chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of product with no reported adverse event; Initial information received on 03-Dec-2021 regarding an unsolicited valid non-serious case from a consumer (patient) via phone.  This case is linked to case 2021SA411214 (CLUSTER).  This case involves a male patient of an unknown age who received an expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On 14-OCT-2021, the patient received a 0.7 ml total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number: UJ500AB, expiry date: 30-JUN-2021 via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency: same day).  It was reported "Patient states that she was told by the facility where she and her husband received their FLUZONE HIGH-DOSE QUADRIVALENT vaccines on 14-OCT-2021 that the product had expired on 30-JUN-2021. Caller wanted to know what was contained in the 2020-2021 FLUZONE HIGH-DOSE QUADRIVALENT vaccine and asked for a strain comparison between 2020 and 2021. Patient states that she does not know how long the vaccine that she received on 14-OCT-2021 will remain in her body and is unsure if she should be revaccinated at this time. Caller states that she will reach out to the facility to determine if they have reported this to Safety first."  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.
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: vaccine exposed to the negative 7.8 degree Celsius over a period of 40 minutes and given to two patients after the excursion with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from a nurse via Agency (Reference number- 00887754) and transmitted to Sanofi on 07-Dec-2021.  This case is linked to case 2021SA412334 (CLUSTER).  This case involves a 14-years-old male patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] exposed to the negative 7.8 degree Celsius over a period of 40 minutes and given to two patients after the excursion (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 03-Dec-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (Frequency: once, lot UT7378KA, expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination. It was an actual medication error due to product storage error (latency: same day).  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
Clinical narrative: patient were administered the Yellow Fever vaccine with the expired diluent, with no reported adverse event; Initial information received on 10-Dec-2021 regarding an unsolicited valid non-serious case received from an other healthcare professional via call center via regulatory agency (Reference number- 00893306).  This case involves a patient of (unknown demographics) who was vaccinated with an expired dose of suspect YELLOW FEVER VACCINE - US [YF-VAX] (expired product administered).  The patient's medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE - US (Vaccine: lot number: UJ372AA and expiry date: 22-Jun-2022 and Diluent: lot number: U6427AA and expiry date: 30-Sep-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  It was reported "Caller stated that the sodium chloride diluent that goes with the vaccine expired and was administered to patients after expiration date. Caller asking if the diluent would still be stable and what should be done. She asks if they were valid doses or if they need to be repeated. She asks if Yellow Fever Vaccine is a live vaccine and how long they need to wait to revaccinate the patients involved."  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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Cough, Dyspnoea, Faeces discoloured, Fatigue
Clinical narrative: black stool; sinus infection; feels shaky; red dots over the right side of her face; throat feels swollen, inside of lips are swollen; throat feels swollen, inside of lips are swollen; shortness of breath; weak; cough; headache; Initial information received on 10-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via call center via Agency (Reference number- 00893533).  This case involves a 79-year-old female patient who experienced weak (asthenia), headache, black stool (faeces discoloured), shortness of breath (dyspnoea), cough, sinus infection (sinusitis), feels shaky (tremor), red dots over the right side of her face (rash erythematous) and throat feels swollen, inside of lips were swollen (lip swelling and pharyngeal swelling) after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, medical treatments, concomitant medication and family history were not provided.  She received FLUZONE HD in 2020 and felt very weak and tired and that symptoms went on for 6 weeks before improvement.  On 10-Nov-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route in the right arm for prophylactic vaccination.  On an unknown date, the patient developed a non-serious weak (asthenia), headache, black stool (faeces discoloured), shortness of breath (dyspnoea), cough, sinus infection (sinusitis), feels shaky (tremor), red dots over the right side of her face (rash erythematous) and throat feels swollen, inside of lips were swollen (lip swelling and pharyngeal swelling) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported "Caller stated she took left over antibiotics from a dental surgery and they improved her condition. Caller did not want to get flu shot this year, but decided to get it 10Nov2021. Caller said she felt fine for a couple of days, but then symptoms started."  She had been to the doctor and tested for COVID which was negative.  It was not reported if the patient received a corrective treatment for the events.  The outcome was unknown for the events.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Headache, Lip swelling, Pharyngeal swelling, Rash erythematous, SARS-CoV-2 test negative
