chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2, COVID19
Symptoms: Seizure, Unresponsive to stimuli, Urine analysis
Clinical narrative: Patient had a seizure and was not able to be awoken from sleep.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2, COVID19
Symptoms: Arthralgia, Myalgia, Pain, Restlessness, Scan
Clinical narrative: Patient had a seizure and was not able to be awoken from sleep.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2, COVID19
Symptoms: Seizure, Sleep disorder, Weight, Weight decreased
Clinical narrative: Patient had a seizure and was not able to be awoken from sleep.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test, Scan brain
Clinical narrative: Patient had a seizure and was not able to be awoken from sleep.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2, COVID19
Symptoms: Weight
Clinical narrative: Patient had a seizure and was not able to be awoken from sleep.
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pyrexia, Sneezing
Clinical narrative: Patient had a fever and excessive sneezing.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain, Back pain, Biopsy pancreas, Blood test, Chest pain
Clinical narrative: Severe abdominal pain, chest and back.     Pain was the worse I ever had.    When pain persisted through the next days,  I went to hospital and was admitted with acute pancreatitis.  This happened in September and then flared up in October, resulting in another trip to ER and another hospital stay
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Endoscopic ultrasound normal, Lipase increased, Pancreatitis acute, Pancreatitis relapsing
Clinical narrative: Severe abdominal pain, chest and back.     Pain was the worse I ever had.    When pain persisted through the next days,  I went to hospital and was admitted with acute pancreatitis.  This happened in September and then flared up in October, resulting in another trip to ER and another hospital stay
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: N/A. NO ADVERSE EVENT TO VACCINE. VACCINE OUTSIDE OF STORAGE REQUIREMENTS. REVACCINATION RECOMMENDED.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, PNC13
Symptoms: Wrong product administered
Clinical narrative: The provider ordered pediarix and I gave Dtap to patient. She was due for dtap as it is part pf the pediarix vaccine. The Hep B is not still due because she has had 3 doses. Pt will still need a 3rd polio vaccine. Pt's mom was informed of all of the above and will recieve IPV at next OV.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Decreased appetite, Exercise tolerance decreased, Fatigue
Clinical narrative: Starting 11/03/2022, I felt like I was getting the flu and I had a strange cough. I was tired but didn't have a fever. I stayed in bed for 48 hours and when I got up I did not have an appetite. I tested negative with a COVID-19 at home test on 11/05/2022 and I waited 48 hours before I tested myself again. On 11/07/2022, I tested myself again and was positive. I started coughing pretty severely but never at any point did I develop a fever. I would eventually test negative on 11/12/2022 with an at home COVID-19 test and ended up leaving the house on 11/14/2022 after testing negative again. I did call my doctor on 11/15/2022 to get some relief from the severe cough and was prescribed some cough medicine. I stayed in bed on 11/16/2022 and 11/17/2022 and I had a telehealth visit on 11/18/2022 for a follow up. At that time, I still had the nasal congestion, sinus drainage, severe fatigue and a cough. The symptoms slowly started to get better and by 11/24/2022 I felt well enough to have people over for the holiday but my cough was still quite persistent. It has slowly been improving since then and I have started back with some regular exercise at this point, and resumed more of my normal daily activities.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Nasal congestion, Paranasal sinus hypersecretion, SARS-CoV-2 test positive
Clinical narrative: Starting 11/03/2022, I felt like I was getting the flu and I had a strange cough. I was tired but didn't have a fever. I stayed in bed for 48 hours and when I got up I did not have an appetite. I tested negative with a COVID-19 at home test on 11/05/2022 and I waited 48 hours before I tested myself again. On 11/07/2022, I tested myself again and was positive. I started coughing pretty severely but never at any point did I develop a fever. I would eventually test negative on 11/12/2022 with an at home COVID-19 test and ended up leaving the house on 11/14/2022 after testing negative again. I did call my doctor on 11/15/2022 to get some relief from the severe cough and was prescribed some cough medicine. I stayed in bed on 11/16/2022 and 11/17/2022 and I had a telehealth visit on 11/18/2022 for a follow up. At that time, I still had the nasal congestion, sinus drainage, severe fatigue and a cough. The symptoms slowly started to get better and by 11/24/2022 I felt well enough to have people over for the holiday but my cough was still quite persistent. It has slowly been improving since then and I have started back with some regular exercise at this point, and resumed more of my normal daily activities.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Feeling cold, Malaise, Nausea
