chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Got up 2am to use the rest room passing out; Hitting my head on the toilet; Hot flash an hr later; Cool chills in the middle of the night; Feeling horrible; Wrong dose administered/2.5 mL of dose was administered; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Got up 2am to use the rest room passing out) in a 36-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043153) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 2.5 milliliter. On 16-Nov-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced INCORRECT DOSE ADMINISTERED (Wrong dose administered/2.5 mL of dose was administered). On 17-Nov-2024, the patient experienced LOSS OF CONSCIOUSNESS (Got up 2am to use the rest room passing out) (seriousness criterion medically significant), HEAD INJURY (Hitting my head on the toilet), HOT FLUSH (Hot flash an hr later), CHILLS (Cool chills in the middle of the night) and FEELING ABNORMAL (Feeling horrible). On 17-Nov-2024, CHILLS (Cool chills in the middle of the night) and FEELING ABNORMAL (Feeling horrible) had resolved with sequelae. At the time of the report, LOSS OF CONSCIOUSNESS (Got up 2am to use the rest room passing out), HEAD INJURY (Hitting my head on the toilet), HOT FLUSH (Hot flash an hr later) and INCORRECT DOSE ADMINISTERED (Wrong dose administered/2.5 mL of dose was administered) outcome was unknown.        Company comment: This spontaneous case concerns a 36-year-old male patient who experienced serious (due to medically significant) unexpected event of Loss of consciousness. The event is assessed as related to vaccination due to close temporal association and known safety profile of vaccine. The patient also experienced non  serious event of Head injury, Hot flush, Chills, Feeling abnormal, Incorrect dose administered. The benefit-risk relationship of product is not affected by this report.     Concomitant medication was not provided. It was reported that, patient felt cool chills in the middle of the night and then hot flash an hour later. He got up at 2am to use the rest room and passed out and hit his head on the toilet, clawed back to bed feeling horrible. Treatment information was not reported.
Age: 60.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Chills, Illness, Pain
Clinical narrative: Body Aches; Chills; Got Sick; This is a spontaneous report received from a Nurse, Program ID.  A 60-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Nov2024 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), in Nov2024 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Rheum Arth Wo Rheum Fctr Mult Sites" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Nov2024, outcome "recovered", described as "Body Aches"; CHILLS (non-serious) with onset Nov2024, outcome "recovered"; ILLNESS (non-serious) with onset Nov2024, outcome "recovered", described as "Got Sick".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Mucous stools
Clinical narrative: Stomach cramping; Passing some mucus; Diarrhea; This is a spontaneous report received from a Consumer or other non HCP.  An 80-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 19Nov2024 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset Nov2024, outcome "unknown", described as "Diarrhea"; MUCOUS STOOLS (non-serious) with onset Nov2024, outcome "unknown", described as "Passing some mucus"; ABDOMINAL PAIN UPPER (non-serious) with onset Nov2024, outcome "unknown", described as "Stomach cramping".  Additional information: patient stated, "her husband and she both had, and they think it might be an adverse reaction from Covid vaccine (clarified as Pfizer Covid 19 vaccine) that they just had. He had his yesterday (20Nov2024), and she had her day before (19Nov2024), and he was a physician (husband), so they thought they should call it and call Pfizer all in." When probed for the adverse events, patient stated, "It was one of the minor one. They both had stomach cramping and a lot of, and she had in some diarrhea and passing some mucus.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Stomach cramping; This is a spontaneous report received from a consumer.  A 77-year-old male patient received BNT162b2 omicron (KP.2) (COMIRNATY (2024-2025 FORMULA)), on 20Nov2024 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset Nov2024, outcome "unknown", described as "Stomach cramping".  Additional Information: The patient had his vaccine the day before reporting (20Nov2024) and they decided to call the company. The patient (physician) and his wife think that it might be an adverse reaction from the Pfizer COVID-19 vaccine that they just had. It is one of the minor ones. They both have stomach cramping.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pyrexia
