chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Audiogram abnormal, Deafness, Deafness unilateral, Ear discomfort, Sudden hearing loss
Clinical narrative: migraine; Deafness  in right ears; pain; migraine after second Vaccine progressively got worse; had pressure and ringing in ears; had pressure and ringing in ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old patient received BNT162b2 (BNT162B2), on 09Jun2021 as dose 2, single (Lot number: EP7533) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CYMBALTA oral taken for anxiety, start date: 2010 (ongoing). Vaccination history included: BNT162b2 (Dose: 1, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EP7533), administration date: 19May2021, for Covid-19 immunization. The following information was reported: MIGRAINE (non-serious) with onset 09Nov2021, outcome "recovering", described as "migraine after second Vaccine progressively got worse"; EAR DISCOMFORT (non-serious), TINNITUS (non-serious) all with onset Nov2021, outcome "unknown" and all described as "had pressure and ringing in ears"; MIGRAINE (disability, medically significant), outcome "unknown"; DEAFNESS (non-serious), outcome "not recovered", described as "Deafness  in right ears"; PAIN (non-serious), outcome "unknown". The events "deafness  in right ears" and "migraine after second vaccine progressively got worse" required physician office visit. The event "migraine" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: (28Mar2021) Unknown Results, notes: Complete hearing loss Rear; (12Apr2021) Unknown Results, notes: Complete hearing loss Rear. Consult for jump aid; (17Dec2021) Unknown Results, notes: Complete hearing loss Rear; (22Dec2021) Unknown Results, notes: Complete hearing loss Rear; Magnetic resonance imaging: (18Nov2021) Negative. Therapeutic measures were taken as a result of migraine, deafness, migraine, ear discomfort, tinnitus.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: migraine; Deafness  in right ears; pain; migraine after second Vaccine progressively got worse; had pressure and ringing in ears; had pressure and ringing in ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old patient received BNT162b2 (BNT162B2), on 09Jun2021 as dose 2, single (Lot number: EP7533) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CYMBALTA oral taken for anxiety, start date: 2010 (ongoing). Vaccination history included: BNT162b2 (Dose: 1, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EP7533), administration date: 19May2021, for Covid-19 immunization. The following information was reported: MIGRAINE (non-serious) with onset 09Nov2021, outcome "recovering", described as "migraine after second Vaccine progressively got worse"; EAR DISCOMFORT (non-serious), TINNITUS (non-serious) all with onset Nov2021, outcome "unknown" and all described as "had pressure and ringing in ears"; MIGRAINE (disability, medically significant), outcome "unknown"; DEAFNESS (non-serious), outcome "not recovered", described as "Deafness  in right ears"; PAIN (non-serious), outcome "unknown". The events "deafness  in right ears" and "migraine after second vaccine progressively got worse" required physician office visit. The event "migraine" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: (28Mar2021) Unknown Results, notes: Complete hearing loss Rear; (12Apr2021) Unknown Results, notes: Complete hearing loss Rear. Consult for jump aid; (17Dec2021) Unknown Results, notes: Complete hearing loss Rear; (22Dec2021) Unknown Results, notes: Complete hearing loss Rear; Magnetic resonance imaging: (18Nov2021) Negative. Therapeutic measures were taken as a result of migraine, deafness, migraine, ear discomfort, tinnitus.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deafness unilateral, Ear discomfort, Magnetic resonance imaging, Pain, Tinnitus
Clinical narrative: migraine; Deafness  in right ears; pain; migraine after second Vaccine progressively got worse; had pressure and ringing in ears; had pressure and ringing in ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old patient received BNT162b2 (BNT162B2), on 09Jun2021 as dose 2, single (Lot number: EP7533) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CYMBALTA oral taken for anxiety, start date: 2010 (ongoing). Vaccination history included: BNT162b2 (Dose: 1, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EP7533), administration date: 19May2021, for Covid-19 immunization. The following information was reported: MIGRAINE (non-serious) with onset 09Nov2021, outcome "recovering", described as "migraine after second Vaccine progressively got worse"; EAR DISCOMFORT (non-serious), TINNITUS (non-serious) all with onset Nov2021, outcome "unknown" and all described as "had pressure and ringing in ears"; MIGRAINE (disability, medically significant), outcome "unknown"; DEAFNESS (non-serious), outcome "not recovered", described as "Deafness  in right ears"; PAIN (non-serious), outcome "unknown". The events "deafness  in right ears" and "migraine after second vaccine progressively got worse" required physician office visit. The event "migraine" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: (28Mar2021) Unknown Results, notes: Complete hearing loss Rear; (12Apr2021) Unknown Results, notes: Complete hearing loss Rear. Consult for jump aid; (17Dec2021) Unknown Results, notes: Complete hearing loss Rear; (22Dec2021) Unknown Results, notes: Complete hearing loss Rear; Magnetic resonance imaging: (18Nov2021) Negative. Therapeutic measures were taken as a result of migraine, deafness, migraine, ear discomfort, tinnitus.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests, Deafness, Ear discomfort, Magnetic resonance imaging, Migraine
