chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pharyngeal swelling
Clinical narrative: minor throat swelling; This case was reported by a consumer via call center representative and described the occurrence of throat swelling in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site swelling (1st dose received on end of September 2020, refer link case US2021014406).   On 4th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 4th December 2020, less than a day after receiving Shingrix, the patient experienced throat swelling. The patient was treated with ibuprofen (Advil). On 5th December 2020, the outcome of the throat swelling was recovered/resolved.   It was unknown if the reporter considered the throat swelling to be related to Shingrix.  Additional details were provided as follow: Caller was the patient and reported a reaction when taking 2nd dose of the Shingrix vaccine.  The patient received 2nd dose of Shingrix vaccine on 4th December 2020 in the morning and reported a minor throat swelling during the night after she received her 2nd Shingrix vaccine.  The reporter asked was this a side effect of Shingrix and took an Advil tablet for the swelling.  The swelling was completely resolved in an hour after taking the Advil tablet. The reporter did not consent to follow-up. The reporter does not give permission to contact HCP.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021014406:same reporter
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Came down with shingles / shingles episode is not totally over; rash is receding ut there are still some eruptions; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 3 weeks after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the rash was recovering/resolving.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in an unspecified arm.  Three weeks later she came down with shingles.  The patient stated she did not necessary think Shingrix caused the shingles outbreak, she said it was probably just a coincidence. She stated that the pharmacist did not give her any literature therefore she did not have the lot number or expiration date of the vaccine.  The shingles episode was not totally over  She said the rash was receding but there were still some eruptions. Consented to follow up.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Blood pressure fluctuation, Parkinson's disease, Somnolence
Clinical narrative: Very harsh dysrhythmia; Parkinson's symptoms got worse with joint contractions, stiffening, and confusion; Napping more; Blood pressure has been haywire, sometimes going high and sometimes low; A spontaneous report was received from a consumer, who was also the daughter of a 93-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a very harsh dysrhythmia (arrhythmia), Parkinson's symptoms got worse with joint contractions, stiffening, and confusion (Parkinson's disease); he has been napping more than before (somnolence), and blood pressure has been haywire, sometimes going high and sometimes low (hypertension, hypotension).  Medical history, as provided by the reporter, included COVID in July 2020 from which he fully recovered, slight dysrhythmia, Parkinson's (tremors only), and slightly elevated blood pressure.  The reported stated the patient's baseline health had been pretty good and he was usually mobile, active, cognitive, and had speech.  Concomitant medications included carbidopa monohydrate (+) levodopa, losartan, beta blocker (unspecified), and liquid morphine.    On 20 Jan 2021, one day prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number: 028L20A) intramuscularly in his right (dominant) arm for prophylaxis of COVID-19 infection.  On 21 Jan 2021, around 2 pm, the patient had "a very harsh" dysrhythmia and his Parkinson's symptoms worsened with joint contractions, stiffening, and confusion.  He had also been napping more than before.  Since getting the vaccine, his blood pressure "has been haywire", sometimes going high and sometimes low.  Treatment information was not provided.  The action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, a very harsh dysrhythmia, Parkinson's symptoms got worse with joint contractions, stiffening, and confusion; napping more than before, and blood pressure has been haywire, sometimes going high and sometimes low, were considered not recovered/not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Erectile dysfunction, Muscular weakness, Taste disorder, Vaccination site pain
Clinical narrative: miembro viril esta muerto-virile member is dead; bad taste in mouth; loss of taste; legs are very weak especially in the knees, sometimes not able to stand in his feet; pain in the arm; A spontaneous report was received from a consumer who was also a 65-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a little pain in the arm, bad taste in the mouth, loss of taste, legs are very weak, specially in the knees, not able to stand on his feet, and "miembro viril esta muerto" meaning "his virile member is dead" or having erectile dysfunction.   The patient's medical history included a hernia intervention on 20 Jan 2021, HIV positive, and has headaches. Products known to have been used by the patient included a multivitamin and HIV medicines. Patient states that he received "injections for headaches in his brain, " however no medications are specified. Patient has no known allergies.  On 25 Jan 2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: 042L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 25 Jan 2021, one day after the mRNA-1273 vaccine was given, the patient noted that he had a little pain in the arm but nothing to worry.  On 28 Jan 2021, the patient stated that he started to have a bad taste in the mouth, loss of taste, legs are very weak, specially in the knees, not able to stand on his feet, and erectile dysfunction.    Treatment information was not provided.   Action taken with mRNA-1273 was not reported.  The outcome of the events, little pain in the arm, bad taste in the mouth, loss of taste, legs are very weak, specially in the knees, not able to stand on his feet, and having erectile dysfunction is unknown.; Reporter's Comments: Based on the current available information, the absence of an other etiologies and temporal association between the use of the product and the start date of the reported event, a causal relationship cannot be excluded. Vaccination site pain is consistent with the known safety profile of the vaccine
