chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headache; A Spontaneous report was received from a nurse concerning a 58-year-old female patient who was participating in the mRNA-1273 Emergency Use Program and developed a severe headache.   The patient's medical history, as provided by the reporter, included a knee operation and throat surgery. No relevant concomitant medications were reported.   On 02 Jan 2021, the same day as the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   The patient experienced a severe headache beginning on 02 Jan 2021.   Action taken with mRNA-1273 in response to the event was not provided .    The event resolved on 04 Jan 2021.  No treatment information was provided.  The outcome of the event severe headache was reported as recovered on 04 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site started swelling; Injection site started aching. She says that she can't lift her arm, can't move it, that it is very painful.; Major headache; A spontaneous report was received from a consumer concerning a 22-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273)and experienced injection site swelling, ache at the injection site, couldn't lift or move her arm, and headache.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05-Jan-2021, approximately two hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L208) intramuscularly in her left arm for prophylaxis of COVID-19 infection.   On 05-Jan-2021, Patient received vaccine and approximately two hours later the patient began feeling an ache at the injection site.  She couldn't lift or move her arm and had a headache and injection site swelling. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events experienced injection site swelling, ache at the injection site, couldn't lift or move her arm, and headache were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial vaginosis
Clinical narrative: Bacteriovaginosis; This spontaneous case was reported by a consumer and describes the occurrence of BACTERIAL VAGINOSIS (Bacteriovaginosis) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history were reported.).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced BACTERIAL VAGINOSIS (Bacteriovaginosis). At the time of the report, BACTERIAL VAGINOSIS (Bacteriovaginosis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on reporter's causality  the event bacterial vaginosisis assessed as unlikely related to mRNA-1273.; Reporter's Comments: Based on reporter's causality  the event bacterial vaginosisis assessed as unlikely related to mRNA-1273.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Rash
Clinical narrative: Shortness of breath; Rash within the whole body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash within the whole body) and DYSPNOEA (Shortness of breath) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.  On 29-Dec-2020 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced RASH (Rash within the whole body). On 30-Dec-2020, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, RASH (Rash within the whole body) and DYSPNOEA (Shortness of breath) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided.  Treatment for the event included Benadryl (diphenhydramine).   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Contact details provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Rash
Clinical narrative: Redness at injection site; Rash on back and stomach; A spontaneous report was received from a consumer (nurse) concerning a 57-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a rash on back and stomach and redness at injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Dec 2020, approximately seven days prior to the onset of the events, the patient received her first of two doses of mRNA-1273(Batch Number: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 05 Jan 2021, the patient developed a rash on back and stomach. On 06 Jan 2021, patient developed redness at injection site.  Treatment details for event rash on back and stomach included hydrocortisone cream. No treatment information was provided for injection site redness.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event rash on back and stomach was considered resolved. The outcome of the event redness at injection site was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Feeling Itchy; Redness; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness), VACCINATION SITE PRURITUS (Feeling Itchy) and VACCINATION SITE ERYTHEMA (Redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2020, the patient experienced VACCINATION SITE PAIN (Soreness). On 25-Dec-2020, the patient experienced VACCINATION SITE PRURITUS (Feeling Itchy) and VACCINATION SITE ERYTHEMA (Redness). On 30-Dec-2020, VACCINATION SITE PRURITUS (Feeling Itchy) and VACCINATION SITE ERYTHEMA (Redness) had resolved. At the time of the report, VACCINATION SITE PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia, Vaccination site erythema
