chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Burning sensation, Dizziness, Feeling hot
Clinical narrative: BURNING SENSATION AT THE BACKSIDE OF HEAD AND FOOT; CRAMPS IN RIGHT LEG; FOOT GETTING HOT; FEELING DIZZY; HIGH BODY TEMPERATURES; HEADACHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-JUL-2021 for prophylactic vaccination. Batch number was not reported. per procedure, no follow up will be requested for this case. No concomitant medications were reported. On JUL-2021, Laboratory data included Body temperature (NR: not provided) High. On 06-JUL-2021, the subject experienced burning sensation at the backside of head and foot. On 06-JUL-2021, the subject experienced cramps in right leg. On 06-JUL-2021, the subject experienced foot getting hot. On 06-JUL-2021, the subject experienced feeling dizzy. On 06-JUL-2021, the subject experienced high body temperatures. On 06-JUL-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headaches, high body temperatures, burning sensation at the backside of head and foot, cramps in right leg, foot getting hot and feeling dizzy was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Muscle spasms
Clinical narrative: BURNING SENSATION AT THE BACKSIDE OF HEAD AND FOOT; CRAMPS IN RIGHT LEG; FOOT GETTING HOT; FEELING DIZZY; HIGH BODY TEMPERATURES; HEADACHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-JUL-2021 for prophylactic vaccination. Batch number was not reported. per procedure, no follow up will be requested for this case. No concomitant medications were reported. On JUL-2021, Laboratory data included Body temperature (NR: not provided) High. On 06-JUL-2021, the subject experienced burning sensation at the backside of head and foot. On 06-JUL-2021, the subject experienced cramps in right leg. On 06-JUL-2021, the subject experienced foot getting hot. On 06-JUL-2021, the subject experienced feeling dizzy. On 06-JUL-2021, the subject experienced high body temperatures. On 06-JUL-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headaches, high body temperatures, burning sensation at the backside of head and foot, cramps in right leg, foot getting hot and feeling dizzy was not reported. This report was non-serious.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; This spontaneous report received from a consumer concerned a 16 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095 expiry: 18-AUG-2021) dose was not reported, administered on 08-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-JUL-2021, the subject experienced inappropriate age at vaccine administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inappropriate age at vaccine administration was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: FEELING ITCHY ALL OVER BODY; INJECTED ARM WAS SORE; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, smoker, and alcohol user, and other pre-existing medical conditions included the patient had history of drug abuse or illicit drug use. The patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 07-JUL-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 07-JUL-2021, the subject experienced injected arm was sore. On 08-JUL-2021, the subject experienced feeling itchy all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling itchy all over body, and the outcome of injected arm was sore was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: ACHES; CHILLS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced aches, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, and chills. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Urticaria, Vital signs measurement
Clinical narrative: Allergic reaction to the vaccine; Hives on the posterior aspect of both arm and the posterior left leg; This spontaneous case was reported by a physician and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction to the vaccine) and URTICARIA (Hives on the posterior aspect of both arm and the posterior left leg) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included BENZTROPINE [BENZATROPINE], HALOPERIDOL, METHADONE, MIRTAZAPINE and POLYETHYLENE for an unknown indication.    On 06-Feb-2021 at 11:35 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021 at 1:27 PM, the patient experienced ALLERGY TO VACCINE (Allergic reaction to the vaccine) (seriousness criterion intervention required) and URTICARIA (Hives on the posterior aspect of both arm and the posterior left leg) (seriousness criterion intervention required). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intramuscular) on 06-Feb-2021 for Adverse event, at a dose of 25 mg once a day; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intramuscular) on 06-Feb-2021 for Adverse event, at a dose of 50 mg once a day and PREDNISONE (oral) on 06-Feb-2021 for Adverse event, at a dose of 60 mg once a day. At the time of the report, ALLERGY TO VACCINE (Allergic reaction to the vaccine) and URTICARIA (Hives on the posterior aspect of both arm and the posterior left leg) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Vital signs measurement: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included 25mg bendaryl IM, 60mg prednisone PO. The patient was not having any breathing difficulty, lungs were clear and vitals were normal. After treatment, the patient was monitored for 30 minutes more and found that itching stopped. The patient went to UC approximately four hours later stating that her symptoms reoccurred.  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.; Sender'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: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy kidney, Blood creatinine, Glomerular filtration rate, Haematuria, IgA nephropathy
