chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: it was inadvertently administered intramuscularly with no reported adverse event; Initial information received on 15-Nov-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and gender patient to whom experienced yellow fever vaccine - US [YF-VAX] was inadvertently administered intramuscularly with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient  inadvertently administered unknown dose of suspect yellow fever vaccine, Solution for injection ( lot number, dose, strength and expiry date not reported) via intramuscularly in unknown administration site for Immunization with no reported adverse event (incorrect route of product administration) (latency: on same day).  Information on the batch number was requested.  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.
Sex: U
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: report a temperature excursion which was not covered by the extended stability data with no reported adverse event; reports that 6 patients received ipol after it experienced a temperature excursion with no reported adverse event; Initial information received on 15-Nov-2023 regarding an unsolicited valid  non-serious case received via Nurse.  This case involves 6 patients with an unknown age and unknown gender and the reporter report a temperature excursion which was not covered by the extended stability data with no reported adverse event and reports that 6 patients received IPV (VERO) [IPOL] after it experienced a temperature excursion with no reported adverse event.  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 IPV (VERO), Suspension for injection (strength, lot number, expiry date: unknown) via unknown route in unknown administration site for immunization and report a temperature excursion which was not covered by the extended stability data with no reported adverse event (product storage error) (latency: unknown) and reports that 6 patients received ipol after it experienced a temperature excursion with no reported adverse event (poor quality product administered) (latency: same day)     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: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: accidentally received two doses of the fluzone high-dose quadrivalent vaccine two weeks apart with no reported 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 2023SA361826.  This case involves a 70 years old female patient who accidentally received two doses of the Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent] two weeks apart with no reported 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  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: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Conjunctivitis
Clinical narrative: Development of conjunctivitis in right eye with onset of symptoms beginning the evening of vaccine administration.  For awareness, also received a COVID-19 vaccine on 9 November 2023 without side effects.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of consciousness, Seizure
Clinical narrative: Loss of consciousness, seizure
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Blood test, IgA nephropathy, Illness, Urine analysis
Clinical narrative: Biopsy on 11/3/2023 confirms condition of IgA nephropathy; he gets sick for 3 days after each COVID shot; This spontaneous case was reported by a consumer and describes the occurrence of IGA NEPHROPATHY (Biopsy on 11/3/2023 confirms condition of IgA nephropathy) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 039B21A and 001B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 03-Nov-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced IGA NEPHROPATHY (Biopsy on 11/3/2023 confirms condition of IgA nephropathy) (seriousness criterion medically significant). On an unknown date, the patient experienced ILLNESS (he gets sick for 3 days after each COVID shot). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, IGA NEPHROPATHY (Biopsy on 11/3/2023 confirms condition of IgA nephropathy) had not resolved and ILLNESS (he gets sick for 3 days after each COVID shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Dec-2021, Urine analysis: urine was brown/red. On 03-Nov-2023, Biopsy: confirms condition of IgA nephropathy in previously healthy patient. On an unknown date, Blood test: Blood work every 6 months since then has shown RBC and blood in the urine, though not visible to naked eye now.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Following 3rd dose on 02-Dec-2021, patient's urine was brown/red. They immediately went to the pediatrician at the time for blood work and the pediatrician sent them to the Nephrologist. Patient will be on lifelong medication to manage. It was unknown if the patient experienced any additional symptoms/events. At the time of each of 3-day sickness, only acetaminophen to manage fever, was needed.  Company Comment This spontaneous case concerns a 19-year-old male patient with no medical history reported who experienced the unexpected medically significant seriousness criteria event of IgA nephropathy; the unexpected event of illness in the context of 3rd. dose of mRNA-1273 vaccine. The patient felt sick for 3 days after each COVID shot; 11 months after the 3rd. dose, a biopsy confirms condition of IgA nephropathy in previously healthy patient. At the time of the report, this condition had not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Eye disorder, Hypoaesthesia, Paraesthesia