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Dizziness
Clinical narrative: Pneumonia; Loss of taste; Loss of smell; stared into space for hours; Covid Positive Test; Felt Spacy; Cough; A spontaneous report was received from a consumer concerning a 46 year-old female patient who experienced Covid-19 positive test [COVID-19], felt spacy [dizziness], stared into space for hours [staring], and pneumonia.  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.  On 13 Jan 2021, approximately five days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the patient started experiencing symptoms of coughing.  On 17 Jan 2021, the patient tested positive for Covid-19.  The patient reported she felt spacy and stared into space for hours.  On 19 Jan 2021, the patient experienced symptoms of loss of taste and smell.  On 24 Jan 2021, the patient's oxygen levels were going down.  Treatment for the event of Covid-19 included azithromycin, prednisone, albuterol, and cough medicine.  On 28 Jan 2021, the patient tested positive for pneumonia.  Treatment for the event of pneumonia included levofloxacin.  Action taken with mRNA-1273 in response to the events was unknown.  The event of pneumonia was considered resolved on an unknown date.  The outcome of the event of Covid-19 was unknown.  The events, felt spacy and stared into space for hours, were considered resolved on an unknown date.; Reporter's Comments: Based on the concurrent Covid-19 infection, the events are assessed as unlikely related to mRNA-1273.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Pneumonia, SARS-CoV-2 test, Staring
Clinical narrative: Pneumonia; Loss of taste; Loss of smell; stared into space for hours; Covid Positive Test; Felt Spacy; Cough; A spontaneous report was received from a consumer concerning a 46 year-old female patient who experienced Covid-19 positive test [COVID-19], felt spacy [dizziness], stared into space for hours [staring], and pneumonia.  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.  On 13 Jan 2021, approximately five days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the patient started experiencing symptoms of coughing.  On 17 Jan 2021, the patient tested positive for Covid-19.  The patient reported she felt spacy and stared into space for hours.  On 19 Jan 2021, the patient experienced symptoms of loss of taste and smell.  On 24 Jan 2021, the patient's oxygen levels were going down.  Treatment for the event of Covid-19 included azithromycin, prednisone, albuterol, and cough medicine.  On 28 Jan 2021, the patient tested positive for pneumonia.  Treatment for the event of pneumonia included levofloxacin.  Action taken with mRNA-1273 in response to the events was unknown.  The event of pneumonia was considered resolved on an unknown date.  The outcome of the event of Covid-19 was unknown.  The events, felt spacy and stared into space for hours, were considered resolved on an unknown date.; Reporter's Comments: Based on the concurrent Covid-19 infection, the events are assessed as unlikely related to mRNA-1273.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Swelling face
Clinical narrative: swelling on the left side of my face; Bell's palsy/ left side can not function properly. I have little eye, mouth and forehead movement; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982), via an unspecified route of administration (at the age of 40-years-old) on 26Jan2021 10:15 at a single dose in Left arm for COVID-19 immunization. Medical history was not applicable (N/A). The patient was not Pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient experienced swelling on the left side of my face and Bell's palsy/ left side can not function properly. I have little eye, mouth and forehead movement on 05Feb2021 10:30. The patient reported, "I have swelling on the left side of my face as well as Bell's palsy. My left side cannot function properly. I have little eye, mouth and forehead movement." The events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The outcome of the events was not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Therapeutic measures were taken as a result of the events which included anti-viral medication and a steroid. The events were assessed as serious (Seriousness criteria-Disabling/Incapacitating). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Anal haemorrhage, Anorectal discomfort, Diarrhoea haemorrhagic, Weight decreased
Clinical narrative: diarrhea and it was just all bright red fresh blood/bright red blood with diarrhea; bright red blood coming from her anal area; feel heaviness, she just feels that heaviness.; she lost weight; This is a spontaneous report from a contactable consumer (patient). A 81-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number EM9809) (at the age of 81-years-old), via an unspecified route of administration on 06Feb2021 between 12:30 and 1PM as a single dose for covid-19 immunization.  