Clinical narrative: I started feeling nauseous. I had a fever. It got up to 102-degrees at its highest. I had a very sore throat. I didn't lose my appetite or sense of smell, but I had a weird taste in my mouth. As the day progressed, I started feeling worse. I got chills and couldn't get warm. I tested for COVID-19 at home that evening. The first test I took was a false negative. I tested again, and it came back positive. It progressively got worse. My sore throat got really painful for the next two nights. My doctor prescribed PAXLOVID. I took my last dose this morning.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, Pyrexia, SARS-CoV-2 test negative, SARS-CoV-2 test positive, Taste disorder
Clinical narrative: I started feeling nauseous. I had a fever. It got up to 102-degrees at its highest. I had a very sore throat. I didn't lose my appetite or sense of smell, but I had a weird taste in my mouth. As the day progressed, I started feeling worse. I got chills and couldn't get warm. I tested for COVID-19 at home that evening. The first test I took was a false negative. I tested again, and it came back positive. It progressively got worse. My sore throat got really painful for the next two nights. My doctor prescribed PAXLOVID. I took my last dose this morning.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness postural, Hypotension
Clinical narrative: I did not have an adverse reaction to the vaccine. On 11/25/22, I work up in the middle of the night and started to get up to go to the bathroom and got very lightheaded. I went on into the bathroom and got back to bed hoping to go back to sleep. I went to the emergency room for evaluation. My blood pressure was low and all other vitals where within normal range. The doctor and nurses in the emergency room said that I got up to fast. They told me I needed to slow down getting up in the morning.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chills, Cough, Dysphonia
Clinical narrative: I received my Moderna booster for COVID-19 on 12/4/2021. On 6/7/2022, I began to feel really run-down during the evening. I also developed a sore throat, hoarseness, and a headache. The symptoms continued into the morning of 6/8/2022. On 6/8/2022, I also had chills and fever; I don't know what my temperature was, since I was unable to find my thermometer. During that night, I developed body aches while I was in bed. By midday on 6/9/2022, the chills, body aches, and fever all dissipated. From that point, I just had sniffles, runny nose, fatigue, and no energy; I basically just felt like I had a cold. On 6/10/2022, I had a minor cough that lasted only briefly. On 6/10/2022, I took a home antigen test, which yielded a positive result. During the next couple of weeks, I had lingering cold-like symptoms like fatigue, lack of energy, runny nose, and headache. I felt better some days and felt worse on other days. The symptoms just waxed and waned. I finally felt like I had made a complete recovery by 6/22/2022.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: I received my Moderna booster for COVID-19 on 12/4/2021. On 6/7/2022, I began to feel really run-down during the evening. I also developed a sore throat, hoarseness, and a headache. The symptoms continued into the morning of 6/8/2022. On 6/8/2022, I also had chills and fever; I don't know what my temperature was, since I was unable to find my thermometer. During that night, I developed body aches while I was in bed. By midday on 6/9/2022, the chills, body aches, and fever all dissipated. From that point, I just had sniffles, runny nose, fatigue, and no energy; I basically just felt like I had a cold. On 6/10/2022, I had a minor cough that lasted only briefly. On 6/10/2022, I took a home antigen test, which yielded a positive result. During the next couple of weeks, I had lingering cold-like symptoms like fatigue, lack of energy, runny nose, and headache. I felt better some days and felt worse on other days. The symptoms just waxed and waned. I finally felt like I had made a complete recovery by 6/22/2022.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I received my Moderna booster for COVID-19 on 12/4/2021. On 6/7/2022, I began to feel really run-down during the evening. I also developed a sore throat, hoarseness, and a headache. The symptoms continued into the morning of 6/8/2022. On 6/8/2022, I also had chills and fever; I don't know what my temperature was, since I was unable to find my thermometer. During that night, I developed body aches while I was in bed. By midday on 6/9/2022, the chills, body aches, and fever all dissipated. From that point, I just had sniffles, runny nose, fatigue, and no energy; I basically just felt like I had a cold. On 6/10/2022, I had a minor cough that lasted only briefly. On 6/10/2022, I took a home antigen test, which yielded a positive result. During the next couple of weeks, I had lingering cold-like symptoms like fatigue, lack of energy, runny nose, and headache. I felt better some days and felt worse on other days. The symptoms just waxed and waned. I finally felt like I had made a complete recovery by 6/22/2022.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMRV, TDAP, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient was given an extra dose of Varicella.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event.  Vaccine expired on 11/11/2022 while vaccine was given on 11/14/2022.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Patient had breakthrough infection.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Immediate post-injection reaction, Injection site pain, Pain, Pain in extremity
