chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: H1N1 influenza
Clinical narrative: Got the swine flu; Initial information received on 03-Jan-2023 regarding an unsolicited valid social media serious case received from a consumer/non-healthcare professional (hcp).  This case involves an unknown age and unknown gender patient who experienced got the swine flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   Patient got the shot of INFLUENZA VACCINE produced by unknown manufacturer in the beginning of Oct-2022 (strength, formulation, route, dose, lot number and expiry date: unknown) in unknown administration site for prophylactic vaccination (Immunisation).  Patient got the swine flu (H1N1 influenza) the beginning of Dec-2022. In the hospital 3 days with it. So, there was no guarantee the shot will keep you well. Patient have gotten a flu shot every year for years. Only had the flu once when he/she was very young. It's horrible!   It is unknown if the patient experienced any additional symptoms/events. It is unknown if there were lab data/results available.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Got the swine flu).  At time of reporting, the outcome was Unknown for the event got the swine flu.; Sender's Comments: Sanofi company comment dated 06-Jan-2023: This case involves an unknown age and unknown gender patient who experienced got the swine flu after receiving vaccine INFLUENZA VACCINE. Additional information regarding concomitant disease or risk factor, medical treatment and lab investigation excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 03-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves a patient of unknown demographics who developed the flu after receiving vaccine Influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  Past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation).  On an unknown date, the patient developed non-serious flu (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: U
Vaccine: DTAPIPVHIB, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: excursion was due to the door being ajar. The temperature of the refrigerator reached 41.0-62.0 degrees Fahrenheit with no adverse event; Initial information received on 03-Jan-2023 regarding an unsolicited valid serious case received from a other health professional.  This case involves an event of product storage error of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (excursion was due to the door being ajar. the temperature of the refrigerator reached 41.0-62.0 degrees fahrenheit with no adverse event).   On 30-Dec-2022, it was reported DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ680ABA), DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U7561AA) and MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE lot (U7576AD) (strength, formulation, dose, route and expiry date: unknown) to be used for immunization was exposed to excursion due to the door being ajar. the temperature of the refrigerator reached 41.0-62.0 degrees fahrenheit with no adverse event (product storage error) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: Unknown.   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 guidelines. 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: 92.0
Sex: F
Vaccine: FLUX
Symptoms: Death, Illness, Immunisation reaction, Interstitial lung disease
Clinical narrative: she was hospitalized and received a diagnosis of acute interstitial pneumonia due to the influenza vaccine; became severely ill and 5 days later she was hospitalized; Initial information received on 04-Jan-2023 regarding an unsolicited valid serious case received from other health professional.  This case involves a 91 years old female patient who experienced she was hospitalized and received a diagnosis of acute interstitial pneumonia due to the influenza vaccine and became severely ill and 5 days later she was hospitalized while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-Oct-2022, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, dose, formulation, expiration date, lot number not reported) via unknown route in unknown administration site for immunization.  On 06-Oct-2022 the patient developed a serious became severely ill and 5 days later she was hospitalized (illness) latency: 1 day.   On an unknown date the patient developed a serious she was hospitalized and received a diagnosis of acute interstitial pneumonia due to the influenza vaccine (interstitial lung disease) (unknown latency).  Final diagnosis was (fatal) she was hospitalized and received a diagnosis of acute interstitial pneumonia due to the influenza vaccine.  Lab data was not reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for both the events.  At time of reporting, the outcome was Unknown for the event became severely ill and 5 days later she was hospitalized and was Fatal for the event she was hospitalized and received a diagnosis of acute interstitial pneumonia due to the influenza vaccine. No autopsy was done. The cause of death was reported as Interstitial pneumonia.   