chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Illness, Nausea, Pyrexia
Clinical narrative: feeling really sick; a headache Today; she had a fever of 101.2/feel a little warm; faint; nauseous; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (faint) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    On 19-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In November 2023, the patient experienced NAUSEA (nauseous). On 19-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced SYNCOPE (faint) (seriousness criterion medically significant) and PYREXIA (she had a fever of 101.2/feel a little warm). On 20-Nov-2023, the patient experienced HEADACHE (a headache Today). On an unknown date, the patient experienced ILLNESS (feeling really sick). At the time of the report, SYNCOPE (faint), PYREXIA (she had a fever of 101.2/feel a little warm), HEADACHE (a headache Today) and NAUSEA (nauseous) had not resolved and ILLNESS (feeling really sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Nov-2023, Body temperature: 101.2.         The patient stated that she's had prior Moderna vaccines. The concomitant medication was not reported by reporter. It was reported that it was her 4th or 5th dose but didn't have the LOT numbers. The treatment medication was not reported by reporter.  Company comment:  This is a spontaneous case concerning a 70-year-old, female patient with no reported medical history, who experienced the unexpected serious (medically significant) event of syncope among other non-serious events one day after the administration of SPIKEVAX 2023-2024 vaccine, used as a fourth or fifth dose. The patient had pyrexia, felt sick and faint the next day of vaccination. No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of SPIKEVAX 2023-2024 Vaccine is not affected by this report.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: feeling really sick; a headache Today; she had a fever of 101.2/feel a little warm; faint; nauseous; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (faint) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    On 19-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In November 2023, the patient experienced NAUSEA (nauseous). On 19-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced SYNCOPE (faint) (seriousness criterion medically significant) and PYREXIA (she had a fever of 101.2/feel a little warm). On 20-Nov-2023, the patient experienced HEADACHE (a headache Today). On an unknown date, the patient experienced ILLNESS (feeling really sick). At the time of the report, SYNCOPE (faint), PYREXIA (she had a fever of 101.2/feel a little warm), HEADACHE (a headache Today) and NAUSEA (nauseous) had not resolved and ILLNESS (feeling really sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Nov-2023, Body temperature: 101.2.         The patient stated that she's had prior Moderna vaccines. The concomitant medication was not reported by reporter. It was reported that it was her 4th or 5th dose but didn't have the LOT numbers. The treatment medication was not reported by reporter.  Company comment:  This is a spontaneous case concerning a 70-year-old, female patient with no reported medical history, who experienced the unexpected serious (medically significant) event of syncope among other non-serious events one day after the administration of SPIKEVAX 2023-2024 vaccine, used as a fourth or fifth dose. The patient had pyrexia, felt sick and faint the next day of vaccination. No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of SPIKEVAX 2023-2024 Vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Blister, COVID-19, Herpes zoster, Stevens-Johnson syndrome
Clinical narrative: COVID-19; Steven Johnson syndrome; Bells Palsy; Shingles; Unsightly blisters all over her body; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), STEVENS-JOHNSON SYNDROME (Steven Johnson syndrome) and BELL'S PALSY (Bells Palsy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization), STEVENS-JOHNSON SYNDROME (Steven Johnson syndrome) (seriousness criterion medically significant), BELL'S PALSY (Bells Palsy) (seriousness criterion medically significant), HERPES ZOSTER (Shingles) and BLISTER (Unsightly blisters all over her body). The patient was treated with CEFALEXIN at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19), STEVENS-JOHNSON SYNDROME (Steven Johnson syndrome), BELL'S PALSY (Bells Palsy), HERPES ZOSTER (Shingles) and BLISTER (Unsightly blisters all over her body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The patient became deathly sick in ICU.  The Moderna flu shot scarred her skin for life.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a female patient of unknown age, with no medical history reported, who experienced the unexpected and serious (due to medically significant) AESI of Stevens-Johnson syndrome, the expected and serious (due to medically significant) AESI of Bell´s palsy, and the unexpected and serious (due to hospitalization) event of COVID-19, which occurred after an unspecified dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. As reported, the patient experienced Bell's Palsy and shingles with every shot. She was also deathly sick in ICU with COVID, and treated with cephalexin. She had Steven Johnson syndrome, and unsightly blisters all over her body, every time she was stressed out.  No information disclosed about diagnostic tests performed. At the time of the report, the events had not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-750558, US-MODERNATX, INC.-MOD-2023-750562 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750558:Same Reporter Different Patient US-MODERNATX, INC.-MOD-2023-750562:Same Reporter Patient