Clinical narrative: fever; chills; joint aches; severe headache; This is a spontaneous report received from a Consumer or other non HCP.  A 50-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 20Nov2024 at 09:00 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATENOLOL; LEXAPRO; LEVOTHYROXINE; WELLBUTRIN; RALOXIFENE. Vaccination history included: BNT162b2 (Dose Number: 1, SINGLE, Batch/Lot No: EL3247, Vaccine Administration Time: 15:20, Anatomical Site of injection: Right Arm, Route of administration: Intramuscular), administration date: 24Feb2021, when the patient was 46-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, SINGLE, Batch/Lot No: EL3248, Vaccine Administration Time: 14:30, Anatomical Site of injection: Right Arm, Route of administration: Intramuscular), administration date: 16Mar2021, when the patient was 46-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: 330308D, Vaccine Administration Time: 10:15, Anatomical Site of injection: Right Arm, Route of administration: Intramuscular), administration date: 29Nov2021, when the patient was 47-year-old, for COVID-19 Immunization; BNT162b2, BNT162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, Lot number: GJ3275, Vaccine Administration Time: 11:30, Anatomical Site of injection: Arm Right), administration date: 04Nov2022, when the patient was 48-year-old, for COVID-19 Immunization; BNT162b2 omi xbb.1.5 (DOSE 1, SINGLE, Lot number: HG2282, Vaccine Administration Time: 18:00, Anatomical Site of injection: Arm Left), administration date: 25Oct2023, when the patient was 49-year-old, for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 20Nov2024 at 21:00, outcome "recovering"; PYREXIA (non-serious) with onset 20Nov2024 at 21:00, outcome "recovering", described as "fever"; ARTHRALGIA (non-serious) with onset 20Nov2024 at 21:00, outcome "recovering", described as "joint aches"; HEADACHE (non-serious) with onset 20Nov2024 at 21:00, outcome "recovering", described as "severe headache". Therapeutic measures were not taken as a result of pyrexia, chills, arthralgia, headache.  Additional information: Patient had no known allergies. The patient did not receive any other vaccines on the same date as the suspect. The patient did not receive any other vaccines within 4 weeks prior to the suspect. The patient was not taking any other medications within 2 weeks of the event starting.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300349543 Same patient, different dose/events;US-PFIZER INC-202201280307 Same patient, different dose/events;US-PFIZER INC-202101701106 Same patient, different dose/events;
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on her hand; This is a spontaneous report received from a Consumer or other non HCP.  A 26-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 21Nov2024 as dose 1, single (Lot number: LM2212) at the age of 26 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Tachycardia" (unspecified if ongoing); "Anemia iron deficiency", start date: 19Nov2024 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1; Lot Number: EW0151), administration date: 2021, for COVID-19 immunisation; Bnt162b2 omi xbb.1.5 (DOSE 2; Lot Number: HG2649), administration date: 2023, for COVID-19 immunisation. The following information was reported: RASH (non-serious) with onset 21Nov2024, outcome "unknown", described as "rash on her hand".  Additional information: It was reported that the patient had blood drawn 2 days ago (19Nov2024) and everything was fine except anemia, iron deficiency and the patient was not taking any treatment for it since she just got it. The patient was not yet taking any treatment for the hand rash but was going to take cetirizine (ZYRTEC).  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : 2021509109 Same patient and product/different dose/ events;
Age: 41.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Herpes zoster
Clinical narrative: first time shingles rash appeared in the right T12 dermatome; This is a spontaneous report received from a Physician.  A 41-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 23Sep2024 as dose 1, single (Lot number: LM2210) at the age of 41 years, in left arm for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), on 23Sep2024 as dose 1, single (Lot number: UT8468NA), in right arm. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN E NOS. The patient also took other concomitant therapy which includes Air Shield Dietary Supplement (batch lot number: 31261-1). The following information was reported: HERPES ZOSTER (non-serious) with onset 13Nov2024, outcome "recovering", described as "first time shingles rash appeared in the right T12 dermatome". Therapeutic measures were taken as a result of herpes zoster.  Additional information: 7 weeks after vaccination, a first time shingles rash appeared in the right T12 dermatome. Patient was a healthy person, without comorbidities, or any other cause for shingles. As a treatment patient received, valaciclovir 1000mg 3 times daily for 7 days.