Clinical narrative: Red patch 4in x 4in at the site of injection; Fever; Body aches; Fatigue; A spontaneous report  was received from a physician  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue, body aches, fever and red patch 4in X 4in at site of injection.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 04 Jan 2021, after receiving the vaccine, the patient experienced fatigue.  On 05 Jan 2021, she experienced body aches and a fever. On 06 Jan 2021, she noticed a red patch, 4in X 4in, at the site of her injection. The patient stated her symptoms have improved but not resolved.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The events, fatigue, body aches, fever and red patch 4in X 4in at site of injection, were considered recovering/resolving .; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Lacrimation increased, Lip pruritus, Nasal pruritus, Pruritus
Clinical narrative: Itching in sensitive areas around the body; Eyes started itching; Itching in lips; Eyes started watering; Itching in nose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRURITUS (Itching in sensitive areas around the body), EYE PRURITUS (Eyes started itching), LIP PRURITUS (Itching in lips), LACRIMATION INCREASED (Eyes started watering) and NASAL PRURITUS (Itching in nose) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical reported history).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced PRURITUS (Itching in sensitive areas around the body), EYE PRURITUS (Eyes started itching), LIP PRURITUS (Itching in lips), LACRIMATION INCREASED (Eyes started watering) and NASAL PRURITUS (Itching in nose). At the time of the report, PRURITUS (Itching in sensitive areas around the body), EYE PRURITUS (Eyes started itching), LIP PRURITUS (Itching in lips), LACRIMATION INCREASED (Eyes started watering) and NASAL PRURITUS (Itching in nose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case concerns a 47-year-old female who experienced NS events of unexpected pruritus, nasal pruritus, lip pruritus, eye pruritus, and lacrimation increased.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment with Zyrtec and Pepcid. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: This case concerns a 47-year-old female who experienced NS events of unexpected pruritus, nasal pruritus, lip pruritus, eye pruritus, and lacrimation increased.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment with Zyrtec and Pepcid. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Ear, nose and throat examination normal, Malaise, Tinnitus
Clinical narrative: Shortly after my second vaccine I woke up with tinnitus. I thought it was from the doxycycline I had been in for about a week. I immediately stopped taking it. The dermatologist didn?t think it was from the Doxy but prescribed a different antibiotic anyway. The tinnitus did not go away. A doctor friend told me sometimes it takes a little while but it never went away. I went to my primary care MD, who also did not think it was the antibiotic. She referred me to an ENT who also does not think it was the antibiotic. The only other thing is the vaccine which did make me sick with the second shot. I am 60 years but I have always taken care of my hearing as I know damage is permanent. I am a nurse.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Biopsy kidney, Blood pressure decreased, Blood test abnormal, Cardiac stress test abnormal
Clinical narrative: Intermittent HA s/p fever, chills, aches, fatigue w/COVID vax #2, 2/27/21. Intractable HA 3/23/21, dbl-vision 3/29/21. At 1° HCP 3/30/21 w/HTN emergencyno previous Dx of HTN. Ambulance to ERBP lowered; no blood, urine tests done. (ER incompetence.) 1° HCP ordered MRI head, brain & CXR: nothing found. Blood, urinalysis 4/27 showed AKI. Visits to specialists Apr-July to find 290/AKI etiology. Urology cytoscopy-nothing notable; cardiology echo, stress test-HTN w exercise, no cardiac disease. Nephrologist tests (many blood, urine tests; sonography; finally renal biopsy) indicate IgA Nephropathy. eGFR 44-50, proteinurea 2+, micro-hematuria 3+ constant since 4/27 testing.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chills, Cystoscopy normal, Diplopia, Echocardiogram normal
Clinical narrative: Intermittent HA s/p fever, chills, aches, fatigue w/COVID vax #2, 2/27/21. Intractable HA 3/23/21, dbl-vision 3/29/21. At 1° HCP 3/30/21 w/HTN emergencyno previous Dx of HTN. Ambulance to ERBP lowered; no blood, urine tests done. (ER incompetence.) 1° HCP ordered MRI head, brain & CXR: nothing found. Blood, urinalysis 4/27 showed AKI. Visits to specialists Apr-July to find 290/AKI etiology. Urology cytoscopy-nothing notable; cardiology echo, stress test-HTN w exercise, no cardiac disease. Nephrologist tests (many blood, urine tests; sonography; finally renal biopsy) indicate IgA Nephropathy. eGFR 44-50, proteinurea 2+, micro-hematuria 3+ constant since 4/27 testing.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Glomerular filtration rate decreased, Haematuria, Headache, Hypertensive emergency
