chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A 60-year-old patient received fluzone high-dose with no adverse event; A 60-year-old patient received fluzone high-dose with no adverse event; Initial information received on 22-Oct-2021 regarding an unsolicited valid non-serious case from pharmacist and consumer/ non health care professional via  Media Information (under reference 00824838) in a specific country.  This case is linked to cases 2021SA356620 and 2021SA356392 (same reporter).  This case involves a 60 years old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other concomitant vaccines.  On 22-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Total, lot UJ769AA and expiration date: 30-6-2022) via intramuscular route in the left arm for prophylactic vaccination.  It was case of an actual medication error due to inappropriate age at vaccine administration and overdose (same day latency).  It was reported "Pharmacist states that today, during a flu-shot clinic, 3 of the patients who received FLUZONE QUADRIVALENT HIGH-DOSE, after attesting to be less than 65 years of age, were found to be younger. Two of the women were 60 and one was 45 years old. Caller asking what should be done."  At time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A 45 years old patient received FLUZONE QUADRIVALENT HIGH-DOSE with no reported adverse event; A 45 years old patient received FLUZONE QUADRIVALENT HIGH-DOSE with no reported adverse event; Initial information received on 22-Oct-2021 regarding an unsolicited valid non-serious case from pharmacist and consumer/ non health care professional via  Media Information (under reference 00824871) in the .  This case is linked to cases 2021SA356620 and 2021SA355376 (same reporter).  This case involves a 45 years old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other concomitant vaccines.  On 22-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Total, lot UJ769AA and expiration date: 30-Jun-2022) via intramuscular route in the left arm for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration and overdose (same day latency).  It was reported "Pharmacist states that today, during a flu-shot clinic, 3 of the patients who received FLUZONE QUADRIVALENT HIGH-DOSE, after attesting to be less than 65 years of age, were found to be younger. Two of the women were 60 and one was 45 years old. Caller asking what should be done."  At time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: YF
Symptoms: Expired product administered, No adverse event
Clinical narrative: YF-VAX was administered to 5 patients using an expired diluent with no reported adverse event;Initial information received on 22-Oct-2021 regarding an unsolicited valid non-serious case received from another health professional and non-health care professional via Medical Information number: 00824899.   This case is linked to cases US-SA-2021SA354616, 2021SA356051, 2021SA355405, 2021SA354618, 2021SA357534 and 2021SA355405 (CLUSTER).  This case involves an unknown age and unknown gender patient was administered YELLOW FEVER VACCINE - US [YF-VAX] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a 0.5 ml dose of suspect YELLOW FEVER VACCINE - US lot number and expiry date not reported not reported via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.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: 29.0
Sex: F
Vaccine: YF
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of YF-VAX was administered with no adverse event reported; Initial information received on 25-Oct-2021 regarding an unsolicited valid non-serious case from other health professional via Global Media information (under the reference: 00826494)  This case involved a 29-year-old female patient receiving expired dose of YELLOW FEVER VACCINE - US [YF-VAX] (expired product administered).  On an unknown date, the patient received a 0.5mL dosage form total dose of suspect YELLOW FEVER VACCINE - US [Frequency: once, Strength: standard lot U6428AA, expiry date: 30-Sep-2021] via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine use. (latency: same day)  It was reported  "expired YF-VAX administered to 5 patients."  At the time of report, no adverse event reported.  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. The classification as a medical error was 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 had contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2021SA356701: US-SA-2021SA354618: US-SA-2021SA355405: US-SA-2021SA357534: US-SA-2021SA356051:
Age: 32.0
Sex: M
Vaccine: YF
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of YF-VAX was administered with no adverse event reported; Initial information received on 25-Oct-2021 regarding an unsolicited valid non-serious case from other health professional via Media information (under the reference: 00826503).  This case involves a 32-year-old male patient receiving expired dose of YELLOW FEVER VACCINE - US [YF-VAX] (expired product administered).  On an unknown date, the patient received a 0.5mL dosage form total dose of suspect YELLOW FEVER VACCINE - US [Frequency: once, strength: standard, lot U6428AA,Expiration Date :30-Sep-2021] via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine use. (latency: same day)  It was reported  "expired YF-VAX administered to 5 patients."  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2021SA356701: US-SA-2021SA354618: US-SA-2021SA355405: US-SA-2021SA357534: US-SA-2021SA356051: US-SA-2021SA354618: US-SA-2021SA354616:
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired dose of ACT-HIB was administered with no reported adverse event; Initial information received on 25-Oct-2021 regarding an unsolicited valid non-serious case from other health professional via Media information (under the reference: 00826716).  This case involved a 15-month-old and patient receiving HIB (PRP/T) VACCINE [ACT-HIB] 4 days after the expiration date of the vaccine (expired product administered).   On an unknown date, the patient received dose of suspect HIB (PRP/T) VACCINE [lot UJ384ABA, expiration date: 15-Oct-2021] via an unknown route at the unknown administration site for prophylactic vaccination  It was a case of actual medication error due to expired vaccine use. (latency: same day)  It was reported "Caller states a dose of ACT-HIB was administered 4 days after the expiration date of the vaccine. Caller was looking for information in regard to possible adverse effects as well as if they need to re-vaccinate."  At the time of report, no adverse event reported.  This suspected adverse reaction report was 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 was 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: 63.0
Sex: M
Vaccine: FLUA4
Symptoms: Chills, Headache
Clinical narrative: Chills; Headache; 63 year old patient received Fluad Quadrivalent; This spontaneous case was received on 08-Oct-2021 from a pharmacist via Med Communications (reference number: SEQW21-03564) and concerned a 63-year-old, male patient.  The patient's medical history was not reported. The patient's concomitant medications included trazodone, zaleplon, Xanax (alprazolam), Aspirin (acetylsalicylic acid), metoprolol and Xalatan (latanoprost), all used for an unreported indication.   On 07-Oct-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, anatomical location: deltoid and route of administration: intramuscular) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 312873 and expiry date was 30-Jun-2022.  On the same day, after receiving Fluad Quadrivalent, the patient experienced chills and headache overnight.  At the time of initial reporting on 08-Oct-2021, the patient was feeling much better and was recovering from the events of chills and headache.  The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  Company comment: A 63-year-old patient was vaccinated with Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient experienced chills and headache. Causal role of the suspect vaccine is assessed as possibly related, considering biological and chronological plausibility. Product administered to patient of inappropriate age is assessed as unrelated per company conventions.; Sender's Comments: A 63-year-old patient was vaccinated with Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient experienced chills and headache. Causal role of the suspect vaccine is assessed as possibly related, considering biological and chronological plausibility. Product administered to patient of inappropriate age is assessed as unrelated per company conventions.
Age: 89.0
Sex: F
Vaccine: FLUA4
Symptoms: Asthenia, Fall, Feeling abnormal, Head discomfort, Neck pain
Clinical narrative: Very strong pain at the back of her neck; Fell down to the floor; Funny sensation in her neck; Felt the brain moving side to side; Felt very weak; Head squeezing; This spontaneous case was received on 15-Oct-2021 from other healthcare professional via Med Communications (reference number: SEQW21-03956) and concerned an 89-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications. The patient was vaccinated with Moderna COVID-19 vaccine in Aug-2021.    On 07-Oct-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 312841 and expiry date 19-May-2022.  On the same day, 15 minutes after receiving Fluad Quadrivalent, the patient experienced funny sensation in her neck, very strong pain at the back of her neck, felt the brain moving side to side and afterwards she felt very weak and fell on the floor.  On an unspecified date in Oct-2021, after one week, she still felt the head was squeezing. She was treated with Advil (ibuprofen).   At the time of initial reporting on 15-Oct-2021, the patient had not recovered from the events since she stated that she was not better.  The reporter did not provide causality assessment.   The case was assessed as non-serious.  Company comment: A 89-year-old, female patient experienced funny sensation in neck, very strong pain at the back of the neck, head discomfort, asthenia and fall, fifteen minutes after vaccination with the suspect product Fluad Quadrivalent. Approximately one week after vaccination, the patient felt tension headache (reported as head squeezing). The patient had no relevant medical history and was not taking any concomitant medications. Information regarding diagnostic data was not provided. Causal role of the suspect vaccine is assessed as possibly related for all events, due to biological and chronological plausibility, except for the event fall for which causality is unassessable.; Sender's Comments: A 89-year-old, female patient experienced funny sensation in neck, very strong pain at the back of the neck, head discomfort, asthenia and fall fifteen minutes after vaccination with the suspect product Fluad Quadrivalent. Approximately one week after vaccination, the patient felt tension headache (reported as head squeezing). The patient had no relevant medical history and was not taking any concomitant medications. Information regarding diagnostic data was not provided. Causal role of the suspect vaccine is assessed as possibly related for all events, due to biological and chronological plausibility, except for the event fall for which causality is unassessable.