Clinical narrative: Active IgA nephropathy; Gross hematuria; This literature-non-study case was reported in a literature article and describes the occurrence of IGA NEPHROPATHY (Active IgA nephropathy) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE: of gross hematuria following Moderna COVID-19 vaccine in patients with IgA nephropathy. Kidney Int. 2021     The patient's past medical history included Hematuria.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced IGA NEPHROPATHY (Active IgA nephropathy) (seriousness criterion medically significant) and HAEMATURIA (Gross hematuria). At the time of the report, IGA NEPHROPATHY (Active IgA nephropathy) outcome was unknown and HAEMATURIA (Gross hematuria) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy kidney: abnormal (abnormal) IgA nephropathy. Among 25 glomeruli sampled, 1 was globally sclerotic. there was mild to moderate, diffuse and global, mesangial hyper cellularity. two glomeruli had segmental endocapillary hyper cellularity including infiltrating monocytes and neutrophils. one glomerulus with an incipient segmental scar contained an overlying segmental fibrous crescent. mild tubular atrophy and interstitial fibrosis involved approximately 10% of the cortex.. In 2021, Blood creatinine: 1.2 (High) 1.2 mg/dl. In 2021, Glomerular filtration rate: abnormal (abnormal) 87 ml/min per 1.73 m2. In 2021, IgA nephropathy: abnormal (abnormal) M1E1S1T0C0. In 2021, Immunology test: positive (Positive) 1 to 2+ granular global mesangial staining for IgA, C3, kappa and lambda. In 2021, Urine analysis: abnormal (abnormal) numerous red blood cells and no proteinuria.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered IGA NEPHROPATHY (Active IgA nephropathy) and HAEMATURIA (Gross hematuria) to be possibly related.    No concomitant medications were reported. No treatment information was provided. 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.   This case was linked to MOD-2021-249638, MOD-2021-249637 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included a full text article received.; Sender'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: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Immunology test, Urine analysis
Clinical narrative: Active IgA nephropathy; Gross hematuria; This literature-non-study case was reported in a literature article and describes the occurrence of IGA NEPHROPATHY (Active IgA nephropathy) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE: of gross hematuria following Moderna COVID-19 vaccine in patients with IgA nephropathy. Kidney Int. 2021     The patient's past medical history included Hematuria.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced IGA NEPHROPATHY (Active IgA nephropathy) (seriousness criterion medically significant) and HAEMATURIA (Gross hematuria). At the time of the report, IGA NEPHROPATHY (Active IgA nephropathy) outcome was unknown and HAEMATURIA (Gross hematuria) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy kidney: abnormal (abnormal) IgA nephropathy. Among 25 glomeruli sampled, 1 was globally sclerotic. there was mild to moderate, diffuse and global, mesangial hyper cellularity. two glomeruli had segmental endocapillary hyper cellularity including infiltrating monocytes and neutrophils. one glomerulus with an incipient segmental scar contained an overlying segmental fibrous crescent. mild tubular atrophy and interstitial fibrosis involved approximately 10% of the cortex.. In 2021, Blood creatinine: 1.2 (High) 1.2 mg/dl. In 2021, Glomerular filtration rate: abnormal (abnormal) 87 ml/min per 1.73 m2. In 2021, IgA nephropathy: abnormal (abnormal) M1E1S1T0C0. In 2021, Immunology test: positive (Positive) 1 to 2+ granular global mesangial staining for IgA, C3, kappa and lambda. In 2021, Urine analysis: abnormal (abnormal) numerous red blood cells and no proteinuria.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered IGA NEPHROPATHY (Active IgA nephropathy) and HAEMATURIA (Gross hematuria) to be possibly related.    No concomitant medications were reported. No treatment information was provided. 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.   This case was linked to MOD-2021-249638, MOD-2021-249637 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included a full text article received.; Sender'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: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: given an expired DAPTACEL, no AE; Initial information received on 01-Jul-2021 regarding an unsolicited valid  non-serious case from a other health professional and physician via Media Information  (under reference).  This case involves a 4-years-old male patient who was vaccinated with an expired dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  Concomitant medications included MEASLES VACCINE;MUMPS VACCINE;RUBELLA VACCINE;VARICELLA ZOSTER VACCINE (lot number and expiry date not reported) via an unknown route in an unknown site of administration for prophylactic vaccination.  On 24-Jun-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (total, lot number : C5624AA and expiry date 10-Jul-2021) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (expired product administered; latency: same day). Also reported that personal assistant (PA) spoke with the mom of a child who was given DAPTACEL. PA called to confirm if child should be revaccinated.  At the time of reporting, no adverse event was 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: 1.17
