chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Cough, Dyspnoea, Emotional distress, Tremor
Clinical narrative: Patient initially coughed twice after the vaccine. We had a 3 minute conversation about over the counter items and then went into her car. After a few minutes returned and said  that she was having difficulty breathing. Could not stop coughing and stated she had chest tightness. Physically the patient looked like she was in distress in the throat and chest area as well as almost wheezing. I administered an adult 0.3mg EpiPen, which the patient's throat and chest looked to relax and she looked alleviated. Stated she felt better and could breath a little bit better. Was shaking a few minutes after administrating the EpiPen and an ambulance was called to assess her.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site nodule
Clinical narrative: Module ( knot ) at injection site
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccination was administered after 72 day BUD.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Psoriatic arthropathy
Clinical narrative: Psoriatic arthritis flare. Started about 5 days after vaccine. 2 months later I've had to double my dose of cosentyx and do 2 prednisone bursts.
Age: 80.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Incorrect product formulation administered, Wrong product administered
Clinical narrative: INCORRECT PFIZER COVID 19 VACCINE ADMINISTERED - SHOULD have been pfizer covid 19 bivalent vaccine
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Rash erythematous, Rash pruritic, Skin discolouration
Clinical narrative: Red itchy  rash appearing on different areas of my body at random intervals,.  Leaves dark spots on my body.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: no symptoms at this time, failed to dilute vial prior to administration
Age: 33.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: incorrect pfizer covid 19 vaccine administered - should have been pfizer covid 19 bivalent vaccine
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: incorrect pfizer covid 19 vaccine administered - should have been pfizer covid 19 bivalent vaccine
Age: 17.0
Sex: F
Vaccine: FLUC4
Symptoms: Anxiety, Loss of consciousness, Syncope
Clinical narrative: Patient developed syncope after receiving flu vaccine in left arm. Patient lost consciousness for 5-10 seconds before regaining consciousness and experiencing anxiety. Patient eventually was able to settle down after deep breathing and hydrating over the course of 20 minutes or so. Emergency services were not required.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rhinorrhoea
Clinical narrative: Patient states within 24 hours after receiving the vaccine he experience itching all over his body with no rash and a runny nose.  He states he has been getting Fluzone HD in previous years with no issue. Patient states after 2-3 days he has gotten better.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Syncope
Clinical narrative: Nurse's Notes: Patient, Female, came in for covid-19 vaccine and flu vaccine. Patient came in conscious, coherent, alert. Covid vaccine was administered. Few minutes later, she verbalized, "I feel faint," she then fainted and almost hit her head on the floor, her head was supported with my hands. Called help from the pharmacist. Water was given and vital signs were taken. Her vitals were normal. Patient explained she had history of fainting and said it's probably because of or due to anxiety. Patient seemed relaxed. Hydration was fluids was advised. Vital signs taken again and were normal.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Back pain, Fatigue, Pyrexia, Urinary retention
Clinical narrative: Fever 103.8F, severe fatigue, inability to urinate, lower back pain. Symptoms lasted for 36 hours.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test normal, COVID-19 pneumonia, Computerised tomogram, Echocardiogram
Clinical narrative: About 2 or so days after the first dose my right knee started to swell. It was not noticeable to me, but wearing shorts others commented on it. After the second dose the swelling in the right knee and now up into thigh was persistent and never went away. It is still happening today. I go to a lymphatic clinic for massage therapy and wear thigh high compressions everyday. I was given a lymphatic pump for lymphedema and I do manual lymphatic drainage myself at home away from the clinic everyday/night.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammatory marker test, Joint swelling, Laboratory test normal, Lymphadenopathy, Lymphoedema
Clinical narrative: About 2 or so days after the first dose my right knee started to swell. It was not noticeable to me, but wearing shorts others commented on it. After the second dose the swelling in the right knee and now up into thigh was persistent and never went away. It is still happening today. I go to a lymphatic clinic for massage therapy and wear thigh high compressions everyday. I was given a lymphatic pump for lymphedema and I do manual lymphatic drainage myself at home away from the clinic everyday/night.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Mobility decreased, Muscle fatigue, Myalgia, Peripheral swelling
Clinical narrative: About 2 or so days after the first dose my right knee started to swell. It was not noticeable to me, but wearing shorts others commented on it. After the second dose the swelling in the right knee and now up into thigh was persistent and never went away. It is still happening today. I go to a lymphatic clinic for massage therapy and wear thigh high compressions everyday. I was given a lymphatic pump for lymphedema and I do manual lymphatic drainage myself at home away from the clinic everyday/night.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary function test, Red blood cell sedimentation rate abnormal, Scan lymph nodes, Ultrasound Doppler
Clinical narrative: About 2 or so days after the first dose my right knee started to swell. It was not noticeable to me, but wearing shorts others commented on it. After the second dose the swelling in the right knee and now up into thigh was persistent and never went away. It is still happening today. I go to a lymphatic clinic for massage therapy and wear thigh high compressions everyday. I was given a lymphatic pump for lymphedema and I do manual lymphatic drainage myself at home away from the clinic everyday/night.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccination is administered after BUD date outside due to a clerical error
Age: 1.17
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccination administered after BUD of 72 days. No adverse reaction noted during 15 minute observation time
Sex: U
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Moderna Monovalent COVID-19 vaccine administered to patients after from 09/01/2022 to 09/12/2022. Will include patient information with report.  No adverse reactions reported.