Clinical narrative: Upon injection,  burning at injection site (expected). Burn area the size of open hand spread out, traveled down outside left upper arm into armpit and into elbow and inside forearm to wrist by day 3. Day 3, 4, and 5, pain held at inside forearm and started radiating into base of left thumb. Day 5 - pain in injection site is waning, inside forearm still sore to touch. Tingling in left hand upon waking in the morning. Arm is irritated all day. Pain slightly alleviated with 500 acetaminophen taken on day 3 and 4.  Contacted my Dr through Portal email, no return response yet.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Skin irritation, Tenderness
Clinical narrative: Upon injection,  burning at injection site (expected). Burn area the size of open hand spread out, traveled down outside left upper arm into armpit and into elbow and inside forearm to wrist by day 3. Day 3, 4, and 5, pain held at inside forearm and started radiating into base of left thumb. Day 5 - pain in injection site is waning, inside forearm still sore to touch. Tingling in left hand upon waking in the morning. Arm is irritated all day. Pain slightly alleviated with 500 acetaminophen taken on day 3 and 4.  Contacted my Dr through Portal email, no return response yet.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal discomfort, Bedridden, Computerised tomogram thorax abnormal, Cough, Decreased appetite
Clinical narrative: I had the flu shot the same day as the Covid vaccine. At the sight of the shot, I had swelling and soreness that lasted a couple of days. Then a few days later I had a fever and aching in my muscles and my stomach was a bit upset. This low-grade fever escalated to a 106 fever. It took about 5 days to get it down to a normal fever, but I could not shake off this fever of 101 for weeks. I was aching all over and did not have an appetite. I was bed ridden, a lot of coughing and phlegm. Eventually the doctor did tests and confirmed I had double pneumonia. My hands and feet were really cold, but I felt hot. They prescribed me medication to bring down the fever and over the counter medication to help with the phlegm. This went on I would say around 5 yo 6 weeks before I started the path to recovery.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Feeling hot, Myalgia, Pain, Peripheral coldness, Pneumonia
Clinical narrative: I had the flu shot the same day as the Covid vaccine. At the sight of the shot, I had swelling and soreness that lasted a couple of days. Then a few days later I had a fever and aching in my muscles and my stomach was a bit upset. This low-grade fever escalated to a 106 fever. It took about 5 days to get it down to a normal fever, but I could not shake off this fever of 101 for weeks. I was aching all over and did not have an appetite. I was bed ridden, a lot of coughing and phlegm. Eventually the doctor did tests and confirmed I had double pneumonia. My hands and feet were really cold, but I felt hot. They prescribed me medication to bring down the fever and over the counter medication to help with the phlegm. This went on I would say around 5 yo 6 weeks before I started the path to recovery.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Productive cough, Pyrexia, SARS-CoV-2 test negative, Swelling
Clinical narrative: I had the flu shot the same day as the Covid vaccine. At the sight of the shot, I had swelling and soreness that lasted a couple of days. Then a few days later I had a fever and aching in my muscles and my stomach was a bit upset. This low-grade fever escalated to a 106 fever. It took about 5 days to get it down to a normal fever, but I could not shake off this fever of 101 for weeks. I was aching all over and did not have an appetite. I was bed ridden, a lot of coughing and phlegm. Eventually the doctor did tests and confirmed I had double pneumonia. My hands and feet were really cold, but I felt hot. They prescribed me medication to bring down the fever and over the counter medication to help with the phlegm. This went on I would say around 5 yo 6 weeks before I started the path to recovery.
Age: 31.0
Sex: F
Vaccine: FLUR4
Symptoms: Anaphylactic reaction, Dizziness, Feeling abnormal, Loss of consciousness, Pharyngeal swelling
Clinical narrative: Aprox 40 min after vaccine, pt was walking dog and started feeling funny i.e light headed, swelling tongue/throat, dizzy and felt like she was having an anaphylactic reaction. Her husband transported her to Care Clinic where she fainted in the waiting area and was unconscious for about 1 min. BP 60/30 - O2% 81 on room air. Clinic admin IV fluid, Benadryl PO and called ambulance. Admin IM Epi, zofran. decadron, and ativan. Pt arrived at hospital and was monitored aprox 5-6 hours until release. They were unsure if this was anaphylaxis related to flu vaccine (which she gets every year w/o incidence) or another outside factor. Pt is well versed in anaphylaxis and states she has never had before and has not changed any household or beauty products that might cause any type of reaction.
