chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, General physical health deterioration, Heart rate increased, Helplessness, Loss of personal independence in daily activities
Clinical narrative: my health deteriorated; my life is totally upside down/I am not even able to drive the car; I had anxiety; I had got you know heart my heart beat went up so high; I got a panic attack; my confidence has been lost; I feel helpless and you know handicapped; This is a spontaneous report from a contactable consumer or other non hcp (patient).A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: number was not reported) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: number was not reported) via an unspecified route of administration on an unspecified date as 2nd dose, single dose for COVID-19 immunization.The patient medical history and concomitant medications were not reported. On an unspecified,Patient stated after getting the first dose of vaccination patient health deteriorated a lot and after taking the second the patient life was totally upside down. The patient had adverse reactions with vaccination. Patient had anxiety, patient had got you know heart patient heart beat went up so high and patient got a panic attack usually patient was a very healthy person. Patient have never experienced such kind of side effects before and it has gone so high that because of this panic attack and patient was not even able to drive the car or patient not the same person. So patient wanted to report about this because you can understand that this is not you know right. Patient wish patient would have known about the side effects patient might have not even taken it. When confirmed whether patient want to report these adverse events and patient want solution for it. Patient stated that of course patient can understand that patient have stayed at home and patient feel helpless and handicapped. Patient couldn't drive. Patient have been driving from past 13 years and patient had to go to emergency and patient life was not the same, patient had lost confidence. So patient was suffering. Consumer was informed about the Pfizer medical information. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Panic attack, Psychiatric symptom
Clinical narrative: my health deteriorated; my life is totally upside down/I am not even able to drive the car; I had anxiety; I had got you know heart my heart beat went up so high; I got a panic attack; my confidence has been lost; I feel helpless and you know handicapped; This is a spontaneous report from a contactable consumer or other non hcp (patient).A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: number was not reported) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: number was not reported) via an unspecified route of administration on an unspecified date as 2nd dose, single dose for COVID-19 immunization.The patient medical history and concomitant medications were not reported. On an unspecified,Patient stated after getting the first dose of vaccination patient health deteriorated a lot and after taking the second the patient life was totally upside down. The patient had adverse reactions with vaccination. Patient had anxiety, patient had got you know heart patient heart beat went up so high and patient got a panic attack usually patient was a very healthy person. Patient have never experienced such kind of side effects before and it has gone so high that because of this panic attack and patient was not even able to drive the car or patient not the same person. So patient wanted to report about this because you can understand that this is not you know right. Patient wish patient would have known about the side effects patient might have not even taken it. When confirmed whether patient want to report these adverse events and patient want solution for it. Patient stated that of course patient can understand that patient have stayed at home and patient feel helpless and handicapped. Patient couldn't drive. Patient have been driving from past 13 years and patient had to go to emergency and patient life was not the same, patient had lost confidence. So patient was suffering. Consumer was informed about the Pfizer medical information. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Epistaxis, Increased tendency to bruise, Migraine