Age: 72.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site nodule, Pain, Vaccination site pain
Clinical narrative: Pain returned with an intense throbbing sensation; Pain and a knot at the injection site; Pain and a knot at the injection site; This spontaneous case was retrieved on 31-Aug-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number 0892299-1), reported by other healthcare professional, and concerned a 72-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 15-Oct-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose reported as '1', route of administration: intramuscular, anatomical location: left arm, indication: not reported). The batch number reported was 279831 (reported batch number was identified by Seqirus to be linked to suspect product Flucelvax Quadrivalent instead of reported suspect product Fluad Quadrivalent).  On the same day, after receiving Flucelvax Quadrivalent, the patient experienced pain and a knot at the injection site.  On 16-Oct-2020, the patient recovered from the event of 'vaccination site nodule', however pain continued.   On 17-Oct-2020, the patient recovered from the event of 'vaccination site pain'.  On 18-Oct-2020, the pain returned with an intense throbbing sensation.   On 24-Oct-2020, the patient visited Physician's Office, however, no further details were reported.  The outcome of the event 'throbbing pain' was unknown.   The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: A 72-year-old patient was vaccinated with Flucelvax Quadrivalent. On the same day, after receiving Flucelvax Quadrivalent, the patient experienced pain and a knot at the injection site. The patient recovered from the vaccination site pain and vaccination site nodule resolved, however, three days later the throbbing pain. Causal role of the suspect vaccine is assessed as possibly related.; Sender's Comments: A 72-year-old patient was vaccinated with Flucelvax Quadrivalent. On the same day, after receiving Flucelvax Quadrivalent, the patient experienced pain and a knot at the injection site. The patient recovered from the vaccination site pain and vaccination site nodule resolved, however, three days later the throbbing pain. Causal role of the suspect vaccine is assessed as possibly related.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Magnetic resonance imaging
Clinical narrative: Difficulty to lift the arm; Pain in the upper left arm; This spontaneous case was retrieved on 06-Sep-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 0972474-1), reported by other health care professional and concerned a 64-year-old, female patient.  The patient's medical history was not reported. The patient's concomitant medications included atorvastatin, glimepiride, lisinopril, metformin, Aspirin (acetylsalicylic acid), all used for unreported indications.  On 15-Nov-2020 the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; dose: reported as 1, anatomical location: left arm, route of administration and indication: not reported). The batch number reported was P100271294 (reported batch number was identified by Seqirus to be linked to suspect product Afluria Quadrivalent instead of reported suspect product Fluad Quadrivalent).   On the same date, after receiving Afluria Quadrivalent, the patient experienced pain in the upper left arm and difficulty to lift the arm. The patient had been taking Advil (ibuprofen) at dose of 4000 mg, two to three times, daily, for months, as a treatment. Additionally, the patient was taking trial of steroid with blood sugar precautions for diabetes.  On an unspecified date, the patient was warranted for magnetic resonance imaging (MRI), however, the results were not reported.  On an unspecified date, the patient visited physician office. However, no further details were provided.   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 of pain in arm and injected limb mobility decreased are considered as possible related to Afluria Quadrivalent due to plausible temporal relationship.; Sender's Comments: The events of pain in arm and injected limb mobility decreased are considered as possible related to Afluria Quadrivalent due to plausible temporal relationship.
