chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Type III immune complex mediated reaction
Clinical narrative: Arthus reaction; Indurated at site of vaccination; red at site of vaccination; inflammation at site of vaccination; Initial information received on 25-Sep-2024 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.  This case involves a 32 years old female patient who experienced arthus reaction after receiving vaccine influenza usp trival a-b subvirion no preservative vaccine [Fluzone].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient was not pregnant at the time of the safety information/side effect.   On 23-Sep-2024, the patient received unknown dose of suspect influenza usp trival a-b subvirion no preservative vaccine (Suspension for injection) (lot number, expiry date strength not reported) via unknown route in unknown administration site for Flu vaccine (Influenza immunization).  On 23-Sep-2024, the patient developed a serious arthus reaction (type iii immune complex mediated reaction) along with its symptoms of Indurated, red and inflammation at site of vaccination (vaccination site induration), (vaccination site erythema) and (vaccination site inflammation) (latency: 10 hours) (2.5in x 1.5in) following the administration of influenza usp trival a-b subvirion no preservative vaccine.  Action taken was not applicable.  No corrective treatment was received for the events.  At time of reporting, the outcome was Recovering / Resolving for all the events.  Seriousness criteria: The events were assessed as medically significant.; Sender's Comments: Sanofi company comment dated 28-Sep-2024: This case involves a 32 years old female patient who experienced arthus reaction after receiving vaccine influenza usp trival a-b subvirion no preservative vaccine [Fluzone]. The patient information regarding medical history, underlying conditions, clinical course, family history and concomitant medication would be needed for complete assessment of the case. Based upon the reported information, the role of a vaccine cannot be assessed.
Age: 11.0
Sex: U
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: DAPTACEL being given to an 11-year-old patient with no reported adverse event; Initial information received on 11-Sep-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 11 years old and unknown gender patient who had administered with Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] 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 11 years old patient received a unknown dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine Suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as immunization and (product administered to patient of inappropriate age) (same day latency).  Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.   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: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, C-reactive protein increased, Chills, Injection site erythema
Clinical narrative: My 7 year old daughter was given dose intended for 12+ year old.  This is the 2024-2025 yearly booster. She has previously had booster in 2023 and had primary series covid vaccine when she got elligible at age 5 in 2022. Was given in lower left arm instead of correct site left upper arm and we were informed of this error 2 days later. Adverse Event is persistent fever, chills, malaise, weakness, local site pain, local site swelling, local site erythema and left arm weakness and lack of sleep and irritablity and stress and anxiety.  She has to be taken to ER for these persistent symptoms and had to undergo ultrasound and blood tests done and more tylenol and motrin given .
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Insomnia, Irritability, Malaise
Clinical narrative: My 7 year old daughter was given dose intended for 12+ year old.  This is the 2024-2025 yearly booster. She has previously had booster in 2023 and had primary series covid vaccine when she got elligible at age 5 in 2022. Was given in lower left arm instead of correct site left upper arm and we were informed of this error 2 days later. Adverse Event is persistent fever, chills, malaise, weakness, local site pain, local site swelling, local site erythema and left arm weakness and lack of sleep and irritablity and stress and anxiety.  She has to be taken to ER for these persistent symptoms and had to undergo ultrasound and blood tests done and more tylenol and motrin given .
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Oedema peripheral, Procalcitonin increased, Product administered at inappropriate site, Product administered to patient of inappropriate age
Clinical narrative: My 7 year old daughter was given dose intended for 12+ year old.  This is the 2024-2025 yearly booster. She has previously had booster in 2023 and had primary series covid vaccine when she got elligible at age 5 in 2022. Was given in lower left arm instead of correct site left upper arm and we were informed of this error 2 days later. Adverse Event is persistent fever, chills, malaise, weakness, local site pain, local site swelling, local site erythema and left arm weakness and lack of sleep and irritablity and stress and anxiety.  She has to be taken to ER for these persistent symptoms and had to undergo ultrasound and blood tests done and more tylenol and motrin given .
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Stress, Ultrasound scan abnormal
Clinical narrative: My 7 year old daughter was given dose intended for 12+ year old.  This is the 2024-2025 yearly booster. She has previously had booster in 2023 and had primary series covid vaccine when she got elligible at age 5 in 2022. Was given in lower left arm instead of correct site left upper arm and we were informed of this error 2 days later. Adverse Event is persistent fever, chills, malaise, weakness, local site pain, local site swelling, local site erythema and left arm weakness and lack of sleep and irritablity and stress and anxiety.  She has to be taken to ER for these persistent symptoms and had to undergo ultrasound and blood tests done and more tylenol and motrin given .