Sex: M
Vaccine: COVID19, FLUX, UNK
Symptoms: Pain in extremity
Clinical narrative: leg seemed a little sore; This is a spontaneous report received from a Consumer or other non HCP.  An infant male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; nirsevimab (BEYFORTUS [NIRSEVIMAB]), as dose number unknown, single) intramuscular for respiratory syncytial virus immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "leg seemed a little sore".  Additional Information: It was reported that the patient's leg seemed a little sore for a day or two.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19, FLU3
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: SARS-COV-2 test positive; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), as dose number unknown, single), in arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE; LISINOPRIL. The following information was reported: COVID-19 (non-serious), outcome "unknown", described as "SARS-COV-2 test positive". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reportedly, the reporter stated that he had a covid vaccine shot on Thursday (as reported) and he was experiencing symptoms of COVID. The reporter had also the flu vaccine at the same time but his wife (patient) had the same two shots the day before, she has tested positive for COVID, the reporter tested negative but  have the same symptoms as his wife (patient).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This is a spontaneous report received from an Other HCP, Program ID.  A 67-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Nov2024 as dose 1, 30ug, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), in Nov2024 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset Nov2024, outcome "unknown", described as "flu like symptoms".  Additional information: The patient reported that for about three days after receiving the covid vaccine (COMIRNATY 2023-24: 30MCG/0.3ML strength) and flu vaccine together, she had flu like symptoms and felt like going to bed. she received the vaccines about three weeks ago.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: it made her arm stiff for days; This is a spontaneous report received from an Other HCP, Program ID.  A 61-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Apr2024 as dose 1, 30 ug single (Batch/Lot number: unknown) at the age of 61 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2024, outcome "unknown", described as "it made her arm stiff for days".  Additional information: The patient reported that the last time she received the vaccine, it made her arm stiff for days and she didn't like that.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Paraesthesia oral, Tension headache
Clinical narrative: Blood pressure increased; Paraesthesia oral; Dizziness; Tension headache; Initial information received on 20-Nov-2024 regarding an unsolicited valid non-serious courtesy case  received from Non-Healthcare Professional via Novavax.  This case involves a 62 years old female patient who had blood pressure increased, paraesthesia oral, dizziness and tension headache after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK] and Novavax COVID-19 Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Phentermine (Phentermine) for Product used for unknown indication.  On 02-Oct-2024, the patient received (dose 1) of suspect Novavax COVID-19 Vaccine not produced by Sanofi Pasteur (lot 6024MF012) via intramuscular route and on an unknown date, INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (unknown strength, dosage, formulation, expiry, lot number and route) in unknown administration site for prophylactic vaccination.  On 02-Oct-2024, the patient developed blood pressure increased, paraesthesia oral, dizziness and tension headache following the administration of Novavax COVID-19 Vaccine and following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Relevant laboratory test results included: Blood pressure measurement - On 02-Oct-2024: [HIGHLY ELEVATED].  Reportedly, also experienced tingling on her lips.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.  Sender's comment: COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula).The events Blood pressure increased, Dizziness, Paraesthesia oral and Tension headache were reported as non-serious.Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Blood pressure increased, Dizziness, Paraesthesia oral, Tension headache is considered possible.
Age: 42.0
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Off label use
Clinical narrative: Intentional Off Label Prescription by HCP: Imovax prescribed with off label Open bite of left upper arm, initial encounter with no reported adverse event; Initial information received on 14-Nov-2024 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 42 years old and unknown gender patient who received IPV (VERO) [IMOVAX] as intentional off label prescription by hcp (health care professional): imovax prescribed with off label open bite of left upper arm, initial encounter 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 received 1 ml (4X) (4 times) of suspect IPV (VERO) Powder for solution for injection via intramuscular route (unknown strength, expiry and lot number) in unknown administration site for pre-exposure and post-exposure prophylaxis against rabbis and Open bite of left upper arm, initial encounter was intentional off label prescription by hcp: imovax prescribed with off label open bite of left upper arm, initial encounter with no reported adverse event (off label use) (unknown latency).  Reportedly, intentional off label prescription by health care professional.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Poor quality product administered