Age: 50.0
Sex: F
Vaccine: FLUC3, VARCEL
Symptoms: Erythema, Feeling of body temperature change, Inflammation, Injection site inflammation
Clinical narrative: Inflammation, redness, temperature change at site; This spontaneous case was retrieved on 18-Aug-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1795460-1) reported by other healthcare professional and concerned a 50-year-old, female patient.  The patient's medical history included asthma. The patient had no known allergies. The patient's concomitant medications included Trelegy (fluticasone furoate, umeclidinium bromide, vilanterol trifenatate), Singulair (montelukast sodium) and Zyrtec (cetirizine hydrochloride) all used for unreported indication.  On 11-Oct-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose reported as 'one', route of administration: intramuscular, anatomical location: left arm, indication: not reported). The batch number reported was 308472 (reported batch number was identified by Seqirus to be linked to suspect product Flucelvax Quadrivalent instead of reported suspect product Fluad Quadrivalent).  On the same day, the patient was vaccinated with non-company, co-suspect Varivax (varicella zoster vaccine live (Oka/Merck); dose: reported as 'two', route of administration: subcutaneous, anatomical location: right arm, indication: not reported). The batch number reported was 6023791.  On 12-Oct-2021, one day after receiving Flucelvax Quadrivalent and non-company, co-suspect Varivax vaccine, the patient experienced inflammation, redness and temperature change at site. Affected area was from right shoulder to elbow.  On an unspecified date in October 2021, the patient recovered from the events. As reported, the events lasted '72+ hours'.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 50-year-old patient developed localised inflammation from right shoulder to elbow one day after receiving the suspect product Flucelvax Quadrivalent (anatomical location: left arm) and non-company, co-suspect Varivax vaccine (anatomical location: right arm). Causality for the reported event is assessed as not related, based on information regarding anatomical location.; Sender's Comments: A 50-year-old patient developed localised inflammation from right shoulder to elbow one day after receiving the suspect product Flucelvax Quadrivalent (anatomical location: left arm) and non-company, co-suspect Varivax vaccine (anatomical location: right arm). Causality for the reported event is assessed as not related, based on information regarding anatomical location.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, C-reactive protein increased, Gait disturbance, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Within a week of receiving the 2nd Pfizer vaccine I developed pain in both hips.  After several more weeks pain and stiffness spread to legs, collarbone and arms.  CRP and Sed. rate were elevated.  Very difficult to get out of chairs, turn over in bed, or to walk up stairs.  My arms would not raise above my head.  This went on for 8 or 9 months.  18 months later, I am much improved, but still have pain in knees, hips and feet.  I remain stiff after rising from sitting for half an hour or so.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Red blood cell sedimentation rate increased
Clinical narrative: Within a week of receiving the 2nd Pfizer vaccine I developed pain in both hips.  After several more weeks pain and stiffness spread to legs, collarbone and arms.  CRP and Sed. rate were elevated.  Very difficult to get out of chairs, turn over in bed, or to walk up stairs.  My arms would not raise above my head.  This went on for 8 or 9 months.  18 months later, I am much improved, but still have pain in knees, hips and feet.  I remain stiff after rising from sitting for half an hour or so.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose normal, Blood pressure increased, Dizziness, Flushing, Hypopnoea
Clinical narrative: Thirty minutes after receiving the booster I had an abrupt full body flushing with presyncope, accelerated hypertension (BP 175/110), tachycardia ) HR 110.  My blood pressure and heart rate has never returned to normal.  I now have POTS and hypertension and am barely responding to beta blockers and calcium channel blockers.  I have had persistent chest pain, out of the blue anxiety, hair loss, brain fog, right ear tinnitus, and imbalance and dizziness ever since receiving the booster.  I didn't have any of these issue before receiving the vaccine.  I had three months of limb weakness and difficulty using my fingers for about 2 months, which has since improved.  I am currently now out of work after working in the health care setting for 27 years, I am about to lose my health insurance if I can't go back to work.  I had none of the symptoms until receiving the moderna booster.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory rate increased
Clinical narrative: Thirty minutes after receiving the booster I had an abrupt full body flushing with presyncope, accelerated hypertension (BP 175/110), tachycardia ) HR 110.  My blood pressure and heart rate has never returned to normal.  I now have POTS and hypertension and am barely responding to beta blockers and calcium channel blockers.  I have had persistent chest pain, out of the blue anxiety, hair loss, brain fog, right ear tinnitus, and imbalance and dizziness ever since receiving the booster.  I didn't have any of these issue before receiving the vaccine.  I had three months of limb weakness and difficulty using my fingers for about 2 months, which has since improved.  I am currently now out of work after working in the health care setting for 27 years, I am about to lose my health insurance if I can't go back to work.  I had none of the symptoms until receiving the moderna booster.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Angiogram, Anxiety, Balance disorder, Chest X-ray
