chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site pain, Mobility decreased
Clinical narrative: Injection site pain; some soreness / painful; felt discomfort at the injection site; felt like she had to support her arm to lift it and it was painful; This case was reported by a pharmacist via other manufacturer and described the occurrence of injection site pain in a female patient who received Flu Seasonal QIV (Fluarix Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, less than 9 months after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced injection site pain, pain, injection site discomfort and mobility decreased. On an unknown date, the outcome of the injection site pain, pain, injection site discomfort and mobility decreased were unknown.   It was unknown if the reporter considered the injection site pain, pain, injection site discomfort and mobility decreased to be related to Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details was reported as follows: The case was reported by patient herself The age at vaccination was not reported. The patient received Fluarix vaccine in September 2020 or 1st October 2020. The patient experienced injection site pain and injection site discomfort. She felt like she had to support her arm to lift it and it was painful. The patient did not have batch lot number or expiration date of vaccine. No other information was available.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Global Medical Information (GMI) (Reference number- 00564905) and transmitted to Sanofi on 16-Apr-2021.  This case involves a 15-month-old female patient who received an expired 0.5 mL dose of HIB (PRP/T) VACCINE [ACT-HIB]( lot UJ137AAA and expiry date: 06-Mar-2021) via an unknown route in an unknown administration site for prophylactic vaccination on 16-Apr-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for prophylactic vaccination.  The caller wanted to know the efficacy and if there are any issues since that expired vaccine was given.  This was a case of actual medication error due to expired vaccine used (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, Product storage error
Clinical narrative: A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (MI) (Reference number- 00567142) and transmitted to Sanofi on 19-Apr-2021.  This case involves a four-year-old female patient who received an expired 0.5 mL of 4th dose of vaccine IPV (VERO) [IPOL] (lot R1B25 and expiry date: 13-Mar-2021) via an intramuscular route in the left thigh for prophylactic vaccination on 15-Apr-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and chickenpox for prophylactic vaccination.  This was a case of actual medication error due to expired vaccine used (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received expired dose of IPOL vacine with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional and physician via Medical Information (MI) (Reference number- 00567207) and transmitted to Sanofi on 19-Apr-2021.  This case involves a 4-years-old female patient who received expired  0.5 mL fourth dose of IPV (VERO) [IPOL] vaccine (frequency: once, Strength: standard, batch number: R1B25 and expiry date: 13-Mar-2021) via intramuscular route at the right thigh (expired product administered) on 13-Apr-2021 for prophylactic vaccination.  Medical history, medical treatment, vaccination and family history were not provided.  List concomitant or no other vaccines reported as DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and CHICKENPOX.  It was a case of actual medication error due to expired vaccine used.   At the time of reporting, reporter questioned that, what do to if 8 patients got expired IPOL vaccine.   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Ipol was administered to a patient/ no adverse event; Initial information regarding an unsolicited valid non-serious case was received on 19-Apr-2021 from a physician via Medical Information (Reference number- 00567285) and transmitted to Sanofi on 19-Apr-2021  This case involves a 4 year-old female patient who was vaccinated with 0.5 mL (once) expired dose of IPV (VERO) [IPOL] (batch number R1B251M; Strength- standard and expiry date 13-Mar-2021) via an intramuscular route at the right arm on 15-Apr-2021 for prophylactic vaccination (expired product administered). Medical Assistant wanted to know how soon they can revaccinate.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was given.   It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Result of assessment was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion, cause unknown, for 18 minutes with a low temperature with no reported adverse event; stability data not provided in temperature excursion  hence non-case
Age: 0.17