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Rash, Tenderness
Clinical narrative: tenderness below the injection site; She stated she had an increase heart rate for probably 24 hours; She stated she has a small rash; This spontaneous case was reported by a patient and describes the occurrence of TENDERNESS (tenderness below the injection site), HEART RATE INCREASED (She stated she had an increase heart rate for probably 24 hours) and RASH (She stated she has a small rash) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Patient did not report any medical history or condition and also did not report any information about previous COVID-19 vaccination doses.     On 20-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In November 2023, the patient experienced TENDERNESS (tenderness below the injection site), HEART RATE INCREASED (She stated she had an increase heart rate for probably 24 hours) and RASH (She stated she has a small rash). At the time of the report, TENDERNESS (tenderness below the injection site), HEART RATE INCREASED (She stated she had an increase heart rate for probably 24 hours) and RASH (She stated she has a small rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: Increased.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was reported that patient had a small rash, tenderness below the injection site. She stated she had an increase heart rate for probably 24 hours. No treatment information was provided.   Reporter did not allow further contact
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphonia, Fatigue, Myalgia, Upper-airway cough syndrome
Clinical narrative: fatigue; muscle soreness; postnasal drip; hoarseness; This spontaneous case was reported by a consumer and describes the occurrence of UPPER-AIRWAY COUGH SYNDROME (postnasal drip), DYSPHONIA (hoarseness), FATIGUE (fatigue) and MYALGIA (muscle soreness) in a 60-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 301280) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 21-Nov-2023, the patient experienced UPPER-AIRWAY COUGH SYNDROME (postnasal drip) and DYSPHONIA (hoarseness). On 22-Nov-2023, the patient experienced FATIGUE (fatigue) and MYALGIA (muscle soreness). At the time of the report, UPPER-AIRWAY COUGH SYNDROME (postnasal drip), DYSPHONIA (hoarseness), FATIGUE (fatigue) and MYALGIA (muscle soreness) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   Patient had fine day of injection and day after. Postnasal drip and hoarseness the second day after. Fatigue and muscle soreness the third day after. It was unknown if the patient experienced any additional symptoms/events.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Thyroid function test, Thyroid function test abnormal
Clinical narrative: suddenly my blood glucose levels spiked really high; slight change in my thyroid levels; This spontaneous case was reported by a patient and describes the occurrence of BLOOD GLUCOSE INCREASED (suddenly my blood glucose levels spiked really high) and THYROID FUNCTION TEST ABNORMAL (slight change in my thyroid levels) in a 65-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetic.    On 02-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 15-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced BLOOD GLUCOSE INCREASED (suddenly my blood glucose levels spiked really high). In November 2023, the patient experienced THYROID FUNCTION TEST ABNORMAL (slight change in my thyroid levels). The patient was treated with INSULIN for Blood glucose increased, at a dose of Long Acting Insulin; INSULIN for Blood glucose increased, at a dose of Insulin pen weekly and INSULIN for Blood glucose increased, at a dose of Fast Acting Insulin,. At the time of the report, BLOOD GLUCOSE INCREASED (suddenly my blood glucose levels spiked really high) had not resolved and THYROID FUNCTION TEST ABNORMAL (slight change in my thyroid levels) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2023, Blood glucose: 340, 423. On 15-Nov-2023, Blood glucose 531, 480, 450, 389 and 529. In November 2023, Thyroid function test: slight change in my thyroid levels.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. The patient received all the Covid-19 vaccinations, never had any issues before. Two weeks after getting recent Covid-19 Moderna vaccine, suddenly her blood glucose levels spiked really high. Normally with insulin it never got above 135. Doctor added a third type of insulin (fast acting insulin) to her medications on 22-Nov-23. Doctor ran all types of test on her, only thing showing was a slight change in her thyroid levels. No changes in diet or prescription medications. The patient was taking Fast Acting Insulin, Long Acting Insulin and a Insulin pen weekly, and levels were still high.