chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 10 Patients administered vaccine past the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 Patients administered vaccine past the beyond use date) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 Patients administered vaccine past the beyond use date). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (10 Patients administered vaccine past the beyond use date) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 10 patients administered vaccine past the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment information was provided by the reporter.  Date the vial was initially stored in the refrigerator: 26-Oct-2021 The Pharmacist administered some vaccinations from a Moderna Covid-19 vial that had been punctured on 04-NOV-2021 and was past the 12 hour beyond use date. 10 patients received vaccine from that vial.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PROPRANOLOL and HYDROXYZINE for Anxiety, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for Depression.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other Concomitant products included unknown drug for birth control.   This case was linked to MOD-2021-378037, MOD-2021-377816 (Patient Link).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Body aches/pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches/pain) and CHILLS (Chills) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced MYALGIA (Body aches/pain) and CHILLS (Chills). On 05-Nov-2021, MYALGIA (Body aches/pain) and CHILLS (Chills) had resolved.            No concomitant medication or treatment were reported.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: My sister just dies from it; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (My sister just dies from it) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2021: Follow Up received include no new information; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy
Clinical narrative: pregnant /no AE; Initial information was received on 03-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional and physician.  This case involves a (unknown age) female patient who was exposed to vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (exposure during pregnancy).   Data regarding this pregnancy were received prospectively, that is before pregnancy outcome was known.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient's medical treatments, vaccinations, concomitant medication and family history were not provided.  The patient had no medical history, concomitant disease or risk factor.   The information regarding the patient's previous pregnancy/ies was not reported.  On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiry date not reported) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of vaccine exposure during pregnancy (same day latency).  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.  There will be no information on the batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Gait inability, Hypoaesthesia, Laboratory test normal, Vision blurred
Clinical narrative: cannot walk; blurred vision; numbness in one leg below the knee; Initial information was regarding an unsolicited valid serious case was received from a consumer/non-healthcare professional via Medical Information (MI) (Reference number- 00841577) and transmitted to Sanofi on 03-Nov-2021.  This case involves an 83-year-old female patient who experienced cannot walk (gait inability), blurred vision (vision blurred) and numbness in one leg below the knee (hypoaesthesia), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (once, lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious cannot walk (gait inability) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was leading to disability.  On an unknown date, the patient developed a non-serious blurred vision (vision blurred) and numbness in one leg below the knee (hypoaesthesia) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  The patient was admitted to the hospital yesterday and has had "a lot of tests" and they all came back normal.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns an 83-year-old female who had gait inability, vision blurred and hypoaesthesia after receiving FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is unknown. Furthermore, information regarding medical history, past medical treatment, vaccinations, concomitant medication, condition at the time of vaccination and laboratory data 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.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Raynaud's phenomenon
Clinical narrative: Raynauds symptoms
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Insomnia, Myalgia
Clinical narrative: Insomnia. shivering, chills, muscle and joint pain
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Oligomenorrhoea
Clinical narrative: Heavy and extended menstruation. My period lasted for  approximately 45 straight days after my 2nd vaccine. It also lasted slightly longer after my first shot (2 weeks vs my average 5-6 days), but I didn?t think anything of because it wasn?t super heavy, just slightly abnormal.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Grip strength decreased, Mobility decreased, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: The day after my shot the left side of my body ached all day then on Nov 1 I woke up and had a bump in the palm of my left hand about the size of a dine. My middle finger felt like it was jammed. When I try to touch my palm by bending my middle finger I can?t. When I grip something for more than a few minutes, when I open my hand the pain level is frequently 9 or 10.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Confusional state, Dry mouth, Fatigue, Headache
