chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: her uncle had dies from Covid; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (her uncle had dies from Covid) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:unknown.     On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (her uncle had dies from Covid) (seriousness criterion death). The reported cause of death was her uncle had dies from covid. An autopsy was not performed.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Dosage text for suspect product was reported as unknown. No treatment medication was provided.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Reported Cause(s) of Death: her uncle had dies from Covid
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: I have "covid arm". While I realize it is not dangerous it is a bit painful.; One day after the injection my arm, near and around the injection site, became painful; One day after the injection my arm, near and around the injection site, became red/ Today, 3 days post injection the redness has grown.; One day after the injection my arm, near and around the injection site, became swollen; One day after the injection my arm, near and around the injection site, became hot; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (I have "covid arm". While I realize it is not dangerous it is a bit painful.), VACCINATION SITE PAIN (One day after the injection my arm, near and around the injection site, became painful), VACCINATION SITE ERYTHEMA (One day after the injection my arm, near and around the injection site, became red/ Today, 3 days post injection the redness has grown.), VACCINATION SITE SWELLING (One day after the injection my arm, near and around the injection site, became swollen) and VACCINATION SITE WARMTH (One day after the injection my arm, near and around the injection site, became hot) in a 57-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 15-Oct-2024, the patient experienced PAIN IN EXTREMITY (I have "covid arm". While I realize it is not dangerous it is a bit painful.), VACCINATION SITE PAIN (One day after the injection my arm, near and around the injection site, became painful), VACCINATION SITE ERYTHEMA (One day after the injection my arm, near and around the injection site, became red/ Today, 3 days post injection the redness has grown.), VACCINATION SITE SWELLING (One day after the injection my arm, near and around the injection site, became swollen) and VACCINATION SITE WARMTH (One day after the injection my arm, near and around the injection site, became hot). At the time of the report, PAIN IN EXTREMITY (I have "covid arm". While I realize it is not dangerous it is a bit painful.), VACCINATION SITE PAIN (One day after the injection my arm, near and around the injection site, became painful), VACCINATION SITE ERYTHEMA (One day after the injection my arm, near and around the injection site, became red/ Today, 3 days post injection the redness has grown.), VACCINATION SITE SWELLING (One day after the injection my arm, near and around the injection site, became swollen) and VACCINATION SITE WARMTH (One day after the injection my arm, near and around the injection site, became hot) had not resolved.            Concomitant medication was not provided. Patient did not report the previous two vaccines. It was reported that patient had no other signs or symptoms. Treatment information was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Bone pain, Dyspnoea, Flushing, Pain in jaw
Clinical narrative: 2.5 hours after getting the vaccine i experienced a drop in blood pressure; wheezing; having trouble breathing; to swelling of the face and throat; to swelling of the face and throat; bone pain; jaw pain; flushing; sinus pain; Initial information received on 08-Oct-2024 regarding an unsolicited valid  serious courtesy case received from a consumer/non-health care profesional.  This case involves Adult female patient who had 2.5 hours after getting the Influenza Quadrivalent Recombinant Vaccine [Flublok] i experienced a drop in blood pressure, wheezing, having trouble breathing, to swelling of the face and throat, to swelling of the face and throat, bone pain, jaw pain, flushing and sinus pain.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Drug hypersensitivity.  Concomitant medications included Isotretinoin ; Ethinylestradiol, Norgestimate (Sprintec); Ascorbic acid, Ferrous fumarate (Vitron c); Levocabastine hydrochloride (Zyrtec); Prednisone acetate (Prednisone); Famotidine and Montelukast .  On 10-Sep-2024, the patient received a unknown dose of suspect Influenza Quadrivalent Recombinant Vaccine strength, expiry date, lot number not reported via unknown route in unknown administration site for Prophylactic vaccination (Immunization). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence.  On an unknown date in 2024, the patient developed 2.5 hours after getting the vaccine i experienced a drop in blood pressure (blood pressure decreased), wheezing , having trouble breathing (dyspnoea) , to swelling of the face and throat (swelling face) , (pharyngeal swelling) , bone pain , jaw pain (pain in jaw) , flushing and sinus pain (unknown latency) following the administration of Influenza Quadrivalent Recombinant Vaccine.  Action taken was not applicable for all the events.  The patient was treated with Epinephrine , Acrivastine (Benadryl), Methylprednisolone sodium succinate (Solumedrol), Oxygen  and Aluminium hydroxide gel, dried, Magnesium carbonate (Pepcid).  At time of reporting, the outcome was Unknown for all the other events, was Not Recovered / Not Resolved for the event to swelling of the face and throat.  Seriousness Criteria : Hospitalized for the events blood pressure decreased, wheezing and dyspnea from 2024.; Sender's Comments: Sanofi Company Comment dated 22-Oct-2024 : This case involves Adult female patient who had 2.5 hours after getting the Influenza Quadrivalent Recombinant Vaccine [Flublok] i experienced a drop in blood pressure, wheezing, having trouble breathing.Further information regarding Past medical history, laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed. further, the patient's concurrent condition would be cofounding factor for this events.