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: between legs skin to red points and itchy skin; between legs skin to red points and itchy skin; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (between legs skin to red points and itchy skin) and ERYTHEMA (between legs skin to red points and itchy skin) in a 58-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 80777-0102-96) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 01-Nov-2023, the patient experienced PRURITUS (between legs skin to red points and itchy skin) and ERYTHEMA (between legs skin to red points and itchy skin). At the time of the report, PRURITUS (between legs skin to red points and itchy skin) and ERYTHEMA (between legs skin to red points and itchy skin) had not resolved.            Concomitant medication and treatment information were not reported.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient somehow accidentally received another dose of Fluzone High-Dose Quadrivalent two weeks apart with no adverse event; Initial information received on 16-Nov-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2023SA362073 (CLUSTER) Wife case.  This case involves a 71 years old male patient somehow accidentally received another dose of influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] two weeks apart with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for Immunisation.  On 01-Nov-2023, the patient received unknown dose (dose 1) of suspect influenza quadrival A-B high dose HV vaccine (lot number, strength, formulation and expiry date not reported) via unknown route in unknown administration site and on 15-Nov-2023 patient somehow accidentally received another dose 0.7 ml  (Dose 2) of the same vaccine  (lot UT8111DA; Expiration Date : 30-JUN-2024; strength and formulation not reported) via intramuscular route in the left deltoid for Immunization two weeks apart with no adverse event (inappropriate schedule of product administration) (latency: on same day) following the last dose.  Action taken: not applicable.  Outcome: Unknown.   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: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: hives; Initial information received on 17-Nov-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 71-year-old male patient who had hives after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza quadrival A-B high dose HV vaccine (strength, form, lot number, expiry date; unknown) via unknown route in unknown administration site for immunization. Information on batch number was requested.  On an unknown date the patient had an event of hives (urticaria) (unknown latency) following the administration of influenza quadrival A-B high dose HV vaccine.  It was unknown if any lab data/test results available.  Action taken with quadrivalent influenza vaccine (Fluzone High-Dose Quadrivalent) was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Medical Assistant recosntituted ACTHIB with sterile water instead of its diluent with no reported adverse event; Initial information was received on 17-Nov-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 2 years old male patient who experienced medical assistant recosntituted HIB (PRP/T) VACCINE [ACT-HIB] with sterile water instead of its diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Nov-2023, the patient received 0.5 ml of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (lot UJ834AA and expiry 23-Feb-24) medical assistant recosntituted acthib with sterile water instead of its diluent with no reported adverse event (product preparation error) via intramuscular route in unknown administration site for prophylactic vaccination (Immunization).  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 and Regulatory Authority 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: 17.0
Sex: F
Vaccine: HPVX, MEN
Symptoms: Body temperature increased, Malaise
Clinical narrative: feeling unwell; had a temperature of 102 degrees; Initial information received on 20-Nov-2023 regarding an unsolicited valid non-serious courtesy case received from partner Novartis via other health professional.  This case involves a 17 years old female patient who experienced feeling unwell and had a temperature of 102 degrees after receiving vaccines HPV VACCINE and MENINGOCOCCAL VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect MENINGOCOCCAL VACCINE produced by unknown manufacturer and HPV VACCINE not produced by Sanofi Pasteur (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization).  On an unknown date the patient was feeling unwell (malaise) and had a temperature of 102 degrees (pyrexia) (unknown latency) following the administration of MENINGOCOCCAL VACCINE and HPV VACCINE.  Relevant laboratory test results included: Body temperature - On an unknown date: 102 Celsius.  Action taken: Not applicable for both the suspects.  It was not reported if the patient received a corrective treatment for both the events.   At time of reporting, the outcome was Unknown for both the events.