Clinical narrative: migraine; Deafness  in right ears; pain; migraine after second Vaccine progressively got worse; had pressure and ringing in ears; had pressure and ringing in ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old patient received BNT162b2 (BNT162B2), on 09Jun2021 as dose 2, single (Lot number: EP7533) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CYMBALTA oral taken for anxiety, start date: 2010 (ongoing). Vaccination history included: BNT162b2 (Dose: 1, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EP7533), administration date: 19May2021, for Covid-19 immunization. The following information was reported: MIGRAINE (non-serious) with onset 09Nov2021, outcome "recovering", described as "migraine after second Vaccine progressively got worse"; EAR DISCOMFORT (non-serious), TINNITUS (non-serious) all with onset Nov2021, outcome "unknown" and all described as "had pressure and ringing in ears"; MIGRAINE (disability, medically significant), outcome "unknown"; DEAFNESS (non-serious), outcome "not recovered", described as "Deafness  in right ears"; PAIN (non-serious), outcome "unknown". The events "deafness  in right ears" and "migraine after second vaccine progressively got worse" required physician office visit. The event "migraine" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: (28Mar2021) Unknown Results, notes: Complete hearing loss Rear; (12Apr2021) Unknown Results, notes: Complete hearing loss Rear. Consult for jump aid; (17Dec2021) Unknown Results, notes: Complete hearing loss Rear; (22Dec2021) Unknown Results, notes: Complete hearing loss Rear; Magnetic resonance imaging: (18Nov2021) Negative. Therapeutic measures were taken as a result of migraine, deafness, migraine, ear discomfort, tinnitus.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Tinnitus
Clinical narrative: migraine; Deafness  in right ears; pain; migraine after second Vaccine progressively got worse; had pressure and ringing in ears; had pressure and ringing in ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old patient received BNT162b2 (BNT162B2), on 09Jun2021 as dose 2, single (Lot number: EP7533) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CYMBALTA oral taken for anxiety, start date: 2010 (ongoing). Vaccination history included: BNT162b2 (Dose: 1, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EP7533), administration date: 19May2021, for Covid-19 immunization. The following information was reported: MIGRAINE (non-serious) with onset 09Nov2021, outcome "recovering", described as "migraine after second Vaccine progressively got worse"; EAR DISCOMFORT (non-serious), TINNITUS (non-serious) all with onset Nov2021, outcome "unknown" and all described as "had pressure and ringing in ears"; MIGRAINE (disability, medically significant), outcome "unknown"; DEAFNESS (non-serious), outcome "not recovered", described as "Deafness  in right ears"; PAIN (non-serious), outcome "unknown". The events "deafness  in right ears" and "migraine after second vaccine progressively got worse" required physician office visit. The event "migraine" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: (28Mar2021) Unknown Results, notes: Complete hearing loss Rear; (12Apr2021) Unknown Results, notes: Complete hearing loss Rear. Consult for jump aid; (17Dec2021) Unknown Results, notes: Complete hearing loss Rear; (22Dec2021) Unknown Results, notes: Complete hearing loss Rear; Magnetic resonance imaging: (18Nov2021) Negative. Therapeutic measures were taken as a result of migraine, deafness, migraine, ear discomfort, tinnitus.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Balance disorder, Nausea, Vertigo
Clinical narrative: 3 days following vaccination, Patient developed intense vertigo.  He was suddenly unable to walk or stand due to the sensation. They tried acetaminophen. They started meclizine. and Prednisone 40 mg taper on 1/25 after seeing ENT, Dr. at clinic.  Audiology exam normal on 1/27. Due to unresolving symptoms, he was admitted to hospital on 2/14. had Neurology evaluation that was normal. Spent time on rehab service, discharged  2/26. Has had very slow improvement. Ongoing symptoms currently.  He is getting on going vestibular rehab services for presumed vestibular neuronitis.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Dysstasia, Gait inability, Headache, Impaired healing