Age: 89.0
Sex: F
Vaccine: FLUA4
Symptoms: Tension headache
Clinical narrative: Very strong pain at the back of her neck; Fell down to the floor; Funny sensation in her neck; Felt the brain moving side to side; Felt very weak; Head squeezing; This spontaneous case was received on 15-Oct-2021 from other healthcare professional via Med Communications (reference number: SEQW21-03956) and concerned an 89-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications. The patient was vaccinated with Moderna COVID-19 vaccine in Aug-2021.    On 07-Oct-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 312841 and expiry date 19-May-2022.  On the same day, 15 minutes after receiving Fluad Quadrivalent, the patient experienced funny sensation in her neck, very strong pain at the back of her neck, felt the brain moving side to side and afterwards she felt very weak and fell on the floor.  On an unspecified date in Oct-2021, after one week, she still felt the head was squeezing. She was treated with Advil (ibuprofen).   At the time of initial reporting on 15-Oct-2021, the patient had not recovered from the events since she stated that she was not better.  The reporter did not provide causality assessment.   The case was assessed as non-serious.  Company comment: A 89-year-old, female patient experienced funny sensation in neck, very strong pain at the back of the neck, head discomfort, asthenia and fall, fifteen minutes after vaccination with the suspect product Fluad Quadrivalent. Approximately one week after vaccination, the patient felt tension headache (reported as head squeezing). The patient had no relevant medical history and was not taking any concomitant medications. Information regarding diagnostic data was not provided. Causal role of the suspect vaccine is assessed as possibly related for all events, due to biological and chronological plausibility, except for the event fall for which causality is unassessable.; Sender's Comments: A 89-year-old, female patient experienced funny sensation in neck, very strong pain at the back of the neck, head discomfort, asthenia and fall fifteen minutes after vaccination with the suspect product Fluad Quadrivalent. Approximately one week after vaccination, the patient felt tension headache (reported as head squeezing). The patient had no relevant medical history and was not taking any concomitant medications. Information regarding diagnostic data was not provided. Causal role of the suspect vaccine is assessed as possibly related for all events, due to biological and chronological plausibility, except for the event fall for which causality is unassessable.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Asthenia, Chills, Fatigue, Malaise
Clinical narrative: Chills, fatigue, nausea, upset stomach, generally feeling unwell, no energy
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea
Clinical narrative: Chills, fatigue, nausea, upset stomach, generally feeling unwell, no energy
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: Pain in heart with deep breathing & laying down
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Injection site pain, Injection site swelling, Pain
Clinical narrative: elevated temperature; severe body aches and pains; injections site swelling and oain
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Pruritus
Clinical narrative: Itchy left arm and pain in joints, knees hips elbows and shoulders.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Fatigue, Pruritus
Clinical narrative: itching, memory loss, fatigue
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Communication disorder, Condition aggravated, Hemiparesis, Ischaemic stroke, NIH stroke scale
Clinical narrative: Patient experiencing left sided weakness, inability to talk and minimal ability to communicate.  Patient had a massive ischemic stroke, and elevated troponin levels debilitating patient completely.  Treatment is to remain mostly comfort measures
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder, Troponin increased
Clinical narrative: Patient experiencing left sided weakness, inability to talk and minimal ability to communicate.  Patient had a massive ischemic stroke, and elevated troponin levels debilitating patient completely.  Treatment is to remain mostly comfort measures
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Prolonged fever of 102° (4+ hours). Tylenol and ice packs will not bring down
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Chest pain, Computerised tomogram thorax, Confusional state, Drooling