Seriousness criteria: Event interstitial lung disease was assessed as medically significant and was leading to death. The patient was hospitalized from OCT-2022 from Illness and interstitial lung disease.; Sender's Comments: Sanofi company comment dated 04-Jan-2023: This case involves a 91 years old female patient who experienced she was hospitalized and received a diagnosis of acute interstitial pneumonia due to the influenza vaccine and became severely ill and 5 days later she was hospitalized while receiving vaccine influenza vaccine. No autopsy was done. The cause of death was reported as Interstitial pneumonia. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information regarding condition at the time of vaccination, past medical history, lifestyle history, concomitant disease or risk factor excluding other predisposing etiologies precludes comprehensive case assessment. Based upon the reported information, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: acute interstitial pneumonia
Age: 16.0
Sex: M
Vaccine: HEP, HEPA, MMR, MNQ
Symptoms: Asthenia
Clinical narrative: Patient received routine vaccines listed above. Patient complained of feeling weak. Patient assessed by RN. Patient vitals checked. P- 88, O2 SAT- 98%, BP- 110/72 R-20. Patient assisted to the floor. Patient legs elevated. Patient states feeling better.  Patient assisted back to chair. Offered to call EMS for patient.  Patient and family member refused. Patient monitored for 30 minutes. Follow up post vaccination instructions from system drink, monitor self, report any lingering physical complaints to own provider. Instruction given regarding calling 911 or going to local emergency room for emergency symptoms. Translation provided. Patient and family verbalized understanding.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Full body rash including face and entire body. The rash is itchy but not unbearable.   Giving child oral antihistamine pills and using hydrocortisone cream.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Full blood count, Haematocrit normal, Haemoglobin normal, Oropharyngeal pain
Clinical narrative: Tolerated first dose of HPV vaccine well, this was patient's second dose in series.  Day after vaccine developed hives around body, ears bright red, one finger became swollen. Red itchy hives to backs of knees. Similar reactions after antibiotics - amoxicillin and cephalosporins. PRN Benadryl seemed to offer some improvement in symptoms temporarily, however hives would return. No difficulty breathing, vomiting, diarrhea or mucosal involvement. Symptoms continue to come and go, today is day 3 of symptoms, will be evaluated in clinic tomorrow. She has now had two ER/Urgent care visits for persistent symptoms. Has now developed sore throat on day 3 of symptoms with swelling of hands and feet - will be assessed for other underlying etiology such as strep throat.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Peripheral swelling, Platelet count normal, Pruritus, Urticaria, White blood cell count increased
Clinical narrative: Tolerated first dose of HPV vaccine well, this was patient's second dose in series.  Day after vaccine developed hives around body, ears bright red, one finger became swollen. Red itchy hives to backs of knees. Similar reactions after antibiotics - amoxicillin and cephalosporins. PRN Benadryl seemed to offer some improvement in symptoms temporarily, however hives would return. No difficulty breathing, vomiting, diarrhea or mucosal involvement. Symptoms continue to come and go, today is day 3 of symptoms, will be evaluated in clinic tomorrow. She has now had two ER/Urgent care visits for persistent symptoms. Has now developed sore throat on day 3 of symptoms with swelling of hands and feet - will be assessed for other underlying etiology such as strep throat.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Redness at Injection Site-Medium
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 73.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Fatigue, Feeling hot, Immediate post-injection reaction, Lethargy
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Patient was receiving 2 vaccines (flu+covid). She fainted immediately after receiving 2nd vaccine. Patient was seating during administration and vaccinator caught her as she was slumping forward. Patient was extremely fatigued and hot after episode. It was 10:30am and patient had not eaten anything yet all day. Patient was given orange juice and crackers. Blood pressure 97/50. Continued to monitor for 15-20 mins. She was able to correctly answer what her name is, where she was, and what happened
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Patient was receiving 2 vaccines (flu+covid). She fainted immediately after receiving 2nd vaccine. Patient was seating during administration and vaccinator caught her as she was slumping forward. Patient was extremely fatigued and hot after episode. It was 10:30am and patient had not eaten anything yet all day. Patient was given orange juice and crackers. Blood pressure 97/50. Continued to monitor for 15-20 mins. She was able to correctly answer what her name is, where she was, and what happened
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Fatigue, Flushing, Hyperhidrosis, Hypotension
