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From the 1/14/2022 release of VAERS data:

Found 1,031,637 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

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VAERS ID: 1988004 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Chest discomfort, Dizziness, Headache, Heart rate, Oxygen saturation, Pain assessment, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: Blood pressure; Result Unstructured Data: Test Result:135/79 mmHg; Test Date: 20211120; Test Name: Body temperature; Result Unstructured Data: Test Result:38.8 Centigrade; Test Date: 20211120; Test Name: Pulse rate; Result Unstructured Data: Test Result:118; Comments: beats/min; Test Date: 20211120; Test Name: Oxygen saturation; Test Result: 97 %; Test Date: 20211120; Test Name: Pain scale; Result Unstructured Data: Test Result:0 points
CDC Split Type: TWPFIZER INC202101849336

Write-up: SYNCOPE; HEADACHE; CHEST TIGHTNESS; dizziness; Body temperature: 38.8 Cel; This is a spontaneous report from a non-contactable healthcare professional from Regulatory Authority via License Party (BIONTECH). Regulatory number: TW-TFDA-TVS-1100014242. Other Case identifier: TW-Fosun-2021FOS007111. This is a spontaneous report received from a non-contactable HCP received via Center for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100014242. A 20-year-old female patient started to receive 2nd dose of Tozinameran (COMIRNATY) (batch number was not reported) on 18-Nov-2021 via intramuscular at single dose (reported as unknown dose with unspecified dosing frequency) for COVID-19 immunization. The 1st dose was received on an unknown date. Medical history was not reported. Concomitant medication and past product were not reported. The patient experienced headache, syncope, chest tightness on 20-Nov-2021. On 18-Nov-2021 the patient received the second agent of BNT vaccine. On 20-Nov-2021 (the second morning), the patient felt chest tightness and dizziness and went to the hospital emergency for medical treatment. Pain index: 0 points; blood oxygen concentration: 97%; blood pressure: 135/79 mmHg; pulse: 118 times/min; Body temperature: 38.8 Cel. The patient was given the prescription of Sodium chloride 0.9%, 500 ml/bag St IV; Acetaminophen 500 mg/Tab 1 # ST PO; Acetaminophen 500 mg/tab 1 # prn qid. After the situation was stable, the patient returned home. After the emergency physician evaluated, the adverse reaction caused by the BNT vaccine could not be excluded. Syncope met the seriousness criterion of Important Medical Event. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were recovering. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. Causality Assessments: Drug: bnt162b2 Headache, Syncope, Chest tightness Per Reporter = Possible Per Company (BioNTech) = Possible Bnt162b2 (COMIRNATY) is under agreement with BioNTech.


VAERS ID: 1988014 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-20
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Trigeminal neuralgia
SMQs:, Demyelination (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101854604

Write-up: TRIGEMINAL NEURALGIA; This is a spontaneous report received from a non-contactable healthcare professional via Regulatory Authority from License Party (BioNTech SE). Regulatory number: TW-TFDA-TVS-1100013932. Other Case identifier: TW-Fosun-2021FOS007142. This is a spontaneous report received from a non-contactable HCP received via a regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100013932. A 38-year-old male patient started to receive 2nd dose of Tozinameran (COMIRNATY) (batch number was not reported) on 15-Nov-2021 via intramuscular at unknown dose with unspecified dosing frequency for COVID-19 immunization. The 1st dose was received on an unknown date. Medical history, concomitant medication and past product were not reported. The patient experienced trigeminal neuralgia on 21-Nov-2021. At night of 21-Nov-2021, the patient went to the hospital emergency, and complaint last day: the right face and headache were uncomfortable, forehead, face, gums. After the diagnosis and treatment, the Acetaminophen, Diclofenac and Thiamine were given. On 22-Nov-2021, TriGeminal Neuralgia. Nicametate, Imipramine were given after diagnosis and treatment. Trigeminal neuralgia met the seriousness criterion of Other Medically Important Condition. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was recovering. Initial report was received on 15-Dec-2021. Causality Assessment: Neuralgia trigeminal; Per Reporter was Possible; Per Company (BioNTech SE) was Possible. BNT162b2 is under agreement with BioNTech SE.


