chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: VACCINE ADMINSTERED AFTER THE 6 HOUR TIME FRAME; This spontaneous report received from a health care professional concerned a 37 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and batch number: 1820095 expiry: 18-AUG-2021) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-JUN-2021, the subject experienced vaccine adminstered after the 6 hour time frame. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine adminstered after the 6 hour time frame was not reported. This report was non-serious. This case, from the same reporter is linked to 20210700374.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE ADMINSTERED AFTER THE 6 HOUR TIME FRAME; This spontaneous report received from a health care professional concerned a 37 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and batch number: 1820095 expiry: 18-AUG-2021) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-JUN-2021, the subject experienced vaccine adminstered after the 6 hour time frame. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine adminstered after the 6 hour time frame was not reported. This report was non-serious. This case, from the same reporter is linked to 20210700374.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Expired product administered
Clinical narrative: VACCINE ADMINISTERED AFTER THE 6 HOURS OF VIAL PUNCTURE TIME FRAME; This spontaneous report received from a health care professional concerned a 41 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: 18-AUG-2021) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced vaccine administered after the 6 hours of vial puncture time frame. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered after the 6 hours of vial puncture time frame was not reported. This report was non-serious. This case, from the same reporter is linked to 20210700282.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE ADMINISTERED AFTER THE 6 HOURS OF VIAL PUNCTURE TIME FRAME; This spontaneous report received from a health care professional concerned a 41 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: 18-AUG-2021) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced vaccine administered after the 6 hours of vial puncture time frame. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered after the 6 hours of vial puncture time frame was not reported. This report was non-serious. This case, from the same reporter is linked to 20210700282.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Adverse event
Clinical narrative: HOT FLASHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included immune thrombocytopenic purpura. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 27-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-JUN-2021, the subject experienced hot flashes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hot flashes was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Discomfort, Dizziness, Hot flush
Clinical narrative: HOT FLASHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included immune thrombocytopenic purpura. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 27-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-JUN-2021, the subject experienced hot flashes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hot flashes was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hot flush
Clinical narrative: HOT FLASHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included immune thrombocytopenic purpura. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 27-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-JUN-2021, the subject experienced hot flashes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hot flashes was not reported. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Diarrhoea, Fall, Gait inability, Headache, Illness
Clinical narrative: Patient states that he has had 2 heart attacks and 4 blood clots since second dose of covid vaccine. He was treated at the Hospital for the first Heart attack and at another hospital for his second heart attack. He does not have a PCP and was seen by a Physician at the Hospital for his first heart attack and is being seen by a doctor at the other hospital. I tried to contact the doctor's office and have not been able to get any more information. I talked to a representative at VAERS on 7/2 to see what to do. She stated to just send what I had and you would contact the patient if you need more information.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Peripheral swelling, Thrombosis, Vomiting
Clinical narrative: Patient states that he has had 2 heart attacks and 4 blood clots since second dose of covid vaccine. He was treated at the Hospital for the first Heart attack and at another hospital for his second heart attack. He does not have a PCP and was seen by a Physician at the Hospital for his first heart attack and is being seen by a doctor at the other hospital. I tried to contact the doctor's office and have not been able to get any more information. I talked to a representative at VAERS on 7/2 to see what to do. She stated to just send what I had and you would contact the patient if you need more information.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Myocardial infarction, Thrombosis