Clinical narrative: Intermittent HA s/p fever, chills, aches, fatigue w/COVID vax #2, 2/27/21. Intractable HA 3/23/21, dbl-vision 3/29/21. At 1° HCP 3/30/21 w/HTN emergencyno previous Dx of HTN. Ambulance to ERBP lowered; no blood, urine tests done. (ER incompetence.) 1° HCP ordered MRI head, brain & CXR: nothing found. Blood, urinalysis 4/27 showed AKI. Visits to specialists Apr-July to find 290/AKI etiology. Urology cytoscopy-nothing notable; cardiology echo, stress test-HTN w exercise, no cardiac disease. Nephrologist tests (many blood, urine tests; sonography; finally renal biopsy) indicate IgA Nephropathy. eGFR 44-50, proteinurea 2+, micro-hematuria 3+ constant since 4/27 testing.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head normal, Nephropathy, Pain, Proteinuria, Pyrexia
Clinical narrative: Intermittent HA s/p fever, chills, aches, fatigue w/COVID vax #2, 2/27/21. Intractable HA 3/23/21, dbl-vision 3/29/21. At 1° HCP 3/30/21 w/HTN emergencyno previous Dx of HTN. Ambulance to ERBP lowered; no blood, urine tests done. (ER incompetence.) 1° HCP ordered MRI head, brain & CXR: nothing found. Blood, urinalysis 4/27 showed AKI. Visits to specialists Apr-July to find 290/AKI etiology. Urology cytoscopy-nothing notable; cardiology echo, stress test-HTN w exercise, no cardiac disease. Nephrologist tests (many blood, urine tests; sonography; finally renal biopsy) indicate IgA Nephropathy. eGFR 44-50, proteinurea 2+, micro-hematuria 3+ constant since 4/27 testing.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan, Urine analysis abnormal
Clinical narrative: Intermittent HA s/p fever, chills, aches, fatigue w/COVID vax #2, 2/27/21. Intractable HA 3/23/21, dbl-vision 3/29/21. At 1° HCP 3/30/21 w/HTN emergencyno previous Dx of HTN. Ambulance to ERBP lowered; no blood, urine tests done. (ER incompetence.) 1° HCP ordered MRI head, brain & CXR: nothing found. Blood, urinalysis 4/27 showed AKI. Visits to specialists Apr-July to find 290/AKI etiology. Urology cytoscopy-nothing notable; cardiology echo, stress test-HTN w exercise, no cardiac disease. Nephrologist tests (many blood, urine tests; sonography; finally renal biopsy) indicate IgA Nephropathy. eGFR 44-50, proteinurea 2+, micro-hematuria 3+ constant since 4/27 testing.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Atrial septal defect, Computerised tomogram, Diplopia, Dizziness
Clinical narrative: One week following the 1st dose of the Pfizer Vaccine, I went to the emergency room after experiencing double vision for approximately 30 minutes, followed by prolonged dizziness. I was evaluated for a possible TIA.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Magnetic resonance imaging
Clinical narrative: One week following the 1st dose of the Pfizer Vaccine, I went to the emergency room after experiencing double vision for approximately 30 minutes, followed by prolonged dizziness. I was evaluated for a possible TIA.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Electrocardiogram normal
Clinical narrative: A thirteen-year-old minor accompanied by his father, reported chest pain ten minutes after the first dose of vaccine at 1600 hrs. in the vaccine clinic yesterday, 08/05/21. He reported pressure pain 5/10 on the sternum area,  consistent and localized, guarding it with right hand periodically. VS within normal limit, including rhythm during assessment. At registration, the patient was noticed reluctant and nervous to have vaccine and exhibited fear of getting it one then . However, his father was seen convincing him for the vaccine. During assessment,  the patient stated ? See, I told them , I won?t get one, this is what happened?. He stated that he was brought to the clinic straight from the school by his father. Meanwhile, the parent of the minor denied the patient of having any underlying health condition, hx of taking medicines or recent hospitalization.  911 was called and the Fire Department was at the site @ around 1603 hr. The paramedic performed EKG and VS which were normal as per them. I gave option and suggested the father that it be better for the safety of his child to be seen by the medical providers in a nearby hospital. The father took my suggestion positively and consented to send his son to the hospital. The Paramedic ambulated him at around 1630 hrs.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Headache, Hyperacusis, Irritability, Photophobia