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: EMS activated; patient's mother declined EMS transport to the hospital; patient appeared to recover from syncopal episode within 30 minutes
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Lethargy, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: EMS activated; patient's mother declined EMS transport to the hospital; patient appeared to recover from syncopal episode within 30 minutes
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect route of product administration
Clinical narrative: NONE
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Tinnitus; mild
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Headache, Inflammation, Injection site reaction, Pain
Clinical narrative: About 12 hours after I received the bivalent booster, around three in the morning, I was awakened with pain in my left thumb I believe, my two wrists, and especially my right elbow. After a day the pain or inflammation in my thumb and wrists went away but it has persisted in my right elbow. There may be one skin lesion, only the size of a pimple, at or very near the site. That has all but gone away. The pain is less now than it was in the beginning. It feels like ?tennis elbow? I have had joint pain with each of these Moderno Covid vaccinations and boosters. But not this sort of more intense inflammation sort of pain. More and achy joint pain like when I have a fever. But this is like an injury ? ? like I said ?tennis elbow? I also get a fever for a day or two. My symptoms in addition to this inflammation pain for the bivalent included a headache, fever of maybe 101, bodyaches, all of which resolved after 1 to 1 1/2 days except for the right elbow pain. My father suffered from severe rheumatoid arthritis but I have never had Anything like this until now.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, Pyrexia, Skin lesion, Sleep disorder
Clinical narrative: About 12 hours after I received the bivalent booster, around three in the morning, I was awakened with pain in my left thumb I believe, my two wrists, and especially my right elbow. After a day the pain or inflammation in my thumb and wrists went away but it has persisted in my right elbow. There may be one skin lesion, only the size of a pimple, at or very near the site. That has all but gone away. The pain is less now than it was in the beginning. It feels like ?tennis elbow? I have had joint pain with each of these Moderno Covid vaccinations and boosters. But not this sort of more intense inflammation sort of pain. More and achy joint pain like when I have a fever. But this is like an injury ? ? like I said ?tennis elbow? I also get a fever for a day or two. My symptoms in addition to this inflammation pain for the bivalent included a headache, fever of maybe 101, bodyaches, all of which resolved after 1 to 1 1/2 days except for the right elbow pain. My father suffered from severe rheumatoid arthritis but I have never had Anything like this until now.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, Product administration error
Clinical narrative: Patient did not disclose that she had alredy recieved an dose of the Moderna Bivalent.  Patient presented an card that did not have the dose of bivalent Moderna on it. We then entered data into Immunization Registry later and discovered she had already recieved an dose of the Bivalent Booster. Vaccine Adminisration Error.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Cardiac monitoring, Chest pain, Dyspnoea, Electrocardiogram
Clinical narrative: chest pains starting a few days after vaccine received, along with shortness of breath. never had chest pain or shortness of breath before. this lasted two months before subsiding in severity, but these symptoms have returned periodically over the past year since I took vaccine. i have arythmia which also started after the vaccine, again never had this before.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Symptom recurrence
Clinical narrative: chest pains starting a few days after vaccine received, along with shortness of breath. never had chest pain or shortness of breath before. this lasted two months before subsiding in severity, but these symptoms have returned periodically over the past year since I took vaccine. i have arythmia which also started after the vaccine, again never had this before.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Rash, Skin warm
Clinical narrative: On 1/3/22 came in to get her Covid Booster. She received the Moderna Bivalent. Her previous COVID shots were Pfizer.  At the time of the shot no symptoms were reported. Her symptoms started around 7 pm that same evening. She developed fever of 101-102 F and a big rash the size of half her arm starting from shoulder to elbow. The rash was hot and remained hot for several days including the day she reported it to us on 1/6/2023. The fever lasted 3 days. She has not sought medical attention. She controlled her fever with pain medication and fever reducer. I informed her that if the rash did not go away by 1/10/22 she needed to seek medical care.
