chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, SARS-CoV-2 test
Clinical narrative: Irregular menstrual cycle; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 2, single (Lot number: EL9261) at the age of 33 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE; CITALOPRAM; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 06Jan2021, when the patient was 33-year-old, for COVID-19 immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 01Mar2021, outcome "not recovered", described as "Irregular menstrual cycle". The event "irregular menstrual cycle" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: The patient did not receive any other vaccine in four weeks. Had no COVID prior vaccination. The patient was tested for COVID post vaccination and test type was Nasal swab. The patient had no known allergies and no medical history.
Sex: M
Vaccine: COVID19
Symptoms: Scrotal swelling
Clinical narrative: scrotum swollen; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: SCROTAL SWELLING (non-serious), outcome "unknown", described as "scrotum swollen". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood phosphorus, Blood sodium, Feeling hot, Weight
Clinical narrative: had no energy; overheated; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "AVM in her stomach" (unspecified if ongoing); "Smoker", stop date: Feb2023, notes: Use to smoke at least half to one pack a day for the last 50 years.; "COPD", start date: 2019 (ongoing), notes: possible Covid strands.; "Asthma", start date: 2019 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Date:  08Feb2021- Pfizer Covid 19 TRIS 12 plus Vaccine , Lot: EL9265, Exp/NDC: Unknown , Time: Unknown; about 3 in the afternoon , Anatomical : Right arm, in the deltoid, intramuscular. Then added, it could have been sub q, but she was not paying attention), administration date: 08Feb2021, when the patient was 67-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Second Dose: Pfizer Covid 19 TRIS 12 plus Vaccine , Date: 01Mar2021, Lot: EN6201, Time Administered : About 1 in the afternoon , Anatomical Location Left arm), administration date: 01Mar2021, when the patient was 67-year-old, for COVID-19 immunization. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "had no energy"; FEELING HOT (non-serious), outcome "unknown", described as "overheated". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated that she went to the same clinic. She was out working and had no energy. She was overheated. Route Administered: Initially stated sub-q, but then stated the form looking at it does not say.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure, Weight
Clinical narrative: had no energy; overheated; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "AVM in her stomach" (unspecified if ongoing); "Smoker", stop date: Feb2023, notes: Use to smoke at least half to one pack a day for the last 50 years.; "COPD", start date: 2019 (ongoing), notes: possible Covid strands.; "Asthma", start date: 2019 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Date:  08Feb2021- Pfizer Covid 19 TRIS 12 plus Vaccine , Lot: EL9265, Exp/NDC: Unknown , Time: Unknown; about 3 in the afternoon , Anatomical : Right arm, in the deltoid, intramuscular. Then added, it could have been sub q, but she was not paying attention), administration date: 08Feb2021, when the patient was 67-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Second Dose: Pfizer Covid 19 TRIS 12 plus Vaccine , Date: 01Mar2021, Lot: EN6201, Time Administered : About 1 in the afternoon , Anatomical Location Left arm), administration date: 01Mar2021, when the patient was 67-year-old, for COVID-19 immunization. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "had no energy"; FEELING HOT (non-serious), outcome "unknown", described as "overheated". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated that she went to the same clinic. She was out working and had no energy. She was overheated. Route Administered: Initially stated sub-q, but then stated the form looking at it does not say.