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: receive a high dose fluzone vaccine in error with no reported adverse event; Initial information received on 09-Sep-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 53 years old female patient who received a high dose influenza quadrival A-B high dose hv vaccine [Fluzone high-dose quadrivalent] in error 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 an unknown dose of influenza quadrival A-B high dose hv vaccine (formulation, strength, lot number and expiry date- unknown) via unknown route in unknown administration site as prophylactic vaccination (Immunization) in error with no reported adverse event (product administered to patient of inappropriate age) (latency- same day).  Information on the batch number was requested corresponding to the one at time of event occurrence  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: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Vaccine exposure during pregnancy with no reported ae; Initial information received on 05-Sep-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 28 years old female patient who was exposed to influenza usp trival A-B subvirion no preservative vaccine [Fluzone] during pregnancy with no reported adverse event.   The reported Vaccine exposure during pregnancy with no reported adverse event occurred at 11 weeks of pregnancy.  The date of last menstrual period was reported as 30-Jun-2024. The estimated due date is 12-Apr-2025. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.  On 04-Sep-2024, the patient received an unknown dose 1 of influenza usp trival A-B subvirion no preservative vaccine Suspension for injection (strength, expiry date - unknown, lot number- UT8423JA) via intramuscular route in unknown administration site as prophylactic vaccination (Immunization) during pregnancy with no reported adverse event (exposure during pregnancy) (latency- same day).  Relevant prenatal testing after exposure was not reported.  Additionally, at time of reporting, the pregnancy is still ongoing.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Paresthesias bilateral hands began 9/22/24
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac monitoring abnormal, Ventricular extrasystoles
Clinical narrative: I began to experience periods of PVCs, my diltizam was increase from 120 to 180 until the PVCs began to lessen on or about 9/22/2024
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Incorrect dose administered
Clinical narrative: Adult dose Hep A administered. No adverse reaction noted.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Urticaria, Vomiting
Clinical narrative: She received the vaccines on Friday 9/27/24, later that night she started feeling dizzy and vomited. Saturday 9/28/24 she broke out in hives all over her body. Vomiting, dizzy continued through Monday 9/30/24 and she came to office.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Discomfort, Erythema, Swelling
Clinical narrative: Localized swelling , redness, and discomfort. First noticed 9/29/2024. Vaccine was administered at pharmacy on 9/25/2024  Treatment: as needed Tylenol, ice application, Zyrtec 1-2 times daily x 7 days
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Paraesthesia
Clinical narrative: Patient received Fluzone HD 9-23-24. Felt tingling on left face, left arm and left leg shortly after shot. Tingling went away. left arm below injection site developed swelling around circumference of arm. Swelling resolved by Monday Sept 30, 2024.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Rash, Rash erythematous
Clinical narrative: Rash, small red bumps all over body that started next day after vaccines.
Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Blood pressure increased, Differential white blood cell count, Exposure during pregnancy, Foetal non-stress test, Full blood count
Clinical narrative: Vaccine received at 34 weeks pregnant. High blood pressure started the following evening, and spiked within 36 hours (157/97, 147/100). This causes a trip to labor and delivery to be monitored, followed by more testing and a return visit to rule out pre-eclampsia
Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Protein urine
Clinical narrative: Vaccine received at 34 weeks pregnant. High blood pressure started the following evening, and spiked within 36 hours (157/97, 147/100). This causes a trip to labor and delivery to be monitored, followed by more testing and a return visit to rule out pre-eclampsia
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus, Swelling, Urticaria
Clinical narrative: Large red welt and swelling by the first night, evolving into large (flattened) red area with INTENSE itching. Still itching on fourth day, excruciating.
Age: 67.0
Sex: F
Vaccine: COVID19, FLU3, VARZOS
Symptoms: Erythema, Fatigue, Feeling hot, Hyperhidrosis
Clinical narrative: hot and sweaty but no fever - tired, fatigue - red spot on both arms
Age: 11.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blood glucose normal, Muscle twitching, Syncope
Clinical narrative: Patient received both vaccinations on 9/28/24 and proceeded to stand up and walk. She took a few steps and fainted while her body was twitching. Her family, myself and one of our technicians ran over to her to assist. She recovered very quickly and began answering a series of questions including her name, what the last thing she remembered, etc. Medical services were contacted and fire department came within a few minutes of the incident. They advised patient seek medical attention.
Age: 81.0
Sex: M
Vaccine: RSV
Symptoms: Erythema, Feeling hot, Pain in extremity
Clinical narrative: Red, hot, pain all the way down my arm.
Age: 12.0
Sex: M
Vaccine: HPV9, MENB, TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient received Bexsero vaccine instead of Menveo.