Clinical narrative: The day after my first shot I came down with a terrible headache. I had trouble focusing on things, was sensitive to light and loud sounds and irritable. I have a terrible headache that comes and goes and is like the headache I had in December when I HAD COVID-19.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Severe chills, headache, sore and stiff arm
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine headache started 24 hrs after 2nd dose on 03/15/2021. It was continuous for 8 days, even while taking prescribed medication. With the exception of two (2) days since then, I have had a migraine which required at least one to two doses of medication to alleviate. My physician was informed  of this on June 3, 2021.. which he stated he?d not heard of this reaction before.  He has increased my medication to a larger dose of 50 mg, and scheduled a follow up exam in mid September.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Hand dermatitis, Pruritus
Clinical narrative: Eczema appeared on my knees, elbows, right foot, and the palm of my right hand. Treated at home with moisturizers and all sites went away except my hand. Waited until the itching was unbearable, and then went to the dermatologist July 19. She prescribed triamcinolone acetonide .1%. The eczema is still on my hand, but some of it has cleared.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient filled out our consent and release form indicating he has NOT received any prior covid vaccination.  when we later in the day processed it thru, his insurance indicated that he HAD received the J & J formulation back on 4/8/21.  I called that administered it to confirm all patient info was the same and it was.  we will not give final dose when patient returns
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody positive, Blood test abnormal, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Red, raised, itchy rash anytime I went out into the sun. After a few weeks, I went to dermatologist who drew blood and I was found to have a positive DNA. Dermatologist referred me to rheumatologist, who did other blood work and diagnosed me with subacute cutaneous lupus. I?ve never had an autoimmune disease until this. Not sure if it?s related to the vaccine or not.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Subacute cutaneous lupus erythematosus
Clinical narrative: Red, raised, itchy rash anytime I went out into the sun. After a few weeks, I went to dermatologist who drew blood and I was found to have a positive DNA. Dermatologist referred me to rheumatologist, who did other blood work and diagnosed me with subacute cutaneous lupus. I?ve never had an autoimmune disease until this. Not sure if it?s related to the vaccine or not.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: After administering the dose at 5:40PM, I noticed that vial BUD was for 10:15PM on 08/08/21 and not 08/09/21 as I had initially read it - one dose had already been given today from the vial by a pharmacist who came in before me to a different patient. The pharmacy manager instructed me to give the patient a dose from a new vial, and I did so.   So, he received one expired dose and one "fresh" dose.   The patient has not currently reported any adverse effects.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia
Clinical narrative: Patient experienced dizziness after receiving the shot. She also stated she felt  tingling in her arms
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Blood test, Chest pain, Echocardiogram, Electrocardiogram
Clinical narrative: Chest pain, pain in heart
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Cold sweat, Dizziness, Feeling cold, Malaise
Clinical narrative: ABOUT 1 MINUTE AFTER ADMINISTRATION, THE PATIENT BEGAN TO GET LIGHTHEADED, COLD, CLAMMY, COLD SWEATS, AND BP DROPPED TO 66/48 . WE CALLED 911. I NEVER OBSERVED THE PATIENT LOSE CONSCIOUSNESS. HE PUT HIS HEAD DOWN ON OUR SMALL TABLE IN THE IMZ BOOTH. HE WAS TALKING AND KNEW WHERE HE WAS AT.  WE THEN LOWERED THE PATIENT TO THE FLOOR FOR SAFETY REASONS BECAUSE HE STATED HE STILL WASN'T FEELING WELL. BEFORE THE AMBULANCE ARRIVED THE PATIENT WAS ALREADY FEELING BETTER AND BP WAS 129/78 WITH PULSE 82. THE PATIENT WALKED OUT ON HIS OWN POWER.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Neck pain, Pyrexia, Spinal X-ray abnormal
Clinical narrative: Etremely fast pulse and high fever. Went to ER. Since then I have been feeling dizzy, sore neck. TOday, the neck x-ray and chirpopractor at the Clinic confirmed that degeneration of spine is kicking into high gear. He said that there are many patients who show these symptoms. I need follow up care by experts.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Spinal osteoarthritis