Clinical narrative: 3 days following vaccination, Patient developed intense vertigo.  He was suddenly unable to walk or stand due to the sensation. They tried acetaminophen. They started meclizine. and Prednisone 40 mg taper on 1/25 after seeing ENT, Dr. at clinic.  Audiology exam normal on 1/27. Due to unresolving symptoms, he was admitted to hospital on 2/14. had Neurology evaluation that was normal. Spent time on rehab service, discharged  2/26. Has had very slow improvement. Ongoing symptoms currently.  He is getting on going vestibular rehab services for presumed vestibular neuronitis.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging head normal, Neurological examination normal, Vertigo, Vestibular neuronitis
Clinical narrative: 3 days following vaccination, Patient developed intense vertigo.  He was suddenly unable to walk or stand due to the sensation. They tried acetaminophen. They started meclizine. and Prednisone 40 mg taper on 1/25 after seeing ENT, Dr. at clinic.  Audiology exam normal on 1/27. Due to unresolving symptoms, he was admitted to hospital on 2/14. had Neurology evaluation that was normal. Spent time on rehab service, discharged  2/26. Has had very slow improvement. Ongoing symptoms currently.  He is getting on going vestibular rehab services for presumed vestibular neuronitis.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Pyrexia, Tremor, Vertigo, Vestibular neuronitis
Clinical narrative: 3 days following vaccination, Patient developed intense vertigo.  He was suddenly unable to walk or stand due to the sensation. They tried acetaminophen. They started meclizine. and Prednisone 40 mg taper on 1/25 after seeing ENT, Dr. at clinic.  Audiology exam normal on 1/27. Due to unresolving symptoms, he was admitted to hospital on 2/14. had Neurology evaluation that was normal. Spent time on rehab service, discharged  2/26. Has had very slow improvement. Ongoing symptoms currently.  He is getting on going vestibular rehab services for presumed vestibular neuronitis.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dyskinesia, Dysstasia, Inner ear inflammation, Nausea, Pyrexia
Clinical narrative: 3 days following vaccination, Patient developed intense vertigo.  He was suddenly unable to walk or stand due to the sensation. They tried acetaminophen. They started meclizine. and Prednisone 40 mg taper on 1/25 after seeing ENT, Dr. at clinic.  Audiology exam normal on 1/27. Due to unresolving symptoms, he was admitted to hospital on 2/14. had Neurology evaluation that was normal. Spent time on rehab service, discharged  2/26. Has had very slow improvement. Ongoing symptoms currently.  He is getting on going vestibular rehab services for presumed vestibular neuronitis.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: 3 days following vaccination, Patient developed intense vertigo.  He was suddenly unable to walk or stand due to the sensation. They tried acetaminophen. They started meclizine. and Prednisone 40 mg taper on 1/25 after seeing ENT, Dr. at clinic.  Audiology exam normal on 1/27. Due to unresolving symptoms, he was admitted to hospital on 2/14. had Neurology evaluation that was normal. Spent time on rehab service, discharged  2/26. Has had very slow improvement. Ongoing symptoms currently.  He is getting on going vestibular rehab services for presumed vestibular neuronitis.
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; The patient received an expired PROQUAD; This spontaneous report was received from registered nurse referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 10-MAR-2022, the patient was vaccinated with and expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (1 dose, lot # was reported as t030943, upon internal validation established as T030943, expiration date: 09-MAR-2022; strength and route were not reported) for prophylaxis (expired product administered).  No additional adverse events were reported.  This is non-valid case due to lack of patient's identifier.  Follow Up information has been received on 22-APR-2022 from registered nurse referring to a 04-year-old female. Her medical history included astigmatism and rhinitis allergic. Concomitant therapies included diphtheria vaccine toxoid (+) pertussis vaccine acellular 5-component  (+)  polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (QUADRACEL) and  and varicella zoster vaccine live (VARIVAX). The operator of vaccine was a healthcare professional, the patient was vaccinated at private doctors office/hospital and was purchased with public funds. No temperature excursion as a result of a reading from a Data Logger  The patient was vaccinated with and expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) subcutaneously on the left arm    The patients weight was updated (unable to read it).  The event of expired product administered was related to measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD).