Age: 70.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Injection site mass, Injection site rash
Clinical narrative: Patient received vaccine on 09/28/24. Patient came to pharmacy and was very tight clothes and couldn't remove them to access the ideal deltoid location. She rolled up the sleeves and the vaccination was administered as high as possible. On 9/30/24 the patient called and said that she has a rash and small lump at the site of injection and believe it was administered subcutaneously and was wondering how long it will take to resolve. I advised the patient to contact her physician and explained that local site reactions at the injection site are possible following influenza vaccination and are typically self-resolving.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had already gotten a flu shot vaccine on 07/29/2024 but went to the pharmacy on 09/27/2024 to get the flu shot again, the vaccine was processed through the insurance and approved. Patient got another dose of flu shot on 09/27/2024. Patient did not have any adverse events.
Age: 7.0
Sex: M
Vaccine: COVID19, FLU3, HEPA, IPV, TDAP
Symptoms: Pyrexia, Seizure
Clinical narrative: Child experienced a seizure (with fever) the next day following vaccines per medical coordinator.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a flu shot on 08/19/2024 and went to the pharmacy to get another flu shot on 09/27/2024. Both vaccines were processed and approved by insurance. Patient got 2 doses of flu vaccines one in August and the other one in September. Patient does not have any adverse reactions or symptoms.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Fibrin D dimer increased, Full blood count, Imaging procedure abnormal, Lymphadenopathy
Clinical narrative: 9/27/24 - sore right neck near clavicle on day after vaccination. 9/28/24 - right neck more swollen, super tender, and redness, which made patient seek evaluation/treatment in the ED
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Swelling, Tenderness, Ultrasound scan normal
Clinical narrative: 9/27/24 - sore right neck near clavicle on day after vaccination. 9/28/24 - right neck more swollen, super tender, and redness, which made patient seek evaluation/treatment in the ED
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event
Clinical narrative: no adverse reaction.  I administered vaccine out of protocol.  I administered injection without a doctor's prescription for a 12 year old.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Pt. contacted the office to report significant itching in the arm of the vaccination x3days, accompanied by swelling and redness extending down to the elbow. Pt. used alcohol to relieve the itch. As of reporting time, pt's symptoms had resolved.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received two flu vaccines. Received one 07/29/2024 came in on saturday 09/28/2024 for a vaccine and requested a flu vaccine. Patient apparently did not remember getting a flu vaccine earlier. pateint was contacted and states she feels fine and has no issues
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Fatigue, Influenza like illness, Injection site pain, Injection site reaction
Clinical narrative: Patient seen in office on Wednesday for nurse only appointment for second meningitis B vaccine. Per mom, she waited the appropriate 15 minutes and no reaction/feeling was present. Patient started feeling tired yesterday along with flu-like symptoms that made her feel like she was "coming down with something" today, some blotching is present close to vaccination site, site is warm to touch and raised, with some soreness. Patient also reports some joint pain. (MA) spoke with PCP and she verbally recommended taking an antihistamine like zyrtec/Claritin to help and if patient begins vomiting/wheezing/or rash worsens she should be seen at ER. PCP also recommended notifying team lead of reaction so it may be reported. Mom showed understanding of PCP advice and will watch patient.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site swelling, Injection site warmth, Rash, Rash macular
Clinical narrative: Patient seen in office on Wednesday for nurse only appointment for second meningitis B vaccine. Per mom, she waited the appropriate 15 minutes and no reaction/feeling was present. Patient started feeling tired yesterday along with flu-like symptoms that made her feel like she was "coming down with something" today, some blotching is present close to vaccination site, site is warm to touch and raised, with some soreness. Patient also reports some joint pain. (MA) spoke with PCP and she verbally recommended taking an antihistamine like zyrtec/Claritin to help and if patient begins vomiting/wheezing/or rash worsens she should be seen at ER. PCP also recommended notifying team lead of reaction so it may be reported. Mom showed understanding of PCP advice and will watch patient.