Clinical narrative: vaccines were given to patients after suffering a Temperature excursion, with no reported adverse event; Initial information received on 15-Nov-2024 regarding an unsolicited valid  non-serious case received from a other healthcare professional.  This case involves an unknown age and unknown gender patient who received  covid-19 vaccine and influenza vaccine after suffering a temperature excursion, with no reported adverse event.  The patient's past medical history, medical treatment(s), Concomitant medications, vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect COVID-19 VACCINE (unknown strength, lot, formulation and expiry date) not produced by Sanofi Pasteur via unknown route in unknown administration site and unknown dose of suspect influenza vaccine (unknown strength, lot, formulation and expiry date) produced by unknown manufacturer via unknown route in unknown administration site for prophylactic vaccination after suffering a temperature excursion, with no reported adverse event (poor quality product administered) (Latency same day).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, The excursion details are unknown. The name of the vaccines are also unknown. The HCP states the manufacturer of the vaccines are PFIZER and SANOFI but did not differentiate which product was manufactured by which company. This report is serving as a precautionary AE since temperature details are unknown. No MERCK products were involved. No symptomatic adverse events were reported.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 18.0
Sex: F
Vaccine: MEN
Symptoms: Extra dose administered, No adverse event
Clinical narrative: inappropriate use due to administering extra dose of MENQUADFI with no reported adverse event; Initial information received on 18-Nov-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 18 years old female patient who had inappropriate use due to administering extra dose of Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On 12-Nov-2024, the patient received a  dose of 0.5 ml of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine (Solution for injection) lot U8193AB,strength, expiry date was unknown via intramuscular route in the right arm for Immunization and inappropriate use due to administering extra dose of menquadfi with no reported adverse event (extra dose administered) (latency : same day).  Reportedly "previous dose 28MAR2022."  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: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Endotracheal intubation, Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome; Initial information received on 18-Nov-2024 regarding an unsolicited valid serious case received from a health professional.  This case involves a 83 years old female patient who experienced guillain-barre syndrome, after receiving vaccine Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Oct-2024, the patient received (0.5 ml) dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (strength: not reported) (lot: U8515CA, Expiry date: not reported) via intramuscular route in the left deltoid for Immunization.  On 13-Nov-2024, the patient developed guillain-barre syndrome (latency: 1 month 5) days following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine.   Reportedly, the patient was hospitalized and intubated shortly after receiving the dose, and she was diagnosed with Guillain-Barre syndrome.  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  Seriousness criteria: This event was assessed as medically significant. The patient was hospitalized for this event.; Sender's Comments: Sanofi company comment dated 26-Nov-2024: This case involves a 83 years old female patient who experienced guillain-barre syndrome, after receiving vaccine Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose].The causal role of the vaccine cannot be denied for the event, however, lack of information regarding past medical history, medical treatment and family history, preclude a comprehensive assessment in this case.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acute myocardial infarction, Angiocardiogram, Cardiac arrest, Deep vein thrombosis, Echocardiogram
Clinical narrative: PFIZER #1 1/27/2021 PFIZER #2 2/24/2021 PFIZER #3 8/20/2021 PFIZER #4 7/8/2022.  PATIENT HAD BASELINE ITP SEVERE HTN SPLENECTOMY UNDERWENT RENAL TRANSPLANT 2020 THEN DEVELOPED ACUTE COVID-19 TREATED WITH MONOCLONAL ANTIBODIES AND HOSPITALIZATION.  AFTER HIS BOUT WITH ACUTE COVID19 THE SERIES OF FOUR MRNA VACCINES WERE GIVEN.  HE THEN DEVELOPED A RIGHT LEG DVT 2023.  IN 2024 HE SUFFERED A CARDIAC ARREST AMI REQUIRED CPR AND RESUSCITATION AND PRIMARY PCI OF LAD AND LCX BY REPORT.  HE HAS BEEN TREATED WITH ELIQUIS, JARDIANCE, VASCEPA, BRILINTA, AMIODARONE, METOPROLOL,  PREDNISON, TACROLIMUS, REPATHA, AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Laboratory test, Percutaneous coronary intervention, Resuscitation, Ultrasound Doppler
Clinical narrative: PFIZER #1 1/27/2021 PFIZER #2 2/24/2021 PFIZER #3 8/20/2021 PFIZER #4 7/8/2022.  PATIENT HAD BASELINE ITP SEVERE HTN SPLENECTOMY UNDERWENT RENAL TRANSPLANT 2020 THEN DEVELOPED ACUTE COVID-19 TREATED WITH MONOCLONAL ANTIBODIES AND HOSPITALIZATION.  AFTER HIS BOUT WITH ACUTE COVID19 THE SERIES OF FOUR MRNA VACCINES WERE GIVEN.  HE THEN DEVELOPED A RIGHT LEG DVT 2023.  IN 2024 HE SUFFERED A CARDIAC ARREST AMI REQUIRED CPR AND RESUSCITATION AND PRIMARY PCI OF LAD AND LCX BY REPORT.  HE HAS BEEN TREATED WITH ELIQUIS, JARDIANCE, VASCEPA, BRILINTA, AMIODARONE, METOPROLOL,  PREDNISON, TACROLIMUS, REPATHA, AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Aspiration joint, Injected limb mobility decreased, Magnetic resonance imaging abnormal, Magnetic resonance imaging joint, Mobility decreased