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; PROQUAD vaccine that was 22 days expired had been administered to her daughter; This spontaneous report was received from nurse and refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 29-MAR-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T030479, expiration date: 07-MAR-2022) (dose and route not reported) that was 22 days expired. The nurse could not confirm or deny whether it had experienced any temperature excursions. Concomitant therapy included sterile diluent.
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Expired product administered
Clinical narrative: no adverse event; PROQUAD vaccine that was 22 days expired had been administered to her daughter; This spontaneous report was received from nurse and refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 29-MAR-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T030479, expiration date: 07-MAR-2022) (dose and route not reported) that was 22 days expired. The nurse could not confirm or deny whether it had experienced any temperature excursions. Concomitant therapy included sterile diluent.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Arthritis, Inflammation, Joint swelling, Knee arthroplasty
Clinical narrative: Severe pain and swelling in my right knee; Severe pain and swelling in my right knee; The fluid was inflammatory.; Fluid drained from knee; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: EW0167) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "Thyroidectomy" (unspecified if ongoing); "Arthritis" (unspecified if ongoing), notes: I have mild arthritis in that knee at, baseline; "TKR" (unspecified if ongoing), notes: TKR in my other knee. Concomitant medication(s) included: SYNTHROID. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Location: Left Arm, Batch/Lot Number: EK9231), administration date: 11Jan2021, when the patient was 53-year-old, for Covid-19 immunization; BNT162b2 (DOSE 1, SINGLE, Location: Left Arm, Batch/Lot Number: EJ1685), administration date: 23Dec2020, when the patient was 53-year-old, for COVID-19 Immunization. The following information was reported: JOINT FLUID DRAINAGE (non-serious) with onset 02Oct2021, outcome "recovered", described as "Fluid drained from knee"; ARTHRALGIA (non-serious), JOINT SWELLING (non-serious) all with onset 02Oct2021, outcome "recovered" and all described as "Severe pain and swelling in my right knee"; INFLAMMATION (non-serious) with onset 02Oct2021, outcome "recovered", described as "The fluid was inflammatory.". The events "severe pain and swelling in my right knee", "the fluid was inflammatory." and "fluid drained from knee" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, joint swelling, inflammation, joint fluid drainage.  Additional information: No other vaccine in four weeks. Other medications in two weeks: Synthroid, Calcium Supplement. Adverse event: 3 days after vaccine the patient developed severe pain and swelling in my right knee. Pain was acute onset and required fluid being removed from my knee. The fluid was inflammatory. The patient had mild arthritis in that knee at baseline. TKR in other knee. Within a week to 10 days all symptoms were resolved. Adverse event start date: 02Oct2021. Ae resulted in: Doctor or other healthcare professional office. The patient recovered. Treatment included: Fluid drained from knee. Anti inflammatory prescr. No covid prior to vaccination. The patient got covid tested post vaccination. Covid test type post vaccination: Nasal Swab. Covid test name post vaccination: PCR. Covid test date:10Jan2022. Covid test result: Positive. Known allergies: No.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Severe pain and swelling in my right knee; Severe pain and swelling in my right knee; The fluid was inflammatory.; Fluid drained from knee; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: EW0167) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "Thyroidectomy" (unspecified if ongoing); "Arthritis" (unspecified if ongoing), notes: I have mild arthritis in that knee at, baseline; "TKR" (unspecified if ongoing), notes: TKR in my other knee. Concomitant medication(s) included: SYNTHROID. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Location: Left Arm, Batch/Lot Number: EK9231), administration date: 11Jan2021, when the patient was 53-year-old, for Covid-19 immunization; BNT162b2 (DOSE 1, SINGLE, Location: Left Arm, Batch/Lot Number: EJ1685), administration date: 23Dec2020, when the patient was 53-year-old, for COVID-19 Immunization. The following information was reported: JOINT FLUID DRAINAGE (non-serious) with onset 02Oct2021, outcome "recovered", described as "Fluid drained from knee"; ARTHRALGIA (non-serious), JOINT SWELLING (non-serious) all with onset 02Oct2021, outcome "recovered" and all described as "Severe pain and swelling in my right knee"; INFLAMMATION (non-serious) with onset 02Oct2021, outcome "recovered", described as "The fluid was inflammatory.". The events "severe pain and swelling in my right knee", "the fluid was inflammatory." and "fluid drained from knee" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, joint swelling, inflammation, joint fluid drainage.  