Clinical narrative: Etremely fast pulse and high fever. Went to ER. Since then I have been feeling dizzy, sore neck. TOday, the neck x-ray and chirpopractor at the Clinic confirmed that degeneration of spine is kicking into high gear. He said that there are many patients who show these symptoms. I need follow up care by experts.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Intermenstrual bleeding, Vertigo
Clinical narrative: Vertigo approx 48 hours post injection, soreness at injection site, spotting
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood prolactin, Blood thyroid stimulating hormone, Human chorionic gonadotropin, Menstruation irregular, Metabolic function test
Clinical narrative: missed menstrual cycle
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Crying, Feeling abnormal, Headache
Clinical narrative: Approximately 13 hours after the injection (4:00am on 6/15/21), I woke up from crying in my sleep because I felt so awful.  I had horrible shooting pain in ALL of my joints, shivering, chills, and a headache. These symptoms persisted, and as the days went on, other symptoms began. The following day (6/16/21), I woke up with a migraine. On that same evening of 6/16/21, I started to experience Trigeminal Neuralgia on the right side of my mouth, both upper and lower jaw. The nerve pain was throbbing horribly; it was incessant and nothing would help....ice, heat, Tylenol, nothing.  It felt like I needed a root canal in all of the teeth on my right side, or that I had bitten into something cold, but over and over without stopping. These symptoms persisted without any relief from 6/16/21 until the morning of 6/19/21. On 6/19/21, I still woke up with the nerve pain, but it was less intense. The headache was barely there. The shooting pain in my joints had subsided some, and the shooting pain in my right Trigeminal Nerve had become lesser and more intermittent. I noticed the symptoms slowly dissipating as the days went on. I currently get a little throbbing in my right Trigeminal Nerve approximately 3-4 times per week, but it is much less intense and does not last for more than a few hours. Also, I had site injection pain starting the morning of 6/15/21, which lasted about a week. The injection site was also very hot to the touch for approximately 10 days.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site warmth, Migraine, Neuralgia, Pain
Clinical narrative: Approximately 13 hours after the injection (4:00am on 6/15/21), I woke up from crying in my sleep because I felt so awful.  I had horrible shooting pain in ALL of my joints, shivering, chills, and a headache. These symptoms persisted, and as the days went on, other symptoms began. The following day (6/16/21), I woke up with a migraine. On that same evening of 6/16/21, I started to experience Trigeminal Neuralgia on the right side of my mouth, both upper and lower jaw. The nerve pain was throbbing horribly; it was incessant and nothing would help....ice, heat, Tylenol, nothing.  It felt like I needed a root canal in all of the teeth on my right side, or that I had bitten into something cold, but over and over without stopping. These symptoms persisted without any relief from 6/16/21 until the morning of 6/19/21. On 6/19/21, I still woke up with the nerve pain, but it was less intense. The headache was barely there. The shooting pain in my joints had subsided some, and the shooting pain in my right Trigeminal Nerve had become lesser and more intermittent. I noticed the symptoms slowly dissipating as the days went on. I currently get a little throbbing in my right Trigeminal Nerve approximately 3-4 times per week, but it is much less intense and does not last for more than a few hours. Also, I had site injection pain starting the morning of 6/15/21, which lasted about a week. The injection site was also very hot to the touch for approximately 10 days.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Trigeminal neuralgia
Clinical narrative: Approximately 13 hours after the injection (4:00am on 6/15/21), I woke up from crying in my sleep because I felt so awful.  I had horrible shooting pain in ALL of my joints, shivering, chills, and a headache. These symptoms persisted, and as the days went on, other symptoms began. The following day (6/16/21), I woke up with a migraine. On that same evening of 6/16/21, I started to experience Trigeminal Neuralgia on the right side of my mouth, both upper and lower jaw. The nerve pain was throbbing horribly; it was incessant and nothing would help....ice, heat, Tylenol, nothing.  