Clinical narrative: Sore Arm, Tiredness, Nausea, Heart Palpitations, Headache, Sweaty/Clammy Skin, Dry Mouth, Light Headedness, Confusion, Poor Sleep
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Pain in extremity, Palpitations, Poor quality sleep
Clinical narrative: Sore Arm, Tiredness, Nausea, Heart Palpitations, Headache, Sweaty/Clammy Skin, Dry Mouth, Light Headedness, Confusion, Poor Sleep
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation (different manufacturer initial and booster)-.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Systemic: Swelling of the lips-Mild, Additional Details: After 20-30 minutes, patient came to the pharmacy and states that he has swelling of the lips after getting his first pfizer vaccine. I asked patient if he has other symptoms such as difficult breathing, swelling in other areas. Patient states it was just the lips.  I give him 2 tablets benadryl and told him to wait for another 30 minutes.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution-
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Flushing, Hyperhidrosis, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient received first covid vaccine dose - no allergies - does not routinely get vaccinated but was not nervous per patient - about 5 minutes after his dose he felt faint and fell down quickly he needed water and was sweating. Patient began to feel better but had the EMS check him out anyways and escort him out after a waiting period to make sure he was ok. His BP was normal.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient received first covid vaccine dose - no allergies - does not routinely get vaccinated but was not nervous per patient - about 5 minutes after his dose he felt faint and fell down quickly he needed water and was sweating. Patient began to feel better but had the EMS check him out anyways and escort him out after a waiting period to make sure he was ok. His BP was normal.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Nausea, Vomiting
Clinical narrative: Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Pt had a period of nausea within 30 seconds after receiving vaccine. Pt vomited a small amount once into the clinic sink and immediately felt better. Pt and Pt's father said that Pt had been very anxious. Monitored Pt for 15 minutes. All of Pt's vital signs were within normal limits. Pt said she was feeling back to normal and was able to independently walk out of the clinic.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Bursitis, Chills, Computerised tomogram
Clinical narrative: First injection: developed low fever, chills, body aches, pain in right shoulder, pain at injection site and swollen glands. Prescribed antibiotics for swollen glands. Second injection: developed fever of 102 for 12 hours, aches, headache, pain in right shoulder intensified and swollen glands in neck intensified. Shoulder pain became so bad after 2 weeks I could not lift my right arm. Seen by orthopedics and told I had bursitis. Received injection in right shoulder. I completed 8 weeks of physical therapy with ongoing should pain today. Also saw doctor for swollen nodes in right-side of neck that continue to cause discomfort. CAT scans and MRI performed. No cause found for continued swelling. Continue to have pain in shoulder and lymph node swelling/discomfort has not subsided since first occurrence. After the first course of antibiotics. I returned to my family doctor about 6 weeks later and told them I continued to have uncomfortable lump in my neck. They performed an X-ray and gave me a referral having found no cause for the swelling. I have another appointment on 11/29/2021 for monitoring of the lymph node.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Headache, Injection site pain, Lymphadenopathy, Magnetic resonance imaging
Clinical narrative: First injection: developed low fever, chills, body aches, pain in right shoulder, pain at injection site and swollen glands. Prescribed antibiotics for swollen glands. Second injection: developed fever of 102 for 12 hours, aches, headache, pain in right shoulder intensified and swollen glands in neck intensified. Shoulder pain became so bad after 2 weeks I could not lift my right arm. Seen by orthopedics and told I had bursitis. Received injection in right shoulder. I completed 8 weeks of physical therapy with ongoing should pain today. Also saw doctor for swollen nodes in right-side of neck that continue to cause discomfort. CAT scans and MRI performed. No cause found for continued swelling. Continue to have pain in shoulder and lymph node swelling/discomfort has not subsided since first occurrence. After the first course of antibiotics. I returned to my family doctor about 6 weeks later and told them I continued to have uncomfortable lump in my neck. They performed an X-ray and gave me a referral having found no cause for the swelling. I have another appointment on 11/29/2021 for monitoring of the lymph node.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain, Pyrexia, X-ray