Sex: M
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: injured; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient 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: INJURY (non-serious), outcome "unknown", described as "injured".  Additional information: The reporter asked if we did have a third-party insurance that may cover injury from the Pfizer covid-19 vaccine. The reporter said that they did have one member who told them that he was injured by Pfizer covid-19 vaccine.  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: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Mar2021 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: TINNITUS (non-serious), outcome "not recovered".  Additional Information: The patient reported that the onset of Tinnitus was after receiving the COVID  vaccination. The patient never experienced it prior to receiving the vaccination in Mar2021, and since then have had continuing effects of Tinnitus.   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: Hypoacusis
Clinical narrative: having a hard time hearing me; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). 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: HYPOACUSIS (non-serious), outcome "unknown", described as "having a hard time hearing me". Additional information: Caller mentioned that he already set an appointment in (Pharmacy name withheld), 6pm today. Caller said that he cannot finalize his reservation because they sent him to the multi-page fact sheet. Created manual AE form because the caller mentioned that he was having a hard time hearing and the caller took the Pfizer vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19-2
Symptoms: Diarrhoea, Gastric infection
Clinical narrative: infection in my stomach that caused me to get diarrhea for 6 months; infection in my stomach that caused me to get diarrhea for 6 months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (201792).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer, Lot number and expiration date not provided.), for COVID-19 immunization. The following information was reported: GASTRIC INFECTION (non-serious), DIARRHOEA (non-serious), outcome "unknown" and all described as "infection in my stomach that caused me to get diarrhea for 6 months". The event "infection in my stomach that caused me to get diarrhea for 6 months" required physician office visit. Therapeutic measures were taken as a result of gastric infection, diarrhoea.  Additional Information: It was reported that the patient did not have a very good feeling about Pfizer because she had the vaccine for the coronavirus booster and ended up getting an infection in her stomach that caused her to get diarrhea for 6 months before the doctor found it (as reported) and gave her medication to treat the symptoms and infection.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 14.0
Sex: M
Vaccine: FLUC3
Symptoms: Headache, Influenza, Influenza B virus test positive, Nasal congestion, Oropharyngeal pain
Clinical narrative: Sneezing; Congestion with productive cough; Congestion with productive cough; Sore throat; Headache; Low grade fever; Tested positive for Influenza B; This spontaneous case was received on 24-Apr-2023 from other non-healthcare professional (consumer's father) via Agency (reference number: SEQW23-01259) with additional information received (being processed together) on 26-Apr-2023, and concerned a 14-year-old, male patient.  The patient's concurrent condition included attention deficit hyperactivity disorder (ADHD). The patient's concomitant medications were not reported.  On unspecified date in early Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; route of administration, dose, anatomical location, and indication: not reported). The batch number was not reported.  On unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent the patient experienced sneezing, severe congestion with productive cough, headache, mild sore throat and low grade fever. The patient was being treated with generic Tamiflu (oseltamivir phosphate) and a combination cough syrup.  On 23-Apr-2023, the patient was tested positive for Influenza B.  At the time of initial reporting, the patient was recovering from events with no complications.  The reporter did not provide a causality assessment.  The events of 'influenza B virus infection' and 'vaccination failure' were considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 14-year-old patient was tested positive for Influenza B approximately seven months after receiving the suspect product Flucelvax Quadrivalent. Reportedly, the patient experienced sneezing, nasal congestion, productive cough, oropharyngeal pain, headache, and low grade fever. The patient was being treated with generic Tamiflu and a combination cough syrup. Due to chronological implausibility, the causal role of the suspect vaccine is assessed as not related, since all mentioned events are consequences of Influenza B.; Sender's Comments: A 14-year-old patient was tested positive for Influenza B approximately seven months after receiving the suspect product Flucelvax Quadrivalent. Reportedly, the patient experienced sneezing, nasal congestion, productive cough, oropharyngeal pain, headache, and low grade fever. The patient was being treated with generic Tamiflu and a combination cough syrup. Due to chronological implausibility, the causal role of the suspect vaccine is assessed as not related, since all mentioned events are consequences of Influenza B.