It felt like I needed a root canal in all of the teeth on my right side, or that I had bitten into something cold, but over and over without stopping. These symptoms persisted without any relief from 6/16/21 until the morning of 6/19/21. On 6/19/21, I still woke up with the nerve pain, but it was less intense. The headache was barely there. The shooting pain in my joints had subsided some, and the shooting pain in my right Trigeminal Nerve had become lesser and more intermittent. I noticed the symptoms slowly dissipating as the days went on. I currently get a little throbbing in my right Trigeminal Nerve approximately 3-4 times per week, but it is much less intense and does not last for more than a few hours. Also, I had site injection pain starting the morning of 6/15/21, which lasted about a week. The injection site was also very hot to the touch for approximately 10 days.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: PATIENT CAME TO GET HIS SECOND PFIZER SHOT TODAY, A WEEK EARLIER THAN HE SHOULD HAVE GOTTEN IT.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse effects at this time.  Patient received a single dose of Moderna that had been at room temperature since 10:15AM on 08/08/21, he was given the dose at 12:05PM on 08/09/21.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Dyspnoea, Electrocardiogram, Full blood count
Clinical narrative: Pt reported chest pain that wasn't relieved by her medications she takes for GERD. she experienced this pain on and off for 5 days before presenting to the ED. She reports substernal chest pain rating 6/10 that does not radiate. Cardiac workup was inconclusive at time of arrival t ED. Pt reports feeling short of breath at times, more so when lying on her left side.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Troponin
Clinical narrative: Pt reported chest pain that wasn't relieved by her medications she takes for GERD. she experienced this pain on and off for 5 days before presenting to the ED. She reports substernal chest pain rating 6/10 that does not radiate. Cardiac workup was inconclusive at time of arrival t ED. Pt reports feeling short of breath at times, more so when lying on her left side.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Pain, Pyrexia
Clinical narrative: Extreme body aches, fever, delayed menstrual period. Currently 4 days late, not pregnant.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abnormal, Fractured sacrum, Gait inability, Hip fracture, Impaired driving ability
Clinical narrative: THREE HOURS AFTER RECEIVING THE SECOND VACCINE, I  ARRIVED HOME AT THE DOOR OF MY UNIT, AND MY RIGHT LEG GAVE WAY.  I MADE MY WAY INSIDE TO THE WALKER IN MY BEDROOM SOMEHOW.  I DIDNT FALL.  PAIN BEGAN SHOOTING UP AND DOWN MY RIGHT LEG FROM MY TOE TO MY HIP.  TREMENDOUS PAIN.  CAN'T RECALL HOW LONG THIS NEUROLOGICAL INCIDENT LASTED BUT I CONSIDERED CALL 911 EMERGENCY FOR THE HOSPTAL.  I DIDN'T.   WHEN I FINALLY GOT A DIAGNOSIS WITH X-RAY, MRI AND CT-SCAN, THE DIAGNOSIS WAS FRACTURES OF THE SACRUM AND THE LOWER RIGHT HIP.  I COULDN'T WALK - OR DRIVE, ALTHOUGH NOW I CAN.  THIS IS MY LAST WEEK OF PHYSICAL THERAPY.  YES, I HAVE SOME OSTEOPOROSIS, WHICH  MY DOCS SEEMED TO THINK IS THE DIAGNOSIS.   I'VE HEARD OF OTHER NEUROLOGICAL ADVERSE REACTIONS, SO I THOUGHT I SHOULD REPORT THIS - BEFORE TAKING ANY BOOSTER SHOT.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging abnormal, Muscular weakness, Neurological symptom, Osteoporosis, Pain
Clinical narrative: THREE HOURS AFTER RECEIVING THE SECOND VACCINE, I  ARRIVED HOME AT THE DOOR OF MY UNIT, AND MY RIGHT LEG GAVE WAY.  I MADE MY WAY INSIDE TO THE WALKER IN MY BEDROOM SOMEHOW.  I DIDNT FALL.  PAIN BEGAN SHOOTING UP AND DOWN MY RIGHT LEG FROM MY TOE TO MY HIP.  TREMENDOUS PAIN.  CAN'T RECALL HOW LONG THIS NEUROLOGICAL INCIDENT LASTED BUT I CONSIDERED CALL 911 EMERGENCY FOR THE HOSPTAL.  I DIDN'T.   WHEN I FINALLY GOT A DIAGNOSIS WITH X-RAY, MRI AND CT-SCAN, THE DIAGNOSIS WAS FRACTURES OF THE SACRUM AND THE LOWER RIGHT HIP.  I COULDN'T WALK - OR DRIVE, ALTHOUGH NOW I CAN.  THIS IS MY LAST WEEK OF PHYSICAL THERAPY.  YES, I HAVE SOME OSTEOPOROSIS, WHICH  MY DOCS SEEMED TO THINK IS THE DIAGNOSIS.   I'VE HEARD OF OTHER NEUROLOGICAL ADVERSE REACTIONS, SO I THOUGHT I SHOULD REPORT THIS - BEFORE TAKING ANY BOOSTER SHOT.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, X-ray abnormal
Clinical narrative: THREE HOURS AFTER RECEIVING THE SECOND VACCINE, I  ARRIVED HOME AT THE DOOR OF MY UNIT, AND MY RIGHT LEG GAVE WAY.  I MADE MY WAY INSIDE TO THE WALKER IN MY BEDROOM SOMEHOW.  I DIDNT FALL.  PAIN BEGAN SHOOTING UP AND DOWN MY RIGHT LEG FROM MY TOE TO MY HIP.  TREMENDOUS PAIN.  CAN'T RECALL HOW LONG THIS NEUROLOGICAL INCIDENT LASTED BUT I CONSIDERED CALL 911 EMERGENCY FOR THE HOSPTAL.  I DIDN'T.   WHEN I FINALLY GOT A DIAGNOSIS WITH X-RAY, MRI AND CT-SCAN, THE DIAGNOSIS WAS FRACTURES OF THE SACRUM AND THE LOWER RIGHT HIP.  I COULDN'T WALK - OR DRIVE, ALTHOUGH NOW I CAN.  THIS IS MY LAST WEEK OF PHYSICAL THERAPY.  YES, I HAVE SOME OSTEOPOROSIS, WHICH  MY DOCS SEEMED TO THINK IS THE DIAGNOSIS.   I'VE HEARD OF OTHER NEUROLOGICAL ADVERSE REACTIONS, SO I THOUGHT I SHOULD REPORT THIS - BEFORE TAKING ANY BOOSTER SHOT.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Head injury, Loss of consciousness