Clinical narrative: First injection: developed low fever, chills, body aches, pain in right shoulder, pain at injection site and swollen glands. Prescribed antibiotics for swollen glands. Second injection: developed fever of 102 for 12 hours, aches, headache, pain in right shoulder intensified and swollen glands in neck intensified. Shoulder pain became so bad after 2 weeks I could not lift my right arm. Seen by orthopedics and told I had bursitis. Received injection in right shoulder. I completed 8 weeks of physical therapy with ongoing should pain today. Also saw doctor for swollen nodes in right-side of neck that continue to cause discomfort. CAT scans and MRI performed. No cause found for continued swelling. Continue to have pain in shoulder and lymph node swelling/discomfort has not subsided since first occurrence. After the first course of antibiotics. I returned to my family doctor about 6 weeks later and told them I continued to have uncomfortable lump in my neck. They performed an X-ray and gave me a referral having found no cause for the swelling. I have another appointment on 11/29/2021 for monitoring of the lymph node.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pruritus, Oral discomfort, Pruritus
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: Patient took a tablet of Benadryl 25 mg due to a "funny" feeling of the upper lip, as well as some itching of the ears and face
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Chest X-ray, Chest discomfort, Pericarditis
Clinical narrative: Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: patient was diagnosed with mild pericarditis following chest xray and given antiinflammatory medications and order to avoid exercise until feeling well.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Patient was given undiluted dose of pediatric Pfizer Covid-19 vaccine. This was caught by the pharmacist on site after administration. Patient did well through observation period in clinic and did not have any immediate reaction. Patient's mother was notified and advised patient may have more impressive immune response due to this increased dose of vaccine.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Head injury, Swelling, Syncope
Clinical narrative: Fainted 11 minutes after shot administered. Fell to floor and was alert again within a couple seconds. Pediatric staff provided ice for bumped head and sips of water, checked vital signs, and extended observation period. Released to go home approx. 20-30 minutes after incident.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Electromyogram, Fatigue, Feeling abnormal
Clinical narrative: Began with tingling sensation in left foot, eventually moved to internal vibrations throughout the entire body, general fatigue, brain foginess, and muscle weakness.  Symptoms started in June 2021 and have gotten progressively worse over time.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Muscular weakness, Paraesthesia, Tremor, Ultrasound thyroid
Clinical narrative: Began with tingling sensation in left foot, eventually moved to internal vibrations throughout the entire body, general fatigue, brain foginess, and muscle weakness.  Symptoms started in June 2021 and have gotten progressively worse over time.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paraesthesia oral, Pruritus
Clinical narrative: Patient presented to vaccine clinic to receive her first dose of Moderna COVID-19 vaccine. Due to her self reported history of anaphylaxis from bee stings she remained in observation for 30 minutes post injection. After being observed for 30 minutes patient reported itching on her arms, face, and head. She also reported tingling of her tongue. No visible hives, respirations within normal limits, unlabored, with open airway. Patient also reported a headache and explained that she was very sensitive to many medications. Provider recommended presenting to the the emergency department with symptoms, or staying in her car near medical facility for at least an hour post injection. Provider also recommended having someone come to pick up the patient so that she was not driving herself alone and seek medical attention if symptoms worsen.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Contusion, Laboratory test, Pain
Clinical narrative: tightness in chest. anxiety feeling, but more so than normal. pain in thighs, as if I ran a marathon. hunger pains, but not hungry. BB size bump on hand that is bruised, no action caused it. body aches, which I was told would happen.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: tightness in chest. anxiety feeling, but more so than normal. pain in thighs, as if I ran a marathon. hunger pains, but not hungry. BB size bump on hand that is bruised, no action caused it. body aches, which I was told would happen.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine vial stored at incorrect temperature
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature decreased, Burning sensation, Chills, Fear, Feeling cold
Clinical narrative: Within 15 minutes after the first, second and third dose of the moderna vaccine I had muscle twitching and tingling in my legs.  I didn?t place much thought about it the first two times and the muscle fasciculations subsided within a week.  After all three doses I also had a massive headache within 2 hours of taking the vaccine. Tylenol  helped the first two times, however not so much after the 3rd dose.  Since the third dose I have severe muscle fasciculations in my legs and arms that persist, also with the sensation of pins and needles. Additionally, Tuesday night I woke up in a night sweat- completely soaking my bed and pjs, my heart pounding and beating so fast that I thought I was going to have to call 911. (my average heart beat is low 40) I was running a fever of 102 while taking Tylenol  q/4 hrs. The night sweat occurred again Wednesday night (I never have experienced night sweats before). The fever finally broke Thursday morning.  