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood creatine phosphokinase increased, Blood lactic acid increased, Electroencephalogram abnormal, Epilepsy, Road traffic accident
Clinical narrative: New onset seizure disorder/epilepsy. Hospitalized after a MVA caused by a seizure, was in status epilepticus, started on IV keppra, discharged home on PO keppra, now scheduled to follow up with neurologist.
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Seizure, Status epilepticus
Clinical narrative: New onset seizure disorder/epilepsy. Hospitalized after a MVA caused by a seizure, was in status epilepticus, started on IV keppra, discharged home on PO keppra, now scheduled to follow up with neurologist.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angiogram normal, Computerised tomogram abdomen normal, Computerised tomogram head abnormal, Computerised tomogram thorax normal, Ischaemic stroke
Clinical narrative: Patient was found down by neighbor.  Brought to hospital and found to have ischemic stroke of left thalamus and basal ganglia per Head CT.  CTA  was performed and did not show any evidence of occlusion.  CT chest/abd/pelvis was performed and negative for any metastases. Patient is still drowsy and unable to be taken off the ventilator.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Mechanical ventilation, Somnolence, Weaning failure
Clinical narrative: Patient was found down by neighbor.  Brought to hospital and found to have ischemic stroke of left thalamus and basal ganglia per Head CT.  CTA  was performed and did not show any evidence of occlusion.  CT chest/abd/pelvis was performed and negative for any metastases. Patient is still drowsy and unable to be taken off the ventilator.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardio-respiratory arrest, Computerised tomogram head abnormal, Critical illness, Death, Endotracheal intubation
Clinical narrative: Patient arrived in critical care with subdural hematoma per Head CT on 12/28/2022.  Patient was subsequently intubated.  Patient was later extubated on 1/5/2023 and coded that evening, and unfortunately died.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Subdural haematoma
Clinical narrative: Patient arrived in critical care with subdural hematoma per Head CT on 12/28/2022.  Patient was subsequently intubated.  Patient was later extubated on 1/5/2023 and coded that evening, and unfortunately died.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, Death, Echocardiogram abnormal, Ejection fraction decreased
Clinical narrative: Patient arrived in critical care with subdural hematoma per Head CT on 12/28/2022.  Patient was subsequently intubated.  Patient was later extubated on 1/5/2023 and coded that evening, and unfortunately died.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Endotracheal intubation, Fall, Hypercapnia, Hypotension, Hypoxia
Clinical narrative: Patient arrived in critical care with subdural hematoma per Head CT on 12/28/2022.  Patient was subsequently intubated.  Patient was later extubated on 1/5/2023 and coded that evening, and unfortunately died.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Life support, Positive airway pressure therapy, Pulseless electrical activity, Respiratory failure, Resuscitation
Clinical narrative: Patient arrived in critical care with subdural hematoma per Head CT on 12/28/2022.  Patient was subsequently intubated.  Patient was later extubated on 1/5/2023 and coded that evening, and unfortunately died.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Subdural haematoma, Unresponsive to stimuli
Clinical narrative: Patient arrived in critical care with subdural hematoma per Head CT on 12/28/2022.  Patient was subsequently intubated.  Patient was later extubated on 1/5/2023 and coded that evening, and unfortunately died.