Age: 31.0
Sex: F
Vaccine: FLUR4
Symptoms: Swollen tongue, Syncope
Clinical narrative: Aprox 40 min after vaccine, pt was walking dog and started feeling funny i.e light headed, swelling tongue/throat, dizzy and felt like she was having an anaphylactic reaction. Her husband transported her to Care Clinic where she fainted in the waiting area and was unconscious for about 1 min. BP 60/30 - O2% 81 on room air. Clinic admin IV fluid, Benadryl PO and called ambulance. Admin IM Epi, zofran. decadron, and ativan. Pt arrived at hospital and was monitored aprox 5-6 hours until release. They were unsure if this was anaphylaxis related to flu vaccine (which she gets every year w/o incidence) or another outside factor. Pt is well versed in anaphylaxis and states she has never had before and has not changed any household or beauty products that might cause any type of reaction.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest X-ray normal, Productive cough, Sinus disorder
Clinical narrative: I tested on November Seventh and did a video call with my Doctor who prescribed Paxlovid for five days, I began symptoms of a sinus infection @ 11/19/2022. On the 20th of November I was prescribed Augmentin. I had a very deep wet cough and it led to the doctor prescribing a chest x-ray on November 28th 2022 which resulted  no result. On November the 27th I was having pain left hip that remains an t the time of the reporting this event. On November 21st my Doctor changed my prescription from Flovent to Advair 250.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient was given a Varicella vaccination which expired 13 days prior to administration. The manufacturer was contacted and "confirmed internal stability data to support the potency of the dose through the date it was given. The patient does not need to be revaccinated and there is no additional risk to the patient beyond the normal adverse effects associated with the vaccine." The patient was notified and suffered no adverse effects from the Varicella vaccination.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Laboratory test, Retching
Clinical narrative: Diarrhea, chills, dry heaves. Went to hospital was admitted stayed 5 days.
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, Interchange of vaccine products
Clinical narrative: PATIENT RECIEVED COVID PFIZER BIVALENT VACCINE ASSUMING IT WAS GOING TO BE IS INITAL DOSE SERIOUS DUE TO THE FACT THAT THIS PRIOR COVID SERIOUS (SPUTNIK V) ARE NOT RECOGNIZED BY THE US.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: N/A. NO ADVERSE EVENT TO VACCINE. VACCINE OUTSIDE OF STORAGE REQUIREMENTS. REVACCINATION RECOMMENDED.
Age: 44.0
Sex: F
Vaccine: UNK
Symptoms: Immediate post-injection reaction, Injection site pain, Joint range of motion decreased, Musculoskeletal stiffness
Clinical narrative: Severe pain upon injection of vaccine. The doctor apologized and said tetanus vaccine hurts because it?s intramuscular.  Immediate pain, stiffness of shoulder. Limited range of motion occurred next day.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Patient had breakthrough infection.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Electrocardiogram, Fatigue, Full blood count, Panic attack
Clinical narrative: Patient had fever, chills, and fatigue. Subsequently, he developed one month of panic attacks.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Patient had fever, chills, and fatigue. Subsequently, he developed one month of panic attacks.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: High Dose administered to a 64 year old patient.  No adverse event was reported.
Age: 46.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Blood test normal, Pruritus, Urticaria
Clinical narrative: Beginning in the first week in November I started developing a severe hives. I went to urgent care and was prescribed antihistamine. It was successful in treating the itching but not the hives. I was referred to a Dermatologist and she put me on a 16 day course of prednisone. At this time I have not improved. My next step would be to see an allergist if my condition does not improve.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Pt came in to clinic this morning @ 0900 for Influenza Vaccine. Completed Questionnaire  and answered "no" to having any allergies or allergic reactions to previous vaccines. Received vaccine and left clinic after 15min.  @ 1050 same day, patient returned to clinic coughing and c/o not being able to take deep breath. Denied SOB, Rash, Vomiting, dysphagia. Was given 50mg of Dipenhydramine @ 1053. VSS, O2 Sats= 99-100% on RA. Started Albuterol Nebulizer Treatment. Pt less coughing and VSS, but continued to c/o feeling  he could not take a deep breath in and something was sitting on his chest. 1135 Administered EpiPen 0.3mg.  1144 (EMS) arrived,  Pt states he is feeling some relief with chest pressure. Pt taken via ambulance to nearest ER for further evaluation and care.
Age: 64.0
Sex: F
Vaccine: FLU4, FLUC4
Symptoms: Extra dose administered, Incorrect dose administered, No adverse event, Wrong product administered
Clinical narrative: A flu vaccine, and Td vaccine were ordered to be performed. In error, two flu vaccines were administered. One high dose, and one normal dose.  The Td vaccine was not administered.  The patient did not have any adverse reactions.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema
Clinical narrative: This is a 66 y/o female presenting to office for f/u reaction pneumovax injection. Patient reports she started experiencing some circular redness around the injection site starting Friday night. It has now grown to a softball sized circular region on left shoulder region.  1. Vaccine reaction, initial encounter (Primary) Assessment & Plan: Doxycycline 100mg BID x 7 days.  Medrol pack as ordered.  Pepcid 40mg daily.  Advised if this worsens, to notify provider.      Orders: -     doxycycline (VIBRAMYCIN) 100 MG capsule; Take 1 capsule by mouth 2 (Two) Times a Day for 7 days.  Dispense: 14 capsule; Refill: 0 -     methylPREDNISolone (MEDROL) 4 MG dose pack; Take as directed on package instructions.  Dispense: 21 each; Refill: 0
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given 14 days after beyond use date.