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal swelling, Sinus pain, Swelling face, Wheezing
Clinical narrative: 2.5 hours after getting the vaccine i experienced a drop in blood pressure; wheezing; having trouble breathing; to swelling of the face and throat; to swelling of the face and throat; bone pain; jaw pain; flushing; sinus pain; Initial information received on 08-Oct-2024 regarding an unsolicited valid  serious courtesy case received from a consumer/non-health care profesional.  This case involves Adult female patient who had 2.5 hours after getting the Influenza Quadrivalent Recombinant Vaccine [Flublok] i experienced a drop in blood pressure, wheezing, having trouble breathing, to swelling of the face and throat, to swelling of the face and throat, bone pain, jaw pain, flushing and sinus pain.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Drug hypersensitivity.  Concomitant medications included Isotretinoin ; Ethinylestradiol, Norgestimate (Sprintec); Ascorbic acid, Ferrous fumarate (Vitron c); Levocabastine hydrochloride (Zyrtec); Prednisone acetate (Prednisone); Famotidine and Montelukast .  On 10-Sep-2024, the patient received a unknown dose of suspect Influenza Quadrivalent Recombinant Vaccine strength, expiry date, lot number not reported via unknown route in unknown administration site for Prophylactic vaccination (Immunization). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence.  On an unknown date in 2024, the patient developed 2.5 hours after getting the vaccine i experienced a drop in blood pressure (blood pressure decreased), wheezing , having trouble breathing (dyspnoea) , to swelling of the face and throat (swelling face) , (pharyngeal swelling) , bone pain , jaw pain (pain in jaw) , flushing and sinus pain (unknown latency) following the administration of Influenza Quadrivalent Recombinant Vaccine.  Action taken was not applicable for all the events.  The patient was treated with Epinephrine , Acrivastine (Benadryl), Methylprednisolone sodium succinate (Solumedrol), Oxygen  and Aluminium hydroxide gel, dried, Magnesium carbonate (Pepcid).  At time of reporting, the outcome was Unknown for all the other events, was Not Recovered / Not Resolved for the event to swelling of the face and throat.  Seriousness Criteria : Hospitalized for the events blood pressure decreased, wheezing and dyspnea from 2024.; Sender's Comments: Sanofi Company Comment dated 22-Oct-2024 : This case involves Adult female patient who had 2.5 hours after getting the Influenza Quadrivalent Recombinant Vaccine [Flublok] i experienced a drop in blood pressure, wheezing, having trouble breathing.Further information regarding Past medical history, laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed. further, the patient's concurrent condition would be cofounding factor for this events.
Age: 18.0
Sex: F
Vaccine: UNK
Symptoms: Breath sounds abnormal, Depressed level of consciousness, Dizziness, Dyskinesia, Dysphonia
Clinical narrative: Tunnel vision; She was unconscious, head tilted backwards; Her body was super cold within 5 min; Semi conscious; Two min after the injection she started feeling dizziness; No control of her body; She was shaking; She was making harsh voice; She was breathing like she was snoring but awake; This spontaneous case initially received on 24-Sep-2024, was reported by a health professional and concerns an adult female patient.  The past historical vaccine includes Flucelvax Quadrivalent, Lot number: 944447 on 17-Sep-2023, she had dizziness but not this violent, she was not unconscious, lightheaded. On 14-Sep-2022, Flucelvax Quadrivalent Lot number: 942389. She had mild dizziness with the same vaccine, so it looks like it's progressing.   Concomitant Medications: no other medications.  Administration of company suspect drug: On 22-Sep-2024, the patient received Flucelvax Quadrivalent for influenza immunization, dose: not reported; route of administration: not reported; Lot number: 946583. Batch number reported as 946583. CSL Seqirus Batch number unable to be matched.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 22-Sep-2024, the patient experienced Tunnel vision (Medically Significant, outcome: Recovered / Resolved), She was unconscious, head tilted backwards (Medically Significant, outcome: Recovered / Resolved), Her body was super cold within 5 min (Medically Significant, outcome: Recovered / Resolved), Semi conscious (Medically Significant, outcome: Recovered / Resolved), Two min after the injection she started feeling dizziness (outcome: Recovered / Resolved), No control of her body (outcome: Recovered / Resolved), She was shaking (outcome: Recovered / Resolved), She was making harsh voice (outcome: Recovered / Resolved), She was breathing like she was snoring but awake (outcome: Recovered / Resolved).  Flucelvax Quadrivalent action taken: Not Applicable.  Treatment measures associated with event: Ambulance was called and came, they checked her vitals.  Reporter assessment: The reporter considered events as non-serious and causality was not reported.; Reporter's Comments: Causality: Events are considered related to the administration of the vaccine, due to close temporal relationship (the same day of vaccine administration) and past similar episodes of dizziness with vaccine.
