chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Hepatitis C test negative, Laboratory test normal, Lymphadenopathy, Malaise, Mycobacterium tuberculosis complex test negative
Clinical narrative: Onset of multiple neurological symptoms 5 days after receiving the 3rd dose of Pfizer's COVID-19 vaccine. Patient was hospitalized, underwent extensive workup and diagnosed with vaccine-induced Acute Inflammatory Demyelinating Polyneuropathy (AIDP - Guillain-Barre Syndrome) with bilateral facial nerve palsy, which is detailed in VAERS Event Report 1759017-1. The patient experienced a second post-vaccination autoimmune inflammatory syndrome, beginning 24 days after the 3rd COVID-19 vaccine (5 days post-hospitalization for AIDP).  It presented with a daily low-grade fever 99.5-100.4, fatigue, malaise, generalized pressure headache; phono-phobia; infrequent nausea with dry heaving; and episodic dizziness with motion. Normal CBC and negative blood cultures x2. Infection and tumor surveys were unremarkable. HIV remained stable and undetectable. Treatment with a 6-day Medrol steroid pack without effect. Continued daily low-grade fever <100.4 with subsequent start of Ibuprofen and then with alternating dosages of Acetaminophen. Elevated temperature breakthrough with prominent constitutional symptoms persisting for 70 days despite Ibuprofen/ Acetaminophen. AIDP neurological symptoms never relapsed and progressively improved over this time period. No patient or family history of autoimmune diseases. Headache characteristics changed with temporal/frontal aching and point tenderness over temporal artery/branch vessels. No respiratory, gastrointestinal, skin or urinary symptoms. Elevated ESR rate of 58 mm/Hr and C-reactive protein of 17.8 mg/L. Rheumatology suspected Giant Cell Arteritis and initiated Prednisone 60mg QD. All symptoms and low-grade fever resolved within 3-5 days. MRI Head Angiogram without evidence of aneurysm or stenosis. No eye abnormalities noted on a dilated fundoscopic examination by Ophthalmology. Pulmonary radiography and computed tomography demonstrated no active disease. Temporal Artery Biopsy after 17 days on high-dose steroids demonstrated no evidence of acute or chronic inflammatory vasculitis.  Positive titer for Serine Protease 3 Antibody with 34 AU/ mL.  Diagnosis of COVID-19 Vaccine-Related ANCA Positive Vasculitis. Prednisone taper x3 months, currently at 10mg QD with continued remission of symptoms/elevated temperature.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Phonophobia, Protein urine present, Pulmonary calcification, Pyrexia
Clinical narrative: Onset of multiple neurological symptoms 5 days after receiving the 3rd dose of Pfizer's COVID-19 vaccine. Patient was hospitalized, underwent extensive workup and diagnosed with vaccine-induced Acute Inflammatory Demyelinating Polyneuropathy (AIDP - Guillain-Barre Syndrome) with bilateral facial nerve palsy, which is detailed in VAERS Event Report 1759017-1. The patient experienced a second post-vaccination autoimmune inflammatory syndrome, beginning 24 days after the 3rd COVID-19 vaccine (5 days post-hospitalization for AIDP).  It presented with a daily low-grade fever 99.5-100.4, fatigue, malaise, generalized pressure headache; phono-phobia; infrequent nausea with dry heaving; and episodic dizziness with motion. Normal CBC and negative blood cultures x2. Infection and tumor surveys were unremarkable. HIV remained stable and undetectable. Treatment with a 6-day Medrol steroid pack without effect. Continued daily low-grade fever <100.4 with subsequent start of Ibuprofen and then with alternating dosages of Acetaminophen. Elevated temperature breakthrough with prominent constitutional symptoms persisting for 70 days despite Ibuprofen/ Acetaminophen. AIDP neurological symptoms never relapsed and progressively improved over this time period. No patient or family history of autoimmune diseases. Headache characteristics changed with temporal/frontal aching and point tenderness over temporal artery/branch vessels. No respiratory, gastrointestinal, skin or urinary symptoms. Elevated ESR rate of 58 mm/Hr and C-reactive protein of 17.8 mg/L. Rheumatology suspected Giant Cell Arteritis and initiated Prednisone 60mg QD. All symptoms and low-grade fever resolved within 3-5 days. MRI Head Angiogram without evidence of aneurysm or stenosis. No eye abnormalities noted on a dilated fundoscopic examination by Ophthalmology. Pulmonary radiography and computed tomography demonstrated no active disease. Temporal Artery Biopsy after 17 days on high-dose steroids demonstrated no evidence of acute or chronic inflammatory vasculitis.  Positive titer for Serine Protease 3 Antibody with 34 AU/ mL.  Diagnosis of COVID-19 Vaccine-Related ANCA Positive Vasculitis. Prednisone taper x3 months, currently at 10mg QD with continued remission of symptoms/elevated temperature.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate increased, Retching, Tenderness, Urine analysis abnormal, Urine protein/creatinine ratio
Clinical narrative: Onset of multiple neurological symptoms 5 days after receiving the 3rd dose of Pfizer's COVID-19 vaccine. Patient was hospitalized, underwent extensive workup and diagnosed with vaccine-induced Acute Inflammatory Demyelinating Polyneuropathy (AIDP - Guillain-Barre Syndrome) with bilateral facial nerve palsy, which is detailed in VAERS Event Report 1759017-1. The patient experienced a second post-vaccination autoimmune inflammatory syndrome, beginning 24 days after the 3rd COVID-19 vaccine (5 days post-hospitalization for AIDP).  It presented with a daily low-grade fever 99.5-100.4, fatigue, malaise, generalized pressure headache; phono-phobia; infrequent nausea with dry heaving; and episodic dizziness with motion. Normal CBC and negative blood cultures x2. Infection and tumor surveys were unremarkable. HIV remained stable and undetectable. Treatment with a 6-day Medrol steroid pack without effect. Continued daily low-grade fever <100.4 with subsequent start of Ibuprofen and then with alternating dosages of Acetaminophen. Elevated temperature breakthrough with prominent constitutional symptoms persisting for 70 days despite Ibuprofen/ Acetaminophen. AIDP neurological symptoms never relapsed and progressively improved over this time period. No patient or family history of autoimmune diseases. Headache characteristics changed with temporal/frontal aching and point tenderness over temporal artery/branch vessels. No respiratory, gastrointestinal, skin or urinary symptoms. Elevated ESR rate of 58 mm/Hr and C-reactive protein of 17.8 mg/L. Rheumatology suspected Giant Cell Arteritis and initiated Prednisone 60mg QD. All symptoms and low-grade fever resolved within 3-5 days. MRI Head Angiogram without evidence of aneurysm or stenosis. No eye abnormalities noted on a dilated fundoscopic examination by Ophthalmology. Pulmonary radiography and computed tomography demonstrated no active disease. Temporal Artery Biopsy after 17 days on high-dose steroids demonstrated no evidence of acute or chronic inflammatory vasculitis.  Positive titer for Serine Protease 3 Antibody with 34 AU/ mL.  Diagnosis of COVID-19 Vaccine-Related ANCA Positive Vasculitis. Prednisone taper x3 months, currently at 10mg QD with continued remission of symptoms/elevated temperature.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vasculitis, Viral titre, Vitamin B12 normal
Clinical narrative: Onset of multiple neurological symptoms 5 days after receiving the 3rd dose of Pfizer's COVID-19 vaccine. Patient was hospitalized, underwent extensive workup and diagnosed with vaccine-induced Acute Inflammatory Demyelinating Polyneuropathy (AIDP - Guillain-Barre Syndrome) with bilateral facial nerve palsy, which is detailed in VAERS Event Report 1759017-1. The patient experienced a second post-vaccination autoimmune inflammatory syndrome, beginning 24 days after the 3rd COVID-19 vaccine (5 days post-hospitalization for AIDP).  It presented with a daily low-grade fever 99.5-100.4, fatigue, malaise, generalized pressure headache; phono-phobia; infrequent nausea with dry heaving; and episodic dizziness with motion. Normal CBC and negative blood cultures x2. Infection and tumor surveys were unremarkable. HIV remained stable and undetectable. Treatment with a 6-day Medrol steroid pack without effect. Continued daily low-grade fever <100.4 with subsequent start of Ibuprofen and then with alternating dosages of Acetaminophen. Elevated temperature breakthrough with prominent constitutional symptoms persisting for 70 days despite Ibuprofen/ Acetaminophen. AIDP neurological symptoms never relapsed and progressively improved over this time period. No patient or family history of autoimmune diseases. Headache characteristics changed with temporal/frontal aching and point tenderness over temporal artery/branch vessels. No respiratory, gastrointestinal, skin or urinary symptoms. Elevated ESR rate of 58 mm/Hr and C-reactive protein of 17.8 mg/L. Rheumatology suspected Giant Cell Arteritis and initiated Prednisone 60mg QD. All symptoms and low-grade fever resolved within 3-5 days. MRI Head Angiogram without evidence of aneurysm or stenosis. No eye abnormalities noted on a dilated fundoscopic examination by Ophthalmology. Pulmonary radiography and computed tomography demonstrated no active disease. Temporal Artery Biopsy after 17 days on high-dose steroids demonstrated no evidence of acute or chronic inflammatory vasculitis.  Positive titer for Serine Protease 3 Antibody with 34 AU/ mL.  Diagnosis of COVID-19 Vaccine-Related ANCA Positive Vasculitis. Prednisone taper x3 months, currently at 10mg QD with continued remission of symptoms/elevated temperature.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Rash
Clinical narrative: a little fatigue; a little rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing), notes: Verbatim: Depression; "Panic attack" (unspecified if ongoing), notes: Verbatim: Panic attacks; "Hypertension" (unspecified if ongoing), notes: Verbatim: Blood pressure high; "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes; "Blood sugar problems" (unspecified if ongoing), notes: Verbatim: Blood sugar problems; "Insomnia" (unspecified if ongoing), notes: Verbatim: Chronic insomnia, chronic insomnia- he cannot sleep; "Thyroid problems" (unspecified if ongoing), notes: Verbatim: Thyroid problems. The patient's concomitant medications were not reported.  The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "a little fatigue"; RASH (non-serious), outcome "unknown", described as "a little rash".  Additional information: Prior Vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) reported as None. AEs did not require a visit to emergency room. Time of administration: around 4 or 5 pm.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (18ct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101171301 same reporter/patient/product, different dose/event.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness, Fatigue, Headache, Injection site erythema
Clinical narrative: pain at the injection site; redness at the injection site; Hives; Muscle pain; Fatigue; Headache; Dizziness; Upset stomach; Fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 7CX2C, expiry date unknown) for prophylaxis.   On 16th October 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 16th October 2021, several hours after receiving Shingrix, the patient experienced injection site pain, injection site erythema, hives, muscle pain, fatigue, headache, dizziness, upset stomach and fever. On 19th October 2021, the outcome of the injection site pain, injection site erythema, hives, muscle pain, fatigue, headache, dizziness, upset stomach and fever were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, hives, muscle pain, fatigue, headache, dizziness, upset stomach and fever to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix into the muscle of her left arm and few hours after the injection, the patient had experienced pain at the injection site, redness at the injection site, hives, muscle pain, fatigue, headache, dizziness, upset stomach and fever. All of her adverse reactions were resolved after 3 days. Reporter stated she had already called in her reaction to VAERS. The reporter did not had the expiration date of the Shingrix vaccine. The reporter gave consent to contact her health care professional. The reporter consented to follow-up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Pyrexia, Urticaria
Clinical narrative: pain at the injection site; redness at the injection site; Hives; Muscle pain; Fatigue; Headache; Dizziness; Upset stomach; Fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 7CX2C, expiry date unknown) for prophylaxis.   On 16th October 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 16th October 2021, several hours after receiving Shingrix, the patient experienced injection site pain, injection site erythema, hives, muscle pain, fatigue, headache, dizziness, upset stomach and fever. On 19th October 2021, the outcome of the injection site pain, injection site erythema, hives, muscle pain, fatigue, headache, dizziness, upset stomach and fever were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, hives, muscle pain, fatigue, headache, dizziness, upset stomach and fever to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix into the muscle of her left arm and few hours after the injection, the patient had experienced pain at the injection site, redness at the injection site, hives, muscle pain, fatigue, headache, dizziness, upset stomach and fever. All of her adverse reactions were resolved after 3 days. Reporter stated she had already called in her reaction to VAERS. The reporter did not had the expiration date of the Shingrix vaccine. The reporter gave consent to contact her health care professional. The reporter consented to follow-up.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory distress syndrome, Condition aggravated, Coronary artery disease, Death
Clinical narrative: pt admitted to hosp after being dc'd from another hospital for ARF with bilateral pneumonia, pt left AMA; pt called his doctor when he started having increasing SOB after going home, was told to go to ER; seen in ER and placed on O2 supplement of 11 L/in with O2 sats in the 90s; bedridden after a tractor accident several years ago; given remedesivir; pt's condition improved and he was dc'd to home; per death certificate pt died in the home with the causes being:  COVID-SARS 19, long hauler, adult respiratory distress syndrome secondary to COVID-SARS 19, Coronary Artery Disease, Hypertensive Cardiovascular Disease
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hypertensive heart disease, Pneumonia, Post-acute COVID-19 syndrome
Clinical narrative: pt admitted to hosp after being dc'd from another hospital for ARF with bilateral pneumonia, pt left AMA; pt called his doctor when he started having increasing SOB after going home, was told to go to ER; seen in ER and placed on O2 supplement of 11 L/in with O2 sats in the 90s; bedridden after a tractor accident several years ago; given remedesivir; pt's condition improved and he was dc'd to home; per death certificate pt died in the home with the causes being:  COVID-SARS 19, long hauler, adult respiratory distress syndrome secondary to COVID-SARS 19, Coronary Artery Disease, Hypertensive Cardiovascular Disease
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Acute cardiac event, Life support, Sudden death
Clinical narrative: The patient has sudden death via presumed cardiac even 2 days after receiving 3rd dose of Moderna vaccination
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, Vaccine breakthrough infection
Clinical narrative: pt brought to ED via EMS with SOB, weakness and lethargy; tested positive for COVID; fever; O2 saturation 83% on RA; diagnosed with COVID pneumonia, respiratory failure, encephalopathy; required intubation with mechanical ventilation; pt's condition worsened and per death certificate pt died in the hospital; causes:  hemorrhagic shock, anticoagulation, A Fib, COVID pneumonia
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Asthenia, Atrial fibrillation, COVID-19, COVID-19 pneumonia
Clinical narrative: pt brought to ED via EMS with SOB, weakness and lethargy; tested positive for COVID; fever; O2 saturation 83% on RA; diagnosed with COVID pneumonia, respiratory failure, encephalopathy; required intubation with mechanical ventilation; pt's condition worsened and per death certificate pt died in the hospital; causes:  hemorrhagic shock, anticoagulation, A Fib, COVID pneumonia
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Dyspnoea, Encephalopathy, Endotracheal intubation, Lethargy
Clinical narrative: pt brought to ED via EMS with SOB, weakness and lethargy; tested positive for COVID; fever; O2 saturation 83% on RA; diagnosed with COVID pneumonia, respiratory failure, encephalopathy; required intubation with mechanical ventilation; pt's condition worsened and per death certificate pt died in the hospital; causes:  hemorrhagic shock, anticoagulation, A Fib, COVID pneumonia
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mechanical ventilation, Pyrexia, Respiratory failure, SARS-CoV-2 test positive, Shock haemorrhagic
Clinical narrative: pt brought to ED via EMS with SOB, weakness and lethargy; tested positive for COVID; fever; O2 saturation 83% on RA; diagnosed with COVID pneumonia, respiratory failure, encephalopathy; required intubation with mechanical ventilation; pt's condition worsened and per death certificate pt died in the hospital; causes:  hemorrhagic shock, anticoagulation, A Fib, COVID pneumonia
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Fatigue, Headache
Clinical narrative: Dizziness, disorientation, headache >36 hours, tachycardia, neck rash, loss of bladder control, fever, fatigue. Patient reported to ER same day as vaccination.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Hypoaesthesia, Nausea, Pain, Pain in extremity
Clinical narrative: Dizziness, disorientation, headache >36 hours, tachycardia, neck rash, loss of bladder control, fever, fatigue. Patient reported to ER same day as vaccination.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Pyrexia, Urinary incontinence
Clinical narrative: Dizziness, disorientation, headache >36 hours, tachycardia, neck rash, loss of bladder control, fever, fatigue. Patient reported to ER same day as vaccination.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disorientation, Dizziness, Fatigue, Headache, Pyrexia
Clinical narrative: Dizziness, disorientation, headache >36 hours, tachycardia, neck rash, loss of bladder control, fever, fatigue. Patient reported to ER same day as vaccination.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Tachycardia, Urinary incontinence
Clinical narrative: Dizziness, disorientation, headache >36 hours, tachycardia, neck rash, loss of bladder control, fever, fatigue. Patient reported to ER same day as vaccination.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Gait disturbance, Nausea
Clinical narrative: About 24 hours after injection I became lightheaded and was unable to bend over and support myself. It was only a little bit but then by the next day I could not physically pick myself up. The entire room was spinning even with the slightest motion of anything. I needed physical help by two grown adults to get me to and from the bathroom. I was told to wait it out or go to the ER or they wouldn?t really be able to do anything for me. So I waited it out thankfully after 48 hours I am capable of getting myself up out of bed by myself. I am going to look into getting a primary to look at me to make sure that I am OK. There?s no way in hell I will be putting another injection into me. I still can?t walk without getting dizzy
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dizziness exertional, Dysstasia, Gait disturbance, Mobility decreased
Clinical narrative: About 24 hours after injection I became lightheaded and was unable to bend over and support myself. It was only a little bit but then by the next day I could not physically pick myself up. The entire room was spinning even with the slightest motion of anything. I needed physical help by two grown adults to get me to and from the bathroom. I was told to wait it out or go to the ER or they wouldn?t really be able to do anything for me. So I waited it out thankfully after 48 hours I am capable of getting myself up out of bed by myself. I am going to look into getting a primary to look at me to make sure that I am OK. There?s no way in hell I will be putting another injection into me. I still can?t walk without getting dizzy
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: About 24 hours after injection I became lightheaded and was unable to bend over and support myself. It was only a little bit but then by the next day I could not physically pick myself up. The entire room was spinning even with the slightest motion of anything. I needed physical help by two grown adults to get me to and from the bathroom. I was told to wait it out or go to the ER or they wouldn?t really be able to do anything for me. So I waited it out thankfully after 48 hours I am capable of getting myself up out of bed by myself. I am going to look into getting a primary to look at me to make sure that I am OK. There?s no way in hell I will be putting another injection into me. I still can?t walk without getting dizzy
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hyperhidrosis, Loss of personal independence in daily activities, Vertigo, Vomiting
Clinical narrative: About 24 hours after injection I became lightheaded and was unable to bend over and support myself. It was only a little bit but then by the next day I could not physically pick myself up. The entire room was spinning even with the slightest motion of anything. I needed physical help by two grown adults to get me to and from the bathroom. I was told to wait it out or go to the ER or they wouldn?t really be able to do anything for me. So I waited it out thankfully after 48 hours I am capable of getting myself up out of bed by myself. I am going to look into getting a primary to look at me to make sure that I am OK. There?s no way in hell I will be putting another injection into me. I still can?t walk without getting dizzy
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Irregular menstrual cycle
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiomegaly, Chest X-ray, Dyspnoea, Electrocardiogram
Clinical narrative: Shortness of breath, enlarged heart
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary function test
Clinical narrative: Shortness of breath, enlarged heart
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Rash erythematous
Clinical narrative: It was started with Itchiness, red rashes. It felt like burning and itchy all over the body from head to toes. Initial two days took OTC allergy tablets and vaseline, That was not effective. So called to telemedicine . Doctor prescribed Cetirizine 10mg tablet and Triamcinolone 0.1% cream for a month.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstruation delayed
Clinical narrative: Menstruation was delayed two weeks with extrememly heavy and disabling flow and pain for 48 hours after onset.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Herpes virus infection, Oral herpes
Clinical narrative: I have had cold sores herpes for 12 years.  Had a total of 2 outbreaks total until vaccination.  Now I?m having 1-12 outbreaks per months sometimes twice per week
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Headache
Clinical narrative: HEADACHE - TOO MUCH CHEST PAIN.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Impaired work ability, Migraine, Nasopharyngitis, SARS-CoV-2 test negative
Clinical narrative: Started with head cold for 1 week, missed 2 days of work. Which now has led to 6 days of a migraine headache
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Hypokinesia, Impaired driving ability, Pain in extremity
Clinical narrative: Patient was not able to move her arm; Pain in the upper left arm; Patient felt tired/Patient felt exhausted; Pain in the left shoulder; could not drive due to pain in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Patient was not able to move her arm), IMPAIRED DRIVING ABILITY (could not drive due to pain in the left arm), PAIN IN EXTREMITY (Pain in the upper left arm), FATIGUE (Patient felt tired/Patient felt exhausted) and ARTHRALGIA (Pain in the left shoulder) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (4 months before the pandemic she got sick for over a month), COVID-19 (but experienced vomiting and high fever during 3 weeks and got dehydrated.) and COVID-19 (3rd time was about 1 month before the first shot.). Concurrent medical conditions included Diabetes. Concomitant products included VITAMINS NOS for an unknown indication.    On 04-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2022, the patient experienced HYPOKINESIA (Patient was not able to move her arm), PAIN IN EXTREMITY (Pain in the upper left arm), FATIGUE (Patient felt tired/Patient felt exhausted) and ARTHRALGIA (Pain in the left shoulder). In January 2022, the patient experienced IMPAIRED DRIVING ABILITY (could not drive due to pain in the left arm). On 05-Jan-2022, FATIGUE (Patient felt tired/Patient felt exhausted) had resolved. On 14-Jan-2022, HYPOKINESIA (Patient was not able to move her arm), PAIN IN EXTREMITY (Pain in the upper left arm) and ARTHRALGIA (Pain in the left shoulder) had resolved. In January 2022, IMPAIRED DRIVING ABILITY (could not drive due to pain in the left arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       After the first shot, patient felt tired and exhausted for one day, and experienced pain in the upper left arm and shoulder, and she could not move it for a week and a half, she was not able to drive during that time lapse.  No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The events did not cause the patient to seek medical care. She had no experienced similar events in the past.  No treatment information was reported.   This case was linked to MOD-2022-479233 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria
Clinical narrative: Dermatographia, continued daily since onset
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Pruritus, Rash macular, Sleep disorder
Clinical narrative: 10 days after receiving the Moderna COVID19 booster I started noticing itching on my neck/scalp. The next morning (Feb 12) I woke up with hives covering most of my torso, back, arms and face. The hives stayed all day, with minimal affect from benadryl or Allegra. The hives would recede and reappear in different spots on my body through Sunday, 13 February. Monday Morning, 14 Feb at 0400 I woke up with a feeling of not being able to breath and the feeling of an object being stuck in my throat. This feeling lasted until 0800 am. I went to the ER at 1100 am 14 February where they prescribed me a 6 day course of prednisone and advised to continue on OTC antihistamines. 15 February at 0830 pm, the hives have mostly receded but red itchy splotches continue to appear randomly across my body. Contact with hot water or heat, such as showering or exercise, causes the hives to reappear.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Urticaria
Clinical narrative: 10 days after receiving the Moderna COVID19 booster I started noticing itching on my neck/scalp. The next morning (Feb 12) I woke up with hives covering most of my torso, back, arms and face. The hives stayed all day, with minimal affect from benadryl or Allegra. The hives would recede and reappear in different spots on my body through Sunday, 13 February. Monday Morning, 14 Feb at 0400 I woke up with a feeling of not being able to breath and the feeling of an object being stuck in my throat. This feeling lasted until 0800 am. I went to the ER at 1100 am 14 February where they prescribed me a 6 day course of prednisone and advised to continue on OTC antihistamines. 15 February at 0830 pm, the hives have mostly receded but red itchy splotches continue to appear randomly across my body. Contact with hot water or heat, such as showering or exercise, causes the hives to reappear.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell?s Palsy
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Pain, Tenderness
Clinical narrative: Pain in left shoulder to any movement and to the touch (seems to be an inner ball just in upper shoulder but feel on the skin to touch). This happened from 4/ Pain in shoulder with any movement; Pain in left shoulder to any movement and to the touch (seems to be an inner ball just in upper shoulder but feel on the skin to touch). This happened from 4/ Pain in shoulder with any movement; lump just in the upper part of the shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jan2022 17:30 (Lot number: Fk9229) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LABETALOL; PANTOPRAZOLE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0173, Location of injection: Arm Left), administration date: 27Apr2021, when the patient was 42 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Er8737, Location of injection: Arm Left), administration date: 30Mar2021, when the patient was 42 years old, for Covid-19 Immunization. The following information was reported: PAIN (non-serious), TENDERNESS (non-serious) all with onset 31Jan2022 12:00, outcome "not recovered" and all described as "Pain in left shoulder to any movement and to the touch (seems to be an inner ball just in upper shoulder but feel on the skin to touch). This happened from 4/ Pain in shoulder with any movement"; AXILLARY MASS (non-serious) with onset 31Jan2022 12:00, outcome "not recovered", described as "lump just in the upper part of the shoulder".   Therapeutic measures were not taken as a result of pain, tenderness, axillary mass.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; the vaccine expired on 28-NOV-2021, but was administered to the patient today; This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 18-JAN-2022, the patient was administered an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 mL, lot # 1621926, expiration date 28-NOV-2021; strength, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). The reporter confirmed the vaccine had no temperature excursions. No additional adverse event (AE) or product quality complaint (PQC) was reported.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Tendonitis
Clinical narrative: swelling in the arm after the injection; tendinitis and pain in the injected arm; tendinitis and pain in the injected arm; This spontaneous report was received from a physician referring to a 53-year-old female patient who was not pregnant. The patient had no known drug reaction/allergy. Information about pertinent medical history and concomitant medication was unknown.   On 10-DEC-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, anatomical location, lot# and expiration date were not reported) intramuscularly for prophylaxis.         On 12-DEC-2021, the patient experienced swelling in the arm after the injection, tendinitis and pain in the injected arm. Information about treatment given for the event, lab diagnostics/studies and medical attention was unknown. The outcome of the events was unknown.   The causality between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AE reported; a two year old was given the adult dose instead of the pediatric dose.; This spontaneous report as received from a licensed practical nurse referring to a 2-year-old patient of unknown age. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On 10-JAN-2022, the patient was given hepatitis a vaccine, inactivated (VAQTA) (0.5 mL, lot # T036739, expiration date 22-APR-2022; strength, route of administration and anatomical location were not reported) for prophylaxis, which was the adult dose instead of the pediatric dose (incorrect dose administered). No additional adverse event (AE) or product quality complaint (PQC) was reported.
Sex: F
Vaccine: COVID19, PPV
Symptoms: Metastatic renal cell carcinoma, Renal cell carcinoma recurrent
Clinical narrative: This spontaneous report was received from a consumer, who was also a female patient of unknown age reporting on herself. The patient's concomitant medications included pregabalin (LYRICA), famotidine, escitalopram, and atorvastatin. The patient did not have any pertinent medical history or known drug allergies. In 2017, the patient was diagnosed with Renal cell carcinoma. She was only treated surgically with the removal of a portion of her left kidney. In 2019 reported as "approximately 3 years ago", the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) also reported as "pneumonia vaccine" (dose, frequency, route of administration, anatomical location, vaccination scheme, lot number and expiration date were not reported), as prevention of pneumonia. In March 2021, April 2021 and October 2021, the patient was vaccinated with the first, second and third dose of elasomeran (MODERNA COVID-19 VACCINE) respectively (dose, frequency, route of administration, anatomical location, vaccination scheme, lot number and expiration date were not reported), as prevention of Coronavirus Disease 2019 (COVID-19). In November 2021, her Renal cell carcinoma returned and had metastasized (renal cell carcinoma recurrent and metastatic renal cell carcinoma).  At the time of the report, the outcome of the events, as well as the causal relationship between the events and the suspect vaccines were unknown. Upon internal review, the events of renal cell carcinoma recurrent and metastatic renal cell carcinoma were determined to be medically significant.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: a patient who received a dose of PNEUMOVAX23 10 years ago and was recently diagnosed with pneumonia.; This spontaneous report was received from Pharmacist and refers to a currently 75-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in Febraury 2012 (reported as 10 years ago), the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, lot #, expiry date, and route of administration were not provided) for prophylaxis.   On an unspecified date also reported as "recently", the patient was diagnosed with pneumonia. It was not mentioned if the patient received treatment for the event. At the time of reporting, the outcome of pneumonia was not known.   The causal relationship between pneumonia and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.   Upon internal review, pneumonia was determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; patient received an improperly stored vaccine; This spontaneous report was received from a medical assistant referring to a 12 month old patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 08-DEC-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # U015677 with an expiration date on 18-MAY-2023) for prophylaxis (product storage error) (strength, dose, anatomical location, and route of administration were not reported).   The dose of varicella virus vaccine live (oka/merck)(VARIVAX) was exposed to a temperature excursion of 39.55 degrees Fahrenheit (°F)  during a time frame of 10 hours. There was no prior temperature excursions.   No additional adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; MMR II was inadvertently administered on 9-FEB-2022, but had labeled expiration date of 12-JAN-2022; This spontaneous report was received from a Medical assistant and refers to a patient of unspecified age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-FEB-2022, the patient medical assistant reported that the patient was inadvertently administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)(strength, lot #, and route of administration were not provided) after the labeled expiration date. Caller stated measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was administered on 09-FEB-2022, but had a labeled expiration date of 12-JAN-2022. Caller stated the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) did not experience any temperature excursions. Caller provided the supported disclaimer based on the information in the Memo. No additional adverse event was reported.
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody, Therapy non-responder
Clinical narrative: patient didn't respond to series; This case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a 34-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Engerix B, the 2nd dose of Engerix B and the 1st dose of Engerix B. On an unknown date, unknown after receiving Engerix B, Engerix B and Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional deatils were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient did not respond to1st series of Engerix B vaccine, which led to therapy non-responder. This case was linked with case US2022021691, for the 2nd series of Engerix B vaccine with same patient and same reporter. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022021691:Same patient, different series
Sex: U
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Numbed feelings on my hand; Pain all along my arm all the way to the tips of each finger; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 1st December 2021, the patient received Shingles vaccine. On 4th December 2021, 3 days after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the patient experienced numbness in hand. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the numbness in hand was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and numbness in hand to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient reported that by the 4th December 2022 ,he/she was in so much pain all along his/her arm all the way to the tips of each finger. The patient was much better now, but still had numbed feelings on his/her hand.
Sex: U
Vaccine: VARZOS
Symptoms: Lymphoedema
Clinical narrative: Lymphedema; This case was reported by a other health professional via interactive digital media and described the occurrence of lymphedema 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 lymphedema. On an unknown date, the outcome of the lymphedema was unknown.   It was unknown if the reporter considered the lymphedema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that Shingrix caused lymphedema in a patient with no prior history of mastectomy/breast cancer. The follow-up would not be possible as no contact details were available.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Nausea, Pain, Pain in extremity, Somnolence
Clinical narrative: Arm incredibly sore, extreme soreness, strong pain; Felt achy all over and extreme arm Soreness/still hurts when lifted; Couldn't lift arm, still hurts when lifted; Nauseated; Sleepy; This case was reported by a nurse and described the occurrence of pain in arm in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 72P9H, expiry date 9th April 2023) for prophylaxis.   Concurrent medical conditions included fatty liver, blood pressure high, obesity and asthma.   On 23rd December 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 23rd December 2021, 2 hrs after receiving Shingrix, the patient experienced pain in arm, mobility decreased, nausea, sleepiness and general body pain. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the mobility decreased, nausea, sleepiness and general body pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm, mobility decreased, nausea, sleepiness and general body pain to be related to Shingrix.  Additional details were reported as follows: The patient received a dose of Shingrix and 2 hours later experienced extreme pain and soreness in arm and was unable to lift the arm at shoulder level. The extreme soreness lasted for 2 days. The first 24 hours of shot the patient experienced nauseated, sleepy and achy all over. The arm pain was not recovered until 6 weeks later after vaccine shot and still hurted while lifting arm. Consent to follow up was granted.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: given Hiberix reconstituted with sterile water; given Hiberix reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number 594CF, expiry date 13th July 2022) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that,the patient received dose of Hiberix that might had been incorrectly reconstituted with sterile water instead of saline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The HCP (health care professional) did not have specific patient information or dates administered at the time of report.  The HCP stated that the specific lot was administered over a range of a couple of months. The reporter consented to follow-up. This is one of 8 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR024234:Same reporter US-GLAXOSMITHKLINE-US2022AMR024235:Same reporter US-GLAXOSMITHKLINE-US2022AMR024236:Same reporter US-GLAXOSMITHKLINE-US2022022662:Same reporter US-GLAXOSMITHKLINE-US2022AMR024237:Same reporter US-GLAXOSMITHKLINE-US2022AMR024238:Same reporter US-GLAXOSMITHKLINE-US2022AMR024240:Same reporter US-GLAXOSMITHKLINE-US2022AMR024241:Same reporter