Clinical narrative: black stool; sinus infection; feels shaky; red dots over the right side of her face; throat feels swollen, inside of lips are swollen; throat feels swollen, inside of lips are swollen; shortness of breath; weak; cough; headache; Initial information received on 10-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via call center via Agency (Reference number- 00893533).  This case involves a 79-year-old female patient who experienced weak (asthenia), headache, black stool (faeces discoloured), shortness of breath (dyspnoea), cough, sinus infection (sinusitis), feels shaky (tremor), red dots over the right side of her face (rash erythematous) and throat feels swollen, inside of lips were swollen (lip swelling and pharyngeal swelling) after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, medical treatments, concomitant medication and family history were not provided.  She received FLUZONE HD in 2020 and felt very weak and tired and that symptoms went on for 6 weeks before improvement.  On 10-Nov-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route in the right arm for prophylactic vaccination.  On an unknown date, the patient developed a non-serious weak (asthenia), headache, black stool (faeces discoloured), shortness of breath (dyspnoea), cough, sinus infection (sinusitis), feels shaky (tremor), red dots over the right side of her face (rash erythematous) and throat feels swollen, inside of lips were swollen (lip swelling and pharyngeal swelling) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported "Caller stated she took left over antibiotics from a dental surgery and they improved her condition. Caller did not want to get flu shot this year, but decided to get it 10Nov2021. Caller said she felt fine for a couple of days, but then symptoms started."  She had been to the doctor and tested for COVID which was negative.  It was not reported if the patient received a corrective treatment for the events.  The outcome was unknown for the events.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Sinusitis, Tremor
Clinical narrative: black stool; sinus infection; feels shaky; red dots over the right side of her face; throat feels swollen, inside of lips are swollen; throat feels swollen, inside of lips are swollen; shortness of breath; weak; cough; headache; Initial information received on 10-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via call center via Agency (Reference number- 00893533).  This case involves a 79-year-old female patient who experienced weak (asthenia), headache, black stool (faeces discoloured), shortness of breath (dyspnoea), cough, sinus infection (sinusitis), feels shaky (tremor), red dots over the right side of her face (rash erythematous) and throat feels swollen, inside of lips were swollen (lip swelling and pharyngeal swelling) after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, medical treatments, concomitant medication and family history were not provided.  She received FLUZONE HD in 2020 and felt very weak and tired and that symptoms went on for 6 weeks before improvement.  On 10-Nov-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route in the right arm for prophylactic vaccination.  On an unknown date, the patient developed a non-serious weak (asthenia), headache, black stool (faeces discoloured), shortness of breath (dyspnoea), cough, sinus infection (sinusitis), feels shaky (tremor), red dots over the right side of her face (rash erythematous) and throat feels swollen, inside of lips were swollen (lip swelling and pharyngeal swelling) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported "Caller stated she took left over antibiotics from a dental surgery and they improved her condition. Caller did not want to get flu shot this year, but decided to get it 10Nov2021. Caller said she felt fine for a couple of days, but then symptoms started."  She had been to the doctor and tested for COVID which was negative.  It was not reported if the patient received a corrective treatment for the events.  The outcome was unknown for the events.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 70-year-old patient who received MENACTRA, with no adverse event; Initial information received on 10-Dec-2021 regarding an unsolicited valid non-serious case from an other health professional via Information (under the reference 00893595).  This case involves a 70 years old male patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Product use issue).  The patient's medical history included Asplenia.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant vaccines.   In 2018, the patient received a dose of suspect MENACTRA (Oral solution, total, once, lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to drug use in unapproved age group (same day latency).  It was reported "Medical assistant states they have a 70-year old patient with asplenia who received MENACTRA in 2018; states he is supposed to get a booster 5 years later. Medical assistant asks if his booster should be 1 dose or 2 doses?"  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.  There would be no information on the batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: came in for a shot of FLUZONE HD, and after the shot had been administered it was found the patient had already received a dose in October of the year/ no AE; Initial information received on 10-Dec-2021 regarding an unsolicited valid non-serious case received from an other health professional via call center via Agency (Reference number- 00893833).  This case involves an unknown age and gender patient who was vaccinated with an extra dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Extra dose administered).  The patient's past medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to extra dose administered (latency: same day).  It was reported "Caller states a patient came in for a shot of FLUZONE HD, and after the shot had been administered it was found the patient had already received a dose in October of the year. Caller would like to know are there any adverse effects that may occur with an extra dose?."  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 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.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUC3