Age: 18.0
Sex: F
Vaccine: UNK
Symptoms: Feeling cold, Loss of consciousness, Posture abnormal, Tremor, Tunnel vision
Clinical narrative: Tunnel vision; She was unconscious, head tilted backwards; Her body was super cold within 5 min; Semi conscious; Two min after the injection she started feeling dizziness; No control of her body; She was shaking; She was making harsh voice; She was breathing like she was snoring but awake; This spontaneous case initially received on 24-Sep-2024, was reported by a health professional and concerns an adult female patient.  The past historical vaccine includes Flucelvax Quadrivalent, Lot number: 944447 on 17-Sep-2023, she had dizziness but not this violent, she was not unconscious, lightheaded. On 14-Sep-2022, Flucelvax Quadrivalent Lot number: 942389. She had mild dizziness with the same vaccine, so it looks like it's progressing.   Concomitant Medications: no other medications.  Administration of company suspect drug: On 22-Sep-2024, the patient received Flucelvax Quadrivalent for influenza immunization, dose: not reported; route of administration: not reported; Lot number: 946583. Batch number reported as 946583. CSL Seqirus Batch number unable to be matched.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 22-Sep-2024, the patient experienced Tunnel vision (Medically Significant, outcome: Recovered / Resolved), She was unconscious, head tilted backwards (Medically Significant, outcome: Recovered / Resolved), Her body was super cold within 5 min (Medically Significant, outcome: Recovered / Resolved), Semi conscious (Medically Significant, outcome: Recovered / Resolved), Two min after the injection she started feeling dizziness (outcome: Recovered / Resolved), No control of her body (outcome: Recovered / Resolved), She was shaking (outcome: Recovered / Resolved), She was making harsh voice (outcome: Recovered / Resolved), She was breathing like she was snoring but awake (outcome: Recovered / Resolved).  Flucelvax Quadrivalent action taken: Not Applicable.  Treatment measures associated with event: Ambulance was called and came, they checked her vitals.  Reporter assessment: The reporter considered events as non-serious and causality was not reported.; Reporter's Comments: Causality: Events are considered related to the administration of the vaccine, due to close temporal relationship (the same day of vaccine administration) and past similar episodes of dizziness with vaccine.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Atrial fibrillation
Clinical narrative: Atrial fibrillation; This serious case was reported by a consumer via sales rep and described the occurrence of atrial fibrillation in a 67-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 01-OCT-2023, the patient received the 1st dose of Arexvy (unknown arm). On 01-APR-2024, 183 days after receiving Arexvy, the patient experienced atrial fibrillation (Verbatim: Atrial fibrillation) (serious criteria hospitalization and GSK medically significant). On 02-APR-2024, the outcome of the atrial fibrillation was resolved (duration 1 day).   It was unknown if the reporter considered the atrial fibrillation to be related to Arexvy.     The company considered the atrial fibrillation to be unrelated to Arexvy.   Additional Information: GSK Receipt Date : 16-OCT-2024 Reporter reported adverse event about his/her mother. Patient took first dose and had Atrial fibrillation. She was hospitalized for Atrial fibrillation in April 2024, that came out of nowhere.  She does not had any health conditions that would have otherwise caused the Atrial fibrillation to occur.  It did not occur to reporter, that this might had been related to the AREXVY vaccination that she had in the Fall of 2023.  Reporter retroactively reported about event, also she had no prior heart condition or episode of Atrial fibrillation.; Sender's Comments: Atrial fibrillation  is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Scar, Skin lesion, Spinal pain
Clinical narrative: Suspected vaccination failure; in 2023, she got shingles; pain was down her spine with lesions around her waist/ pain was in the spinal column; pain was down her spine with lesions around her waist/ pain was in the spinal column; Scars; pain was down her spine; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had 15-20 years ago) and diverticulitis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: in 2023, she got shingles), skin lesion (Verbatim: pain was down her spine with lesions around her waist/ pain was in the spinal column), pain in spine (Verbatim: pain was down her spine with lesions around her waist/ pain was in the spinal column), scar (Verbatim: Scars) and pain (Verbatim: pain was down her spine ). The outcome of the vaccination failure was unknown and the outcome of the shingles, skin lesion, pain in spine and pain were not reported and the outcome of the scar was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, skin lesion, pain in spine, scar and pain to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles, skin lesion, pain in spine, scar and pain to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 16-OCT-2024 The case was self reported by patient. The patient had a history of shingles (15-20 years ago) and had the shingles vaccine (1 dose) and also a history of diverticulitis with antibiotics and then has shingles 2nd times 4 years ago. The patient stated 4 years ago she had the Shingrix vaccine. Then in 2023, she got shingles which was 1000 times worse than ever had it. The pain was down her spine with lesions around her waist. Most of the pain was in the spinal  column. She stated that she had over 10 lesions and still had those scares.