Thursday I experienced chills all day despite having no fever. I was running cold around 96. In the afternoon I was standing at my computer and my toes and feet went completely numb, with the exception of my big toe. This scared me. I have never experienced this before. I am healthy, not diabetic etc. In an effort to warm up I went for a walk to see if I would gain the feeling in my feet/toes. The was walk initially painful on my feet. Finally 40 minutes into the  walk I started to regain the feeling in my toes. They burned and tingled. Today, Friday morning I am reporting this as I did not sleep once again last night due to severe muscle fasciculations and tingling which is now also in my arms and hands.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Hyperhidrosis, Hypoaesthesia, Muscle contractions involuntary
Clinical narrative: Within 15 minutes after the first, second and third dose of the moderna vaccine I had muscle twitching and tingling in my legs.  I didn?t place much thought about it the first two times and the muscle fasciculations subsided within a week.  After all three doses I also had a massive headache within 2 hours of taking the vaccine. Tylenol  helped the first two times, however not so much after the 3rd dose.  Since the third dose I have severe muscle fasciculations in my legs and arms that persist, also with the sensation of pins and needles. Additionally, Tuesday night I woke up in a night sweat- completely soaking my bed and pjs, my heart pounding and beating so fast that I thought I was going to have to call 911. (my average heart beat is low 40) I was running a fever of 102 while taking Tylenol  q/4 hrs. The night sweat occurred again Wednesday night (I never have experienced night sweats before). The fever finally broke Thursday morning.  Thursday I experienced chills all day despite having no fever. I was running cold around 96. In the afternoon I was standing at my computer and my toes and feet went completely numb, with the exception of my big toe. This scared me. I have never experienced this before. I am healthy, not diabetic etc. In an effort to warm up I went for a walk to see if I would gain the feeling in my feet/toes. The was walk initially painful on my feet. Finally 40 minutes into the  walk I started to regain the feeling in my toes. They burned and tingled. Today, Friday morning I am reporting this as I did not sleep once again last night due to severe muscle fasciculations and tingling which is now also in my arms and hands.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Night sweats, Pain in extremity, Palpitations, Paraesthesia
Clinical narrative: Within 15 minutes after the first, second and third dose of the moderna vaccine I had muscle twitching and tingling in my legs.  I didn?t place much thought about it the first two times and the muscle fasciculations subsided within a week.  After all three doses I also had a massive headache within 2 hours of taking the vaccine. Tylenol  helped the first two times, however not so much after the 3rd dose.  Since the third dose I have severe muscle fasciculations in my legs and arms that persist, also with the sensation of pins and needles. Additionally, Tuesday night I woke up in a night sweat- completely soaking my bed and pjs, my heart pounding and beating so fast that I thought I was going to have to call 911. (my average heart beat is low 40) I was running a fever of 102 while taking Tylenol  q/4 hrs. The night sweat occurred again Wednesday night (I never have experienced night sweats before). The fever finally broke Thursday morning.  Thursday I experienced chills all day despite having no fever. I was running cold around 96. In the afternoon I was standing at my computer and my toes and feet went completely numb, with the exception of my big toe. This scared me. I have never experienced this before. I am healthy, not diabetic etc. In an effort to warm up I went for a walk to see if I would gain the feeling in my feet/toes. The was walk initially painful on my feet. Finally 40 minutes into the  walk I started to regain the feeling in my toes. They burned and tingled. Today, Friday morning I am reporting this as I did not sleep once again last night due to severe muscle fasciculations and tingling which is now also in my arms and hands.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: Within 15 minutes after the first, second and third dose of the moderna vaccine I had muscle twitching and tingling in my legs.  I didn?t place much thought about it the first two times and the muscle fasciculations subsided within a week.  After all three doses I also had a massive headache within 2 hours of taking the vaccine. Tylenol  helped the first two times, however not so much after the 3rd dose.  Since the third dose I have severe muscle fasciculations in my legs and arms that persist, also with the sensation of pins and needles. Additionally, Tuesday night I woke up in a night sweat- completely soaking my bed and pjs, my heart pounding and beating so fast that I thought I was going to have to call 911. (my average heart beat is low 40) I was running a fever of 102 while taking Tylenol  q/4 hrs. The night sweat occurred again Wednesday night (I never have experienced night sweats before). The fever finally broke Thursday morning.  Thursday I experienced chills all day despite having no fever. I was running cold around 96. In the afternoon I was standing at my computer and my toes and feet went completely numb, with the exception of my big toe. This scared me. I have never experienced this before. I am healthy, not diabetic etc. In an effort to warm up I went for a walk to see if I would gain the feeling in my feet/toes. The was walk initially painful on my feet. Finally 40 minutes into the  walk I started to regain the feeling in my toes. They burned and tingled. Today, Friday morning I am reporting this as I did not sleep once again last night due to severe muscle fasciculations and tingling which is now also in my arms and hands.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Limb injury, Pain, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine vial stored at incorrect temperature