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Ipol vaccine was administered to a patient with no AE; Initial information received on 19-Apr-2021 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 2 month old female patient who received an 0.5 mL dose of expired IPV (VERO) [IPOL] [lot number: R1B251M and expiry date: 13-Mar-2021] via an unknown intramuscular route in the left thigh for prophylactic vaccination on 15-Apr-2021 (Expired product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to expired product administered. [Latency: at the same time of vaccination].  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Ipol was administered to patient with no ae; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Global Medical Information (GMI) (Reference number- 00567366) and transmitted to Sanofi on 19-Apr-2021.  This case involves a 4 years old female patient who an expired 0.5 mL dose of IPV (VERO) [IPOL] (lot R1B251M and expiry date: 13-Mar-2021) via intramuscular route in the left arm (expired product administered) for prophylactic vaccination on 06-Apr-2021.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  No other vaccines received by patient.   It was an actual medication error case due to expired vaccine used (latency: same day).   The reporter wanted to know how soon they can revaccinate and wanted to reverify the information.   At the time of reporting, the patient experienced no specific adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: patient given expired dose of Menactra, no AE; Initial information received on 20-Apr-2021 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient (unknown demographics) who was vaccinated with an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 16-Apr-2021, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: not reported expiry date: 02-Apr-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  It was also reported that Caller does not have any information on the patient details for the questionnaire, so questionnaire not filled out. Provided caller with inquiry to call us with information once be obtains that from the site that gave the vaccine.   At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.75
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: 9-month old male received an expired dose of Ipol with no reported adverse event; Initial information received on 20-Apr-2021 regarding an unsolicited valid non-serious case received from a physician.  This case involves a nine month old male patient who was vaccinated with an expired dose of IPV (VERO) [IPOL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  On an unknown date, the patient received a 0.5 ml dose of suspect IPV (VERO) (lot R1B252M and expiry date: 13-Mar-2021) (Frequency: once) via an intramuscular route in the right thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  Reporter relationship: (HCP) health care professional Product used: used still using product: no  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Muscle spasms, Night sweats
Clinical narrative: Night sweats, cramping and menstration longer and heavy
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abnormal, Dyspnoea, Haematocrit normal, Haemoglobin decreased, Pain in extremity
Clinical narrative: Patient received COVID J&J vaccine on 4/6, Presented to ED on 4/27/21 with complaint of 3 days of increasing leg pain and SOB
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count normal, Pulmonary embolism
Clinical narrative: Patient received COVID J&J vaccine on 4/6, Presented to ED on 4/27/21 with complaint of 3 days of increasing leg pain and SOB
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Angiopathy, Blood test, Computerised tomogram, Magnetic resonance imaging, Tinnitus
Clinical narrative: Pulsatile tinnitus. I hear my heartbeat on my right ear.  It is a vascular problem in the head.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Venogram
Clinical narrative: Pulsatile tinnitus. I hear my heartbeat on my right ear.  It is a vascular problem in the head.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Injection site pain, Muscle spasms, Muscle twitching
Clinical narrative: I started to get muscle twitching in my left arm, it moved to my breast bone and around to the upper portion of my rib cage. I also experienced quite a bit of deep muscle pain around the injection site and extreme tiredness. I spoke to my doctor and he prescribed cyclobenzaprine for the twitching
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: I started to get muscle twitching in my left arm, it moved to my breast bone and around to the upper portion of my rib cage. I also experienced quite a bit of deep muscle pain around the injection site and extreme tiredness. I spoke to my doctor and he prescribed cyclobenzaprine for the twitching
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Asthenia, Burning sensation, Injected limb mobility decreased, Loss of personal independence in daily activities
Clinical narrative: I had the shot 7 weeks ago and am still suffering debilitating effects. The shot was administered too low and has caused nerve damage. I have pins and needles in my hand, limited arm motion, pain in my shoulder, difficulty sleeping due to pain, I cannot do normal everyday things like put on a coat properly due to limited movement. Constant ache in my shoulder and muscle. Burning sensation running down my arm especially after teaching all day.