Clinical narrative: When I woke up the next day my left eye was half closed and the left side of my face is numb and tingly; When I woke up the next day my left eye was half closed and the left side of my face is numb and tingly; When I woke up the next day my left eye was half closed and the left side of my face is numb and tingly; This spontaneous case was reported by a consumer and describes the occurrence of EYE DISORDER (When I woke up the next day my left eye was half closed and the left side of my face is numb and tingly), HYPOAESTHESIA (When I woke up the next day my left eye was half closed and the left side of my face is numb and tingly) and PARAESTHESIA (When I woke up the next day my left eye was half closed and the left side of my face is numb and tingly) in a 56-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     null Patient was diagnosed with Covid 19.  The patient's past medical history included COVID-19 in April 2022.    On 13-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 14-Nov-2023, the patient experienced EYE DISORDER (When I woke up the next day my left eye was half closed and the left side of my face is numb and tingly), HYPOAESTHESIA (When I woke up the next day my left eye was half closed and the left side of my face is numb and tingly) and PARAESTHESIA (When I woke up the next day my left eye was half closed and the left side of my face is numb and tingly). At the time of the report, EYE DISORDER (When I woke up the next day my left eye was half closed and the left side of my face is numb and tingly), HYPOAESTHESIA (When I woke up the next day my left eye was half closed and the left side of my face is numb and tingly) and PARAESTHESIA (When I woke up the next day my left eye was half closed and the left side of my face is numb and tingly) had not resolved.            Concomitant and treatment medications were not reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Fatigue, Muscular weakness, Pyrexia
Clinical narrative: muscle weakness in legs; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (muscle weakness in legs), PYREXIA (fever) and FATIGUE (fatigue) in a 55-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Clot blood (blood clot in legs) and Gout.    On 18-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 18-Nov-2023, the patient experienced MUSCULAR WEAKNESS (muscle weakness in legs), PYREXIA (fever) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 500 milligram/ every 4 hours for 1.5 days. At the time of the report, MUSCULAR WEAKNESS (muscle weakness in legs), PYREXIA (fever) and FATIGUE (fatigue) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: High.    No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Neck pain
Clinical narrative: experienced severe body pains; specifically back of the neck and lower back; Initial information received on 15-Nov-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case involves a 57 years old female patient who experienced severe body pains and specifically back of the neck and lower back while receiving vaccine Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In 2022, the patient received an unknown dose of suspect Influenza Quadrival A-B Vaccine (unknown formulation, strength, batch number and expiry date) via unknown route in unknown administration site for prophylactic vaccination(Immunization). Information regarding batch number has been requested.  In 2022 the patient developed a non-serious experienced severe body pains (pain) AND of the neck and lower back (neck pain) (unknown latency) following the administration of Influenza Quadrival A-B Vaccine.  It was reported that Patient reported that last year when she received the Sanofi Flu product she had a bad reaction, and she did not report it at the time. She received the shot late afternoon on a Thursday and by Friday she was "flat out on the bed. She is not sure if the product she received last year was the Flublok or the Fluzone QIV  Action taken;  not applicable.  It was not reported if the patient received a corrective treatment for both the events. (experienced severe body pains, specifically back of the neck and lower back).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for both the events.
Age: 38.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Insomnia, Pain, Pyrexia
Clinical narrative: Pain, soreness all over, slight fever.  Insomnia
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Dyskinesia, Glassy eyes, Lethargy, Unresponsive to stimuli
Clinical narrative: Temperature: 101.2; lethargic with glazed eyes, Mouth was ajar and resident mouth was unable to closed, unresponsive
Age: 49.0
Sex: F
Vaccine: COVID19, TDAP
Symptoms: Bell's palsy, Blood test normal, Computerised tomogram head normal, Eye swelling, Hypoaesthesia oral
Clinical narrative: Started with numb tongue on 11/12, during the week it progressed to face drooping, eye swelling and lip numb.  Went to ER and was diagnosed with Bell's Palsy.  Was prescribed steroids and antiviral.
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Patient received his first Shingrix vaccine on 11/07/2023 which resulted in development of Guillain Barre syndrome. He was hospitalized on 11/16/2023 with progressive ascending muscle weakness.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysuria, Prostatitis, Pyrexia, Urine analysis normal
Clinical narrative: On November 2 I was diagnosed with Prostatitis and taking SMZ/TMP for 14 days, 2 pills each day. Also got COVID booster on that day. I am having bouts of vertigo and increasing dizziness starting around November 6. The prostatitis symptoms have gone away. Fever gone and no more pain when urinating.