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was scheduled with siblings to receive COVID booster. After administering the Pfizer 5-11 bivalent booster it was realized that the patient never received her 2nd dose of the primary dose. Reviewed with CDC and was told to treat as her second dose and that she should receive the bivalent booster in 2 months.
Age: 13.0
Sex: F
Vaccine: FLUR4
Symptoms: Incorrect product formulation administered, Product administered to patient of inappropriate age
Clinical narrative: Patient received an incorrect Flu vaccine.  She received FluBlok ( 18 years and old) when she was only 13 years old.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: N/A. NO ADVERSE EVENT TO VACCINE. VACCINE OUTSIDE OF STORAGE REQUIREMENTS. REVACCINATION RECOMMENDED.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Fatigue, Headache, Hypophagia
Clinical narrative: Saturday at 3AM, I woke up with pain in my left arm. I sleep on the side, so I must have turned over on my left side and it hurt right away. It was my arm that was hurting and it felt like it was up my neck. I hurt down all my left side. Within minutes, it triggered a migraine. It makes sense if pain is coming from my neck, it can trigger a migraine. I got up and took my UBRELVY and that at least stopped the migraine. The pain in my body was still persistent from my head to my left side. By the time I got up, I was pretty exhausted. I couldn't go anywhere that day. I was supposed to go somewhere but I couldn't because I was sick all day. I couldn't get up and I barely ate. It was like a flu. I was sick to my stomach, very weak and I was in bed all day. I don't remember what happened over the night. By Sunday, I was feeling a little better. I didn't leave the house all day Saturday because I didn't feel well. I'm usually active doing things around the house or outside and doing normal daily activities, but I could not do any of that that day. By the beginning of the week on Monday, I was starting to feel back to normal. I talked to some neighbors and they also experienced some kind of flu like symptoms after their 2nd booster. These neighbors are all 70 years or older. I had three vaccines before this one, and I've never experienced the migraine and pain in the arm. It was unlike me to be in bed all day.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Malaise, Migraine, Mobility decreased, Neck pain
Clinical narrative: Saturday at 3AM, I woke up with pain in my left arm. I sleep on the side, so I must have turned over on my left side and it hurt right away. It was my arm that was hurting and it felt like it was up my neck. I hurt down all my left side. Within minutes, it triggered a migraine. It makes sense if pain is coming from my neck, it can trigger a migraine. I got up and took my UBRELVY and that at least stopped the migraine. The pain in my body was still persistent from my head to my left side. By the time I got up, I was pretty exhausted. I couldn't go anywhere that day. I was supposed to go somewhere but I couldn't because I was sick all day. I couldn't get up and I barely ate. It was like a flu. I was sick to my stomach, very weak and I was in bed all day. I don't remember what happened over the night. By Sunday, I was feeling a little better. I didn't leave the house all day Saturday because I didn't feel well. I'm usually active doing things around the house or outside and doing normal daily activities, but I could not do any of that that day. By the beginning of the week on Monday, I was starting to feel back to normal. I talked to some neighbors and they also experienced some kind of flu like symptoms after their 2nd booster. These neighbors are all 70 years or older. I had three vaccines before this one, and I've never experienced the migraine and pain in the arm. It was unlike me to be in bed all day.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Saturday at 3AM, I woke up with pain in my left arm. I sleep on the side, so I must have turned over on my left side and it hurt right away. It was my arm that was hurting and it felt like it was up my neck. I hurt down all my left side. Within minutes, it triggered a migraine. It makes sense if pain is coming from my neck, it can trigger a migraine. I got up and took my UBRELVY and that at least stopped the migraine. The pain in my body was still persistent from my head to my left side. By the time I got up, I was pretty exhausted. I couldn't go anywhere that day. I was supposed to go somewhere but I couldn't because I was sick all day. I couldn't get up and I barely ate. It was like a flu. I was sick to my stomach, very weak and I was in bed all day. I don't remember what happened over the night. By Sunday, I was feeling a little better. I didn't leave the house all day Saturday because I didn't feel well. I'm usually active doing things around the house or outside and doing normal daily activities, but I could not do any of that that day. By the beginning of the week on Monday, I was starting to feel back to normal. I talked to some neighbors and they also experienced some kind of flu like symptoms after their 2nd booster. These neighbors are all 70 years or older. I had three vaccines before this one, and I've never experienced the migraine and pain in the arm. It was unlike me to be in bed all day.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was under ~ 17 1/2 yrs old at time of vaccine administration.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Device connection issue, Syringe issue, Underdose
Clinical narrative: Needle was inserted into patient's arm and as the plunger of the syringe was being pushed down, the syringe and needle separated. The patient got less than half the dose and the rest went onto the floor after the two separated.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt under 18 at time of administration. No adverse event as per patient.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Cardio-respiratory arrest, Chest X-ray abnormal, Death