Clinical narrative: Patient states that he has had 2 heart attacks and 4 blood clots since second dose of covid vaccine. He was treated at the Hospital for the first Heart attack and at another hospital for his second heart attack. He does not have a PCP and was seen by a Physician at the Hospital for his first heart attack and is being seen by a doctor at the other hospital. I tried to contact the doctor's office and have not been able to get any more information. I talked to a representative at VAERS on 7/2 to see what to do. She stated to just send what I had and you would contact the patient if you need more information.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Abdominal pain upper, Blood test, Cerebrovascular accident, Coronary arterial stent insertion, Impaired driving ability
Clinical narrative: Patient states that he has had 2 heart attacks and 4 blood clots since second dose of covid vaccine. He was treated at the Hospital for the first Heart attack and at another hospital for his second heart attack. He does not have a PCP and was seen by a Physician at the Hospital for his first heart attack and is being seen by a doctor at the other hospital. I tried to contact the doctor's office and have not been able to get any more information. I talked to a representative at VAERS on 7/2 to see what to do. She stated to just send what I had and you would contact the patient if you need more information.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Intensive care, Myocardial infarction, Pain in extremity, Peripheral swelling, Pulmonary embolism
Clinical narrative: Patient states that he has had 2 heart attacks and 4 blood clots since second dose of covid vaccine. He was treated at the Hospital for the first Heart attack and at another hospital for his second heart attack. He does not have a PCP and was seen by a Physician at the Hospital for his first heart attack and is being seen by a doctor at the other hospital. I tried to contact the doctor's office and have not been able to get any more information. I talked to a representative at VAERS on 7/2 to see what to do. She stated to just send what I had and you would contact the patient if you need more information.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Thrombosis, X-ray
Clinical narrative: Patient states that he has had 2 heart attacks and 4 blood clots since second dose of covid vaccine. He was treated at the Hospital for the first Heart attack and at another hospital for his second heart attack. He does not have a PCP and was seen by a Physician at the Hospital for his first heart attack and is being seen by a doctor at the other hospital. I tried to contact the doctor's office and have not been able to get any more information. I talked to a representative at VAERS on 7/2 to see what to do. She stated to just send what I had and you would contact the patient if you need more information.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Off label use, Product administered to patient of inappropriate age
Clinical narrative: THERE WERE NO ADVERSE EVENTS.  AS STATED BY THE MANUFACTURER, THIS IS AN OFF LABEL USE BECAUSE THE PATIENT IS 15 YEARS OLD.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin, Hyperplasia, Hypersensitivity, Immunohistochemistry, Rash erythematous
Clinical narrative: Approximately 1 week after receiving the first Covid dose (in my left arm), I developed a red spot on my (right) arm that did not go away.  To be clear, I do not know whether this has anything to do with the Moderna vaccine but figured I should report it (and also want to be clear that the red spot is in my right arm, whereas the vaccine was in my left arm).  After waiting a few weeks, I visited the doctor a dermatologist.  She did a punch biopsy, which recently returned an "unusual" result.  The lab showed it to multiple people, including a physician with a hematopathology specialty and the Dermatopathology.   Their conclusion was that "overall findings are consistent with a florid hypersensitivity reaction in the appropriate clinical setting."  However, they also suggest another biopsy if deemed clinically appropriate.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Cardiomegaly, Laboratory test, Myocarditis
Clinical narrative: Went to ER.  Stayed in Cardiac  Ward.  3 days.  Treated  with heparin, nitro drip.  Several test done.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Skin warm, Thirst
Clinical narrative: PATIENT FELT DIZZY IMMEDIATELY AFTER VACCINATION,  STARTED SWEATING PROFUSELY,  FELT THIRSTY.  HIS BODY WAS WARM AND  WANTED TO LIE DOWN.  HE LIED DOWN WITH FEET ELEVATED.  STARTED FEELING BETTER AFTER 15 MINUTES.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Light headache
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blood test, Discomfort, Myalgia, Pain in extremity
Clinical narrative: I started feeling pain in my lower back and my piriformis and ouside of my shin on the right side at about the time of my 1st Pfizer shot. I also started having tingling sensation in my right foot.  I do not know if it is related to the shot or if it is something else. I called my insurance remote doctor for consultation about 2 weeks after I started having the symptoms and followed that up a week later when the pain and discomfort still persisted. About another week or 2 later I went to see my primary physician. After 3 weeks of no improvement, I was referred  to a Physical Therapist and after 8 sessions I still have the same pain.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, X-ray