Age: 23.0
Sex: M
Vaccine: HPV9
Symptoms: Nausea, Rash, Urticaria, Vomiting
Clinical narrative: hive-like rash on both arms and inguinal area. also, transient nausea with one episode of vomiting
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Idiopathic urticaria, Lip swelling
Clinical narrative: She said that her symptoms began after receiving the Moderna Covid Vaccine. After her second vaccine, her lips swelled significantly and that is when she started having issues with the idiopathic urticaria. She said that the vaccination "woke something up" in her and she developed this condition. Prior to the vaccination, she had no issues of the sort.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Injection site pain, Injection site reaction, Injection site warmth, Pruritus
Clinical narrative: Swelling at neck, pruritis at neck and jaw, welt (9cmX4cm) at site, extreme warmness and pain of injection site, psoriasis flare on legs
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Psoriasis, Swelling, Urticaria
Clinical narrative: Swelling at neck, pruritis at neck and jaw, welt (9cmX4cm) at site, extreme warmness and pain of injection site, psoriasis flare on legs
Age: 70.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pain in extremity, Skin warm
Clinical narrative: Pain in arm, warm to touch, no redness or inflammation, pt took tylenol and placed cold compress
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram, Full blood count, Metabolic function test, Syncope
Clinical narrative: Three episodes of syncope and dizziness.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blister, Chest pain, Dysphagia, Dyspnoea
Clinical narrative: Blisters in nose, mouth, throat, eyelids. Throat swelling. Burning sensation in chest, stomach pain, shortness of breath, difficulty swallowing (ice chips melted in mouth only). Body aches. Fatigue
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasal mucosal blistering, Oral mucosal blistering, Oropharyngeal blistering, Pain
Clinical narrative: Blisters in nose, mouth, throat, eyelids. Throat swelling. Burning sensation in chest, stomach pain, shortness of breath, difficulty swallowing (ice chips melted in mouth only). Body aches. Fatigue
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Streptococcus test negative
Clinical narrative: Blisters in nose, mouth, throat, eyelids. Throat swelling. Burning sensation in chest, stomach pain, shortness of breath, difficulty swallowing (ice chips melted in mouth only). Body aches. Fatigue
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: hives and welts. patient is taking Benadryl and improving
Age: 36.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Wrong product administered
Clinical narrative: THE ERROR WAS THAT THE WRONG COVID VACCINE WAS GIVEN.  THE PATIENT EXPECTED THE NOVAVAX COVID -19 VACCINE 2024-25, BUT WAS GIVEN SPIVEVAX COVID 19 VACCINE 2024-25.  THE PATIENT WAS NOTIFIED OF THE ERROR, AND ENCOURGED TO INFORM HER PRIMARY CARE PHYSICIAN.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site inflammation, Injection site rash
Clinical narrative: RASH AND INFLAMMATION AND THE VACCINE SITE
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Patient is over 65, 0.5 mL of Fluzone was administered instead of Fluzone High Dose.  Called the patient and informed him to report the the pharmacy at his earlies convenience to receive the correct dose of the flu vaccinaiton.
Age: 54.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak in multiple locations on left side of body. Including   Temple near eye, under left breast, waist near midline, under pannus
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Patient had large red welt at sight of vaccination(larger than golfball) and redness in a large area around injection site.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Urinary incontinence
Clinical narrative: She had a fever and chills at midnight after the shot.  She also was unable to control her bladder X3.  She has never had anything like this before.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: pt's arm is red and itchy with heat present
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: SPIKEVAX (50 MCG/ 0.5 ML)  WAS ADMINISTERED INSTEAD OF MODERNA (25 MCG/ 0.25 ML) (PEDS DOSE).
Age: 76.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: localized redness/itching day after vaccine administration.  Pt applied Benadryl cream which improved symptoms. Patient denied SOB/difficulty breathing.
Age: 44.0
Sex: M
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: VAQTA given instead of Havrix
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anosmia, Atrial fibrillation, Cardiac ablation, Cardioversion, Echocardiogram
Clinical narrative: MODERNA #1 3/18/2021 MODERNA #2 4/15/2021 MODERNA #3 12/6/2021 DEVELOPED VACCINE INDUCED PAROXYSMAL ATRIAL FIBRILLATION AND ANOSMIA.  HOSPITALIZED CARDIOVERSION X 2 AND ABLATION X 1 TREATED WITH DILTIAZEM ELIQUIS FLECAINIDE BISOPROLOL AND PROTOCOL BASE SPIKE DETOXIFICATION   Clinical Approach to Post-acute Sequelae After COVID-19 Infection and Vaccination.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Laboratory test
Clinical narrative: MODERNA #1 3/18/2021 MODERNA #2 4/15/2021 MODERNA #3 12/6/2021 DEVELOPED VACCINE INDUCED PAROXYSMAL ATRIAL FIBRILLATION AND ANOSMIA.  HOSPITALIZED CARDIOVERSION X 2 AND ABLATION X 1 TREATED WITH DILTIAZEM ELIQUIS FLECAINIDE BISOPROLOL AND PROTOCOL BASE SPIKE DETOXIFICATION   Clinical Approach to Post-acute Sequelae After COVID-19 Infection and Vaccination.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: The patient received Energix 0.5 ml vaccine which is less than what the recommended dose.