VAERS ID: 1988015 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-29
Onset:2021-11-20
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101853358

Write-up: This is a spontaneous report received from non-contactable healthcare professional from License Party (BioNTech SE) and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100013949 (Regulatory Authority). Other Case identifier(s): TW-Fosun-2021FOS007144. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100013949. A 23-year-old male patient started to receive a dose of Tozinameran (COMIRNATY) (batch number was not reported) on 29-Oct-2021 via intramuscular at unknown dose with unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication and past product were not reported. The patient experienced dyspnea and chest tightness on 20-Nov-2021. On 29-Oct-2021, the patient was inoculated with BNT vaccine. On 20-Nov-2021, the patient experienced dyspnea and chest tightness. On 22-Nov-2021, the patient was transferred to the general ward and the situation was ok. The symptoms had a mitigation. On 24-Nov-2021, the patient was discharged. On 29-Nov-2021, the patient''s symptoms were alleviated. Dyspnoea and chest tightness met the seriousness criterion of Life Threatening and Hospitalization. At the time of the report, the outcomes of the events were recovering. The patient was discharged on 24-Nov-2021. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. Causality Assessment: Dyspnoea, Chest tightness Per Reporter = Possible Per Company (BioNTech SE) = Possible BNT162B2 (COMIRNATY) is under agreement with BioNTech SE. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1988048 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101854877

Write-up: HEART PAIN; HEADACHE; NAUSEA; This is a spontaneous report received from a non-contactable healthcare professional from Regulatory Authority, via License Party (BioNTech). Regulatory number: TW-TFDA-TVS-1100014425 Regulatory Authority. Other Case identifier: TW-Fosun-2021FOS007211 Regulatory Authority. This is a spontaneous report received from a non-contactable HCP received via Agency Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100014425. A 20-year-old female patient started to receive 2nd dose of Tozinameran (COMIRNATY) (batch number: unknown) on 20-Nov-2021 via unknown route at an unknown dose with unspecified dosing frequency for COVID-19 immunization. The 1st dose was received on an unknown date. Medical history, concomitant medications and past product were not reported. The patient experienced headache, nausea, heart pain on 20-Nov-2021. On 20-Nov-2021, the patient received 2nd dose of BNT vaccine. At 7:00 pm in the evening, the patient start pain, nausea and heart pain. On 21-Nov-2021, due to the above symptoms did not improve, the patient the visited hospital and was given diphenhydramine, acetamol injection and fucole parant after diagnosis for treatment. Heart pain met the seriousness criterion of Other Medically Important Condition. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were recovering. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. Causality Assessments: the causality of the events headache, nausea and cardiac pain was considered possible per reporter and company (BioNTech). Bnt162b2 (COMIRNATY) is under agreement with BioNTech.


VAERS ID: 1989640 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Neuropathy peripheral, Paraesthesia
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Immune-mediated/autoimmune disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101789890

Write-up: This is a spontaneous report received from a contactable other HCP, via the regulatory authority (678785 TGA ADR#). A 25-year-old female patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), on Nov 19, 2021, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications not reported. The patient developed peripheral neuropathy (medically significant), hypoesthesia and paresthesia, all onset Nov 20, 2021, with outcome of not recovered. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.


VAERS ID: 1989782 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cardiovascular insufficiency, Chest discomfort, Computerised tomogram head, Dyspnoea, Electrocardiogram, Fatigue, Feeling cold, Immunisation, Laboratory test, Limb discomfort, Neurological examination, Pain in extremity, Paraesthesia, Physical examination, Skin discolouration, Ultrasound Doppler, Vaccination site paraesthesia, X-ray
SMQs:, Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Gilbert''s syndrome
Preexisting Conditions: Medical History/Concurrent Conditions: Anticoagulant therapy (during pregnancy, due to suspected thrombosis); Coronary heart disease (grandfather died of coronary heart disease); Myocardial infarction (grandfather had a myocardial infarction at the age of 33); Ovarian cystectomy (Ovarian repair); Stroke (the grandmother had a stroke at age 57 and died of the same diagnosis at age 77); Comments: Family history: grandfather had a myocardial infarction at the age of 33 and died of coronary heart disease; the grandmother had a stroke at age 57 and died of the same diagnosis at age 77; parents are healthy Allergy: none
Allergies:
Diagnostic Lab Data: Test Date: 20211130; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:125/80 mmHg; Test Date: 20211129; Test Name: Brain CT; Result Unstructured Data: Test Result:paresthesia; Test Date: 20211128; Test Name: ECG; Result Unstructured Data: Test Result:probably musculoskeletal etiology; Test Date: 20211128; Test Name: Laboratory test; Result Unstructured Data: Test Result:probably musculoskeletal etiology; Test Date: 20211129; Test Name: Laboratory test; Result Unstructured Data: Test Result:paresthesia; Test Date: 20211129; Test Name: Neurological examination; Result Unstructured Data: Test Result:paresthesia; Test Date: 2021; Test Name: Physical examination; Result Unstructured Data: Test Result:When examined, the left shoulder does not hurt; Comments: there is no sensory disturbance, a slightly sensitive cervical spine, no limitation of mobility, pupils are equal, the tongue crawls in the middle and is wet, the head does not hurt. Chvostek sign negative, Romberg negative, taxis targeting, Mingazzini negative, the left hand seems slightly weaker and the hand is a lighter color; Test Date: 20211128; Test Name: Doppler ultrasound; Result Unstructured Data: Test Result:probably musculoskeletal etiology; Test Date: 20211128; Test Name: X-ray; Result Unstructured Data: Test Result:probably musculoskeletal etiology
CDC Split Type: CZPFIZER INC202101799151

