chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RSV
Symptoms: Hypoacusis
Clinical narrative: hard of hearing; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOACUSIS (non-serious), outcome "unknown", described as "hard of hearing".  Additional information: Caller called in seeking assistance with the Abrysvo vaccine. During the call caller stated." Can you talk a little slower I'm hard of hearing."  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstruation delayed
Clinical narrative: Every time I vaccinated, my cycle is severly delayed with weeks of cramping; Every time I vaccinated, my cycle is severly delayed with weeks of cramping; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Lot number: EN6199) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: MENSTRUATION DELAYED (non-serious), DYSMENORRHOEA (non-serious), outcome "unknown" and all described as "Every time I vaccinated, my cycle is severly delayed with weeks of cramping". Additional information: Vaccination date reported as "04Mar2021" and "05Mar2021".  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201341646 same patient/vaccine/event, different dose number;
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective
Clinical narrative: I received 2 Pfizer COVID vaccinations and one Pfizer Booster, and have had COVID 3 times; I received 2 Pfizer COVID vaccinations and one Pfizer Booster, and have had COVID 3 times; I received 2 Pfizer COVID vaccinations and one Pfizer Booster, and have had COVID 3 times; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, 0.3 ml single (Lot number: EN6203, Expiration Date: 30Jun2021), on 25Mar2021 as dose 2, single (Lot number: ER8730) and on 30Mar2022 as dose 3 (booster), single (Lot number: FK9895) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "I received 2 Pfizer COVID vaccinations and one Pfizer Booster, and have had COVID 3 times". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient stated, "I received 2 Pfizer COVID vaccinations and one Pfizer Booster, and have had COVID 3 times." The patient further described, "I have had it 3 times the third being Recently - diagnosed 10Feb2024." Treatment for the events included PAXLOVID.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Skin test positive
Clinical narrative: severe injection site reaction; Initial information received on 13-Jan-2024 regarding an unsolicited valid non-serious case received from a patient.  This case involves a 2 years old male patient who experienced severe injection site reaction, after receiving vaccine Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Egg allergy.  On 10-Jan-2024, the patient received a dose of suspect Influenza Quadrival A-B Vaccine (lot number: U8230CA, expiry date: 30-Jun-2024) via subcutaneous route in unknown administration site for prophylactic vaccination (immunization).  On 10-Jan-2024, the patient developed severe injection site reaction (vaccination site reaction) (latency: same day) following the administration of Influenza Quadrival Thiomersal Multidose Vaccine.  Relevant laboratory test results included: Skin test - On an unknown date: Positive  Action taken : not applicable.  Corrective treatment: Patient just put on oral corticosteroids  At time of reporting, the outcome was Not Recovered / Not Resolved for the event.  Based on information previously received, the following information Influenza Quadrival Thiomersal Multidose Vaccine' (524) To Influenza Quadrival A-B Vaccine (Fluzone Quadrivalent) (450).] has been amended. .   ; Reporter's Comments: .   Initial information received on 13-Jan-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 2 years old male patient who experienced severe injection site reaction while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].     The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Egg allergy. Notes: Egg allergy    On 10-Jan-2024, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U8230CA via subcutaneous route in unknown administration site.  On 10-JAN-2024 the patient developed a non-serious severe injection site reaction (vaccination site reaction) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Relevant laboratory test results included: Skin test - On an unknown date: Positive  (Other relevant tests included Test Name: Skin test,Date: , Notes: ;  .)  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) was not applicable.  An unknown corrective treatment was received for the event (severe injection site reaction).  At time of reporting, the outcome was Not Recovered / Not Resolved for the event severe injection site reaction.         Additional information was received on 13-Jan-2024
Sex: U
Vaccine: TDAP
Symptoms: Decorticate posture
Clinical narrative: decorticate posture\hands clenched together tightly towards chest; Initial information was received on 19-Feb-2024 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced decorticate posture\hands clenched together tightly towards chest after receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant disease and family history were not provided.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, Suspension for injection (dose, strength, lot and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient developed a serious decorticate posture\hands clenched together tightly towards chest (decorticate posture) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (decorticate posture\hands clenched together tightly towards chest).  At time of reporting, the outcome was Unknown for the event decorticate posture\hands clenched together tightly towards chest.  Seriousness Criteria: This event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 22-FEB-2024: This case involves Adult and unknown gender patient who experienced decorticate posture\hands clenched together tightly towards chest after receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. Additional information regarding condition at the time of vaccination or risk factor excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of suspect cannot be assessed.