Clinical narrative: I developed SIRVA in the left arm.  Over a 4 year period I experienced progressive arm weakness, pain, loss of mobility.  After I received my shot Oct 2020 I had a little soreness but it stayed constant for several months while I worked at the hospital through the pandemic.  Eventually I was seen, by orthopedics, physical therapy and the primary MD.  I have recovered about 75% but still have soreness when utilized too much.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pain, Pain in extremity, Rotator cuff syndrome, Shoulder injury related to vaccine administration
Clinical narrative: I developed SIRVA in the left arm.  Over a 4 year period I experienced progressive arm weakness, pain, loss of mobility.  After I received my shot Oct 2020 I had a little soreness but it stayed constant for several months while I worked at the hospital through the pandemic.  Eventually I was seen, by orthopedics, physical therapy and the primary MD.  I have recovered about 75% but still have soreness when utilized too much.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Tendon disorder
Clinical narrative: I developed SIRVA in the left arm.  Over a 4 year period I experienced progressive arm weakness, pain, loss of mobility.  After I received my shot Oct 2020 I had a little soreness but it stayed constant for several months while I worked at the hospital through the pandemic.  Eventually I was seen, by orthopedics, physical therapy and the primary MD.  I have recovered about 75% but still have soreness when utilized too much.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Injection site bruising, Injection site discharge, Injection site haemorrhage, Injection site induration, Injection site mass
Clinical narrative: Patient reported to us on 11/26 signs of bruising/ bleeding / blackish color and a knot or hardness near where the injection was given.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain developed 1 week after COVID-19 and Influenza vaccine administered.  Pain mild but persisted for 5 days.  Possibly pericarditis per description of pain.  Pain spontaneously resolved.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: PATIENT GOT VERY SWOLLEN ARM FOR SEVERAL DAYS, HAD TO TAKE BENEDRYL. ARM IS STILL SORE A WEEK LATER
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: The next day the patient awoke with a swollen face. Patient called their Dr who suggested they take tylenol and Benadryl, by the evening the swelling was down and patient was feeling normal.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine administration error: administered dose subcutaneously. Misread instructions for what to do in this case and thought it said to administer a repeat dose that day. Administered another dose IM approximately 5-10 minutes later, in the same arm per patient request. Later on, told a fellow nurse about administering the second dose and that nurse informed me that I should not have administered a 2nd dose.
Age: 46.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Hypoaesthesia, Impaired driving ability, Mental impairment, Throat tightness
Clinical narrative: Within 30 of the vaccines, I began to feel dizzy and numb in my left side. Started to feel my throat close up and was hard to comprehend and communicate. The doctor in the clinic at the time told me to sit in the waiting room which I did, for about an hour, because I did not feel comfortable driving and felt like I was having an allergic reaction.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Urticaria
Clinical narrative: Hives: scalp, face, ears,  arms, upper thighs, groin, ears, neck, stomach, back
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: Patient presented to clinic with foster parent for 4 month immunizations for DTap, IPV, HIB, PCV, Rotarix. Vaccines verified by MA. Administered oral rotarix and IM injection of PCV to right thigh. Partially administered combo IM injection of DTap,HIB, IPV to left thigh, partial injection related to patient movement. When administering this injection pt flexed her leg, parent was hold pt and attempted to help with holding pts leg. When I was injecting the vaccine, the plunger stopped and because of mothers positioning of her arm I was unable to see the needle, for safety I removed the needle and noted the injection was not fully administered.  This is a report of parial administration no adverse reaction was noted or reported per foster mother.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Presyncope
Clinical narrative: Patient with nausea and vasovagal response approx 5 min after vaccine administered
Age: 68.0
Sex: M
Vaccine: TDAP
Symptoms: Biopsy skin abnormal, Hypersensitivity, Urticaria
Clinical narrative: Hives breakout covering arms, legs, stomach and butt
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Started with a few hives in the pm of the 25th of November on my upper inner right arm then moved to my left inner arm. By 3 am on November 26th my arms and legs were covered in hives and spreading to neck face back chest and abdomen. Taking benadryl and Prednisone
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: The patient received a second flu shot on 11/25 after receiving one on 9/13 at this location.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: He got the flucelvax on 8/22 then again on 11/25. The patient has had no problems since this last vaccine to our knowledge. He has not been available so far when we have tried to call him.