Write-up: Fatigue; Feeling of pressure on the outside of the left upper limb; Feeling cold; No blood supply to the fingertips; Paresthesia of the left upper limb; Grayish skin discolouration; Chest pressure; Poor breathing; Left lower limb pain; Paresthesia of the calf and foot of the left lower limb/Paresthesia of the left lower limb; Booster; Paresthesia around the injection site; This is a spontaneous report received from a contactable reporter(s) (Physician) Regulatory number: CZ-CZSUKL-21012780. A 42 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 42 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Ovarian cyst surgery on the right", start date: 2009 (not ongoing), notes: Ovarian repair; "Anticoagulant therapy" (unspecified if ongoing), notes: during pregnancy, due to suspected thrombosis; "Gilbert''s syndrome" (ongoing). No allergies were reported. Family history included: "Myocardial infarction" (not ongoing), notes: grandfather had a myocardial infarction at the age of 33; "Coronary heart disease" (not ongoing), notes: grandfather died of coronary heart disease; "Stroke" (not ongoing), notes: the grandmother had a stroke at age 57 and died of the same diagnosis at age 77. Parents are healthy. There were no concomitant medications. Vaccination history included: Comirnaty (Dose 1), administration date: 11Mar2021, for COVID-19 immunisation; Comirnaty (Dose 2), administration date: 01Apr2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; CARDIOVASCULAR INSUFFICIENCY (medically significant) with onset 29Nov2021, outcome "unknown", described as "No blood supply to the fingertips"; VACCINATION SITE PARAESTHESIA (medically significant) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Paresthesia around the injection site"; PARAESTHESIA (medically significant) with onset 22Nov2021, outcome "recovering", described as "Paresthesia of the calf and foot of the left lower limb/Paresthesia of the left lower limb"; CHEST DISCOMFORT (medically significant) with onset 27Nov2021, outcome "recovering", described as "Chest pressure"; DYSPNOEA (medically significant) with onset 27Nov2021, outcome "recovering", described as "Poor breathing"; PARAESTHESIA (medically significant) with onset 29Nov2021, outcome "recovering", described as "Paresthesia of the left upper limb"; SKIN DISCOLOURATION (medically significant) with onset 29Nov2021, outcome "recovering", described as "Grayish skin discolouration"; PAIN IN EXTREMITY (non-serious) with onset 22Nov2021, outcome "recovering", described as "Left lower limb pain"; FEELING COLD (non-serious) with onset 29Nov2021, outcome "recovering", described as "Feeling cold"; FATIGUE (non-serious) with onset 30Nov2021, outcome "recovering", described as "Fatigue"; LIMB DISCOMFORT (non-serious) with onset 30Nov2021, outcome "recovering", described as "Feeling of pressure on the outside of the left upper limb". The events "no blood supply to the fingertips", "paresthesia of the calf and foot of the left lower limb/paresthesia of the left lower limb", "chest pressure", "poor breathing", "paresthesia of the left upper limb", "grayish skin discolouration", "left lower limb pain", "feeling cold", "fatigue" and "feeling of pressure on the outside of the left upper limb" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (30Nov2021) 125/80 mmHg; computerised tomogram head: (29Nov2021) paresthesia; electrocardiogram: (28Nov2021) probably musculoskeletal etiology; laboratory test: (28Nov2021) probably musculoskeletal etiology; (29Nov2021) paresthesia; neurological examination: (29Nov2021) paresthesia; ultrasound doppler: (28Nov2021) probably musculoskeletal etiology; x-ray: (28Nov2021) probably musculoskeletal etiology; physical examination: (2021) when examined, the left shoulder does not hurt, notes: there is no sensory disturbance, a slightly sensitive cervical spine, no limitation of mobility, pupils are equal, the tongue crawls in the middle and is wet, the head does not hurt. Chvostek sign negative, Romberg negative, taxis targeting, Mingazzini negative, the left hand seems slightly weaker and the hand is a lighter color. Therapeutic measures were taken as a result of cardiovascular insufficiency, vaccination site paraesthesia, paraesthesia, chest discomfort, paraesthesia, dyspnoea, paraesthesia, skin discolouration, pain in extremity, feeling cold, fatigue, limb discomfort. Clinical course: About 3-4 hours after the application, the patient had paresthesia around the injection site, and the symptom disappeared by the next day. On 22Nov2021 the patient had paresthesia of her left leg on her calf and foot, she took magnesium, paresthesia and slight pain of varying intensity in the following days. On 27Nov2021 paresthesia of the entire left lower limb, she felt pressure on her chest and she was breathing poorly. The next morning, the paresthesia''s subsided, but they returned during the exercise, the patient went to the hospital to the emergency, with no temperature, and the shoulder was no longer a problem. At the hospital, they performed laboratory tests, X-rays, ECGs, and Doppler ultrasound of the left lower limb, and doctors concluded that they were probably a problem of musculoskeletal etiology. Analgesics were recommended to the patient as needed and checked by a general practitioner. On 29Nov2021: In the morning without any problems, during the morning again paresthesia of the left upper limb, greyish skin color, feeling cold and not blood supply to the fingertips. The patient went to the emergency room again, where she had a laboratory examination, brain CT. Neurological examination with conclusion - paresthesia of the left limbs. The patient was advised to rest, fluids, temporarily increase magnesium intake, and MRI of the brain. On 30Nov2021 during the examination, the patient feels pressure and fatigue on the outside of the entire left upper limb. In addition to the problem, she feels normal. Milgamma or Neuritogen, Secatoxin in ascending dose, and Magnosolv were recommended to the patient. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1990225 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7911 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chest pain, Dyspnoea, Electrocardiogram, Influenza like illness, Migraine, Oxygen saturation, Oxygen saturation decreased, Ultrasound scan
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211128; Test Name: Electrocardiography; Result Unstructured Data: Test Result:within normal ranges; Test Date: 20211128; Test Name: Arterial oxygen saturation; Result Unstructured Data: Test Result:Desaturation; Test Date: 20211128; Test Name: Ultrasound; Result Unstructured Data: Test Result:within normal ranges
CDC Split Type: FRPFIZER INC202101798981