Age: 14.0
Sex: M
Vaccine: FLUC3
Symptoms: Productive cough, Pyrexia, Respiratory tract congestion, Sneezing, Vaccination failure
Clinical narrative: Sneezing; Congestion with productive cough; Congestion with productive cough; Sore throat; Headache; Low grade fever; Tested positive for Influenza B; This spontaneous case was received on 24-Apr-2023 from other non-healthcare professional (consumer's father) via Agency (reference number: SEQW23-01259) with additional information received (being processed together) on 26-Apr-2023, and concerned a 14-year-old, male patient.  The patient's concurrent condition included attention deficit hyperactivity disorder (ADHD). The patient's concomitant medications were not reported.  On unspecified date in early Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; route of administration, dose, anatomical location, and indication: not reported). The batch number was not reported.  On unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent the patient experienced sneezing, severe congestion with productive cough, headache, mild sore throat and low grade fever. The patient was being treated with generic Tamiflu (oseltamivir phosphate) and a combination cough syrup.  On 23-Apr-2023, the patient was tested positive for Influenza B.  At the time of initial reporting, the patient was recovering from events with no complications.  The reporter did not provide a causality assessment.  The events of 'influenza B virus infection' and 'vaccination failure' were considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 14-year-old patient was tested positive for Influenza B approximately seven months after receiving the suspect product Flucelvax Quadrivalent. Reportedly, the patient experienced sneezing, nasal congestion, productive cough, oropharyngeal pain, headache, and low grade fever. The patient was being treated with generic Tamiflu and a combination cough syrup. Due to chronological implausibility, the causal role of the suspect vaccine is assessed as not related, since all mentioned events are consequences of Influenza B.; Sender's Comments: A 14-year-old patient was tested positive for Influenza B approximately seven months after receiving the suspect product Flucelvax Quadrivalent. Reportedly, the patient experienced sneezing, nasal congestion, productive cough, oropharyngeal pain, headache, and low grade fever. The patient was being treated with generic Tamiflu and a combination cough syrup. Due to chronological implausibility, the causal role of the suspect vaccine is assessed as not related, since all mentioned events are consequences of Influenza B.
Age: 10.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: COVID-19, Condition aggravated, Eosinophil count increased, Eosinophil percentage increased, Eosinophilia
Clinical narrative: prolonged fever starting 1 day after vaccination. He has existed rash but rash got worsen. Complained of pain with weight bearing. On admission (10 days after admission), work up showed leukocytosis (42.6K) with elevated absolute eosinophil (256). Initial work up diagnosis was MIS-C (fever, rash, hypotensive episodes, positive COVID spike in a non COVID vaccinated patient), elevated . Patient received IVIG and high dose steroid. Fever and rash improved with the treatment. However, with the wean of steroid, his leukocytosis and eosinophilia were worsened (max eosinophilia of 1464), before downtrending with the increase dose of steroid. Giving fever, rash and the above workup, there is a concern for DRESS syndrome secondary to the vaccines.
Age: 10.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Full blood count abnormal, Haemoglobin normal, Hypotension, Immunoglobulin therapy, Leukocytosis
Clinical narrative: prolonged fever starting 1 day after vaccination. He has existed rash but rash got worsen. Complained of pain with weight bearing. On admission (10 days after admission), work up showed leukocytosis (42.6K) with elevated absolute eosinophil (256). Initial work up diagnosis was MIS-C (fever, rash, hypotensive episodes, positive COVID spike in a non COVID vaccinated patient), elevated . Patient received IVIG and high dose steroid. Fever and rash improved with the treatment. However, with the wean of steroid, his leukocytosis and eosinophilia were worsened (max eosinophilia of 1464), before downtrending with the increase dose of steroid. Giving fever, rash and the above workup, there is a concern for DRESS syndrome secondary to the vaccines.
Age: 10.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Lymphocyte percentage decreased, Multisystem inflammatory syndrome in children, Pain, Platelet count normal, Pyrexia
Clinical narrative: prolonged fever starting 1 day after vaccination. He has existed rash but rash got worsen. Complained of pain with weight bearing. On admission (10 days after admission), work up showed leukocytosis (42.6K) with elevated absolute eosinophil (256). Initial work up diagnosis was MIS-C (fever, rash, hypotensive episodes, positive COVID spike in a non COVID vaccinated patient), elevated . Patient received IVIG and high dose steroid. Fever and rash improved with the treatment. However, with the wean of steroid, his leukocytosis and eosinophilia were worsened (max eosinophilia of 1464), before downtrending with the increase dose of steroid. Giving fever, rash and the above workup, there is a concern for DRESS syndrome secondary to the vaccines.