Age: 69.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Injection site hypoaesthesia, Injection site mass, Injection site pain, Injection site paraesthesia, Pain in extremity
Clinical narrative: PT STATES SORE ARM ON BOTH ARMS. THERE WAS A KNOT ON THE RIGHT ARM. PT STATES ARM WAS SORE AND NUMB/TINGLING ON LEFT ARM WHERE RSV SHOT WAS GIVEN. PT STATES TOOK SOME ASPIRIN BECAUSE SHE WAS AFRAID THE NUMBNESS WAS A POTENTIL HEART ATTACK.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Cerebral artery occlusion, Cerebral artery stenosis, Computerised tomogram head abnormal, Computerised tomogram neck abnormal, Dyspnoea
Clinical narrative: I am reporitng an Adverse Event that was notified to the Health Department by treating facility Hospital. Patient admitted on 09/23/2024 for numbness of lower extremities about 2 weeks after flu vaccine and progressing to difficutly breathing and upper right side extremity. Treating physician at hospitial is MD. Pt admitted to ICU and is currently being treated for Guillain-Barre Syndrome secondary to flu shot on 09/10/2024. Pt's primary care provider listed as DO.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count normal, Guillain-Barre syndrome, Hypoaesthesia, Intensive care, Metabolic function test normal
Clinical narrative: I am reporitng an Adverse Event that was notified to the Health Department by treating facility Hospital. Patient admitted on 09/23/2024 for numbness of lower extremities about 2 weeks after flu vaccine and progressing to difficutly breathing and upper right side extremity. Treating physician at hospitial is MD. Pt admitted to ICU and is currently being treated for Guillain-Barre Syndrome secondary to flu shot on 09/10/2024. Pt's primary care provider listed as DO.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Scan with contrast abnormal
Clinical narrative: I am reporitng an Adverse Event that was notified to the Health Department by treating facility Hospital. Patient admitted on 09/23/2024 for numbness of lower extremities about 2 weeks after flu vaccine and progressing to difficutly breathing and upper right side extremity. Treating physician at hospitial is MD. Pt admitted to ICU and is currently being treated for Guillain-Barre Syndrome secondary to flu shot on 09/10/2024. Pt's primary care provider listed as DO.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin lesion
Clinical narrative: A few days after administration of vaccine, developed a rash on trunk (mainly on sides near waist and near bra), some lesions on belly, and a few on top of thigh. One lesion on top of head. Two types of lesions - non trunk were dime size red with hard center resembling bug bites (they were not bug bites). Trunk lesions were smaller, different sizes. All of them were very itchy. I did not use anything different such as lotions or detergents. I don't remember any unusual foods. The lesions got better by end of 2 weeks, however some remnents left stil by today, 9/30/2024. Went to primary care doc today. Not sure what caused rash.
Age: 73.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Gait disturbance, Hypotonia, Injection site pain, Muscle spasms, Nervous system disorder
Clinical narrative: pt states she had a neurological reaction after getting both vaccines. Her mind could not was not connecting with body funtions. She was having trouble sitting up and was falling over. She was having trouble walking. She had spasms in the right arm while sleeping.  Pain at the injection site.
Age: 72.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: THE PATIENT WAS ADMINISTERED THE PEDIATRIC DOSE OF MODERNA (0.25ML) INSTEAD OF THE ADULT DOSE (SPIKEVAX 0.5ML)
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given a flublok instead of fluzone.  Doctor was advised.  Nurse called vaccine shoppe and spoke with vaccine personnel regarding incorrect choice of flu vaccine by MA.  Once research on dose was complete, father of child was advised via telephone.  He was advised, there are no untoward adverse effects  Father stated child had no complaints, doing well.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received Flulaval 0.5 mL vaccine on 9/26/24 after having already received one dose of seasonal flu vaccine from his primary care office on 9/13/24. This is medication error; Patient has not experienced and adverse side effects from this additional dose.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: PATIENT WAS ADMINISTERED THE MODERNA 6M-11Y DOSE (0.25ML) INSTEAD OF SPIKEVAX ADULT (0.5ML)
Age: 25.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Patient fainted upon receipt of vaccine. EMS was called and patient was checked out and had normal vitals. Patient was able to leave pharmacy on their own without going to hospital.