Sex: F
Vaccine: DTAPIPV, MMR, PNC, UNK, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received Quadracel instead of Pentacel, no AE; Initial information received on 02-Jul-2021 regarding an unsolicited valid  non-serious case from a consumer/non-healthcare professional.  This case involves a 1-years-old female patient who was vaccinated with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE), PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) (lot number and expiration date not reported) via unknown route and site of administration for prophylactic vaccination.  On 09-Jun-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number : C5778BA and expiry date : 07-Oct-2022) via an intramuscular route in the left vastus lateralis for prophylactic vaccination.  It was an actual medication error case due to wrong vaccine administered (wrong product administered, latency: same day).  At the time of reporting, no adverse event was 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: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Confusional state, Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Chills-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Additional Details: The patient felt dizzy about 3 minutes after receiving vaccine (after walking and sitting in observation area). Pharmacist ran out and caught patient as he lost consciousness and the patient was not injured. Patient regained consciousness after ~10 seconds. Pharmacist and Technician helped patient to lay on the floor and elevated feet. Vitals taken every 5 minutes. Lowest BP reading was 98/60. Patient offered water and drank some. Patient laid down for ~25 minutes, BP came up to 116/84.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient recovered pretty quickly. Original BP 159/90 HR 71 and 2nd reading 160/89 HR 65. Patient was also anxious will recheck once she gets homoe.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Mouth swelling, Ocular hyperaemia, Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: patient reported redness in her eyes, and went to urgent care and noted inflammation and prescribed steriod eye drop for redness which helped with redness.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Hypoaesthesia, Injection site pain, Injection site swelling, Joint range of motion decreased
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: patient stated he is experiencing severe arm pain from the moment he received the vaccine til now. recieved on 05/03/21. stated he has limited arm movement but has not been seen by a doctor. Recommdened on the call today to go follow up with md and see if its nerve pain/damage. I stated to patient it could also be a clot that is causing pain so need to follow up with MD. Pt acknowledged and and will make an appt asap. I told patient I am starting a safety report and we will followup soon.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: patient stated he is experiencing severe arm pain from the moment he received the vaccine til now. recieved on 05/03/21. stated he has limited arm movement but has not been seen by a doctor. Recommdened on the call today to go follow up with md and see if its nerve pain/damage. I stated to patient it could also be a clot that is causing pain so need to follow up with MD. Pt acknowledged and and will make an appt asap. I told patient I am starting a safety report and we will followup soon.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Muscular weakness, Neck pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: patient stated he is experiencing severe arm pain from the moment he received the vaccine til now. recieved on 05/03/21. stated he has limited arm movement but has not been seen by a doctor. Recommdened on the call today to go follow up with md and see if its nerve pain/damage. I stated to patient it could also be a clot that is causing pain so need to follow up with MD. Pt acknowledged and and will make an appt asap. I told patient I am starting a safety report and we will followup soon.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Facial discomfort, Hypoaesthesia oral, Muscle twitching, Paraesthesia oral, Pharyngeal hypoaesthesia
Clinical narrative: Following administration of Pfizer Covid vaccine, dose #1, pt. experienced hive-like rash with significant shaking. Symptoms began within 5 min of admin. Breath sounds clear and equal bialt. B/P-170/92, P-124, R-18, SaO2-99%. c/o tingling and numbness on lips, progressing to tongue and back of throat. Patient transported to ED, where she was noted to have twitching of her right leg, perioral numbness, and a change in sensation of her face, as well as a urticarial rash to bilateral upper back and shoulders. Patient received 50mg PO benadryl and 20mg PO famotidine. She was observed for ~90 minutes and discharged with a prescription for an epi-pen and a referral to an allergist. She was instructed not to get the 2nd dose of vaccine until approved by her PCP or allergist.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal paraesthesia, Rash, Tremor, Urticaria