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Myalgia, Nerve injury, Paraesthesia, Sleep disorder, Wrong technique in product usage process
Clinical narrative: I had the shot 7 weeks ago and am still suffering debilitating effects. The shot was administered too low and has caused nerve damage. I have pins and needles in my hand, limited arm motion, pain in my shoulder, difficulty sleeping due to pain, I cannot do normal everyday things like put on a coat properly due to limited movement. Constant ache in my shoulder and muscle. Burning sensation running down my arm especially after teaching all day.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Computerised tomogram normal, Contusion, Decreased appetite, Deep vein thrombosis
Clinical narrative: As soon as I took the vaccine shot I had an immediate headache, after taking the vaccine I took Tylenol and slept in the rest of the day. The next day I woke up and my arm was red and swollen. I was running fever, still had the headache and now blurry vision. My entire body was hurting. My left side of my body felt numb and tingling. The next two days the pain became worse. I did not really have an appetite. When I did eat I could barely hold my food down. On Wednesday morning I could barely get out of bed, I also felt extreme pain in my lower legs, stabbing pain in stomach and right lower side. I also had ringing in my ears, more in the right ear. I then notice a bruise on my left leg, that it was not originally there, and was also tender to touch. I went to the emergency room on the same day and I was admitted. I was in there for 4 days, they tested my leg and stated it was not a blood clot, although it look and felt like one. They discharge me and advise me that it was a migraine that was causing all my pain.  This was on Sunday, I had a follow up with my PCP on the Friday, however to being in so much pain and shortness of breath, and arm pain I was advise to go to the ER on the Thursday and was admitted again. I was told in the ER I had a blood clot in my right arm and it was most likely from the IV from the previous visit. My blood pressure and heart rate was so high that they put me on medication. No matter the pain medication they gave me, it would not completely take the pain away. They discharge me again on Monday and after me begging them to get run any and all test, they said they found nothing. I'm still in the same amount of pain and same symptoms, still having trouble keeping my food down. The only thing that changed is my left arm is not as sore, however I still have a huge knot and its still warm to touch. I don't know what else to do that is why im contacting the CDC for help. I'm in a extreme amount of pain and pounding headaches.  Please help
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Flank pain, Headache, Heart rate increased
Clinical narrative: As soon as I took the vaccine shot I had an immediate headache, after taking the vaccine I took Tylenol and slept in the rest of the day. The next day I woke up and my arm was red and swollen. I was running fever, still had the headache and now blurry vision. My entire body was hurting. My left side of my body felt numb and tingling. The next two days the pain became worse. I did not really have an appetite. When I did eat I could barely hold my food down. On Wednesday morning I could barely get out of bed, I also felt extreme pain in my lower legs, stabbing pain in stomach and right lower side. I also had ringing in my ears, more in the right ear. I then notice a bruise on my left leg, that it was not originally there, and was also tender to touch. I went to the emergency room on the same day and I was admitted. I was in there for 4 days, they tested my leg and stated it was not a blood clot, although it look and felt like one. They discharge me and advise me that it was a migraine that was causing all my pain.  This was on Sunday, I had a follow up with my PCP on the Friday, however to being in so much pain and shortness of breath, and arm pain I was advise to go to the ER on the Thursday and was admitted again. I was told in the ER I had a blood clot in my right arm and it was most likely from the IV from the previous visit. My blood pressure and heart rate was so high that they put me on medication. No matter the pain medication they gave me, it would not completely take the pain away. They discharge me again on Monday and after me begging them to get run any and all test, they said they found nothing. I'm still in the same amount of pain and same symptoms, still having trouble keeping my food down. The only thing that changed is my left arm is not as sore, however I still have a huge knot and its still warm to touch. I don't know what else to do that is why im contacting the CDC for help. I'm in a extreme amount of pain and pounding headaches.  Please help
