chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Hypoaesthesia, Loss of personal independence in daily activities, Lumbar puncture
Clinical narrative: Adverse neurological symptoms; Daily headaches; Nausea; Numbness on left side of body; Cognitive impairment; Memory loss; Ringing in ears; Dissociative feeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 15 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Aug2021 (Lot number: FIA7485) at the age of 15 years as dose 1, single for covid-19 immunisation at Pharmacy or Drug Store. The patient had no relevant medical history. There were no concomitant medications. Other vaccine in four weeks: No. Other medications in two weeks: No. Covid prior vaccination: No. The following information was reported: NEUROLOGICAL SYMPTOM (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Adverse neurological symptoms"; HEADACHE (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Daily headaches"; NAUSEA (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Nausea"; HYPOAESTHESIA (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Numbness on left side of body"; COGNITIVE DISORDER (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Cognitive impairment"; AMNESIA (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Memory loss"; TINNITUS (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Ringing in ears"; DISSOCIATIVE DISORDER (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Dissociative feeling". The patient was hospitalized for neurological symptom, headache, nausea, hypoaesthesia, cognitive disorder, amnesia, tinnitus, dissociative disorder (hospitalization duration: 2 day(s)). The events "adverse neurological symptoms", "daily headaches", "nausea", "numbness on left side of body", "cognitive impairment", "memory loss", "ringing in ears" and "dissociative feeling" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (30Dec2021) positive, notes: Blood test, post vaccination. Therapeutic measures were taken as a result of headache. Treatment with Pain reliever for headache symptoms only.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging normal, Pain
Clinical narrative: Adverse neurological symptoms; Daily headaches; Nausea; Numbness on left side of body; Cognitive impairment; Memory loss; Ringing in ears; Dissociative feeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 15 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Aug2021 (Lot number: FIA7485) at the age of 15 years as dose 1, single for covid-19 immunisation at Pharmacy or Drug Store. The patient had no relevant medical history. There were no concomitant medications. Other vaccine in four weeks: No. Other medications in two weeks: No. Covid prior vaccination: No. The following information was reported: NEUROLOGICAL SYMPTOM (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Adverse neurological symptoms"; HEADACHE (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Daily headaches"; NAUSEA (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Nausea"; HYPOAESTHESIA (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Numbness on left side of body"; COGNITIVE DISORDER (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Cognitive impairment"; AMNESIA (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Memory loss"; TINNITUS (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Ringing in ears"; DISSOCIATIVE DISORDER (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Dissociative feeling". The patient was hospitalized for neurological symptom, headache, nausea, hypoaesthesia, cognitive disorder, amnesia, tinnitus, dissociative disorder (hospitalization duration: 2 day(s)). The events "adverse neurological symptoms", "daily headaches", "nausea", "numbness on left side of body", "cognitive impairment", "memory loss", "ringing in ears" and "dissociative feeling" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (30Dec2021) positive, notes: Blood test, post vaccination. Therapeutic measures were taken as a result of headache. Treatment with Pain reliever for headache symptoms only.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Cognitive disorder, Dissociative disorder, Headache, Hypoaesthesia
Clinical narrative: Adverse neurological symptoms; Daily headaches; Nausea; Numbness on left side of body; Cognitive impairment; Memory loss; Ringing in ears; Dissociative feeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 15 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Aug2021 (Lot number: FIA7485) at the age of 15 years as dose 1, single for covid-19 immunisation at Pharmacy or Drug Store. The patient had no relevant medical history. There were no concomitant medications. Other vaccine in four weeks: No. Other medications in two weeks: No. Covid prior vaccination: No. The following information was reported: NEUROLOGICAL SYMPTOM (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Adverse neurological symptoms"; HEADACHE (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Daily headaches"; NAUSEA (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Nausea"; HYPOAESTHESIA (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Numbness on left side of body"; COGNITIVE DISORDER (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Cognitive impairment"; AMNESIA (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Memory loss"; TINNITUS (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Ringing in ears"; DISSOCIATIVE DISORDER (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Dissociative feeling". The patient was hospitalized for neurological symptom, headache, nausea, hypoaesthesia, cognitive disorder, amnesia, tinnitus, dissociative disorder (hospitalization duration: 2 day(s)). The events "adverse neurological symptoms", "daily headaches", "nausea", "numbness on left side of body", "cognitive impairment", "memory loss", "ringing in ears" and "dissociative feeling" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (30Dec2021) positive, notes: Blood test, post vaccination. Therapeutic measures were taken as a result of headache. Treatment with Pain reliever for headache symptoms only.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Neurological symptom, SARS-CoV-2 antibody test, Tinnitus
Clinical narrative: Adverse neurological symptoms; Daily headaches; Nausea; Numbness on left side of body; Cognitive impairment; Memory loss; Ringing in ears; Dissociative feeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 15 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Aug2021 (Lot number: FIA7485) at the age of 15 years as dose 1, single for covid-19 immunisation at Pharmacy or Drug Store. The patient had no relevant medical history. There were no concomitant medications. Other vaccine in four weeks: No. Other medications in two weeks: No. Covid prior vaccination: No. The following information was reported: NEUROLOGICAL SYMPTOM (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Adverse neurological symptoms"; HEADACHE (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Daily headaches"; NAUSEA (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Nausea"; HYPOAESTHESIA (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Numbness on left side of body"; COGNITIVE DISORDER (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Cognitive impairment"; AMNESIA (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Memory loss"; TINNITUS (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Ringing in ears"; DISSOCIATIVE DISORDER (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Dissociative feeling". The patient was hospitalized for neurological symptom, headache, nausea, hypoaesthesia, cognitive disorder, amnesia, tinnitus, dissociative disorder (hospitalization duration: 2 day(s)). The events "adverse neurological symptoms", "daily headaches", "nausea", "numbness on left side of body", "cognitive impairment", "memory loss", "ringing in ears" and "dissociative feeling" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (30Dec2021) positive, notes: Blood test, post vaccination. Therapeutic measures were taken as a result of headache. Treatment with Pain reliever for headache symptoms only.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: SUBJECTIVE: HPI: Patient comes in today because of 4-week pain on her left arm medial aspect near to the elbow.  She had a Moderna booster 4 weeks ago, her and her husband the same day developed some pain on the lower medial aspect of the left arm.  That is the side where she had the shot.  Apparently the shot was given high in the deltoid.  The pain is mostly sensitivity and discomfort on the skin, when she also does overhead activities.  On exam there is hyperesthesia on an area that its 5 x 5 cm on the medial aspect of the left third lower arm.  There is no discoloration, there is now palpation of any mass under the skin.  However she is very uncomfortable with palpation of the area.  There is also some pain on the medial epicondyles of the left elbow.  She already reported this is a possible vaccine reaction to the CDC website.  However it is a possibility that she could have a C8-T1 radiculopathy, for this reason she is agreeing on an x-ray of the C-spine.   However am recommending that she would ice the area, take some anti-inflammatories such as ibuprofen or Aleve for at least a week.  Make sure the anti-inflammatory are taken with a full stomach and drinking plenty of fluids.  She will follow-up with us in 4 weeks.   She needs also refills for her montelukast she is doing very well with her moderate asthma.  And some hydrocortisone 2.5% lotion for eczema.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperaesthesia, Pain in extremity, Product administered at inappropriate site, Sensitive skin, Skin discomfort
Clinical narrative: SUBJECTIVE: HPI: Patient comes in today because of 4-week pain on her left arm medial aspect near to the elbow.  She had a Moderna booster 4 weeks ago, her and her husband the same day developed some pain on the lower medial aspect of the left arm.  That is the side where she had the shot.  Apparently the shot was given high in the deltoid.  The pain is mostly sensitivity and discomfort on the skin, when she also does overhead activities.  On exam there is hyperesthesia on an area that its 5 x 5 cm on the medial aspect of the left third lower arm.  There is no discoloration, there is now palpation of any mass under the skin.  However she is very uncomfortable with palpation of the area.  There is also some pain on the medial epicondyles of the left elbow.  She already reported this is a possible vaccine reaction to the CDC website.  However it is a possibility that she could have a C8-T1 radiculopathy, for this reason she is agreeing on an x-ray of the C-spine.   However am recommending that she would ice the area, take some anti-inflammatories such as ibuprofen or Aleve for at least a week.  Make sure the anti-inflammatory are taken with a full stomach and drinking plenty of fluids.  She will follow-up with us in 4 weeks.   She needs also refills for her montelukast she is doing very well with her moderate asthma.  And some hydrocortisone 2.5% lotion for eczema.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Hydrocephalus, Pulmonary embolism, SARS-CoV-2 test positive
Clinical narrative: Hospitalized with breakthrough COVID infection
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Hospitalized with breakthrough COVID infection
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: 2 shots of Moderna + Pfizer booster; 2 shots of Moderna + Pfizer booster; have gotten Covid; have gotten Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna vaccine (dose 1), for COVID-19 immunization; Moderna vaccine (dose 2), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "2 shots of Moderna + Pfizer booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "have gotten Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Clinical course: The patient mentioned that it got him, despite 2 shots of Moderna and Pfizer booster-last Wednesday he tested positive for Covid. Symptoms minimal-mostly scratchy throat that disappeared in hours-never any fever or loss of taste. He was isolating and wears mask.   The lot number for bnt162b2 was not provided and will be requested during follow up.  Clinical Course: New information was received from 19Jan2022, Patient was unsure when he got Covid, but he was definitely back to working currently on his TV show. He was a public figure - white male maybe in 40s or 50s. He did not know him personally as he hosts a talk show all information about him can be found online. He believed they may have recovered, as he had seen them on a clip that was released about two weeks ago in which they were featured. It seems at least they have resumed work. He was probably vaccinated but he actually did not know. More than likely not was vaccinated.  Follow-up (19Jan2022): New information was received from a same contactable Consumer. This Consumer reported in response to Consumer letter sent to Consumer via Email follow-up activity which included that: Clinical information.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Malaise, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: 2 shots of Moderna + Pfizer booster; 2 shots of Moderna + Pfizer booster; have gotten Covid; have gotten Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna vaccine (dose 1), for COVID-19 immunization; Moderna vaccine (dose 2), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "2 shots of Moderna + Pfizer booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "have gotten Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Clinical course: The patient mentioned that it got him, despite 2 shots of Moderna and Pfizer booster-last Wednesday he tested positive for Covid. Symptoms minimal-mostly scratchy throat that disappeared in hours-never any fever or loss of taste. He was isolating and wears mask.   The lot number for bnt162b2 was not provided and will be requested during follow up.  Clinical Course: New information was received from 19Jan2022, Patient was unsure when he got Covid, but he was definitely back to working currently on his TV show. He was a public figure - white male maybe in 40s or 50s. He did not know him personally as he hosts a talk show all information about him can be found online. He believed they may have recovered, as he had seen them on a clip that was released about two weeks ago in which they were featured. It seems at least they have resumed work. He was probably vaccinated but he actually did not know. More than likely not was vaccinated.  Follow-up (19Jan2022): New information was received from a same contactable Consumer. This Consumer reported in response to Consumer letter sent to Consumer via Email follow-up activity which included that: Clinical information.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Echocardiogram, Endocarditis, Infection
Clinical narrative: stroke; endocarditis/The infection had attached the repaired mitral valve; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 16:00 (Lot number: EW0172) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mitral valve prolapse" (unspecified if ongoing); "mitral valve repair surgery", start date: 12Jan2021 (unspecified if ongoing). Concomitant medication(s) included: BABY ASPIRIN; IRON. Past drug history included: Gentamicin, reaction(s): "known allergies gentamicin". Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: ER8734, Location of injection: Arm Left), administration date: 08Apr2021, when the patient was 47 years old, for COVID-19 immunization. No other vaccine in four weeks. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization) with onset 13Jun2021, outcome "recovered with sequelae", described as "stroke"; ENDOCARDITIS (hospitalization) with onset 13Jun2021, outcome "recovered with sequelae", described as "endocarditis/The infection had attached the repaired mitral valve". Approximately 6 weeks after her 2nd Covid vaccine dose, patient had a stroke that was caused by endocarditis. The infection had attached the repaired mitral valve. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jul2021) negative, notes: Nasal Swab; (17Jul2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of cerebrovascular accident, endocarditis with mitral valve REPLACEMENT/IV meds.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Magnetic resonance imaging, Mitral valve repair
Clinical narrative: stroke; endocarditis/The infection had attached the repaired mitral valve; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 16:00 (Lot number: EW0172) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mitral valve prolapse" (unspecified if ongoing); "mitral valve repair surgery", start date: 12Jan2021 (unspecified if ongoing). Concomitant medication(s) included: BABY ASPIRIN; IRON. Past drug history included: Gentamicin, reaction(s): "known allergies gentamicin". Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: ER8734, Location of injection: Arm Left), administration date: 08Apr2021, when the patient was 47 years old, for COVID-19 immunization. No other vaccine in four weeks. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization) with onset 13Jun2021, outcome "recovered with sequelae", described as "stroke"; ENDOCARDITIS (hospitalization) with onset 13Jun2021, outcome "recovered with sequelae", described as "endocarditis/The infection had attached the repaired mitral valve". Approximately 6 weeks after her 2nd Covid vaccine dose, patient had a stroke that was caused by endocarditis. The infection had attached the repaired mitral valve. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jul2021) negative, notes: Nasal Swab; (17Jul2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of cerebrovascular accident, endocarditis with mitral valve REPLACEMENT/IV meds.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Endocarditis, SARS-CoV-2 test
Clinical narrative: stroke; endocarditis/The infection had attached the repaired mitral valve; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 16:00 (Lot number: EW0172) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mitral valve prolapse" (unspecified if ongoing); "mitral valve repair surgery", start date: 12Jan2021 (unspecified if ongoing). Concomitant medication(s) included: BABY ASPIRIN; IRON. Past drug history included: Gentamicin, reaction(s): "known allergies gentamicin". Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: ER8734, Location of injection: Arm Left), administration date: 08Apr2021, when the patient was 47 years old, for COVID-19 immunization. No other vaccine in four weeks. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization) with onset 13Jun2021, outcome "recovered with sequelae", described as "stroke"; ENDOCARDITIS (hospitalization) with onset 13Jun2021, outcome "recovered with sequelae", described as "endocarditis/The infection had attached the repaired mitral valve". Approximately 6 weeks after her 2nd Covid vaccine dose, patient had a stroke that was caused by endocarditis. The infection had attached the repaired mitral valve. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jul2021) negative, notes: Nasal Swab; (17Jul2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of cerebrovascular accident, endocarditis with mitral valve REPLACEMENT/IV meds.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Lymphadenopathy, Pruritus, Rash pruritic, Vaccination site pain
Clinical narrative: Felt like she had COVID-19; Sick for 4 or 5 days; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (Felt like she had COVID-19) and ILLNESS (Sick for 4 or 5 days) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (It lasted for approximately one month) on 20-Nov-2020 and Surgery (Vein). Concurrent medical conditions included Allergy (To the glue that is used after surgery to close wounds) and Low blood pressure.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced SUSPECTED COVID-19 (Felt like she had COVID-19) and ILLNESS (Sick for 4 or 5 days). In May 2021, ILLNESS (Sick for 4 or 5 days) had resolved. At the time of the report, SUSPECTED COVID-19 (Felt like she had COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported. No concomitant medication was reported.  Company comment This is a spontaneous case concerning a 58-year-old female patient with no relevant medical history, who experienced the non-serious, unexpected, according RA, AESI event of COVID-19 and other another non-serious event. The event COVID-19 occurred the same day after the first dose of mRNA-1273 vaccine and was sick for 4 or 5 days. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-455049, MOD-2022-454960 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 58-year-old female patient with no relevant medical history, who experienced the non-serious, unexpected, according RA, AESI event of COVID-19 and other another non-serious event. The event COVID-19 occurred the same day after the first dose of mRNA-1273 vaccine and was sick for 4 or 5 days. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness, Suspected COVID-19
Clinical narrative: Felt like she had COVID-19; Sick for 4 or 5 days; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (Felt like she had COVID-19) and ILLNESS (Sick for 4 or 5 days) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (It lasted for approximately one month) on 20-Nov-2020 and Surgery (Vein). Concurrent medical conditions included Allergy (To the glue that is used after surgery to close wounds) and Low blood pressure.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced SUSPECTED COVID-19 (Felt like she had COVID-19) and ILLNESS (Sick for 4 or 5 days). In May 2021, ILLNESS (Sick for 4 or 5 days) had resolved. At the time of the report, SUSPECTED COVID-19 (Felt like she had COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported. No concomitant medication was reported.  Company comment This is a spontaneous case concerning a 58-year-old female patient with no relevant medical history, who experienced the non-serious, unexpected, according RA, AESI event of COVID-19 and other another non-serious event. The event COVID-19 occurred the same day after the first dose of mRNA-1273 vaccine and was sick for 4 or 5 days. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-455049, MOD-2022-454960 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 58-year-old female patient with no relevant medical history, who experienced the non-serious, unexpected, according RA, AESI event of COVID-19 and other another non-serious event. The event COVID-19 occurred the same day after the first dose of mRNA-1273 vaccine and was sick for 4 or 5 days. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: hives; This case was reported by a consumer via call center representative and described the occurrence of hives in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th January 2022, the patient received the 1st dose of Shingrix. In January 2022, less than 2 weeks after receiving Shingrix, the patient experienced hives. The patient was treated with prednisone and ambiguous medication nos (Claritin (Nos)). On an unknown date, the outcome of the hives was recovering/resolving.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received the 1st dose of Shingrix in his left upper arm and experienced hives 7-10 days later. The patient stated that he was prescribed Prednisone and Claritin and that calmed it down. The patient reported that hives have 99.5 percent resolved. The patient wanted to know if the 2nd dose was recommended and how effective the dose was after 1 dose. The reporter was given medical disclaimer and referred to health care professional. Provided Medical Information telephone number and website for health care professional contact. The reporter consented to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: hives; This case was reported by a consumer via call center representative and described the occurrence of hives in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th January 2022, the patient received the 1st dose of Shingrix. In January 2022, less than 2 weeks after receiving Shingrix, the patient experienced hives. The patient was treated with prednisone and ambiguous medication nos (Claritin (Nos)). On an unknown date, the outcome of the hives was recovering/resolving.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received the 1st dose of Shingrix in his left upper arm and experienced hives 7-10 days later. The patient stated that he was prescribed Prednisone and Claritin and that calmed it down. The patient reported that hives have 99.5 percent resolved. The patient wanted to know if the 2nd dose was recommended and how effective the dose was after 1 dose. The reporter was given medical disclaimer and referred to health care professional. Provided Medical Information telephone number and website for health care professional contact. The reporter consented to follow up.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Full blood count, Metabolic function test, Pain in extremity, Ultrasound Doppler
Clinical narrative: Note Call received from (include name): (mother)   Reason for call: called to report that every since patient gt his covid booster his leg has been painful and he has been fatigued. Denies swelling, denies discoloration. Patient was seen 1-6-22 for this but it is still ongoing.    o Date of onset/duration: 1-11-22   o Are there other encounters in database regarding this:  no   o    o Additional Information:  I did not see availability
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Blood test, Pain in extremity, Ultrasound scan
Clinical narrative: Note Call received from (include name): (mother)   Reason for call: called to report that every since patient gt his covid booster his leg has been painful and he has been fatigued. Denies swelling, denies discoloration. Patient was seen 1-6-22 for this but it is still ongoing.    o Date of onset/duration: 1-11-22   o Are there other encounters in database regarding this:  no   o    o Additional Information:  I did not see availability
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Note Call received from (include name): (mother)   Reason for call: called to report that every since patient gt his covid booster his leg has been painful and he has been fatigued. Denies swelling, denies discoloration. Patient was seen 1-6-22 for this but it is still ongoing.    o Date of onset/duration: 1-11-22   o Are there other encounters in database regarding this:  no   o    o Additional Information:  I did not see availability
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: General symptom
Clinical narrative: unknown
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: unknown
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Vaccine administered after temperature excursion; This spontaneous report as received from a nurse referring to a specified patient (age and gender not provided). The pertinent medical history, concomitant therapies and drug allergy or reactions were unknown.  On 17-DEC-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 ml (lot #T030945, which has been verified to be valid, expiration date: 09-MAR-2022, therapy type: rHA) subcutaneously for prophylaxis after temperature excursion (Product storage error). No additional adverse events reported (no adverse event).  The vaccine was stored at temperature of 6.8 degrees Fahrenheit for 8 hours and 5 minutes. There was no previous temperature excursion.
Sex: M
Vaccine: VARCEL
Symptoms: Injection site abscess, Injection site erythema, Injection site swelling
Clinical narrative: his son developing transient synovitis-fluid on left hip joint 3 inches from his injection site, which was still red and swollen- after the second dose of the varicella vaccine; This spontaneous report was received from the patient's father and refers to a 5 year old male patient. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On an unknown date, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX), reported as "the varicella vaccine from Merck," for prophylaxis (strength, dose, route of administration, frequency, lot/batch # and expiration date were not reported).      The reporter referred his concern due to his son developing transient synovitis-fluid on left hip joint 3 inches from his injection site, which was still red and swollen- after the second dose of the varicella virus vaccine live (oka/merck) (VARIVAX) when he was 5 years old.     The outcome of synovitis was unknown.        The causal relationship between the event and varicella virus vaccine live (oka/merck) (VARIVAX) was not provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event reported; Rotateq was administered after a temperature excursion; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On 18-JAN-2022, the patient was vaccinated with one dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1742463, expiration date: 20-SEP-2022) (dose and vaccination site were not provided) as prophylaxis. (product storage error). The vaccine underwent a temperature excursion of 27.3 Fahrenheit for 27 hours 25 minutes. Previous temperature excursion was not applicable. No additional adverse event reported, no further information provided. This is one of 8 reports from the same reporter.
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event reported; Expired vaccine used; This spontaneous report was received from a nurse practitioner referring to a 4-year-old female patient. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On 19-JAN-2022, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) rHA (Lot# T023918 and expiration date 09-JAN-2022) (exact dose and frequency were not reported) as prophylaxis. (expired product administered).  No temperature excursions reported. No additional adverse event reported, no further information provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; VARIVAX was administered after the excursion: 30 F for 30 min; This spontaneous report was received from medical assistant (office manager) and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 18-JAN-2022, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #U020244, expiration date: 28-JUN-2023, (dosing schedule and route of administration were not reported) for prophylaxis. Administered dose of vaccine was exposed to temperature 30 F for 30 minutes. No previous temperature excursion was noted. No additional adverse event (AE) was reported.
Sex: M
Vaccine: PPV
Symptoms: Headache, Pain in extremity, Sleep disorder
Clinical narrative: He received PNEUMOVAX23 and he had sore arm, had a headahce last night and couldn't sleep well; He received PNEUMOVAX23 and he had sore arm, had a headahce last night and couldn't sleep well; He received PNEUMOVAX23 and he had sore arm, had a headahce last night and couldn't sleep well; This spontaneous was received from a male company representative regarding himself. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions, and allergies were not provided.   On 19-JAN-2022, he was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, route of administration, lot number, and expiration date were not provided). Therefore, on the same date, he had sore arm (pain in extremity), he had headache, and could not sleep (poor quality sleep).   The outcome of the events pain in extremity, headache, and poor-quality sleep was not provided.   The causal relationship between the events pain in extremity, headache, and poor-quality sleep and vaccine Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Reported a temperature excursion for VAQTA which was supported; Patient had no known side effects; Information has been received regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 05-JAN-2022, the patient was vaccinated with 1 dose of hepatitis a vaccine, inactivated (VAQTA) lot # U024505 with expiration date on 15-OCT-2022, for prophylaxis (strength, route of administration and anatomical location were not provided) that underwent a temperature excursion. Patient had no known side effects.
Age: 36.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; expired vaccine administered; This spontaneous report was received from an administrator referring to a 36-year-old patient of unknown gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 18-JAN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(rHA)(M-M-R II) 0.5 milliliter, lot number S037498, expiration date 20-NOV-2021 (route of administration not reported) for prophylaxis (expired product administered). No adverse event was reported. The vaccine had not had any temperature excursion
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; A patient was administered VARIVAX two days after the administration of MMR II; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.       On 20-JUL-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided).      On 22-JUL-2021, the patient was vaccinated varicella virus vaccine live (oka/merck) (VARIVAX) (inappropriate schedule of product administration) 0.5 milliliter, for prophylaxis (lot number S032355 had been determined to be valid for varicella virus vaccine live (oka/merck), expiration date reported and established as 14-OCT-2021)  (strength, route of administration and anatomical location were not provided).     No adverse event reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No further AE's reported; Expired dose of MMRII given yesterday; This spontaneous report was received from a pharmacist technician referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 20-JAN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) 0.5 milliliter, lot number T000890, expiration date 08-JAN-2022 (route of administration not reported) for prophylaxis (expired product administered). The vaccine was dilute with sterile diluent 0.5 milliliter lot number T004403, expiration date 13-OCT-2022. No adverse event was reported.
Age: 28.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No other AE ocurred; The patient is 28 years old and recieved PROQUAD by mistake on 07-JAN-2022; The patient is 28 years old and recieved PROQUAD by mistake on 07-JAN-2022; This spontaneous report was received from a medical assistant regarding a 28 year-old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, concomitants, drug reactions, and allergies were not provided.   On 07-JAN-2022, a 28 year-old patient received a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) one dose, lot number T028300, expiration date: 16-FEB-2022 (route of administration was not provided) for prophylaxis (wrong product administered) (product administered to patient of inappropriate age). The reported expressed that the patient was scheduled to received the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), and varicella virus vaccine live (Oka/Merck) (manufacturer unknown) vaccines separately (vaccines were not administered), and it was confirmed that no other adverse event occurred.
Sex: F
Vaccine: FLUN3
Symptoms: Death, Loss of personal independence in daily activities
Clinical narrative: DEATH-CAUSE UNSPECIFIED; A report has been received from a physician via Merck medical representative, concerning a female patient.    Relevant medical history, concurrent diseases and concomitant medications were not reported.    On unspecified date, the patient received nasal FluMist (influenza virus vaccine live, intranasal).  Another vaccine was given on same day, quadrivalent human papilloma virus vaccine. It was unknown if the quadrivalent human papilloma virus injection was the first, second, or third in a series of three injections. The patient went back to the doctor's office the same day she received the injection for an unspecified reason.    The next day, the patient did not participate in gym class at school for an unspecified reason and died (preferred term: death) at an unknown time.  Cause of death was unspecified. It was unknown whether autopsy was performed.    The reporter assessed the case as serious with death criterion.; Sender's Comments: The case describes a female patient of unknown age who died after being treated with Flumist. The cause of death is not further specified. There is missing information on the cause of death, patient's medical history, concomitant medications, concurrent diseases and autopsy results making it difficult to assess a causal relationship.; Reported Cause(s) of Death: DEATH-CAUSE UNSPECIFIED
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced Covid-19 test positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Covid-19 test positive was not reported. This report was non-serious. This report was associated with Product quality complaint: 90000213435. Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID AFTER RECEIVING THE JANSSEN COVID-19 VACCINE (COVID-19 TEST POSITIVE); This spontaneous report received from a patient concerned a 27 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: 14-DEC-2021) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced covid after receiving the janssen covid-19 vaccine (covid-19 test positive). Laboratory data (dates unspecified) included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid after receiving the janssen covid-19 vaccine (covid-19 test positive) was not reported. This report was non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID-19; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, expiry: 21-DEC-2021) dose was not reported, administered on 29-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-JAN-2022, the patient experienced tested positive for covid-19. Laboratory data included: COVID-19 antigen test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 was not reported. This report was non-serious.