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease and medical history of shingles) is considered unrelated to GSK vaccine Shingrix.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: Suspected vaccination failure; in 2023, she got shingles; pain was down her spine with lesions around her waist/ pain was in the spinal column; pain was down her spine with lesions around her waist/ pain was in the spinal column; Scars; pain was down her spine; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had 15-20 years ago) and diverticulitis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: in 2023, she got shingles), skin lesion (Verbatim: pain was down her spine with lesions around her waist/ pain was in the spinal column), pain in spine (Verbatim: pain was down her spine with lesions around her waist/ pain was in the spinal column), scar (Verbatim: Scars) and pain (Verbatim: pain was down her spine ). The outcome of the vaccination failure was unknown and the outcome of the shingles, skin lesion, pain in spine and pain were not reported and the outcome of the scar was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, skin lesion, pain in spine, scar and pain to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles, skin lesion, pain in spine, scar and pain to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 16-OCT-2024 The case was self reported by patient. The patient had a history of shingles (15-20 years ago) and had the shingles vaccine (1 dose) and also a history of diverticulitis with antibiotics and then has shingles 2nd times 4 years ago. The patient stated 4 years ago she had the Shingrix vaccine. Then in 2023, she got shingles which was 1000 times worse than ever had it. The pain was down her spine with lesions around her waist. Most of the pain was in the spinal  column. She stated that she had over 10 lesions and still had those scares.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease and medical history of shingles) is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: COVID19
Symptoms: Device breakage, Device physical property issue
Clinical narrative: the plunger had broken off the syringe/vaccine was not administered; she pulled it out and there was no plunger on it for the prefilled syringe and the other half of the plunger was in the little tray; The initial case was missing the following minimum criteria: identifiable event. Upon receipt of follow-up information on 14Oct2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Pharmacist from product quality group.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Lot number: LM2211, Expiration Date: 03Apr2025) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE PHYSICAL PROPERTY ISSUE (non-serious) with onset Oct2024, outcome "unknown", described as "she pulled it out and there was no plunger on it for the prefilled syringe and the other half of the plunger was in the little tray"; DEVICE BREAKAGE (non-serious) with onset Oct2024, outcome "unknown", described as "the plunger had broken off the syringe/vaccine was not administered".  Causality for "the plunger had broken off the syringe/vaccine was not administered" and "she pulled it out and there was no plunger on it for the prefilled syringe and the other half of the plunger was in the little tray" was determined associated to device constituent of BNT162b2 omicron (kp.2) (malfunction).  Additional information: The reporter said that when she went to grab one (COVID-19 vaccine) out this weekend (Oct2024). The plunger had broken off the syringe; the vaccine was not administered to any patient. The reporter pulled it out and there was no plunger on it for the prefilled syringe and the other half of the plunger was in the little tray.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Multisystem inflammatory syndrome in children, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; Multisystem inflammatory syndrome in children; This is a literature report for the following literature source(s).  A case of a 9-year-old girl who received two doses of Pfizer-BioNTech Covid19 vaccine 30 days before developing MIS-C (31 days from vaccine to onset). She had a Sars-Cov2 PCR test for travel purposes while asympomatic that resulted positive 16 days before the onset of her clinical manifestations characterized by fever, gastrointestinal manifestations and prolonged thrombocytopenia. Anti-Spike and anti-Nucleocapsid not tested.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2 cannot be fully excluded. The event multisystem inflammatory syndrome in children is conservatively assessed as related to the suspect drug BNT162B2 based on plausible temporal association but consider also possible contributory effects from medical history of the patient intercurrent CoVID-19 infection and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Inflammation