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Hypoaesthesia, Immediate post-injection reaction, Laboratory test normal, Magnetic resonance imaging normal
Clinical narrative: As soon as I took the vaccine shot I had an immediate headache, after taking the vaccine I took Tylenol and slept in the rest of the day. The next day I woke up and my arm was red and swollen. I was running fever, still had the headache and now blurry vision. My entire body was hurting. My left side of my body felt numb and tingling. The next two days the pain became worse. I did not really have an appetite. When I did eat I could barely hold my food down. On Wednesday morning I could barely get out of bed, I also felt extreme pain in my lower legs, stabbing pain in stomach and right lower side. I also had ringing in my ears, more in the right ear. I then notice a bruise on my left leg, that it was not originally there, and was also tender to touch. I went to the emergency room on the same day and I was admitted. I was in there for 4 days, they tested my leg and stated it was not a blood clot, although it look and felt like one. They discharge me and advise me that it was a migraine that was causing all my pain.  This was on Sunday, I had a follow up with my PCP on the Friday, however to being in so much pain and shortness of breath, and arm pain I was advise to go to the ER on the Thursday and was admitted again. I was told in the ER I had a blood clot in my right arm and it was most likely from the IV from the previous visit. My blood pressure and heart rate was so high that they put me on medication. No matter the pain medication they gave me, it would not completely take the pain away. They discharge me again on Monday and after me begging them to get run any and all test, they said they found nothing. I'm still in the same amount of pain and same symptoms, still having trouble keeping my food down. The only thing that changed is my left arm is not as sore, however I still have a huge knot and its still warm to touch. I don't know what else to do that is why im contacting the CDC for help. I'm in a extreme amount of pain and pounding headaches.  Please help
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Mobility decreased, Nodule, Pain, Pain in extremity
Clinical narrative: As soon as I took the vaccine shot I had an immediate headache, after taking the vaccine I took Tylenol and slept in the rest of the day. The next day I woke up and my arm was red and swollen. I was running fever, still had the headache and now blurry vision. My entire body was hurting. My left side of my body felt numb and tingling. The next two days the pain became worse. I did not really have an appetite. When I did eat I could barely hold my food down. On Wednesday morning I could barely get out of bed, I also felt extreme pain in my lower legs, stabbing pain in stomach and right lower side. I also had ringing in my ears, more in the right ear. I then notice a bruise on my left leg, that it was not originally there, and was also tender to touch. I went to the emergency room on the same day and I was admitted. I was in there for 4 days, they tested my leg and stated it was not a blood clot, although it look and felt like one. They discharge me and advise me that it was a migraine that was causing all my pain.  This was on Sunday, I had a follow up with my PCP on the Friday, however to being in so much pain and shortness of breath, and arm pain I was advise to go to the ER on the Thursday and was admitted again. I was told in the ER I had a blood clot in my right arm and it was most likely from the IV from the previous visit. My blood pressure and heart rate was so high that they put me on medication. No matter the pain medication they gave me, it would not completely take the pain away. They discharge me again on Monday and after me begging them to get run any and all test, they said they found nothing. I'm still in the same amount of pain and same symptoms, still having trouble keeping my food down. The only thing that changed is my left arm is not as sore, however I still have a huge knot and its still warm to touch. I don't know what else to do that is why im contacting the CDC for help. I'm in a extreme amount of pain and pounding headaches.  Please help
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling, Pyrexia, Skin warm, Tenderness