Clinical narrative: Initially started with chest pain at 1400 on 10/23/2021 lasted for 2 hours and resolved. Then at 0500 on 10/24/2021 started with chest and left arm pain, rapid irregular heart beat up to 140's when walking to room to be placed on monitor felt heart flip and slow down to low 110's.  Sudden onset of violent vomiting  for about 5 mins.  Then developed left arm numbness, heaviness, left facial numbness, left leg numbness, confusion, expressive aphasia, blurred vision. Labs, ekg, Mri, MRA, carotid us CTA of chest, IV fluids, Krider, zofran, hydromorphone, ativan discharged home.  Returned on 10/25/2021 to er with drooling facial numbness, left arm numbness and heaviness, pain in bil legs, extreme muscle pain. neurology consult, lab, mri brain,  ketoralac, nubain given  discharge home
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate increased, Hypoaesthesia, Laboratory test, Limb discomfort
Clinical narrative: Initially started with chest pain at 1400 on 10/23/2021 lasted for 2 hours and resolved. Then at 0500 on 10/24/2021 started with chest and left arm pain, rapid irregular heart beat up to 140's when walking to room to be placed on monitor felt heart flip and slow down to low 110's.  Sudden onset of violent vomiting  for about 5 mins.  Then developed left arm numbness, heaviness, left facial numbness, left leg numbness, confusion, expressive aphasia, blurred vision. Labs, ekg, Mri, MRA, carotid us CTA of chest, IV fluids, Krider, zofran, hydromorphone, ativan discharged home.  Returned on 10/25/2021 to er with drooling facial numbness, left arm numbness and heaviness, pain in bil legs, extreme muscle pain. neurology consult, lab, mri brain,  ketoralac, nubain given  discharge home
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Magnetic resonance imaging head, Myalgia, Pain in extremity, Ultrasound scan
Clinical narrative: Initially started with chest pain at 1400 on 10/23/2021 lasted for 2 hours and resolved. Then at 0500 on 10/24/2021 started with chest and left arm pain, rapid irregular heart beat up to 140's when walking to room to be placed on monitor felt heart flip and slow down to low 110's.  Sudden onset of violent vomiting  for about 5 mins.  Then developed left arm numbness, heaviness, left facial numbness, left leg numbness, confusion, expressive aphasia, blurred vision. Labs, ekg, Mri, MRA, carotid us CTA of chest, IV fluids, Krider, zofran, hydromorphone, ativan discharged home.  Returned on 10/25/2021 to er with drooling facial numbness, left arm numbness and heaviness, pain in bil legs, extreme muscle pain. neurology consult, lab, mri brain,  ketoralac, nubain given  discharge home
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Vomiting
Clinical narrative: Initially started with chest pain at 1400 on 10/23/2021 lasted for 2 hours and resolved. Then at 0500 on 10/24/2021 started with chest and left arm pain, rapid irregular heart beat up to 140's when walking to room to be placed on monitor felt heart flip and slow down to low 110's.  Sudden onset of violent vomiting  for about 5 mins.  Then developed left arm numbness, heaviness, left facial numbness, left leg numbness, confusion, expressive aphasia, blurred vision. Labs, ekg, Mri, MRA, carotid us CTA of chest, IV fluids, Krider, zofran, hydromorphone, ativan discharged home.  Returned on 10/25/2021 to er with drooling facial numbness, left arm numbness and heaviness, pain in bil legs, extreme muscle pain. neurology consult, lab, mri brain,  ketoralac, nubain given  discharge home
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Received shot in left arm. Now with worsening left armpit pain. Probably swollen lymph nodes
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Similar to my reaction after the 2nd dose - chills and extreme fatigue. However, the symptoms ldidnt last nearly as long. I felt better later in the morning rather than symptoms lasting all day
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood creatinine increased, Full blood count normal, International normalised ratio increased, Metabolic function test abnormal
Clinical narrative: nausea, vomiting, aches, weakness,
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: nausea, vomiting, aches, weakness,
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing, Pruritus, Pyrexia, Swelling face
Clinical narrative: On or about 4 hrs after Administration, generalized flush red coloring all over body, itching and swelling in face. Administered EpiPen autoinjector and symptoms subsided. Fever remained between 101-103F as of this writing.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Flushing, Hyperhidrosis, Nausea