Clinical narrative: per pt, had an adverse reaction to Fluarix, redness & inflammation
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Received second dose of same flu shot on 10/22/2024.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Large welt on arm in area of injection, just after administration per Pharmacy Intern.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Loss of consciousness, Musculoskeletal stiffness, Syncope, Urinary incontinence
Clinical narrative: Patient had syncope episode approx. 4 minutes following administration of vaccine.  Patient was sitting on bed and stated, "I feel dizzy" LVN then laid patient on bed and she then loss consciousness for approx. 5 seconds. Rapid response initiated to RN and Physican.  Patient had upper body stiffness then became incontinent of urine. Patient was aware and communicative following brief syncope episode. Patient remained in office for 1 hour following administration and was monitored by LVN, RN and Physician.
Age: 68.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Gingival recession, Tooth disorder, Toothache, X-ray dental abnormal
Clinical narrative: Tooth pain upper left
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine given too early for patient's stated age. Patient was to receive Flublok, but patient was given Fluzone High-Dose.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Pruritus, Throat clearing
Clinical narrative: Patient history of mRNA COVID vaccination 3/2021, firs, which triggered a laryngeal click typical for h/o laryngospasm, dizziness, voice changes, and throat clearing/non-productive cough. Tongue felt odd and minimally visible swollen. Pt took diphenhydramine with relief, visited ED x 2 hours, diagnosed with anxiety. Post ED, patient had late phase symptoms  not as severe, without tongue involvement. Had persistent chest tightness/cough x 1.5 wks subsequently.  Pt subsequnetly tolerated 2 Johnson and Johnson viral vector COVID vaccines without complication. Per allergy practice recommendations, readministration of COVID mRNA vaccine was attempted in a monitored setting.   Patient had full dose Moderna vaccine and ~30min following developed itchiness without urticaria and frequent throat clearing, without objective airway angioedema. Patient was given EPI 0.3mg IM, fexofenadine 180mg x 1 and albuterol with normalization of symptoms, however had full recurrence 47 minutes later, prompting rapid response and transport to emergency room from clinic. Patient discharged from the emergency room with dx of low grade anaphylaxis  4 hours following.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Patient said the vaccine hurt and was really sore the next day. A few days later a huge bruise covering most of his deltoid appeared on his arm. He says that the bruise is not painful to the touch and there is no heat present.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Blepharospasm, Blood albumin decreased, Blood alkaline phosphatase increased
Clinical narrative: From hospital discharge summary note:  2-month-old female presenting with status epilepticus.  Patient is a 39 week full-term infant born via SVD without complications.  Went home with mom and has done well.  Mother reports infant has been growing at each we will check.  Yesterday afternoon received for different vaccines (Mother can recall Hep B, RSV immunoprophylaxis and she received 2 more-Mother reports immunizations were at health center).  Following vaccine she was fussy but ate normally without significant problem.  Around 10:00 p.m. mother noted that the patient was occasionally jerking.  What mother describes as the patient is sleeping and then having a myoclonic jerk awake and fussy for a few minutes and then falling back asleep.  And then about 10 30 mother picked the patient up and noticed eyes fluttering, head turned to the side, and jerking of the hands and feet.  They waited for about 3 minutes and then loaded up into their car and came to the hospital.   In the emergency room patient presented with ongoing seizures.  Mother reports it was about 45 minutes from the time they started until they arrived in the emergency room.  Patient was noted to be febrile to 104.  Patient was given Ativan which did not resolve the seizures.  Was then loaded with 20 per kilos of phenobarbital.  5 minutes later the seizure stopped.  Mother estimates a total of 1 hour of seizures.  Blood work and blood cultures were sent, head CT and chest x-ray were obtained.  Given prolonged seizure infant was admitted to the pediatric ICU.   Mother report the patient lives at home with father and 1 older sibling.  Currently no one at home has URI or sick symptoms.  No medications at home, no known drug allergies.  Hospital Course  2-month-old female admitted with complex febrile seizure following 2 month vaccines, also found to be rhino virus positive.  Admitted for antibiotic therapy concern for sepsis and meningitis.  HD1- Broad spectrum antibiotics, continued to be febrile, no further seizure activity, blood culture positive for GPC in clusters.  HD2- Afebrile, no further seizures, eating normally, GPCs are negative for MRSA-vancomycin stopped. blood culture speciated to coag negative staff, likely contaminate, all antibiotics stopped.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose increased