Write-up: Arterial oxygen saturation decreased; Chest pain; Dyspnea; Asthenia / intense fatigue; Violent daily migraines; Influenza like illness / Fever; This is a spontaneous report received from a contactable reporter (Pharmacist) from the regulatory authority-WEB. Regulatory number: FR-AFSSAPS-NC20216156. A 16 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 20Nov2021 (Lot number: FG7911) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1, Anatomical site: arm left), administration date: 23Oct2021, for Covid-19 immunisation. The following information was reported: OXYGEN SATURATION DECREASED (medically significant) with onset 28Nov2021, outcome "not recovered", described as "Arterial oxygen saturation decreased"; INFLUENZA LIKE ILLNESS (non-serious) with onset 20Nov2021, outcome "not recovered", described as "Influenza like illness / Fever"; MIGRAINE (non-serious) with onset 21Nov2021, outcome "not recovered", described as "Violent daily migraines"; CHEST PAIN (non-serious) with onset 24Nov2021, outcome "not recovered", described as "Chest pain"; DYSPNOEA (non-serious) with onset 24Nov2021, outcome "not recovered", described as "Dyspnea"; ASTHENIA (non-serious) with onset 24Nov2021, outcome "not recovered", described as "Asthenia / intense fatigue". The events "arterial oxygen saturation decreased", "influenza like illness / fever", "violent daily migraines", "chest pain", "dyspnea" and "asthenia / intense fatigue" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: electrocardiogram: (28Nov2021) within normal ranges; oxygen saturation: (28Nov2021) desaturation; ultrasound scan: (28Nov2021) within normal ranges. Therapeutic measures were taken as a result of migraine with Paracetamol. Clinical course: The declarant reported ''Fever in the hours that followed the injection. Feeling of constriction from 24Nov, around the chest, with stitches on the left side. Low saturation (taken by the medical centre on 28Nov. Violent daily migraines and intense fatigue. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1990260 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-11-20
   Days after vaccination:142
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Bronchial carcinoma; COPD
Preexisting Conditions: Medical History/Concurrent Conditions: Lung upper lobectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20211259566