The facility where COVID-19 vaccine was a doctor's office and administered anatomically located on the right arm. The patient medical history included: She has been diagnosed years ago 10 years ago, which was since she smoked with COPD and she is on breathing medication, but she has not had it due to getting in a donut hole with insurance and she cannot afford it, her hands also won't let her use it, She hasn't had it for 2 months. Arthritis. She has had no other vaccines on the same day or in the past 4 weeks, she had the flu shot back in Oct2020. Family Medical History: Her dad had heart problems and cancer. Her brother had cancer. Her mother had heart conditions. Concomitant medications included: Acetaminophen and Naproxen sodium. She was taking a lot of acetaminophen and Naproxen sodium for arthritis pain, but she has not had any since Friday night 05Feb2021. She did not want to take anything before the shot. She hasn't been weighed in a while, she lost weight. On 06Feb2021, at 8 o clock on the night, she experienced bright red blood coming from her anal area; then, she had diarrhea and it was just all bright red fresh blood, it was fresh new blood not dark at all. Today she is still having bright red blood with diarrhea; the blood seems like it is decreasing, it's being colored by diarrhea. She felt maybe in so many years is like when you have a period at times and feel heaviness, she just feels that heaviness. Caller reports that she does have a standing appointment with her provider tomorrow. The clinical outcome of the events bloody diarrhea and anal bleeding was not recovered, heaviness and weight decreased was unknown. She is scheduled for the second dose on 10Feb2021.
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Erythema, Hypersensitivity
Clinical narrative: face was really red like an allergy; blood pressure went up to 170; face was really red like an allergy and neck was very red; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional. (Reference number- 00457128) and transmitted to Sanofi on 02-Feb-2021  This case involves a 68 year old female patient who had face was really red like an allergy (hypersensitivity), while she received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided.   On 30-Dec-2015, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UI517AA and expiry date: 23-Jun-2016) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed face was really red like an allergy (hypersensitivity) with their symptoms face was really red like an allergy and neck was very red (erythema) and blood pressure went up to 170 (hypertension) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Laboratory data was not provided.  Patient was given 4 shots of steroids and her symptoms resolved after a few days.   Patient also had to take Benadryl and went to a dermatologist because the redness on her face would not go away.  At the time of reporting, the patient was not recovered from erythema and recovered from  rest of the events.
Age: 18.0
Sex: F
Vaccine: DTAPIPVHIB, MNQ
Symptoms: Injection site rash, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: rash at the injection site; 18 year old female patient inadvertently administered Pentacel instead of Menactra; 18 year old female patient inadvertently administered dose of Pentacel; Initial information received on 11-Feb-2021 regarding an unsolicited valid non-serious case received from a nurse in the United States.  This case involves a 18 years old female patient who inadvertently administered dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] instead of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (wrong product administered and product administered to patient of inappropriate age) and patient who experienced rash at the injection site (vaccination site rash), while she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On 08-Feb-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ337AAA and expiry date: 05-Jul-2021) via an intramuscular route in the left deltoid for prophylactic vaccination. It was a case of actual medication error due to wrong product administered and product administered to patient of inappropriate age (latency on same).  On 10-Feb-2021, the patient developed a non-serious rash at the injection site (vaccination site rash) two days following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Details of laboratory data not reported.   The patient was treated with MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA).  At the time of reporting, the patient had not recovered from the vaccination site rash (also reported that rash does not go away in a few days).  Reporter relationship: health care professional (HCP), Product used: used still using product: no  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Noticed redness at injection site and and just below injection site around 2 am Tuesday, February 23, 2021.   It's not painful to the touch and does not itch.  Some areas look like "welts".
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT PRESENTS TO COVID SITE FOR COVID VACCINATION. PATIENT'S PFIZER FORM INDICATES A FIRST DOSE NEEDED AND NO DOSE PREVIOUSLY GIVEN. PATIENT IS ADMINISTERED ONE PFIZER VACCINE LOT # EL9269 EXP 5/21 IN R DELTOID. UPON ENTRY INTO TENNIIS, IT IS DISCOVERED THAT THE PATIENT HAD IN FACT RECEIVED A FIRST DOSE OF MODERNA VACCINE LOT# 011J20A ON 1/11/21.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Haematoma, Injection site erythema, Injection site swelling, Intra-abdominal haematoma
Clinical narrative: redness and swelling at injection site, hematoma in lower abdomen, hematoma in right forearm
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chills, Fatigue, Headache, Mastitis
Clinical narrative: On 2/15 I begin to have chill, body aches, headache, fatigue and breast pains which continued into the next day.  I was again prescribed the same 7 day antibiotic and disagnosed again with Mastitis but this time the symptoms lasted a little longer and after about day 5 I began to feel myself again.  A mammogram and an ultrasound has been ordered to see why I developed the Mastitis so frequently but is not scheduled for another few weeks out from today.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: On 2/15 I begin to have chill, body aches, headache, fatigue and breast pains which continued into the next day.  I was again prescribed the same 7 day antibiotic and disagnosed again with Mastitis but this time the symptoms lasted a little longer and after about day 5 I began to feel myself again.  A mammogram and an ultrasound has been ordered to see why I developed the Mastitis so frequently but is not scheduled for another few weeks out from today.