Clinical narrative: From hospital discharge summary note:  2-month-old female presenting with status epilepticus.  Patient is a 39 week full-term infant born via SVD without complications.  Went home with mom and has done well.  Mother reports infant has been growing at each we will check.  Yesterday afternoon received for different vaccines (Mother can recall Hep B, RSV immunoprophylaxis and she received 2 more-Mother reports immunizations were at health center).  Following vaccine she was fussy but ate normally without significant problem.  Around 10:00 p.m. mother noted that the patient was occasionally jerking.  What mother describes as the patient is sleeping and then having a myoclonic jerk awake and fussy for a few minutes and then falling back asleep.  And then about 10 30 mother picked the patient up and noticed eyes fluttering, head turned to the side, and jerking of the hands and feet.  They waited for about 3 minutes and then loaded up into their car and came to the hospital.   In the emergency room patient presented with ongoing seizures.  Mother reports it was about 45 minutes from the time they started until they arrived in the emergency room.  Patient was noted to be febrile to 104.  Patient was given Ativan which did not resolve the seizures.  Was then loaded with 20 per kilos of phenobarbital.  5 minutes later the seizure stopped.  Mother estimates a total of 1 hour of seizures.  Blood work and blood cultures were sent, head CT and chest x-ray were obtained.  Given prolonged seizure infant was admitted to the pediatric ICU.   Mother report the patient lives at home with father and 1 older sibling.  Currently no one at home has URI or sick symptoms.  No medications at home, no known drug allergies.  Hospital Course  2-month-old female admitted with complex febrile seizure following 2 month vaccines, also found to be rhino virus positive.  Admitted for antibiotic therapy concern for sepsis and meningitis.  HD1- Broad spectrum antibiotics, continued to be febrile, no further seizure activity, blood culture positive for GPC in clusters.  HD2- Afebrile, no further seizures, eating normally, GPCs are negative for MRSA-vancomycin stopped. blood culture speciated to coag negative staff, likely contaminate, all antibiotics stopped.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Blood magnesium increased, Blood potassium decreased, Blood sodium normal, Blood urea normal, Carbon dioxide normal
Clinical narrative: From hospital discharge summary note:  2-month-old female presenting with status epilepticus.  Patient is a 39 week full-term infant born via SVD without complications.  Went home with mom and has done well.  Mother reports infant has been growing at each we will check.  Yesterday afternoon received for different vaccines (Mother can recall Hep B, RSV immunoprophylaxis and she received 2 more-Mother reports immunizations were at health center).  Following vaccine she was fussy but ate normally without significant problem.  Around 10:00 p.m. mother noted that the patient was occasionally jerking.  What mother describes as the patient is sleeping and then having a myoclonic jerk awake and fussy for a few minutes and then falling back asleep.  And then about 10 30 mother picked the patient up and noticed eyes fluttering, head turned to the side, and jerking of the hands and feet.  They waited for about 3 minutes and then loaded up into their car and came to the hospital.   In the emergency room patient presented with ongoing seizures.  Mother reports it was about 45 minutes from the time they started until they arrived in the emergency room.  Patient was noted to be febrile to 104.  Patient was given Ativan which did not resolve the seizures.  Was then loaded with 20 per kilos of phenobarbital.  5 minutes later the seizure stopped.  Mother estimates a total of 1 hour of seizures.  Blood work and blood cultures were sent, head CT and chest x-ray were obtained.  Given prolonged seizure infant was admitted to the pediatric ICU.   Mother report the patient lives at home with father and 1 older sibling.  Currently no one at home has URI or sick symptoms.  No medications at home, no known drug allergies.  Hospital Course  2-month-old female admitted with complex febrile seizure following 2 month vaccines, also found to be rhino virus positive.  Admitted for antibiotic therapy concern for sepsis and meningitis.  HD1- Broad spectrum antibiotics, continued to be febrile, no further seizure activity, blood culture positive for GPC in clusters.  HD2- Afebrile, no further seizures, eating normally, GPCs are negative for MRSA-vancomycin stopped. blood culture speciated to coag negative staff, likely contaminate, all antibiotics stopped.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Chest X-ray, Computerised tomogram head, Culture urine negative, Dyskinesia, Febrile convulsion