Clinical narrative: Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Medium
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Tremor, Unresponsive to stimuli, Vomiting
Clinical narrative: Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Medium
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Electroencephalogram normal, Magnetic resonance imaging normal, Malaise
Clinical narrative: Received 2nd dose @ 9:15 am  on 9/25/21.  I have never had seizure activity.  On 9/29/21 @ 9:00 PM   (108 hours after 2nd dose),  I had a seizure while sitting in my living room.  Was taken to hospital by ambulance.  Blood work, covid test, CAT Scan and other test were run.   Nothing showed any reason to why I had the seizure and was released from ER.    On 10/1/21 around 4:30 pm, I was resting on my bed and had another seizure.  My daughter timed this one it was 2 minutes long and  I was taken back to ER by my husband.   Some test were run again and showed nothing.   Released from ER with Keppra 500MG 2xdaily
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Neurological examination, SARS-CoV-2 test, Seizure
Clinical narrative: Received 2nd dose @ 9:15 am  on 9/25/21.  I have never had seizure activity.  On 9/29/21 @ 9:00 PM   (108 hours after 2nd dose),  I had a seizure while sitting in my living room.  Was taken to hospital by ambulance.  Blood work, covid test, CAT Scan and other test were run.   Nothing showed any reason to why I had the seizure and was released from ER.    On 10/1/21 around 4:30 pm, I was resting on my bed and had another seizure.  My daughter timed this one it was 2 minutes long and  I was taken back to ER by my husband.   Some test were run again and showed nothing.   Released from ER with Keppra 500MG 2xdaily
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Skin warm
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Arm hot to the touch, recomended ibuprofen and to follow up with pcp if ibuprofen doesn't clear it up
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: After receiving vaccinations the patient felt faint and as she was walking to her chair she passed out for about 10 seconds. 911 was called and the patient was cleared to leave.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Heart rate increased, Palpitations, Tremor
Clinical narrative: Began getting chills around 6PM. Went to sleep but was shaking so bad/teeth chattering. Around 11PM my heart began pounding and beating rapidly. When I stood up to call the DR. I became dizzy and felt like I was going to pass out. I laid back down and my heart continued to pound for several hours.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong patient
Clinical narrative: Error: Wrong Patient (documentation in EMR)-
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Musculoskeletal stiffness, Physical examination, Swelling
Clinical narrative: Stiff neck and spine on left side of upper back beginning the morning after the shot and lasting two weeks. I took Tylenol, Advil, Aleve, had a professional massage, and saw a chiropractor before being seen by my pcp. My pcp prescribed muscle relaxers which were only a temporary fix.  It?s taken a month, but I finally feel normal again.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Medium
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Visual impairment
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Medium
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Systemic: Vomiting-Mild
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb injury, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Balance disorder, Cerebrovascular accident, Chills, Coagulopathy
Clinical narrative: 3-26-2021 Fell tried to stand and fell again. Lack of equilibrium. Not dizzy, not vertigo just could not stand. Had periodic vertigo after that and vertigo. Had common side effects next couple days, fever, chills, nausea next couple days but periodic loss of equilibrium, stumbling fell couple times. Poor short term memory. 5-5-2021 TIA or small stroke, Driving difficulty staying in lane, could not park car, stumbling and catching self by grabbing something, at doctor office left side neurological symptom, Left arm drift and left heel to right leg abnormal. Change in cognition.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Computerised tomogram normal, Dysstasia, Electrocardiogram normal, Electroencephalogram normal