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Injection site bruising, Lethargy
Clinical narrative: Site: Bruising at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Vomiting-Mild, Systemic: Weakness-Mild, Additional Details: EMT/EMS called and patient had caregiver come pick him up
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: Site: Bruising at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Vomiting-Mild, Systemic: Weakness-Mild, Additional Details: EMT/EMS called and patient had caregiver come pick him up
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Blood test, Chest pain, Electrocardiogram, Pain in extremity
Clinical narrative: Adverse reaction- Pleurisy ...went to hospital with heart attack like symptoms pain in left side of chest and arm (vaccine in left arm) several test - blood work, ekg and x-rays...given 800 mg ibuprofen for pain and swelling
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pleurisy, Swelling, X-ray
Clinical narrative: Adverse reaction- Pleurisy ...went to hospital with heart attack like symptoms pain in left side of chest and arm (vaccine in left arm) several test - blood work, ekg and x-rays...given 800 mg ibuprofen for pain and swelling
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Systemic: Visual Changes/Disturbances-Mild
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Visual impairment
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Systemic: Visual Changes/Disturbances-Mild
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Injection site pain, Injection site swelling, Limb injury
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: according to patient, vaccine was administered by standing pharmacist. Vaccine was given too far forward and to the front of shoulder as opposed to in the deltoid
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Product administered at inappropriate site
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: according to patient, vaccine was administered by standing pharmacist. Vaccine was given too far forward and to the front of shoulder as opposed to in the deltoid
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Limb injury, Pain, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Irritability, Nausea, Pain in extremity
Clinical narrative: Fatigue, nauseous, sore arm, irritable
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb injury, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Received annual flu vaccine. Arm became extremely reddened, swollen, hot to touch and itchy.  Experienced body aches, diarrhea, headache. Symptoms have resolved at this time, except injection site is still reddened and warm to touch, although, not as severe as earlier.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Pain
Clinical narrative: Received annual flu vaccine. Arm became extremely reddened, swollen, hot to touch and itchy.  Experienced body aches, diarrhea, headache. Symptoms have resolved at this time, except injection site is still reddened and warm to touch, although, not as severe as earlier.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pallor
Clinical narrative: Patient reports feeling marked presents profuse sweating and pale color. Patient is evaluated by emergency medical personnel. 66r es Pulse 68 os/06 DXT 96 R 20. He is placed on a stretcher and observed for 30 minutes. Doctor is notified by family refers family history of vagal vessel. Vitals discharge SAT 100  Pulse 76 B/P 95/60 There are no restrictions when breathing.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Moderna 3/12 and 4/9. Positive on 11/11
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine vial stored at incorrect temperature
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Pruritus, Tongue pruritus
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient reported an itchy/tingling sensation on her tongue.  Gave her water and 50mg of Benadryl and monitored for 30 minutes.  She reported that it may have been nerves and "hyperchondriac" feeling. Patient was fine a few minutes later and for the duration of observation
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: 3cm  pink , slightly  swollen  areas around injection  sites.   Hydroxyzine  oral . Triamcinolone 0/1% cream
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood culture positive, Blood glucose decreased, COVID-19, COVID-19 pneumonia, Chest X-ray abnormal
Clinical narrative: Pt received Pfizer vaccines on 03/05/21 and 03/26/21. Pt presented to the ED from a nursing home facility on 11/10/21 with complaints of low blood sugar, SOB, and AMS. Health care facility noted that pt was COVID positive on November 4th. CXR showed COVID pneumonia. Blood sugars found to be critically low. Pt was placed on 15L nonrebreather while in the ED and eventually intubated on 11/10. Blood cultures were positive for Klebsiella Pneumoniae.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Endotracheal intubation, Mental status changes, SARS-CoV-2 test positive