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: On November 2 I was diagnosed with Prostatitis and taking SMZ/TMP for 14 days, 2 pills each day. Also got COVID booster on that day. I am having bouts of vertigo and increasing dizziness starting around November 6. The prostatitis symptoms have gone away. Fever gone and no more pain when urinating.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Inappropriate schedule of product administration, Infection
Clinical narrative: Patient reports she was late to dose due to infection and reaction to COVID vaccine. No additional information provided. Patient does not consent to be contacted.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Blood culture negative, Blood potassium decreased, CSF culture negative, CSF glucose decreased, CSF lymphocyte count increased
Clinical narrative: Patient is a 21-year-old female with no past medical history who presented to the ED due to worsening headache.   Her headache started 5 days ago.  She also endorses nausea with vomiting, myalgias and a fever of 102 at home.  She has been unable to eat or drink the last 5 days.  Denies any dysuria or abdominal pain, diarrhea but feels slightly constipated. Yesterday she went to a walk-in clinic and was given IV Tylenol and some nausea medication. This morning she developed a erythematous rash that was mildly pruritic, diffusely throughout her upper and lower extremities and how no resolved. She then went home and had little relief with persistence in her headache.  She has been taking Tylenol at home last dose was 630 this morning.  She does not have any medical problems and does not take any chronic medications.  She denies any history of prior headaches or chronic migraines.  She currently lives in an apartment complex but is not in college and does not live in a shared dormitory.  Her mother states she is up-to-date on her vaccinations and believes she has gotten her meningitis vaccine prior with her pediatrician. Patient denies any known ill contacts except just people that have the "common cold" she denies any recent travel.  She is sexually active but has not been for the last year.  She has had about 16 sexual partners.  She denies any previous history of STDs.  She denies any cold sores or genital rash/ulcers.  Denies any abnormal vaginal discharge. She is agreeable to STD screening. She has a Nexplanon in place and her periods are often erratic.  On arrival to the ER patient afebrile, blood pressure 116/67, pulse 78 saturating 96% on room air respiratory rate 18.  Lab results remarkable for white count of 12.3 with left shift, hemoglobin of 11.5 prior lab work hemoglobin was 12.7, potassium 3.4 pregnancy test negative UA with some ketones protein.  MRI brain negative for any acute findings. Fluoroscopy-guided LP performed in the ED total neutrophil count 146 no RBCs glucose 49 protein 53.  Patient given Toradol, Zofran and a 1 L bolus of NS.  To be transferred to obs for further management and to await CSF culture which is pending.  Patient feels substantially better this morning.  Her headache has resolved.  Her neck stiffness is significantly better as well.  No further symptoms of fever or chills.  Blood culture remain negative thus far.  CSF Gram stain and culture negative thus far as well.  Differential from her CSF came back 100% lymphocytes.  Findings all consistent with more of a viral meningitis.  Further culture data pending at this time.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: CSF neutrophil count increased, CSF protein normal, CSF red blood cell count, Constipation, Contraceptive implant
Clinical narrative: Patient is a 21-year-old female with no past medical history who presented to the ED due to worsening headache.   Her headache started 5 days ago.  She also endorses nausea with vomiting, myalgias and a fever of 102 at home.  She has been unable to eat or drink the last 5 days.  Denies any dysuria or abdominal pain, diarrhea but feels slightly constipated. Yesterday she went to a walk-in clinic and was given IV Tylenol and some nausea medication. This morning she developed a erythematous rash that was mildly pruritic, diffusely throughout her upper and lower extremities and how no resolved. She then went home and had little relief with persistence in her headache.  She has been taking Tylenol at home last dose was 630 this morning.  She does not have any medical problems and does not take any chronic medications.  She denies any history of prior headaches or chronic migraines.  She currently lives in an apartment complex but is not in college and does not live in a shared dormitory.  Her mother states she is up-to-date on her vaccinations and believes she has gotten her meningitis vaccine prior with her pediatrician. Patient denies any known ill contacts except just people that have the "common cold" she denies any recent travel.  She is sexually active but has not been for the last year.  She has had about 16 sexual partners.  She denies any previous history of STDs.  She denies any cold sores or genital rash/ulcers.  Denies any abnormal vaginal discharge. She is agreeable to STD screening. She has a Nexplanon in place and her periods are often erratic.  On arrival to the ER patient afebrile, blood pressure 116/67, pulse 78 saturating 96% on room air respiratory rate 18.  