Clinical narrative: From hospital discharge summary note:  2-month-old female presenting with status epilepticus.  Patient is a 39 week full-term infant born via SVD without complications.  Went home with mom and has done well.  Mother reports infant has been growing at each we will check.  Yesterday afternoon received for different vaccines (Mother can recall Hep B, RSV immunoprophylaxis and she received 2 more-Mother reports immunizations were at health center).  Following vaccine she was fussy but ate normally without significant problem.  Around 10:00 p.m. mother noted that the patient was occasionally jerking.  What mother describes as the patient is sleeping and then having a myoclonic jerk awake and fussy for a few minutes and then falling back asleep.  And then about 10 30 mother picked the patient up and noticed eyes fluttering, head turned to the side, and jerking of the hands and feet.  They waited for about 3 minutes and then loaded up into their car and came to the hospital.   In the emergency room patient presented with ongoing seizures.  Mother reports it was about 45 minutes from the time they started until they arrived in the emergency room.  Patient was noted to be febrile to 104.  Patient was given Ativan which did not resolve the seizures.  Was then loaded with 20 per kilos of phenobarbital.  5 minutes later the seizure stopped.  Mother estimates a total of 1 hour of seizures.  Blood work and blood cultures were sent, head CT and chest x-ray were obtained.  Given prolonged seizure infant was admitted to the pediatric ICU.   Mother report the patient lives at home with father and 1 older sibling.  Currently no one at home has URI or sick symptoms.  No medications at home, no known drug allergies.  Hospital Course  2-month-old female admitted with complex febrile seizure following 2 month vaccines, also found to be rhino virus positive.  Admitted for antibiotic therapy concern for sepsis and meningitis.  HD1- Broad spectrum antibiotics, continued to be febrile, no further seizure activity, blood culture positive for GPC in clusters.  HD2- Afebrile, no further seizures, eating normally, GPCs are negative for MRSA-vancomycin stopped. blood culture speciated to coag negative staff, likely contaminate, all antibiotics stopped.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Gram stain positive, Haematocrit decreased, Haemoglobin decreased, Human rhinovirus test positive, Infant irritability
Clinical narrative: From hospital discharge summary note:  2-month-old female presenting with status epilepticus.  Patient is a 39 week full-term infant born via SVD without complications.  Went home with mom and has done well.  Mother reports infant has been growing at each we will check.  Yesterday afternoon received for different vaccines (Mother can recall Hep B, RSV immunoprophylaxis and she received 2 more-Mother reports immunizations were at health center).  Following vaccine she was fussy but ate normally without significant problem.  Around 10:00 p.m. mother noted that the patient was occasionally jerking.  What mother describes as the patient is sleeping and then having a myoclonic jerk awake and fussy for a few minutes and then falling back asleep.  And then about 10 30 mother picked the patient up and noticed eyes fluttering, head turned to the side, and jerking of the hands and feet.  They waited for about 3 minutes and then loaded up into their car and came to the hospital.   In the emergency room patient presented with ongoing seizures.  Mother reports it was about 45 minutes from the time they started until they arrived in the emergency room.  Patient was noted to be febrile to 104.  Patient was given Ativan which did not resolve the seizures.  Was then loaded with 20 per kilos of phenobarbital.  5 minutes later the seizure stopped.  Mother estimates a total of 1 hour of seizures.  Blood work and blood cultures were sent, head CT and chest x-ray were obtained.  Given prolonged seizure infant was admitted to the pediatric ICU.   Mother report the patient lives at home with father and 1 older sibling.  Currently no one at home has URI or sick symptoms.  No medications at home, no known drug allergies.  Hospital Course  2-month-old female admitted with complex febrile seizure following 2 month vaccines, also found to be rhino virus positive.  Admitted for antibiotic therapy concern for sepsis and meningitis.  HD1- Broad spectrum antibiotics, continued to be febrile, no further seizure activity, blood culture positive for GPC in clusters.  HD2- Afebrile, no further seizures, eating normally, GPCs are negative for MRSA-vancomycin stopped. blood culture speciated to coag negative staff, likely contaminate, all antibiotics stopped.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Intensive care, Myoclonus, Neutrophil count normal, Platelet count increased, Posture abnormal