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given Bivalent covid booster instead of monovalent.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Basedow's disease, Blood test, Computerised tomogram abnormal, Dyspnoea, Heart rate increased
Clinical narrative: Patient had rapid heart beat 145 per min sustained after dose 2 within 1.5 weeks.   it was sustained never ceased to calm. She was breathing heavy, no sleep from rapid heart rate.  Hospital visit within a week of complaints confirmed Hyperthyroidism.  Followup with PA  of an Urgent Care allowed imaging to confirm Thyroid damage.  Folowup with Endocrinologists (2 seperate doctors from 2 seperate offices) confirmed Graves Disease as final diagnosis of the disease which  she now suffers from indefinetly.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperthyroidism, Insomnia, Magnetic resonance imaging head, Scan with contrast abnormal, Thyroid gland injury
Clinical narrative: Patient had rapid heart beat 145 per min sustained after dose 2 within 1.5 weeks.   it was sustained never ceased to calm. She was breathing heavy, no sleep from rapid heart rate.  Hospital visit within a week of complaints confirmed Hyperthyroidism.  Followup with PA  of an Urgent Care allowed imaging to confirm Thyroid damage.  Folowup with Endocrinologists (2 seperate doctors from 2 seperate offices) confirmed Graves Disease as final diagnosis of the disease which  she now suffers from indefinetly.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid hormones test
Clinical narrative: Patient had rapid heart beat 145 per min sustained after dose 2 within 1.5 weeks.   it was sustained never ceased to calm. She was breathing heavy, no sleep from rapid heart rate.  Hospital visit within a week of complaints confirmed Hyperthyroidism.  Followup with PA  of an Urgent Care allowed imaging to confirm Thyroid damage.  Folowup with Endocrinologists (2 seperate doctors from 2 seperate offices) confirmed Graves Disease as final diagnosis of the disease which  she now suffers from indefinetly.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody negative, Blood homocysteine normal, Blood iron normal, Blood thyroid stimulating hormone normal, COVID-19
Clinical narrative: 02/21/21 brain fog & fatigue for 1 day 08/2021 gradual onset of moderate pain posterior thigh, no pain at rest - only with contraction, no improvement with exercise 05/2022 brain fog/fatigue for 1 day, tested pos for COVID, 10 bpm spike in Fitbit resting heart rate over 5 days 06/2022 leg pain getting worse, 2 months of physical therapy some improvement, more improvement with 6-inch wedge gel-foam seat pad 08/2022 difficulty walking, unable to take full step without effort - ongoing but stride recovered within a month or so of onset  08/2022 onset of numbness in 1st 2 toes of both feet, ongoing, may be getting worse, noticed when 1st toe R foot started bleeding while wearing sandals. Toe feels like its broken.  09/ 10/2022 (1 mo post booster) brain fog/fatigue for 1 day, spike in fitness watch resting heart rate, no COVID test, assumed positive 01/2022 Leg symptoms persist, unsteady gait gradually worsening.  I think this is long COVD syndrome induced by the initial vaccine doses since it started prior to my first and only positive COVID test (see tests results to R/O other causes.)  I have observed increased urine foam (protein) since the spring of 2021.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Ceruloplasmin normal, Differential white blood cell count normal, Fatigue, Feeling abnormal, Full blood count normal
Clinical narrative: 02/21/21 brain fog & fatigue for 1 day 08/2021 gradual onset of moderate pain posterior thigh, no pain at rest - only with contraction, no improvement with exercise 05/2022 brain fog/fatigue for 1 day, tested pos for COVID, 10 bpm spike in Fitbit resting heart rate over 5 days 06/2022 leg pain getting worse, 2 months of physical therapy some improvement, more improvement with 6-inch wedge gel-foam seat pad 08/2022 difficulty walking, unable to take full step without effort - ongoing but stride recovered within a month or so of onset  08/2022 onset of numbness in 1st 2 toes of both feet, ongoing, may be getting worse, noticed when 1st toe R foot started bleeding while wearing sandals. Toe feels like its broken.  09/ 10/2022 (1 mo post booster) brain fog/fatigue for 1 day, spike in fitness watch resting heart rate, no COVID test, assumed positive 01/2022 Leg symptoms persist, unsteady gait gradually worsening.  I think this is long COVD syndrome induced by the initial vaccine doses since it started prior to my first and only positive COVID test (see tests results to R/O other causes.)  I have observed increased urine foam (protein) since the spring of 2021.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Haemorrhage, Heart rate increased, Hypoaesthesia, Immunology test