Sex: U
Vaccine: MMRV
Symptoms: Unevaluable event
Clinical narrative: Vaccine was not administered to a patient. MMRV was placed in fridge and not freezer over the weekend. I called Merk and discussed what temp the vaccine was stored. Merk stated vaccine was still able to be used due to vaccine being placed in Freezer this morning. Case# 02680628
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: THE PATIENT RECEIVED THE MODERNA 6M-11Y DOSE 0.25ML, INSTEAD OF THE MODERN ADULT DOSE 0.5ML SPIKEVAX.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site induration
Clinical narrative: Reports localized hard red area at injection site. Denies fever, chills. Currently 28 weeks pregnant with EDD 12/14/24
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme, widespread, 6 days post vaccination. Symptoms present for about 24 hours when patient was seen. Placed on a course of oral steroids and antihistamine daily.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: nurse who collected chart after the visit reviewed vaccine report for registry.  Physician notified patient received flublok instead of flu zone.  She then advised me about the mistake.  I spoke with staff at vaccine location and was advised no unexpected untoward effects were expected  and nurse was told not to repeat the flu dose. Father notified by RN, specifically there are no adverse effects or expected problems with the flu given.  Report completed and will be signed by MA at next schedule patient care day she is working.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: THE MODERNA 6M-11Y 0.25ML  VACCINE WAS ADMINISTERED TO THE PATIENT, INSTEAD OF THE ADULT SPIKEVAX MODERNA 0.5ML
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Feeding disorder, Heart rate increased
Clinical narrative: I was not able to eat the food i normally do because my heart was beating so fast and i wasnt able to eat that much. I am only 100 lbs 5'5. I have been drinking ensure but i cant drink it now. My lung doctor pushed me to get it.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram head, Electrocardiogram, Electroencephalogram, Syncope, Tinnitus
Clinical narrative: Severe tinnitus both ears, syncopal episode
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: THE PATIENT RECEIVED THE MODERNA 6M-11Y 0.25ML DOSE, INSTEAD OF THE ADULT MODERNA SPIKEVAX 0.5ML
Age: 77.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Headache, Nausea, Vitreous floaters
Clinical narrative: Patient reported have floaters in both her eye, headache, and nausea for 3 days following vaccination.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: covid infection after vaccination
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: covid infection after vaccination
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, MMRV, DTAPIPV, HEPA, MMRV
Symptoms: Chills, Confusional state, Decreased appetite, Facial paralysis, Gait disturbance
Clinical narrative: Muscle weakness, dropping face, loss of thigh muscle, involuntary twitches, ticks, limping, fever, chills, tremors , lethargy, confusion, loss of appetite, stiff
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, MMRV, DTAPIPV, HEPA, MMRV
Symptoms: Laboratory test, Lethargy, Muscle atrophy, Muscle twitching, Muscular weakness
Clinical narrative: Muscle weakness, dropping face, loss of thigh muscle, involuntary twitches, ticks, limping, fever, chills, tremors , lethargy, confusion, loss of appetite, stiff
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, MMRV, DTAPIPV, HEPA, MMRV
Symptoms: Musculoskeletal stiffness, Pyrexia, Tic, Tremor
Clinical narrative: Muscle weakness, dropping face, loss of thigh muscle, involuntary twitches, ticks, limping, fever, chills, tremors , lethargy, confusion, loss of appetite, stiff
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, MMRV, DTAPIPV, HEPA, MMRV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Muscle weakness, dropping face, loss of thigh muscle, involuntary twitches, ticks, limping, fever, chills, tremors , lethargy, confusion, loss of appetite, stiff
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, MMRV, DTAPIPV, HEPA, MMRV
Symptoms: Chills, Confusional state, Decreased appetite, Facial paralysis, Gait disturbance
Clinical narrative: PAIN AND SWELLING AT THE SITE OF INJECTION WAS SEEN AT ER
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, MMRV, DTAPIPV, HEPA, MMRV
Symptoms: Laboratory test, Lethargy, Muscle atrophy, Muscle twitching, Muscular weakness
Clinical narrative: PAIN AND SWELLING AT THE SITE OF INJECTION WAS SEEN AT ER
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, MMRV, DTAPIPV, HEPA, MMRV
Symptoms: Musculoskeletal stiffness, Pyrexia, Tic, Tremor
Clinical narrative: PAIN AND SWELLING AT THE SITE OF INJECTION WAS SEEN AT ER
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, MMRV, DTAPIPV, HEPA, MMRV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: PAIN AND SWELLING AT THE SITE OF INJECTION WAS SEEN AT ER
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Depressed level of consciousness, Dyskinesia, Moaning, Tremor, Vomiting
Clinical narrative: Pt extremely nervous prior to vaccine - hx of sycope with previous vaccines at age 11.  Pt laying down during injection, doing fine for 10-15 seconds following vaccination but instructed by nurse to remain laying down. He then began moaning loudly for a few seconds, then stopped and was noted to be unalert and have tremors/jerking movements in arms a legs for 5-10 seconds.  This quickly subsided and pt became alert again and states he was going to be sick - then vomited several times over the next minute.  Pt felt better after this and remained laying down for 10 minutes without further issue.  Sat up and monitored for another 10 minutes while pt drank juice and states he is feeling back to baseline.  Abulated out of clinic with parents without further issue.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Chest discomfort, Cold sweat, Depressed level of consciousness, Dizziness
