingrix on the same day and was now experiencing pain and soreness and fatigue. The reporter consent to follow up. Additional Supportive Information: The patient received two doses of Shingrix on the same day, which led to overdose.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in Oct2021, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose in October 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-DEC-2022 Reporter's Comments: The reporter did not provide the lot number an expiration date of the first dose administered. A pharmacist asked for information about a patient who received the first dose of Shingrix and then never received the second dose. The pharmacist asked if the patient needs only a booster dose of Shingrix or if it needs to start over with the vaccination. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Rash pruritic, Skin warm
Clinical narrative: Itching at the injection site; Itchy rash under skin near elbow; Warm to the touch; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2022, the patient received the 1st dose of Shingrix. In November 2022, less than 2 weeks after receiving Shingrix, the patient experienced itchy rash and skin warm. On an unknown date, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was recovered/resolved and the outcome of the itchy rash and skin warm were not recovered/not resolved.   It was unknown if the reporter considered the injection site itching, itchy rash and skin warm to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-DEC-2022 Reporter's Comment: The reporter was a patient. The patient stated that she received her first shingles vaccine dose 3 weeks ago in her left arm.  The patient stated that after received Shingrix vaccine she experienced little itching at the injection site that was went away.  The patient stated that now she has a itchy rash under her skin and near her elbow that appeared a week ago that was a little warm to the touch but not hot and it was can be felt but not seen.  No other information was provided. The patient did not know the lot number and expiration date of the shingrix vaccine she received. The patient was unable to give her phone number. The reporter did not consent to follow up