Clinical narrative: 02/21/21 brain fog & fatigue for 1 day 08/2021 gradual onset of moderate pain posterior thigh, no pain at rest - only with contraction, no improvement with exercise 05/2022 brain fog/fatigue for 1 day, tested pos for COVID, 10 bpm spike in Fitbit resting heart rate over 5 days 06/2022 leg pain getting worse, 2 months of physical therapy some improvement, more improvement with 6-inch wedge gel-foam seat pad 08/2022 difficulty walking, unable to take full step without effort - ongoing but stride recovered within a month or so of onset  08/2022 onset of numbness in 1st 2 toes of both feet, ongoing, may be getting worse, noticed when 1st toe R foot started bleeding while wearing sandals. Toe feels like its broken.  09/ 10/2022 (1 mo post booster) brain fog/fatigue for 1 day, spike in fitness watch resting heart rate, no COVID test, assumed positive 01/2022 Leg symptoms persist, unsteady gait gradually worsening.  I think this is long COVD syndrome induced by the initial vaccine doses since it started prior to my first and only positive COVID test (see tests results to R/O other causes.)  I have observed increased urine foam (protein) since the spring of 2021.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Iron binding capacity total normal, Metabolic function test normal, Pain in extremity, SARS-CoV-2 test positive, Serum ferritin normal
Clinical narrative: 02/21/21 brain fog & fatigue for 1 day 08/2021 gradual onset of moderate pain posterior thigh, no pain at rest - only with contraction, no improvement with exercise 05/2022 brain fog/fatigue for 1 day, tested pos for COVID, 10 bpm spike in Fitbit resting heart rate over 5 days 06/2022 leg pain getting worse, 2 months of physical therapy some improvement, more improvement with 6-inch wedge gel-foam seat pad 08/2022 difficulty walking, unable to take full step without effort - ongoing but stride recovered within a month or so of onset  08/2022 onset of numbness in 1st 2 toes of both feet, ongoing, may be getting worse, noticed when 1st toe R foot started bleeding while wearing sandals. Toe feels like its broken.  09/ 10/2022 (1 mo post booster) brain fog/fatigue for 1 day, spike in fitness watch resting heart rate, no COVID test, assumed positive 01/2022 Leg symptoms persist, unsteady gait gradually worsening.  I think this is long COVD syndrome induced by the initial vaccine doses since it started prior to my first and only positive COVID test (see tests results to R/O other causes.)  I have observed increased urine foam (protein) since the spring of 2021.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Thyroxine free normal, Vitamin B1, Vitamin B12 normal, Vitamin B6 increased, Vitamin D
Clinical narrative: 02/21/21 brain fog & fatigue for 1 day 08/2021 gradual onset of moderate pain posterior thigh, no pain at rest - only with contraction, no improvement with exercise 05/2022 brain fog/fatigue for 1 day, tested pos for COVID, 10 bpm spike in Fitbit resting heart rate over 5 days 06/2022 leg pain getting worse, 2 months of physical therapy some improvement, more improvement with 6-inch wedge gel-foam seat pad 08/2022 difficulty walking, unable to take full step without effort - ongoing but stride recovered within a month or so of onset  08/2022 onset of numbness in 1st 2 toes of both feet, ongoing, may be getting worse, noticed when 1st toe R foot started bleeding while wearing sandals. Toe feels like its broken.  09/ 10/2022 (1 mo post booster) brain fog/fatigue for 1 day, spike in fitness watch resting heart rate, no COVID test, assumed positive 01/2022 Leg symptoms persist, unsteady gait gradually worsening.  I think this is long COVD syndrome induced by the initial vaccine doses since it started prior to my first and only positive COVID test (see tests results to R/O other causes.)  I have observed increased urine foam (protein) since the spring of 2021.