Age: 0.58
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Immediate post-injection reaction, Injection site mass, Injection site nodule, Injection site swelling
Clinical narrative: Parents noted a lump/bump at injection site immediately after vaccine administration. They brought him in for an unrelated reason 1 month later and mentioned that the bump was still there. Small nodule palpated at injection site. Nodule not visible d/t size and fat distribution. No signs of infection or inflammation. Nodule appears to be cutaneous lymphoid hyperplasia.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: area surrounding the injection site is swollen, red, raised area, warm to the touch and itching. size of a tangerine.  I recommended that patient take Tylenol to help with swelling and discomfort, and to contact her primary care for potential preventative antibiotic in case of cellutitis
Age: 4.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Contusion, Immune thrombocytopenia, Petechiae, Platelet count decreased
Clinical narrative: Developed bruising and petechiae, found to have ITP with platelet count of 7 on 10/18/24.  Seen in the ED, treated with steroids and platelet count improved.  Clinically doing well now.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Blood test, Cardiovascular disorder, Chest scan, Cough
Clinical narrative: Constant coughing (smoker's cough), fluid in lungs, pneumonia, collapsed lung. Began within two weeks of injection and progressed to reduced oxygen, lack of blood flow, difficulty breathing, fluid in lungs, pneumonia and a collapsed lung. Child spent 4 weeks in the NICU to recover from this injury and has sustained long lasting asthma and difficulties with breathing in general.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Endotracheal intubation, Intensive care, Magnetic resonance imaging, Oxygen saturation decreased
Clinical narrative: Constant coughing (smoker's cough), fluid in lungs, pneumonia, collapsed lung. Began within two weeks of injection and progressed to reduced oxygen, lack of blood flow, difficulty breathing, fluid in lungs, pneumonia and a collapsed lung. Child spent 4 weeks in the NICU to recover from this injury and has sustained long lasting asthma and difficulties with breathing in general.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, Pneumothorax, Pulmonary oedema, Ultrasound scan, X-ray
Clinical narrative: Constant coughing (smoker's cough), fluid in lungs, pneumonia, collapsed lung. Began within two weeks of injection and progressed to reduced oxygen, lack of blood flow, difficulty breathing, fluid in lungs, pneumonia and a collapsed lung. Child spent 4 weeks in the NICU to recover from this injury and has sustained long lasting asthma and difficulties with breathing in general.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray normal, Cough, Cyanosis, Dyspnoea, Ocular hyperaemia
Clinical narrative: Child began having difficulty breathing, pulse ox reporting o2 as low as 93, low grade fever 101, child is having coughing fits resulting in blood loss to the brain as evidence by reddened eyes, blue lips.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Child began having difficulty breathing, pulse ox reporting o2 as low as 93, low grade fever 101, child is having coughing fits resulting in blood loss to the brain as evidence by reddened eyes, blue lips.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Periorbital swelling
Clinical narrative: Patient  received her Spikevax vaccine lot 8081561  on left arm on 11/17/2024. On 2024 she came by the pharmacy and explained she had been informed by prescriber that puffiness in her left eye was due to the Spikevax covid vaccine that she recieved on 11/17/2024
Age: 29.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Headache, Lethargy, Lymphadenopathy, Myalgia
Clinical narrative: Fever, muscle aches, headache, lethargy, weakness, swollen post auricular lymph nodes  1 week post vaccine
Age: 29.0
Sex: F
Vaccine: RSV
Symptoms: Pyrexia
Clinical narrative: Fever, muscle aches, headache, lethargy, weakness, swollen post auricular lymph nodes  1 week post vaccine
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Balance disorder, Burning sensation, COVID-19, Cognitive disorder, Computerised tomogram head
