chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Dysphagia, Fear, Insomnia, Musculoskeletal stiffness, Parkinson's disease
Clinical narrative: symptoms may indicate Parkinson's disease; difficulties with swallowing; It all began with a tremor in my right hand; Arm stiffness/ I have been waking up every morning with a frozen left arm; I have been unable to sleep properly; constant fear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARKINSON'S DISEASE (medically significant), outcome "unknown", described as "symptoms may indicate Parkinson's disease"; DYSPHAGIA (non-serious), outcome "unknown", described as "difficulties with swallowing"; TREMOR (non-serious), outcome "unknown", described as "It all began with a tremor in my right hand"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "Arm stiffness/ I have been waking up every morning with a frozen left arm"; INSOMNIA (non-serious), outcome "unknown", described as "I have been unable to sleep properly"; FEAR (non-serious), outcome "unknown", described as "constant fear". The event "symptoms may indicate parkinson's disease" required physician office visit. Clinical course: It began with a tremor in the patient's right hand, followed by difficulties with swallowing. Additionally, the patient had been waking up every morning with a frozen left arm and encountering a few other uncomfortable health problems. The patient had always been a very health-conscious individual, maintaining a nutritious diet and engaging in regular exercise. The patient never imagined that something like this would happen, patient did not wish to become a burden on the patient's children. Based on the opinions of two specialists, it seems that the symptoms may indicate Parkinson's disease. The patient had been unable to sleep properly or find peace of mind. The patient wanted assistance or guidance, as the patient was living in constant fear, uncertain about what the future holds for the patient.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: symptoms may indicate Parkinson's disease; difficulties with swallowing; It all began with a tremor in my right hand; Arm stiffness/ I have been waking up every morning with a frozen left arm; I have been unable to sleep properly; constant fear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARKINSON'S DISEASE (medically significant), outcome "unknown", described as "symptoms may indicate Parkinson's disease"; DYSPHAGIA (non-serious), outcome "unknown", described as "difficulties with swallowing"; TREMOR (non-serious), outcome "unknown", described as "It all began with a tremor in my right hand"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "Arm stiffness/ I have been waking up every morning with a frozen left arm"; INSOMNIA (non-serious), outcome "unknown", described as "I have been unable to sleep properly"; FEAR (non-serious), outcome "unknown", described as "constant fear". The event "symptoms may indicate parkinson's disease" required physician office visit. Clinical course: It began with a tremor in the patient's right hand, followed by difficulties with swallowing. Additionally, the patient had been waking up every morning with a frozen left arm and encountering a few other uncomfortable health problems. The patient had always been a very health-conscious individual, maintaining a nutritious diet and engaging in regular exercise. The patient never imagined that something like this would happen, patient did not wish to become a burden on the patient's children. Based on the opinions of two specialists, it seems that the symptoms may indicate Parkinson's disease. The patient had been unable to sleep properly or find peace of mind. The patient wanted assistance or guidance, as the patient was living in constant fear, uncertain about what the future holds for the patient.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Liver disorder, Pain, Polycythaemia vera
Clinical narrative: developed Polycythemia Vera; my liver is giving me trouble; increased my pain level by double; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pain" (ongoing). The patient's concomitant medications were not reported. The following information was reported: POLYCYTHAEMIA VERA (medically significant), outcome "unknown", described as "developed Polycythemia Vera"; LIVER DISORDER (non-serious), outcome "unknown", described as "my liver is giving me trouble"; PAIN (non-serious), outcome "unknown", described as "increased my pain level by double". Clinical course: Patient had watched that vaccine put her sister through, and she hates it. It had also increased her pain level by double. Suddenly her liver was giving her trouble. And she developed Polycythemia Vera after taking it as well. And it changes their DNA. As well as the fact that it had killed a lot of people by the problems it caused them.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202300200346 same reporter/drug, different patient/event.