Clinical narrative: Did not realize until I was visiting with friends about the vaccine that I do have a history of seizures. They have happened since 1993 (the death of my husband and left with 5 small children to raise). They come on only if I am under stress. The last one I had was in the spring of 2012 when I was going through a stressful time. I believe I have had perhaps 10 episodes over those years. I had the vaccine (Pfizer) at 8:30 in the morning and do remember walking up on the bathroom floor sometime past midnight. I do not know for how long I was out but did hit my head pretty hard on the way down. I do remember feeling the "faint" coming on and thought I had sat down on the edge of the bathtub steps. It was actually not until a day later when I went to wash my hair that i felt the knot on my head and realized I had hit it when I when down.When I awoke I got into bed and went to sleep (probably not a very good idea, but I live alone) In the morning I stayed home all day and relaxed. There were never any more effects other than the seizer. I was not stressed about the vaccine at all so perhaps a bodily reaction.  My doctor has recently retired so I have not gone to visit and explain what happened.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Ear pain, Pain, Sleep disorder, Tinnitus
Clinical narrative: 1) Intermittent Chest pain of two types - dull ache lasting minutes OR sharp pain lasting a few seconds.  Both occur sporadically throughout day multiple times a day.   2) Pain and ringing in left ear that migrated to both ears the next day.  Ringing in ears sounds like a high pitched squeal and seems louder at night and disrupts my ability to sleep.  Both of the above side effects have lasted for a full 2 weeks at time of this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Magnetic resonance imaging head normal, Magnetic resonance imaging neck
Clinical narrative: Developed pulsatile tinnitus. Started out intermittently in occurrence and is now constant. It is a low pulsating roar that seems to occur with my pulse. Is especially noticeable at night. If I wake in the middle of the night it affects my ability to go back to sleep. Ive never had anything like this happen before and is definitely related to the vaccine as it developed after that. It is quite debilitating as it affects my quality of sleep. I face constant fatigue from how this tinnitus has affected my ability to get a good night's sleep. It is a low roar or a swishing sound that occurs in my head constantly, but is heard prominently when I am in a quiet room or at night.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pulse abnormal, Sleep disorder, Tinnitus
Clinical narrative: Developed pulsatile tinnitus. Started out intermittently in occurrence and is now constant. It is a low pulsating roar that seems to occur with my pulse. Is especially noticeable at night. If I wake in the middle of the night it affects my ability to go back to sleep. Ive never had anything like this happen before and is definitely related to the vaccine as it developed after that. It is quite debilitating as it affects my quality of sleep. I face constant fatigue from how this tinnitus has affected my ability to get a good night's sleep. It is a low roar or a swishing sound that occurs in my head constantly, but is heard prominently when I am in a quiet room or at night.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dyskinesia, Hypopnoea, Oxygen saturation decreased, Seizure
Clinical narrative: Low oxygen/turning gray , elevated bp 1) 139/124 pulse 87, 2) 137/74 pulse 72 nonresponding , shadow breath, seizure/jerking symdrome,
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Unresponsive to stimuli
Clinical narrative: Low oxygen/turning gray , elevated bp 1) 139/124 pulse 87, 2) 137/74 pulse 72 nonresponding , shadow breath, seizure/jerking symdrome,
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Inflammation, Myalgia, Pain
Clinical narrative: The morning following the vaccine, I woke up with painful, throbbing /tingling hands. It has been nearly 4 months now and I have been waking up several times throughout every night with the same painful, throbbing hands ever since I received that injection. Additionally, approximately 2 weeks after that injection, I began experiencing debilitating muscle pain in my hips, my right elbow, left knee and in both ankles. I've been seeing a chiropractor and a massage therapist twice a week, resulting in only slight relief from my, now chronic, widespread muscle pain and inflammation.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Sleep disorder