Clinical narrative: 10/22/22: burning sensation up neck seconds following injection, few hours later, spent almost 24 hours unable to be awake, walk, dizzy, unwell, severe flu like symptoms. Lifted about 24 hours later.  11/18/22 & 11/24/22: evil headaches, not typical. 11/26/22: dropped to ground with vertigo. 12/9/22: dizzy sensations. 1/19/24: dizzy. Starting 2/3/23 and going for several weeks: dizzy showering/water pricks on neck/hot, cooking, pressure eyes, L eye shadow, headaches, ears ringing, feet & knees down tingling, hands numb, jumping gym trigger, sinus headache, weird to swallow, tension, fatigue, L face nerve pain, burning left side back neck/down arm, cognition impaired, visual/auditory hypersensitivity. 3/12/23: first panic attack. 3/14/23: L horizontal canal cupulolithiasis. BPPV on and off DX. Vestibular hypo function and balance issues on and off. PPPD. CT Sinus. Brain MRI. VNG/audiologist. ENT. Zoloft. Vestibular PT. Vision Therapy. OT, Cranial Sacral. Massage. Brainspotting Therapy. Ativan. Valium. Neurologist consults x2. Symptoms continued for several months, responded to treatments, then got covid + 9/12/23 and regressed backwards. Covid again 8/25/24 and regressed backwards again.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dizziness, Dysphagia, Electronystagmogram, Fatigue, Gait inability
Clinical narrative: 10/22/22: burning sensation up neck seconds following injection, few hours later, spent almost 24 hours unable to be awake, walk, dizzy, unwell, severe flu like symptoms. Lifted about 24 hours later.  11/18/22 & 11/24/22: evil headaches, not typical. 11/26/22: dropped to ground with vertigo. 12/9/22: dizzy sensations. 1/19/24: dizzy. Starting 2/3/23 and going for several weeks: dizzy showering/water pricks on neck/hot, cooking, pressure eyes, L eye shadow, headaches, ears ringing, feet & knees down tingling, hands numb, jumping gym trigger, sinus headache, weird to swallow, tension, fatigue, L face nerve pain, burning left side back neck/down arm, cognition impaired, visual/auditory hypersensitivity. 3/12/23: first panic attack. 3/14/23: L horizontal canal cupulolithiasis. BPPV on and off DX. Vestibular hypo function and balance issues on and off. PPPD. CT Sinus. Brain MRI. VNG/audiologist. ENT. Zoloft. Vestibular PT. Vision Therapy. OT, Cranial Sacral. Massage. Brainspotting Therapy. Ativan. Valium. Neurologist consults x2. Symptoms continued for several months, responded to treatments, then got covid + 9/12/23 and regressed backwards. Covid again 8/25/24 and regressed backwards again.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Hyperacusis, Hypoaesthesia, Magnetic resonance imaging head, Malaise
Clinical narrative: 10/22/22: burning sensation up neck seconds following injection, few hours later, spent almost 24 hours unable to be awake, walk, dizzy, unwell, severe flu like symptoms. Lifted about 24 hours later.  11/18/22 & 11/24/22: evil headaches, not typical. 11/26/22: dropped to ground with vertigo. 12/9/22: dizzy sensations. 1/19/24: dizzy. Starting 2/3/23 and going for several weeks: dizzy showering/water pricks on neck/hot, cooking, pressure eyes, L eye shadow, headaches, ears ringing, feet & knees down tingling, hands numb, jumping gym trigger, sinus headache, weird to swallow, tension, fatigue, L face nerve pain, burning left side back neck/down arm, cognition impaired, visual/auditory hypersensitivity. 3/12/23: first panic attack. 3/14/23: L horizontal canal cupulolithiasis. BPPV on and off DX. Vestibular hypo function and balance issues on and off. PPPD. CT Sinus. Brain MRI. VNG/audiologist. ENT. Zoloft. Vestibular PT. Vision Therapy. OT, Cranial Sacral. Massage. Brainspotting Therapy. Ativan. Valium. Neurologist consults x2. Symptoms continued for several months, responded to treatments, then got covid + 9/12/23 and regressed backwards. Covid again 8/25/24 and regressed backwards again.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Neuralgia, Ocular discomfort, Otolithiasis, Pain, Panic attack
Clinical narrative: 10/22/22: burning sensation up neck seconds following injection, few hours later, spent almost 24 hours unable to be awake, walk, dizzy, unwell, severe flu like symptoms. Lifted about 24 hours later.  11/18/22 & 11/24/22: evil headaches, not typical. 11/26/22: dropped to ground with vertigo. 12/9/22: dizzy sensations. 1/19/24: dizzy. Starting 2/3/23 and going for several weeks: dizzy showering/water pricks on neck/hot, cooking, pressure eyes, L eye shadow, headaches, ears ringing, feet & knees down tingling, hands numb, jumping gym trigger, sinus headache, weird to swallow, tension, fatigue, L face nerve pain, burning left side back neck/down arm, cognition impaired, visual/auditory hypersensitivity. 3/12/23: first panic attack. 3/14/23: L horizontal canal cupulolithiasis. BPPV on and off DX. Vestibular hypo function and balance issues on and off. PPPD. CT Sinus. Brain MRI. VNG/audiologist. ENT. Zoloft. Vestibular PT. Vision Therapy. OT, Cranial Sacral. Massage. Brainspotting Therapy. Ativan. Valium. Neurologist consults x2. Symptoms continued for several months, responded to treatments, then got covid + 9/12/23 and regressed backwards. Covid again 8/25/24 and regressed backwards again.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Persistent postural-perceptual dizziness, Photophobia, SARS-CoV-2 test positive, Skin burning sensation