Sex: U
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: ACTHIB with the wrong diluent and administered with no reported adverse event; Initial information received on 18-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient for whom HIB (PRP/T) vaccine [ACT-HIB] with the wrong diluent was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received 0.5 ml dose and of standard strength suspect HIB (PRP/T) vaccine powder and solvent for solution for injection with the wrong diluent, It was reconstituted with sterile water via unknown route in unknown administration site with unknown batch number & expiry date for Immunization with no reported adverse event (product preparation error) (latency: same day). Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: U
Vaccine: MEN
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Menquadfi reached a low temperature of 32.9F with no reported adverse event; vaccine was administered to 8 people after the excursion. She says that the excursion was caused by additional gel packs being placed in the refrigerator with no reported adverse event; Initial information received on 18-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2023SA157696(CLUSTER) and 2023SA157204(CLUSTER).  This case involves a 18 years old and unknown gender patient who was administered meningococcal A-C-Y-W135 (T conj) vaccine [Menquadfi] after the excursion that reached a low temperature of 32.9f with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV vaccine VLP RL1 4V (YEAST) (Gardasil) and meningococcal vaccine B (Meningococcal Vaccine B) for Prophylactic vaccination (immunization).  On 10-May-2023, the patient received 0.5 mL dose 2 of suspect meningococcal A-C-Y-W135 (T conj) vaccine, solution for injection (lot: U7576AB; expiry date: 28-Feb-2025) via intramuscular route in the left arm for immunization with no reported adverse event (poor quality product administered) (same day latency) and on an unknown date underwent excursion, reached a low temperature of 32.9f with no reported adverse event (product storage error) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.  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: 1.83
Sex: M
Vaccine: DTAP
Symptoms: Injection site nodule, Intentional self-injury, Irritability postvaccinal, Sleep terror
Clinical narrative: hitting himself in the head.; became increasingly fussy; night terrors; a knot on his leg at the injection site; Initial information received on 22-May-2023 along with live follow-up received on same day both were processed together regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 22 months old male patient who experienced hitting himself in the head, became increasingly fussy, night terrors and a knot on his leg at the injection site after receiving vaccine diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel].  The patient had family history of vaccination reactions The patient's past medical history, treatment(s), vaccination(s) were not provided.   On an unknown date in February 2023, the patient received an unknown dose (dose 1) of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (Suspension for injection) (lot number; expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization). On 28-Apr-2023 he also received a dose 2 of the same vaccine (lot number; expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization). Information regarding batch number was requested in the case.  On an unknown date in May-2023 the patient experienced night terrors (sleep terror) and a knot on his leg at the injection site (vaccination site mass) (latency: few days approximately).  On an unknown date the patient was hitting himself in the head. (intentional self-injury) and became increasingly fussy (irritability postvaccinal) (unknown latency).  Reportedly, the patient's mother questioned what she was doing with the information she was providing on her son; she was worried that her telling the details of his reaction would prevent him from receiving other doses of DTAP. She reports she has checked with Hospital, and they told her he needs to have a dose every 2 months until, caller questioning if they delay the 3rd dose is there a possibility that he will not produce sufficient antibodies.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.  The event hitting himself in the head was assessed as medically significant.; Sender's Comments: Sanofi company comment for information received on 24-May-2023: This case involves a 22 months old male patient who experienced hitting himself in the head, became increasingly fussy, night terrors and a knot on his leg at the injection site after receiving vaccine diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel]. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based on the data provided, the role of vaccine(s) cannot be assessed.