Clinical narrative: 3-26-2021 Fell tried to stand and fell again. Lack of equilibrium. Not dizzy, not vertigo just could not stand. Had periodic vertigo after that and vertigo. Had common side effects next couple days, fever, chills, nausea next couple days but periodic loss of equilibrium, stumbling fell couple times. Poor short term memory. 5-5-2021 TIA or small stroke, Driving difficulty staying in lane, could not park car, stumbling and catching self by grabbing something, at doctor office left side neurological symptom, Left arm drift and left heel to right leg abnormal. Change in cognition.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Enzyme level test, Fall, Gait disturbance, Impaired driving ability, Laboratory test normal
Clinical narrative: 3-26-2021 Fell tried to stand and fell again. Lack of equilibrium. Not dizzy, not vertigo just could not stand. Had periodic vertigo after that and vertigo. Had common side effects next couple days, fever, chills, nausea next couple days but periodic loss of equilibrium, stumbling fell couple times. Poor short term memory. 5-5-2021 TIA or small stroke, Driving difficulty staying in lane, could not park car, stumbling and catching self by grabbing something, at doctor office left side neurological symptom, Left arm drift and left heel to right leg abnormal. Change in cognition.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Magnetic resonance imaging normal, Nausea, Neurological symptom, Pyrexia
Clinical narrative: 3-26-2021 Fell tried to stand and fell again. Lack of equilibrium. Not dizzy, not vertigo just could not stand. Had periodic vertigo after that and vertigo. Had common side effects next couple days, fever, chills, nausea next couple days but periodic loss of equilibrium, stumbling fell couple times. Poor short term memory. 5-5-2021 TIA or small stroke, Driving difficulty staying in lane, could not park car, stumbling and catching self by grabbing something, at doctor office left side neurological symptom, Left arm drift and left heel to right leg abnormal. Change in cognition.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack, Upper motor neurone lesion, Vertigo
Clinical narrative: 3-26-2021 Fell tried to stand and fell again. Lack of equilibrium. Not dizzy, not vertigo just could not stand. Had periodic vertigo after that and vertigo. Had common side effects next couple days, fever, chills, nausea next couple days but periodic loss of equilibrium, stumbling fell couple times. Poor short term memory. 5-5-2021 TIA or small stroke, Driving difficulty staying in lane, could not park car, stumbling and catching self by grabbing something, at doctor office left side neurological symptom, Left arm drift and left heel to right leg abnormal. Change in cognition.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Nausea, Nervousness
Clinical narrative: Following vaccine vaccine  flow VERY HEAVY- never been before , felt shaky and nauseous too
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nervousness, Overdose, Product preparation error, Vaccination site swelling
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills 13-24 hrs after jab Fever (99.4F) 24 hrs after jab Headache 18-28 hrs after jab
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Emotional disorder, Fatigue, Full blood count, Headache, Influenza like illness
Clinical narrative: Fever 101.6 all day on date after shot, flu like symptoms (achy, tired, headache).  One week later i had a mental breakdown and was taken to the ER for observation. Although I suffer from depression and anxiety, I became out of character and uncontrollable. My family and friends (seeing me in this state of mind) vehemently felt that something chemically was imbalanced.   I was suicidal for 6 days afterwards.  Saw a psychiatrist for the first time in my life.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Thyroid function test
Clinical narrative: Fever 101.6 all day on date after shot, flu like symptoms (achy, tired, headache).  One week later i had a mental breakdown and was taken to the ER for observation. Although I suffer from depression and anxiety, I became out of character and uncontrollable. My family and friends (seeing me in this state of mind) vehemently felt that something chemically was imbalanced.   I was suicidal for 6 days afterwards.  Saw a psychiatrist for the first time in my life.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Injection site pain, Paranasal sinus discomfort, Vertigo