Age: 10.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Rash, SARS-CoV-2 test positive, Weight bearing difficulty, White blood cell count increased
Clinical narrative: prolonged fever starting 1 day after vaccination. He has existed rash but rash got worsen. Complained of pain with weight bearing. On admission (10 days after admission), work up showed leukocytosis (42.6K) with elevated absolute eosinophil (256). Initial work up diagnosis was MIS-C (fever, rash, hypotensive episodes, positive COVID spike in a non COVID vaccinated patient), elevated . Patient received IVIG and high dose steroid. Fever and rash improved with the treatment. However, with the wean of steroid, his leukocytosis and eosinophilia were worsened (max eosinophilia of 1464), before downtrending with the increase dose of steroid. Giving fever, rash and the above workup, there is a concern for DRESS syndrome secondary to the vaccines.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dyspnoea, Eye swelling, Hypersensitivity, Increased bronchial secretion, Mouth swelling
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: mucus buildup in nose and lungs-Mild, Additional Details: patient experiences shortness of breath secondary to phlem buildup in lungs in addition to slight swelling of the skin under the eyes and runny nose which persisted days after vaccine administration and has been kept under control with otc benadryl 25 mg. patient is experiensing mild symptoms and has not seeked medical help reporting gradual improvement. advised patient to seek medical care if necessary.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Periorbital swelling, Productive cough, Rhinorrhoea, Skin swelling, Swelling face
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: mucus buildup in nose and lungs-Mild, Additional Details: patient experiences shortness of breath secondary to phlem buildup in lungs in addition to slight swelling of the skin under the eyes and runny nose which persisted days after vaccine administration and has been kept under control with otc benadryl 25 mg. patient is experiensing mild symptoms and has not seeked medical help reporting gradual improvement. advised patient to seek medical care if necessary.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Swollen tongue
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: mucus buildup in nose and lungs-Mild, Additional Details: patient experiences shortness of breath secondary to phlem buildup in lungs in addition to slight swelling of the skin under the eyes and runny nose which persisted days after vaccine administration and has been kept under control with otc benadryl 25 mg. patient is experiensing mild symptoms and has not seeked medical help reporting gradual improvement. advised patient to seek medical care if necessary.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 96.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 86.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 18.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 28.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 87.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 91.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 39.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Full blood count abnormal, Injection site erythema, Platelet count decreased
Clinical narrative: Pt reported a red circle 3 inches in diameter at the injection site that appeared 3 days after administration.  Pt also stated that he had laboratory results that included a low platelet count value reportedly around 100,000 on 4/25/2023
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Immediate post-injection reaction, Nausea
Clinical narrative: Patient felt nauseous and faint immediately after vaccination. Assisted to supine position with legs elevated. After approximately 15 minutes of rest, patient felt well enough to move to post-vaccination area.