Clinical narrative: 10/22/22: burning sensation up neck seconds following injection, few hours later, spent almost 24 hours unable to be awake, walk, dizzy, unwell, severe flu like symptoms. Lifted about 24 hours later.  11/18/22 & 11/24/22: evil headaches, not typical. 11/26/22: dropped to ground with vertigo. 12/9/22: dizzy sensations. 1/19/24: dizzy. Starting 2/3/23 and going for several weeks: dizzy showering/water pricks on neck/hot, cooking, pressure eyes, L eye shadow, headaches, ears ringing, feet & knees down tingling, hands numb, jumping gym trigger, sinus headache, weird to swallow, tension, fatigue, L face nerve pain, burning left side back neck/down arm, cognition impaired, visual/auditory hypersensitivity. 3/12/23: first panic attack. 3/14/23: L horizontal canal cupulolithiasis. BPPV on and off DX. Vestibular hypo function and balance issues on and off. PPPD. CT Sinus. Brain MRI. VNG/audiologist. ENT. Zoloft. Vestibular PT. Vision Therapy. OT, Cranial Sacral. Massage. Brainspotting Therapy. Ativan. Valium. Neurologist consults x2. Symptoms continued for several months, responded to treatments, then got covid + 9/12/23 and regressed backwards. Covid again 8/25/24 and regressed backwards again.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Syncope, Tension, Tinnitus, Vertigo, Vertigo positional
Clinical narrative: 10/22/22: burning sensation up neck seconds following injection, few hours later, spent almost 24 hours unable to be awake, walk, dizzy, unwell, severe flu like symptoms. Lifted about 24 hours later.  11/18/22 & 11/24/22: evil headaches, not typical. 11/26/22: dropped to ground with vertigo. 12/9/22: dizzy sensations. 1/19/24: dizzy. Starting 2/3/23 and going for several weeks: dizzy showering/water pricks on neck/hot, cooking, pressure eyes, L eye shadow, headaches, ears ringing, feet & knees down tingling, hands numb, jumping gym trigger, sinus headache, weird to swallow, tension, fatigue, L face nerve pain, burning left side back neck/down arm, cognition impaired, visual/auditory hypersensitivity. 3/12/23: first panic attack. 3/14/23: L horizontal canal cupulolithiasis. BPPV on and off DX. Vestibular hypo function and balance issues on and off. PPPD. CT Sinus. Brain MRI. VNG/audiologist. ENT. Zoloft. Vestibular PT. Vision Therapy. OT, Cranial Sacral. Massage. Brainspotting Therapy. Ativan. Valium. Neurologist consults x2. Symptoms continued for several months, responded to treatments, then got covid + 9/12/23 and regressed backwards. Covid again 8/25/24 and regressed backwards again.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vestibular disorder, Visual impairment
Clinical narrative: 10/22/22: burning sensation up neck seconds following injection, few hours later, spent almost 24 hours unable to be awake, walk, dizzy, unwell, severe flu like symptoms. Lifted about 24 hours later.  11/18/22 & 11/24/22: evil headaches, not typical. 11/26/22: dropped to ground with vertigo. 12/9/22: dizzy sensations. 1/19/24: dizzy. Starting 2/3/23 and going for several weeks: dizzy showering/water pricks on neck/hot, cooking, pressure eyes, L eye shadow, headaches, ears ringing, feet & knees down tingling, hands numb, jumping gym trigger, sinus headache, weird to swallow, tension, fatigue, L face nerve pain, burning left side back neck/down arm, cognition impaired, visual/auditory hypersensitivity. 3/12/23: first panic attack. 3/14/23: L horizontal canal cupulolithiasis. BPPV on and off DX. Vestibular hypo function and balance issues on and off. PPPD. CT Sinus. Brain MRI. VNG/audiologist. ENT. Zoloft. Vestibular PT. Vision Therapy. OT, Cranial Sacral. Massage. Brainspotting Therapy. Ativan. Valium. Neurologist consults x2. Symptoms continued for several months, responded to treatments, then got covid + 9/12/23 and regressed backwards. Covid again 8/25/24 and regressed backwards again.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Syncope, Vertigo
Clinical narrative: severe calf/leg pain. This was AFTER significant vertigo and syncope.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site inflammation, Injection site swelling
Clinical narrative: THERE WAS A CIRCULAR BRUISING AROUND THE SITE OF THE INJECTION AND THE LEFT DELTOID WAS INFLAMED AND SWOLLEN.  MOTHER SAID THAT IT HAS GOTTEN WORSE INSTEAD OF SUBSIDING.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Erythema, Pruritus, Rash
Clinical narrative: Noted with redness, rashes and hives to his upper chest area and abdomen, c/o itchiness. Increase weakness noted and shivering.  MD orders to send to ER for further evaluation.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Noted with redness, rashes and hives to his upper chest area and abdomen, c/o itchiness. Increase weakness noted and shivering.  MD orders to send to ER for further evaluation.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth to area inferior to but not including injection site. Treatment for presumed cellulitis with Keflex for 5d.