Lab results remarkable for white count of 12.3 with left shift, hemoglobin of 11.5 prior lab work hemoglobin was 12.7, potassium 3.4 pregnancy test negative UA with some ketones protein.  MRI brain negative for any acute findings. Fluoroscopy-guided LP performed in the ED total neutrophil count 146 no RBCs glucose 49 protein 53.  Patient given Toradol, Zofran and a 1 L bolus of NS.  To be transferred to obs for further management and to await CSF culture which is pending.  Patient feels substantially better this morning.  Her headache has resolved.  Her neck stiffness is significantly better as well.  No further symptoms of fever or chills.  Blood culture remain negative thus far.  CSF Gram stain and culture negative thus far as well.  Differential from her CSF came back 100% lymphocytes.  Findings all consistent with more of a viral meningitis.  Further culture data pending at this time.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to communicable disease, Feeding disorder, Fluid intake reduced, Gram stain negative, Haemoglobin
Clinical narrative: Patient is a 21-year-old female with no past medical history who presented to the ED due to worsening headache.   Her headache started 5 days ago.  She also endorses nausea with vomiting, myalgias and a fever of 102 at home.  She has been unable to eat or drink the last 5 days.  Denies any dysuria or abdominal pain, diarrhea but feels slightly constipated. Yesterday she went to a walk-in clinic and was given IV Tylenol and some nausea medication. This morning she developed a erythematous rash that was mildly pruritic, diffusely throughout her upper and lower extremities and how no resolved. She then went home and had little relief with persistence in her headache.  She has been taking Tylenol at home last dose was 630 this morning.  She does not have any medical problems and does not take any chronic medications.  She denies any history of prior headaches or chronic migraines.  She currently lives in an apartment complex but is not in college and does not live in a shared dormitory.  Her mother states she is up-to-date on her vaccinations and believes she has gotten her meningitis vaccine prior with her pediatrician. Patient denies any known ill contacts except just people that have the "common cold" she denies any recent travel.  She is sexually active but has not been for the last year.  She has had about 16 sexual partners.  She denies any previous history of STDs.  She denies any cold sores or genital rash/ulcers.  Denies any abnormal vaginal discharge. She is agreeable to STD screening. She has a Nexplanon in place and her periods are often erratic.  On arrival to the ER patient afebrile, blood pressure 116/67, pulse 78 saturating 96% on room air respiratory rate 18.  Lab results remarkable for white count of 12.3 with left shift, hemoglobin of 11.5 prior lab work hemoglobin was 12.7, potassium 3.4 pregnancy test negative UA with some ketones protein.  MRI brain negative for any acute findings. Fluoroscopy-guided LP performed in the ED total neutrophil count 146 no RBCs glucose 49 protein 53.  Patient given Toradol, Zofran and a 1 L bolus of NS.  To be transferred to obs for further management and to await CSF culture which is pending.  Patient feels substantially better this morning.  Her headache has resolved.  Her neck stiffness is significantly better as well.  No further symptoms of fever or chills.  Blood culture remain negative thus far.  CSF Gram stain and culture negative thus far as well.  Differential from her CSF came back 100% lymphocytes.  Findings all consistent with more of a viral meningitis.  Further culture data pending at this time.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging head normal, Meningitis viral, Menstruation irregular, Musculoskeletal stiffness
Clinical narrative: Patient is a 21-year-old female with no past medical history who presented to the ED due to worsening headache.   Her headache started 5 days ago.  She also endorses nausea with vomiting, myalgias and a fever of 102 at home.  She has been unable to eat or drink the last 5 days.  Denies any dysuria or abdominal pain, diarrhea but feels slightly constipated. Yesterday she went to a walk-in clinic and was given IV Tylenol and some nausea medication. This morning she developed a erythematous rash that was mildly pruritic, diffusely throughout her upper and lower extremities and how no resolved. She then went home and had little relief with persistence in her headache.  She has been taking Tylenol at home last dose was 630 this morning.  She does not have any medical problems and does not take any chronic medications.  She denies any history of prior headaches or chronic migraines.  She currently lives in an apartment complex but is not in college and does not live in a shared dormitory.  Her mother states she is up-to-date on her vaccinations and believes she has gotten her meningitis vaccine prior with her pediatrician. Patient denies any known ill contacts except just people that have the "common cold" she denies any recent travel.  She is sexually active but has not been for the last year.  She has had about 16 sexual partners.  She denies any previous history of STDs.  She denies any cold sores or genital rash/ulcers.  Denies any abnormal vaginal discharge. She is agreeable to STD screening. She has a Nexplanon in place and her periods are often erratic.  