Additional information: No other vaccine in four weeks. Other medications in two weeks: Synthroid, Calcium Supplement. Adverse event: 3 days after vaccine the patient developed severe pain and swelling in my right knee. Pain was acute onset and required fluid being removed from my knee. The fluid was inflammatory. The patient had mild arthritis in that knee at baseline. TKR in other knee. Within a week to 10 days all symptoms were resolved. Adverse event start date: 02Oct2021. Ae resulted in: Doctor or other healthcare professional office. The patient recovered. Treatment included: Fluid drained from knee. Anti inflammatory prescr. No covid prior to vaccination. The patient got covid tested post vaccination. Covid test type post vaccination: Nasal Swab. Covid test name post vaccination: PCR. Covid test date:10Jan2022. Covid test result: Positive. Known allergies: No.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Inflammation, Joint fluid drainage, Joint swelling, SARS-CoV-2 test
Clinical narrative: Severe pain and swelling in my right knee; Severe pain and swelling in my right knee; The fluid was inflammatory.; Fluid drained from knee; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: EW0167) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "Thyroidectomy" (unspecified if ongoing); "Arthritis" (unspecified if ongoing), notes: I have mild arthritis in that knee at, baseline; "TKR" (unspecified if ongoing), notes: TKR in my other knee. Concomitant medication(s) included: SYNTHROID. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Location: Left Arm, Batch/Lot Number: EK9231), administration date: 11Jan2021, when the patient was 53-year-old, for Covid-19 immunization; BNT162b2 (DOSE 1, SINGLE, Location: Left Arm, Batch/Lot Number: EJ1685), administration date: 23Dec2020, when the patient was 53-year-old, for COVID-19 Immunization. The following information was reported: JOINT FLUID DRAINAGE (non-serious) with onset 02Oct2021, outcome "recovered", described as "Fluid drained from knee"; ARTHRALGIA (non-serious), JOINT SWELLING (non-serious) all with onset 02Oct2021, outcome "recovered" and all described as "Severe pain and swelling in my right knee"; INFLAMMATION (non-serious) with onset 02Oct2021, outcome "recovered", described as "The fluid was inflammatory.". The events "severe pain and swelling in my right knee", "the fluid was inflammatory." and "fluid drained from knee" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, joint swelling, inflammation, joint fluid drainage.  Additional information: No other vaccine in four weeks. Other medications in two weeks: Synthroid, Calcium Supplement. Adverse event: 3 days after vaccine the patient developed severe pain and swelling in my right knee. Pain was acute onset and required fluid being removed from my knee. The fluid was inflammatory. The patient had mild arthritis in that knee at baseline. TKR in other knee. Within a week to 10 days all symptoms were resolved. Adverse event start date: 02Oct2021. Ae resulted in: Doctor or other healthcare professional office. The patient recovered. Treatment included: Fluid drained from knee. Anti inflammatory prescr. No covid prior to vaccination. The patient got covid tested post vaccination. Covid test type post vaccination: Nasal Swab. Covid test name post vaccination: PCR. Covid test date:10Jan2022. Covid test result: Positive. Known allergies: No.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Hosp on 4/20 VAERS electronic number was discharged 4/25.  READMIT 4/25 with Acute respiratory failure and probable multiple septic emboli of lungs. Patient had a PEA arrest, ACLS with ROSC x 2 on 4/26, care was withdrawn and patient passed away 4/26.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, Angiogram pulmonary abnormal, Cardiac arrest, Death, Life support
Clinical narrative: Hosp on 4/20 VAERS electronic number was discharged 4/25.  READMIT 4/25 with Acute respiratory failure and probable multiple septic emboli of lungs. Patient had a PEA arrest, ACLS with ROSC x 2 on 4/26, care was withdrawn and patient passed away 4/26.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy mediastinal, Pulmonary mass, Pulseless electrical activity, Septic pulmonary embolism
Clinical narrative: Hosp on 4/20 VAERS electronic number was discharged 4/25.  READMIT 4/25 with Acute respiratory failure and probable multiple septic emboli of lungs. Patient had a PEA arrest, ACLS with ROSC x 2 on 4/26, care was withdrawn and patient passed away 4/26.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: Pregnant at the time of first dose//Pregnant at the time of 2nd dose; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant at the time of first dose//Pregnant at the time of 2nd dose) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 24-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant at the time of first dose//Pregnant at the time of 2nd dose). The delivery occurred, which was reported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Delivered NOS. On 24-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant at the time of first dose//Pregnant at the time of 2nd dose) had resolved.            No concomitant and treatment medications were reported. Patient was 27 weeks pregnant at the time of first dose and 31 weeks pregnant at the time of second dose. Patient did not breastfeed at all.  