Clinical narrative: As soon as I took the vaccine shot I had an immediate headache, after taking the vaccine I took Tylenol and slept in the rest of the day. The next day I woke up and my arm was red and swollen. I was running fever, still had the headache and now blurry vision. My entire body was hurting. My left side of my body felt numb and tingling. The next two days the pain became worse. I did not really have an appetite. When I did eat I could barely hold my food down. On Wednesday morning I could barely get out of bed, I also felt extreme pain in my lower legs, stabbing pain in stomach and right lower side. I also had ringing in my ears, more in the right ear. I then notice a bruise on my left leg, that it was not originally there, and was also tender to touch. I went to the emergency room on the same day and I was admitted. I was in there for 4 days, they tested my leg and stated it was not a blood clot, although it look and felt like one. They discharge me and advise me that it was a migraine that was causing all my pain.  This was on Sunday, I had a follow up with my PCP on the Friday, however to being in so much pain and shortness of breath, and arm pain I was advise to go to the ER on the Thursday and was admitted again. I was told in the ER I had a blood clot in my right arm and it was most likely from the IV from the previous visit. My blood pressure and heart rate was so high that they put me on medication. No matter the pain medication they gave me, it would not completely take the pain away. They discharge me again on Monday and after me begging them to get run any and all test, they said they found nothing. I'm still in the same amount of pain and same symptoms, still having trouble keeping my food down. The only thing that changed is my left arm is not as sore, however I still have a huge knot and its still warm to touch. I don't know what else to do that is why im contacting the CDC for help. I'm in a extreme amount of pain and pounding headaches.  Please help
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Tinnitus, Vision blurred, Vomiting
Clinical narrative: As soon as I took the vaccine shot I had an immediate headache, after taking the vaccine I took Tylenol and slept in the rest of the day. The next day I woke up and my arm was red and swollen. I was running fever, still had the headache and now blurry vision. My entire body was hurting. My left side of my body felt numb and tingling. The next two days the pain became worse. I did not really have an appetite. When I did eat I could barely hold my food down. On Wednesday morning I could barely get out of bed, I also felt extreme pain in my lower legs, stabbing pain in stomach and right lower side. I also had ringing in my ears, more in the right ear. I then notice a bruise on my left leg, that it was not originally there, and was also tender to touch. I went to the emergency room on the same day and I was admitted. I was in there for 4 days, they tested my leg and stated it was not a blood clot, although it look and felt like one. They discharge me and advise me that it was a migraine that was causing all my pain.  This was on Sunday, I had a follow up with my PCP on the Friday, however to being in so much pain and shortness of breath, and arm pain I was advise to go to the ER on the Thursday and was admitted again. I was told in the ER I had a blood clot in my right arm and it was most likely from the IV from the previous visit. My blood pressure and heart rate was so high that they put me on medication. No matter the pain medication they gave me, it would not completely take the pain away. They discharge me again on Monday and after me begging them to get run any and all test, they said they found nothing. I'm still in the same amount of pain and same symptoms, still having trouble keeping my food down. The only thing that changed is my left arm is not as sore, however I still have a huge knot and its still warm to touch. I don't know what else to do that is why im contacting the CDC for help. I'm in a extreme amount of pain and pounding headaches.  Please help
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Hyperhidrosis, Pyrexia
Clinical narrative: EXTREME chills and fever.  Alternated 4 or 5 cycles.  Woke up with having thrown off my blankets and had to get ice packs and open windows to cool down enough to sleep, a few hours later woke up SHIVERING like I never have before.  I thought I was convulsing until I realized I could control it with my breathing. I was shivering so hard that I bit my tongue several times.  I didn't have much energy so it took several minutes before I could grab blankets and even longer before I could close the window.  I was wrapped in several layers of blankets and was still shivering until I fell asleep.  I woke up again and my blankets were soaked in my sweat.  This cycle got more and more intense until the next day.  *I've been hospitalized with pneumonia and this felt 100 times worse. The next day, I had the worst diarrheic that I've ever had, sudden urge.. barely made it to toilet and INSTANTLY discharged what felt like a gallon of brown liquid (it was probably less but felt pretty nasty).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Tongue biting