Age: 94.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Protocol states that 2nd dose should be given 2 months after the 1st dose. Vaccine was given 21 days later from the 1 st monovalent dose
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Antinuclear antibody positive, Pruritus, Rash, Urticaria
Clinical narrative: New onset re-occurring urticarial rash over entire body, including face few times a week, lasts for less than 12 hours, mild pruritis, resolves on own.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Rash, Rash pruritic
Clinical narrative: Rash on forehead/neck that is itching/burning. Patient treated with Acyclovir 800mg, 1 tab 5 times daily for 7 days
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate increased, Tachycardia
Clinical narrative: Was notified by patient's wife this morning, that patient experienced tachycardia for a space of around 2 hours in the middle of the night with HR reporting around 150. Patient did not notify wife of reaction until this morning, where patient's wife checked HR again and it had normalized to the 80s. Patient did not experience any HA, nausea, sweating, chest pain, or any other negative symptoms aside from the elevated heart rate.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Eyelids pruritus, Fatigue, Headache, Pruritus
Clinical narrative: Customer called for the first time on Saturday, April 29th. He said his forehead and eyelid were itchy. He at first said it started on Thursday. After asking if it could be due to something else, he later stated that maybe it started earlier in the week to a smaller degree and he is just now noticing it. He also has had a headache all week and has felt fatigued.  He will also call his doctor.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rash, Urticaria
Clinical narrative: Rash, hives on right forearm
Age: 0.75
Sex: M
Vaccine: PNC13
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 3rd dose of Prevnar at 9 months. However, dose was given too early since last dose was given to patient at 7 months of age. Patient will return to office in July to receive next dose of Prevnar.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Chest X-ray abnormal, Chest discomfort, Electrocardiogram, Headache
Clinical narrative: Bloodwork 5 days later showed severely elevated systemic inflammation? developed pulmonary inflammation (as seen on X-ray) neurological symptoms of tremors and muscle twitching (confirmed by neurologist)  headaches, chest pressure/heart palpitations (went to a cardiologist) Was treated with NSSRI and Omeprazole
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Muscle twitching, Neurological examination abnormal, Neurological symptom, Palpitations
Clinical narrative: Bloodwork 5 days later showed severely elevated systemic inflammation? developed pulmonary inflammation (as seen on X-ray) neurological symptoms of tremors and muscle twitching (confirmed by neurologist)  headaches, chest pressure/heart palpitations (went to a cardiologist) Was treated with NSSRI and Omeprazole
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonitis, Systemic inflammatory response syndrome, Tremor
Clinical narrative: Bloodwork 5 days later showed severely elevated systemic inflammation? developed pulmonary inflammation (as seen on X-ray) neurological symptoms of tremors and muscle twitching (confirmed by neurologist)  headaches, chest pressure/heart palpitations (went to a cardiologist) Was treated with NSSRI and Omeprazole
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Asthenia, Blood test, COVID-19
Clinical narrative: Since mid February through current, I?ve experienced joint pain, muscle pain, muscle twitching, anxiety, extreme pronounced veins through skin , heart palpitations, brain buzzing and electrical shocks.  After getting Covid in July 2022 add to this list extreme leg pain, hip pain and weakness, burning skin pain (similar to small fiber  neuropathy), tremors and pain all along the spinal cord.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Cytokine test, Electric shock sensation, Electromyogram, Magnetic resonance imaging head, Magnetic resonance imaging spinal
Clinical narrative: Since mid February through current, I?ve experienced joint pain, muscle pain, muscle twitching, anxiety, extreme pronounced veins through skin , heart palpitations, brain buzzing and electrical shocks.  After getting Covid in July 2022 add to this list extreme leg pain, hip pain and weakness, burning skin pain (similar to small fiber  neuropathy), tremors and pain all along the spinal cord.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching, Myalgia, Pain in extremity, Pain of skin, Palpitations
Clinical narrative: Since mid February through current, I?ve experienced joint pain, muscle pain, muscle twitching, anxiety, extreme pronounced veins through skin , heart palpitations, brain buzzing and electrical shocks.  After getting Covid in July 2022 add to this list extreme leg pain, hip pain and weakness, burning skin pain (similar to small fiber  neuropathy), tremors and pain all along the spinal cord.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Skin burning sensation, Spinal X-ray, Spinal pain, Tremor, Ultrasound Doppler
Clinical narrative: Since mid February through current, I?ve experienced joint pain, muscle pain, muscle twitching, anxiety, extreme pronounced veins through skin , heart palpitations, brain buzzing and electrical shocks.  After getting Covid in July 2022 add to this list extreme leg pain, hip pain and weakness, burning skin pain (similar to small fiber  neuropathy), tremors and pain all along the spinal cord.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Vein disorder, Vibratory sense increased, X-ray of pelvis and hip