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administering expired PENTACEL with no reported AE; Initial information received on 23-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age male patient who was administered expired vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for prophylactic vaccination (Immunization).  On 16-May-2023, the patient received 0.25 ml 1x (total) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (Suspension for injection) Frequency = once, Strength = standard (lot UJ671AAA and expiry date: 13-May-2023) via unknown route in Left Vastus Lateralis administration site for immunization.  On 16-May-2023, the patient was administered expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE with no reported adverse event (expired product administered) (latency: same day).  It was reported that"Nurse is asking if there's any side effects that go along with administering expired PENTACEL to a patient."  Action taken: Not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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: 2.0
Sex: M
Vaccine: UNK
Symptoms: Extra dose administered, Medication error
Clinical narrative: received complete 4-dose series of pentacle, they inadvertently received a 5th dose with no reported adverse event; Initial information received on 23-May-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 2-year-old male patient who received complete 4-dose series of pentacle, they inadvertently received a 5th dose with no reported adverse event after receiving diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) for Prophylactic vaccination.  On 22-May-2023, the patient received 0.5 ml total dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (strength: unknown) (lot: UJ799AA) (expiry date: 10-Feb-2023) via intramuscular route in the left vastus lateralis.  On 22-May-2023 the patient had an event of received complete 4-dose series of pentacle, they inadvertently received a 5th dose with no reported adverse event (extra dose administered) (latency: same day) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine.  Action taken with diphtheria, tetanus, AC pertussis, IPV and HIB vaccine (Pentacel (Vero)) was not applicable.  Outcome: unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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: 2.0
Sex: M
Vaccine: MEN
Symptoms: Medication error, No adverse event, Product dose omission issue
Clinical narrative: He missed the dose of MENQUADFI with no adverse event; Initial information received on 24-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old male patient who missed the dose of Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] with no 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 missed a dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection (Expiry: 18-Apr-2024) (lot number, strength, dose not reported) via unknown route in unknown administration site as prophylactic vaccination with no adverse event (product dose omission issue) (Latency- same day).  It was reported "Her pediatric patient was meant to receive one dose each of MENQUADFI and YF-VAX. However, the patient received one dose of TYPHIM-VI and two doses of YF-VAX. He missed the dose of MENQUADFI."  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Nurse requested information about revaccination of VARIVAX after the titer showed no immunity to varicella virus. The patient believes she received the varicella vaccine as a child, but does not have any records to confirm it. Precautionary AE filed.; This spontaneous report was received from Other Health Professional and refers to a 38-year-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, nurse requested information about revaccination of  varicella virus vaccine live (oka/merck) (VARIVAX) after the titer showed no immunity to varicella virus (Antibody test negative). The patient believes she received the varicella vaccine as a child, but does not have any records to confirm it. Precautionary AE  filed. At the time of reporting, the outcome of the event Antibody test negative was not known. The action taken with VARIVAX regarding Antibody test negative was reported as Not Applicable.   The causal relationship between Antibody test negative and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.
Sex: F
Vaccine: MMR
Symptoms: Vaccination failure
Clinical narrative: patient received 2 MMR II vaccines but is showing no immunity to Mumps; This spontaneous report was received from a nurse referring to a 38-year-old female patient. The patient's medical history, historical drugs, past drug reactions or allergies, concomitant drugs, and concurrent conditions were not reported.   On unknown dates, the patient received two doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported) for immunization.   The patient had received two doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), however, on an unknown date, the patient had no immunity to mumps (vaccination failure). The outcome of the event was unknown. The causal relationship between vaccination failure and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was related.