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Pt stated she felt dizzy and pressure around her sinuses. Stated she felt room spinning. Pt felt pain at the injection site and behind her head. Pt declined ambulance or emergency services. PT stated she'd only had a cereal for breakfast. Gave PT glucose and her spouse gave her water. Spouse called the primary care MD for advice. MD agreed with RPH that PT should sit and wait out the symptoms and call her back if no change. After about 30 minutes PT and spouse stated she was feeling better.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Pt stated she felt dizzy and pressure around her sinuses. Stated she felt room spinning. Pt felt pain at the injection site and behind her head. Pt declined ambulance or emergency services. PT stated she'd only had a cereal for breakfast. Gave PT glucose and her spouse gave her water. Spouse called the primary care MD for advice. MD agreed with RPH that PT should sit and wait out the symptoms and call her back if no change. After about 30 minutes PT and spouse stated she was feeling better.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Chills, Dizziness, Feeling abnormal
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Weakness-Medium, Additional Details: Pt received booster vaccine monday 10/25, came next day with slight bruising/swelling. appeared to be injection site rxn confirmed by both rph. Told him to follow up with md if it gets worse. Wed called and said feeling better, then hours later called and felt worse. Went to md friday and they suspect an infection and given abx awaiting blood work to confirm
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Infection, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Weakness-Medium, Additional Details: Pt received booster vaccine monday 10/25, came next day with slight bruising/swelling. appeared to be injection site rxn confirmed by both rph. Told him to follow up with md if it gets worse. Wed called and said feeling better, then hours later called and felt worse. Went to md friday and they suspect an infection and given abx awaiting blood work to confirm
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Weakness-Medium, Additional Details: Pt received booster vaccine monday 10/25, came next day with slight bruising/swelling. appeared to be injection site rxn confirmed by both rph. Told him to follow up with md if it gets worse. Wed called and said feeling better, then hours later called and felt worse. Went to md friday and they suspect an infection and given abx awaiting blood work to confirm
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Feeling abnormal, Feeling hot
Clinical narrative: After leaving the site I started feeling dizzy and ignored it. I drank some water and I didn?t feel bad anymore.   When I woke up the next day I could barely walk on my own and I had a massive headache. I called off of work due to the situation I was in. I took my temperature in the morning and it indicated that I had a fever. I had chills throughout the night and I woke up feeling very warm. I was also a little nauseous and didn?t have  much of an appetite.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Impaired work ability, Nausea, Pyrexia
Clinical narrative: After leaving the site I started feeling dizzy and ignored it. I drank some water and I didn?t feel bad anymore.   When I woke up the next day I could barely walk on my own and I had a massive headache. I called off of work due to the situation I was in. I took my temperature in the morning and it indicated that I had a fever. I had chills throughout the night and I woke up feeling very warm. I was also a little nauseous and didn?t have  much of an appetite.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: Vomiting headache
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Extra dose administered, Fatigue
Clinical narrative: Within 6-8 hours after receiving the vaccine I had the same side effects I'd experienced with the previous doses: fatigue, chills, fever, intense body aches, pain at injection, swelling of lymph node at left armpit.   Over the next 6 hours,  I  noticed a NEW and UNEXPECTED SIDE EFFECT:  I LOST MY SENSES OF TASTE AND SMELL.   Contacted doctor who suspected it was booster related but suggested a PCR test out of an abundance of caution and because I work with the public.  Appox. 48 hours after vax, taste and smell began to return and were fully back by 72 hours after vax.  PCR test results were negative, suggesting loss of taste and smell were a vaccine side effect.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lymphadenopathy, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Within 6-8 hours after receiving the vaccine I had the same side effects I'd experienced with the previous doses: fatigue, chills, fever, intense body aches, pain at injection, swelling of lymph node at left armpit.   