Clinical narrative: Since mid February through current, I?ve experienced joint pain, muscle pain, muscle twitching, anxiety, extreme pronounced veins through skin , heart palpitations, brain buzzing and electrical shocks.  After getting Covid in July 2022 add to this list extreme leg pain, hip pain and weakness, burning skin pain (similar to small fiber  neuropathy), tremors and pain all along the spinal cord.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Immediate post-injection reaction, Loss of consciousness, Pallor, Syncope
Clinical narrative: MCV vaccine was administered FIRST.  Syncope immediately after injection of Tdap (second vaccine).  Patient became pale and lost tone, was laid down on exam table and reportedly regained consciousness in under a minute. Mother of child, sisters of child and medical assistant administering vaccine were all present in the room for the event. When he "came to" he state he had to "go pee" and was noted to be diaphoretic. VS stable. Was accompanied to the restroom where he voided and was able to walk back to exam room independently. He left the clinic about 15min after the event occurred.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, X-ray
Clinical narrative: Patient reported information to pharmacy on 4/24/23. Patient received Shingrix Vaccine on 9/24/2021.  She states that she immediately had pain at the injection site which she states is her right arm.  Our documentation shows that the vaccine was administered in the left arm.  She states the pain was present when she saw her physician sometime in January of 2022.  She says that the Doctor told her at that time that it was from the vaccine and she should not repeat with the 2nd dose.  In April of 2023 patient saw chiropract who also said it is from the vaccine.  continued below. Patient stated that she had some Xrays completed and is currently under treatment for this by Dr. She hasbeen using OTC rememdies and her own exercise program to treat.  Pain is still present to this day per patient.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: She developed rashes on right and left side of neck & upper left cheek of face.  The rashes lasted about for 1 week. It was itchy, however, she did not take any medications. The rashes were gone she feels good today.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Sciatica, Vomiting
Clinical narrative: NAUSEA AND VOMITING, PATIENT HAD SCIATICA ATTACK THE SAME DAY BUT SEEMS UNRELATED
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Ringing in my ears
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Syringe issue, Underdose
Clinical narrative: upon vaccination  vaccine leaked outside of the needle where it was screwed on to the syringe.  most of the vaccine leaked out of the syringe.  vaccine was re-adminstered to ensure patient is fully protected
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Induration, Nodule, Stomatitis
Clinical narrative: night that she got the vaccines she started to feel sores form in her mouth. then the next day a knot the size of a half dollar formed and got harder and harder.  the sores got worse and are still active in her mouth on day of this report. brusing on left arm. going to doctor on monday 5/1/23
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt states she has been experiencing arm pain for a few months and is unable to lift her arms. She believes it may be due to the vaccination she received. She states her pain began a few days after receiving the vaccine and has not resolved. Informed to consult with her provider to make sure there are no other underlying causes for her arm pain.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema
Clinical narrative: Patient got a bruise/redness on her left arm
Age: 16.0
Sex: F
Vaccine: COVID19-2
Symptoms: Consciousness fluctuating, Dyskinesia, Eye movement disorder, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Immediately after the vaccine was administered the patient's eyes rolled back in her head and she closed her eyes then passed out.  She clenched her hands and had tremors or minor convulsions for a few seconds then began to regain consciousness.  She lost bladder control.  She became very pale.  She then proceeded to drift in and out of consciousness for the next several minutes.  HR was 60bpm per Apple watch the patient wor into the pharmacy.  EMS was notified at the suggestion of the pharmacist and request of the parent.  Upon arrival EMS measure blood pressure which was approximately 88/54 mm/hg seated and standing.  Patient was alert and awake when transported to the hospital after getting examined by EMS.
Age: 16.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pallor, Seizure, Tremor, Urinary incontinence
Clinical narrative: Immediately after the vaccine was administered the patient's eyes rolled back in her head and she closed her eyes then passed out.  She clenched her hands and had tremors or minor convulsions for a few seconds then began to regain consciousness.  She lost bladder control.  She became very pale.  She then proceeded to drift in and out of consciousness for the next several minutes.  HR was 60bpm per Apple watch the patient wor into the pharmacy.  EMS was notified at the suggestion of the pharmacist and request of the parent.  Upon arrival EMS measure blood pressure which was approximately 88/54 mm/hg seated and standing.  Patient was alert and awake when transported to the hospital after getting examined by EMS.