It was reported, after booster dose patient had a lot of vertigo during the month of December 2021. The vertigo eventually went away.  Company Comment: This Regulatory Authority case of maternal exposure during pregnancy concerns a 33-year-old female patient, with no medical history reported, who experienced the unexpected and serious (hospitalization) event of Vaginal discharge. The patient received first and second dose of mRNA-1273 during the third trimester of gestation, and gave birth to a healthy baby approximately 3 weeks after the second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-546462 (Patient Link).; Sender's Comments: This Regulatory Authority case of maternal exposure during pregnancy concerns a 33-year-old female patient, with no medical history reported, who experienced the unexpected and serious (hospitalization) event of Vaginal discharge. The patient received first and second dose of mRNA-1273 during the third trimester of gestation, and gave birth to a healthy baby approximately 3 weeks after the second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant at the time of first dose//Pregnant at the time of 2nd dose; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant at the time of first dose//Pregnant at the time of 2nd dose) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 24-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant at the time of first dose//Pregnant at the time of 2nd dose). The delivery occurred, which was reported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Delivered NOS. On 24-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant at the time of first dose//Pregnant at the time of 2nd dose) had resolved.            No concomitant and treatment medications were reported. Patient was 27 weeks pregnant at the time of first dose and 31 weeks pregnant at the time of second dose. Patient did not breastfeed at all.  It was reported, after booster dose patient had a lot of vertigo during the month of December 2021. The vertigo eventually went away.  Company Comment: This Regulatory Authority case of maternal exposure during pregnancy concerns a 33-year-old female patient, with no medical history reported, who experienced the unexpected and serious (hospitalization) event of Vaginal discharge. The patient received first and second dose of mRNA-1273 during the third trimester of gestation, and gave birth to a healthy baby approximately 3 weeks after the second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-546462 (Patient Link).; Sender's Comments: This Regulatory Authority case of maternal exposure during pregnancy concerns a 33-year-old female patient, with no medical history reported, who experienced the unexpected and serious (hospitalization) event of Vaginal discharge. The patient received first and second dose of mRNA-1273 during the third trimester of gestation, and gave birth to a healthy baby approximately 3 weeks after the second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Cold sweat, Fatigue, Headache
Clinical narrative: Chills, fever, hardening of muscle, headache, joint pain, muscle pain, body aches, cold sweats, red splotches at injection site, inability to move left arm without severe pain, fatigue.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Myalgia, Myosclerosis, Pain
Clinical narrative: Chills, fever, hardening of muscle, headache, joint pain, muscle pain, body aches, cold sweats, red splotches at injection site, inability to move left arm without severe pain, fatigue.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Chills, fever, hardening of muscle, headache, joint pain, muscle pain, body aches, cold sweats, red splotches at injection site, inability to move left arm without severe pain, fatigue.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Contraception, Heavy menstrual bleeding, Laboratory test, Magnetic resonance imaging, Menstrual disorder
Clinical narrative: My menstrual cycle changed. My period was normally every 27-28 days, now it's changed to every 34-36 days, it's really heavy and lasting for about 10 days. I went to my Gynecologist. I had labs done, with X-rays and an MRI. Uterine Fibroids were found. Took birth control for 3 months hoping that it would regulate my period, but it hasn't helped. The next step would be for my doctor to perform an Ablation. I haven't had this done yet.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Uterine leiomyoma, X-ray
Clinical narrative: My menstrual cycle changed. My period was normally every 27-28 days, now it's changed to every 34-36 days, it's really heavy and lasting for about 10 days. I went to my Gynecologist. I had labs done, with X-rays and an MRI. Uterine Fibroids were found. Took birth control for 3 months hoping that it would regulate my period, but it hasn't helped. The next step would be for my doctor to perform an Ablation. I haven't had this done yet.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Feeling abnormal, Headache, Immediate post-injection reaction, Mobility decreased