Write-up: COVID-19 PNEUMONIA; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a physician by a Regulatory Authority (FR-AFSSAPS-RS20214316) on 28-DEC-2021 and concerned a 64 year old male. The patient''s weight was 96.6 kilograms, and height was 176 centimeters. The patient''s past medical history included: lung upper lobectomy, and concurrent conditions included: COPD (Chronic obstructive pulmonary disease) and bronchial carcinoma. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, intramuscular, batch number was not reported) 1 dosage forms, 1 total was administered on JUL-2021 for covid-19 vaccination. The batch number was not reported. Per procedure, no follow-up will be requested fort his case. No concomitant medications were reported. On 20-NOV-2021, the patient experienced covid-19 pneumonia and had suspected clinical vaccination failure. On an unspecified date, the patient was hospitalized. Number of days of hospitalization was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19 pneumonia and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint.


VAERS ID: 1990419 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Electrocardiogram, Hypoaesthesia, Immunisation, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Insulin dependent diabetic.
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:heart was working as normal; Test Date: 20211215; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101806185

Write-up: Heavy chest pain; The patient received third (booster) dose.; light feeling limbs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112150818109350-MSFK0 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26337823 (MHRA).A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK9413) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Insulin dependent diabetic" (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Insulin degludec for Diabetic. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: Unknown Route of administration: Unspecified), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE; Lot number: Unknown Route of administration: Unspecified), for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 20Nov2021, outcome "unknown", described as "The patient received third (booster) dose."; CHEST PAIN (hospitalization, medically significant) with onset 22Nov2021, outcome "recovered" (27Nov2021), described as "Heavy chest pain"; HYPOAESTHESIA (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "light feeling limbs". The patient was hospitalized for immunisation, chest pain, hypoaesthesia (start date: 2021). Heavy chest pain and light feeling limbs. Had an ECG which confirmed heart was working as normal and doctors said it''s most likely side effect to vaccine. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Report doesn''t relate to possible inflammation of the heart (myocarditis or pericarditis). The patient underwent the following laboratory tests and procedures: electrocardiogram: (unspecified date) heart was working as normal; sars-cov-2 test: (15Dec2021) no - negative covid-19 test.No follow-up attempts are possible. No further information is expected.


VAERS ID: 1990618 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test, Tinnitus
SMQs:, Hearing impairment (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; CLOPIDOGREL; INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20211209; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Worsening of tinnitus; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26351338) on 19-Dec-2021 and was forwarded to Moderna on 19-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of TINNITUS (Worsening of tinnitus) in a 61-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped). Concomitant products included ATORVASTATIN from 16-Aug-2021 to an unknown date and CLOPIDOGREL from 16-Aug-2021 to an unknown date for Stroke, INFLUENZA VACCINE (INFLUENZA VIRUS) from 12-Oct-2021 to an unknown date for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced TINNITUS (Worsening of tinnitus) (seriousness criterion medically significant). At the time of the report, TINNITUS (Worsening of tinnitus) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Dec-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had a normal reaction to the booster the following day, sore arm, headache and generally feeling a little unwell. The clicking noise in patient ear started at exactly the same time the side effects began. Patient already suffer from tinnitus in the same ear and have done so for a number of years. No treatment drug was provided by reporter. Company comment: This regulatory authority case concerns a 61-year-old female patient with a relevant medical history of Stroke and Tinnitus, who experienced the unexpected serious (medically significant) event of Worsening of tinnitus after mRNA- 1273 Moderna vaccine. Additionally, the patient also experienced the expected non serious events of Vaccination site pain and Headache. The events occurred approximately 1 day after the booster dose of mRNA- 1273 vaccine. The patient visited an ENT specialist and tinnitus and myoclonus were considered as provisional diagnosis. Very limited information is available regarding clinical course and further assessment. The seriousness criterion of the event was assessed as per regulatory authority report. Previous history of stroke and tinnitus remain a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 61-year-old female patient with a relevant medical history of Stroke and Tinnitus, who experienced the unexpected serious (medically significant) event of Worsening of tinnitus after mRNA- 1273 Moderna vaccine. Additionally, the patient also experienced the expected non serious events of Vaccination site pain and Headache. The events occurred approximately 1 day after the booster dose of mRNA- 1273 vaccine. The patient visited an ENT specialist and tinnitus and myoclonus were considered as provisional diagnosis. Very limited information is available regarding clinical course and further assessment. The seriousness criterion of the event was assessed as per regulatory authority report. Previous history of stroke and tinnitus remain a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.