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Aldolase, Angiogram, Antinuclear antibody, Aspiration pleural cavity, Autoantibody test
Clinical narrative: Pericardial Effusion, Pulmonary Effusion, Kidney Failure (likely due to treatment, not vaccine)
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood culture, Blood fibrinogen, Blood lactate dehydrogenase, Blood lactic acid, Blood magnesium
Clinical narrative: Pericardial Effusion, Pulmonary Effusion, Kidney Failure (likely due to treatment, not vaccine)
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Body fluid analysis, C-reactive protein, Computerised tomogram thorax, Culture urine, Cytogenetic analysis
Clinical narrative: Pericardial Effusion, Pulmonary Effusion, Kidney Failure (likely due to treatment, not vaccine)
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cytology, Drug level, Electrocardiogram, Eosinophils urine, Fibrin D dimer
Clinical narrative: Pericardial Effusion, Pulmonary Effusion, Kidney Failure (likely due to treatment, not vaccine)
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Full blood count, Glycosylated haemoglobin, Gram stain, HIV antibody, HIV antigen
Clinical narrative: Pericardial Effusion, Pulmonary Effusion, Kidney Failure (likely due to treatment, not vaccine)
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Influenza virus test, Lipase, Liver function test, Metabolic function test, Microscopy
Clinical narrative: Pericardial Effusion, Pulmonary Effusion, Kidney Failure (likely due to treatment, not vaccine)
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: N-terminal prohormone brain natriuretic peptide, Pathology test, Pericardial effusion, Pleural effusion, Procalcitonin
Clinical narrative: Pericardial Effusion, Pulmonary Effusion, Kidney Failure (likely due to treatment, not vaccine)
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Renal failure, Renal function test, Respiratory pathogen panel, SARS-CoV-2 test, Serum ferritin
Clinical narrative: Pericardial Effusion, Pulmonary Effusion, Kidney Failure (likely due to treatment, not vaccine)
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Sputum culture, Thyroxine free, Troponin, Urine analysis, X-ray
Clinical narrative: Pericardial Effusion, Pulmonary Effusion, Kidney Failure (likely due to treatment, not vaccine)
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: pH body fluid
Clinical narrative: Pericardial Effusion, Pulmonary Effusion, Kidney Failure (likely due to treatment, not vaccine)
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given the 12+ Pfizer Vaccine, when he is in the 5-12 Pfizer Vaccine age range. Patient did not experience any adverse side effects, but management was immediately notified, staff meeting was held, patient's family was notified, and this report was filed.
Age: 59.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Asthenia, Balance disorder, Electric shock sensation, Hypoaesthesia, Paraesthesia
Clinical narrative: PRN symptoms. Tingling, Numbness, small fiber electric shock, weakness, balance in feet.