Over the next 6 hours,  I  noticed a NEW and UNEXPECTED SIDE EFFECT:  I LOST MY SENSES OF TASTE AND SMELL.   Contacted doctor who suspected it was booster related but suggested a PCR test out of an abundance of caution and because I work with the public.  Appox. 48 hours after vax, taste and smell began to return and were fully back by 72 hours after vax.  PCR test results were negative, suggesting loss of taste and smell were a vaccine side effect.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Around 24 hours after vaccine, a rash started on stomach and thighs. Next morning, rash was bright red, hot to touch, and spread to under arms, arms, and chest. Went to an urgent care facility, was giving a steroid shot of methylprednisolone sodium succ. Prescribed a 6 day dose of Prednisone starting the following day,   Rash did not show improvement for 24 hours after methylprednisolone injection, but started recede after. Still on going.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Fatigue, Nausea, Pain in extremity
Clinical narrative: extreme chills, nausea, stomach cramps, extreme fatigue, severe arm pain ; 24 hour duration of events
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Tachycardia, X-ray
Clinical narrative: Tachycardia
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Decreased appetite, Fatigue, Heart rate increased, Hypermetabolism
Clinical narrative: Minor Soreness at injection Site, Severe fatigue, muscle pain, general malaise,loss of appetite,confusion, acceleration of metabolism,,loss of regulation of body heat and cold. Lowered blood pressure, high pulse rate.(100). Continues for about 36 hours and subsided. Note that same reaction for second dose but not as severe.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Injection site pain, Malaise, Myalgia, Temperature regulation disorder
Clinical narrative: Minor Soreness at injection Site, Severe fatigue, muscle pain, general malaise,loss of appetite,confusion, acceleration of metabolism,,loss of regulation of body heat and cold. Lowered blood pressure, high pulse rate.(100). Continues for about 36 hours and subsided. Note that same reaction for second dose but not as severe.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Dyspnoea, Heart rate increased, Hypertension
Clinical narrative: High pulse, shortness of breath High Blood pressure (171/101, loss of balance, weakness
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Lymphadenopathy, Myalgia
Clinical narrative: soreness and redness at place of injection, itchy at arm and shoulder, swelled lymph node on left, achy muscles all over,  stuffy nose
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasal congestion, Pruritus
Clinical narrative: soreness and redness at place of injection, itchy at arm and shoulder, swelled lymph node on left, achy muscles all over,  stuffy nose
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: pt stated she went to doctor and he said she she had contracted cellulitis refused to give further details to us
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Computerised tomogram, Cough, Dyspnoea
Clinical narrative: Shortness of breath, chest pain, cough. Pericarditis was diagnosed.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Pericarditis
Clinical narrative: Shortness of breath, chest pain, cough. Pericarditis was diagnosed.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Pyrexia
Clinical narrative: fever 101  headache joint pains extreme weakness  extremely tired
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Insomnia, Paraesthesia
Clinical narrative: Terrible insomnia! Tingly hands and feet. Anxiety through the roof!
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Chills, Erythema, Fatigue, Induration
Clinical narrative: Chills, fatigue and 101 fever 24 hours after vac. Symptoms gone in 6 hours. Redness, swelling and subcutaneous hardness with blistering  on skin 3 days after injection. Still currently with symptoms.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: Chills, fatigue and 101 fever 24 hours after vac. Symptoms gone in 6 hours. Redness, swelling and subcutaneous hardness with blistering  on skin 3 days after injection. Still currently with symptoms.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicectomy, Appendicitis
Clinical narrative: Appendicitis and appendectomy on July 24, 2021  My spouse, had same 2nd does from Pfizer lot ER8731 and he also had appendicitis and appendectomy on  Sept 24, 2021.