Clinical narrative: From hospital discharge summary note:  2-month-old female presenting with status epilepticus.  Patient is a 39 week full-term infant born via SVD without complications.  Went home with mom and has done well.  Mother reports infant has been growing at each we will check.  Yesterday afternoon received for different vaccines (Mother can recall Hep B, RSV immunoprophylaxis and she received 2 more-Mother reports immunizations were at health center).  Following vaccine she was fussy but ate normally without significant problem.  Around 10:00 p.m. mother noted that the patient was occasionally jerking.  What mother describes as the patient is sleeping and then having a myoclonic jerk awake and fussy for a few minutes and then falling back asleep.  And then about 10 30 mother picked the patient up and noticed eyes fluttering, head turned to the side, and jerking of the hands and feet.  They waited for about 3 minutes and then loaded up into their car and came to the hospital.   In the emergency room patient presented with ongoing seizures.  Mother reports it was about 45 minutes from the time they started until they arrived in the emergency room.  Patient was noted to be febrile to 104.  Patient was given Ativan which did not resolve the seizures.  Was then loaded with 20 per kilos of phenobarbital.  5 minutes later the seizure stopped.  Mother estimates a total of 1 hour of seizures.  Blood work and blood cultures were sent, head CT and chest x-ray were obtained.  Given prolonged seizure infant was admitted to the pediatric ICU.   Mother report the patient lives at home with father and 1 older sibling.  Currently no one at home has URI or sick symptoms.  No medications at home, no known drug allergies.  Hospital Course  2-month-old female admitted with complex febrile seizure following 2 month vaccines, also found to be rhino virus positive.  Admitted for antibiotic therapy concern for sepsis and meningitis.  HD1- Broad spectrum antibiotics, continued to be febrile, no further seizure activity, blood culture positive for GPC in clusters.  HD2- Afebrile, no further seizures, eating normally, GPCs are negative for MRSA-vancomycin stopped. blood culture speciated to coag negative staff, likely contaminate, all antibiotics stopped.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Protein total decreased, Pyrexia, Respiratory pathogen panel, Seizure, Staphylococcus test negative
Clinical narrative: From hospital discharge summary note:  2-month-old female presenting with status epilepticus.  Patient is a 39 week full-term infant born via SVD without complications.  Went home with mom and has done well.  Mother reports infant has been growing at each we will check.  Yesterday afternoon received for different vaccines (Mother can recall Hep B, RSV immunoprophylaxis and she received 2 more-Mother reports immunizations were at health center).  Following vaccine she was fussy but ate normally without significant problem.  Around 10:00 p.m. mother noted that the patient was occasionally jerking.  What mother describes as the patient is sleeping and then having a myoclonic jerk awake and fussy for a few minutes and then falling back asleep.  And then about 10 30 mother picked the patient up and noticed eyes fluttering, head turned to the side, and jerking of the hands and feet.  They waited for about 3 minutes and then loaded up into their car and came to the hospital.   In the emergency room patient presented with ongoing seizures.  Mother reports it was about 45 minutes from the time they started until they arrived in the emergency room.  Patient was noted to be febrile to 104.  Patient was given Ativan which did not resolve the seizures.  Was then loaded with 20 per kilos of phenobarbital.  5 minutes later the seizure stopped.  Mother estimates a total of 1 hour of seizures.  Blood work and blood cultures were sent, head CT and chest x-ray were obtained.  Given prolonged seizure infant was admitted to the pediatric ICU.   Mother report the patient lives at home with father and 1 older sibling.  Currently no one at home has URI or sick symptoms.  No medications at home, no known drug allergies.  Hospital Course  2-month-old female admitted with complex febrile seizure following 2 month vaccines, also found to be rhino virus positive.  Admitted for antibiotic therapy concern for sepsis and meningitis.  HD1- Broad spectrum antibiotics, continued to be febrile, no further seizure activity, blood culture positive for GPC in clusters.  HD2- Afebrile, no further seizures, eating normally, GPCs are negative for MRSA-vancomycin stopped. blood culture speciated to coag negative staff, likely contaminate, all antibiotics stopped.