VAERS ID: 1991007 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-13
Onset:2021-11-20
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Ultrasound Doppler
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211202; Test Name: Colour doppler scan; Result Unstructured Data: Test Result:deep vein thrombosis of popliteal vein confirmed; Comments: deep vein thrombosis of popliteal vein confirmed
CDC Split Type: ITPFIZER INC202101793000

Write-up: Left deep vein thrombosis; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: IT-MINISAL02-819528. A 45 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 13Nov2021 (Lot number: FG4686, Expiration Date: 28Feb2022) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DEEP VEIN THROMBOSIS (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Left deep vein thrombosis". The patient underwent the following laboratory tests and procedures: ultrasound doppler: (02Dec2021) deep vein thrombosis of popliteal vein confirmed, notes: deep vein thrombosis of popliteal vein confirmed. Therapeutic measures were taken as a result of deep vein thrombosis. Additional information: Medical History: no concurrent conditions, no recent trauma, no thrombophilia. 14Dec2021 Regional Pharmacovigilance Centre: follow up information: 02Dec2021 Echocolor doppler: deep vein thrombosis of popliteal vein confirmed. Thrombosis of the popliteal vein was confirmed, with the proximal end probably at the femoropopliteal junction, extended distally to the confluence with the veins of the lower limb; the echogenicity of the thrombus itself was slightly increased, as in the case of subacute findings. Sender''s comment: 10Dec2021: requested additional follow up information from the reporter regarding the case (clinical doc). Waiting. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1991398 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2382 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Retinal detachment
SMQs:, Accidents and injuries (broad), Retinal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MICARDIS PLUS; NOLPAZA
Current Illness: Hypertension arterial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SIPFIZER INC202101799810

Write-up: booster; minor retinal rupture (at 9 o''clock on the right eye); This is a spontaneous report received from contactable reporters (Physicians) from the regulatory authority. Regulatory number: SI-JAZMP-NCPHV-2021SI1434_1434 (JAZMP). Other Case identifier(s): JAZMP-300019266 (JAZMP:VigiFlow). A 67 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 20Nov2021 (Lot number: FF2382) at the age of 67 years as dose 3 (booster) 30 ug, single for covid-19 immunisation. Relevant medical history included: "Hypertension arterial" (ongoing). Concomitant medication(s) included: MICARDIS PLUS; NOLPAZA. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 2, manufacturer unknown), for covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "booster"; RETINAL DETACHMENT (medically significant) with onset 20Nov2021, outcome "unknown", described as "minor retinal rupture (at 9 o''clock on the right eye)". Clinical course: On 20Nov2021, the patient experienced minor retinal rupture (at 9 o''clock on the right eye) 1 day after the 3rd dose of Comirnaty.


VAERS ID: 1991450 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-10
Onset:2021-11-20
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abdominal pain upper, Back pain, Diarrhoea, Ear discomfort, Headache, Muscular weakness, Nausea, Pyrexia, Respiration abnormal, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101818727

Write-up: BREATHING ABNORMAL; HEADACHE; FEVER; NAUSEA; STOMACHACHE; ABDOMINAL PAIN; DIARRHEA (WATERY DIARRHEA); A SUDDEN EAR; BACK PAIN; VERTIGO; HANDS WEAKNESS; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party(BioNTech) and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014362 (Regulatory Authority). Other Case identifier(s): TW-Fosun-2021FOS006840. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100014362. A 19-year-old female patient started to receive 2nd dose of Tozinameran (COMIRNATY) (batch number was not reported) on 10-Nov-2021 via unknown route at unknown dose with unspecified dosing frequency for COVID-19 immunization. The 1st dose was received on an unknown date. Medical history included was not reported. Concomitant medications and past product were not reported. The patient experienced headache, nausea, stomachache, abdominal pain, diarrhea (watery diarrhea) and fever on 20-Nov-2021, experienced a sudden ear, hands weakness, breathing abnormal, back pain and vertigo on an unknown date. On 10-Nov-2021, the patient was given 2nd dose of vaccination. On 20-Nov-2021, the patient had abdominal pain and diarrhea. On 22-Nov-2021, the patient had a fever when returned to the clinic. Treatments of oral medicine "normal saline (N/S) 500ml, buscopan inj. 20mg/ml 1ml needle and Loperamide 2mg" were prescribed. The patient was recommended that outpatient transfers to hospitalize. On 24-Nov-2021, the physicians allowed the patient discharged. It was reported that "pharmaceutical hygiene, and inform the situation of emergency return, arranged to return". On 01-Dec-2021, the patient still had a sudden ear, hands weakness, breathing abnormal, back pain and occasionally a sudden symptom of vertigo. Headache, nausea, stomachache, abdominal pain, diarrhea (watery diarrhea), fever, a sudden ear, hands weakness, breathing abnormal, back pain and vertigo met the seriousness criterion of hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were recovering. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE. Causality Assessments: Headache, Fever,Nausea,Stomachache,Abdominal pain,Watery diarrhea,Ear discomfort, Abnormal breathing,Back pain,vertigo ,Hands weakness of Per Reporter= Possible Per Company (BioNTech) = Possible