Age: 56.0
Sex: F
Vaccine: FLUC3
Symptoms: Contusion, Injection site erythema, Injection site haemorrhage, Injection site swelling, Injection site vesicles
Clinical narrative: Blister/ clear fluid, large, tree centimetre, bullous lesion; Petechial skin lesions in that area; Warmth; Swelling; Redness; Bruising; Pain in the arm; This spontaneous case was received on 14-NOV-2023 from a physician (reference number: SEQW23-04269) and concerned a 56-year-old female patient.  The patient's concurrent conditions included Levaquin (levofloxacin) allergy. The patient's concomitant medications were not reported.  On 10-NOV-2023 the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular, dose and anatomical location: not reported) for prevention of influenza disease. The batch number reported was 370664.  On the same date, after receiving Flucelvax Quadrivalent, the patient developed bruising.  On 11-Nov-2023, one day after receiving Flucelvax Quadrivalent, the patient started experiencing petechial skin lesion in that area, redness, warmth, and swelling. The patient also developed a blister.   On an unspecified date in Nov-2023, the patient developed bullous lesion in the same area. There were no other systematic symptoms just the pain in the arm.   On 14-Nov-2023, the patient continues to have clear fluid, large, tree centimetre, bullous lesion. The patient has been applying Mycin (rifampicin) and took Advil (mefenamic acid) on her own. There was no fever, no chills.   At the time of initial reporting, on 14-Nov-2023, the patient had not recovered from the event of 'bullae'. The reporter's plan was to take any histamine, to give her topical steroid and to continue with non-steroidal.   The outcome of the events of redness, swelling, bruising, pain in arm, 'skin warm', and 'petechial rash' was not reported.     The reporter assessed the events as related to Flucelvax Quadrivalent. The reporter stated that it seems to be attributable to the vaccine.  The case was assessed as non-serious.  Company comment: On the same date, after receiving Flucelvax Quadrivalent, the patient developed bruising. The next day, the patient started experiencing petechial skin lesion in that area, redness, warmth, swelling, blister and pain in the arm. On 14-Nov-2023, the patient continues to have clear fluid, large, tree centimetre, bullous lesion. Based on anatomical and chronological plausibility, causal role of Flucelvax Quadrivalent is assessed as possibly related for all events.; Reporter's Comments: The reporter stated that it seems to be attributable to the vaccine.; Sender's Comments: On the same date, after receiving Flucelvax Quadrivalent, the patient developed bruising. The next day, the patient started experiencing petechial skin lesion in that area, redness, warmth, swelling, blister and pain in the arm. On 14-Nov-2023, the patient continues to have clear fluid, large, tree centimetre, bullous lesion. Based on anatomical and chronological plausibility, causal role of Flucelvax Quadrivalent is assessed as possibly related for all events.
Age: 56.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: Blister/ clear fluid, large, tree centimetre, bullous lesion; Petechial skin lesions in that area; Warmth; Swelling; Redness; Bruising; Pain in the arm; This spontaneous case was received on 14-NOV-2023 from a physician (reference number: SEQW23-04269) and concerned a 56-year-old female patient.  The patient's concurrent conditions included Levaquin (levofloxacin) allergy. The patient's concomitant medications were not reported.  On 10-NOV-2023 the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular, dose and anatomical location: not reported) for prevention of influenza disease. The batch number reported was 370664.  On the same date, after receiving Flucelvax Quadrivalent, the patient developed bruising.  On 11-Nov-2023, one day after receiving Flucelvax Quadrivalent, the patient started experiencing petechial skin lesion in that area, redness, warmth, and swelling. The patient also developed a blister.   On an unspecified date in Nov-2023, the patient developed bullous lesion in the same area. There were no other systematic symptoms just the pain in the arm.   On 14-Nov-2023, the patient continues to have clear fluid, large, tree centimetre, bullous lesion. The patient has been applying Mycin (rifampicin) and took Advil (mefenamic acid) on her own. There was no fever, no chills.   At the time of initial reporting, on 14-Nov-2023, the patient had not recovered from the event of 'bullae'. The reporter's plan was to take any histamine, to give her topical steroid and to continue with non-steroidal.   The outcome of the events of redness, swelling, bruising, pain in arm, 'skin warm', and 'petechial rash' was not reported.     The reporter assessed the events as related to Flucelvax Quadrivalent. The reporter stated that it seems to be attributable to the vaccine.  The case was assessed as non-serious.  