Clinical narrative: About 15 minutes after receiving the shot I began to have really fast heart rate and feel super dizzy, like i was going to pass out. I went to the charge nurse and later down. I started to get really sweaty and feel clammy. I started to have difficulty breathing, tight chest, and started to hyperventilate. I also started to have like muscle spasms of some kind and I felt like I was losing consciousness. They took my down to the ER where they have me Benadryl and Ativan. They put on a EKG and monitored my heart rate and blood pressure which were both high. I was then sent home to rest
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Electrocardiogram, Heart rate increased, Hyperhidrosis, Hyperventilation
Clinical narrative: About 15 minutes after receiving the shot I began to have really fast heart rate and feel super dizzy, like i was going to pass out. I went to the charge nurse and later down. I started to get really sweaty and feel clammy. I started to have difficulty breathing, tight chest, and started to hyperventilate. I also started to have like muscle spasms of some kind and I felt like I was losing consciousness. They took my down to the ER where they have me Benadryl and Ativan. They put on a EKG and monitored my heart rate and blood pressure which were both high. I was then sent home to rest
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms
Clinical narrative: About 15 minutes after receiving the shot I began to have really fast heart rate and feel super dizzy, like i was going to pass out. I went to the charge nurse and later down. I started to get really sweaty and feel clammy. I started to have difficulty breathing, tight chest, and started to hyperventilate. I also started to have like muscle spasms of some kind and I felt like I was losing consciousness. They took my down to the ER where they have me Benadryl and Ativan. They put on a EKG and monitored my heart rate and blood pressure which were both high. I was then sent home to rest
Age: 50.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Condition aggravated, Seizure
Clinical narrative: Started seizing in chair after receiving the shingrix vaccine.  She was lay flat on the floor with head in her mom's lap.  EMS was called by Nurse Practicioner.
Age: 0.58
Sex: F
Vaccine: MMR
Symptoms: Rash, Urticaria
Clinical narrative: Rash, urticaria, developed >5 days following the vacine
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Rash papular
Clinical narrative: 1.  Raised, hot to touch, itchy, irregular shape rash on left arm. Size of rash:  2 inches tall x 2 inches wide. Top of rash was 1 inch down from top vaccine injection site and 1/2 inch down from lower vaccine injection site.  Rash was not surrounding either injection site itself, but more below and slightly to the left of the injection sites.   Applied topical benadryl gel to site and ice pack.    2. Also, The top vaccine injection site was raised and red.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Rash pruritic
Clinical narrative: 1.  Raised, hot to touch, itchy, irregular shape rash on left arm. Size of rash:  2 inches tall x 2 inches wide. Top of rash was 1 inch down from top vaccine injection site and 1/2 inch down from lower vaccine injection site.  Rash was not surrounding either injection site itself, but more below and slightly to the left of the injection sites.   Applied topical benadryl gel to site and ice pack.    2. Also, The top vaccine injection site was raised and red.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash macular
Clinical narrative: the next day caregiver noticed blotchy patches at site, increased to red swollen site and was still slightly red and warm to the touch on 9/28, no fever - patient isn't able to communicate discomfort due to learning disability, but didn't appear agitated
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was 7 and received the Kinrix , meant for <6, No adverse event
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Dizziness, Hyperhidrosis, Migraine
Clinical narrative: Received flu shot midday Friday and on Sunday I was feeling extremely dizzy with very bad body pain. Pain in my joints , sweating, fever, raging migraine, lots of dizziness and a lot of lower back pain.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Received flu shot midday Friday and on Sunday I was feeling extremely dizzy with very bad body pain. Pain in my joints , sweating, fever, raging migraine, lots of dizziness and a lot of lower back pain.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Patient emailed the Health District on 9/27/2024 noting, "I received a flu shot at the community preparedness event on September 7. My arm where I received the shot is still extremely sore and I have a lot of difficulty with range of motion. It is hard for me to move my arm up above shoulder level or straight out when I lift up. It's different than muscle pain from working out or straining, it is right where I received the shot. I keep waiting for it to go away or get better but it hasn't. I'm hoping someone can help me with my problem because it hurts a lot and it's making life very difficult."  I found documentation of the vaccination in our administered by a colleague I found documentation of the vaccination by a colleague and then spoke with patient today to review the situation and submit a VARES report.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pain, Rhinorrhoea