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives; Itching; This spontaneous case was received on 29-Nov-2021 from certified pharmacy technician (CPhT) via agency (reference number: SEQW21-05707) and concerned a 70-year-old, female patient.  The patient had no relevant medical history and no allergies. The patient was not taking any concomitant medications (reported as 'not on regular medications').  On an unknown date in 2020, reported as last year, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular (IM), anatomical location: deltoid, arm) for influenza prophylaxis. The batch number reported was 281833 and expiry date: 30-Jun-2021.  On an unknown date in 2020, reported as last year, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced hives and itching. It was unknown if the patient receive any treatment measures.  The outcome of the events was unknown.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: The events were assessed as related to Flucelvax Quadrivalent.; Sender's Comments: The events were assessed as related to Flucelvax Quadrivalent.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Mobility decreased, Musculoskeletal stiffness, Pyrexia
Clinical narrative: I had a COVID booster and I had a mild fever about 12 hours later.  and a slight headache the next day. I was, and am, fine. Beginning about an hour after injection, my arm ached around the injection site. That increased over time and my arm felt stiff around the injection sight and I was still able to move it. Finally, I had a Flu shot in my left arm about twenty minutes after I had my COVID Booster shot.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient given Moderna 50 mcg Booster dose instead of Pfizer 30 mcg Booster dose.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Heart rate increased
Clinical narrative: Woke up to rapid heartbeat and funny feeling in tips of fingers and with headache the day after receiving booster shot.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Swollen lymph nodes, fever, headache, body aches, stomach upset for 3 days
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Autopsy, Death, Intracardiac thrombus
Clinical narrative: Died of a blood clot to the heart.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Confusional state, Flushing, Hyperhidrosis, Loss of consciousness
Clinical narrative: Systemic: Confusion-Severe, Systemic: Lost awareness and consciousness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient receives COVIDSHIELD on September 7th in (Privacy) . This was not accurately relayed to pharmacy technician who administered a full dose of Moderna(0.5)ml to patient. Patient apparently passed out in his chair until technician realized he was sweating. He was given water to drink and was okay after 30 minutes. We called the CDC and was advised it was an adverse event and not administration error.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Systemic: Confusion-Severe, Systemic: Lost awareness and consciousness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient receives COVIDSHIELD on September 7th in (Privacy) . This was not accurately relayed to pharmacy technician who administered a full dose of Moderna(0.5)ml to patient. Patient apparently passed out in his chair until technician realized he was sweating. He was given water to drink and was okay after 30 minutes. We called the CDC and was advised it was an adverse event and not administration error.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Cold sweat, Dizziness, Flushing, Headache
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Additional Details: 2-3 minutes after vaccine administration child complained his head hurt and he felt dizzy. His skin became pale and clammy, lips colorless, and he had slow responses verbally. Breathing and pulse were normal. Patient's condiotion was not improving for approximately 5 minutes so to be safe 911 was called. Paremedics responded and all vitals, reflexes, and blood glucose levels were normal and child's condition slowly started to improve, he was able to return home with parent.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Lip discolouration, Pallor, Speech disorder
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Additional Details: 2-3 minutes after vaccine administration child complained his head hurt and he felt dizzy. His skin became pale and clammy, lips colorless, and he had slow responses verbally. Breathing and pulse were normal. Patient's condiotion was not improving for approximately 5 minutes so to be safe 911 was called. Paremedics responded and all vitals, reflexes, and blood glucose levels were normal and child's condition slowly started to improve, he was able to return home with parent.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Chills, Eye swelling, Flushing
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Abdominal Pain-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Lymph Node Swelling-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Severe, Additional Details: severe heavy mensustral bleeding
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Hyperhidrosis, Injection site pain, Lymphadenopathy, Mouth swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Abdominal Pain-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Lymph Node Swelling-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Severe, Additional Details: severe heavy mensustral bleeding