Clinical narrative: I started feeling pain in my lower back and my piriformis and ouside of my shin on the right side at about the time of my 1st Pfizer shot. I also started having tingling sensation in my right foot.  I do not know if it is related to the shot or if it is something else. I called my insurance remote doctor for consultation about 2 weeks after I started having the symptoms and followed that up a week later when the pain and discomfort still persisted. About another week or 2 later I went to see my primary physician. After 3 weeks of no improvement, I was referred  to a Physical Therapist and after 8 sessions I still have the same pain.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Laboratory test, Oropharyngeal pain
Clinical narrative: pt presents to the ED for sore throat, chills and dizziness that he attributes to the second dose of the Moderna vaccine which he received on 29Jun2021 at 1400.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: 24 year old otherwise healthy male presents to the emergency room with complaints of chills, myalgias, and mild headache beginning last night after receiving the second shot of the Moderna COVID-19 vacination.  The patient denies fevers, abdominal pain, leg pain, weight loss, night sweats, worst headache of life, sick exposures, or recent travel.        Symptoms consistent with expected post vaccination reaction following the 2nd Moderna COVID-19 vaccination. No evidence of life threatening pathology and doubt pneumonia, myocardial infarction, pneumothorax, meningitis, PE.  Patient tolerating oral fluids and solids without difficulty.  Will treat symptomatically, place on 48 hours quarters, and arrange follow up with primary care practitioner.  The patient was given strict return precautions and was comfortable with the plan.  Discharged to a safe ride home.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Musculoskeletal stiffness, Oropharyngeal pain
Clinical narrative: Pt reports to ED 1day s/p now w/ L arm stiffness, sore throat, HA, "shivers and chills" w/o relief s/p motrin.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure during pregnancy, Ultrasound antenatal screen abnormal
Clinical narrative: Patient did not know she was pregnant during the first COVID-19 vaccine. When she found out, estimated gestation age is 9 weeks, which means she was pregnant before the first vaccine was given. She chose to undergo the 2nd vaccine even after knowing she's pregnant, then presented to our facility on 6-14-21 for obstetric care. Patient previously had 4 live births without complications. EDD for this pregnancy would have been January 13, 2022.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Blood iron, Blood thyroid stimulating hormone, Dizziness, Dizziness postural
Clinical narrative: Five minutes after getting the vaccine, I started experiencing mild sweating in my palms, a symptom which has continued to flare up since. A half hour later, when walking up the stairs, I felt unusual skin sensitivity in response to the wind blowing, and a strange proprioception problem: when I reached my right hand out to grab the railing, I missed it, for the first time ever. A few hours later, I felt a pain behind my right eye. The next day I felt my heart pounding in my chest and a sharp head pain in the rear right occipital area (bottom of my skull).  My tinnitus began to worsen. Four days later, when I stood up from a sitting position, I experienced dizziness and fast heart rate (postural tachycardia). Since that time, my heart rate has spiked when standing up, from 71 lying down to 108-110 standing up. Several times I've felt extreme heaviness in both my legs while walking. I've also experienced more dizziness and lightheadedness, especially when moving, like making a turn in my car or lying on a moving hammock. Lying down with my legs supported on pillows  seems to help. Today I went on a brief walk and felt like my nervous system wasn't working properly; I actually had to mentally force myself to put one foot in front of the other. It was a very scary feeling.  I've been reading about vestibular nerve inflammation, postural orthostatic tachycardia syndrome, dysautonomia, and other autoimmune conditions, and my sense is that the vaccine triggered an autoimmune reaction throughout my nervous system.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Full blood count, Headache, Hyperhidrosis, Limb discomfort