Clinical narrative: EXTREME chills and fever.  Alternated 4 or 5 cycles.  Woke up with having thrown off my blankets and had to get ice packs and open windows to cool down enough to sleep, a few hours later woke up SHIVERING like I never have before.  I thought I was convulsing until I realized I could control it with my breathing. I was shivering so hard that I bit my tongue several times.  I didn't have much energy so it took several minutes before I could grab blankets and even longer before I could close the window.  I was wrapped in several layers of blankets and was still shivering until I fell asleep.  I woke up again and my blankets were soaked in my sweat.  This cycle got more and more intense until the next day.  *I've been hospitalized with pneumonia and this felt 100 times worse. The next day, I had the worst diarrheic that I've ever had, sudden urge.. barely made it to toilet and INSTANTLY discharged what felt like a gallon of brown liquid (it was probably less but felt pretty nasty).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast mass, Breast pain, Fatigue, Pain in extremity
Clinical narrative: Sore arm for a few days with fatigue, resolved after a week. On the morning of 4/23 the bottom of my shot (left) arm felt bruised, tender. By the night of 4/23 my left armpit was also sore, tender. Late night 4/23 my left breast was extremely sore and I noticed lumps, very swollen ducts? As of now, late night on 4/28, or very early morn 4/29, the lumps are large, extremely painful and don?t seem to be going away . I?m anxious about my second shot.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Sore arm for a few days with fatigue, resolved after a week. On the morning of 4/23 the bottom of my shot (left) arm felt bruised, tender. By the night of 4/23 my left armpit was also sore, tender. Late night 4/23 my left breast was extremely sore and I noticed lumps, very swollen ducts? As of now, late night on 4/28, or very early morn 4/29, the lumps are large, extremely painful and don?t seem to be going away . I?m anxious about my second shot.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling abnormal, Feeling cold, Headache
Clinical narrative: Body aches and 101 fever 12 hrs after shot. Chills and headache after. Next day arm soreness and a rash around the vaccination site, lasting 4 days and still going. On day 4 after vaccine, dizziness, weakness and vertigo. Brain fog. Still ongoing
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Vaccination site rash, Vertigo
Clinical narrative: Body aches and 101 fever 12 hrs after shot. Chills and headache after. Next day arm soreness and a rash around the vaccination site, lasting 4 days and still going. On day 4 after vaccine, dizziness, weakness and vertigo. Brain fog. Still ongoing
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dysmenorrhoea, Fatigue, Menstruation irregular
Clinical narrative: Fever. Chills. Nausea. Fatigue. Dizziness. Pain in arm. Hives. Hot skin. Stronger menstrual cramps. Irregular period.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Skin warm, Urticaria
Clinical narrative: Fever. Chills. Nausea. Fatigue. Dizziness. Pain in arm. Hives. Hot skin. Stronger menstrual cramps. Irregular period.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus, bi lateral
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Diabetes mellitus, Diabetic ketoacidosis, Hepatic vein thrombosis, Platelet count decreased
Clinical narrative: Vaccine- Induced Thrombotic Thrombocytopenia Portal and hepatic vein thromboses Diabetic Ketoacidosis
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Platelet factor 4, Portal vein thrombosis, Thrombocytopenia
Clinical narrative: Vaccine- Induced Thrombotic Thrombocytopenia Portal and hepatic vein thromboses Diabetic Ketoacidosis
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: ADAMTS13 activity assay, Acute hepatic failure, Alanine aminotransferase, Aspartate aminotransferase, Asterixis
Clinical narrative: Vaccine- Induced Thrombotic Thrombocytopenia Portal and hepatic vein thromboses Diabetic Ketoacidosis
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood bilirubin, Blood creatinine, Blood fibrinogen, Cell marker, Computerised tomogram
Clinical narrative: Vaccine- Induced Thrombotic Thrombocytopenia Portal and hepatic vein thromboses Diabetic Ketoacidosis
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abdomen, Fibrin D dimer, Haemoglobin, Hepatic encephalopathy, Immune thrombocytopenia
Clinical narrative: Vaccine- Induced Thrombotic Thrombocytopenia Portal and hepatic vein thromboses Diabetic Ketoacidosis
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: International normalised ratio, Platelet count, Platelet factor 4, Portal vein thrombosis, Thrombocytopenia
Clinical narrative: Vaccine- Induced Thrombotic Thrombocytopenia Portal and hepatic vein thromboses Diabetic Ketoacidosis
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler, White blood cell count