On arrival to the ER patient afebrile, blood pressure 116/67, pulse 78 saturating 96% on room air respiratory rate 18.  Lab results remarkable for white count of 12.3 with left shift, hemoglobin of 11.5 prior lab work hemoglobin was 12.7, potassium 3.4 pregnancy test negative UA with some ketones protein.  MRI brain negative for any acute findings. Fluoroscopy-guided LP performed in the ED total neutrophil count 146 no RBCs glucose 49 protein 53.  Patient given Toradol, Zofran and a 1 L bolus of NS.  To be transferred to obs for further management and to await CSF culture which is pending.  Patient feels substantially better this morning.  Her headache has resolved.  Her neck stiffness is significantly better as well.  No further symptoms of fever or chills.  Blood culture remain negative thus far.  CSF Gram stain and culture negative thus far as well.  Differential from her CSF came back 100% lymphocytes.  Findings all consistent with more of a viral meningitis.  Further culture data pending at this time.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pregnancy test negative, Protein urine present, Pyrexia
Clinical narrative: Patient is a 21-year-old female with no past medical history who presented to the ED due to worsening headache.   Her headache started 5 days ago.  She also endorses nausea with vomiting, myalgias and a fever of 102 at home.  She has been unable to eat or drink the last 5 days.  Denies any dysuria or abdominal pain, diarrhea but feels slightly constipated. Yesterday she went to a walk-in clinic and was given IV Tylenol and some nausea medication. This morning she developed a erythematous rash that was mildly pruritic, diffusely throughout her upper and lower extremities and how no resolved. She then went home and had little relief with persistence in her headache.  She has been taking Tylenol at home last dose was 630 this morning.  She does not have any medical problems and does not take any chronic medications.  She denies any history of prior headaches or chronic migraines.  She currently lives in an apartment complex but is not in college and does not live in a shared dormitory.  Her mother states she is up-to-date on her vaccinations and believes she has gotten her meningitis vaccine prior with her pediatrician. Patient denies any known ill contacts except just people that have the "common cold" she denies any recent travel.  She is sexually active but has not been for the last year.  She has had about 16 sexual partners.  She denies any previous history of STDs.  She denies any cold sores or genital rash/ulcers.  Denies any abnormal vaginal discharge. She is agreeable to STD screening. She has a Nexplanon in place and her periods are often erratic.  On arrival to the ER patient afebrile, blood pressure 116/67, pulse 78 saturating 96% on room air respiratory rate 18.  Lab results remarkable for white count of 12.3 with left shift, hemoglobin of 11.5 prior lab work hemoglobin was 12.7, potassium 3.4 pregnancy test negative UA with some ketones protein.  MRI brain negative for any acute findings. Fluoroscopy-guided LP performed in the ED total neutrophil count 146 no RBCs glucose 49 protein 53.  Patient given Toradol, Zofran and a 1 L bolus of NS.  To be transferred to obs for further management and to await CSF culture which is pending.  Patient feels substantially better this morning.  Her headache has resolved.  Her neck stiffness is significantly better as well.  No further symptoms of fever or chills.  Blood culture remain negative thus far.  CSF Gram stain and culture negative thus far as well.  Differential from her CSF came back 100% lymphocytes.  Findings all consistent with more of a viral meningitis.  Further culture data pending at this time.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic, Sexually active, Shift to the left
Clinical narrative: Patient is a 21-year-old female with no past medical history who presented to the ED due to worsening headache.   Her headache started 5 days ago.  She also endorses nausea with vomiting, myalgias and a fever of 102 at home.  She has been unable to eat or drink the last 5 days.  Denies any dysuria or abdominal pain, diarrhea but feels slightly constipated. Yesterday she went to a walk-in clinic and was given IV Tylenol and some nausea medication. This morning she developed a erythematous rash that was mildly pruritic, diffusely throughout her upper and lower extremities and how no resolved. She then went home and had little relief with persistence in her headache.  She has been taking Tylenol at home last dose was 630 this morning.  She does not have any medical problems and does not take any chronic medications.  She denies any history of prior headaches or chronic migraines.  She currently lives in an apartment complex but is not in college and does not live in a shared dormitory.  Her mother states she is up-to-date on her vaccinations and believes she has gotten her meningitis vaccine prior with her pediatrician. Patient denies any known ill contacts except just people that have the "common cold" she denies any recent travel.  She is sexually active but has not been for the last year.  She has had about 16 sexual partners.  She denies any previous history of STDs.  She denies any cold sores or genital rash/ulcers.  Denies any abnormal vaginal discharge. She is agreeable to STD screening. She has a Nexplanon in place and her periods are often erratic.  