Clinical narrative: The morning following the vaccine, I woke up with painful, throbbing /tingling hands. It has been nearly 4 months now and I have been waking up several times throughout every night with the same painful, throbbing hands ever since I received that injection. Additionally, approximately 2 weeks after that injection, I began experiencing debilitating muscle pain in my hips, my right elbow, left knee and in both ankles. I've been seeing a chiropractor and a massage therapist twice a week, resulting in only slight relief from my, now chronic, widespread muscle pain and inflammation.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amenorrhoea, Condition aggravated, Night sweats
Clinical narrative: Night sweats & Amenorrhea began the day after 1st dose.  Night sweats stopped and period returned 5 weeks after 2nd dose.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Cough, Immediate post-injection reaction, Throat irritation
Clinical narrative: Patient had an immediate reaction to the vaccine complaining of throat burning and causing her to cough continuously.  She said she did not feel as if her throat was closing or she was having any shortness of breath. she did say she felt very anxious and felt like an anxiety attack was starting and complaing of chest tightening right after the benadryl being administer. I administered 2 benadryl 25mg tablets and within 15 minutes, she was feeling better and stated the chest tightness, burning in throat and coughing had subsided. She waited around in the store for about 30 more minutes and said she was feeling back to normal and no drowsiness from the benadryl and left. I called at 1:30 on 8/9/2021 to check on patient and she reported she was feeling fine and back to normal and much much better.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: Facial muscle twitching .  Visible. Frequency increases with time.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring, Electrocardiogram, Palpitations
Clinical narrative: Heart palpitations, ongoing
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Computerised tomogram, Pain in extremity, Tremor
Clinical narrative: Body Tremors, burning feeling on back going down to my toes, extreme pain in legs
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient age of 15 got Moderna shot. Patient did not have any adverse reactions after the shot
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Patient was given 0.3 ml of undiluted Pfizer Covid Vaccine. Patient was advised to watch for side effects, especially injection site reactions.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Men B NVS (Bexsero) (batch number abxb35aa, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th July 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The Physician reported that the patient was administrated with Bexsero after a below freezing temperature Excursion,which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case was 1 of 29 linked cases,reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164798:Same reporter. US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164797:Same reporter. US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164799:Same reporter. US-GLAXOSMITHKLINE-US2021164795:Same reporter. US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number abxb35aa, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd July 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 23rd July 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The Physician reported that the patient was administrated with Bexsero after a below freezing temperature Excursion,which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case was 1 of 29 linked cases,reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164795:Same reporter. US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164798:Same reporter. US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164797:Same reporter. US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164799:Same reporter. US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Positive for COVID; A spontaneous report was received from a consumer concerning a 38-year old, male consumer  who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced positive for COVID.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 24 Dec 2020, the patient received his first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On an unknown date following vaccine administration, the patient tested positive for COVID-19. Per the reporter the patient has not experienced any symptoms or side effects.   Treatment details was unknown.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event positive for COVID was unknown.; Reporter's Comments: Based on reporter's causality, the event COVID-19 positive  is assessed as unlikely related to mRNA-1273. However, Further information is requested.