Age: 51.0
Sex: F
Vaccine: TD, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: medical assistant administered tenivac in error instead of adacel with no reported adverse event; Initial information was received on 22-Feb-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 51 years old female patient to whom medical assistant administered diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] in error instead of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Feb-2024, the patient received a 0.5 ml, once (total) dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (lot U7927AA, expiration date: unknown, strength: standard) via intramuscular route in the left deltoid for prophylactic vaccination (Immunization) and medical assistant administered tenivac in error instead of adacel with no reported adverse event (wrong product administered) (Latency: same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 90.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient that was administered with an expired TENIVAC with no reported adverse event; Initial information received on 22-Feb-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 90 years old male patient who was administered with an expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Feb-2024, the patient received a Dose of 0.5 ml (dose 1) once of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (Suspension for injection) (lot: U7183AA;expiry date: 24-Sep-2023; strength: standard) via intramuscular route in the left deltoid for Immunization.  On 21-Feb-2024 the patient was administered with an expired tenivac with no reported adverse event (expired product administered) (latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: inappropriate use due to patient was administered with only the diluent with no reported adverse event; Initial information received on 22-Feb-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2024SA063693(CLUSTER), 2024SA063603(CLUSTER) and 2024SA063578(CLUSTER).  This case involves a 1 years old female patient who was administered with only the diluent and no active ingredient of HIB (PRP/T) Vaccine [ACT-HIB] 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 in Sep-2023, the patient had received 0.5 ml, with only the diluent and no active ingredient of suspect HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) (lot UJ835AA; expiration date: 22-Feb-2024; strength, route and administration site not reported) for prophylactic vaccination with no reported adverse event (product preparation error) (latency: same day).  It was reported "that they had one box with 5 doses of ACTHIB vaccine and Now she has two vaccines left from that box and one vaccine in the box doesn't have a diluent to match it. So, she suspects that of the 4 doses given, one was given with only the diluent. They are not sure which of the patients got only a diluent."  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUC3
Symptoms: Exposure to communicable disease, Influenza, Influenza A virus test positive, Pyrexia, Vaccination failure
Clinical narrative: Influenza / Flu A; Influenza / Flu A / LoE; Vomiting; Fever; This spontaneous case from the United States was received on 15-Feb-2024 from other non-healthcare professional via Communications (reference number: SEQW24-00644) and concerned a child, female patient.  The patient's medical history and concomitant medications were not reported.  On 14-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, anatomical location: right deltoid; route of administration: not reported) for active immunization against influenza disease. The batch number reported was 944444 and the expiry date was 22-May-2024.  On 14-Feb-2024, four months after receiving Flucelvax Quadrivalent, the patient experienced vomiting and fever. The patient had contracted influenza.  On 15-Feb-2024, the fever continued. The patient's parents took the patient to the pediatrician and confirmed via nasal swab that the patient was positive for Flu A (explicitly coded as 'Vaccination failure'). Influenza was confirmed despite having been vaccination this campaign. The most likely source of infection was reported as daycare, as other kids were reporting Flu infections from school.   At the time of initial reporting, on 15-Feb-2024, the patient had not recovered from the events of 'influenza A virus infection', vomiting and fever.  The reporter did not provide a causality assessment.  The events of 'influenza A virus infection' and 'vaccination failure' were considered to be medically significant by a Physician within Seqirus' Pharmacovigilance Department.  Company comment: On 14-Feb-2024, four months after receiving Flucelvax Quadrivalent, the patient experienced vomiting and fever. The patient had contracted influenza. It was confirmed via nasal swab that the patient was positive for Flu A. The events of influenza and vaccine failure are assessed as possibly related, since developed within the 21-180 days postvaccination period. The events of vomiting and fever were also assessed as possibly related, as considered as a symptoms of influenza.; Sender's Comments: On 14-Feb-2024, four months after receiving Flucelvax Quadrivalent, the patient experienced vomiting and fever. The patient had contracted influenza. It was confirmed via nasal swab that the patient was positive for Flu A. The events of influenza and vaccine failure are assessed as possibly related, since developed within the 21-180 days postvaccination period. The events of vomiting and fever were also assessed as possibly related, as considered as a symptoms of influenza.