Clinical narrative: Tested positive for low von willebrande factor; After 2 dose I started to bruise extremely easily; the migraine like symptoms increased to multiple times per week with extreme sen; extreme sensitivity to light and vomiting; extreme sensitivity to light and vomiting; Cuts that would bleed excessively; Nose bleeds; A 27-year-old (Non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number:ER8727) via unspecified route of administration in left arm on 31Mar2021 13:00 as (at age of 27years) 2nd dose, single dose for COVID-19 Immunization. Patient medical history includes Attention deficit hyperactivity disorder (ADHD), Anxiety from unspecified date and unknown till ongoing. Patient is allergic to the drugs include Penicillin, Omeprazole from unknown date till ongoing. Patient concomitant medications include lisdexamfetamine mesilate(VYVANSE) and drospirenone, ethinylestradiol(GIANVI) used for unspecified indication from unknown date and unknown if ongoing. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6207) via unspecified route of administration in left arm on 11Mar2021 09:00 (at age of 27years) as single dose for COVID-19 Immunization and experienced 1 week after first dose patient began getting severe migraine like symptoms followed by extremely heavy menstrual cycle. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID. On unspecified date, after 2 dose patient started to bruise extremely easily and the migraine like symptoms increased to multiple times per week with extreme sensitivity to light and vomiting. Patient had cuts that would bleed excessively, woke up with nose bleeds and tested positive for Low von willebrande factor with no history of any type of bleeding disorder. The adverse events resulted in physician office visit. Patient received treatment for events .Patient underwent lab test and procedures include CT Scan of head, blood tests result was unknown and vonwillebrande was positive . The Clinical outcome of all events was Recovering.   Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, Vomiting, Von Willebrand's disease, Von Willebrand's factor activity test, Wound haemorrhage
Clinical narrative: Tested positive for low von willebrande factor; After 2 dose I started to bruise extremely easily; the migraine like symptoms increased to multiple times per week with extreme sen; extreme sensitivity to light and vomiting; extreme sensitivity to light and vomiting; Cuts that would bleed excessively; Nose bleeds; A 27-year-old (Non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number:ER8727) via unspecified route of administration in left arm on 31Mar2021 13:00 as (at age of 27years) 2nd dose, single dose for COVID-19 Immunization. Patient medical history includes Attention deficit hyperactivity disorder (ADHD), Anxiety from unspecified date and unknown till ongoing. Patient is allergic to the drugs include Penicillin, Omeprazole from unknown date till ongoing. Patient concomitant medications include lisdexamfetamine mesilate(VYVANSE) and drospirenone, ethinylestradiol(GIANVI) used for unspecified indication from unknown date and unknown if ongoing. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6207) via unspecified route of administration in left arm on 11Mar2021 09:00 (at age of 27years) as single dose for COVID-19 Immunization and experienced 1 week after first dose patient began getting severe migraine like symptoms followed by extremely heavy menstrual cycle. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID. On unspecified date, after 2 dose patient started to bruise extremely easily and the migraine like symptoms increased to multiple times per week with extreme sensitivity to light and vomiting. Patient had cuts that would bleed excessively, woke up with nose bleeds and tested positive for Low von willebrande factor with no history of any type of bleeding disorder. The adverse events resulted in physician office visit. Patient received treatment for events .Patient underwent lab test and procedures include CT Scan of head, blood tests result was unknown and vonwillebrande was positive . The Clinical outcome of all events was Recovering.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia; This is a spontaneous report from a contactable consumer(patient). A female patient of 64 year of age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 15Mar2021 as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced pneumonia. Therapeutic measures were taken because of pneumonia, patient was prescribed prednisone and also stated that she could not get the second dose while taking prednisone. It was reported that patient wanted to know if she needs to start the vaccination series over. The outcome of events remains unknown.  Information about the Lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: This is a spontaneous report from a non-contactable nurse.  An adult male patient of unspecified age received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in Jun2021, for COVID-19 immunization. The first dose of BNT162B2 vaccine was administered on an unknown date. Medical history and concomitant medications were not reported. The patient took the second dose of Covid 19 vaccine and died sometime in the same week, on an unspecified date in Jun2021. Cause of death was unknown. It was unknown if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Event unknown cause of death is assessed as related until sufficient information is available to confirm an unrelated cause of death. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: The patient took the second dose of Covid 19 vaccine and died sometime in the same week