Clinical narrative: Following administration of Pfizer Covid vaccine, dose #1, pt. experienced hive-like rash with significant shaking. Symptoms began within 5 min of admin. Breath sounds clear and equal bialt. B/P-170/92, P-124, R-18, SaO2-99%. c/o tingling and numbness on lips, progressing to tongue and back of throat. Patient transported to ED, where she was noted to have twitching of her right leg, perioral numbness, and a change in sensation of her face, as well as a urticarial rash to bilateral upper back and shoulders. Patient received 50mg PO benadryl and 20mg PO famotidine. She was observed for ~90 minutes and discharged with a prescription for an epi-pen and a referral to an allergist. She was instructed not to get the 2nd dose of vaccine until approved by her PCP or allergist.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Dizziness, Fall, Flushing
Clinical narrative: Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Systemic: Shakiness-Mild, Additional Details: He felt lightheaded, tried to stand up and get the pharmacy staff's attention, then fell. He said he doesnt remember the fall. The pharmacy staff helped him to sit up and he asked for water. He felt sweaty and clammy, asked the pharmacist to hold his hands. The LVN came over to check on him and started taking his BP, he then felt nauseated and threw up. The pharmacy called 911, the EMT came and every thing checked out normal. The LVN called his family and he is resting in the LVN's room.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypertension, Nausea, Tremor, Vomiting
Clinical narrative: Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Systemic: Shakiness-Mild, Additional Details: He felt lightheaded, tried to stand up and get the pharmacy staff's attention, then fell. He said he doesnt remember the fall. The pharmacy staff helped him to sit up and he asked for water. He felt sweaty and clammy, asked the pharmacist to hold his hands. The LVN came over to check on him and started taking his BP, he then felt nauseated and threw up. The pharmacy called 911, the EMT came and every thing checked out normal. The LVN called his family and he is resting in the LVN's room.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Constant hissing in ears.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, RV1
Symptoms: Vaccination error
Clinical narrative: No adverse event. the patient was given the vaccines in error. Call mom states that the patient was okay
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Diarrhoea, Injection site erythema, Injection site pain, Nausea
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Patient had a big red circle down her arm, not where we injected her vaccine. It itched and burned. Patient had diarrhea and nausea and also had blisters in her mouth
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal blistering, Pruritus
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Patient had a big red circle down her arm, not where we injected her vaccine. It itched and burned. Patient had diarrhea and nausea and also had blisters in her mouth
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Flushing, Hyperhidrosis, Hypoaesthesia, Nervousness
Clinical narrative: Systemic: Chills-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient visibly nervous about getting vaccine. No issue at time of injection. After about 3 minutes developed sweats (patient attributes potentially to nervousness) and tingling/numbness in extremities. Assessment of patient did not warrant epinephrine administration or contact EMS. Advised patient may take benadryl/acetaminophen. Contact MD if symptoms are not resolving.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Tremor
Clinical narrative: Systemic: Chills-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient visibly nervous about getting vaccine. No issue at time of injection. After about 3 minutes developed sweats (patient attributes potentially to nervousness) and tingling/numbness in extremities. Assessment of patient did not warrant epinephrine administration or contact EMS. Advised patient may take benadryl/acetaminophen. Contact MD if symptoms are not resolving.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient had injection, appeared fine, moved to additional seating area and within 2 minutes had fainted. She regained conciousness immediately but we had her lay flat for approx 30 minutes. Her color returned, and she was talking and recovered. We told patient to report to MD her reaction and obtained pcp info to report as well. Parents advised if any additional interactions to take in to be seen.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pruritus
Clinical narrative: Systemic: Allergic: Itch Generalized-Medium, Additional Details: Pt reports 'itching all over and difficult to work'. I suggested Benadryl but pt at work and makes her drowsy. No swelling or any other issues per pt.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness, Disturbance in attention, Ear discomfort, Head discomfort