Age: 87.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive for covid after covid vaccines; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Positive for covid after covid vaccines) in an 87-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     Patient had no other medical conditions.     On 12-May-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-May-2023, the patient experienced COVID-19 (Positive for covid after covid vaccines). At the time of the report, COVID-19 (Positive for covid after covid vaccines) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2023, SARS-CoV-2 test: Positive.         No concomitant medication information was provided.   It was reported that all of the vaccines the patient received were the Moderna covid vaccines. Patient received first dose on 03-Feb-2021, second dose on 03-Mar-2021 and first Moderna booster on 03-Feb-2022. Patient further stated at the time of report, patient was covid positive but had not yet started the Paxlovid treatment. Patient was prescribed 100mg of Paxlovid with 3 doses in the morning and 3 in the evening and to take six a day for 5 days. Patient stated that she had not felt anything, had not had any testing or treatment and had not done anything except for the covid testing positive.   This case was linked to US-MODERNATX, INC.-MOD-2023-725637 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-May-2023: Follow-up received contains non-significant information. On 24-May-2023: Product quality complaint number was added in the case.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-725637:husband case
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Tachycardia
Clinical narrative: high blood pressure; tachicardia/she already had this problem and was taking medication before receiving the vaccines/she was doing fine until the vaccine flurred it up; This spontaneous case was reported by a patient and describes the occurrence of HYPERTENSION (high blood pressure) and TACHYCARDIA (tachicardia/she already had this problem and was taking medication before receiving the vaccines/she was doing fine until the vaccine flurred it up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A, 013A21A, 017F21A and 033K21-2A) for COVID-19 prophylaxis.     It was reported that the patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Tachycardia (treated with low dose (25mg) of Metoprolol ) and Cataract. Concomitant products included METOPROLOL for Tachycardia.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced HYPERTENSION (high blood pressure) and TACHYCARDIA (tachicardia/she already had this problem and was taking medication before receiving the vaccines/she was doing fine until the vaccine flurred it up). At the time of the report, HYPERTENSION (high blood pressure) and TACHYCARDIA (tachicardia/she already had this problem and was taking medication before receiving the vaccines/she was doing fine until the vaccine flurred it up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Blood pressure measurement: high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had the 5th dose of moderna bivalent vaccine (AS714413) on 09-Sep-2022 and also 6th dose (057H22A).  It was reported that the patient already had this problem and was taking medication before receiving the vaccines. But the patient thought  that the shots made it worth, and was having a breakthrough. It was also reported that the patient went to the ER about a year ago for tachycardia and high blood pressure. The patient was fine before this. The patient was doing fine until the vaccine flurred it up. No treatment medication was reported.
Age: 68.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Chest pain, Injection site erythema, Injection site pain, Pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Fever-Mild
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Fever-Mild
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Sudden cardiac death
Clinical narrative: Died Suddenly Cardiac Event
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Metastases to central nervous system, Metastases to lung, Neoplasm malignant
Clinical narrative: Tumor in left thigh. This then spread to lungs and brain. From diagnosis in brain was dead in 5 weeks.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angina pectoris, Symptom recurrence
Clinical narrative: STABLE ANGINA 9/24/2022 -- RECURRENCE OF SAME SYMPTOMS
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Respiratory failure
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypotension
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOTENSION ALLERGIC REACTION, SUBSEQ
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, No adverse event, SARS-CoV-2 test positive
Clinical narrative: I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 in 03/2023. I went to an urgent care center and was given the prescription for PAXLOVID. I tolerated the medication without any complications. As of today, I do not have any lingering symptoms.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine should have been given as IM not SQ.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE NON ST ELEVATION MI
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccination given as SQ when it should have been IM
Age: 27.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Covid Bivalent vaccine given was outdated
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine should have been given IM not SQ
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Symptom recurrence
Clinical narrative: HYPOXIA 6/27/2022 &  10/6/2022  --  RECURRENCE OF SAME SYMPTOMS
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccination was given SQ when it should have been IM
Age: 14.0
Sex: F
Vaccine: COVID19-2
Symptoms: Adverse reaction
Clinical narrative: Other complications following immunization, not elsewhere classified, initial encounter on 2023-02-06.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Immunisation reaction, Vertigo
Clinical narrative: Vertigo NOS on 2020-12-17, Adverse effect of other vaccines and biological substances, initial encounter on 2020-12-17, Unspecified abdominal pain on 2020-12-22.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Vertigo
Clinical narrative: Vertigo NOS on 2020-12-17, Adverse effect of other vaccines and biological substances, initial encounter on 2020-12-17.
Age: 1.58
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5, UNK
Symptoms: Post vaccination fever, Pyrexia
Clinical narrative: Fever NOS on 2022-02-02, Postvaccination fever on 2022-02-02.