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Swelling face, Swollen tongue
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Abdominal Pain-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Lymph Node Swelling-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Severe, Additional Details: severe heavy mensustral bleeding
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Injection site pain, Limb injury, Mobility decreased
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: numbness, unable to move her arm
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chills, Dizziness, Hypertension, Nausea
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium, Systemic: Nausea-Medium, Additional Details: patient reported dizziness, chills, nausea post vaccination. had patient lie down for 30 minutes, monitored blood pressure: readings 140/90, 168/110 and 170/111 every 10 minutes. we were going to call 911 due to elevated blood pressure but patient refused and stated she felt a lot better and wanted to go home and rest.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site induration
Clinical narrative: COVID arm - red, hard lump at injection site, warm to the touch, swelling in the injection arm; fatigue; headache; chills; aches
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site swelling, Injection site warmth, Pain, Vaccination site reaction
Clinical narrative: COVID arm - red, hard lump at injection site, warm to the touch, swelling in the injection arm; fatigue; headache; chills; aches
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Hypotension, Syncope, Tinnitus
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Systemic: Tinnitus-Mild, Additional Details: Patient reported to NP about 5 min after receiving vaccine symptoms of ringing in ear and lightheadedness, then fainted and fell forward, NP caught patient and assisted to floor. No injury with fall.  Patient regained consciousness within 5-10 seconds. He was able to sit up and aware of surroundings. call placed to 911. BP initially 86/58, rechecked and up to 94/60. HR 75, O2 98%.  Pt reports improvement of sxs and drank water. EMS arrived, BP up to 126/82 while seated, not taken to ED
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Systemic: Tinnitus-Mild, Additional Details: Patient reported to NP about 5 min after receiving vaccine symptoms of ringing in ear and lightheadedness, then fainted and fell forward, NP caught patient and assisted to floor. No injury with fall.  Patient regained consciousness within 5-10 seconds. He was able to sit up and aware of surroundings. call placed to 911. BP initially 86/58, rechecked and up to 94/60. HR 75, O2 98%.  Pt reports improvement of sxs and drank water. EMS arrived, BP up to 126/82 while seated, not taken to ED
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Erythema, Fatigue, Hyperhidrosis
Clinical narrative: Chills, Muscle Aches, Fatigue, & Arm Hurts Bad. Symptoms Not As Bad As 2nd Vaccine. Later very red neck and trouble catching breath. Started December 16, 2021 the night of the booster shot around 11pm.  December 17th, still having same side effects, but neck started turning very red and still red on December 18th. Started having shortness of breath December 18th and sweating. It is almost 8 am on December 18th, as I report these symptoms and I am still experiencing arm soreness, very red neck, shortness of breath as and lethargic.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Myalgia, Pain in extremity
Clinical narrative: Chills, Muscle Aches, Fatigue, & Arm Hurts Bad. Symptoms Not As Bad As 2nd Vaccine. Later very red neck and trouble catching breath. Started December 16, 2021 the night of the booster shot around 11pm.  December 17th, still having same side effects, but neck started turning very red and still red on December 18th. Started having shortness of breath December 18th and sweating. It is almost 8 am on December 18th, as I report these symptoms and I am still experiencing arm soreness, very red neck, shortness of breath as and lethargic.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Inflammation, Loss of personal independence in daily activities, Mobility decreased, Pain in extremity
Clinical narrative: 5 days severe pain and inability to move arm?entire shoulder joint area inflamed?tried massage and CBD cream  nothing helped finally started to subside after 5 days?extremely uncomfortable and unable to dress myself properly
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Electrocardiogram, Fatigue, Skin laceration, Syncope
Clinical narrative: Went to the bathroom after waking up feeling dehydrated and fatigued. On my way back from the bathroom I fainted and had a severe laceration on my nose. I was on the ground momentarily before getting back up.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: Patient reported itching and tenderness at injection site without redness or swelling.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchy skin and hives three days straight now. Have to keep taking Benadryl for relief.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Lymph node pain, Lymphadenopathy, Pain in extremity
Clinical narrative: Swelling and moderate soreness/pain in lymph nodes in left armpit and left side of chest under left arm, minor swelling and pain at injection site on left arm. Symptoms did not begin until the morning after (approx 12 hours) receiving the booster but seem to be worsening as of second morning following booster. Seem to have minor pain and tingling sensation down the left arm into left hand/fingers as well. Treated with ibuprofen for pain.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Swelling and moderate soreness/pain in lymph nodes in left armpit and left side of chest under left arm, minor swelling and pain at injection site on left arm. Symptoms did not begin until the morning after (approx 12 hours) receiving the booster but seem to be worsening as of second morning following booster. Seem to have minor pain and tingling sensation down the left arm into left hand/fingers as well. Treated with ibuprofen for pain.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Small intestinal obstruction