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Death
Clinical narrative: I was notified on 2/22/21 that this patient passed away over the weekend. I do not know the details, nor can I confirm anything beyond what I was told. I believe the death occurred on 2/20/21 due to a massive stroke.
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebral artery occlusion, Cerebrovascular accident, Death, Thrombotic cerebral infarction
Clinical narrative: I was notified on 2/22/21 that this patient passed away over the weekend. I do not know the details, nor can I confirm anything beyond what I was told. I believe the death occurred on 2/20/21 due to a massive stroke.
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Death
Clinical narrative: CVA thrombotic L middle cerebral artery occlusion, large infarct on Feb 17, 2021.  Admitted  Hospital.  Died Feb 18, 2021.  No known coronary artery disease, no peripheral vascular disease, did have past TIA vs. lacunar infarct 2013 with progressive short term memory loss that seemed to start about the time of that event.  No known hypercoagulable states, was in normal health walking and talking the day of the stroke.  No history of cardiac dysrhythmias, no atrial fibrillation, no hx of any embolic issues.  Concern would be possibility of vaccine related to increased risk of thrombic events, so needs to be tracked in data base and not just dismissed due to his age and risk factors.
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebral artery occlusion, Cerebrovascular accident, Death, Thrombotic cerebral infarction
Clinical narrative: CVA thrombotic L middle cerebral artery occlusion, large infarct on Feb 17, 2021.  Admitted  Hospital.  Died Feb 18, 2021.  No known coronary artery disease, no peripheral vascular disease, did have past TIA vs. lacunar infarct 2013 with progressive short term memory loss that seemed to start about the time of that event.  No known hypercoagulable states, was in normal health walking and talking the day of the stroke.  No history of cardiac dysrhythmias, no atrial fibrillation, no hx of any embolic issues.  Concern would be possibility of vaccine related to increased risk of thrombic events, so needs to be tracked in data base and not just dismissed due to his age and risk factors.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: During observation, patient stated he was lightheaded. Denied any other symptoms. No SOB, no oral or facial swelling, no rash or swelling. Vitals stable- BP 100/62, pulse 62, RR 12. Ate breakfast but had not had lunch. Patient was observed for 30 minutes and given water. Symptoms resolved by end of observation period.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Low grade temp.  Body aches, head ache, and fatigue
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Started turning red on 2/2/21.  Noticed when getting dressed.  Red circle around injection site  about size of half of orange.  Later in day started itching a little.  Next day size of half a grapefruit.  Itching off and on.  Didn't disappear until 2/7/21.  Read online to use arm and apply cold.  So i did this.  every so often.  N
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cytokine test, Dyspnoea, Full blood count, Laboratory test, Lip swelling
Clinical narrative: pt initially noted palpitations and shortness of breath. After several minutes improved and then pt developed lip and tongue swelling
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Metabolic function test, Palpitations, SARS-CoV-2 antibody test, Swollen tongue
Clinical narrative: pt initially noted palpitations and shortness of breath. After several minutes improved and then pt developed lip and tongue swelling
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Chest discomfort, Discomfort, Pain
Clinical narrative: pt initially noted palpitations and shortness of breath. After several minutes improved and then pt developed lip and tongue swelling
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Chest discomfort, Discomfort, Dysphagia, Dyspnoea
Clinical narrative: pt initially noted palpitations and shortness of breath. After several minutes improved and then pt developed lip and tongue swelling
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eye swelling, Fatigue, Lethargy, Mouth swelling, Pain
Clinical narrative: pt initially noted palpitations and shortness of breath. After several minutes improved and then pt developed lip and tongue swelling
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swelling face, Swollen tongue, Tachycardia, Throat tightness, Tremor
Clinical narrative: pt initially noted palpitations and shortness of breath. After several minutes improved and then pt developed lip and tongue swelling
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Sensation of foreign body
Clinical narrative: pt felt a lump in sternum like he swallowed something and it was stuck.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Nasopharyngitis, Pyrexia
Clinical narrative: Headache, felt like I was starting a bad cold , chills, low grade fever and every joint ached for 36 hours. Then it just went away.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Severe and debilitating lower back pain that lasted roughly 3 hours. Use of a heating pad for an extended period of time assisted with recovery.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: C/o feeling itchy on arms, neck, knee. No rash noted at injection site or on arms. Blotchy essential noted neck right clavicle area. Denies pain, SOB, dizziness, nausea. P76. Checked by EMT. EMT instruct ti take oral benadryl when she gets home. Client stated that perfums,perfume, lotions can set off itchy feeling when shesmells perfume.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Malaise, Pyrexia, Tremor
Clinical narrative: Flu like symptoms 24 hours after shot. Fever, chills, sick to stomach, uncontrollable shaking!