Age: 3.0
Sex: M
Vaccine: PNC13, UNK
Symptoms: Abnormal faeces, Immunisation reaction
Clinical narrative: Adverse effect of other vaccines and biological substances, initial encounter on 2021-12-14, Bulky stools on 2021-12-15.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash NOS on 2022-02-18, Other complications following immunization, not elsewhere classified, initial encounter on 2022-03-07.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Immunisation reaction, Syncope
Clinical narrative: Fainting on 2022-02-16, Adverse effect of other vaccines and biological substances, initial encounter on 2022-02-16.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Adverse effect of other vaccines and biological substances, initial encounter on 2020-12-16.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, PNC13, UNK
Symptoms: Adverse event
Clinical narrative: Adverse effect of other vaccines and biological substances, initial encounter on 2020-12-18.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Adverse effect of other vaccines and biological substances, initial encounter on 2020-12-19, Adverse effect of other vaccines and biological substances, initial encounter on 2021-01-11.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine was given SQ when it should have been IM
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Diabetes mellitus
Clinical narrative: Vaccine given in incorrect route
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine given as SQ instead of IM
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Pain in extremity, SARS-CoV-2 test positive
Clinical narrative: I had a sore arm for about a day after receiving the vaccine. I tested positive for COVID-19 on 05/10/2023. I contacted a provider and got a prescription for an antibiotic but on the advice of my pharmacist I didn't get it. I did get a prescription for PAXLOVID. I tolerated the medication without any complications. As of today, I do not have any lingering symptoms.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: ANGIOEDEMA, INIT ANGIOEDEMA, SEQUELA
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine given SQ instead of IM
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia
Clinical narrative: HYPOXIA
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine given SQ instead of IM
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: given subQ instead of IM
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine given SQ instead of IM
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Presyncope
Clinical narrative: Pt had a vagal response. Recovered within 30 seconds. Oriented to time and place.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Unknown
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine was given SQ instead of IM
Age: 1.5
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine was given SQ instead of IM
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: TRANSIENT CEREBRAL ISCHEMIA
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Malaise, Oropharyngeal pain
Clinical narrative: I had a sore arm for about a day after receiving the vaccine. I tested positive for COVID-19 on 05/10/2023. I had a fever, mild sore throat, cough and body aches. I was really sick for 72 hours. I contacted my provider via telehealth and got a prescription for PAXLOVID. I tolerated the medication without any complications. I did have loose stools taking PAXLOVID. As of today, I still feel fatigued.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I had a sore arm for about a day after receiving the vaccine. I tested positive for COVID-19 on 05/10/2023. I had a fever, mild sore throat, cough and body aches. I was really sick for 72 hours. I contacted my provider via telehealth and got a prescription for PAXLOVID. I tolerated the medication without any complications. I did have loose stools taking PAXLOVID. As of today, I still feel fatigued.
Age: 0.25
Sex: F
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine given SQ instead of IM
Age: 0.25
Sex: F
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Incorrect route of product administration, Off label use
Clinical narrative: Vaccine given SQ instead of IM
Age: 1.42
Sex: F
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine given as SQ instead of IM
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Symptom recurrence
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOTENSION 5/10/2022 -- RECURRENCE OF SAME SYMPTOMS
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Obstructive sleep apnoea syndrome
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE OBSTRUCTIVE SLEEP APNEA STABLE ANGINA
Age: 23.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Product preparation issue, Wrong product administered
Clinical narrative: 2 pediatric doses of Vaqta were mixed together and given. Patient should have received an Adult hep a
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Hypotension
Clinical narrative: ACUTE NON ST ELEVATION MI HYPOTENSION
Age: 31.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Lichen planopilaris