Sex: F
Vaccine: FLUC3
Symptoms: Vomiting
Clinical narrative: Influenza / Flu A; Influenza / Flu A / LoE; Vomiting; Fever; This spontaneous case from the United States was received on 15-Feb-2024 from other non-healthcare professional via Communications (reference number: SEQW24-00644) and concerned a child, female patient.  The patient's medical history and concomitant medications were not reported.  On 14-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, anatomical location: right deltoid; route of administration: not reported) for active immunization against influenza disease. The batch number reported was 944444 and the expiry date was 22-May-2024.  On 14-Feb-2024, four months after receiving Flucelvax Quadrivalent, the patient experienced vomiting and fever. The patient had contracted influenza.  On 15-Feb-2024, the fever continued. The patient's parents took the patient to the pediatrician and confirmed via nasal swab that the patient was positive for Flu A (explicitly coded as 'Vaccination failure'). Influenza was confirmed despite having been vaccination this campaign. The most likely source of infection was reported as daycare, as other kids were reporting Flu infections from school.   At the time of initial reporting, on 15-Feb-2024, the patient had not recovered from the events of 'influenza A virus infection', vomiting and fever.  The reporter did not provide a causality assessment.  The events of 'influenza A virus infection' and 'vaccination failure' were considered to be medically significant by a Physician within Seqirus' Pharmacovigilance Department.  Company comment: On 14-Feb-2024, four months after receiving Flucelvax Quadrivalent, the patient experienced vomiting and fever. The patient had contracted influenza. It was confirmed via nasal swab that the patient was positive for Flu A. The events of influenza and vaccine failure are assessed as possibly related, since developed within the 21-180 days postvaccination period. The events of vomiting and fever were also assessed as possibly related, as considered as a symptoms of influenza.; Sender's Comments: On 14-Feb-2024, four months after receiving Flucelvax Quadrivalent, the patient experienced vomiting and fever. The patient had contracted influenza. It was confirmed via nasal swab that the patient was positive for Flu A. The events of influenza and vaccine failure are assessed as possibly related, since developed within the 21-180 days postvaccination period. The events of vomiting and fever were also assessed as possibly related, as considered as a symptoms of influenza.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Chronic pigmented purpura, Inflammatory marker test, Laboratory test normal, Rheumatoid factor negative
Clinical narrative: Developed pigmented purpuric dermatosis shortly after receiving third dose of COVID vaccine confirmed with pathology and dermatology
Sex: F
Vaccine: RSV
Symptoms: Dyspnoea, Peripheral swelling
Clinical narrative: localized swelling in arm; Difficulty Breathing; This serious case was reported by a other health professional and described the occurrence of swelling arm in a 84-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included multiple allergies (Patient had underlying allergies/immune suppression) and asthma (Severe).   On an unknown date, the patient received the 1st dose of Arexvy (right arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced swelling arm (Verbatim: localized swelling in arm) (serious criteria hospitalization) and difficulty breathing (Verbatim: Difficulty Breathing) (serious criteria hospitalization). The outcome of the swelling arm and difficulty breathing were resolved.   It was unknown if the reporter considered the swelling arm and difficulty breathing to be related to Arexvy.     It was unknown if the company considered the swelling arm and difficulty breathing to be related to Arexvy.   Additional Information: GSK Receipt date: 20-FEB-2024 Th reporter was physician's assistant. A reporter reported that a patient was in hospital for started with localized swelling in arm for several days, then patient was admitted within a week of receiving vaccine patient was admitted to hospital with breathing difficulties.  A patient had underlying allergies/immune suppression; provider feels she might not had been a good candidate to receive the RSV vaccine.  Provider did not recommend vaccine to the patient. The reporter consented to follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: headache; Very sore arm; body aches; I still have pain in my arm in the area of injection site; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Very sore arm), MYALGIA (body aches), VACCINATION SITE PAIN (I still have pain in my arm in the area of injection site) and HEADACHE (headache) in a 57-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Patient was diagnosed with Covid 19) on 28-May-2022. Concurrent medical conditions included Hashimoto's thyroiditis, Hypothyroidism, Parathyroid disorder, Hyperparathyroidism, Osteoporosis, Arthritis, Fibromyalgia (possible fibromyalgia) and Hypercholesterolemia (High cholesterol).    On 08-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 08-Nov-2023, the patient experienced PAIN IN EXTREMITY (Very sore arm), MYALGIA (body aches) and VACCINATION SITE PAIN (I still have pain in my arm in the area of injection site). On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Vaccination site pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Very sore arm), MYALGIA (body aches), VACCINATION SITE PAIN (I still have pain in my arm in the area of injection site) and HEADACHE (headache) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter. Patient experienced still have pain in arm in injection site and felt that almost like someone had punched. She never experienced this with any other vaccination before. It was unknown if the patient experienced any additional symptoms/events.
Age: 33.0
Sex: M
Vaccine: HEPAB
Symptoms: Cold sweat, Diarrhoea, Hyperhidrosis, Hypoaesthesia, Macroglossia
Clinical narrative: Sore arm and tingling/numbness into hands same day. Over the next five days, patient developed macroglossia, lingual erythema, light sensitivity, clamminess of skin, increased diaphoresis, and loose stools. The symptoms slowly resolved over two weeks.