Age: 56.0
Sex: F
Vaccine: TDAP, TYP, YF
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: 4/12/23 Client reported she received vaccines on 4/4/23 and on 4/10/23 she noticed a red, itchy swollen rash at the site of the yellow fever vaccination. Client used OTC cortisone cream and hot and cold packs for relief if sx. On 4/18/21 client contacted the health dept and reported that after using these measures the rash had resolved for approximately 2-3 days but the rash has now returned and appears larger than previously noted. Client reports no systemic symptoms. Referred client to her PCP for an evaluation and also to an allergist for evaluation.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Fatigue
Clinical narrative: Fatigue not horrible. Abdominal pain very bad
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Impaired work ability, Pyrexia, Rash, Rash erythematous
Clinical narrative: Sore, red, raised rash 3 inches in circumference appearing 12 hours after injection.  Chills and fever 20 hours after injection., even tough I took 1 Tylenol before injection. I had to take 3 Tylenol and 1 ibuprofen together every 4 hours  and was unable to work the second day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular
Clinical narrative: Sore, red, raised rash 3 inches in circumference appearing 12 hours after injection.  Chills and fever 20 hours after injection., even tough I took 1 Tylenol before injection. I had to take 3 Tylenol and 1 ibuprofen together every 4 hours  and was unable to work the second day.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Severe, Systemic: Joint Pain-Mild, Additional Details: Patient reports 3 days later after having her 2nd dose of Shingrix that her arm is still swollen (size of a softball at the injection site), it is raised, red, hot to the touch.  She has taken tylenol.  I advised her to also take some benadryl in addition.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Severe, Systemic: Joint Pain-Mild, Additional Details: Patient reports 3 days later after having her 2nd dose of Shingrix that her arm is still swollen (size of a softball at the injection site), it is raised, red, hot to the touch.  She has taken tylenol.  I advised her to also take some benadryl in addition.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Pain
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Severe, Systemic: Joint Pain-Mild, Additional Details: Patient reports 3 days later after having her 2nd dose of Shingrix that her arm is still swollen (size of a softball at the injection site), it is raised, red, hot to the touch.  She has taken tylenol.  I advised her to also take some benadryl in addition.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood pressure increased, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Fever-Mild, Systemic: blood pressure was a little elevated-Mild, Systemic: Headache-Medium
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Pruritus, Pyrexia
Clinical narrative: Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Fever-Mild, Systemic: blood pressure was a little elevated-Mild, Systemic: Headache-Medium
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Eye swelling, Influenza like illness, Lymphadenopathy, Mouth swelling
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: Patient noticed swelling the evening of injection, flu like symptoms the next day and difficulty swallowing. Went to urgent care on 4/23/23. Took benadryl, prednisone, tylenol, and ibuprofen. Followed up with her primary care doctor. The swelling has improved and is no longer having difficulty swallowing as of 4/26/23
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face, Swollen tongue, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: Patient noticed swelling the evening of injection, flu like symptoms the next day and difficulty swallowing. Went to urgent care on 4/23/23. Took benadryl, prednisone, tylenol, and ibuprofen. Followed up with her primary care doctor. The swelling has improved and is no longer having difficulty swallowing as of 4/26/23
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Was given Pfizer COVID Vaccine for 6 months and up on 4/6/2023 and was given Moderna Bivalent COVID Vaccine for 6 months and up 22 days later on 4/28/23.  Incorrect manufacturer product given at incorrect spacing interval.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Pain in extremity, Pulmonary embolism, Surgery
Clinical narrative: Calf pain, saddle. pulmonary embolism, emergency surgery
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Calf pain, saddle. pulmonary embolism, emergency surgery
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Acoustic stimulation tests, Neuropathy peripheral, Tinnitus
Clinical narrative: I developed moderate tinnitus a couple of hours after receiving the Moderna vaccine booster.  I also started a slow progression of neuropathy to both feet.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Audiogram abnormal, Deafness unilateral, Ear discomfort, Otoacoustic emissions test abnormal, Reflex test abnormal
Clinical narrative: 2/1/2023 onset of sudden hearing loss right ear, aural pressure and Tinnitus. Urgent Care facility 2/4/2023 prescribed antibiotic Augmentin. Primary doctor 2/17/2023 prescribed antibiotic  Cefdinir and Prednisone, ENT 3/9, 3/31, 4/14,4/26 given audiology tests including Audiogram, Tympanogram, Otoacoustic emissions, Reflexes  and Tinnitus matching . Prescribed oral steroid, Prednisone on each visit.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Sudden hearing loss, Tinnitus, Tympanometry abnormal
Clinical narrative: 2/1/2023 onset of sudden hearing loss right ear, aural pressure and Tinnitus. Urgent Care facility 2/4/2023 prescribed antibiotic Augmentin. Primary doctor 2/17/2023 prescribed antibiotic  Cefdinir and Prednisone, ENT 3/9, 3/31, 4/14,4/26 given audiology tests including Audiogram, Tympanogram, Otoacoustic emissions, Reflexes  and Tinnitus matching . Prescribed oral steroid, Prednisone on each visit.