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait inability, Muscle spasms, Oedema peripheral, Tremor
Clinical narrative: bilateral lower leg edema started 24 hours after vaccine, associated with dizziness, leg spasm/tremors, unable to walk, resolved in 4 days. no prior history, no other new medications taken
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Tenderness
Clinical narrative: Moderna COVID-19 Vaccine EUA. Minor and expected tenderness the day after injection. Noticed 9 days after vaccination that the injection site is getting swollen and very itchy. Increasing redness. Taking OTC antihistamines and ibuprofen as needed. No need for additional intervention yet, but felt obligated to report and help provide information. Currently on injection day +10,  increased redness, swelling, and itching.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Large (3 inch in diameter), red, hot, itchy, bump on left arm.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Reddness, swelling and warmth below injection site.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Unresponsive to stimuli
Clinical narrative: Hospice patient with multiple comorbidities. Within hours of injection became lethargic and unresponsive, she remained in this state for 3 days.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Client arrived to vaccine clinic with stomach ache. Denied fever or other symptoms and stated he thought he had food poisoning. Vaccine administered per client request. Client observed for 15 minutes and no other reaction noted. Patient left after 15 minutes. Later facility was told client returned to his apartment and called 911 to go the ER to be seen for stomach pain. Paramedics notified patient had received COVID-19 vaccine.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain, Pain in extremity
Clinical narrative: severe chills. shivering at night for 2 hours. no fever, some aching and malaise. this was  4 days after shot. all previous days was fatigued alittle chilled and arm sore. taking alot of tylenol drinking alot of water. things did not get worse.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Nausea, Pain, Pyrexia
Clinical narrative: Had body aches and low grade fever 99 +, took Tylenol 500mg, and fever broke. Next day just didn't feel well, tired and little nauseated. That lasted all day but next day felt fine.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Blood sodium decreased, Hyponatraemia
Clinical narrative: profound hyponatremia
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose of Moderna given to early.  First dose given on 1/29/2021 and 2nd dose given 2/17/2021.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chapped lips, Epistaxis, Facial pain, Headache, Lethargy
Clinical narrative: Starting 16 hrs. Post vaccine;  sniffles, fever 102 F. , mild bloody nose,  arm pain, excruciating head ache and facial pain not relieved by #2 50mg Ultram every 4 to 5 hrs, lethargy, chapped lips and cold sore.  February 23rd most symptoms gone except lethargy and cold sore.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Pain in extremity, Pyrexia, Rhinorrhoea
Clinical narrative: Starting 16 hrs. Post vaccine;  sniffles, fever 102 F. , mild bloody nose,  arm pain, excruciating head ache and facial pain not relieved by #2 50mg Ultram every 4 to 5 hrs, lethargy, chapped lips and cold sore.  February 23rd most symptoms gone except lethargy and cold sore.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Confusional state, Haematemesis, Ileus, Intestinal obstruction