Clinical narrative: 11/2/21 pt to ED with c/o SOB; states had a positive COVID test 4 days earlier; pt tested positive in ED; CXR showed COVID pneumonia; O2 supplementation; O2 sats began to drop; transferred to MICU; given Decadron, ABX, Combivent Inhaler; suffered cardiopulmonary arrest and passed away in the hospital
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Intensive care, Oxygen saturation decreased, SARS-CoV-2 test positive
Clinical narrative: 11/2/21 pt to ED with c/o SOB; states had a positive COVID test 4 days earlier; pt tested positive in ED; CXR showed COVID pneumonia; O2 supplementation; O2 sats began to drop; transferred to MICU; given Decadron, ABX, Combivent Inhaler; suffered cardiopulmonary arrest and passed away in the hospital
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Coordination abnormal, Laboratory test, Polyneuropathy
Clinical narrative: Patient rapidly lost strength and coordination in legs followed by his arms about a week later
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test positive, Blood glucose increased, Blood test, Dyspnoea, Glycosylated haemoglobin increased
Clinical narrative: I received my Moderna COVID-19 booster on 12/5/2021. A few days after getting the booster, I experienced shortness of breath, and I assumed it was caused by anxiety. On the night of 12/20/2021, I woke up 3 times to go urinate, which is very unusual for me. On the night of 12/22/2021, it happened again; I had to get up to urinate about 3 or 4 times. While I was urinating, I noticed that my urine had a different smell; it actually had a sweet scent. I work at a hospital, so when I went to work on the morning of 12/23/2021, I asked a coworker to check my blood sugar with a blood glucose meter; when he did, my blood glucose was at 442. I was in disbelief, and since I had had a caramel macchiato earlier that morning, I felt that that must have been the cause of the high reading. On 12/23/2021, when I came to work, I again asked my coworker to check my blood glucose level. This time, I had previously fasted for 12 hours to ensure an accurate reading; this time, my blood glucose measured at 412. I was now very concerned, so I asked a doctor I work with to order some lab work (blood work, urinalysis) for me. When the lab work was done, it was found that my A1C level was 9.2, plus my urine tested positive for the presence of ketones. The doctor was very concerned, so he sent me to a general practitioner to have further tests done. The doctor who had run the tests gave me a diagnosis of type II diabetes. After the GP did further lab work, though, the diagnosis was changed to type I diabetes. The doctor who had done the first lab work immediately put me on insulin. Ever since then, I have regularly taken insulin, cut out carbs, exercised, and watched my diet very carefully. I was really surprised to get the diabetes diagnosis, though, because I take pretty good care of myself. I don't smoke or drink, and I have always had a pretty healthy diet. I don't know if there is a relationship between the booster and my diabetes, but it is strange that I didn't begin having the symptoms of diabetes until shortly after getting the booster. I also still experience shortness of breath, though it's not as frequent now as it was in the beginning. I now wonder if the shortness of breath was caused by something other than anxiety.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Nocturia, Type 1 diabetes mellitus, Urine analysis abnormal, Urine ketone body present
Clinical narrative: I received my Moderna COVID-19 booster on 12/5/2021. A few days after getting the booster, I experienced shortness of breath, and I assumed it was caused by anxiety. On the night of 12/20/2021, I woke up 3 times to go urinate, which is very unusual for me. On the night of 12/22/2021, it happened again; I had to get up to urinate about 3 or 4 times. While I was urinating, I noticed that my urine had a different smell; it actually had a sweet scent. I work at a hospital, so when I went to work on the morning of 12/23/2021, I asked a coworker to check my blood sugar with a blood glucose meter; when he did, my blood glucose was at 442. I was in disbelief, and since I had had a caramel macchiato earlier that morning, I felt that that must have been the cause of the high reading. On 12/23/2021, when I came to work, I again asked my coworker to check my blood glucose level. This time, I had previously fasted for 12 hours to ensure an accurate reading; this time, my blood glucose measured at 412. I was now very concerned, so I asked a doctor I work with to order some lab work (blood work, urinalysis) for me. When the lab work was done, it was found that my A1C level was 9.2, plus my urine tested positive for the presence of ketones. The doctor was very concerned, so he sent me to a general practitioner to have further tests done. The doctor who had run the tests gave me a diagnosis of type II diabetes. After the GP did further lab work, though, the diagnosis was changed to type I diabetes. The doctor who had done the first lab work immediately put me on insulin. Ever since then, I have regularly taken insulin, cut out carbs, exercised, and watched my diet very carefully. I was really surprised to get the diabetes diagnosis, though, because I take pretty good care of myself. I don't smoke or drink, and I have always had a pretty healthy diet. I don't know if there is a relationship between the booster and my diabetes, but it is strange that I didn't begin having the symptoms of diabetes until shortly after getting the booster. I also still experience shortness of breath, though it's not as frequent now as it was in the beginning. I now wonder if the shortness of breath was caused by something other than anxiety.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Urine odour abnormal