Age: 33.0
Sex: M
Vaccine: HEPAB
Symptoms: Pain in extremity, Paraesthesia, Photophobia, Tongue erythema
Clinical narrative: Sore arm and tingling/numbness into hands same day. Over the next five days, patient developed macroglossia, lingual erythema, light sensitivity, clamminess of skin, increased diaphoresis, and loose stools. The symptoms slowly resolved over two weeks.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Anaphylactic reaction, Cough, Tachypnoea, Urticaria, Vomiting
Clinical narrative: The patient received Quadracel (Dtap+Polio) and Proquad (MMR + Varicella) vaccines at approx 2:15 today, 2/26/24. When the patient was leaving the office he developed anaphylatic reaction (Emesis x 1, Uticaria on right thigh and lower left arm, cough, wheeze and tachypnea. EMS was called and the patient given albuterol nebulizer (approx 240p) and 0.15 mg IM of epinephrine. The patients breathing improved. The patient was transported to MC.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Wheezing
Clinical narrative: The patient received Quadracel (Dtap+Polio) and Proquad (MMR + Varicella) vaccines at approx 2:15 today, 2/26/24. When the patient was leaving the office he developed anaphylatic reaction (Emesis x 1, Uticaria on right thigh and lower left arm, cough, wheeze and tachypnea. EMS was called and the patient given albuterol nebulizer (approx 240p) and 0.15 mg IM of epinephrine. The patients breathing improved. The patient was transported to MC.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC
Symptoms: Crying, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Inconsolable crying x 4-6 hours starting about 8 hours after vaccination with localized swelling & redness of the right thigh
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Biopsy salivary gland, Computerised tomogram, Laboratory test, Magnetic resonance imaging, Mandibular mass
Clinical narrative: I get related disease w/submandibular mass, Pancreatic involvment
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pancreatic disorder
Clinical narrative: I get related disease w/submandibular mass, Pancreatic involvment
Age: 19.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Cold sweat, Dizziness, Presyncope
Clinical narrative: Vasovagal episode after standing.  Patient stand up and experiences lightheadedness, feels clammy.  He is lowered to the floor.  Afterwards, there are improvement in symptoms.  He reports to emergency room.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Sick starting next day
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Headache, Hyperhidrosis, Immediate post-injection reaction, Pruritus
Clinical narrative: AT THE TIME OF ADMINISTERING THE VACCINE, HE FELT DIZZY AND HAD A HEADACHE. SHORT-LIVED SYMPTOMS. THAT SAME DAY, AT ABOUT SEVEN O'CLOCK IN THE EVENING, SHE BEGAN TO DEVELOP A RASH ON HER BODY, ITCHING, SWEATING AND TACHYCARDIA. THE NEXT DAY, AUGUST 24, THE MOTHER TOOK THE CHILD TO THE PRIMARY CARE PHYSICIAN AND HE PRESCRIBED HER MEDICATION HYDROXYNE HCL 10MG/5ML WITH WHICH THE SYMPTOMS WERE RELIEVED
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Rash, Tachycardia
Clinical narrative: AT THE TIME OF ADMINISTERING THE VACCINE, HE FELT DIZZY AND HAD A HEADACHE. SHORT-LIVED SYMPTOMS. THAT SAME DAY, AT ABOUT SEVEN O'CLOCK IN THE EVENING, SHE BEGAN TO DEVELOP A RASH ON HER BODY, ITCHING, SWEATING AND TACHYCARDIA. THE NEXT DAY, AUGUST 24, THE MOTHER TOOK THE CHILD TO THE PRIMARY CARE PHYSICIAN AND HE PRESCRIBED HER MEDICATION HYDROXYNE HCL 10MG/5ML WITH WHICH THE SYMPTOMS WERE RELIEVED
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Brain fog, COVID-19, Chest pain, Condition aggravated, Echocardiogram abnormal
Clinical narrative: PFIZER #1 2/26/2021 PFIZER #2 3/24/2021 THEN ON OR ABOUT 9/1/2021 TOOK A PFIZER BOOSTER LOST VACCINE CARD DEVELOPED HEADACHES, BRAIN FOG, PALPITATIONS, CHEST PAIN, POST-EXERTIONAL FATIGUE, VACCINE FAILED AND SHE HAD RECURRENT ACUTE COVID-19
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Fatigue, Headache, Hypertension, Immunisation reaction
Clinical narrative: PFIZER #1 2/26/2021 PFIZER #2 3/24/2021 THEN ON OR ABOUT 9/1/2021 TOOK A PFIZER BOOSTER LOST VACCINE CARD DEVELOPED HEADACHES, BRAIN FOG, PALPITATIONS, CHEST PAIN, POST-EXERTIONAL FATIGUE, VACCINE FAILED AND SHE HAD RECURRENT ACUTE COVID-19
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Microscopy, Palpitations, Pericarditis, Small fibre neuropathy
Clinical narrative: PFIZER #1 2/26/2021 PFIZER #2 3/24/2021 THEN ON OR ABOUT 9/1/2021 TOOK A PFIZER BOOSTER LOST VACCINE CARD DEVELOPED HEADACHES, BRAIN FOG, PALPITATIONS, CHEST PAIN, POST-EXERTIONAL FATIGUE, VACCINE FAILED AND SHE HAD RECURRENT ACUTE COVID-19
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination failure
Clinical narrative: PFIZER #1 2/26/2021 PFIZER #2 3/24/2021 THEN ON OR ABOUT 9/1/2021 TOOK A PFIZER BOOSTER LOST VACCINE CARD DEVELOPED HEADACHES, BRAIN FOG, PALPITATIONS, CHEST PAIN, POST-EXERTIONAL FATIGUE, VACCINE FAILED AND SHE HAD RECURRENT ACUTE COVID-19
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error, Underdose
Clinical narrative: Patient received just the diluent for Pentacel vaccine  at yesterday's visit. Provider spoke to mother  and informed of vaccine error.  We scheduled patient an appointment for Pentacel vaccination for 03/11/24.