Age: 18.0
Sex: M
Vaccine: COVID19-2
Symptoms: Bronchitis, Condition aggravated, Cough, Dyspnoea
Clinical narrative: had resolving bronchitis but cough and sob worse few hours after vaccination with bivalent vaccine
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: VACCINE WAS ADMINISTERED INTRAMUSCULARLY INSTEAD OF SUB-Q.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram head, Discomfort, Dizziness, Dyspepsia, Full blood count
Clinical narrative: Gradual onset of headache, pressure, dizziness, visual disturbances, nausea, indigestion which have become constant and still exist. Visited the E.R. at the hospital on December 31, 2022. Was treated with Benadryl, Ativan, Toradol to break headache.  Sent home. Symptoms still persist.   Visited neurologist January 6, 2023.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Nausea, Urine analysis, Visual impairment
Clinical narrative: Gradual onset of headache, pressure, dizziness, visual disturbances, nausea, indigestion which have become constant and still exist. Visited the E.R. at the hospital on December 31, 2022. Was treated with Benadryl, Ativan, Toradol to break headache.  Sent home. Symptoms still persist.   Visited neurologist January 6, 2023.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Eye pruritus, Ocular hyperaemia
Clinical narrative: Developed extremely itchy left eye near tear duct. Right eye slightly itchy. Very red and aggravated; burning, itching, irritated. Lasted ~36 hours,
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Soreness, and big bruise around the site of injection
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Cellulitis, Injection site erythema, Pyrexia, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Fever the first night resolved. Now redness, warmth and swelling to left upper around around the vaccine site consistent with cellulitis. Physical exam 1/7/23 and started on antibiotics.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Inflammation, Insomnia, Pain in extremity, Pruritus
Clinical narrative: I started experiencing bloody noses and welts and itchiness about a day after the shot. My left arm was sore as well, but what was bad was I started feeling inflammation of left arm, heart and head. It was low at first and actually helped with sleep the first day or two, but increased day by day, little by little. After a few days, it started affecting my sleep and the inflammation continued to trend worse each day. I had a real bad experience with a hospital prior to the pandemic, and came to the conclusion doctors there would not be able to help with something like this. Plus, it was in the middle of the pandemic and I didn't want to go to a hospital. I read a lot, took vitamins, and start fasting and using hot/cold therapies at home. The hot/cold therapies weren't that helpful, but I noticed a difference with the fasting. I knew my knees would hate longer fasts (did a 3 day one before--brain loved it, knees hated it). I noticed that after the first 30+ hours fast, the inflammation seemed a little better, but would increase again slowly so I fasted every week for 3+ months until the inflammation of heart and head felt under control. I know I should have reported this earlier and I actually downloaded the form, but got sidetracked. I want to report this in case it helps someone. Many of us experiencing adverse events aren't in the mood to fill out forms, especially while the event is occuring.  Some of us also needed time to process. I never went back for another shot. To this day, just the thought of another Covid shot makes my left arm hurt.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I started experiencing bloody noses and welts and itchiness about a day after the shot. My left arm was sore as well, but what was bad was I started feeling inflammation of left arm, heart and head. It was low at first and actually helped with sleep the first day or two, but increased day by day, little by little. After a few days, it started affecting my sleep and the inflammation continued to trend worse each day. I had a real bad experience with a hospital prior to the pandemic, and came to the conclusion doctors there would not be able to help with something like this. Plus, it was in the middle of the pandemic and I didn't want to go to a hospital. I read a lot, took vitamins, and start fasting and using hot/cold therapies at home. The hot/cold therapies weren't that helpful, but I noticed a difference with the fasting. I knew my knees would hate longer fasts (did a 3 day one before--brain loved it, knees hated it). I noticed that after the first 30+ hours fast, the inflammation seemed a little better, but would increase again slowly so I fasted every week for 3+ months until the inflammation of heart and head felt under control. I know I should have reported this earlier and I actually downloaded the form, but got sidetracked. I want to report this in case it helps someone. Many of us experiencing adverse events aren't in the mood to fill out forms, especially while the event is occuring.  Some of us also needed time to process. I never went back for another shot. To this day, just the thought of another Covid shot makes my left arm hurt.