Clinical narrative: I received my Moderna COVID-19 booster on 12/5/2021. A few days after getting the booster, I experienced shortness of breath, and I assumed it was caused by anxiety. On the night of 12/20/2021, I woke up 3 times to go urinate, which is very unusual for me. On the night of 12/22/2021, it happened again; I had to get up to urinate about 3 or 4 times. While I was urinating, I noticed that my urine had a different smell; it actually had a sweet scent. I work at a hospital, so when I went to work on the morning of 12/23/2021, I asked a coworker to check my blood sugar with a blood glucose meter; when he did, my blood glucose was at 442. I was in disbelief, and since I had had a caramel macchiato earlier that morning, I felt that that must have been the cause of the high reading. On 12/23/2021, when I came to work, I again asked my coworker to check my blood glucose level. This time, I had previously fasted for 12 hours to ensure an accurate reading; this time, my blood glucose measured at 412. I was now very concerned, so I asked a doctor I work with to order some lab work (blood work, urinalysis) for me. When the lab work was done, it was found that my A1C level was 9.2, plus my urine tested positive for the presence of ketones. The doctor was very concerned, so he sent me to a general practitioner to have further tests done. The doctor who had run the tests gave me a diagnosis of type II diabetes. After the GP did further lab work, though, the diagnosis was changed to type I diabetes. The doctor who had done the first lab work immediately put me on insulin. Ever since then, I have regularly taken insulin, cut out carbs, exercised, and watched my diet very carefully. I was really surprised to get the diabetes diagnosis, though, because I take pretty good care of myself. I don't smoke or drink, and I have always had a pretty healthy diet. I don't know if there is a relationship between the booster and my diabetes, but it is strange that I didn't begin having the symptoms of diabetes until shortly after getting the booster. I also still experience shortness of breath, though it's not as frequent now as it was in the beginning. I now wonder if the shortness of breath was caused by something other than anxiety.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Patient had breakthrough infection.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Wheezing
Clinical narrative: It started with a cough that would not go away. I do have environmental cough for years, but after this vaccine the cough changed to wheezing. I do not know if it was environment or it was triggered by the vaccine or maybe the vaccine made it worse, but I cannot shake off this cough.
Age: 19.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pt was given the varicella vaccine too close to the MMR.   No adverse side effects.      Pt timeline:  11/21- MMR #1  12/2- Varicella #1 (only 11 days from previous live virus vaccine MMR).
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient accidently received 2 influenza shots in 1 day.  Patient received influenza vaccine at the md office and later got another influenza vaccine at pharmacy by accident. Patient was fine and did not have any reactions on the next day when follow up call was made.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Death, Dyspnoea, Respiratory distress
Clinical narrative: pt brought to ED, cardiac arrest; EMS was called to pick up pt due to SOB and respiratory distress; pt arrested when EMS arrived; history of COVID; pt passed away in the ED
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A vaccine was given that expired on 12/02/2022
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient has only received one dose of the Moderna monovalent vaccine a fact which was missed by the pharmacy staff. This caused the patient to receive the Bivalent booster when in fact she should've received the Monovalent vaccine. Upon realization of the mistake the error was reported to the district manager for pharmacy and after reviewing the protocol we offered the patient the option to receive to proper vaccination to complete her series. At the time she declined to return into the store and stated that she may at a later point with the stipulation that she must return prior to the 1st of the year due to the monovalent vaccine being fazed out.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient < 18 at time of vaccine administration - no known adverse event.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given 7 days after the use by date.
Age: 36.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: none
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Patient had a breakthrough infection.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: It did not need to be treatment and called Mother and let her know about vaccination. Mother understood about it.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient reports: Vaccine reaction symptoms (swelling, redness, warmth, itching) have completely resolved. She states she is "back to normal". Thursday 12/1: Lot of swelling all over arm and shoulder and warm. Monday 12/5, a week after the vaccine they have redness spreading 4 inches in diameter from injection site and itchy. Taking Benadryl helped a little bit, but mostly time allowed the symptoms to resolve.
Age: 1.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received an accidental 4th dose of the Pfizer 6mo-4year dose.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given 5 days after beyond use date.