Clinical narrative: Developed chest cough with periodic coughing spasms. Also body aches and runny nose
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Atrioventricular block first degree, Dizziness, Electrocardiogram abnormal, Fatigue, Full blood count normal
Clinical narrative: On 09/18/24 "in the evening", pt and wife began to feel lightheaded and fatigued. These symptoms persist through today. On 09/26/24, pt had syncopal event. Was picked up by ambulance, noted to be pale and diaphoretic. Was taken to ED at 11:37 a.m. Pt was discharged sometime after 16:11 and told to follow up with PCP.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Metabolic function test, N-terminal prohormone brain natriuretic peptide, Pallor, Sinus rhythm
Clinical narrative: On 09/18/24 "in the evening", pt and wife began to feel lightheaded and fatigued. These symptoms persist through today. On 09/26/24, pt had syncopal event. Was picked up by ambulance, noted to be pale and diaphoretic. Was taken to ED at 11:37 a.m. Pt was discharged sometime after 16:11 and told to follow up with PCP.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Troponin normal
Clinical narrative: On 09/18/24 "in the evening", pt and wife began to feel lightheaded and fatigued. These symptoms persist through today. On 09/26/24, pt had syncopal event. Was picked up by ambulance, noted to be pale and diaphoretic. Was taken to ED at 11:37 a.m. Pt was discharged sometime after 16:11 and told to follow up with PCP.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear discomfort
Clinical narrative: Dizziness, "blocked ears" started the evening 09/18/24 and still persist today.  BP today: 189/97 (pt reported).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Chills, Condition aggravated, Diabetes mellitus, Laboratory test
Clinical narrative: I got the chills that evening and i expexted that I went to bed. I woke up naueous and i checked my blood sugar which was high. I hgave myself insulin. And i fought it all day it would go down a little and then shoot back up. it would go into the 300's go down a little and go back up. Saturday morning it was still the same and this went on until early monday morning at 3 i got to check and i threw up and the tuesday it was still climbing and i was getting ready sick i was at 411 and i called 911. I kept giving myself insulin but it wasnt bringing it down enough. I drank water and everything and i didn't know what to do. I have my self a shot in my stomach just in case my pump didnt work. It did go down so i didnt go to the hospital and later that day it went up again and i went to the ER and they put 2 bags of saline in me it was at 511 over the time frame of 400 it was brought down to 300. The doctor told me to double up my insulin and to watch my blood sugars very carefully. The next day it started to come down.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Vomiting
Clinical narrative: I got the chills that evening and i expexted that I went to bed. I woke up naueous and i checked my blood sugar which was high. I hgave myself insulin. And i fought it all day it would go down a little and then shoot back up. it would go into the 300's go down a little and go back up. Saturday morning it was still the same and this went on until early monday morning at 3 i got to check and i threw up and the tuesday it was still climbing and i was getting ready sick i was at 411 and i called 911. I kept giving myself insulin but it wasnt bringing it down enough. I drank water and everything and i didn't know what to do. I have my self a shot in my stomach just in case my pump didnt work. It did go down so i didnt go to the hospital and later that day it went up again and i went to the ER and they put 2 bags of saline in me it was at 511 over the time frame of 400 it was brought down to 300. The doctor told me to double up my insulin and to watch my blood sugars very carefully. The next day it started to come down.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Gave RSV vaccination and after administration learned patient had already had the vaccine and only authorized for one dose
Age: 1.17
Sex: M
Vaccine: HIBV
Symptoms: Febrile convulsion
Clinical narrative: Had febrile seizure. Was taken to hospital and monitored. Fever subsided. No further issues.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: report of parasthesia in the 4th and 5th finger of the left arm, unknown when the symptoms started after vaccination on 9/24/24, no treatment used, no follow up with a hospital or doctor
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Malaise, Vomiting
Clinical narrative: Later that night i was very cold and didnt feel good and the next morning i threw up and i didnt feel good for 2 or 3 days after
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Patient developed a red, itchy, warm, painful, swollen rash at the site of injection. Patient was prescribed Hydroxyzine HCL 10mg tablets from her pcp.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Patient developed a red, itchy, warm, painful, swollen rash at the site of injection. Patient was prescribed Hydroxyzine HCL 10mg tablets from her pcp.
Age: 50.0
Sex: F
Vaccine: HEPAB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT WAS ADMINISTERED A SECOND DOSE OF TWINRIX ON 09/27/2024 AND SHE ALREADY HAD THE FOLLOWING VACCINES: HEP B ADULT ON 05/03/2019, TWINRIX ON 08/25/2023, HEP B ADULT ON 04/26/2024. THE DOSE OF TWINRIX GIVEN REPRESENTED A FOURTH DOSE OF THE HEPATITIS B COMPONENT. PATIENT DID NOT REPORTED ANY ADVERSE EVENT TO THE VACCINE GIVEN.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Patient reports fever of 104 the day following the vaccine administration and is currently unable to nurse her 12 week old baby.