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 3 people that were fully vaccinated with the Pfizer covid 19 vaccine and have contracted covid; 3 people that were fully vaccinated with the Pfizer covid 19 vaccine and have contracted covid; This is a spontaneous report received from a contactable pharmacist. A male patient of an unspecified age received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, via an unspecified route of administration on an unspecified date (Batch/Lot Number: el8982) as 2nd dose, single dose, via an unspecified route of administration on an unspecified date (Batch/Lot Number: en5318) as 1st dose, single dose for covid-19 immunisation. The patient medical history was notand concomitant medications were not reported. On an unspecified date, a fully vaccinated patient with the pfizer covid 19 vaccine had contracted covid. Reporter had 3 people that were fully vaccinated with the Pfizer covid 19 vaccine and had contracted covid. He asked if there were any issues with specific lot numbers: el8982, en5318. He did not have any information to provide for the people. The patient underwent lab tests and procedures which included sars-cov-2 test: contracted covid. The seriousness was reported as non serious by the reporter. The outcome were unknown.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-2021669273 same reporter/drug/event, different patient;US-PFIZER INC-2021669261 same reporter/drug/event, different patient
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Ultrasound scan
Clinical narrative: after I got my 2nd vaccine I was diagnosed with blood clot; This is a spontaneous report from a contactable consumer (patient).  A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0173; Expiration Date: 31Aug2021), via intramuscular route of administration, administered in Arm Left on 20May2021 13:00 (at the age of 74-year-old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included Blood pressure from an unknown date and unknown if ongoing. Concomitant medication included nebivolol hydrochloride (BYSTOLIC) taken for blood pressure, start and stop date were not reported. The patient previously received first dose of BNT162B2 (Lot number: EW0172; 74-year age at time vaccination) intramuscular, administered in Arm Left on 29Apr2021 (approximately 1pm afternoon) for COVID-19 immunisation. Patient stated, I do not know if it was related to the vaccine, but I thought it was interesting that 2 weeks to the day after I got my 2nd vaccine I was diagnosed with blood clot (28May2021), and I never had a blood clot I am on blood thinners now, I just said that was interesting I don't know where it came from I had no injury, I am very active. there was no reason for me to have the blood clot other than I do get the vaccine 2 weeks prior to the diagnoses. Again stated, I got the vaccine on 20May, I started noticing it on 28May. Patient stated, I did not go to the hospital to get diagnosed I had ultrasound. Patient stated diagnosis date of blood clot was 03Jun2021 and Eliquis (each pill is 5 milligrams and I have to take 4pills a day) used for blood thinner. The patient underwent lab tests and procedures which included ultrasound: blood clot on 03Jun2021.Therapeutic measures were taken as a result of after patient got my 2nd vaccine i was diagnosed with blood clot. The outcome of event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Pemphigus
Clinical narrative: pemphigus; This is a spontaneous report from a contactable pharmacist reporting same event under the same suspect product for six patients. This is one of six reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pemphigus on an unspecified date with outcome of unknown. It was reported that while consulting her (reporter) dermatologist, she was informed that there are 6 patient who had pemphigus after receiving COVID vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021615653 Same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Pemphigus
Clinical narrative: pemphigus; This spontaneous report from a contactable pharmacist reporting same event under the same suspect product for 6 patients. This is one of six reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pemphigus on an unspecified date with outcome of unknown. It was reported that while consulting her (reporter) dermatologist, she was informed that there are 6 patients who had pemphigus after receiving COVID vaccine.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021615653 Same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Pemphigus