Clinical narrative: I was diagnosed with Frontal Fibrosting Alopecia 12MAY2023, I first noted in the summer of 2021 looking back in pictures it actally started in 2020.  I did not seek medical attention until April 2023. Symtoms started before I was ever vaccinated and I have had confirmed  COVID-19 January 2022 and unconfirmed in January 2020.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain in extremity, Skin warm
Clinical narrative: patient reported pain in arm to finger. the shoulder was hard red and hot
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: STABLE ANGINA
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE NON ST ELEVATION MI
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOXIA
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA HYPOTENSION
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest pain, Erythema, Pain in extremity, Skin warm
Clinical narrative: I received my vaccine and in 24 hours my arm was red and felt hot. The pain went down my arm and across my chest. This lasted about a week. I took TYLENOL or ADVIL to help with the pain.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Ageusia, Anosmia, Asthenia, COVID-19
Clinical narrative: In January I started developed a cough that would not go away, it just got progressively worse. I was taking over the counter cough syrup and MUCINEX to try and quell the cough, it was not working. In early February my friends and I went for our annual lady's spa day. I wasn't aware that I was acting any differently, but I awoke in the car as I had fallen asleep in the spa, my friends and staff carried me out to the car. I called my doctor's office to try to get in to see my doctor. They were not able to get me in, but their sister office was able to get me as they had an opening. I had a PCR rapid COVID-19 test that came back positive, I was prescribed PAXLOVID that I feel is a miracle drug. Although it did take a month for me to get my energy back, I am finally starting to feel like myself. I actually got my taste and smell back that I lost in 2021.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, SARS-CoV-2 test positive
Clinical narrative: In January I started developed a cough that would not go away, it just got progressively worse. I was taking over the counter cough syrup and MUCINEX to try and quell the cough, it was not working. In early February my friends and I went for our annual lady's spa day. I wasn't aware that I was acting any differently, but I awoke in the car as I had fallen asleep in the spa, my friends and staff carried me out to the car. I called my doctor's office to try to get in to see my doctor. They were not able to get me in, but their sister office was able to get me as they had an opening. I had a PCR rapid COVID-19 test that came back positive, I was prescribed PAXLOVID that I feel is a miracle drug. Although it did take a month for me to get my energy back, I am finally starting to feel like myself. I actually got my taste and smell back that I lost in 2021.
Age: 1.58
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: This patient received the Monovalent Covid vaccine after the FDA amended the emergency use authorization.
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: This patient received the Monovalent Covid vaccine after the FDA amended the emergency use authorization.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Transient ischaemic attack
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE TRANSIENT CEREBRAL ISCHEMIA RIGHT BELLS PALSY
Age: 4.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient administered 25 mcg for third dose. This was due to information RN had at time of injection  indicated patient was receiving 2nd dose.  Discovered after injection it was indeed the 3rd dose.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Erythema, Follicular disorder, Lichen planopilaris, Madarosis
Clinical narrative: 2/17/2022 I went in for a regular Dermatology visit. The doctor discovered I had Frontal Fibrosing Alopecia. I am losing my eyebrows and my hair from my sideburns back. My scalp is red and itchy. The follicles are being attacked by my body which causes the hair to fall out and not grow out in that particular follicle. There is no cure, but the medication prescribed to me is supposed to slow it down. The medication I was prescribed finasteride, a steroid solution to put on my scalp, RETIN A to use on my forehead for the bumps. I also was to start on ROGAINE. I was recently prescribed doxycycline. I stopped taking finasteride and doxycycline because of the side effects and the fact that this condition continues to progress. I am still using the topicals.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: 2/17/2022 I went in for a regular Dermatology visit. The doctor discovered I had Frontal Fibrosing Alopecia. I am losing my eyebrows and my hair from my sideburns back. My scalp is red and itchy. The follicles are being attacked by my body which causes the hair to fall out and not grow out in that particular follicle. There is no cure, but the medication prescribed to me is supposed to slow it down. The medication I was prescribed finasteride, a steroid solution to put on my scalp, RETIN A to use on my forehead for the bumps. I also was to start on ROGAINE. I was recently prescribed doxycycline. I stopped taking finasteride and doxycycline because of the side effects and the fact that this condition continues to progress. I am still using the topicals.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN ACUTE DVT OF RIGHT CALF, UNSPECIFIED VEIN