Company comment: On the same date, after receiving Flucelvax Quadrivalent, the patient developed bruising. The next day, the patient started experiencing petechial skin lesion in that area, redness, warmth, swelling, blister and pain in the arm. On 14-Nov-2023, the patient continues to have clear fluid, large, tree centimetre, bullous lesion. Based on anatomical and chronological plausibility, causal role of Flucelvax Quadrivalent is assessed as possibly related for all events.; Reporter's Comments: The reporter stated that it seems to be attributable to the vaccine.; Sender's Comments: On the same date, after receiving Flucelvax Quadrivalent, the patient developed bruising. The next day, the patient started experiencing petechial skin lesion in that area, redness, warmth, swelling, blister and pain in the arm. On 14-Nov-2023, the patient continues to have clear fluid, large, tree centimetre, bullous lesion. Based on anatomical and chronological plausibility, causal role of Flucelvax Quadrivalent is assessed as possibly related for all events.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Deep vein thrombosis, Pain in extremity, Peripheral swelling, Ultrasound Doppler abnormal
Clinical narrative: IM reported to medical with pain and swelling of left leg swelling and pain near the ankle
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Asthma, Bronchitis, COVID-19, Chronic obstructive pulmonary disease
Clinical narrative: Admission Diagnoses: Acute hypoxemic respiratory failure [J96.01]COVID [U07.1]  Discharge Diagnoses: Active Problems:   Asthma exacerbation with COPD (chronic obstructive pulmonary disease)     Acute bronchitis due to COVID-19 virus;   Hypoxemia;   Type 2 diabetes mellitus with hyperglycemia, without long-term current use of insulin;   Panlobular emphysema (*);     Overview: had asthma in her 20's   Smoker with COPD presents with dyspnea and is found to have COVID without pneumonia.  She was admitted and treated with nebs and steroids with resolution of symptoms and resolution of hypoxemia.  She was discharge to home at her request.  She was advised to stop smoking.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspnoea, Emphysema, Hyperglycaemia, Hypoxia
Clinical narrative: Admission Diagnoses: Acute hypoxemic respiratory failure [J96.01]COVID [U07.1]  Discharge Diagnoses: Active Problems:   Asthma exacerbation with COPD (chronic obstructive pulmonary disease)     Acute bronchitis due to COVID-19 virus;   Hypoxemia;   Type 2 diabetes mellitus with hyperglycemia, without long-term current use of insulin;   Panlobular emphysema (*);     Overview: had asthma in her 20's   Smoker with COPD presents with dyspnea and is found to have COVID without pneumonia.  She was admitted and treated with nebs and steroids with resolution of symptoms and resolution of hypoxemia.  She was discharge to home at her request.  She was advised to stop smoking.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tobacco user, Type 2 diabetes mellitus
Clinical narrative: Admission Diagnoses: Acute hypoxemic respiratory failure [J96.01]COVID [U07.1]  Discharge Diagnoses: Active Problems:   Asthma exacerbation with COPD (chronic obstructive pulmonary disease)     Acute bronchitis due to COVID-19 virus;   Hypoxemia;   Type 2 diabetes mellitus with hyperglycemia, without long-term current use of insulin;   Panlobular emphysema (*);     Overview: had asthma in her 20's   Smoker with COPD presents with dyspnea and is found to have COVID without pneumonia.  She was admitted and treated with nebs and steroids with resolution of symptoms and resolution of hypoxemia.  She was discharge to home at her request.  She was advised to stop smoking.
Age: 87.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Malaise
Clinical narrative: She got her vaccine, she was fine for the next day, on Friday she got up and did not feel well.  She then felt OK the rest of the day.  On Saturday when she woke up she had terrible dizziness.  This lasted until Sunday when she was a little bit better, and by Monday the dizziness was gone.  She did not take anything for her symptoms.  She did not have any other dizziness, other than the day before she did not feel well and figured it was from the vaccine.    She then read her sheet over that she had gotten and then realized the reaction was from the vaccine.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Cancer screening normal, Dyspnoea, Echocardiogram, Echocardiogram abnormal
Clinical narrative: Influenza vaccination 10/24/23 Swelling at Left upper Extremity injection site, joint pain, fever, sweats. Shortness for breath occurred beginning Wednesday 10/25/23 and became significant prompting ER visit. Presented to ER 10/30/23- clot burden of 70% occlusion R pulmonary tree, 50% occlusion left pulmonary tree. Cardiac doppler R ventricle 50% increased in size and strained. Began Heparin drip and transfer to tertiary center for thrombectomy occurring 10/30. Patient was unable to fill Eliquis due to financial burden. Required Thrombectomy second time on 11/1/23.  Lower extremity dopplers 11/1/23 negative, Doppler Left upper extremity superficial clot in cephalic vein. Patient is on Eliquis for 6 months. Additional lab screening for PSA and other cancers have been negative. Appropriate screening for cancers per patient age.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Electrocardiogram ST-T segment abnormal, Fibrin D dimer increased, Hyperhidrosis, Inability to afford medication, Injection site swelling