Clinical narrative: Thirty minutes after receiving the booster I had an abrupt full body flushing with presyncope, accelerated hypertension (BP 175/110), tachycardia ) HR 110.  My blood pressure and heart rate has never returned to normal.  I now have POTS and hypertension and am barely responding to beta blockers and calcium channel blockers.  I have had persistent chest pain, out of the blue anxiety, hair loss, brain fog, right ear tinnitus, and imbalance and dizziness ever since receiving the booster.  I didn't have any of these issue before receiving the vaccine.  I had three months of limb weakness and difficulty using my fingers for about 2 months, which has since improved.  I am currently now out of work after working in the health care setting for 27 years, I am about to lose my health insurance if I can't go back to work.  I had none of the symptoms until receiving the moderna booster.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Echocardiogram, Feeling abnormal, Flushing
Clinical narrative: Thirty minutes after receiving the booster I had an abrupt full body flushing with presyncope, accelerated hypertension (BP 175/110), tachycardia ) HR 110.  My blood pressure and heart rate has never returned to normal.  I now have POTS and hypertension and am barely responding to beta blockers and calcium channel blockers.  I have had persistent chest pain, out of the blue anxiety, hair loss, brain fog, right ear tinnitus, and imbalance and dizziness ever since receiving the booster.  I didn't have any of these issue before receiving the vaccine.  I had three months of limb weakness and difficulty using my fingers for about 2 months, which has since improved.  I am currently now out of work after working in the health care setting for 27 years, I am about to lose my health insurance if I can't go back to work.  I had none of the symptoms until receiving the moderna booster.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Impaired work ability, Laboratory test, Magnetic resonance imaging head, Magnetic resonance imaging spinal
Clinical narrative: Thirty minutes after receiving the booster I had an abrupt full body flushing with presyncope, accelerated hypertension (BP 175/110), tachycardia ) HR 110.  My blood pressure and heart rate has never returned to normal.  I now have POTS and hypertension and am barely responding to beta blockers and calcium channel blockers.  I have had persistent chest pain, out of the blue anxiety, hair loss, brain fog, right ear tinnitus, and imbalance and dizziness ever since receiving the booster.  I didn't have any of these issue before receiving the vaccine.  I had three months of limb weakness and difficulty using my fingers for about 2 months, which has since improved.  I am currently now out of work after working in the health care setting for 27 years, I am about to lose my health insurance if I can't go back to work.  I had none of the symptoms until receiving the moderna booster.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Postural orthostatic tachycardia syndrome, Presyncope, Tachycardia, Tinnitus
Clinical narrative: Thirty minutes after receiving the booster I had an abrupt full body flushing with presyncope, accelerated hypertension (BP 175/110), tachycardia ) HR 110.  My blood pressure and heart rate has never returned to normal.  I now have POTS and hypertension and am barely responding to beta blockers and calcium channel blockers.  I have had persistent chest pain, out of the blue anxiety, hair loss, brain fog, right ear tinnitus, and imbalance and dizziness ever since receiving the booster.  I didn't have any of these issue before receiving the vaccine.  I had three months of limb weakness and difficulty using my fingers for about 2 months, which has since improved.  I am currently now out of work after working in the health care setting for 27 years, I am about to lose my health insurance if I can't go back to work.  I had none of the symptoms until receiving the moderna booster.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, UNK, COVID19
Symptoms: Blood urea, COVID-19, Drug ineffective, Dyspnoea, Electrocardiogram
Clinical narrative: Cardiac flutter; short of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022SA211752.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EN6208) at the age of 74 years for covid-19 immunisation; insulin glargine (LANTUS), (Lot number: IF034A, Expiration Date: 31May2024) at daily (100 iu/ml 15 u daily) for type 1 diabetes mellitus. The patient's relevant medical history included: "Diabetic", start date: 1982 (ongoing), notes: At the time of the event, the patient had ongoing Diabetic in 1982.; "Road traffic accident" (unspecified if ongoing), notes: Road traffic accident with while driving and had an accident. Concomitant medication(s) included: HUMALOG taken for type 1 diabetes mellitus; NOVOLOG taken for type 1 diabetes mellitus; RAMIPRIL; ATORVASTATIN; LEVEMIR, start date: 2011.  The following information was reported: CARDIAC FLUTTER (medically significant), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "short of breath". The action taken for insulin glargine was unknown. Therapeutic measures were taken as a result of cardiac flutter.  Follow-Up (26Sep2022): Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, UNK, COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Cardiac flutter; short of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022SA211752.