VAERS ID: 1991454 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-10
Onset:2021-11-20
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Diarrhoea, Dizziness, Dyspnoea, Myocarditis, Nausea, Palpitations, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101818736

Write-up: SHORTNESS OF BREATH; PALPITATION; CHEST TIGHTNESS; DIZZINESS; NAUSEA; MYOCARDITIS; VOMITING; WATER DIARRHEA; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party(BioNTech) and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014369 (Center for Disease Control). Other Case identifier(s): TW-Fosun-2021FOS006844 (Fosun). This is a spontaneous report received from a non-contactable HCP received via Center for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100014369. A 50-year-old female patient started to receive 2nd dose of Tozinameran (COMIRNATY) (batch number was not reported) on 10-Nov-2021 via unknown route at 0.3 ml with unspecified dosing frequency for COVID-19 immunization. The 1st dose was received on 29-Sep-2021. Medical history, concomitant medication and past product were not reported. The patient experienced vomiting and water diarrhea on 20-Nov-2021, nausea, myocarditis, shortness of breath, palpitation, chest tightness and dizziness on 25-Nov-2021. On 29-Sep-2021, the patient received the first dose of BNT vaccine in a health institute. On 10-Nov-2021, the patient received the second dose of BNT vaccine in a clinic. Since 20-Nov-2021, the patient had vomiting and water diarrhea. The symptoms did not improve. In the morning on 25-Nov-2021, the patient felt shortness of breath, palpitation, chest tightness and dizziness. Besides, the symptoms of vomiting and water diarrhea did not improve, so the patient went to the gastroenterology department of a hospital for help. Treatments of "smectite 1pk tid, Loperamide 2mg bid, prochlorperazine 5mg 1 # tid and infloran-bifidobacterium bifidum/ Lactobacillus acidophilus 1 # bid" were prescribed. Vomiting, water diarrhea, shortness of breath, palpitation, chest tightness, dizziness, nausea, myocarditis met the seriousness criterion of other medically important condition. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcome of the events were recovering. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. Causality Assessments: Vomiting,Watery diarrhea,Shortness of breath, Palpitation,Chest tightness,Dizziness Per Reporter= Possible Per Company (BioNTech) = Possible


VAERS ID: 1991480 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-20
Onset:2021-11-20
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis, Insomnia
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101855427