Clinical narrative: Pt received Pfizer vaccines on 03/05/21 and 03/26/21. Pt presented to the ED from a nursing home facility on 11/10/21 with complaints of low blood sugar, SOB, and AMS. Health care facility noted that pt was COVID positive on November 4th. CXR showed COVID pneumonia. Blood sugars found to be critically low. Pt was placed on 15L nonrebreather while in the ED and eventually intubated on 11/10. Blood cultures were positive for Klebsiella Pneumoniae.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb injury, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Paraesthesia oral, Sensation of foreign body, Throat tightness
Clinical narrative: Difficulty Swallowing, Throat Tightness-Mild, and Tingling (specify: facial area, extemities)-Mild. The patient complained for tingling in lips and difficultly swallowing/feeling of lumps in throat. Patient was administered epi-pen and observed for 40minutes after epi-pen. Patient felt fine after and went home. Patient was contacted about 2 hours later and she said she was feeling fine.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Feeling abnormal
Clinical narrative: Confusion-Mild, Dizziness, Lightheadedness-Mild, and Foggy Headed-Mild.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood culture, Full blood count, Metabolic function test, Viral test
Clinical narrative: Generalized weakness. Found on floor twice by daughter, brought to ED and he was admitted for observation
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Coordination abnormal, Dysstasia, Fall
Clinical narrative: 2 hours after vaccine was administered, I developed a migraine, and was nauseated.  Then 12 hours later, I developed fever and chills and the next morning I was unable to stand on my own.  I fell twice due to lack of balance and coordination.  This lasted over 12 hours.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Pyrexia
Clinical narrative: 2 hours after vaccine was administered, I developed a migraine, and was nauseated.  Then 12 hours later, I developed fever and chills and the next morning I was unable to stand on my own.  I fell twice due to lack of balance and coordination.  This lasted over 12 hours.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT WAS GIVEN PEDIATRIC DOSE IN ERROR. PT JUST TURNED 12 AND WAS ACCIDENTLY GIVEN THE PEDIATRIC DOSE.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Dysphemia
Clinical narrative: PATIENT DEVELOPED STUTTERING 3 DAYS AFTER VACCINATION
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Friday: Hives started on the arms Saturday: Took benadryl PO q 4 hours, hives continued to spread Sunday: Woke up with hives on face, proceeded to Express care; started script of prednisone 40mg q daily
Age: 92.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Cough, Fall
Clinical narrative: Pt received Pfizer Vaccines in March of 2021. Pt presented to the ED on 11/03/21 with complaints of a cough. Pt was found to be COVID positive and was discharged home on 11/03/21. Pt presented to the ED on 11/10/21 after a fall. CXR showed COVID pneumonia and pt was requiring supplemental oxygen during admission.
Age: 92.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza virus test, Respiratory syncytial virus test, SARS-CoV-2 test positive
Clinical narrative: Pt received Pfizer Vaccines in March of 2021. Pt presented to the ED on 11/03/21 with complaints of a cough. Pt was found to be COVID positive and was discharged home on 11/03/21. Pt presented to the ED on 11/10/21 after a fall. CXR showed COVID pneumonia and pt was requiring supplemental oxygen during admission.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vomiting
Clinical narrative: Patient was nervous before vaccination process. After being inoculated he suffered dizziness and a minor episode of vomiting. He was attended and refused to take vitas or assistance from nursing or paramedics
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Insomnia, Nausea, Pain
Clinical narrative: Achy body, some nausea, chills, unable to sleep Tired throughout 11/11 Rested well and feel good 11/12
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Vomiting
Clinical narrative: sore arm, the following day: fatigue, vomitting
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Arthralgia, Burning sensation, Chills, Confusional state
Clinical narrative: 10/27/21 aprox 02:00 hrs, I woke from a sleep with itching under my arms and between my toes, and slight body aches. I took Benadryl for relief.  The next morning, 10/28/21 I woke around 0600 hrs with a headache.  Throughout the day I was slightly confused, very tired and a headache.  My right arm, the injection site, was very painful.  Around 17:30 hrs, I had a fever, chills and body aches.  My left shoulder joint was in severe pain.  I had severe cramps in my arms and legs throughout the night.  I felt as if I had covid again.  10/29/21 woke with a slight headache, and took Tylenol for relief. The rest of the day was uneventful.  10/30/21 again suffering from mild headaches, treated with Tylenol for relief. 10/31/21, mild headaches slightly tired and aprox 22:30 my heart rate was about 110 and my 02-saturation fluctuated between 91 and 94 at rest.  My left hand felt like it was swelling and my ring finger was throbbing through the night. Since that night I have on-going headaches, difficulty finding my words while in a full sentence and for the last three days sudden burning and tingling in feet.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Injection site pain, Malaise