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EN6208) at the age of 74 years for covid-19 immunisation; insulin glargine (LANTUS), (Lot number: IF034A, Expiration Date: 31May2024) at daily (100 iu/ml 15 u daily) for type 1 diabetes mellitus. The patient's relevant medical history included: "Diabetic", start date: 1982 (ongoing), notes: At the time of the event, the patient had ongoing Diabetic in 1982.; "Road traffic accident" (unspecified if ongoing), notes: Road traffic accident with while driving and had an accident. Concomitant medication(s) included: HUMALOG taken for type 1 diabetes mellitus; NOVOLOG taken for type 1 diabetes mellitus; RAMIPRIL; ATORVASTATIN; LEVEMIR, start date: 2011.  The following information was reported: CARDIAC FLUTTER (medically significant), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "short of breath". The action taken for insulin glargine was unknown. Therapeutic measures were taken as a result of cardiac flutter.  Follow-Up (26Sep2022): Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, UNK, COVID19
Symptoms: Blood glucose abnormal, Blood glucose decreased, Electrocardiogram
Clinical narrative: Cardiac flutter; short of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022SA211752.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EN6208) at the age of 74 years for covid-19 immunisation; insulin glargine (LANTUS), (Lot number: IF034A, Expiration Date: 31May2024) at daily (100 iu/ml 15 u daily) for type 1 diabetes mellitus. The patient's relevant medical history included: "Diabetic", start date: 1982 (ongoing), notes: At the time of the event, the patient had ongoing Diabetic in 1982.; "Road traffic accident" (unspecified if ongoing), notes: Road traffic accident with while driving and had an accident. Concomitant medication(s) included: HUMALOG taken for type 1 diabetes mellitus; NOVOLOG taken for type 1 diabetes mellitus; RAMIPRIL; ATORVASTATIN; LEVEMIR, start date: 2011.  The following information was reported: CARDIAC FLUTTER (medically significant), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "short of breath". The action taken for insulin glargine was unknown. Therapeutic measures were taken as a result of cardiac flutter.  Follow-Up (26Sep2022): Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, UNK, COVID19
Symptoms: Cardiac flutter, Dyspnoea
Clinical narrative: Cardiac flutter; short of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022SA211752.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EN6208) at the age of 74 years for covid-19 immunisation; insulin glargine (LANTUS), (Lot number: IF034A, Expiration Date: 31May2024) at daily (100 iu/ml 15 u daily) for type 1 diabetes mellitus. The patient's relevant medical history included: "Diabetic", start date: 1982 (ongoing), notes: At the time of the event, the patient had ongoing Diabetic in 1982.; "Road traffic accident" (unspecified if ongoing), notes: Road traffic accident with while driving and had an accident. Concomitant medication(s) included: HUMALOG taken for type 1 diabetes mellitus; NOVOLOG taken for type 1 diabetes mellitus; RAMIPRIL; ATORVASTATIN; LEVEMIR, start date: 2011.  The following information was reported: CARDIAC FLUTTER (medically significant), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "short of breath". The action taken for insulin glargine was unknown. Therapeutic measures were taken as a result of cardiac flutter.  Follow-Up (26Sep2022): Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, COVID-19, Electrolyte imbalance, SARS-CoV-2 test positive
Clinical narrative: Patient is a 58 yo M w PMHX of EtOH abuse, cirrhosis 2/2 Hemochromatosis, COPD, tobacco abuse and pulm HTN who presented to ED w/ 2-3 weeks of progressive weakness. Found to have severe electrolyte abnormalities and incidiental COVID positive.  Lot #'s 9/21/22--GH9702 5/20/21--EW0183 4/29/21--EW0179
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure increased, Dizziness postural, Headache
Clinical narrative: worsened ability to think; Lightheadedness; blood pressure fluctuating between 150/90 to 224/147; electrical shocking; pain; muscle spasm; new non migraine headaches; This case was reported by a consumer via call center representative and described the occurrence of difficulty thinking in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced difficulty thinking (serious criteria GSK medically significant), light headedness, blood pressure fluctuation, electric shock sensation, pain, muscle spasm and headache. On an unknown date, the outcome of the difficulty thinking, light headedness, blood pressure fluctuation, electric shock sensation, pain, muscle spasm and headache were not recovered/not resolved.   It was unknown if the reporter considered the difficulty thinking, light headedness, blood pressure fluctuation, electric shock sensation, pain, muscle spasm and headache to be related to Shingrix.     Additional Information: Additional Information: GSK receipt date: 16-SEP-2022 Reporters comment: This case was reported by a consumer. The patient receive shingrix vaccine and experienced Lightheadedness, blood pressure fluctuating between 150/90 to 224/147, worsened ability to think, electrical shocking, pain, muscle spasm, new non migraine headaches. The patient reported that he/she was on day three of severe reaction and it did not match extremely limited list of symptoms. The patient wish he/she had the shingles back. The follow up information received on same day and updated the patient initial and contact details
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure fluctuation, Dizziness, Electric shock sensation, Headache, Mental impairment