Age: 10.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Death, Gastric cancer stage IV
Clinical narrative: My dad's PSA levels skyrocketed from 2021 to 2022 resulting in a diagnosis of curable Prostate Cancer.  As of the date of this diagnosis he had received 4 covid vaccinations.  He received the 5th covid vaccination shortly after beginning radiation for curable Prostate Cancer.  Prior to the 5th dose on 9/2022, my dad had no other cancers.  The scans and bloodwork showed no metastases.  On 10/2022 my dad was diagnosed with Stage 4 gastric cancer.  Unrelated to the existing prostate cancer.  The Gastric Cancer was a second primary - which is very rare.  Additionally, his gastric cancer was PDL1 positive and metastasized at an unusually aggressive speed.  He went to heaven on 12/2022.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 56.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 58.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Bivalent booster dose given in place of 2nd dose.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: V.
Age: 8.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 19.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 23.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 29.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 72.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 66.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 47.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product use issue
Clinical narrative: Vaccine given 1 day out of date beyond use date. Patient does not report any unusual signs and symptoms or local reactions.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Gait disturbance, Pain
Clinical narrative: Patient experienced pain all over her body within 15 minutes after receiving the vaccine. She was unsteady and unsure if she could drive home.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 77.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 18.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 95.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 18.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product use issue
Clinical narrative: Vaccine given 1 day out of date beyond use date. Patient does not report any unusual signs and symptoms or local reactions.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 26.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine given 1 day out of date beyond use date. Patient does not report any unusual signs and symptoms or local reactions.
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine given 1 day out of date beyond use date. Patient does not report any unusual signs and symptoms or local reactions.
Age: 28.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine given 2 days out of date beyond use date. Patient does not report any unusual signs and symptoms or local reactions.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Breast pain, Glossodynia, Lip pain, Oral pain
Clinical narrative: Sore knot under left breast and sinus infection. Dr prescribed antibiotic, zpack, to help with both. Size of knot under breast was reduced and soreness went away. After I finished antibiotics, mouth got sore. Left side of tongue and inside top lip. I am taking Benadryl, benzocaine lozenges, and  Ambesol right now (started 1/7/2023).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Sore knot under left breast and sinus infection. Dr prescribed antibiotic, zpack, to help with both. Size of knot under breast was reduced and soreness went away. After I finished antibiotics, mouth got sore. Left side of tongue and inside top lip. I am taking Benadryl, benzocaine lozenges, and  Ambesol right now (started 1/7/2023).
Age: 86.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Bladder catheter replacement, Blood pressure increased, Blood test
Clinical narrative: 08/07/2022 Awoke early morning with pain back of head,neck, shoulder, and upper chest. Self tested with Covid 19 Home Kit. Result negative, Could not get back to sleep wondering what was wrong.  Went to local ER. Test for Covid was negative. Did further testing (Bloodwork, Xrays.etc.)  Kept overnight for observation. Woke up following motning and felt fine. Diagnosis was Acute Pericarditis. Sent home with (5 ? )new medications including Colchicine, Pantoprozole, Ibuprofen. Returned to ER later that day with a leaking supra pubic catheter. Changed tube and told to see my Urologist who prescribed Solifenacin. In the days and weeks following the ER visits, I began to develop
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Decreased appetite, Device leakage, Dry mouth, Eosinophil count increased
Clinical narrative: 08/07/2022 Awoke early morning with pain back of head,neck, shoulder, and upper chest. Self tested with Covid 19 Home Kit. Result negative, Could not get back to sleep wondering what was wrong.  Went to local ER. Test for Covid was negative. Did further testing (Bloodwork, Xrays.etc.)  Kept overnight for observation. Woke up following motning and felt fine. Diagnosis was Acute Pericarditis. Sent home with (5 ? )new medications including Colchicine, Pantoprozole, Ibuprofen. Returned to ER later that day with a leaking supra pubic catheter. Changed tube and told to see my Urologist who prescribed Solifenacin. In the days and weeks following the ER visits, I began to develop