Clinical narrative: Small bowel obstruction. No history of prior abdominal surgery.  Occurred approximately 10 days after first dose. Spent 3 days in hospital.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthropod bite, Blood test, Skin irritation, Skin swelling, Temperature intolerance
Clinical narrative: As weather turned warm in the summer I started having extreme reactions to the heat and bug bites (skin irritation, large bug reactions that became swollen, full of pus and lasted weeks. I had. Ever had reactions like this before. The frequency was at least 4x/ week.  In September 2021 had a full body reaction to heat that resulted in hives from shoulders to knees. Have seen doctor multiple times. Treatments have included: 10 days prednisone, Pepcid, Zyrtec; Allegra; Benadryl; anti steroid creams. Diagnosed with chronic urticaria in Nov 2021. Hives will return ( rating in severity) within 24 hours of stopping  medication. I am currently just taking Zyrtec daily with good success. But hives will return after 24 hours if I stop.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria, Urticaria chronic
Clinical narrative: As weather turned warm in the summer I started having extreme reactions to the heat and bug bites (skin irritation, large bug reactions that became swollen, full of pus and lasted weeks. I had. Ever had reactions like this before. The frequency was at least 4x/ week.  In September 2021 had a full body reaction to heat that resulted in hives from shoulders to knees. Have seen doctor multiple times. Treatments have included: 10 days prednisone, Pepcid, Zyrtec; Allegra; Benadryl; anti steroid creams. Diagnosed with chronic urticaria in Nov 2021. Hives will return ( rating in severity) within 24 hours of stopping  medication. I am currently just taking Zyrtec daily with good success. But hives will return after 24 hours if I stop.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Vision blurred
Clinical narrative: Employee complained of lightheadedness and blurred vision. No treatment other than monitoring and evaluation.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Extreme arm pain and soreness.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pityriasis rosea
Clinical narrative: Pityriasis rosea
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic, Skin warm
Clinical narrative: Large Itchy rash below injection site that extended to the elbow. Hot to touch. Lasted approx 5 days.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Carbohydrate intolerance, Irritable bowel syndrome, Lactose intolerance
Clinical narrative: Developed possible IBS symptoms such as lactose intolerance, and low tolerance for carbohydrates, that were not present previously. Treatment so far is following a low FODMAP diet to help identify the triggers to the symptoms.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Pain, Sleep disorder
Clinical narrative: Woke up in the middle of the night with horrible joint pain. Couldn?t lay comfortably in any position. Every single joint in my body was aching, even the small joints in my fingers. It was especially horrible in my upper back and shoulders.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever, Cills
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: My lymph nodes in my left armpit we're very swollen little larger and then an egg for about 24 hours then the swelling went away but they were still tender.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itchiness, redness, and swelling at the site of injection Dizziness, stomach pain, and nauseous after administration
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Itchiness, redness, and swelling at the site of injection Dizziness, stomach pain, and nauseous after administration
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast pain, Ear pain, Eye pain, Hypoaesthesia
Clinical narrative: 30 minutes after vaccine I developed left facial numbness and excessive eye watering left eye. Reported to pharmacist.  I also developed an earache and shooting pains behind the left eye the same day. The day after I developed left inner arm pain and numbness and tingling left hand that is still unresolved. Extreme neck and shoulder pain both sides. Tingling in toes left foot. Hands and feet swell at end of day. I called my family doctor who was not impressed. Since then, I have had severe pain in both breasts(implants). Had a mammogram and the radiologist is sending me for an MRI. Something is wrong.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Mammogram, Neck pain, Pain, Pain in extremity
Clinical narrative: 30 minutes after vaccine I developed left facial numbness and excessive eye watering left eye. Reported to pharmacist.  I also developed an earache and shooting pains behind the left eye the same day. The day after I developed left inner arm pain and numbness and tingling left hand that is still unresolved. Extreme neck and shoulder pain both sides. Tingling in toes left foot. Hands and feet swell at end of day. I called my family doctor who was not impressed. Since then, I have had severe pain in both breasts(implants). Had a mammogram and the radiologist is sending me for an MRI. Something is wrong.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: 30 minutes after vaccine I developed left facial numbness and excessive eye watering left eye. Reported to pharmacist.  I also developed an earache and shooting pains behind the left eye the same day. The day after I developed left inner arm pain and numbness and tingling left hand that is still unresolved. Extreme neck and shoulder pain both sides. Tingling in toes left foot. Hands and feet swell at end of day. I called my family doctor who was not impressed. Since then, I have had severe pain in both breasts(implants). Had a mammogram and the radiologist is sending me for an MRI. Something is wrong.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Fatigue, Herpes zoster, Injection site pain, Muscle tightness