Clinical narrative: pemphigus; This spontaneous report from a contactable pharmacist reporting same event under the same suspect product for 6 patients. This is one of six reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pemphigus on an unspecified date with outcome of unknown. It was reported that while consulting her (reporter) dermatologist, she was informed that there are 6 patients who had pemphigus after receiving COVID vaccine.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021615653 Same reporter/drug/event, different patient
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Off label use, Product administered to patient of inappropriate age
Clinical narrative: 66 year-old was administered Adacel/no AE; Initial information was received on 25-May-2021 regarding an unsolicited valid non-serious case received from a Nurse Practitioner via Medical Information (Reference number- 00615161).  This case involves a 66 year-old male patient who was vaccinated with 0.5 mL (once; standard) dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number: U6900AA and expiry date 18-Nov-2022) via an intramuscular route at left deltoid on 25-May-2021 for prophylactic vaccination (Off label use in unapproved age group).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication was given.   It was a case of off label use (latency was on same day).  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 75.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: medical assistant had administered an expired vaccine to patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Medical Information (Reference number- 00628493) and transmitted to Sanofi on 04-Jun-2021.  This case involves a 75 years old female patient who received 0.5 ml of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6265AA, expiry date: 19-Apr-2021) via intramuscular route in unknown administration site for prophylactic vaccination on 24-May-2021 (Expired product administered)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It was a case of an actual medication error due to Expired vaccine used (latency same day)  At the time of report, no adverse event was reported.  Caller stated a medical assistance accidentally administered the diphtheria tetanus (TD) vaccine. Caller asked if there is anything they need to do, were there any adverse effects and what were the next steps  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: F
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A 6 month old patient was administered Quadracel instead of Pentacel, no AE; A 6 month old patient was administered Quadracel, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Medical Information (Reference number- 00628649) and transmitted to Sanofi on 04-Jun-2021.  This case involves a 6 months old female patient who was administered 0.5 ml third dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5763AA, expiry date: 26-Aug-2022, Injection) via intramuscular route in the left thigh for prophylactic vaccination on 04-Jun-2021 (Product administered to patient of inappropriate age) instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (Wrong vaccine administered)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ), HEPATITIS B VACCINE and HIB VACCINE CONJ (TET TOX) (ACT-HIB) for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate age at vaccine administration and Wrong product administered (latency same day)  At the time of report, no adverse event was reported.  The caller said that a health care professional (HCP) accidently gave a 6 month patient Quadracel which is for patients with ages 4 to 6 years and asked if there were any concerns. She was supposed to get Pentacel as one of her immunizations but, Quadracel was given    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lymphadenopathy, Muscle swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Lymph Node Swelling-Severe, Additional Details: patient complaint of soreness/redness and extreme swelling in lymph node and trap muscle on arm.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Patient did not want to take benadryl. will take allegra
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Sporadic Dizziness/Light headedness.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, tiredness.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Pt c/o dizziness following Pfizer vaccine. VS BP=137/62, HR= 80, RR= 18, SP02= 99% RA.  Monitored afor over 30 minutes and all symptoms resolved. Pt cleared to go home with family by medical provider.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chills, Muscle tightness, Nausea
Clinical narrative: Swelling in RIGHT hand, fever, chills, nausea, tightness in chest and back, joint pain
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Swelling in RIGHT hand, fever, chills, nausea, tightness in chest and back, joint pain
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Fatigue, Headache, Insomnia