Clinical narrative: Immediately after my vaccine I became disoriented and had to sit down for about 30 minutes. Felt bad that night and woke up in the middle of the night with a bad headache. I took Tylenol and it helped a little. Two weeks later I started getting Vertigo, it was so bad I could barely function. It's lessened over time. Now I get these episodes every couple of months. It's still off and on.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Immediately after my vaccine I became disoriented and had to sit down for about 30 minutes. Felt bad that night and woke up in the middle of the night with a bad headache. I took Tylenol and it helped a little. Two weeks later I started getting Vertigo, it was so bad I could barely function. It's lessened over time. Now I get these episodes every couple of months. It's still off and on.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Fatigue, Headache
Clinical narrative: Client presented at the vaccination site on 12.26.21. Client reported he received first dose of Pfizer COVID vaccine on 04/29/21, she had only pain at the injection site lasted only one day. Client reported with her second dose of Pfizer COVID vaccine on 05/20/21, she said after five to six hours she had the chills, headache, tiredness, fever, body ache which lasted for three days. Client reported she took Tylenol for the fever and body ache with the second dose of Pfizer COVID vaccine on her second day. Client also reported with her second dose of Pfizer COVID vaccine, she lost her sense of taste and smell for three weeks. She stated she didn?t get tested during the two doses of Pizer COVID vaccine. Client stated she got COVID tested four days ago with a negative result. She reported she didn?t follow-up with her PCP after both doses. She denied shortness of breath, dizziness, or any anaphylactic symptoms with both doses. Client reported she has no chronic illnesses or any known allergy. Client is requesting for booster dose of Pfizer COVID vaccine. PHN submitted a medical consult via text message to clinical project coordinator requesting to proceed with the booster dose of Pfizer COVID vaccine. PHN received approval to proceed with the booster dose of Pfizer COVID vaccine was obtained via text message from clinical project coordinator, per CDC guidelines. Client received the booster dose of Pfizer COVID vaccine, LOT#: FL3197 on 12/26/21 at 1708 by RN. The client did not report any symptoms during the 30-minute observation period. PHN educated client on possible adverse reactions and when to seek EMS. Client verbalized understanding. Client left vaccination site at 1738 unassisted and with a steady gait.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Client presented at the vaccination site on 12.26.21. Client reported he received first dose of Pfizer COVID vaccine on 04/29/21, she had only pain at the injection site lasted only one day. Client reported with her second dose of Pfizer COVID vaccine on 05/20/21, she said after five to six hours she had the chills, headache, tiredness, fever, body ache which lasted for three days. Client reported she took Tylenol for the fever and body ache with the second dose of Pfizer COVID vaccine on her second day. Client also reported with her second dose of Pfizer COVID vaccine, she lost her sense of taste and smell for three weeks. She stated she didn?t get tested during the two doses of Pizer COVID vaccine. Client stated she got COVID tested four days ago with a negative result. She reported she didn?t follow-up with her PCP after both doses. She denied shortness of breath, dizziness, or any anaphylactic symptoms with both doses. Client reported she has no chronic illnesses or any known allergy. Client is requesting for booster dose of Pfizer COVID vaccine. PHN submitted a medical consult via text message to clinical project coordinator requesting to proceed with the booster dose of Pfizer COVID vaccine. PHN received approval to proceed with the booster dose of Pfizer COVID vaccine was obtained via text message from clinical project coordinator, per CDC guidelines. Client received the booster dose of Pfizer COVID vaccine, LOT#: FL3197 on 12/26/21 at 1708 by RN. The client did not report any symptoms during the 30-minute observation period. PHN educated client on possible adverse reactions and when to seek EMS. Client verbalized understanding. Client left vaccination site at 1738 unassisted and with a steady gait.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Gastroenteritis viral, Nausea, Pyrexia
Clinical narrative: Stomach virus, lasting from 4/17/2022 to 4/21/2022. Symptoms included fever, nausea, and diarrhea
Age: 52.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Glycosylated haemoglobin increased, Type 2 diabetes mellitus