Clinical narrative: worsened ability to think; Lightheadedness; blood pressure fluctuating between 150/90 to 224/147; electrical shocking; pain; muscle spasm; new non migraine headaches; This case was reported by a consumer via call center representative and described the occurrence of difficulty thinking in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced difficulty thinking (serious criteria GSK medically significant), light headedness, blood pressure fluctuation, electric shock sensation, pain, muscle spasm and headache. On an unknown date, the outcome of the difficulty thinking, light headedness, blood pressure fluctuation, electric shock sensation, pain, muscle spasm and headache were not recovered/not resolved.   It was unknown if the reporter considered the difficulty thinking, light headedness, blood pressure fluctuation, electric shock sensation, pain, muscle spasm and headache to be related to Shingrix.     Additional Information: Additional Information: GSK receipt date: 16-SEP-2022 Reporters comment: This case was reported by a consumer. The patient receive shingrix vaccine and experienced Lightheadedness, blood pressure fluctuating between 150/90 to 224/147, worsened ability to think, electrical shocking, pain, muscle spasm, new non migraine headaches. The patient reported that he/she was on day three of severe reaction and it did not match extremely limited list of symptoms. The patient wish he/she had the shingles back. The follow up information received on same day and updated the patient initial and contact details
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Muscle spasms, Pain
Clinical narrative: worsened ability to think; Lightheadedness; blood pressure fluctuating between 150/90 to 224/147; electrical shocking; pain; muscle spasm; new non migraine headaches; This case was reported by a consumer via call center representative and described the occurrence of difficulty thinking in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced difficulty thinking (serious criteria GSK medically significant), light headedness, blood pressure fluctuation, electric shock sensation, pain, muscle spasm and headache. On an unknown date, the outcome of the difficulty thinking, light headedness, blood pressure fluctuation, electric shock sensation, pain, muscle spasm and headache were not recovered/not resolved.   It was unknown if the reporter considered the difficulty thinking, light headedness, blood pressure fluctuation, electric shock sensation, pain, muscle spasm and headache to be related to Shingrix.     Additional Information: Additional Information: GSK receipt date: 16-SEP-2022 Reporters comment: This case was reported by a consumer. The patient receive shingrix vaccine and experienced Lightheadedness, blood pressure fluctuating between 150/90 to 224/147, worsened ability to think, electrical shocking, pain, muscle spasm, new non migraine headaches. The patient reported that he/she was on day three of severe reaction and it did not match extremely limited list of symptoms. The patient wish he/she had the shingles back. The follow up information received on same day and updated the patient initial and contact details
Age: 4.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Headache, Incorrect dose administered, Pyrexia, Rash
Clinical narrative: 4 year old daughter was recently mistakenly given an adult COVID booster; 4 year old daughter was recently mistakenly given an adult COVID booster; Rash/ rash on her arm/ She had a rash at the site of injection; Congestion; Headache; low grade fever; fussy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 4-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 3 (booster), single (Lot number: GJ5342) at the age of 4 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN [LORATADINE] taken for hypersensitivity. Vaccination history included: BNT162b2 (Dose 1, Lot number: FT9142), administration date: 25Jun2022, when the patient was 4-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Lot number: FT9142), administration date: 17Jul2022, when the patient was 4-year-old, for COVID-19 immunization. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 11Sep2022, outcome "unknown" and all described as "4 year old daughter was recently mistakenly given an adult COVID booster"; NASAL CONGESTION (non-serious) with onset Sep2022, outcome "unknown", described as "Congestion"; HEADACHE (non-serious) with onset Sep2022, outcome "unknown"; VACCINATION SITE RASH (non-serious) with onset Sep2022, outcome "recovered" (Sep2022), described as "Rash/ rash on her arm/ She had a rash at the site of injection"; IRRITABILITY POSTVACCINAL (non-serious) with onset Sep2022, outcome "recovered" (Sep2022), described as "fussy"; PYREXIA (non-serious) with onset Sep2022, outcome "recovered" (Sep2022), described as "low grade fever".  Additional information: The patient had a rash at the site of injection, congestion, and had complained of a headache most days since the vaccination. Reporter was unsure if any of that was associated with the vaccine. Reporter was desperately seeking someone to walk her through this situation. The events did not result to emergency room nor physician office visit. Her daughter was fussy and had a low grade fever for a couple days and a rash on her arm but not enough of anything to take her daughter to the doctor. The rash was almost immediately seen around the injection site and lasted 3-4 days. She was fussy starting around that time and lasted 2-3 days. Her low grade fever started that evening but wasn't even enough to think she was sick.