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Cough, Dyspnoea, Radiation pneumonitis, SARS-CoV-2 test negative
Clinical narrative: I had a cough, shortness of breath, dyspnea. I used a home COVID19 test that came back negative. I went in to have a chest x-ray that came back showing I had radiation pneumonitis. I was given medication and I am currently healing from this.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Adult patient was given a pediatric dose. No s/sx of adverse event noted
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Symptom recurrence
Clinical narrative: ACUTE ST ELEVATION MI, UNSPECIFIED ACUTE NON ST ELEVATION MI 3/22/2022 -- RECURRENCE OF SAME SYMPTOMS
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: given subQ instead of IM
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paresis, Ischaemic stroke, Partial seizures
Clinical narrative: FOCAL MOTOR SEIZURE ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY LEFT FACIAL MUSCLE WEAKNESS
Age: 43.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Provider told me give patient vaccine before recommneded date.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Joint swelling, Pain in extremity, Paraesthesia, Peripheral swelling, Pruritus
Clinical narrative: Pt had a TDAP on 5/22/23 and the following day underneath her right  upper arm started itching and she is having swelling on her affected side in her face, arm, neck, leg, and ankle. Pt has a history of lymphedema due to breast cancer. her injection was given in the left arm and all side effects are on the right. She has a flexi motor pump thath she uses daily in the right arm prior to this for the lymphedema. she did contact her lymphedema specialist regarding if she should use her pump more and they suggested she wait and try to let her system adjust. She will be in close contact with them.  She reports her underarm feels like pens and needles  and  it is achy
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling, Swelling face
Clinical narrative: Pt had a TDAP on 5/22/23 and the following day underneath her right  upper arm started itching and she is having swelling on her affected side in her face, arm, neck, leg, and ankle. Pt has a history of lymphedema due to breast cancer. her injection was given in the left arm and all side effects are on the right. She has a flexi motor pump thath she uses daily in the right arm prior to this for the lymphedema. she did contact her lymphedema specialist regarding if she should use her pump more and they suggested she wait and try to let her system adjust. She will be in close contact with them.  She reports her underarm feels like pens and needles  and  it is achy
Age: 16.0
Sex: F
Vaccine: HIBV
Symptoms: Wrong product administered
Clinical narrative: Patient was given HIB vs Meningococcal vaccine
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicectomy, COVID-19, Exposure to SARS-CoV-2, Malaise, SARS-CoV-2 test positive
Clinical narrative: I did not have an adverse reaction to the vaccine. I was exposed to COVID-19 during a vacation. On 03/25/2023, I tested positive for COVID-19. I contacted a provider and got a prescription for molnupiravir. I tolerated the medication without any complications. I'm not sure that it helped me. I was sick for two weeks. On 04/11/2023, I had an appendectomy. As of today, I do not have any lingering symptoms.
Age: 39.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Pt reported "I don't remember getting a third vaccine."  Vaccine not listed on system. HPV given.  Reviewed immunization record with pt. Pt stated " I remember getting the 1st two, one month apart. I don't remember getting a 3rd."
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Symptom recurrence
Clinical narrative: RIGHT BELLS PALSY 9/5/2022,  9/27/2022,  1/24/2023  --  RECURRENCE OF SAME SYMPTOMS
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ageusia, COVID-19, Cough, Diarrhoea, Dysgeusia
Clinical narrative: Runny nose, dry cough, extreme fatigue, vomiting, diarrhea, rash on my arms and trunk area, slight loss of sweet sensation, constant taste of bile in my mouth although I believe this was from the PAXLOVID I was prescribed.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Rash, Rhinorrhoea, SARS-CoV-2 test positive, Vomiting
Clinical narrative: Runny nose, dry cough, extreme fatigue, vomiting, diarrhea, rash on my arms and trunk area, slight loss of sweet sensation, constant taste of bile in my mouth although I believe this was from the PAXLOVID I was prescribed.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Incorrect route of product administration
Clinical narrative: The vaccine was administered subcutaneous routine instead of intramuscular.  There were no signs of any immediate reaction.