Clinical narrative: Extreme full body pain, intense headache, chest pains, Sleeplessness, shortness of breath lasting about 3 days. Lingering fatigue a week later.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Extreme full body pain, intense headache, chest pains, Sleeplessness, shortness of breath lasting about 3 days. Lingering fatigue a week later.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Heart rate increased, Heart rate irregular
Clinical narrative: Noticed occasional increased/irregular heart rate, shortness of breath, discomfort in chest beginning around June 2.  Symptoms have continued occur multiple times a day since then. Taking NSAIDs (naproxen, aspirin) has helped, but symptoms do continue to come back.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Irregular breathing, Muscle contractions involuntary, Nausea, Pharyngeal swelling
Clinical narrative: 06/08/21 2nd dose of Pfzier.Vaccination administered @ 10:44. According to client arm fasciculation ? started one minute after vaccine. Nausea 2 minutes after. Complaints of dizziness. Respirations 24 at 10:59. Respirations 28 and irregular at 11:04. Tightness in throat @11:10. Tongue not swollen. Breath sounds unobstructed(report given via school nurse), RN, PHN 06/09/2021 Mom reports child had fever and lump in throat the evening of event. The next morning child vommited x1. RN, PHN 06/11/2021 Mom reports no new side effects since the morning of 06/09/21 and the child is feeling fine. RN, PHN
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Throat tightness, Vomiting
Clinical narrative: 06/08/21 2nd dose of Pfzier.Vaccination administered @ 10:44. According to client arm fasciculation ? started one minute after vaccine. Nausea 2 minutes after. Complaints of dizziness. Respirations 24 at 10:59. Respirations 28 and irregular at 11:04. Tightness in throat @11:10. Tongue not swollen. Breath sounds unobstructed(report given via school nurse), RN, PHN 06/09/2021 Mom reports child had fever and lump in throat the evening of event. The next morning child vommited x1. RN, PHN 06/11/2021 Mom reports no new side effects since the morning of 06/09/21 and the child is feeling fine. RN, PHN
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac imaging procedure abnormal, Chest pain, Myocarditis, Troponin
Clinical narrative: Chest pain
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac imaging procedure abnormal, Chest pain, Echocardiogram normal, Electrocardiogram abnormal, Myocarditis
Clinical narrative: Chest pain
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pericardial effusion, Troponin increased
Clinical narrative: Chest pain
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Skin laceration, Suture insertion, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient was fine after she received her vaccine, we monitored her for 15 minutes and let her go home. Today on june 11, she comes in to pick up a script and she has stitches under her eyebrow, she stated that the day after she received the vaccine, she woke and developed flu like symptoms. And she said since she was 14 years old, she has had a history of fainting when she feels ill, she acknowledged that she was counseled on flu like symptoms. She fainted the next day and lacerated above her eye
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong dosage formulation
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: 42 y/o with medical history of Cervicalgia who presents with numbness to the right arm post vaccination. Patient states that this is the second dose in the two-dose Pfizer series. Patient states that after the first vaccination with similar complaints that only lasted a few minutes. Patient states that vaccination was received to the right arm. Patient denies headache, vision changes, neck pain, facial numbness, sore throat or difficulty breathing, chest pain. Patient evaluated by the NP and Paramedics. Patient initial BP was elevated 153/93 but subsequent bps normal (126/85). All other vitals within normal limits (97-98% SPO2, 78-80 HR). Patient with improvement of symptoms within 15 mins post observation. Patient advised that Tylenol has be taken if any pain to injection site or discomfort to R arm. Patient aware of symptoms persist or worsen to please seek medical attention, patient verbalized understanding. Patient discharged in stable condition with her father.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PATIENT IS  17 YEARS OLD  AT TIME OF VACCINE ADMINISTERATION
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Computerised tomogram normal, Fall, Head injury, Headache