Clinical narrative: Shingles. After receiving the vaccine on March 31 I experience being tired which I expected. Soreness at injection site for a couple days. Then felt fine until April 8 when I woke to a little tightness in my right lower back. The pain progress as shingles does and on the afternoon of the 9th i went to the emergency room and learned I had shingles. Blisters developed while at the hospital. I took the 2nd shot on schedule with very miner after effects of shingles. I hope that people will consider the shingles vaccine or allow for people under 50 to get it. A 35 year old friend had same issue but will not fill out a report  :-/
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Feeling cold, Tinnitus, Tremor
Clinical narrative: Loud electrical buzzing in the ears.  I drove home from the injection and was freezing and shaking.  The buzzing was noticed when I got out of the car.  It has been constant since.  I have lost hearing since the injection.  I was on a steroid for a knee injury and while taking the steroid the buzzing was diminished.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Carotid angioplasty, Computerised tomogram, Ischaemic stroke
Clinical narrative: Ischemic Stroke occurred  on December 8, 2021 at 8:25am and was transferred to local hospital where he received emergency surgery for carotid angioplasty. Patient is still in the hospital receiving treatment and has not yet been released.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Severe itchiness and hives on body. Prednisone, azithromyisin, Hydroxyzine, and Allegra have all been taken for relief and hives and itchiness are still present.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood electrolytes normal, Full blood count normal, Laboratory test normal, Muscle contractions involuntary
Clinical narrative: Twitching in pectoral muscle several hours after injection. Progressed to leg and calf muscle facilations over next few weeks. 8 weeks post the facilations spread to rest of body, muscle weakness in legs, extreme anxiety and nervous system issues, sleep disorders. Pain in leg muscles after walking short distances and legs twitch upon resting. All labs are normal.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching, Muscular weakness, Nervous system disorder, Pain, Pain in extremity
Clinical narrative: Twitching in pectoral muscle several hours after injection. Progressed to leg and calf muscle facilations over next few weeks. 8 weeks post the facilations spread to rest of body, muscle weakness in legs, extreme anxiety and nervous system issues, sleep disorders. Pain in leg muscles after walking short distances and legs twitch upon resting. All labs are normal.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Vitamin D
Clinical narrative: Twitching in pectoral muscle several hours after injection. Progressed to leg and calf muscle facilations over next few weeks. 8 weeks post the facilations spread to rest of body, muscle weakness in legs, extreme anxiety and nervous system issues, sleep disorders. Pain in leg muscles after walking short distances and legs twitch upon resting. All labs are normal.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling hot, Injection site pain, Lymphadenopathy, Nausea
Clinical narrative: Swollen lymph nodes, achy joints, hot, nauseous, pain and soreness at injection site.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Feeling hot, Heart rate increased
Clinical narrative: High heart rate at rest. 125-130bpm. Watch kept giving me alerts that my resting heart rate was high. I felt very anxious and was feeling hot most of the day. Symptoms went away within 24hrs.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache, Injection site pain, Pain
Clinical narrative: Fatigue, headaches, body aches, slight chill, very painful injection site, pain in underarm of the injected arm Lasted until about 48 hours after the shot
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Fatigue, headaches, body aches, slight chill, very painful injection site, pain in underarm of the injected arm Lasted until about 48 hours after the shot
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Discomfort, Pruritus, Urticaria
Clinical narrative: Hives developed inside thighs and chest that was noticed about 24 hours later.  At 36 hours, entire torso, front and back, neck, scalp and arms covered in hives. No additional hives below waist, inside thighs still present.  Treated with Benadryl and generic Allegra antihistamines. No changes to severity of hives. Visited urgent care clinic, received prescription antihistamine and steroids, some small improvement after on days dosage but hives still present. No other adverse effects present.  No fever, no pain, no sore throat, no swollen lymph nodes, no hives on face, no issues breathing. Minimal discomfort and itching even without medication.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cerebrovascular accident, Computerised tomogram head, Computerised tomogram neck, Dizziness