Clinical narrative: Five minutes after getting the vaccine, I started experiencing mild sweating in my palms, a symptom which has continued to flare up since. A half hour later, when walking up the stairs, I felt unusual skin sensitivity in response to the wind blowing, and a strange proprioception problem: when I reached my right hand out to grab the railing, I missed it, for the first time ever. A few hours later, I felt a pain behind my right eye. The next day I felt my heart pounding in my chest and a sharp head pain in the rear right occipital area (bottom of my skull).  My tinnitus began to worsen. Four days later, when I stood up from a sitting position, I experienced dizziness and fast heart rate (postural tachycardia). Since that time, my heart rate has spiked when standing up, from 71 lying down to 108-110 standing up. Several times I've felt extreme heaviness in both my legs while walking. I've also experienced more dizziness and lightheadedness, especially when moving, like making a turn in my car or lying on a moving hammock. Lying down with my legs supported on pillows  seems to help. Today I went on a brief walk and felt like my nervous system wasn't working properly; I actually had to mentally force myself to put one foot in front of the other. It was a very scary feeling.  I've been reading about vestibular nerve inflammation, postural orthostatic tachycardia syndrome, dysautonomia, and other autoimmune conditions, and my sense is that the vaccine triggered an autoimmune reaction throughout my nervous system.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of proprioception, Palpitations, Red blood cell sedimentation rate, Sensitive skin, Serum ferritin
Clinical narrative: Five minutes after getting the vaccine, I started experiencing mild sweating in my palms, a symptom which has continued to flare up since. A half hour later, when walking up the stairs, I felt unusual skin sensitivity in response to the wind blowing, and a strange proprioception problem: when I reached my right hand out to grab the railing, I missed it, for the first time ever. A few hours later, I felt a pain behind my right eye. The next day I felt my heart pounding in my chest and a sharp head pain in the rear right occipital area (bottom of my skull).  My tinnitus began to worsen. Four days later, when I stood up from a sitting position, I experienced dizziness and fast heart rate (postural tachycardia). Since that time, my heart rate has spiked when standing up, from 71 lying down to 108-110 standing up. Several times I've felt extreme heaviness in both my legs while walking. I've also experienced more dizziness and lightheadedness, especially when moving, like making a turn in my car or lying on a moving hammock. Lying down with my legs supported on pillows  seems to help. Today I went on a brief walk and felt like my nervous system wasn't working properly; I actually had to mentally force myself to put one foot in front of the other. It was a very scary feeling.  I've been reading about vestibular nerve inflammation, postural orthostatic tachycardia syndrome, dysautonomia, and other autoimmune conditions, and my sense is that the vaccine triggered an autoimmune reaction throughout my nervous system.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Tinnitus, Vitamin B12
Clinical narrative: Five minutes after getting the vaccine, I started experiencing mild sweating in my palms, a symptom which has continued to flare up since. A half hour later, when walking up the stairs, I felt unusual skin sensitivity in response to the wind blowing, and a strange proprioception problem: when I reached my right hand out to grab the railing, I missed it, for the first time ever. A few hours later, I felt a pain behind my right eye. The next day I felt my heart pounding in my chest and a sharp head pain in the rear right occipital area (bottom of my skull).  My tinnitus began to worsen. Four days later, when I stood up from a sitting position, I experienced dizziness and fast heart rate (postural tachycardia). Since that time, my heart rate has spiked when standing up, from 71 lying down to 108-110 standing up. Several times I've felt extreme heaviness in both my legs while walking. I've also experienced more dizziness and lightheadedness, especially when moving, like making a turn in my car or lying on a moving hammock. Lying down with my legs supported on pillows  seems to help. Today I went on a brief walk and felt like my nervous system wasn't working properly; I actually had to mentally force myself to put one foot in front of the other. It was a very scary feeling.  I've been reading about vestibular nerve inflammation, postural orthostatic tachycardia syndrome, dysautonomia, and other autoimmune conditions, and my sense is that the vaccine triggered an autoimmune reaction throughout my nervous system.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Thrombosis, Varicophlebitis
Clinical narrative: On left feet under knee and up swelling vain, red and hard when I touch, really painful.  Looks for me like thrombosis
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Blood urine present, Chest X-ray abnormal, Conjunctival haemorrhage, Dyspnoea