Clinical narrative: Influenza vaccination 10/24/23 Swelling at Left upper Extremity injection site, joint pain, fever, sweats. Shortness for breath occurred beginning Wednesday 10/25/23 and became significant prompting ER visit. Presented to ER 10/30/23- clot burden of 70% occlusion R pulmonary tree, 50% occlusion left pulmonary tree. Cardiac doppler R ventricle 50% increased in size and strained. Began Heparin drip and transfer to tertiary center for thrombectomy occurring 10/30. Patient was unable to fill Eliquis due to financial burden. Required Thrombectomy second time on 11/1/23.  Lower extremity dopplers 11/1/23 negative, Doppler Left upper extremity superficial clot in cephalic vein. Patient is on Eliquis for 6 months. Additional lab screening for PSA and other cancers have been negative. Appropriate screening for cancers per patient age.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Prostatic specific antigen normal, Pulmonary thrombosis, Pyrexia, Right ventricular dysfunction, Right ventricular enlargement
Clinical narrative: Influenza vaccination 10/24/23 Swelling at Left upper Extremity injection site, joint pain, fever, sweats. Shortness for breath occurred beginning Wednesday 10/25/23 and became significant prompting ER visit. Presented to ER 10/30/23- clot burden of 70% occlusion R pulmonary tree, 50% occlusion left pulmonary tree. Cardiac doppler R ventricle 50% increased in size and strained. Began Heparin drip and transfer to tertiary center for thrombectomy occurring 10/30. Patient was unable to fill Eliquis due to financial burden. Required Thrombectomy second time on 11/1/23.  Lower extremity dopplers 11/1/23 negative, Doppler Left upper extremity superficial clot in cephalic vein. Patient is on Eliquis for 6 months. Additional lab screening for PSA and other cancers have been negative. Appropriate screening for cancers per patient age.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Superficial vein thrombosis, Thrombectomy, Ultrasound Doppler abnormal
Clinical narrative: Influenza vaccination 10/24/23 Swelling at Left upper Extremity injection site, joint pain, fever, sweats. Shortness for breath occurred beginning Wednesday 10/25/23 and became significant prompting ER visit. Presented to ER 10/30/23- clot burden of 70% occlusion R pulmonary tree, 50% occlusion left pulmonary tree. Cardiac doppler R ventricle 50% increased in size and strained. Began Heparin drip and transfer to tertiary center for thrombectomy occurring 10/30. Patient was unable to fill Eliquis due to financial burden. Required Thrombectomy second time on 11/1/23.  Lower extremity dopplers 11/1/23 negative, Doppler Left upper extremity superficial clot in cephalic vein. Patient is on Eliquis for 6 months. Additional lab screening for PSA and other cancers have been negative. Appropriate screening for cancers per patient age.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Gastroenteritis
Clinical narrative: Indication for Admission: COVID with generalized weakness  Hospital Course: Elderly man with severe Parkinsons and debility living at home alone contracted COVID and presents with severe generalized weakness.  Admitted and developed gastroenteritis also.  Treated with supportive care and steroids and slowly but incompletely improved.  Seen by PT and OT who recommended based rehab.  Arrangements made for same to facilitate his recovery from COVID-19.  Disposition: Rehab Facility/Unit
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, COVID-19, Confusional state, Cough, Fall
Clinical narrative: Pt is an 82-year-old male with a past medical history significant for BPH, diabetes not on any medications, CKD, dementia and hypertension.  He presented to the emergency department with a chief complaint of confusion.  Wife states he has been confused the last couple days.  They thought he had a urinary tract infection so he was started on Augmentin outpatient.  He intermittently self caths secondary to BPH.  Wife states that he has been urinating and weird spots around the home and has been confused.  He also admits to falling out of bed but denies any pain.  He denies any chest pain, shortness of breath, nausea, vomiting, abdominal pain, headache, vision changes or focal weakness.  He does admit to a cough which is nonproductive.  In the emergency department patient was found to be positive for COVID.  He will be admitted for further management.  Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)   Patient was admitted to medicine.  He was observed overnight.  PT/OT were consulted - he was deemed safe for home.  For 1 night, seroquel was reduced.  Steroids were deferred as he was not hypoxic.  Altered MS resolved and he was discharged home.  Foley was removed prior to discharge.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Mental status changes, SARS-CoV-2 test positive, Urinary tract infection