Age: 79.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Chills, Headache, Nausea
Clinical narrative: Four hours of severe chills, headache and nausea, eight hours after injection.
Age: 79.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Four hours of severe chills, headache and nausea, eight hours after injection.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No adverse events noted. Patient received the wrong Covid vaccine. She received a Spike Vax 0.25ml, instead of getting a Moderna 6mo-11yrs old.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy test, Pain in extremity, Peripheral swelling, Urticaria, Urticaria pressure
Clinical narrative: Delayed Pressure Urticaria (swollen painful welts on the skin after exposure to pressure, and hives) developed in January 2022 shortly after immunization in December 2021, but was not diagnosed until November of 2023. Antihistamines have been effective against hives, but may not be effective against the main pressure induced welts.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Delusion, Disorientation, Memory impairment
Clinical narrative: Experienced  some disorientation and delusional thinking.  Almost like dream -like  episodic thoughts that I couldn?t ascertain if I was remembering past events, dreams or reality.  Lasted for about an hour followed by some forgetfulness.  I have never experienced this before.
Age: 26.0
Sex: F
Vaccine: JEV1
Symptoms: Rash, Swelling face, Vomiting
Clinical narrative: Patient presented with rash and vomiting (12:30) , she was transported to the ER where t was documented that she had facial swelling without compromise to her airway, a rash and vomiting, she was given an epi pen and Benadryl.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Extra dose of hib given not needed Pentacel was given should have give Kinrix Dtap IPV
Age: 16.0
Sex: F
Vaccine: HEP, HPV9, IPV, MENB, MMR, MNQ, TD
Symptoms: Extra dose administered
Clinical narrative: Patient received TD, MMR and Hep B that were not needed.
Age: 3.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Cough, Erythema, Product administered to patient of inappropriate age, Rhinorrhoea
Clinical narrative: The patient was given 0.25ml of the wrong formulation for the patient's age. The patient had some runny nose, cough and redness on cheek on the day the vaccine was administered but these symptoms were all gone as of 2/26/2024.
Age: 18.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Lip swelling, Swelling face, Urticaria
Clinical narrative: Patient had total body urticaria, face and lip swelling that started the day after receiving vaccines on 2/21/24. Came to the clinic on 2/27/24 with persistent symptoms.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Gait disturbance
Clinical narrative: Dizziness, couldn't walk without assistance, loss of appetite, fever and chills, pain where shot was given, headache, eyes couldn't focus, lights hurt my eyes, and I was so tired I slept most of 36 hours straight.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Headache, Hypersomnia, Injection site pain, Photophobia, Pyrexia
Clinical narrative: Dizziness, couldn't walk without assistance, loss of appetite, fever and chills, pain where shot was given, headache, eyes couldn't focus, lights hurt my eyes, and I was so tired I slept most of 36 hours straight.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Vision blurred
Clinical narrative: Dizziness, couldn't walk without assistance, loss of appetite, fever and chills, pain where shot was given, headache, eyes couldn't focus, lights hurt my eyes, and I was so tired I slept most of 36 hours straight.