Clinical narrative: After 2nd vaccine the next evening had Body aches low grade fever. That was a Sunday I started feeling aches and short of breath from that point on. Mostly when I moved around I couldn?t breathe. Couldn?t walk up stairs without resting on each step. Went to urgent care where oxygen was 80 something percent. Took covid test it came back negative. Lung X-ray looked like I had pneumonia or something . Urgent care told me I had to go to the emergency room. Went to the emergency room and was admitted for two days from June 3 until the fifth. They wanted me to stay an extra day but I had to work so I left. They said it was bacterial pneumonia, but there nobody was for sure. While there I developed blood clotting under my left eye and I started urinating blood as well. I was putOn a lot of antibiotics and steroids while I was there and when I went home.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea exertional, Mobility decreased, Pain, Pneumonia bacterial, Pyrexia
Clinical narrative: After 2nd vaccine the next evening had Body aches low grade fever. That was a Sunday I started feeling aches and short of breath from that point on. Mostly when I moved around I couldn?t breathe. Couldn?t walk up stairs without resting on each step. Went to urgent care where oxygen was 80 something percent. Took covid test it came back negative. Lung X-ray looked like I had pneumonia or something . Urgent care told me I had to go to the emergency room. Went to the emergency room and was admitted for two days from June 3 until the fifth. They wanted me to stay an extra day but I had to work so I left. They said it was bacterial pneumonia, but there nobody was for sure. While there I developed blood clotting under my left eye and I started urinating blood as well. I was putOn a lot of antibiotics and steroids while I was there and when I went home.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, White blood cell count decreased
Clinical narrative: After 2nd vaccine the next evening had Body aches low grade fever. That was a Sunday I started feeling aches and short of breath from that point on. Mostly when I moved around I couldn?t breathe. Couldn?t walk up stairs without resting on each step. Went to urgent care where oxygen was 80 something percent. Took covid test it came back negative. Lung X-ray looked like I had pneumonia or something . Urgent care told me I had to go to the emergency room. Went to the emergency room and was admitted for two days from June 3 until the fifth. They wanted me to stay an extra day but I had to work so I left. They said it was bacterial pneumonia, but there nobody was for sure. While there I developed blood clotting under my left eye and I started urinating blood as well. I was putOn a lot of antibiotics and steroids while I was there and when I went home.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: I was in the shower and had my eyes closed for a couple minutes.  I could see the red of my eyelids.  Suddenly, I thought the power/lights suddenly went out because everything became pitch black vs the light red you normally see from the eyelids.  However, when I opened my eyes, everything was lit.  When I close my eyes again, it goes pitch black, as if I have some cover over my eyelids.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Patient reported getting hives starting 1 week after  getting 2nd Moderna shot.  It started on the arms then progresses to stomach and then everywhere on body.   She reports no reaction after the 1st shot.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Nausea, Pallor
Clinical narrative: Client reported an onset of "feeling lightheaded" while ambulating from vaccination area to observation area. The client subsequently developed nausea and dizziness following the receiving the 1st COVID vaccine Pfizer. The client notified personnel in the observation area of symptoms and laid down. She states she also developed mild chest tightness which resolved a few hours later. The client was provided a juice in the observation area. The client stated she tried to drink the juice, but spit it up immediately after. No medications were provided at the vaccination site. The client states she sought care at an urgent care immediately following departure from the vaccination site. The client states they obtained "vitals and checked my lungs" at the urgent care. The client also stated "my blood pressure was a little high." The client did not take any medication following the initial episode of feeling lightheaded and dizziness. She states her symptoms resolved about 24 hours after onset. The client stated she reported her initial reaction to her PCP and her PCP gave approval to receive the 2nd COVID Pfizer dose. Vitals obtained by RN Barberan were obtained by RN Barberan at 7:56PM were as follows HR 78 and BP 115/90. A medical consult was submitted via text message. Approval to proceed with 2nd COVID vaccine Pfizer was obtained by Summer Leal, Vaccine Operations via telephone. Client received the 2nd COVID vaccine Pfizer Lot# EW0191 at 8:24PM in the anti-gravity chair. RN Withers educated the client on s/s of anaphylaxis, when to seek EMS, 30 minute observation recommendation, and V-safe. The client voiced understanding of this. At 8:32PM the client reported nausea to EMT Bustamonte. RN Withers responded. Vitals obtained at 8:36PM were as follows: HR 78 and BP 144/100. The client denied SOB or dizziness at the time. The client removed their mask and RN Withers noted pallor on the client's face. At 8:39PM the client denied any dizziness or feeling lightheaded. Vitals obtained at 08:44PM were as follows: BP 140/98 and HR 74. The client noted mild improvement of her nausea at that time. Repeat vitals obtained at 08:54PM were as follows 142/92 and HR 78. The client reported her nausea was "a little better." At 08:59 PM RN Withers offered to call EMS to evaluate the patient. The client denied EMS. RN Withers let the client know she could seek care at an urgent care, emergency department, or monitor her symptoms at home. The client elected to monitor her symptoms at home. RN Withers reiterated when to seek EMS and s/s of anaphylaxis. The client voiced understanding of this. The client stood up from the anti gravity chair without assistance, ambulated with a steady gait unassisted, and was visualized getting into a person vehicle driven by her husband at 9:03PM.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Malaise, Pyrexia, Rash pruritic