Clinical narrative: Within 24 hours of getting the first vaccine dose, my ears starting ringing and a feeling of pressure increased in my head/ears to an uncomfortable amount and made it hard to concentrate and to hear.  The effect is similar to being underwater - pressure filled head and muffled hearing.  The ringing continued for about 48 hours.  The pressure effect in my ears and head continued for several days.  It has come and gone over the last several months, lasting a few days at a time then waning for a few days before coming back and sometimes comes with mild pain in ears.  I thought it was possibly a new reaction to seasonal allergies that I just have never have experienced and started taking decongestant.  It gave a little relief however inconsistently.  I asked my primary care doctor at my annual appointment about it and she referred me to an ENT. Completed a physical exam and his office completed an audiology and pressure test.  Pressure in the ears was normal, however the audiology test showed hearing loss in my right ear.  Said that sudden hearing loss was likely due to a virus and pressure feeling came along with hearing loss.  The ear pain may be related to teeth grinding.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: Within 24 hours of getting the first vaccine dose, my ears starting ringing and a feeling of pressure increased in my head/ears to an uncomfortable amount and made it hard to concentrate and to hear.  The effect is similar to being underwater - pressure filled head and muffled hearing.  The ringing continued for about 48 hours.  The pressure effect in my ears and head continued for several days.  It has come and gone over the last several months, lasting a few days at a time then waning for a few days before coming back and sometimes comes with mild pain in ears.  I thought it was possibly a new reaction to seasonal allergies that I just have never have experienced and started taking decongestant.  It gave a little relief however inconsistently.  I asked my primary care doctor at my annual appointment about it and she referred me to an ENT. Completed a physical exam and his office completed an audiology and pressure test.  Pressure in the ears was normal, however the audiology test showed hearing loss in my right ear.  Said that sudden hearing loss was likely due to a virus and pressure feeling came along with hearing loss.  The ear pain may be related to teeth grinding.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Eye swelling, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Mild
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Nausea, Pruritus, Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Mild
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Mild
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Anti-thyroid antibody, Anti-thyroid antibody negative, Blood thyroid stimulating hormone, Hypothyroidism, Thyroxine decreased
Clinical narrative: patient presented with profound hypothyroidism within weeks of second COVID vaccine
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Thyroxine free decreased, Tri-iodothyronine normal
Clinical narrative: patient presented with profound hypothyroidism within weeks of second COVID vaccine
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Musculoskeletal stiffness
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: patient stated stiffness and pain in the arm, saw md who stated monitor and that will go away over time.  I recommended Ibuprofen for a few days and follow back up with md if not improving over time.  as of June 19, 2021 there was still stiffness but was getting better
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Mild, Additional Details: Patient reported to RPH on duty on 6/28/2021 that there was a small bump and severe pain at injection.  Rph on duty recommended tylenol and compresses and to see MD or hospital if worsening.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Electrocardiogram normal, Fatigue, Pain
Clinical narrative: Arm soreness only for 36 hours.  Occasional heart palpitations noticed approximately three weeks laters.  Second dose 6/15/2021.  Arm soreness and mild fever, aches, fatigue for 48 hours.  Occasional palpitations continued.  ER for treatment. Diagnosis: sinus arrhythmia with occasional premature ventricular complexes.   Patient had normal ECG pre-vaccine (5/5/2021) based on annual wellness exam.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations, Pyrexia, Sinus arrhythmia
Clinical narrative: Arm soreness only for 36 hours.  Occasional heart palpitations noticed approximately three weeks laters.  Second dose 6/15/2021.  Arm soreness and mild fever, aches, fatigue for 48 hours.  Occasional palpitations continued.  ER for treatment. Diagnosis: sinus arrhythmia with occasional premature ventricular complexes.   Patient had normal ECG pre-vaccine (5/5/2021) based on annual wellness exam.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Exophthalmos, Exostosis, Fatigue, Headache, Peripheral swelling
Clinical narrative: fatique, headaches (still have them. They go from one side of head to the other), swollen hands (continuing issue), bone spur on foot (7/10/21), sores in mouth (June 2021), bulging left eye ( June 2021). None of these issues have been resolved. Something new every week. Body's immune system is under attack. I  had none of these issues prior to the 2nd vaccination. The first vaccination I got severe covid arm.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Stomatitis