Age: 8.0
Sex: M
Vaccine: TYP, YF
Symptoms: Dizziness, Syncope
Clinical narrative: 10-15 minutes after vaccine was given patient got up to leave the room and once the patient got to the hallway, he started to feel lightheaded and fainted.  The patient's father was able to catch him and help him to the ground.  The RN and Doctor were both notified.  Patient was helped to a chair where we put his feet up and gave him a snack and drink until he felt better.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: HPV ordered by provider and given by MA. After immunization given it was found that patient was pregnant. She did not know and staff did not know  that she was pregnant at time med was given. second pregnancy,  est date of delivery 10/25/2024
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: No symptoms or adverse effects experienced by patient. The vaccine was not diluted properly and undiluted dose of 0.3ml was given to the patient. Parent informed and provided information from VIS.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Visual impairment
Clinical narrative: The next morning when I woke up and laying in bed and then got up and walked there was a white fan like movement in my left eye.  That continued every single day for about 1-2hrs in the am until my 2nd dose, then it was in both eyes going in opposite directions until Jan when a black line went across my left eye and I couldn't see out of that eye.  My second dose was the same place and Pfizer EW0187
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Pallor, Rash, Rash maculo-papular, Urticaria
Clinical narrative: Face, trunk with macular papular blanching  erythema; left mid back with patch of raised blanching erythema 4cm wide(hive like)
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: Site of injection initially swollen to "baseball" size on the first day, which I felt was normal. On day 3 I started noticing redness in a circular pattern about 3 inches in diameter to injection site.  Day 4 the redness started streaking down my arm about 4 inches from the injection site. On day 5 the redness ran down the length of my upper arm. On day 5 I started taking Loratadine daily. Day 6 the swelling started going down, redness still present. By day 8 the redness started dissipating and no swelling was noted.  Day 9 and 10 still showed shadowing of previous redness, but no pain or swelling of note.
Age: 1.58
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt was schedule for Hep B vaccine. Vaccine was not due but was given.
Age: 76.0
Sex: M
Vaccine: RSV, RSV, RSV, VARCEL
Symptoms: Arthritis, Condition aggravated, Eyelid function disorder, Fatigue, Hypoaesthesia oral
Clinical narrative: vaccine given on 2/23/24. that night had a lot of let arm soreness that then progressed to arthritis of knuckles in both hand and severe neuropathy of hands and feet (has h/o this but significantly worse). feels his eyelids are hard to open. reports subjective weakness of UE/LE bilaterally. fatigued. numbness of lips
Age: 76.0
Sex: M
Vaccine: RSV, RSV, RSV, VARCEL
Symptoms: Muscular weakness, Neuropathy peripheral, Pain in extremity
Clinical narrative: vaccine given on 2/23/24. that night had a lot of let arm soreness that then progressed to arthritis of knuckles in both hand and severe neuropathy of hands and feet (has h/o this but significantly worse). feels his eyelids are hard to open. reports subjective weakness of UE/LE bilaterally. fatigued. numbness of lips
Age: 76.0
Sex: M
Vaccine: RSV, RSV, RSV, VARCEL
Symptoms: Arteriospasm coronary, Arthralgia, Electromyogram abnormal, Extremity contracture, Fatigue
Clinical narrative: vaccine given on 2/23/24. that night had a lot of let arm soreness that then progressed to arthritis of knuckles in both hand and severe neuropathy of hands and feet (has h/o this but significantly worse). feels his eyelids are hard to open. reports subjective weakness of UE/LE bilaterally. fatigued. numbness of lips
Age: 76.0
Sex: M
Vaccine: RSV, RSV, RSV, VARCEL
Symptoms: Guillain-Barre syndrome, Immediate post-injection reaction, Immunoglobulin therapy, Injection site pain, Pain
Clinical narrative: vaccine given on 2/23/24. that night had a lot of let arm soreness that then progressed to arthritis of knuckles in both hand and severe neuropathy of hands and feet (has h/o this but significantly worse). feels his eyelids are hard to open. reports subjective weakness of UE/LE bilaterally. fatigued. numbness of lips
Age: 76.0
Sex: M
Vaccine: RSV, RSV, RSV, VARCEL
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: vaccine given on 2/23/24. that night had a lot of let arm soreness that then progressed to arthritis of knuckles in both hand and severe neuropathy of hands and feet (has h/o this but significantly worse). feels his eyelids are hard to open. reports subjective weakness of UE/LE bilaterally. fatigued. numbness of lips