Clinical narrative: Patient presented for his first dose of Pfizer Covid vaccine.  Immediately after administering shot, patient lost consciousness, fell to the floor, and hit his head.  Loss of consciousness lasted approximately 3-5 seconds.  Upon waking, patient was alert and oriented x4.  Vitals upon waking: BP 75/35, P: 62, O2 Sat: 90%.  Water was administered orally.  Patient c/o neckache 6/10 and headache immediately upon waking.  Vitals continued to be monitored frequently and BP continued to be 80's/40's.  Blood sugar 76.  EMS called and arrived.  Patient's blood pressure increased to 130/80 for approximately 10 minutes and then dropped again to 78/45.  Patient taken to local hospital for further evaluation accompanied by parents.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Loss of consciousness, Neck pain
Clinical narrative: Patient presented for his first dose of Pfizer Covid vaccine.  Immediately after administering shot, patient lost consciousness, fell to the floor, and hit his head.  Loss of consciousness lasted approximately 3-5 seconds.  Upon waking, patient was alert and oriented x4.  Vitals upon waking: BP 75/35, P: 62, O2 Sat: 90%.  Water was administered orally.  Patient c/o neckache 6/10 and headache immediately upon waking.  Vitals continued to be monitored frequently and BP continued to be 80's/40's.  Blood sugar 76.  EMS called and arrived.  Patient's blood pressure increased to 130/80 for approximately 10 minutes and then dropped again to 78/45.  Patient taken to local hospital for further evaluation accompanied by parents.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Patient Too Young for Vaccine Administered
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Fatigue, Headache, Nasal congestion
Clinical narrative: 3 hours post headache, fatigue lasted 32 hours.  12 hours post sore throat, sinus drainage, lasted 48 hours. 36 hours post chest tightness, stuffy nose congestion and dry cough.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Sinus operation
Clinical narrative: 3 hours post headache, fatigue lasted 32 hours.  12 hours post sore throat, sinus drainage, lasted 48 hours. 36 hours post chest tightness, stuffy nose congestion and dry cough.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: left axillary lymphadenopathy
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Troponin increased
Clinical narrative: chest pain
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Myocarditis, Pain in extremity
Clinical narrative: chest pain
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Angiogram, Angiogram pulmonary normal, Bradycardia, Bundle branch block right, Chest X-ray normal
Clinical narrative: chest pain
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram abnormal, Pain, Pain in extremity, Painful respiration
Clinical narrative: chest pain
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Troponin increased
Clinical narrative: chest pain
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acute kidney injury, Angiogram pulmonary normal, Blood creatinine increased, Bundle branch block right, Cardiac imaging procedure abnormal
Clinical narrative: chest pain
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac telemetry normal, Chest pain, Condition aggravated, Dehydration, Echocardiogram normal
Clinical narrative: chest pain
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Fibrin D dimer increased, Haematocrit normal, Haemoglobin normal, Laboratory test
Clinical narrative: chest pain
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging heart, Myocarditis, Pericardial effusion, Sinus bradycardia, Troponin increased
Clinical narrative: chest pain
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Fall, Pallor, Syncope
Clinical narrative: APPROXIMATELY 5 MINUTES AFTER VACCINATION, PATIENT HAD EPISODE OF WHAT APPEARED TO BE VASOVAGAL SYNCOPE - PALLID, CLAMMY, SHAKY, WEAKNESS, FELL TO THE FLOOR AND QUICKLY CAME BACK TO CONSIOUSNESS.    BP WAS TAKEN IMMEDIATELY AFTER, WAS WITHIN NORMAL LIMITS.  PARAMEDICS AND STORE MANAGEMENT RESPONDED TO EPISODE.  PARAMEDICS ASSESSED AND MONITORED PATIENT, PATIENT DID NOT REQUIRE TRANSPORT TO HOSPITAL.    PATIENT REMAINED AT THE PHARMACY FOR A FEW MINUTES AFTER PARAMEDICS LEFT THE SCENE.  PARENTS WERE WITH HIM DURING VACCINATION AND ESCORTED HIM HOME.  ALTHOUGH STILL A LITTLE PALE, PATIENT HAD RECOVERED AND LEFT ON HIS OWN, WELL AFTER THE NORMAL 15 MINUTES MANDATED WAITING PERIOD.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: APPROXIMATELY 5 MINUTES AFTER VACCINATION, PATIENT HAD EPISODE OF WHAT APPEARED TO BE VASOVAGAL SYNCOPE - PALLID, CLAMMY, SHAKY, WEAKNESS, FELL TO THE FLOOR AND QUICKLY CAME BACK TO CONSIOUSNESS.    BP WAS TAKEN IMMEDIATELY AFTER, WAS WITHIN NORMAL LIMITS.  PARAMEDICS AND STORE MANAGEMENT RESPONDED TO EPISODE.  PARAMEDICS ASSESSED AND MONITORED PATIENT, PATIENT DID NOT REQUIRE TRANSPORT TO HOSPITAL.    PATIENT REMAINED AT THE PHARMACY FOR A FEW MINUTES AFTER PARAMEDICS LEFT THE SCENE.  PARENTS WERE WITH HIM DURING VACCINATION AND ESCORTED HIM HOME.  ALTHOUGH STILL A LITTLE PALE, PATIENT HAD RECOVERED AND LEFT ON HIS OWN, WELL AFTER THE NORMAL 15 MINUTES MANDATED WAITING PERIOD.