On arrival to the ER patient afebrile, blood pressure 116/67, pulse 78 saturating 96% on room air respiratory rate 18.  Lab results remarkable for white count of 12.3 with left shift, hemoglobin of 11.5 prior lab work hemoglobin was 12.7, potassium 3.4 pregnancy test negative UA with some ketones protein.  MRI brain negative for any acute findings. Fluoroscopy-guided LP performed in the ED total neutrophil count 146 no RBCs glucose 49 protein 53.  Patient given Toradol, Zofran and a 1 L bolus of NS.  To be transferred to obs for further management and to await CSF culture which is pending.  Patient feels substantially better this morning.  Her headache has resolved.  Her neck stiffness is significantly better as well.  No further symptoms of fever or chills.  Blood culture remain negative thus far.  CSF Gram stain and culture negative thus far as well.  Differential from her CSF came back 100% lymphocytes.  Findings all consistent with more of a viral meningitis.  Further culture data pending at this time.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Urine ketone body present, Vomiting, White blood cell count increased, X-ray
Clinical narrative: Patient is a 21-year-old female with no past medical history who presented to the ED due to worsening headache.   Her headache started 5 days ago.  She also endorses nausea with vomiting, myalgias and a fever of 102 at home.  She has been unable to eat or drink the last 5 days.  Denies any dysuria or abdominal pain, diarrhea but feels slightly constipated. Yesterday she went to a walk-in clinic and was given IV Tylenol and some nausea medication. This morning she developed a erythematous rash that was mildly pruritic, diffusely throughout her upper and lower extremities and how no resolved. She then went home and had little relief with persistence in her headache.  She has been taking Tylenol at home last dose was 630 this morning.  She does not have any medical problems and does not take any chronic medications.  She denies any history of prior headaches or chronic migraines.  She currently lives in an apartment complex but is not in college and does not live in a shared dormitory.  Her mother states she is up-to-date on her vaccinations and believes she has gotten her meningitis vaccine prior with her pediatrician. Patient denies any known ill contacts except just people that have the "common cold" she denies any recent travel.  She is sexually active but has not been for the last year.  She has had about 16 sexual partners.  She denies any previous history of STDs.  She denies any cold sores or genital rash/ulcers.  Denies any abnormal vaginal discharge. She is agreeable to STD screening. She has a Nexplanon in place and her periods are often erratic.  On arrival to the ER patient afebrile, blood pressure 116/67, pulse 78 saturating 96% on room air respiratory rate 18.  Lab results remarkable for white count of 12.3 with left shift, hemoglobin of 11.5 prior lab work hemoglobin was 12.7, potassium 3.4 pregnancy test negative UA with some ketones protein.  MRI brain negative for any acute findings. Fluoroscopy-guided LP performed in the ED total neutrophil count 146 no RBCs glucose 49 protein 53.  Patient given Toradol, Zofran and a 1 L bolus of NS.  To be transferred to obs for further management and to await CSF culture which is pending.  Patient feels substantially better this morning.  Her headache has resolved.  Her neck stiffness is significantly better as well.  No further symptoms of fever or chills.  Blood culture remain negative thus far.  CSF Gram stain and culture negative thus far as well.  Differential from her CSF came back 100% lymphocytes.  Findings all consistent with more of a viral meningitis.  Further culture data pending at this time.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Child was given adult dose of moderna vaccine
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoxia
Clinical narrative: Hospitalized for hypoxia
Age: 68.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Injection site pain, Musculoskeletal disorder, Pain, Product administered at inappropriate site, X-ray
Clinical narrative: Horrible pain at injection site about 3-4 hours after injection. I could not move my arm without significant pain.  This intense pain lasted for at least  12 hours. At that point, I had no use of my right arm and pain was dull and achy.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Electromyogram, Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Paraesthesia
Clinical narrative: Administrator inserted the needle, I believe hit my bone, and stated that they couldn't inject. I told them to pull the needle back a little. Once they did that, the vaccine was able to be injected. I had pain and tenderness immediately and since then, have been unable to sleep on my right arm due to nightly numbness and tingling at night. During the day, I have tenderness and soreness on that right arm
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given had been moved from freezer to fridge on 10/18/2023, to be used by 11/18/2023. The vaccine was given to this patient one day after the use by date. The event was discovered by pharmacy staff on 11/20/2023. No harm was done to the patient, pharmacy staff have contacted Moderna to determine if the vaccine given was viable or if the patient should receive an additional vaccine.