Clinical narrative: Vaccine- Induced Thrombotic Thrombocytopenia Portal and hepatic vein thromboses Diabetic Ketoacidosis
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Extremely heavy menstrual bleeding started thirteen days post vaccine and has not stopped (going on two weeks). This bleeding includes huge clots, some so large that they have to be ?pushed? out...some clots are the size of a small fist.  The bleeding is consistent and has several episodes of gushing causing blood to overtake feminine hygiene products and spill all over clothing/furniture. During this bleeding clots can be felt passing as well even when seated.  The clots have subsided somewhat compared to when this first started and bleeding appears to be slowing somewhat in the past day.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Flu symptoms
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Fairly loud tinnitus all the time.  Descdribed by constant tinny sound, not whooshing, high pitched
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: Fever around 40 degrees Celsius for 24 hours, chills, headache, strong sweating, general weakness of the body. After a day, lower-grade fever (38 degrees Celsius for the next day and 37 degrees later on) and general body weakness for the next 5 days.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Lymphadenopathy, Pain
Clinical narrative: 4/26: pain at injection site, containing to strengthen as day progressed.  8pm: swollen lump nodes in neck, fatigue.  4/27: 4am; fever, chills, body aches, fatigue. Pain at injection site and swollen lump nodes in neck and left arm pit. Continues throughout the day, off and on fever every couple of hours.  6pm; fever gone, chills gone, extreme fatigue gone.  4/28: 4am; swollen lymph nodes, neck and left armpit.  Painful injection site and left armpit lymph node. Minor body aches.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 4/26: pain at injection site, containing to strengthen as day progressed.  8pm: swollen lump nodes in neck, fatigue.  4/27: 4am; fever, chills, body aches, fatigue. Pain at injection site and swollen lump nodes in neck and left arm pit. Continues throughout the day, off and on fever every couple of hours.  6pm; fever gone, chills gone, extreme fatigue gone.  4/28: 4am; swollen lymph nodes, neck and left armpit.  Painful injection site and left armpit lymph node. Minor body aches.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Insomnia, Pain
Clinical narrative: Headache/Sweating/Insomnia- 2:30AM  4/25/21 Body Aches/Fatigue- 10AM 4/25/21 All Symptoms Self-Resolved- 4PM 4/26/21
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Lip swelling, Pyrexia
Clinical narrative: Fever, intense chills and then sweat/chills throughout 1st night. Super bad headache at 3:00am and then lip swelling started - by 9:00am they were enormous.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Inability to move L arm due to pain.  Experiencing SOB - pt reports this is due to pain.  Vaccine  administered through public health event at vaccination site.  Seen in office on 4/27 - no edema, erythema, warmth at vaccine site.  EDC mid June
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Inability to move L arm due to pain.  Experiencing SOB - pt reports this is due to pain.  Vaccine  administered through public health event at vaccination site.  Seen in office on 4/27 - no edema, erythema, warmth at vaccine site.  EDC mid June
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstrual disorder
Clinical narrative: Menstrual cycle changed day after receiving vaccine. Approximately 2 weeks early.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Eye swelling, Hypertension, Menstruation irregular, Pain
Clinical narrative: Menstrual cycle changed day after receiving vaccine. Approximately 2 weeks early.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site warmth, Rash erythematous
Clinical narrative: Red hot rash around area of injection.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Loss of consciousness, Nausea, Vomiting
Clinical narrative: Headache, nausea, vomiting, dizziness.  Patient fell unconscious at least once and began vomiting.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Pain in extremity, Urticaria
Clinical narrative: Small - dime-sized - raised welt at injection site.  Area is warm to touch and mildly itchy.  Only other side effect was arm soreness for 3 days after injection.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: On 4/14, one week after my second Moderna shot, I experience swelling of the lymph nodes under my left arm/armpit area. It was painful and a bit freaky until I did some research that said that this is a side effect of the Moderna vaccine.  It is still painful and swollen today, 4/28/21, although definitely not as much as two weeks ago. I do believe it will be back to normal by next week, judging by how the swelling and pain have decreased.  I did get the same milder symptoms under my right arm/armpit but those are gone now.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Herpes simplex, Nausea