Age: 14.0
Sex: F
Vaccine: UNK
Symptoms: Loss of consciousness, Malaise, Pallor
Clinical narrative: About 2-3 minutes after injection, while patient was waiting in the lobby, Mother reports patient was not feeling well and asked for a wet paper towel for her neck and forehead. When I returned from getting her a wet paper towel patient became pale and passed out for 1-2 seconds while sitting in the chair in the lobby. Mother was holding daughter so that she did not slip out of the chair. No injury at this time.  Patient became alert quickly, patient reports she felt a little sick.  Mother reports this is the first time she has passed out after any vaccine. When talking with the patient she reports that she was nervous about the shot. Patient also reports that she only ate banana today and nothing else. Water given to patient, instructed to take small sips. At 3:40 when back out to check on patient, she reports that she feels better. Discussed with mother that I will file a VAERS report and they will call to follow up with the her and the patient. 3:43 HR taken at 68 bpm, regular, RR 18, breathing clear and unlabored, patient no longer pale, radial pulses strong.  Patient reports that she does feel better and mother reports she will take her to get something to eat. Discussed with mother to continue to monitor patient and if she has any other signs of difficulty breathing or not acting like herself to take her straight to the ER. Mother in agreement and verbalizes understanding.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient received the vaccine, then used the restroom and came back to wait, 5 minutes post vaccine, he fainted. Regained consciousness when his name was called out, was provided soda and ice pack behind neck. Stated seated, then laid down for a few minutes and then seated upright. EMS was called in to ensure no other injuries.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Immediate post-injection reaction, Increased appetite
Clinical narrative: At 6 am this morning I started having the chills. I have had them ever since and it is almost 2 pm my time. The second I received the injection I felt pain and soreness in my arm, it?s been sore ever since. Lingering head ache all day and muscle aches, worse in my back than anywhere else, though I feel achy all over. Extreme lethargy, very tired and want to sleep. Increased appetite since receiving the vaccine, increased thirst.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lethargy, Myalgia, Pain, Thirst
Clinical narrative: At 6 am this morning I started having the chills. I have had them ever since and it is almost 2 pm my time. The second I received the injection I felt pain and soreness in my arm, it?s been sore ever since. Lingering head ache all day and muscle aches, worse in my back than anywhere else, though I feel achy all over. Extreme lethargy, very tired and want to sleep. Increased appetite since receiving the vaccine, increased thirst.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient returned to us on 6/11/21 to get her second dose of Moderna and reported that her arm was still a little sore from the first dose.  The patient stated that the day after getting her first dose (5/15/21), she experience arm soreness. Over the next few days she stated that the pain got better, but she was still feeling a little sore as of 6/11/21.  She reported no loss of movement, nor was the area red or swollen.  The patient was informed to reach out to her pcp.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea
Clinical narrative: Very painful menses
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diahrrea still ongoing 8-9 days post vaccine. Moderate to severe. Just wondering when to expect it to go away.  Called pharmacy they recommended Imodium. Have not tried it yet.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Paraesthesia, Paraesthesia oral, Pharyngeal paraesthesia, Taste disorder
Clinical narrative: on 5/18/21 five minutes after  first vaccination tongue warming sensation & couldn't move arm for 2 days on 6/8/21 received second dose  at 6pm and by 9pm mouth, cheeks, and throat tingling and weird, sweet taste in mouth for one hour (patient did not inform vaccinator about side effects when coming for second dose)
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Gait disturbance, Hyperhidrosis, Hypopnoea