Clinical narrative: Pt is an 82-year-old male with a past medical history significant for BPH, diabetes not on any medications, CKD, dementia and hypertension.  He presented to the emergency department with a chief complaint of confusion.  Wife states he has been confused the last couple days.  They thought he had a urinary tract infection so he was started on Augmentin outpatient.  He intermittently self caths secondary to BPH.  Wife states that he has been urinating and weird spots around the home and has been confused.  He also admits to falling out of bed but denies any pain.  He denies any chest pain, shortness of breath, nausea, vomiting, abdominal pain, headache, vision changes or focal weakness.  He does admit to a cough which is nonproductive.  In the emergency department patient was found to be positive for COVID.  He will be admitted for further management.  Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)   Patient was admitted to medicine.  He was observed overnight.  PT/OT were consulted - he was deemed safe for home.  For 1 night, seroquel was reduced.  Steroids were deferred as he was not hypoxic.  Altered MS resolved and he was discharged home.  Foley was removed prior to discharge.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Aspiration, Breath sounds abnormal, COVID-19, Cachexia, Cardiac failure congestive
Clinical narrative: Hospital Course: Chronically ill man living at home with frequent medical visits and prior lacunar stroke with residual right hemiparesis, fell at home sustaining right humeral and left femoral fractures and was hospitalized where he was treated for CHF, ORIF, and discharged to a local rehab.  During his hospitalization he was judged to be at risk for aspiration but refused alteration of his diet.  He now is sent to ER with confusion and round on ER evaluation to have a large new RLL pneumonia superimposed on his severe COPD from tobacco use.  Patient was treated with IV antibiotics for aspiration, did very well and was transitioned back for further rehab on oral clindamycin (he has an allergy reported to pencillins.)  He was to resume his chronic medications and his current activity restrictions as guided by orthopedics.  He was incidentally found to also have COVID PCR positive.  Discharge Exam: NAD Tolerating 2 l/min NC oxygen BP 126/64 (BP Location: Right arm, Patient Position: Lying)  | Pulse 67  | Temp 37 °C (98.6 °F) (Oral)  | Resp 17  | Ht 1.753 m (5' 9")  | Wt 55.3 kg (122 lb)  | SpO2 93%  | BMI 18.02 kg/m²  HEENT negative except cachexia  Chest notes diminished breath sounds right chest, scattered rhonchi  and rales  RRR distant heart sounds Abdomen scaphoid non tender normal bowel sounds No cyanosis No edema Incisions right arm and left leg clean and dry and without evidence of infection  No cyanosis Chronic 4 + edema  Neuro notes diffuse weakness, worse on right  Disposition: Skilled Nursing Facility
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Confusional state, Fall, Femur fracture, Gastrointestinal examination normal
Clinical narrative: Hospital Course: Chronically ill man living at home with frequent medical visits and prior lacunar stroke with residual right hemiparesis, fell at home sustaining right humeral and left femoral fractures and was hospitalized where he was treated for CHF, ORIF, and discharged to a local rehab.  During his hospitalization he was judged to be at risk for aspiration but refused alteration of his diet.  He now is sent to ER with confusion and round on ER evaluation to have a large new RLL pneumonia superimposed on his severe COPD from tobacco use.  Patient was treated with IV antibiotics for aspiration, did very well and was transitioned back for further rehab on oral clindamycin (he has an allergy reported to pencillins.)  He was to resume his chronic medications and his current activity restrictions as guided by orthopedics.  He was incidentally found to also have COVID PCR positive.  Discharge Exam: NAD Tolerating 2 l/min NC oxygen BP 126/64 (BP Location: Right arm, Patient Position: Lying)  | Pulse 67  | Temp 37 °C (98.6 °F) (Oral)  | Resp 17  | Ht 1.753 m (5' 9")  | Wt 55.3 kg (122 lb)  | SpO2 93%  | BMI 18.02 kg/m²  HEENT negative except cachexia  Chest notes diminished breath sounds right chest, scattered rhonchi  and rales  RRR distant heart sounds Abdomen scaphoid non tender normal bowel sounds No cyanosis No edema Incisions right arm and left leg clean and dry and without evidence of infection  No cyanosis Chronic 4 + edema  Neuro notes diffuse weakness, worse on right  Disposition: Skilled Nursing Facility
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Hemiparesis, Humerus fracture, Open reduction of fracture, Rales, Rhonchi
Clinical narrative: Hospital Course: Chronically ill man living at home with frequent medical visits and prior lacunar stroke with residual right hemiparesis, fell at home sustaining right humeral and left femoral fractures and was hospitalized where he was treated for CHF, ORIF, and discharged to a local rehab.  During his hospitalization he was judged to be at risk for aspiration but refused alteration of his diet.  He now is sent to ER with confusion and round on ER evaluation to have a large new RLL pneumonia superimposed on his severe COPD from tobacco use.  Patient was treated with IV antibiotics for aspiration, did very well and was transitioned back for further rehab on oral clindamycin (he has an allergy reported to pencillins.)  He was to resume his chronic medications and his current activity restrictions as guided by orthopedics.  He was incidentally found to also have COVID PCR positive.  Discharge Exam: NAD Tolerating 2 l/min NC oxygen BP 126/64 (BP Location: Right arm, Patient Position: Lying)  | Pulse 67  | Temp 37 °C (98.6 °F) (Oral)  | Resp 17  | Ht 1.753 m (5' 9")  | Wt 55.3 kg (122 lb)  | SpO2 93%  | BMI 18.02 kg/m²  HEENT negative except cachexia  Chest notes diminished breath sounds right chest, scattered rhonchi  and rales  RRR distant heart sounds Abdomen scaphoid non tender normal bowel sounds No cyanosis No edema Incisions right arm and left leg clean and dry and without evidence of infection  No cyanosis Chronic 4 + edema  Neuro notes diffuse weakness, worse on right  Disposition: Skilled Nursing Facility