Clinical narrative: Diagnosed with type 2 diabetes. Prior to vaccine, A1C was always under 7.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Client presented at the vaccination site on 01.06.22. Client?s parent reported she received first dose of Pfizer COVID vaccine on 12/16/21. Client?s parent reported within 15 minutes after the vaccine, the client had a nose bleeding which lasted for 5 minutes only. Client?s parents denied any dizziness or shortness of breath with first dose of Pfizer COVID vaccine. Client?s parent reported no medications administered. Client?s father stated it happened the same with him when he was young that he has nose bleeding too after certain vaccines. Client?s parent reported he didn?t take child to follow-up with her PCP. Client?s parent reported client has no chronic conditions, medications, or allergies. Client?s parent is requesting for second dose of Pfizer COVID vaccine today. PHN submitted a medical consult via text message to clinical project coordinator requesting to proceed with the second dose of Pfizer COVID vaccine. Per the doctor, approval to proceed with the second dose of Pfizer COVID vaccine was obtained via text message from clinical project coordinator. Client received the second dose of Pfizer COVID vaccine, LOT #: FF5618 on 01.06.22 at 1545 by LVN. The client did not report any symptoms during the 30-minute observation period. PHN educated client?s parent on possible adverse reactions and when to seek EMS. Client?s parent verbalized understanding. Client left vaccination site with his parent at 1615 unassisted and with a steady gait.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Asthenia, Laboratory test normal, Urticaria
Clinical narrative: Severe chronic hives after angioedema.  Very debilitating.  Taking large quantities of daily medicine to help and having to take zolair and still daily hives.  No sign of improvement
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster, Immunisation, Off label use
Clinical narrative: Off label use; Booster; shingles; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 3 (Booster), Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (Primary immunization series completed, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), outcome "unknown"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; HERPES ZOSTER (non-serious), outcome "unknown", described as "shingles". Therapeutic measures were taken as a result of herpes zoster.  Additional Information: Patient stated that I received the fourth dosis of your Covid vaccine a few days ago. Right now, I am on bed because I have developed shingles. I visited dermatologist, then she diagnosed the deseas. I am taking antivirals and cream. I have had a very uncomfortable time.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Device connection issue, Incorrect dose administered, No adverse event
Clinical narrative: no additional adverse events; needle and syringe malfunctioned and disconnected from each other" while administering PROQUAD; uncertain how much vaccine was given to patient; This spontaneous report has been received from a licensed practical nurse referring to a 1-year-old patient of unspecified age. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies were not reported.   On 28-MAR-2022, the patient was vaccinated with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) (dose, route of administration, vaccine scheme, and anatomical site of vaccination was not reported; lo number U029322 has been verified to be valid, expiration date reported and established as 19-MAR-2023) as prophylaxis.   The reporter stated that while administering measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD), the needle and syringe malfunctioned and disconnected from each other (device connection issue). It was uncertain how much vaccine was given to patient (incorrect dose administered) and if it should be repeated. No additional adverse event was reported (no adverse event).   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA010353:
Age: 1.92
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; VARIVAX was administered after a temperature excursion; This spontaneous report has been received from a medical assistant referring to a 23-month-old female patient. The patient's pertinent medical history, previous drug reactions or allergies, concurrent conditions, and concomitant therapies were not reported.  On 11-APR-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliters (ml) (route of administration, anatomical site of vaccination, and vaccine scheme were not reported; lot number U015688 has been verified to be valid, expiration date reported and established as 18-MAY-2023) as prophylaxis.   It was reported that the vaccine was exposed to a temperature excursion of 12.95 degrees Fahrenheit (F), during a time frame of 21 hours and 15 minutes before it was administered to the patient (product storage error). No additional adverse event was reported (no adverse event). No previous temperature excursion was reported.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection, Seizure
Clinical narrative: 2 years old patient received ROTAETQ; patient received ROTATEQ and was later diagnosed with rotavirus and esperienced seizures; patient received ROTATEQand was later diagnosed with rotavirus; This spontaneous report has been received from consumer and refers to a 2-year-old patient.  The patient's concurrent conditions, medical history, concomitant therapies and previous drugs reactions or allergies were not reported.   On an unknown date in 2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis (strength, lot number, and expiration date were not provided).  On 28-MAR-2022, the patient was diagnosed with rotavirus (rotavirus infection) and experienced seizures. The causal relationship between therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and rotavirus infection and  seizures and the outcome of the events were not reported.  Upon internal review, seizures was determined to be medically significant.