Clinical narrative: fatique, headaches (still have them. They go from one side of head to the other), swollen hands (continuing issue), bone spur on foot (7/10/21), sores in mouth (June 2021), bulging left eye ( June 2021). None of these issues have been resolved. Something new every week. Body's immune system is under attack. I  had none of these issues prior to the 2nd vaccination. The first vaccination I got severe covid arm.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Impaired work ability
Clinical narrative: Night after the shot, I had an extremely bad headache. The following day the headache persisted until 5 PM. I also was fatigued and unable to do any work due to headache. Five days later, on May 11 I had similar symptoms, So I left work.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy that lasted for 28 hours
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Pt admitted to the hospital for COVID 19 post vaccination.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Paraesthesia oral, Secretion discharge, Tongue disorder
Clinical narrative: Reported tingling lips after dose #2 as well as a "thick tongue" and mucous.  Patient reported use of epi-pen and tingling lips with vaccine #1.  Provider contacted.  BP 179/103, HR 73.  Instructed to give Benadryl 25 mg PO and repeat the dose when got home.   Lips and tongue felt better after benadryl.   Received Epi after 1st shot of Covid Vaccine. This was #2.  Note states had an epi-pen for dose #1 and tingling lips. Do not see documented with past immunization.   Upon release:  Elevated BP - instructed patient to contact PCP.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Very loud ringing in the ears
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Admitted to the hospital with covid 19 after vaccination.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Lymphadenopathy
Clinical narrative: After 6 days: armpit lymphadenopath  After 8 days:   skin rash on the arm where intramuscular injection was done
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Autopsy, Connective tissue disorder, Death, Disseminated intravascular coagulation, Haemorrhagic disorder
Clinical narrative: Found unresponsive on the floor of her residence; DOA in the ER
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Histology, Myocarditis, SARS-CoV-2 test negative, Systemic inflammatory response syndrome, Toxicologic test
Clinical narrative: Found unresponsive on the floor of her residence; DOA in the ER
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Found unresponsive on the floor of her residence; DOA in the ER
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Feeling abnormal, Lethargy, Pain
Clinical narrative: Body aches, feeling lousy, sore shoulder, very lethargic
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-neutrophil cytoplasmic antibody positive vasculitis, Chest pain, Dyspnoea, Laboratory test, Pyrexia
Clinical narrative: tachycardia,sob, cp,  fevers, SIRS, elevated troponin anca vasculitis
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Systemic inflammatory response syndrome, Tachycardia, Troponin increased
Clinical narrative: tachycardia,sob, cp,  fevers, SIRS, elevated troponin anca vasculitis
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pruritus, Sunburn
Clinical narrative: After an hour or so of my shot the left side of my face felt numb and was itchy.  To explain the numbness it was like what your face feels like after getting your mouth numb to have dental work done.   It lasted all day.  The numbness has went away but still doesn't feel right.  3 days after my shot i got a severe sunburn on the arm I received my shot.  I don't normally sunburn and I was under a tent most of the day.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling of right side arm, hand, leg, foot
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Breast mass, Echocardiogram, Electrocardiogram ambulatory, Fatigue
Clinical narrative: Fatigue, swollen glands, body pain, heart palpitations, lump in breast (gland)
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Mammogram, Pain, Palpitations
Clinical narrative: Fatigue, swollen glands, body pain, heart palpitations, lump in breast (gland)
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Pain
Clinical narrative: Severe pain in my left shoulder that continues one month after second vaccine dose. Constant pain of around 5 - 6 (1 - 10 pain scale) and pain level of 8-9 when moving arm/doing PT exercises. Pain medication and OTC drugs (ibuprofen. Tylenol)  have no affect on pain level
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Vaginal haemorrhage
Clinical narrative: Spotting and blood signs under skin
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiomegaly, Cerebrovascular accident, Gastrointestinal disorder, Hepatomegaly, Seizure
Clinical narrative: Patient stated that about 5 days after receiving 2nd dose she had a mild stroke, she was having seizures, she was a ventilator at the hospital when she was taken, 2 blood transfusion, large intestine enlarged, heart is enlarged , liver is enlarged,. Patient stated that she is still having seizures
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Ultrasound scan normal, Urticaria