Age: 36.0
Sex: M
Vaccine: FLUC4
Symptoms: Burning sensation, Injection site nerve damage, Pain
Clinical narrative: A FEW DAYS AFTER  RECIEVING THE FLU SHOT ON NOV 6TH, I HAVE BEEN EXPERIENCING SHARP PAIN AND BURNING SENSATIONS WHEN I MOVE MY ARM.  HOWEVER, WHEN I DO NOT MOVE MY ARM THE SIDE EFFECTS GO AWAY.  I WENT TO URGERT CARE ON NOV 10TH AND WAS PRESCRIBED CLINDAMYCIN AND PREDNISONE. THE NEXT DAY, NOV 11TH, I SAW MY PCM AND SHE SUSPECTS THAT WHEN I RECEIVED THE SHOT, THE ADMINISTRATOR STRUCT AN NERVE IN MY ARM.  I AM SCHEDULING AN APPOINTMENT TO RECIEVE AN MRI.  THE DAY AND TIME OF THE MRI IS TBD.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Patient  tested positive for Covid 19 on 11/17/2023 at his nursing home, he was admitted to hospital on 11/21/2023 for comfort care and died the same day.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Cardiac monitoring normal, Computerised tomogram head normal, Electrocardiogram normal, Presyncope
Clinical narrative: Fainted - Vagal Reaction blood pressure when I came to ED was 83/53
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainted - Vagal Reaction blood pressure when I came to ED was 83/53
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: widespread itchiness
Age: 61.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Influenza like illness
Clinical narrative: For more than a month (up to today), after receiving the new COVID booster and Flu (for senior) shots together. I don't feel normal. Symptoms:  Flu like feeling, chill, fatigue, no energy, lost 13 lbs,
Age: 61.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: SARS-CoV-2 test negative, Weight decreased
Clinical narrative: For more than a month (up to today), after receiving the new COVID booster and Flu (for senior) shots together. I don't feel normal. Symptoms:  Flu like feeling, chill, fatigue, no energy, lost 13 lbs,
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Immunisation reaction, Pityriasis lichenoides et varioliformis acuta
Clinical narrative: Pleva. Had a Biopsy and was told it's a result of the covid vaccine.
Age: 56.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Incorrect dose administered, Pain in extremity, Wrong product administered
Clinical narrative: Patient was expecting to receive a regular dose influenza vaccine today with her COVID vaccine. The technician pulled the dose for the pharmacist and got the medication ready for administration by placing a needle on the vaccine.  The pharmacist went to administer the vaccine and did not realize the the prefilled syringe was a HIGH DOSE flu shot instead. This patient is only 56 years old. It was administered in her right arm.  We explained to patient what had happened. She remained in the pharmacy for 15 minutes after vaccine administration to verify she was not going to have an immediate serious reaction.  We followed up with patient that evening (11/21/23 at 6:00 pm ) and again the next morning (11/22/23  at 8:30 am) . She was not experiencing any side effects, except a sore arm. She did not have fatigue, body aches, headache, chills, fever, or nausea.
Age: 16.0
Sex: M
Vaccine: HEPA, MENB, MNQ
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: The patient did not experience any adverse effects.    I accidentally gave this student an adult dose of Hep A,   using Havrix instead of Vaqta.     I informed my supervisor when the mistake was discovered.   I phoned the parent to explain the mistake.   We agreed he would monitor his son for any ill effects.   His son is 16 and adult-sized.   I followed up with a phone call the next day and no ill effects were observed by the patient or his family.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Atrioventricular block, Myocarditis
Clinical narrative: afib and myocarditits over past year or two, now cabg needed, stress tests etc. before covid vaccine showed a strong heart, now multiple blockages and 1 90-95% blocked
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, FLUC4, PNC20, RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Medical assistant gave an influenza vaccine to patient who is outside of the recommended age group.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Blood pressure increased, Brain fog, Diarrhoea, Fatigue, Hepatic enzyme increased
Clinical narrative: I am in my 4th week of reaction. Full body muscular aches, exhaustion, diarrhea, brain fog. Blood test showed elevated liver function.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Myalgia
Clinical narrative: I am in my 4th week of reaction. Full body muscular aches, exhaustion, diarrhea, brain fog. Blood test showed elevated liver function.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Magnetic resonance imaging, Pain
Clinical narrative: EXTREME PAIN STARTED IMMEDIATELY. COULDN'T MOVE ARM BY THE NEXT DAY. RANGE OF MOTION IS AFFECTED.