Age: 4.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Headache, Irritability postvaccinal, Nasal congestion, Overdose, Product administered to patient of inappropriate age
Clinical narrative: 4 year old daughter was recently mistakenly given an adult COVID booster; 4 year old daughter was recently mistakenly given an adult COVID booster; Rash/ rash on her arm/ She had a rash at the site of injection; Congestion; Headache; low grade fever; fussy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 4-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 3 (booster), single (Lot number: GJ5342) at the age of 4 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN [LORATADINE] taken for hypersensitivity. Vaccination history included: BNT162b2 (Dose 1, Lot number: FT9142), administration date: 25Jun2022, when the patient was 4-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Lot number: FT9142), administration date: 17Jul2022, when the patient was 4-year-old, for COVID-19 immunization. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 11Sep2022, outcome "unknown" and all described as "4 year old daughter was recently mistakenly given an adult COVID booster"; NASAL CONGESTION (non-serious) with onset Sep2022, outcome "unknown", described as "Congestion"; HEADACHE (non-serious) with onset Sep2022, outcome "unknown"; VACCINATION SITE RASH (non-serious) with onset Sep2022, outcome "recovered" (Sep2022), described as "Rash/ rash on her arm/ She had a rash at the site of injection"; IRRITABILITY POSTVACCINAL (non-serious) with onset Sep2022, outcome "recovered" (Sep2022), described as "fussy"; PYREXIA (non-serious) with onset Sep2022, outcome "recovered" (Sep2022), described as "low grade fever".  Additional information: The patient had a rash at the site of injection, congestion, and had complained of a headache most days since the vaccination. Reporter was unsure if any of that was associated with the vaccine. Reporter was desperately seeking someone to walk her through this situation. The events did not result to emergency room nor physician office visit. Her daughter was fussy and had a low grade fever for a couple days and a rash on her arm but not enough of anything to take her daughter to the doctor. The rash was almost immediately seen around the injection site and lasted 3-4 days. She was fussy starting around that time and lasted 2-3 days. Her low grade fever started that evening but wasn't even enough to think she was sick.
Age: 4.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Pyrexia, Vaccination site rash
Clinical narrative: 4 year old daughter was recently mistakenly given an adult COVID booster; 4 year old daughter was recently mistakenly given an adult COVID booster; Rash/ rash on her arm/ She had a rash at the site of injection; Congestion; Headache; low grade fever; fussy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 4-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 3 (booster), single (Lot number: GJ5342) at the age of 4 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN [LORATADINE] taken for hypersensitivity. Vaccination history included: BNT162b2 (Dose 1, Lot number: FT9142), administration date: 25Jun2022, when the patient was 4-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Lot number: FT9142), administration date: 17Jul2022, when the patient was 4-year-old, for COVID-19 immunization. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 11Sep2022, outcome "unknown" and all described as "4 year old daughter was recently mistakenly given an adult COVID booster"; NASAL CONGESTION (non-serious) with onset Sep2022, outcome "unknown", described as "Congestion"; HEADACHE (non-serious) with onset Sep2022, outcome "unknown"; VACCINATION SITE RASH (non-serious) with onset Sep2022, outcome "recovered" (Sep2022), described as "Rash/ rash on her arm/ She had a rash at the site of injection"; IRRITABILITY POSTVACCINAL (non-serious) with onset Sep2022, outcome "recovered" (Sep2022), described as "fussy"; PYREXIA (non-serious) with onset Sep2022, outcome "recovered" (Sep2022), described as "low grade fever".  Additional information: The patient had a rash at the site of injection, congestion, and had complained of a headache most days since the vaccination. Reporter was unsure if any of that was associated with the vaccine. Reporter was desperately seeking someone to walk her through this situation. The events did not result to emergency room nor physician office visit. Her daughter was fussy and had a low grade fever for a couple days and a rash on her arm but not enough of anything to take her daughter to the doctor. The rash was almost immediately seen around the injection site and lasted 3-4 days. She was fussy starting around that time and lasted 2-3 days. Her low grade fever started that evening but wasn't even enough to think she was sick.