Clinical narrative: Client received the COVID vaccine (Pfizer dose 1, lot # ER8736, expiration date 7/5/2021) at 1725 from RN.  RN escorted the client to a chair in observation area at 1730. Per RN, the client's gait became unsteady as he ambulated and the client became unresponsive as he sat in his chair. The  client was observed to slump forward, and he was caught by RN and his mother. EMT and RN responded at that time. The client remained unresponsive for approximately 90 seconds. While he was unresponsive, the client's breathing was rapid and shallow, and his pulse was thready. At 1732, the client became responsive and was drowsy but oriented x4. The client was transferred to the zero gravity chair at this time by RN and RPh. The client's vital signs at that time were: blood pressure 76/40, heart rate 64, respiratory rate 24, and O2 91%. The client appeared pale and diaphoretic. The client reported dizziness and blurry vision which had both progressed to "blacked out vision" before he went unresponsive. The client reported still feeling dizzy and having blurry vision. The client denied shortness of breath, chest pain, or headache. At 1737, the client's vital signs were as follows: blood pressure 102/52, heart rate 61, O2 98%. The client's pupils were equal and reactive to light. At 1738, the client was offered water, juice, and a snack, which he started to eat and drink. Per the client's mother, the client hadn't eaten prior to his appointment but was given water and a snack while in line for his vaccine. The client's mother stated that the client has no medical conditions or allergies and that he takes no medications. The client's mother stated he does not have a history of syncope. At 1740, the client's vital signs were as follows: blood pressure 96/48, heart rate 82. The client complained of feeling hot and he was provided with a cool pack. The client's color had returned to normal at this time and his pulse was normal as well. At 1745, the client's vital signs were as follows: blood pressure 96/48, O2 99%, heart rate 65. At 1750, the client stated that his dizziness and blurry vision had resolved. He was no longer diaphoretic. At 1755, the client's pulse was 74, his blood pressure was 102/52, and his O2 was 99%. Education was provided to the client and his mother by RN regarding primary care follow up and EMS activation. At 1800, the client's vital signs were as follows: heart rate 68, O2 98%, and blood pressure 106/58. The client was able to stand up without dizziness and ambulated out to the car escorted by his mother and EMT, ambulating with a steady gait.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor, Pulse abnormal, Respiratory rate increased, Somnolence, Unresponsive to stimuli
Clinical narrative: Client received the COVID vaccine (Pfizer dose 1, lot # ER8736, expiration date 7/5/2021) at 1725 from RN.  RN escorted the client to a chair in observation area at 1730. Per RN, the client's gait became unsteady as he ambulated and the client became unresponsive as he sat in his chair. The  client was observed to slump forward, and he was caught by RN and his mother. EMT and RN responded at that time. The client remained unresponsive for approximately 90 seconds. While he was unresponsive, the client's breathing was rapid and shallow, and his pulse was thready. At 1732, the client became responsive and was drowsy but oriented x4. The client was transferred to the zero gravity chair at this time by RN and RPh. The client's vital signs at that time were: blood pressure 76/40, heart rate 64, respiratory rate 24, and O2 91%. The client appeared pale and diaphoretic. The client reported dizziness and blurry vision which had both progressed to "blacked out vision" before he went unresponsive. The client reported still feeling dizzy and having blurry vision. The client denied shortness of breath, chest pain, or headache. At 1737, the client's vital signs were as follows: blood pressure 102/52, heart rate 61, O2 98%. The client's pupils were equal and reactive to light. At 1738, the client was offered water, juice, and a snack, which he started to eat and drink. Per the client's mother, the client hadn't eaten prior to his appointment but was given water and a snack while in line for his vaccine. The client's mother stated that the client has no medical conditions or allergies and that he takes no medications. The client's mother stated he does not have a history of syncope. At 1740, the client's vital signs were as follows: blood pressure 96/48, heart rate 82. The client complained of feeling hot and he was provided with a cool pack. The client's color had returned to normal at this time and his pulse was normal as well. At 1745, the client's vital signs were as follows: blood pressure 96/48, O2 99%, heart rate 65. At 1750, the client stated that his dizziness and blurry vision had resolved. He was no longer diaphoretic. At 1755, the client's pulse was 74, his blood pressure was 102/52, and his O2 was 99%. Education was provided to the client and his mother by RN regarding primary care follow up and EMS activation. At 1800, the client's vital signs were as follows: heart rate 68, O2 98%, and blood pressure 106/58. The client was able to stand up without dizziness and ambulated out to the car escorted by his mother and EMT, ambulating with a steady gait.