Clinical narrative: Patient showed signs of light headedness and shortness of breath the day after vaccination. Lightheadedness resolved. Shortness of breath and waking up from sleep short of breath continued intermittently over the course of several months, worsening when patient had an upper respiratory infection in late June. Patient saw Dr. on August 4, 2021 and had an EKG as part of his physical examination. Atrial Fibrillation was noted. Patient was referred to cardiology. Shortness of breath persisted intermittently. Echocardiogram found a healthy heart with slight hypertensive changes. December 2, 2021 patient suffered minor strokes in the Thalamus and Temporal lobe, right side. On December 9, 2021 patient suffered a massive right hemisphere infarction and is hospitalized.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Echocardiogram abnormal, Electrocardiogram abnormal, Hypertension
Clinical narrative: Patient showed signs of light headedness and shortness of breath the day after vaccination. Lightheadedness resolved. Shortness of breath and waking up from sleep short of breath continued intermittently over the course of several months, worsening when patient had an upper respiratory infection in late June. Patient saw Dr. on August 4, 2021 and had an EKG as part of his physical examination. Atrial Fibrillation was noted. Patient was referred to cardiology. Shortness of breath persisted intermittently. Echocardiogram found a healthy heart with slight hypertensive changes. December 2, 2021 patient suffered minor strokes in the Thalamus and Temporal lobe, right side. On December 9, 2021 patient suffered a massive right hemisphere infarction and is hospitalized.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Infarction, Laboratory test, Sleep disorder, Upper respiratory tract infection
Clinical narrative: Patient showed signs of light headedness and shortness of breath the day after vaccination. Lightheadedness resolved. Shortness of breath and waking up from sleep short of breath continued intermittently over the course of several months, worsening when patient had an upper respiratory infection in late June. Patient saw Dr. on August 4, 2021 and had an EKG as part of his physical examination. Atrial Fibrillation was noted. Patient was referred to cardiology. Shortness of breath persisted intermittently. Echocardiogram found a healthy heart with slight hypertensive changes. December 2, 2021 patient suffered minor strokes in the Thalamus and Temporal lobe, right side. On December 9, 2021 patient suffered a massive right hemisphere infarction and is hospitalized.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Ear inflammation, Electrocardiogram, Nasal inflammation, Physical examination
Clinical narrative: Vertigo of left ear and accompanying inflamed/swollen  nasal/ear passages
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo of left ear and accompanying inflamed/swollen  nasal/ear passages
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Lymph node pain, Muscle rupture, Musculoskeletal chest pain, Pain
Clinical narrative: My lymph nodes on the left side (where I got my shot) started getting sore about 1-2 weeks after the second shot. It was painful to even keep my arm against my body. I read this was normal and since the side effect went away in about a week, I didn't think much of it. However, several days ago (4 months after the 2nd shot) the lymph node started getting sore again just like I'm August. Over the following few days the pain and soreness moved to the inner side of my arm, the bicep area, and continued to move down to my forearm (left side, where I received the shot). The arm was very sore to the touch and it was very painful to extend it - if I try to lift it shoulder-height or higher, it feels like the limb/muscle is being torn apart. The soreness was not caused by physical activity - I have not done any physical activity prior to the pain or since.  I've also started feeling a burning sensation on the left side of my torso - slightly below the top of the left rib cage. This pain was consistent for about a week straight and it started about 1-2 weeks after I received my 2nd shot. The pain/sensation still comes and goes on and off. I'm getting tests done to see what the issue it. I don't know if it was a side effect of the vaccine but the timing of it is concerning.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My lymph nodes on the left side (where I got my shot) started getting sore about 1-2 weeks after the second shot. It was painful to even keep my arm against my body. I read this was normal and since the side effect went away in about a week, I didn't think much of it. However, several days ago (4 months after the 2nd shot) the lymph node started getting sore again just like I'm August. Over the following few days the pain and soreness moved to the inner side of my arm, the bicep area, and continued to move down to my forearm (left side, where I received the shot). The arm was very sore to the touch and it was very painful to extend it - if I try to lift it shoulder-height or higher, it feels like the limb/muscle is being torn apart. The soreness was not caused by physical activity - I have not done any physical activity prior to the pain or since.  I've also started feeling a burning sensation on the left side of my torso - slightly below the top of the left rib cage. This pain was consistent for about a week straight and it started about 1-2 weeks after I received my 2nd shot. The pain/sensation still comes and goes on and off. I'm getting tests done to see what the issue it. I don't know if it was a side effect of the vaccine but the timing of it is concerning.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Pain in extremity
Clinical narrative: Headache, sore arm, sore stomach
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Have experienced tinnitus since the day after the vaccine.  It manifests as a low level buzzing, like radio static.  It's at a low level (so not able to be heard most of the time when other noise is present) but constant.