Clinical narrative: Fever, malaise 24 to 48 hours after vax, sore arm around injection site for 4 days, itchy rash forming on day 5 around injection site.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Night sweats, Pyrexia
Clinical narrative: Several weeks after vaccination, had mild cough, fatigue, and fever whenever tired, usually at night. Cough and night sweats still recurring when fatigued 5 weeks after vaccination.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Blood potassium decreased, COVID-19
Clinical narrative: pt tested covid positive 6/21/2021 pt admitted to hospital 7/1/2021 - fever, sore throat, difficulty swallowing, leukocytosis, low potassium
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Culture urine, Dysphagia, Leukocytosis, Oropharyngeal pain, Pyrexia
Clinical narrative: pt tested covid positive 6/21/2021 pt admitted to hospital 7/1/2021 - fever, sore throat, difficulty swallowing, leukocytosis, low potassium
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Urinary tract infection, Urine analysis abnormal
Clinical narrative: pt tested covid positive 6/21/2021 pt admitted to hospital 7/1/2021 - fever, sore throat, difficulty swallowing, leukocytosis, low potassium
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pruritus, Urticaria
Clinical narrative: Hives, itchiness all over body, general fatigue
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash on legs and tops of feet that ended up in broken blood vessels (on tops of feet) .  Thought it might be related to sun exposure, but went to specialty doctor who recommended blood work done. When that came back as normal, doctor said it may be due to reaction from vaccine. Took antihistamine for several days and the rash and itching has gotten better.  The doctor thought it could possibly be a reaction to the second dose of vaccine and urged us to report it.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Very heavy vaginal bleeding
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event, Product label confusion
Clinical narrative: no additional AE reported; expired dose was inadvertently administered; expiration date format confusion; This spontaneous report was received from a pharmacist and refers to a patient of an unspecified age or gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not provided.  On 11-JUN-2021, the patient was inadvertently vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA, lot # S015961 expiration date was provided and also validated as 23-MAY-2021 (dose, strength, route of administration and anatomical location were not provided) for prophylaxis (expired vaccine used). The vaccine was reconstitued in not expired sterile diluent (manufacturer unknown) (concomitant), lot # S032584, expiration date reported and also validated as 23-JUL-2022.  The pharmacist stated, that the vaccine format used for labeling the expiration date was confusing. It was listed as "2021MAY23", which caused him to think that the vaccine would not be expiring until year 2023, and therefore he administered an expired vaccine by accident (expiration date format confusion). No additional adverse event (AE) was reported (no adverse event). No product quality complaint (PQC).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's reported; Improperly Stored; Administered; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 16-JUN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot number: T000698, expiration date: 07-JAN-2022; dose and route of administration were not provided). The vaccine was stored in temperature:  11.3 degrees Celsius for 15 minutes. There was no previous temperature excursion. Digital data lodger was involved.  No adverse event was reported. The patient was asymptomatic.  This is one of the four reports from the same reporter.; Sender's Comments:  US-009507513-2106USA005206: US-009507513-2106USA005204: US-009507513-2106USA005205:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's reported; Improperly Stored; Administered; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 16-JUN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot number: T000698, expiration date: 07-JAN-2022; dose and route of administration were not provided). The vaccine was stored in temperature:  11.3 degrees Celsius for 15 minutes. There was no previous temperature excursion. Digital data lodger was involved.  No adverse event was reported. The patient was asymptomatic.  