Age: 1.33
Sex: M
Vaccine: DTAP, FLU4
Symptoms: Injection site erythema, Malaise, Skin lesion
Clinical narrative: The vaccine just says DTaP. It was not specific to Infanrix.  Patient became ill and had a red target lesion measuring the size of a quarter on his right thigh. Unsure if the reaction was for the DTaP or Influenza. I will be following up with the healthcare provider to determine which vaccine caused the redness on the skin.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt under 18 at time of vaccine administration - no known adverse event.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Decreased appetite, Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: symptoms: congestion and loss of appetite started on 12/6/2022
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Death, Decreased appetite, Diarrhoea
Clinical narrative: pt brought to ED from assisted living facility with c/o generalized weakness, headache, diarrhea, poor appetite; found to be positive for COVID; given antidiarrheals, oral steroids, O2 supplementation; pt made improvement, O2 sats good; dc'd from hospital; pt passed away at home
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test positive
Clinical narrative: pt brought to ED from assisted living facility with c/o generalized weakness, headache, diarrhea, poor appetite; found to be positive for COVID; given antidiarrheals, oral steroids, O2 supplementation; pt made improvement, O2 sats good; dc'd from hospital; pt passed away at home
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given 7 days after beyond use date.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Feeling hot, Immediate post-injection reaction, Induration, Pain, Swelling
Clinical narrative: She got her vaccine, it was painful right after she got it.  Then the next day it started swelling and painful.  Each now and now it's big, hard and painful.  When it is touched it is hard.  She has been trying to rub it to get rid of the soreness, but it is still very sore and hard.  She called the doctors office, spoke with the nurse who informed her to put ice on it, but it is still very hard, as large as a baseball, warm to touch and can put her whole hand around it, swollen like a ball and sore.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, COVID-19, Headache, Malaise, Pain
Clinical narrative: I had Covid-19, I had a headache; body aches, wasn't feeling very good and I was very sick; I went to the doctor and he told me I have post Covid syndrome, I'm also very weak.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Post-acute COVID-19 syndrome, SARS-CoV-2 test positive
Clinical narrative: I had Covid-19, I had a headache; body aches, wasn't feeling very good and I was very sick; I went to the doctor and he told me I have post Covid syndrome, I'm also very weak.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Patient had a breakthrough infection.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: NO SYMPTOMS. Patient received expired vaccine (12/06/22). Was taken out of freezer without checking expiration date (11/24/22). Called Moderna, who said that for most cases it is fine with no change in efficacy due to short timeframe of expiration date until administration and that it was taken out of freezer on administration date. Called and left message with patient.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Magnetic resonance imaging, Optic ischaemic neuropathy, Vision blurred
Clinical narrative: Pt woke up while on vacation with blurred vision. Sought out treatment from optometry who referred her to neurology. Pt was diagnosed with anterior ischemic optic neuropathy. While this is not uncommon with MS, pt reports that neurologist felt like this was not related to her MS and given the proximity of the incident to her vaccine, was suspicious this could have contributed to this.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Wa supposed to be given the new bivalent booster, 4th shot in the series. Confirmed with technician while he has the syringe that it was the bivalent booster he was going to give me. He said yes. 20 minutes after the appointment I got a call from Pharmacy apologizing saying that while everything said updated, they actually gave me a covid 19 monovalent ahot
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired at time of administration. Expiration date 11/30/2022. No adverse reaction. Repeat dose with unexpired vaccine pending receipt of product.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt received an expired Covid vaccine, Pfizer primary series (gray top) Lot # FP7140 with expiration date of 11/30/2022. No adverse effect on patient. Pt will receive repeat dose once new product becomes available.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Hyperhidrosis, Nausea
Clinical narrative: Chills, Sweats, Nausea lasted 24 hours
Age: 64.0
Sex: M
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: Pain radiating down arm to tips of fingers (left side).  Shooting pain to tips of fingers periodically for last seven days.  This began immediately (5 minutes) after influenza vaccine.  Pain becomes worse with use or position.
Age: 1.33
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Rash
Clinical narrative: Patient developed rash over torso, back, abdomen, neck, and face 10 minutes after receiving first dose of Pfizer COVID Vaccine.
Age: 29.0
Sex: M
Vaccine: FLU4
Symptoms: Lumbar puncture, Magnetic resonance imaging, Miller Fisher syndrome
Clinical narrative: Miller Fischer syndrome
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: LM WITH PATIENT. Patient received expired vaccine (12/06/22). Was taken out of freezer without checking expiration date (11/24/22). Called Moderna, who said that for most cases it is fine with no change in efficacy due to short timeframe of expiration date until administration and that it was taken out of freezer on administration date. Called and left message with patient.