Clinical narrative: DX: Ileus Chief Complaint:  Coffee-ground emesis, bowel obstruction Source of History: Patient   History The patient is a 92 y.o. female with a past medical history notable for COPD, dementia, history of DVT, reflux, hypertension, hypothyroidism, recent small bowel obstruction. The patient presents for evaluation of  Worsening issues of coffee-ground emesis once more. This is very similar patient's last hospitalization were patient required NG to and monitoring for blood loss. Patient continues to be confused and not a good source of history. Staff notes that patient started this 1 day prior at skilled care facility was sent into the ER. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. Patient shows no signs of any pain or discomfort
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment
Clinical narrative: DX: Ileus Chief Complaint:  Coffee-ground emesis, bowel obstruction Source of History: Patient   History The patient is a 92 y.o. female with a past medical history notable for COPD, dementia, history of DVT, reflux, hypertension, hypothyroidism, recent small bowel obstruction. The patient presents for evaluation of  Worsening issues of coffee-ground emesis once more. This is very similar patient's last hospitalization were patient required NG to and monitoring for blood loss. Patient continues to be confused and not a good source of history. Staff notes that patient started this 1 day prior at skilled care facility was sent into the ER. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. Patient shows no signs of any pain or discomfort
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: 30 minutes after vaccination on left arm  2 inch round red spot, bigger than half dollar, hot and hard, sore
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Blood glucose increased, Erythema, Fatigue
Clinical narrative: TUESDAY NIGHT, NIGHT OF INJECTION, ANXIOUSNESS. NEXT DAY  IRRATIBILTIY, HIGH GLUCOSE READING IN AM , SORE SWOLLEN ARM (INJECTION SITE). LATE AFTERNOON DAY 2, SEVERE PAIN HANDS AND FEET, ESPECIALLY TOES AND FINGERS, VERY TIRED, AND INCREASE IN APPETITE AND JOINT PAIN. DAY 3 ALL DAY 2 EXCEPT GLUCOSE  AM WAS BACK TO NORMAL, BUT ARM MORE SORE , SWOLLEN AND RED AND NOW HOT TO TOUCH. THESE SYMPTOMS  CONTINUED UNTIL THE FOLLOWING SUNDAY. THE ARM CONTINUED TO BE SORE, RED AND SWOLLEN.  TODAY, 2/23/2021, IS 3 WEEKS SINCE I WAS VACCNATED. MY ARM IS STILL SORE BUT I HAVE A LARGE SPOT ON MY UPPER ARM, INJECTION SITE, WHICH IS STILL SWOLLEN, RED AND HOT TO TOUCH BUT ALSO VERY ITCHY. CAN I HAVE SHOT #2?
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Increased appetite, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: TUESDAY NIGHT, NIGHT OF INJECTION, ANXIOUSNESS. NEXT DAY  IRRATIBILTIY, HIGH GLUCOSE READING IN AM , SORE SWOLLEN ARM (INJECTION SITE). LATE AFTERNOON DAY 2, SEVERE PAIN HANDS AND FEET, ESPECIALLY TOES AND FINGERS, VERY TIRED, AND INCREASE IN APPETITE AND JOINT PAIN. DAY 3 ALL DAY 2 EXCEPT GLUCOSE  AM WAS BACK TO NORMAL, BUT ARM MORE SORE , SWOLLEN AND RED AND NOW HOT TO TOUCH. THESE SYMPTOMS  CONTINUED UNTIL THE FOLLOWING SUNDAY. THE ARM CONTINUED TO BE SORE, RED AND SWOLLEN.  TODAY, 2/23/2021, IS 3 WEEKS SINCE I WAS VACCNATED. MY ARM IS STILL SORE BUT I HAVE A LARGE SPOT ON MY UPPER ARM, INJECTION SITE, WHICH IS STILL SWOLLEN, RED AND HOT TO TOUCH BUT ALSO VERY ITCHY. CAN I HAVE SHOT #2?
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Irritability, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: TUESDAY NIGHT, NIGHT OF INJECTION, ANXIOUSNESS. NEXT DAY  IRRATIBILTIY, HIGH GLUCOSE READING IN AM , SORE SWOLLEN ARM (INJECTION SITE). LATE AFTERNOON DAY 2, SEVERE PAIN HANDS AND FEET, ESPECIALLY TOES AND FINGERS, VERY TIRED, AND INCREASE IN APPETITE AND JOINT PAIN. DAY 3 ALL DAY 2 EXCEPT GLUCOSE  AM WAS BACK TO NORMAL, BUT ARM MORE SORE , SWOLLEN AND RED AND NOW HOT TO TOUCH. THESE SYMPTOMS  CONTINUED UNTIL THE FOLLOWING SUNDAY. THE ARM CONTINUED TO BE SORE, RED AND SWOLLEN.  TODAY, 2/23/2021, IS 3 WEEKS SINCE I WAS VACCNATED. MY ARM IS STILL SORE BUT I HAVE A LARGE SPOT ON MY UPPER ARM, INJECTION SITE, WHICH IS STILL SWOLLEN, RED AND HOT TO TOUCH BUT ALSO VERY ITCHY. CAN I HAVE SHOT #2?