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Erythema, Inappropriate schedule of product administration, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: The second one her fever only lasted 1 day; huge red mark from shoulder to elbow; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (The second one her fever only lasted 1 day) and ERYTHEMA (huge red mark from shoulder to elbow) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (The second one her fever only lasted 1 day) and ERYTHEMA (huge red mark from shoulder to elbow). At the time of the report, PYREXIA (The second one her fever only lasted 1 day) had resolved and ERYTHEMA (huge red mark from shoulder to elbow) outcome was unknown.            No concomitant medication was provided by reporter. She stated that when she got the booster last time, it was a half dose. No treatment medication was provided by reporter.   This case was linked to MOD-2022-649158 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pyrexia
Clinical narrative: The second one her fever only lasted 1 day; huge red mark from shoulder to elbow; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (The second one her fever only lasted 1 day) and ERYTHEMA (huge red mark from shoulder to elbow) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (The second one her fever only lasted 1 day) and ERYTHEMA (huge red mark from shoulder to elbow). At the time of the report, PYREXIA (The second one her fever only lasted 1 day) had resolved and ERYTHEMA (huge red mark from shoulder to elbow) outcome was unknown.            No concomitant medication was provided by reporter. She stated that when she got the booster last time, it was a half dose. No treatment medication was provided by reporter.   This case was linked to MOD-2022-649158 (Patient Link).
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccination administered after BUD of 72 days. No adverse reaction noted during 15 minute observation time.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccination administered after BUD of 72 days. No adverse reaction noted during 15 minute observation time
Age: 76.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Injection site rash, Rash, Rash pruritic
Clinical narrative: Patient said that one day after she got two vaccines she noticed rash on injection site, then it spreads all over the body. It is not painful but itchy.
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: sore arm, chills , headache , body ache
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diabetic ketoacidosis, Type 1 diabetes mellitus
Clinical narrative: Type 1 Diabetes, Diabetic Ketoacidosis.  I was not a diabetic prior to this. After receiving these vaccines I almost lost my life in November 2021. Diagnosed Type 1.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Peripheral swelling, Skin discolouration
Clinical narrative: Pinky turned purple with some minor swelling
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chest pain, Chills, Cough, Fatigue
Clinical narrative: Severe chills started within 12 hours of the dose, no fever.    Fatigue, intermittent chills (which eased a little) and body aches throughout the next next 24 hours started.   By the end of 24 hours, and going into the next 48 hours, a mild cough, nasal drainage, and at the end of 72 hours chest burning started.   At the 72 hour mark, two rapid COVID tests were taken and I am now positive for COVID for the first time since the pandemic started.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Severe chills started within 12 hours of the dose, no fever.    Fatigue, intermittent chills (which eased a little) and body aches throughout the next next 24 hours started.   By the end of 24 hours, and going into the next 48 hours, a mild cough, nasal drainage, and at the end of 72 hours chest burning started.   At the 72 hour mark, two rapid COVID tests were taken and I am now positive for COVID for the first time since the pandemic started.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood test, Cardiac imaging procedure, Chest pain, Colonoscopy
Clinical narrative: Within 2 weeks I was breathless,  chest pains, loss of appetite fatique, unable to work, muscel pain, neck pain, blurry vision, anxiety
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Decreased appetite, Dyspnoea, Endoscopy, Fatigue
Clinical narrative: Within 2 weeks I was breathless,  chest pains, loss of appetite fatique, unable to work, muscel pain, neck pain, blurry vision, anxiety
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Myalgia, Neck pain
Clinical narrative: Within 2 weeks I was breathless,  chest pains, loss of appetite fatique, unable to work, muscel pain, neck pain, blurry vision, anxiety
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Within 2 weeks I was breathless,  chest pains, loss of appetite fatique, unable to work, muscel pain, neck pain, blurry vision, anxiety
Age: 31.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypotension, Injection site pain, Lethargy
Clinical narrative: 1. Hypotension - patient's usual blood pressure is about 106/68 - 2 blood pressure readings around 14:00 on the same day was 86/54 and 84/56 - no treatment provided 2. Lethargic 3. Injection site soreness