Age: 21.0
Sex: M
Vaccine: ANTH, FLU4, TYP, YF
Symptoms: Chest discomfort, Cough, Injection site rash, Rash, Wheezing
Clinical narrative: Patient had a rash surrounding the injection site of the yellow fever immunization. A rash began to form up around his waist line and then the patient's chest began to feel tight, not so long after the patient developed a wheeze and a cough. Patient went to Hospital to receive further treatment.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The Kinrix was given before the age of 4.  Child was 3 years 6 months.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Arteriogram carotid, Blood test normal, Computerised tomogram head, Computerised tomogram normal, Head discomfort
Clinical narrative: ear ringing, muffled hearing in right ear, severe frontal headache, crushing pressure in head and severe neck pain with stiffness and decreased range of motion
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Headache, Hypoacusis, Joint range of motion decreased, Musculoskeletal stiffness, Neck pain
Clinical narrative: ear ringing, muffled hearing in right ear, severe frontal headache, crushing pressure in head and severe neck pain with stiffness and decreased range of motion
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Red blood cell sedimentation rate normal, Tinnitus
Clinical narrative: ear ringing, muffled hearing in right ear, severe frontal headache, crushing pressure in head and severe neck pain with stiffness and decreased range of motion
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Vaccination site hypoaesthesia, Vaccination site paraesthesia
Clinical narrative: Patient reports that approximately 1/2 hour after receiving his COVID vaccination, he experienced numbness and tingling in his left arm, the same arm that he was vaccinated. He describes it extending down to his elbow and up to his shoulder. It also progressed to his neck and face to a small extent. He denies any other symptoms such as swelling, hives, shortness of breath,  or throat tightness. He states it subsided after about 8 hours. Today the numbness and tingling started again as he used his arm at work, but intermittently. Advised to report this reaction to his PCP, to seek emergent evaluation with any progression of symptoms. He states understanding, and will get clearance from his PCP regarding any further COVID vaccinations in the future.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Pain, Product administered at inappropriate site
Clinical narrative: Constant mild left shoulder pain, with increased pain on abduction and rotation of the shoulder. Not treated. Persistent 3 weeks after vaccine administration.  I get this vaccine annually and it was placed very high this time, at the level of the joint.
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Ageusia, Blood test, Cardiovascular evaluation, Computerised tomogram head, Dizziness
Clinical narrative: Gillian Barrett Syndrome; hands and feet intense neuropothy; numbness feet, hands, back, belly;paralysis right side of face; tingling in face and head; tongue numb and no taste; muscle weakness and loss of grip strength;dizziness
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Facial paralysis, Grip strength decreased, Guillain-Barre syndrome, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Gillian Barrett Syndrome; hands and feet intense neuropothy; numbness feet, hands, back, belly;paralysis right side of face; tingling in face and head; tongue numb and no taste; muscle weakness and loss of grip strength;dizziness
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Lumbar puncture, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Muscular weakness, Neuropathy peripheral
Clinical narrative: Gillian Barrett Syndrome; hands and feet intense neuropothy; numbness feet, hands, back, belly;paralysis right side of face; tingling in face and head; tongue numb and no taste; muscle weakness and loss of grip strength;dizziness
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Paraesthesia, X-ray
Clinical narrative: Gillian Barrett Syndrome; hands and feet intense neuropothy; numbness feet, hands, back, belly;paralysis right side of face; tingling in face and head; tongue numb and no taste; muscle weakness and loss of grip strength;dizziness
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: The medication being available to clinicians occurred due to vaccines being left in the clinic or products being returned by the clinic and not appropriately segregated when returned to the pharmacy. This was a quick change, and we all worked to communicate as quickly as possible. Vaccine was given one day beyond date approved to administer.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient received wrong dose of Covid-19 vaccine. Patient was supposed to received Pfizer 12+ State Dose (0.3 mL/30 ug), but instead received Pfizer 5-11 State (0.3ml/10 ug). In process of contacting patients guardian to have patient return and administer additional 0.2/20ug to equal intended 30 ug dose.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Extra dose administered
Clinical narrative: The patient was given 2 flu shots. The first on sept. 13, 2023, and the second on Nov. 16, 2023
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Decreased appetite, Fatigue
Clinical narrative: Headache, fever, fatigue, myalgia, chills, shaking, weakness, arthralgia fingers, arms, shoulders, back, legs, lack of appetite Tylenol every 4 hours Symptoms continue
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, Tremor
Clinical narrative: Headache, fever, fatigue, myalgia, chills, shaking, weakness, arthralgia fingers, arms, shoulders, back, legs, lack of appetite Tylenol every 4 hours Symptoms continue