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Somnolence
Clinical narrative: Chills about 16 hours after vaccine.. lasted one hour   sore arm  2 days    . fatigue for 3 days ,  longer sleeping than usual.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Grip strength decreased, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: Arthritic type flare in right hand with  pain, swelling.  Unable to grip due to stiffness and pain.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Starting at 6 pm in 17 the. Feelings of electrical shocks in various places in my body every 15 to 20 minutes stopping at 5 pm the 18 the. A sensation like getting a shock from an exposed outlet but not on skin, it was inside my body. Enough of a shock to be startling. One time it would be in right upper arm then upper leg, lower leg, sides, etc...
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: 6 hours after receiving the vaccine I developed a sore arm & severe headache, later followed by chills, all over body aches, severe fatigue, nausea, diarrhea, and then a fever of 102.1 which lasted three days and did not break or go down with Tylenol. On the third day I had no symptoms at all other than slight fatigue.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: 6 hours after receiving the vaccine I developed a sore arm & severe headache, later followed by chills, all over body aches, severe fatigue, nausea, diarrhea, and then a fever of 102.1 which lasted three days and did not break or go down with Tylenol. On the third day I had no symptoms at all other than slight fatigue.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Influenza like illness, Migraine, Nasal congestion, Pain
Clinical narrative: I was fine til about 2am when I was faint and light headed with flu-like symptoms, stuffy nose, body aches + terrible migraine headache. Was so sick that I was unable to find my migraine meds (prescribed by doctor). Have history of migraines but haven't had one in several month...I was dizzy and worried about thowing up and fainting. Note: usually never recieve the flu shot but not during 2020.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: I was fine til about 2am when I was faint and light headed with flu-like symptoms, stuffy nose, body aches + terrible migraine headache. Was so sick that I was unable to find my migraine meds (prescribed by doctor). Have history of migraines but haven't had one in several month...I was dizzy and worried about thowing up and fainting. Note: usually never recieve the flu shot but not during 2020.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Vertigo
Clinical narrative: Intense dizziness and vertigo. First two days- nearly constant and accompanied by nausea and headache.  Dizziness lasting for more than 1 week. Vertigo still present after 7 days if laying in certain positions. Taking meclizine as needed for dizziness and motion sickness.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyskinesia
Clinical narrative: Three days after vaccine administration, patient indicates feeling weakness and involuntary movements in both legs.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Dizziness, Fatigue
Clinical narrative: Fatigue, Dizziness, pain in breast and fullness/uncomfortable feeling under armpit
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Computerised tomogram, Laboratory test, Nausea
Clinical narrative: 4 DAYS AFTER 1ST DOSE MODERNA HAD SEVERE ABDOMEN PAIN WITH NAUSEA, TO THE ER WITH CT SCAN AND LABS DONE. DOSE 2 MODERNA 2/18/2021 AND 2 DAYS LATER HAD SAME SEVERE ABDOMEN PAIN AND NAUSEA .FIRST EPISODE LASTED ABOUT 3 DAYS AND SECOND EPISODE LASTED 2 DAYS
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Hypoaesthesia
Clinical narrative: PATIENT EXPERIANCED CHEST PAIN AND ARM NUMBNESS.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time, Asthenia, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood glucose
Clinical narrative: DX: CVA History The patient is a 92 y.o. female with a past medical history notable for  History of CVA, history of arthritis, history of COPD, history of DVT, history of reflux, history of hypertension, history of hyperthyroidism, recent GI bleed. The patient presents for evaluation of worsening weakness at skilled care facility. Patient had history of stroke. Patient was assessed there was found of have another stroke. Patient's other care and therapies were reviewed. Patient's blood thinners recently stopped within the last 3 months due to GI bleed requiring multiple transfusions. Patient has been slow to recover. Patient has struggled with intake and weight loss. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Blood magnesium, Cerebrovascular accident, Chest X-ray, Computerised tomogram head, Culture urine
Clinical narrative: DX: CVA History The patient is a 92 y.o. female with a past medical history notable for  History of CVA, history of arthritis, history of COPD, history of DVT, history of reflux, history of hypertension, history of hyperthyroidism, recent GI bleed. The patient presents for evaluation of worsening weakness at skilled care facility. Patient had history of stroke. Patient was assessed there was found of have another stroke. Patient's other care and therapies were reviewed. Patient's blood thinners recently stopped within the last 3 months due to GI bleed requiring multiple transfusions. Patient has been slow to recover. Patient has struggled with intake and weight loss. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dysphagia, Electrocardiogram, Fibrin D dimer, Full blood count