Clinical narrative: 10/27/21 aprox 02:00 hrs, I woke from a sleep with itching under my arms and between my toes, and slight body aches. I took Benadryl for relief.  The next morning, 10/28/21 I woke around 0600 hrs with a headache.  Throughout the day I was slightly confused, very tired and a headache.  My right arm, the injection site, was very painful.  Around 17:30 hrs, I had a fever, chills and body aches.  My left shoulder joint was in severe pain.  I had severe cramps in my arms and legs throughout the night.  I felt as if I had covid again.  10/29/21 woke with a slight headache, and took Tylenol for relief. The rest of the day was uneventful.  10/30/21 again suffering from mild headaches, treated with Tylenol for relief. 10/31/21, mild headaches slightly tired and aprox 22:30 my heart rate was about 110 and my 02-saturation fluctuated between 91 and 94 at rest.  My left hand felt like it was swelling and my ring finger was throbbing through the night. Since that night I have on-going headaches, difficulty finding my words while in a full sentence and for the last three days sudden burning and tingling in feet.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain, Paraesthesia, Peripheral swelling, Pruritus
Clinical narrative: 10/27/21 aprox 02:00 hrs, I woke from a sleep with itching under my arms and between my toes, and slight body aches. I took Benadryl for relief.  The next morning, 10/28/21 I woke around 0600 hrs with a headache.  Throughout the day I was slightly confused, very tired and a headache.  My right arm, the injection site, was very painful.  Around 17:30 hrs, I had a fever, chills and body aches.  My left shoulder joint was in severe pain.  I had severe cramps in my arms and legs throughout the night.  I felt as if I had covid again.  10/29/21 woke with a slight headache, and took Tylenol for relief. The rest of the day was uneventful.  10/30/21 again suffering from mild headaches, treated with Tylenol for relief. 10/31/21, mild headaches slightly tired and aprox 22:30 my heart rate was about 110 and my 02-saturation fluctuated between 91 and 94 at rest.  My left hand felt like it was swelling and my ring finger was throbbing through the night. Since that night I have on-going headaches, difficulty finding my words while in a full sentence and for the last three days sudden burning and tingling in feet.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: 10/27/21 aprox 02:00 hrs, I woke from a sleep with itching under my arms and between my toes, and slight body aches. I took Benadryl for relief.  The next morning, 10/28/21 I woke around 0600 hrs with a headache.  Throughout the day I was slightly confused, very tired and a headache.  My right arm, the injection site, was very painful.  Around 17:30 hrs, I had a fever, chills and body aches.  My left shoulder joint was in severe pain.  I had severe cramps in my arms and legs throughout the night.  I felt as if I had covid again.  10/29/21 woke with a slight headache, and took Tylenol for relief. The rest of the day was uneventful.  10/30/21 again suffering from mild headaches, treated with Tylenol for relief. 10/31/21, mild headaches slightly tired and aprox 22:30 my heart rate was about 110 and my 02-saturation fluctuated between 91 and 94 at rest.  My left hand felt like it was swelling and my ring finger was throbbing through the night. Since that night I have on-going headaches, difficulty finding my words while in a full sentence and for the last three days sudden burning and tingling in feet.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Chills, Pain
Clinical narrative: 11/11/2021  2:30pm:  Body Aches and Chills 11/12/2021 7:00am:   It felt my heart was hurting but went away at 8am.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Headache, fever, body aches, chills, sweating, blurred vision
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Headache, fever, body aches, chills, sweating, blurred vision
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Injection site pain, Myalgia
Clinical narrative: Fever, chills, nausea, muscle aches, injection site soreness, headache, hip pain
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever, chills, nausea, muscle aches, injection site soreness, headache, hip pain
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomitedx1. Pt was fine afterwards. Asked to stay another 15 minutes for observation. Dad stated that there was a ?bug going around and his friend also had similar symptoms this week?
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node in the armpit of the arm that received the shot.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Anxiety, Dysuria, Hypoaesthesia, Pain in extremity
Clinical narrative: pt is having intermittent numbness with pain in left arm, numbness in legs, difficulty urinating, ascending numbness from waist upward, increase in anxiety. Includes abdominal distension. Onset 4 days after 2nd vaccine. Occurs every night.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose of SHINGRIX vaccine was administered 16 days earlier than the recommended time of 2 months.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Back pain, Chills, Crying, Dizziness
Clinical narrative: Severe headache, dizziness, electric shock feeling body aches in legs and arms.. Chills, hot flashes, had a laughing attack for 1/2 hour followed by waves of crying. Severe arm pain at site with redness and itching. tiredness and anxiety .. severe lower back pain and shock like sensation at temple area.