This is one of the four reports from the same reporter.; Sender's Comments:  US-009507513-2106USA005205: US-009507513-2106USA005206: US-009507513-2106USA005134:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's reported; Improperly Stored; Administered; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 16-JUN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot number: T028308, expiration date: 20-AUG-2022; dose and route of administration were not provided). The vaccine was stored in temperature:  11.3 degrees Celsius for 15 minutes. There was no previous temperature excursion. Digital data lodger was involved.  No adverse event was reported. The patient was asymptomatic.  This is one of the four reports from the same reporter.; Sender's Comments:  US-009507513-2106USA005134: US-009507513-2106USA005206: US-009507513-2106USA005204:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's reported; Improperly Stored; Administered; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 16-JUN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot number: T028308, expiration date: 20-AUG-2022; dose and route of administration were not provided). The vaccine was stored in temperature:  11.3 degrees Celsius for 15 minutes. There was no previous temperature excursion. Digital data lodger was involved.  No adverse event was reported. The patient was asymptomatic.  This is one of the four reports from the same reporter.; Sender's Comments:  US-009507513-2106USA005205: US-009507513-2106USA005134: US-009507513-2106USA005204:
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; patient received her first dose of GARDASIL 9 three years ago (exact date unspecified). Patient received the second dose today (June 21, 2021).; This spontaneous report was received from a nurse practitioner who was reporting on female patient of unknown age. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On an unknown date in 2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 milliliter (strength, route of administration, anatomical location, lot number and expiration date were not provided) for prophylaxis. Second dose of the vaccine also 0.5 milliliter was administered on 21-JUN-2021 (inappropriate schedule of product administration). No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no other AEs reported; PROQU AD was accidentally administered intramuscularly on 22Jun2021.; This spontaneous report was received from a nurse who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 22-JUN-2021, the patient was accidentally vaccinated with dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) 1 injection, via intramuscular route (lot number T016989 was confirmed to be valid; expiration date was not reported but upon internal validation process, it was established as 11-NOV-2021; strength, dose, route of administration and anatomical location were not provided) for prophylaxis. No adverse events were reported.
Age: 9.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: she had a high fever for a week. going up to 105 degrees; This spontaneous report was received via Pfizer from a currently 63 years old female patient reporting on herself. The patient's pertinent medical history included fever of 105F when she was a baby after receiving the Smallpox vaccine. Concurrent conditions included  hypersensitivity and concomitant medication was not provided.  On an unspecified date, when the patient was 9 years old, she was was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) dose, route of administration, anatomical location, lot number and expiration date were not provided for prophylaxis.  On an unspecified date, the patient experienced a high fever for a week, going up to 105 degrees. The reporter stated that her physicians said that her body reacted "fairly strenuously to the introduction of foreign substances".  The outcome of pyrexia was unknown, the reporter did not assess the causal relationship between the fever and the vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown).
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 22-MAR-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided.   This is one of the multiple reports reported by the same reporter.; Sender's Comments:  US-009507513-2106USA007360: US-009507513-2106USA007361: US-009507513-2106USA007362:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 26-MAR-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided.   This is one of the multiple reports reported by the same reporter. ; Sender's Comments:  US-009507513-2106USA007355:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 21-JUN-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided.   This is one of the multiple reports reported by the same reporter.; Sender's Comments:  US-009507513-2106USA007355:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 29-MAR-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided.   This is one of the multiple reports reported by the same reporter.; Sender's Comments:  US-009507513-2106USA007355:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 31-MAR-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided.   This is one of the multiple reports reported by the same reporter.; Sender's Comments:  US-009507513-2106USA007355: