chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Tachycardia
Clinical narrative: Tachycardia; Dose received:3/ dose number=3; This is a spontaneous report from a contactable reporter (Other HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 07Dec2021 at 11:45 (Lot number: 32030BD) at the age of 54 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa Drugs and "Allergy to antibiotic" (unspecified if ongoing), notes: Known allergies: Tetracyclines. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: ER8732; Administration Time: 13:45: Anatomical location: Left Arm; Route of administration: Unspecified), administration date: 01Apr2021, when the patient was 53 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: EW0171; Administration Time: 13:45: Anatomical location: Left Arm; Route of administration: Unspecified), administration date: 22Apr2021, when the patient was 53 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 at 11:45, outcome "unknown", described as "Dose received:3/ dose number=3"; TACHYCARDIA (non-serious) with onset 08Dec2021 at 00:00, outcome "recovering", described as "Tachycardia". The event "Tachycardia" was evaluated at the physician office visit. Therapeutic measures were taken as a result of tachycardia.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. Treatment for TACHYCARDIA included Bystolic (Beta Blocker).
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Burning sensation, Headache, Herpes zoster, Impaired work ability
Clinical narrative: vestibular neuritis; shingles in the right ear; head tingling; headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Jul2021 11:00 (Lot number: EW0196) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mitral valve prolapse" (unspecified if ongoing); (unspecified if ongoing); "Upper wall aneurysm" (unspecified if ongoing); "penicillian allergy" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0187, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 11Jun2021, when the patient was 50 years old, for Covid-19 immunization. The following information was reported: VESTIBULAR NEURONITIS (medically significant) with onset 13Jul2021 12:00, outcome "recovered with sequelae", described as "vestibular neuritis"; HERPES ZOSTER OTICUS (medically significant) with onset 13Jul2021 12:00, outcome "recovered with sequelae", described as "shingles in the right ear"; PARAESTHESIA (non-serious) with onset 13Jul2021 12:00, outcome "recovered with sequelae", described as "head tingling"; HEADACHE (non-serious) with onset 13Jul2021 12:00, outcome "recovered with sequelae", described as "headaches". The events "vestibular neuritis", "shingles in the right ear", "head tingling" and "headaches" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Jul2021) negative, notes: Nasal Swab; (19Jul2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of vestibular neuronitis, herpes zoster oticus, paraesthesia, headache: Antiviral acyclovir and nerve gabapentin. He was out of work for 6 weeks while the neuritis subsided. No covid prior vaccination.  No follow-up attempts are needed. No further information is expected
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test, Skin burning sensation, Vestibular neuronitis
Clinical narrative: vestibular neuritis; shingles in the right ear; head tingling; headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Jul2021 11:00 (Lot number: EW0196) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mitral valve prolapse" (unspecified if ongoing); (unspecified if ongoing); "Upper wall aneurysm" (unspecified if ongoing); "penicillian allergy" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0187, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 11Jun2021, when the patient was 50 years old, for Covid-19 immunization. The following information was reported: VESTIBULAR NEURONITIS (medically significant) with onset 13Jul2021 12:00, outcome "recovered with sequelae", described as "vestibular neuritis"; HERPES ZOSTER OTICUS (medically significant) with onset 13Jul2021 12:00, outcome "recovered with sequelae", described as "shingles in the right ear"; PARAESTHESIA (non-serious) with onset 13Jul2021 12:00, outcome "recovered with sequelae", described as "head tingling"; HEADACHE (non-serious) with onset 13Jul2021 12:00, outcome "recovered with sequelae", described as "headaches". The events "vestibular neuritis", "shingles in the right ear", "head tingling" and "headaches" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Jul2021) negative, notes: Nasal Swab; (19Jul2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of vestibular neuronitis, herpes zoster oticus, paraesthesia, headache: Antiviral acyclovir and nerve gabapentin. He was out of work for 6 weeks while the neuritis subsided. No covid prior vaccination.  No follow-up attempts are needed. No further information is expected
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Herpes zoster oticus, Paraesthesia, SARS-CoV-2 test, Vestibular neuronitis
Clinical narrative: vestibular neuritis; shingles in the right ear; head tingling; headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Jul2021 11:00 (Lot number: EW0196) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mitral valve prolapse" (unspecified if ongoing); (unspecified if ongoing); "Upper wall aneurysm" (unspecified if ongoing); "penicillian allergy" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0187, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 11Jun2021, when the patient was 50 years old, for Covid-19 immunization. The following information was reported: VESTIBULAR NEURONITIS (medically significant) with onset 13Jul2021 12:00, outcome "recovered with sequelae", described as "vestibular neuritis"; HERPES ZOSTER OTICUS (medically significant) with onset 13Jul2021 12:00, outcome "recovered with sequelae", described as "shingles in the right ear"; PARAESTHESIA (non-serious) with onset 13Jul2021 12:00, outcome "recovered with sequelae", described as "head tingling"; HEADACHE (non-serious) with onset 13Jul2021 12:00, outcome "recovered with sequelae", described as "headaches". The events "vestibular neuritis", "shingles in the right ear", "head tingling" and "headaches" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Jul2021) negative, notes: Nasal Swab; (19Jul2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of vestibular neuronitis, herpes zoster oticus, paraesthesia, headache: Antiviral acyclovir and nerve gabapentin. He was out of work for 6 weeks while the neuritis subsided. No covid prior vaccination.  No follow-up attempts are needed. No further information is expected
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Insomnia, SARS-CoV-2 test, Thrombosis, Ultrasound chest
Clinical narrative: my pulse rate was 90-118; My blood pressure was elevated; A D-Dimer test was done and the value came back at 512 which was elevated; chest pain; the pain kept me from sleeping; short of breath; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 08:30 (Lot number: 331308A) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). None known allergies. None other medical history. There were no concomitant medications. No other vaccine in four weeks. None other medications in two weeks. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9264, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 19Apr2021, when the patient was 49 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 05:30 PM), administration date: 19Mar2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 03Dec2021 03:00, outcome "unknown", described as "booster"; CHEST PAIN (medically significant) with onset 08Dec2021 03:00, outcome "recovered", described as "chest pain"; INSOMNIA (medically significant) with onset 08Dec2021 03:00, outcome "recovered", described as "the pain kept me from sleeping"; DYSPNOEA (medically significant) with onset 08Dec2021 03:00, outcome "recovered", described as "short of breath"; FIBRIN D DIMER INCREASED (non-serious) with onset 08Dec2021 11:00, outcome "recovered", described as "A D-Dimer test was done and the value came back at 512 which was elevated"; HEART RATE INCREASED (non-serious) with onset 09Dec2021 03:00, outcome "recovered", described as "my pulse rate was 90-118"; BLOOD PRESSURE INCREASED (non-serious) with onset 09Dec2021 03:00, outcome "recovered", described as "My blood pressure was elevated". The events "chest pain", "the pain kept me from sleeping", "short of breath", "a d-dimer test was done and the value came back at 512 which was elevated", "my pulse rate was 90-118" and "my blood pressure was elevated" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (09Dec2021) elevated; blood test: (08Dec2021) normal; chest scan: (08Dec2021) nothing showed; computerised tomogram: (08Dec2021) nothing showed; heart rate: (09Dec2021) 90-118; sars-cov-2 test: (unspecified date) negative, notes: Nasal Swab; thrombosis: (08Dec2021) 512; ultrasound chest: (08Dec2021) nothing showed. Therapeutic measures were not taken as a result of chest pain, insomnia, dyspnoea, fibrin d dimer increased, heart rate increased, blood pressure increased.
Age: 40.0
Sex: M
Vaccine: COVID19, FLUX, COVID19
Symptoms: Pain in extremity
Clinical narrative: COVID booster; influenza vaccine (FLU), administered in arm left, administration date 21Nov2021; Moderate soreness in left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in leg left, administration date 21Nov2021 14:00 (Lot number: 330308D) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm left, administration date 21Nov2021 (Batch/Lot number: unknown) as dose number unknown, single. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Zinacef, reaction(s): "Allergy: Zinacef". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EPF955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 01Apr2021, when the patient was 40 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 09Mar2021, when the patient was 40 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 21Nov2021, outcome "unknown", described as "COVID booster"; PRODUCT USE ISSUE (non-serious) with onset Nov2021, outcome "recovering", described as "influenza vaccine (FLU), administered in arm left, administration date 21Nov2021"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "recovering", described as "Moderate soreness in left arm". Therapeutic measures were not taken as a result of product use issue, pain in extremity.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Reported Event: (injection arm for both the COVID booster and the GSK flu shot) ,adverse event start date: 01Nov2021, adverse event start time: 05:00 PM. Prior to vaccination patient, did not diagnosed with COVID-19. Since the vaccination, patient didn't tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19, FLUX, COVID19
Symptoms: Immunisation, Pain in extremity, Product use issue
Clinical narrative: COVID booster; influenza vaccine (FLU), administered in arm left, administration date 21Nov2021; Moderate soreness in left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in leg left, administration date 21Nov2021 14:00 (Lot number: 330308D) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm left, administration date 21Nov2021 (Batch/Lot number: unknown) as dose number unknown, single. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Zinacef, reaction(s): "Allergy: Zinacef". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EPF955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 01Apr2021, when the patient was 40 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 09Mar2021, when the patient was 40 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 21Nov2021, outcome "unknown", described as "COVID booster"; PRODUCT USE ISSUE (non-serious) with onset Nov2021, outcome "recovering", described as "influenza vaccine (FLU), administered in arm left, administration date 21Nov2021"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "recovering", described as "Moderate soreness in left arm". Therapeutic measures were not taken as a result of product use issue, pain in extremity.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Reported Event: (injection arm for both the COVID booster and the GSK flu shot) ,adverse event start date: 01Nov2021, adverse event start time: 05:00 PM. Prior to vaccination patient, did not diagnosed with COVID-19. Since the vaccination, patient didn't tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Agonal respiration, Apnoea, Death, Pneumonia, Respiratory arrest
Clinical narrative: ACUTE RESPIRATORY FAILURE
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Fatigue, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: cough, fevers, worsening nausea and vomiting, hypoxia  + COVID 19 test
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Hypoxia, Nausea, Pyrexia
Clinical narrative: cough, fevers, worsening nausea and vomiting, hypoxia  + COVID 19 test
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Vomiting
Clinical narrative: cough, fevers, worsening nausea and vomiting, hypoxia  + COVID 19 test
Age: 66.0
Sex: F
Vaccine: COVID19, FLUA4, COVID19, FLU3
Symptoms: Tinnitus
Clinical narrative: Other vaccine same date: fluzone HD; Other vaccine same date: fluzone HD; Booster; tinnitus - ringing in my ears.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 08:00 (Lot number: FF2589) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), administered in arm right, administration date 04Oct2021 (Batch/Lot number: unknown) as dose 1, single. Relevant medical history included: "Known allergies: nickel" (unspecified if ongoing); "Sensitive to fragrance" (unspecified if ongoing); "night shade vegetables" (unspecified if ongoing), notes: night shade vegetables; "Known allergies: eye solution preservative" (unspecified if ongoing), notes: Known allergies: eye solution preservative; "tinnitus" (unspecified if ongoing), notes: I have had tinnitus for almost 6 years. Concomitant medication(s) included: FISH OIL; VIT D [COLECALCIFEROL]; TURMERIC [CURCUMA LONGA]; B12 [CYANOCOBALAMIN]. Past drug history included: Known allergies: erythromycin, reaction(s): "Known allergies: Erythromycin". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8730, Location of injection: Arm Left, Vaccine Administration Time: 11:00), administration date: 20Mar2021, when the patient was 65 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6198, Location of injection: Arm Left, Vaccine Administration Time: 09:45), administration date: 27Feb2021, when the patient was 65 years old, for COVID-19 immunization; Shingles vaccine. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 04Oct2021 08:00, outcome "unknown" and all described as "Other vaccine same date: fluzone HD"; IMMUNISATION (non-serious) with onset 04Oct2021 08:00, outcome "unknown", described as "Booster"; TINNITUS (non-serious) with onset Oct2021, outcome "not recovered", described as "tinnitus - ringing in my ears. ". Therapeutic measures were not taken as a result of tinnitus.  Additional information: Patient had no seriousness criteria-Results in death. Patient had no Seriousness Criteria-Life threatening. Patient had no Seriousness Criteria-Caused/prolonged hospitalization. Patient had no Seriousness Criteria-Disabling/Incapacitating. Patient had no Seriousness Criteria-Congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Fluzone HD vaccine NDC no. 49281-0121-65. Patient had no prolonged hospitalization. Patient was not diagnosed with COVID-19, prior to vaccination. The patient was not tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, FLUA4, COVID19, FLU3
Symptoms: Immunisation, Off label use, Product use issue, Tinnitus
Clinical narrative: Other vaccine same date: fluzone HD; Other vaccine same date: fluzone HD; Booster; tinnitus - ringing in my ears.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 08:00 (Lot number: FF2589) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), administered in arm right, administration date 04Oct2021 (Batch/Lot number: unknown) as dose 1, single. Relevant medical history included: "Known allergies: nickel" (unspecified if ongoing); "Sensitive to fragrance" (unspecified if ongoing); "night shade vegetables" (unspecified if ongoing), notes: night shade vegetables; "Known allergies: eye solution preservative" (unspecified if ongoing), notes: Known allergies: eye solution preservative; "tinnitus" (unspecified if ongoing), notes: I have had tinnitus for almost 6 years. Concomitant medication(s) included: FISH OIL; VIT D [COLECALCIFEROL]; TURMERIC [CURCUMA LONGA]; B12 [CYANOCOBALAMIN]. Past drug history included: Known allergies: erythromycin, reaction(s): "Known allergies: Erythromycin". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8730, Location of injection: Arm Left, Vaccine Administration Time: 11:00), administration date: 20Mar2021, when the patient was 65 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6198, Location of injection: Arm Left, Vaccine Administration Time: 09:45), administration date: 27Feb2021, when the patient was 65 years old, for COVID-19 immunization; Shingles vaccine. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 04Oct2021 08:00, outcome "unknown" and all described as "Other vaccine same date: fluzone HD"; IMMUNISATION (non-serious) with onset 04Oct2021 08:00, outcome "unknown", described as "Booster"; TINNITUS (non-serious) with onset Oct2021, outcome "not recovered", described as "tinnitus - ringing in my ears. ". Therapeutic measures were not taken as a result of tinnitus.  Additional information: Patient had no seriousness criteria-Results in death. Patient had no Seriousness Criteria-Life threatening. Patient had no Seriousness Criteria-Caused/prolonged hospitalization. Patient had no Seriousness Criteria-Disabling/Incapacitating. Patient had no Seriousness Criteria-Congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Fluzone HD vaccine NDC no. 49281-0121-65. Patient had no prolonged hospitalization. Patient was not diagnosed with COVID-19, prior to vaccination. The patient was not tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Borrelia test, Chills, Deep vein thrombosis, Fatigue
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a patient concerned a 70 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 (dose number in series 1) (suspension for injection, route of administration not reported, batch number: 043A21A, expiry: 19-SEP-2021) dose was not reported, 01 total administered on 08-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 27-NOV-2021, the patient experienced blood clots, thrombosis which caused hospitalization. He woke up and left leg was three times bigger than the right leg and he went to the ER (emergency room) and was admitted on the same day. Surgery was performed on 28-NOV-2021. He was sent home on 29-NOV-2021. His leg was still swollen on the same day. He went to ER on 30-DEC-2021, surgery was performed on that day. Second Surgery performed on 01-DEC-2021. He was hospitalized for 14 days. He was discharged from hospital on 10-DEC-2021. Treating physician stated it was blood clots issues. He was being treated with warfarin sodium (Coumadin) tablets and acetylsalicylic acid (Aspirin). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clots on 10-DEC-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211245200-COVID-19 VACCINE AD26.COV2.S-Blood clots. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Feeling of body temperature change, Gait inability, Headache, Peripheral swelling
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a patient concerned a 70 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 (dose number in series 1) (suspension for injection, route of administration not reported, batch number: 043A21A, expiry: 19-SEP-2021) dose was not reported, 01 total administered on 08-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 27-NOV-2021, the patient experienced blood clots, thrombosis which caused hospitalization. He woke up and left leg was three times bigger than the right leg and he went to the ER (emergency room) and was admitted on the same day. Surgery was performed on 28-NOV-2021. He was sent home on 29-NOV-2021. His leg was still swollen on the same day. He went to ER on 30-DEC-2021, surgery was performed on that day. Second Surgery performed on 01-DEC-2021. He was hospitalized for 14 days. He was discharged from hospital on 10-DEC-2021. Treating physician stated it was blood clots issues. He was being treated with warfarin sodium (Coumadin) tablets and acetylsalicylic acid (Aspirin). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clots on 10-DEC-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211245200-COVID-19 VACCINE AD26.COV2.S-Blood clots. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder, Thrombectomy
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a patient concerned a 70 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 (dose number in series 1) (suspension for injection, route of administration not reported, batch number: 043A21A, expiry: 19-SEP-2021) dose was not reported, 01 total administered on 08-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 27-NOV-2021, the patient experienced blood clots, thrombosis which caused hospitalization. He woke up and left leg was three times bigger than the right leg and he went to the ER (emergency room) and was admitted on the same day. Surgery was performed on 28-NOV-2021. He was sent home on 29-NOV-2021. His leg was still swollen on the same day. He went to ER on 30-DEC-2021, surgery was performed on that day. Second Surgery performed on 01-DEC-2021. He was hospitalized for 14 days. He was discharged from hospital on 10-DEC-2021. Treating physician stated it was blood clots issues. He was being treated with warfarin sodium (Coumadin) tablets and acetylsalicylic acid (Aspirin). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clots on 10-DEC-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211245200-COVID-19 VACCINE AD26.COV2.S-Blood clots. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a patient concerned a 70 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 (dose number in series 1) (suspension for injection, route of administration not reported, batch number: 043A21A, expiry: 19-SEP-2021) dose was not reported, 01 total administered on 08-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 27-NOV-2021, the patient experienced blood clots, thrombosis which caused hospitalization. He woke up and left leg was three times bigger than the right leg and he went to the ER (emergency room) and was admitted on the same day. Surgery was performed on 28-NOV-2021. He was sent home on 29-NOV-2021. His leg was still swollen on the same day. He went to ER on 30-DEC-2021, surgery was performed on that day. Second Surgery performed on 01-DEC-2021. He was hospitalized for 14 days. He was discharged from hospital on 10-DEC-2021. Treating physician stated it was blood clots issues. He was being treated with warfarin sodium (Coumadin) tablets and acetylsalicylic acid (Aspirin). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clots on 10-DEC-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211245200-COVID-19 VACCINE AD26.COV2.S-Blood clots. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Hyperpyrexia, Inappropriate schedule of product administration, Mobility decreased, Tremor
Clinical narrative: This felt as bad as having COVID.; fever Saturday night that reached 105F),/"Yeah. Bye brain cells; mistakenly give me the Moderna booster and then gave me a primary dose 30 minutes after; mistakenly give me the Moderna booster and then gave me a primary dose 30 minutes after; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (This felt as bad as having COVID.), PYREXIA (fever Saturday night that reached 105F),/"Yeah. Bye brain cells), ACCIDENTAL OVERDOSE (mistakenly give me the Moderna booster and then gave me a primary dose 30 minutes after) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (mistakenly give me the Moderna booster and then gave me a primary dose 30 minutes after) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Dec-2021 at 10:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Dec-2021 at 11:20 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Dec-2021, the patient experienced FEELING ABNORMAL (This felt as bad as having COVID.), PYREXIA (fever Saturday night that reached 105F),/"Yeah. Bye brain cells), ACCIDENTAL OVERDOSE (mistakenly give me the Moderna booster and then gave me a primary dose 30 minutes after) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (mistakenly give me the Moderna booster and then gave me a primary dose 30 minutes after). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 4 dosage form once. On 18-Dec-2021, ACCIDENTAL OVERDOSE (mistakenly give me the Moderna booster and then gave me a primary dose 30 minutes after) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (mistakenly give me the Moderna booster and then gave me a primary dose 30 minutes after) had resolved. At the time of the report, FEELING ABNORMAL (This felt as bad as having COVID.) and PYREXIA (fever Saturday night that reached 105F),/"Yeah. Bye brain cells) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2021, Body temperature: 105f (High) 105F fever.         No concomitant medications were reported.  Patient went to get his first dose of the Moderna vaccine (069H21A) and there was a bunch of confusion at the pharmacy. They initially thought he was there to get the Pfizer vaccine, but the patient corrected them. The patient stated that they mistakenly give him the Moderna booster and then gave him a primary dose 30 minutes after. He was on his butt entire weekend.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Accidental overdose, Body temperature, Feeling abnormal, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: This felt as bad as having COVID.; fever Saturday night that reached 105F),/"Yeah. Bye brain cells; mistakenly give me the Moderna booster and then gave me a primary dose 30 minutes after; mistakenly give me the Moderna booster and then gave me a primary dose 30 minutes after; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (This felt as bad as having COVID.), PYREXIA (fever Saturday night that reached 105F),/"Yeah. Bye brain cells), ACCIDENTAL OVERDOSE (mistakenly give me the Moderna booster and then gave me a primary dose 30 minutes after) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (mistakenly give me the Moderna booster and then gave me a primary dose 30 minutes after) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Dec-2021 at 10:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Dec-2021 at 11:20 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Dec-2021, the patient experienced FEELING ABNORMAL (This felt as bad as having COVID.), PYREXIA (fever Saturday night that reached 105F),/"Yeah. Bye brain cells), ACCIDENTAL OVERDOSE (mistakenly give me the Moderna booster and then gave me a primary dose 30 minutes after) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (mistakenly give me the Moderna booster and then gave me a primary dose 30 minutes after). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 4 dosage form once. On 18-Dec-2021, ACCIDENTAL OVERDOSE (mistakenly give me the Moderna booster and then gave me a primary dose 30 minutes after) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (mistakenly give me the Moderna booster and then gave me a primary dose 30 minutes after) had resolved. At the time of the report, FEELING ABNORMAL (This felt as bad as having COVID.) and PYREXIA (fever Saturday night that reached 105F),/"Yeah. Bye brain cells) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2021, Body temperature: 105f (High) 105F fever.         No concomitant medications were reported.  Patient went to get his first dose of the Moderna vaccine (069H21A) and there was a bunch of confusion at the pharmacy. They initially thought he was there to get the Pfizer vaccine, but the patient corrected them. The patient stated that they mistakenly give him the Moderna booster and then gave him a primary dose 30 minutes after. He was on his butt entire weekend.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna not approved for age
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haemorrhage, Paraesthesia, Pruritus, Urticaria
Clinical narrative: "Allergic type of reaction " Internal tingling throughout body, escalated, continued over for 6 days to extreme itchy, hives, rashes all over body, internally and externally. Head, scalp, ears, neck, eyes, arms, feet, hands, abdomen, chest, breasts, back, legs
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Paraesthesia, Pruritus, Rash, Urticaria
Clinical narrative: "Allergic type of reaction " Internal tingling throughout body, escalated, continued over for 6 days to extreme itchy, hives, rashes all over body, internally and externally. Head, scalp, ears, neck, eyes, arms, feet, hands, abdomen, chest, breasts, back, legs
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Breast pain, Discomfort, Insomnia, Mammogram
Clinical narrative: I developed lumps in my left breast.; I have had sore to painful breasts since that 1 month mark.; My nipples are also sore to painful at times.; I had a mammogram which showed abnormal tissue in the right breast.; It is very uncomfortable and distracting. It affects my sleep as well.; It affects my sleep as well.; This is a spontaneous report received from contactable consumer (patient).  A 38-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 19Jun2021 (Lot number: EW0168) at the age of 38 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Lot number: EW0168, Left Arm), administration date: 29May2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: BREAST MASS (disability) with onset 01Jul2021, outcome "not recovered", described as "I developed lumps in my left breast."; BREAST PAIN (disability) with onset 01Jul2021, outcome "not recovered", described as "I have had sore to painful breasts since that 1 month mark."; NIPPLE PAIN (disability) with onset 01Jul2021, outcome "not recovered", described as "My nipples are also sore to painful at times."; MAMMOGRAM ABNORMAL (disability) with onset 01Jul2021, outcome "not recovered", described as "I had a mammogram which showed abnormal tissue in the right breast."; DISCOMFORT (disability) with onset 01Jul2021, outcome "not recovered", described as "It is very uncomfortable and distracting. It affects my sleep as well."; INSOMNIA (disability) with onset 01Jul2021, outcome "not recovered", described as "It affects my sleep as well.". The events "i developed lumps in my left breast.", "i have had sore to painful breasts since that 1 month mark.", "my nipples are also sore to painful at times.", "i had a mammogram which showed abnormal tissue in the right breast.", "it is very uncomfortable and distracting. it affects my sleep as well." and "it affects my sleep as well." were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: mammogram: (01Jul2021) abnormal tissue in the right breast; sars-cov-2 test: (26Nov2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of breast mass, breast pain, nipple pain, mammogram abnormal, discomfort, insomnia  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Mammogram abnormal, Nipple pain, SARS-CoV-2 test
Clinical narrative: I developed lumps in my left breast.; I have had sore to painful breasts since that 1 month mark.; My nipples are also sore to painful at times.; I had a mammogram which showed abnormal tissue in the right breast.; It is very uncomfortable and distracting. It affects my sleep as well.; It affects my sleep as well.; This is a spontaneous report received from contactable consumer (patient).  A 38-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 19Jun2021 (Lot number: EW0168) at the age of 38 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Lot number: EW0168, Left Arm), administration date: 29May2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: BREAST MASS (disability) with onset 01Jul2021, outcome "not recovered", described as "I developed lumps in my left breast."; BREAST PAIN (disability) with onset 01Jul2021, outcome "not recovered", described as "I have had sore to painful breasts since that 1 month mark."; NIPPLE PAIN (disability) with onset 01Jul2021, outcome "not recovered", described as "My nipples are also sore to painful at times."; MAMMOGRAM ABNORMAL (disability) with onset 01Jul2021, outcome "not recovered", described as "I had a mammogram which showed abnormal tissue in the right breast."; DISCOMFORT (disability) with onset 01Jul2021, outcome "not recovered", described as "It is very uncomfortable and distracting. It affects my sleep as well."; INSOMNIA (disability) with onset 01Jul2021, outcome "not recovered", described as "It affects my sleep as well.". The events "i developed lumps in my left breast.", "i have had sore to painful breasts since that 1 month mark.", "my nipples are also sore to painful at times.", "i had a mammogram which showed abnormal tissue in the right breast.", "it is very uncomfortable and distracting. it affects my sleep as well." and "it affects my sleep as well." were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: mammogram: (01Jul2021) abnormal tissue in the right breast; sars-cov-2 test: (26Nov2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of breast mass, breast pain, nipple pain, mammogram abnormal, discomfort, insomnia  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: How long will the anticoagulant in the vaccine affect my cycle?; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (How long will the anticoagulant in the vaccine affect my cycle?) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (How long will the anticoagulant in the vaccine affect my cycle?). At the time of the report, MENSTRUAL DISORDER (How long will the anticoagulant in the vaccine affect my cycle?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported No treatment medication were reported
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Paternal exposure before pregnancy
Clinical narrative: Husband received Moderna vaccine at the time of wife's pregnancy; This spontaneous case was reported by a consumer and describes the occurrence of PATERNAL EXPOSURE BEFORE PREGNANCY (Husband received Moderna vaccine at the time of wife's pregnancy) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A, D33B21A and 027H21B) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jun-2021, the patient experienced PATERNAL EXPOSURE BEFORE PREGNANCY (Husband received Moderna vaccine at the time of wife's pregnancy). In 2021, PATERNAL EXPOSURE BEFORE PREGNANCY (Husband received Moderna vaccine at the time of wife's pregnancy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications and treatment information was not provided.  The patient's wife mentioned that she had registered for pregnancy registry earlier in the day. She mentioned that her husband had received the vaccine before she was pregnant. Date of last menstrual period of caller: 04-JUN-2021. She believed she became pregnant on 15-JUN-2021.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Respiratory disorder
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (full body itch) and RESPIRATORY DISORDER (respiratory issues) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013LQ0A, 010AQ1A and 014F21A) for COVID-19 vaccination.No Medical History information was reported. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (full body itch) and RESPIRATORY DISORDER (respiratory issues). At the time of the report, PRURITUS (full body itch) and RESPIRATORY DISORDER (respiratory issues) outcome was unknown. Patient had allergy to tromethamine.  Patient had the event doctor says they see "100 patients a week" with inflammatory process response to booster dose access to VAERS data and has seen 500,000 reactions from Moderna booster pure tromethamine should not be used as a stabilizer as others have this allergy and it is statistically significant. Concomitant medication information not provided. Treatment information not provided. Email received to provide pictures. Most recent FOLLOW-UP information incorporated above includes: On 20-Dec-2021: Non significant Follow-up.