Clinical narrative: Walking out of the clinic after 15 minutes of observation, noted sharp stabbing pain in left calf/thigh.  Returned to the vaccine clinic and observed breaking out in hives.  EMS as called.  Given epinephrine and benadryl.  Transferred to the ED.  Upon exam, hives were improved.  Remained in the ED for a few hours for observation.  Vital signs were stable.  Ultrasound was done to rule out DVT.  DVT was negative.  Discharged home.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site urticaria
Clinical narrative: Left deltoid, 1.5cm wheal at injection site. No itching or pain. No fever or warmth at area of injection.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Hypoaesthesia, Peripheral swelling
Clinical narrative: Feet and calf swelling.  nerves on top of feet burn and numb.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Eye swelling, Ocular discomfort, Ophthalmological examination abnormal, Subretinal fluid
Clinical narrative: three days post injections, visual changes in left eye inability to see and feeling of pressure behind eye. As time progressed vision became worse and worse. On Saturday after injection went to eye dr
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate increased, Hypotension, Pyrexia
Clinical narrative: Patient reported that his heart rate has increased to 150 pm since the shot, also had shaking chills and 103 fever, severe headache for 3 days
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Insomnia, Myalgia, Pain in extremity, Sleep disorder
Clinical narrative: Shoulder pain. Mid bicep pain. Pain in elbow and forearm, from time to time. Mostly daily shoulder pain. I have trouble sleeping because the left arm has on one comfortable position, and when I sleep, I move it and the pain wakes me up all night. It's been about 10 weeks and is still very painful. I wear a sling on the days that it hurts the most. The shoulder is the worst area of pain. It hurts sometimes front to back, and sometimes on the top of the shoulder. It hurts most days, but sometimes the pain goes away completely for a few hours. It always hurts when I get up in the morning, but calms down after awhile.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Angiogram, Chills, Computerised tomogram head, Cough, Ear pain
Clinical narrative: Subjective fever, chills, headache for several days after Shingrix dose #2 on 6/10/2021. After this resolved, he developed cold-like symptoms which included a cough and headache. Around 6/29/2021 he noticed the headache was persistent. On 7/5/2021, he noticed his headache lateralized to the right side, and new onset pressure behind his right eye, sharp pain just inferior to his right ear. On 7/7/2021 he presented with symptoms consistent with Bell's Palsy.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Full blood count, Headache, Metabolic function test, Ocular discomfort, Pyrexia
Clinical narrative: Subjective fever, chills, headache for several days after Shingrix dose #2 on 6/10/2021. After this resolved, he developed cold-like symptoms which included a cough and headache. Around 6/29/2021 he noticed the headache was persistent. On 7/5/2021, he noticed his headache lateralized to the right side, and new onset pressure behind his right eye, sharp pain just inferior to his right ear. On 7/7/2021 he presented with symptoms consistent with Bell's Palsy.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Chest pain, Dyspnoea, Electrocardiogram
Clinical narrative: Patient reported chest pain and shortness of breath 2-3 days following her vaccination. She did not present until one month later.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness unilateral, Cerebrovascular accident, Computerised tomogram head abnormal, Surgery, Visual impairment
Clinical narrative: frontal CVA with right eye vision loss, monocular vision loss
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Malaise, Myalgia, Nausea
Clinical narrative: nausea lack of appetite fever comes and goes coughing muscle aches "not feeling well"
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: nausea lack of appetite fever comes and goes coughing muscle aches "not feeling well"
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Loss of consciousness
Clinical narrative: 2 minutes after injection - patient passed out. Woke and alert yet clammy.  BP 77/29; HR 53;. 6 minutes after injection BP 81/40, HR 66.  Layed on litter.  At 8 minutes BP 75/5, HR 70.   Repeated BP 104/80.  BP laying down 108/33.  Sitting up 98/48.  Observed for 40 minutes. BP siting 116/35, HR 69.  BP Standing 105/43, HR 88.  Patient felt better and okay to leave with son.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Post-acute COVID-19 syndrome
Clinical narrative: Covid Arm.  Injection site is Red, fever, sore, swollen, itchy.  Started about 1 week 1 day after vaccination.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Covid Arm.  Injection site is Red, fever, sore, swollen, itchy.  Started about 1 week 1 day after vaccination.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Headache, body aches, fever, fatigue, joint pain.  Resolved in 24/36 hours
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Pneumonia, Pyelonephritis, SARS-CoV-2 test negative, Sepsis
Clinical narrative: Patient admitted for sepsis/pyelonephritis/pneumonia/hypoxemia. COVID 19 negative.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient had no known adverse effects after injection. Patient was underage but authorization from legal guardian was granted.