Age: 76.0
Sex: M
Vaccine: RSV, RSV, RSV, VARCEL
Symptoms: Asthenia, Guillain-Barre syndrome, Hypoaesthesia, Neuropathy peripheral, Pain
Clinical narrative: vaccine given on 2/23/24. that night had a lot of let arm soreness that then progressed to arthritis of knuckles in both hand and severe neuropathy of hands and feet (has h/o this but significantly worse). feels his eyelids are hard to open. reports subjective weakness of UE/LE bilaterally. fatigued. numbness of lips
Age: 76.0
Sex: M
Vaccine: RSV, RSV, RSV, VARCEL
Symptoms: Paraesthesia
Clinical narrative: vaccine given on 2/23/24. that night had a lot of let arm soreness that then progressed to arthritis of knuckles in both hand and severe neuropathy of hands and feet (has h/o this but significantly worse). feels his eyelids are hard to open. reports subjective weakness of UE/LE bilaterally. fatigued. numbness of lips
Age: 76.0
Sex: M
Vaccine: RSV, RSV, RSV, VARCEL
Symptoms: Asthenia, Electromyogram abnormal, Fatigue, Finger deformity, Guillain-Barre syndrome
Clinical narrative: vaccine given on 2/23/24. that night had a lot of let arm soreness that then progressed to arthritis of knuckles in both hand and severe neuropathy of hands and feet (has h/o this but significantly worse). feels his eyelids are hard to open. reports subjective weakness of UE/LE bilaterally. fatigued. numbness of lips
Age: 76.0
Sex: M
Vaccine: RSV, RSV, RSV, VARCEL
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Muscular weakness, Musculoskeletal disorder, Musculoskeletal stiffness
Clinical narrative: vaccine given on 2/23/24. that night had a lot of let arm soreness that then progressed to arthritis of knuckles in both hand and severe neuropathy of hands and feet (has h/o this but significantly worse). feels his eyelids are hard to open. reports subjective weakness of UE/LE bilaterally. fatigued. numbness of lips
Age: 76.0
Sex: M
Vaccine: RSV, RSV, RSV, VARCEL
Symptoms: Pain in extremity, Peripheral nerve injury
Clinical narrative: vaccine given on 2/23/24. that night had a lot of let arm soreness that then progressed to arthritis of knuckles in both hand and severe neuropathy of hands and feet (has h/o this but significantly worse). feels his eyelids are hard to open. reports subjective weakness of UE/LE bilaterally. fatigued. numbness of lips
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Amyloidosis, Asthenia, Brain fog, Condition aggravated, Diastolic dysfunction
Clinical narrative: PFIZER #1 3/2/2021 PFIZER #2 3/23/2021 PFIZER #3 10/25/2021, PFIZER #4 6/3/2022 PFIZER #5 10/172021, PT DEVELOPED BRAIN FOG, POST EXERTIONAL FATIGUE, NEUROPATHY, WORSENED EDEMA, GENERALIZED WEAKNESS, AND DOE, EXAM SHOWED 4+ EDEMA, LIVER ENLARGEMENT, AND DIASTOLIC DYSFUNCTION ON ECHOCARDIOGRAPHY SUSPICIOUS FOR AMYLOIDOSIS
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea exertional, Echocardiogram abnormal, Electrocardiogram, Fatigue, Hepatomegaly
Clinical narrative: PFIZER #1 3/2/2021 PFIZER #2 3/23/2021 PFIZER #3 10/25/2021, PFIZER #4 6/3/2022 PFIZER #5 10/172021, PT DEVELOPED BRAIN FOG, POST EXERTIONAL FATIGUE, NEUROPATHY, WORSENED EDEMA, GENERALIZED WEAKNESS, AND DOE, EXAM SHOWED 4+ EDEMA, LIVER ENLARGEMENT, AND DIASTOLIC DYSFUNCTION ON ECHOCARDIOGRAPHY SUSPICIOUS FOR AMYLOIDOSIS
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Laboratory test, Neuropathy peripheral, Oedema
Clinical narrative: PFIZER #1 3/2/2021 PFIZER #2 3/23/2021 PFIZER #3 10/25/2021, PFIZER #4 6/3/2022 PFIZER #5 10/172021, PT DEVELOPED BRAIN FOG, POST EXERTIONAL FATIGUE, NEUROPATHY, WORSENED EDEMA, GENERALIZED WEAKNESS, AND DOE, EXAM SHOWED 4+ EDEMA, LIVER ENLARGEMENT, AND DIASTOLIC DYSFUNCTION ON ECHOCARDIOGRAPHY SUSPICIOUS FOR AMYLOIDOSIS
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site discharge, Injection site erythema, Injection site swelling, Mass
Clinical narrative: Pt developed lump and redness. On follow up 8/20/23, injection site is still raised and red, and has overlying eschar and is draining clear liquid.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site eschar
Clinical narrative: Pt developed lump and redness. On follow up 8/20/23, injection site is still raised and red, and has overlying eschar and is draining clear liquid.
Age: 68.0
Sex: F
Vaccine: COVID19, HEP, RSV
Symptoms: Asthenia, Blood glucose increased, Diabetes mellitus, Malaise, Pain in extremity
Clinical narrative: Client is diabetic and she states that her sugars were in the 200's all night.  Both of her arms were sore all night.  She did not sleep at all.  She felt weak all night and generally did not feel well.  Client call at 11:30 today and states that she is feeling better now.  She is unsure whether she should receive the second dose of Hepatitis B.  I referred client to discuss this with her PCP.