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Superinfection, Tobacco user
Clinical narrative: Hospital Course: Chronically ill man living at home with frequent medical visits and prior lacunar stroke with residual right hemiparesis, fell at home sustaining right humeral and left femoral fractures and was hospitalized where he was treated for CHF, ORIF, and discharged to a local rehab.  During his hospitalization he was judged to be at risk for aspiration but refused alteration of his diet.  He now is sent to ER with confusion and round on ER evaluation to have a large new RLL pneumonia superimposed on his severe COPD from tobacco use.  Patient was treated with IV antibiotics for aspiration, did very well and was transitioned back for further rehab on oral clindamycin (he has an allergy reported to pencillins.)  He was to resume his chronic medications and his current activity restrictions as guided by orthopedics.  He was incidentally found to also have COVID PCR positive.  Discharge Exam: NAD Tolerating 2 l/min NC oxygen BP 126/64 (BP Location: Right arm, Patient Position: Lying)  | Pulse 67  | Temp 37 °C (98.6 °F) (Oral)  | Resp 17  | Ht 1.753 m (5' 9")  | Wt 55.3 kg (122 lb)  | SpO2 93%  | BMI 18.02 kg/m²  HEENT negative except cachexia  Chest notes diminished breath sounds right chest, scattered rhonchi  and rales  RRR distant heart sounds Abdomen scaphoid non tender normal bowel sounds No cyanosis No edema Incisions right arm and left leg clean and dry and without evidence of infection  No cyanosis Chronic 4 + edema  Neuro notes diffuse weakness, worse on right  Disposition: Skilled Nursing Facility
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Breath sounds abnormal, COVID-19, Chest X-ray abnormal, Dyspnoea, Pneumothorax
Clinical narrative: Patient has a background of severe COPD, panlobular emphysema but is not on home supplemental oxygen. She developed shortness of breath and initially required supplemental oxygen per nasal cannula @ 4 L suggesting acute respiratory failure with hypoxia.  She was found to have COVID infection.  Chest film did not reveal any infiltrates but note was made a small right pneumothorax. This was informally reviewed with Pulmonary and no intervention was recommended. She was started on DECADRON and REMDESIVIR in addition to nebulization treatments though she was not demonstrating any wheezing.  The day following admission the patient was demonstrating oxygen saturation of 99-100% on room air at rest. A repeat chest film reported decreased size of pneumothorax Patient felt that she was at her baseline for respiratory status. Her examination revealed diminished breath sounds but no wheezes, rhonchi or rales.  There was consideration of prescribing PAXLOVID at discharge but the cost was prohibitive. Patient was advised that is she experienced any sudden increase in her shortness of breath that she should be evaluated immediately.   Discharged to home.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: 12 yo patient received Moderna vaccine at a dose for 6mo to 11yo formula.  The error was identified five days later, the parents of the child were contacted and informed that the incorrect dose was given. Consult with the primary care pharmacist, who per cdc guidelines recommended re vaccinating the patient with the correct dose. The patient received the correct Moderna vaccine on 11/22.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Product preparation error
Clinical narrative: Vaccine mixed with wrong diluent. Mixed with sterile diluent instead of the one provided in the box.
Age: 1.25
Sex: F
Vaccine: HEPA, PNC20, HEPA, PNC20
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: At patient's 15 month appointment, she did not receive the appropriate 15 month vaccination. She received her 12 month vaccines again. While this makes her MMR current, she did receive extra doses of PCV and Hep A (hep A was given 3 months apart). She also did not receive any of the appropriate 15 month vaccinations (dTap, varicella, and Hib).
Age: 1.25
Sex: F
Vaccine: HEPA, PNC20, HEPA, PNC20
Symptoms: Extra dose administered
Clinical narrative: At patient's 15 month appointment, she did not receive the appropriate 15 month vaccination. She received her 12 month vaccines again. While this makes her MMR current, she did receive extra doses of PCV and Hep A (hep A was given 3 months apart). She also did not receive any of the appropriate 15 month vaccinations (dTap, varicella, and Hib).