Clinical narrative: DX: CVA History The patient is a 92 y.o. female with a past medical history notable for  History of CVA, history of arthritis, history of COPD, history of DVT, history of reflux, history of hypertension, history of hyperthyroidism, recent GI bleed. The patient presents for evaluation of worsening weakness at skilled care facility. Patient had history of stroke. Patient was assessed there was found of have another stroke. Patient's other care and therapies were reviewed. Patient's blood thinners recently stopped within the last 3 months due to GI bleed requiring multiple transfusions. Patient has been slow to recover. Patient has struggled with intake and weight loss. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin, Libido decreased, Liver function test, Magnetic resonance imaging, Metabolic function test
Clinical narrative: DX: CVA History The patient is a 92 y.o. female with a past medical history notable for  History of CVA, history of arthritis, history of COPD, history of DVT, history of reflux, history of hypertension, history of hyperthyroidism, recent GI bleed. The patient presents for evaluation of worsening weakness at skilled care facility. Patient had history of stroke. Patient was assessed there was found of have another stroke. Patient's other care and therapies were reviewed. Patient's blood thinners recently stopped within the last 3 months due to GI bleed requiring multiple transfusions. Patient has been slow to recover. Patient has struggled with intake and weight loss. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Prothrombin time, Transfusion, Troponin I, Weight decreased
Clinical narrative: DX: CVA History The patient is a 92 y.o. female with a past medical history notable for  History of CVA, history of arthritis, history of COPD, history of DVT, history of reflux, history of hypertension, history of hyperthyroidism, recent GI bleed. The patient presents for evaluation of worsening weakness at skilled care facility. Patient had history of stroke. Patient was assessed there was found of have another stroke. Patient's other care and therapies were reviewed. Patient's blood thinners recently stopped within the last 3 months due to GI bleed requiring multiple transfusions. Patient has been slow to recover. Patient has struggled with intake and weight loss. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hot flush
Clinical narrative: C/o feeling hot flush heart rate 104. Denies no  dizziness, nausea, chest pain, or SOB. EMS evaluated P 94 148/99.   Ok to walk with husband as nd left for home w husband 12:26 pm.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site pruritus
Clinical narrative: On 2/6/21 I experienced headache, fatigue, fever, chills, and body aches. along with sore arm on injection site.  This lasted 24 hours.  On  2/19/21 I noticed continued soreness in my arm on the injection site.  I also began noticing itchiness.  I now have a spotty rash all over the same arm along with itching and soreness.  It looks like hives.  It is localized to the arm of the infection.  I did not experience these side effects, other than a sore arm, after the first dose I was given on 1/8/2021.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site urticaria, Pain, Pyrexia
Clinical narrative: On 2/6/21 I experienced headache, fatigue, fever, chills, and body aches. along with sore arm on injection site.  This lasted 24 hours.  On  2/19/21 I noticed continued soreness in my arm on the injection site.  I also began noticing itchiness.  I now have a spotty rash all over the same arm along with itching and soreness.  It looks like hives.  It is localized to the arm of the infection.  I did not experience these side effects, other than a sore arm, after the first dose I was given on 1/8/2021.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: within 5 minutes of receiving second Moderna vaccine, patient c/o itching to face.  no visible hives.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Menstruation delayed
Clinical narrative: large cyst developed on left side of vagina, menstrual cycle was 3 weeks late
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: PT BEGAN TO C/O FEELING FUNNY AND DIZZY IMMEDIATELY FOLLOWING INJECTION. PT ALERT AND ORIENTED X 4, NO LOSS OF CONCIOUSNESS, BREATHING NORMAL, SKIN NATURALLY PALE, W/D WITH NO DIAPHORESIS. PT STATES SHE HAS NOT EATEN TODAY. TAKES BP MED AT 2PM. GAVE A PIECE OF MINT CANDY , OFFERED CRACKERS BUT DECLINED; SHE ALSO TOOK HER BP MED.  OUTCOME: FELT BETTER AFTER 5 MINUTES, SHE STATES SHE THINKS IT WAS HER BLOOD SUGAR. CONTINUED TO MONITOR X 15 MINUTES WITH NO FURTHER INCIDENCE
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue
Clinical narrative: Fatigue and difficulty concentrating
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash
Clinical narrative: A rash appeared more intensely at injection site but all over limbs and body.  Went to general practioner who administered cetirizine 10mg 1x/day montelukast 10 mg 1x/day rash is drying and not as bright currently