Age: 68.0
Sex: F
Vaccine: COVID19, HEP, RSV
Symptoms: Sleep disorder
Clinical narrative: Client is diabetic and she states that her sugars were in the 200's all night.  Both of her arms were sore all night.  She did not sleep at all.  She felt weak all night and generally did not feel well.  Client call at 11:30 today and states that she is feeling better now.  She is unsure whether she should receive the second dose of Hepatitis B.  I referred client to discuss this with her PCP.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 5 days after receiving the RSV vaccine.  The patient calls us to report of itching and swelling at the injection site with a little warmth to touch.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCIEN FROZEN INSTEAD OF REFRIGERATED
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Pain
Clinical narrative: patient describes pain in his upper shoulder that is not brought on by any specific event. At first he noticed that his shoulder was sore after receiving the vaccine  and it had lingered for more than a month.  The pain is a shooting pain that goes away after he feels it.  Patient works out and does not have any issues with lifting his arm but notices that pain in his  shoulder periodically.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Localized reaction: localized area of erythema, itching, tenderness on left upper arm after getting vaccine.  Cool and hot compresses and antihistamine advised.  Symptoms partially improved but not yet resolved 1 week later.
Age: 14.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: No adverse event, Wrong patient received product
Clinical narrative: ADMINISTRATION ERROR.  THE VACCINES WERE GIVEN TO THE WRONG PATIENTS. PATIENT CAME IN WITH HIS BROTHER AND PARENTS.  WHEN THE MA. WENT IN TO THE EXAM ROOM TO GIVE THE VACCINE, PATIENT WAS SITTING IN THE EXAM BED. AND MOTHER DID NOT REALIZE THE CONSENT FORM WAS FOR THE BROTHER UNTIL AFTER THE VACCINES WERE GIVEN. PATIENT DID NOT HAVE ANY REACTION AND PARENTS SHOWED NO CONCERN OF THE ERROR.  THE RIGHT PT GOT THE VACCINE.   DR. DID ADVISE PARENTS THAT THERE SHOULD NOT BE ANY PROBLEM, BUT PLEASE CALL HIM WITH ANY CONCERNS.
Age: 18.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Incorrect age given for labeled vaccine, no adverse events were reported by patient
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Gait inability
Clinical narrative: Couldn't walk around house, lost strength, tightness in chest,
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, FLU4, PNC20, RV5
Symptoms: Product administered to patient of inappropriate age, Wrong patient received product
Clinical narrative: Two brothers came to office visit. Staff drew up vaccines for both patients per order given. This nurse was asked to assist in administering vaccines. Responsibility of this nurse was administration of Vaxelis for one pt and Influenza for other pt. Pt. was first to receive vaccines. This nurse accidently gave Fluarix 0.5mL to wrong pt. Staff noticed mistake and immediately brought it to this nurse's attention. Nurses excused ourselves from patient room and notified present provider of misdose; instructed to give intended medication, Vaxelis and file incident report. Was notified once present and agreed with treatment plan by Dr. Instructed nurse to give Vaxelis in leg that received Prevnar, left thigh. This nurse apologized profusely to mother and notified of mistake given. Advised to watch for viral symptoms in patient, mother voiced understanding. Verified appropriate doses of vaccines for older brother with provider. Upon re-entering the patient room, pt. received appropriate vaccines as ordered and then other pt. received Vaxelis in leg instructed, left leg after verbal verification with second nurse. Mother educated by nurse that patient may experience viral symptoms and to watch right leg (injection location) for reaction, he will most likely have a knot in muscle due to volume given, and to wait 5 hours before dosing medication such as Tylenol. Mother voiced understanding.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient presented to clinic on 2/16/2024 with erythematous area and swelling on patient's right upper thigh.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Ecchymosis, Headache, Injection site pain, Injection site swelling
Clinical narrative: 24 hours after receiving vaccine, she developed moderate headache, body ache, nausea and tenderness throughout her left deltoid. Trouble sleeping when laying on that side. Today upon exam, ecchymosis to her lateral arm that extends the proximal one half of her upper arm. Swelling of her left deltoid. Increase in discomfort with ROM. She has taken Tylenol and ibuprofen as needed for discomfort.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Sleep disorder
Clinical narrative: 24 hours after receiving vaccine, she developed moderate headache, body ache, nausea and tenderness throughout her left deltoid. Trouble sleeping when laying on that side. Today upon exam, ecchymosis to her lateral arm that extends the proximal one half of her upper arm. Swelling of her left deltoid. Increase in discomfort with ROM. She has taken Tylenol and ibuprofen as needed for discomfort.