Clinical narrative: Fever, chills, headache, nausea, fatigue, HSV1 and HSV2 outbreaks
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, chills, headache, nausea, fatigue, HSV1 and HSV2 outbreaks
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Goitre, Thyroid pain
Clinical narrative: Enlarged, sore thyroid gland
Sex: M
Vaccine: RAB
Symptoms: Angiofibroma, Autoimmune disorder, Chronic fatigue syndrome, Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: On 30-Nov-2017, the patient received the first dose of Rabipure (Inactivated Rabies Virus Vaccine, Batch number 641011E) and the first dose of co-suspect vaccine Ixiaro (Batch number JEV16D22B), both administered at an unknown dosage regimen, unknown route of administration and for an unknown indication.  On 13-Dec-2017 (13 days after the first dose- inappropriate schedule of vaccine administered), the patient received the second dose of Rabipur (Inactivated Rabies Virus Vaccine, Batch number 64111E) and first dose of Nimenrix at an unknown dosage regimen, unknown route of administration and for unknown indication.  On 12-Jan-2018, (43 days after the first dose- inappropriate schedule of vaccine administered), the patient received the third dose of Rabipur (Inactivated Rabies Virus Vaccine, Batch number 641011E) at an unknown dosage regimen, unknown route of administration and for an unknown indication.  On 19-Jan-2018, the patient received the second dose of co-suspect Ixiaro vaccine (Batch number JEV16F288) at an unknown dosage regimen, unknown route of administration and for unknown indication.  On an unknown date during Christmas Days in 2018, approximately 347 days after receiving the last dose of Rabipur and 340 days after the last dose of Ixiaro vaccinations, the patient developed cold problems with flu-like symptoms, limb pain, resting tremor of the hands *(explicitly coded as 'Tremor of hands)*, angiofibroma in the facial area *(explicitly coded as 'Angiofibroma')*, sleep disorders and migraines. Initially, a suspected diagnosis of an autoimmune reaction after vaccinations was revealed.   On 18-Jan-2019, approximately 1 year after receiving the last dose of Rabipur, the patient was diagnosed with chronic fatigue syndrome and myalgic encephalomyelitis, which made the patient incapacitated and is now suing for vaccination damage.  The reporter did not provide outcome for the events of chronic fatigue syndrome, myalgic encephalomyelitis, *resting tremor of the hands and angiofibroma in the facial area*.
Sex: M
Vaccine: RAB
Symptoms: Migraine, Nasopharyngitis, Pain in extremity, Post viral fatigue syndrome, Resting tremor
Clinical narrative: On 30-Nov-2017, the patient received the first dose of Rabipure (Inactivated Rabies Virus Vaccine, Batch number 641011E) and the first dose of co-suspect vaccine Ixiaro (Batch number JEV16D22B), both administered at an unknown dosage regimen, unknown route of administration and for an unknown indication.  On 13-Dec-2017 (13 days after the first dose- inappropriate schedule of vaccine administered), the patient received the second dose of Rabipur (Inactivated Rabies Virus Vaccine, Batch number 64111E) and first dose of Nimenrix at an unknown dosage regimen, unknown route of administration and for unknown indication.  On 12-Jan-2018, (43 days after the first dose- inappropriate schedule of vaccine administered), the patient received the third dose of Rabipur (Inactivated Rabies Virus Vaccine, Batch number 641011E) at an unknown dosage regimen, unknown route of administration and for an unknown indication.  On 19-Jan-2018, the patient received the second dose of co-suspect Ixiaro vaccine (Batch number JEV16F288) at an unknown dosage regimen, unknown route of administration and for unknown indication.  On an unknown date during Christmas Days in 2018, approximately 347 days after receiving the last dose of Rabipur and 340 days after the last dose of Ixiaro vaccinations, the patient developed cold problems with flu-like symptoms, limb pain, resting tremor of the hands *(explicitly coded as 'Tremor of hands)*, angiofibroma in the facial area *(explicitly coded as 'Angiofibroma')*, sleep disorders and migraines. Initially, a suspected diagnosis of an autoimmune reaction after vaccinations was revealed.   On 18-Jan-2019, approximately 1 year after receiving the last dose of Rabipur, the patient was diagnosed with chronic fatigue syndrome and myalgic encephalomyelitis, which made the patient incapacitated and is now suing for vaccination damage.  The reporter did not provide outcome for the events of chronic fatigue syndrome, myalgic encephalomyelitis, *resting tremor of the hands and angiofibroma in the facial area*.