Write-up: facial nerve paralysis (reported as color paralysis); severe insomnia; This is a spontaneous report received from a non-contactable healthcare professional via Regulatory Authority (RA) from License Party (BioNTech SE). Regulatory number: TW-TFDA-TVS-1100014636 (RA). Other Case identifier: TW-Fosun-2021FOS006904 (RA). This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100014636. A 47-year-old female patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number was not reported) on 20-Oct-2021 via unknown route at unknown dose with unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medications and past product were not reported. The patient experienced insomnia on 20-Oct-2021, experienced facial nerve paralysis (Facial Palsy) on 29-Nov-2021. On 20-Oct-2021 (PENDING CLARIFICATION), the patient experienced severe insomnia after vaccination of BNT vaccine. On 29-Nov-2021, the patient experienced facial nerve paralysis (reported as color paralysis). Insomnia and facial nerve paralysis (Facial Palsy) met the seriousness criterion of Other Medically Important Condition. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were recovering. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. BNT162b2 is under agreement with BioNTech SE. The events Facial nerve paralysis and Insomnia were assessed as possible by reporter and BioNTech SE to COMIRNATY. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1991486 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Amylase, Angina pectoris, Aspartate aminotransferase, Back pain, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood creatinine, Blood glucagon, Blood potassium, Blood sodium, Blood thyroid stimulating hormone, Blood urea, C-reactive protein, Chest discomfort, Fibrin D dimer, Haemoglobin, Lipase, Myalgia, Pain assessment, Platelet count, Red blood cell count, Thyroxine free, Troponin I, Vaccination site erythema, Vaccination site swelling, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: GPT; Result Unstructured Data: Test Result:71 IU/l; Test Date: 20211120; Test Name: Amylase; Result Unstructured Data: Test Result:69 IU/l; Test Date: 20211120; Test Name: Glutamic-oxaloacetic transferase; Result Unstructured Data: Test Result:48 IU/l; Test Date: 20211120; Test Name: CPK; Result Unstructured Data: Test Result:140 IU/l; Test Date: 20211120; Test Name: CK-MB; Result Unstructured Data: Test Result:1.0 ng/ml; Test Date: 20211120; Test Name: Creatinine; Test Result: 1.12 mg/dl; Test Date: 20211120; Test Name: Blood glucagon; Test Result: 88 mg/dl; Test Date: 20211120; Test Name: K; Result Unstructured Data: Test Result:3.6 mmol/L; Test Date: 20211120; Test Name: Serum sodium; Result Unstructured Data: Test Result:134.1 mmol/L; Test Date: 20211120; Test Name: TSH; Result Unstructured Data: Test Result:1.700 uiU/mL; Test Date: 20211120; Test Name: Urea; Test Result: 12.4 mg/dl; Test Date: 20211120; Test Name: C-reactive protein; Result Unstructured Data: Test Result:4.86 mg/l; Test Date: 20211120; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:0.27; Comments: Units:ug/mL{class}; Test Date: 20211120; Test Name: Hemoglobin; Result Unstructured Data: Test Result:15.7 g/dl; Test Date: 20211120; Test Name: Lipase; Result Unstructured Data: Test Result:40 IU/l; Test Date: 20211120; Test Name: Pain scale; Result Unstructured Data: Test Result:6 points; Test Date: 20211120; Test Name: Platelet count; Result Unstructured Data: Test Result:251 x10 6/mm3; Test Date: 20211120; Test Name: Red blood cell count; Result Unstructured Data: Test Result:4.94 10*6/uL; Test Date: 20211120; Test Name: Free T4; Result Unstructured Data: Test Result:0.86 ng/dL; Test Date: 20211120; Test Name: Troponin I; Result Unstructured Data: Test Result:0.004 ng/ml; Test Date: 20211120; Test Name: WBC; Result Unstructured Data: Test Result:13.15 x10 6/mm3
CDC Split Type: TWPFIZER INC202101855189

Write-up: LEFT REAR BACK PAIN; CARDIAC CHEST PAIN; CHEST TIGHTNESS; MUSCLE ACHE; INOCULATION SITE RED; SWELLING AT THE INJECTION SITE; This is a spontaneous report received from non-contactable healthcare professional from License Party (BioNTech SE) and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100013908 (Regulatory Authority). Other Case identifier(s): TW-Fosun-2021FOS006927 (Fosun). This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100013908. A 34-year-old male patient started to receive 2nd dose of Tozinameran (COMIRNATY) (batch number was not reported) on 19-Nov-2021 via unknown route of administration at single dose (reported as unknown dose with unspecified dosing frequency) for COVID-19 immunization. The 1st dose was received on an unknown date. Medical history included hypertension. Concomitant medications and past product were not reported. The patient experienced muscle ache, inoculation site red, swelling at the injection site, left rear back pain, cardiac chest pain, chest tightness on 20-Nov-2021. At about 09:30 to 10:30 of 19-Nov-2021, the patient received the 2nd dose of BNT vaccine. At 10:30 of 20-Nov-2021, the patient experienced left chest and left rear back pain, especially when the shoulder activity, aggravated by deep breathing. Then the patient went to emergency due to chest pain and chest tightness. It was suspected cardiac chest pain and chest tightness, and pain index was 6 points. The patient''s laboratory tests included: White Blood Cells (WBC): 13.15 *1000 / UL; Red Blood Cell (RBC): 4.94 *10^6 /UL; Hemoglobin (HgB): 15.7 g / dL; Platelet count (PLT): 251 *1000 /UL; Sugar: 88 mg /dL; Glutamic-oxaloacetic transaminase (GOT): 48 IU/L; Glutamic-pyruvic transaminase (GPT): 71 IU/L; Amylase: 69 U/L; Lipase: 40 U/L; C-reactive protein (CRP): 4.86 mg/L; Urean: 12.4 mg/dL; Creatinine: 1.12 mg/dL; Na: 134.1 mmol/L; K: 3.6 mmol/L; Creatine phosphokinase (CPK): 140 IU/L; Creatine phosphokinase MB (CK-MB (S)): 1.0 ng/mL; Tropo-I: 0.004 ng/mL; Thyroid stimulating hormone (TSH): 1.700 UIU/mL; Free T4: 0.86 ng/dL; D-Dimer: 0.27 ug/mL. The patient was given following treatment: Chlorzoxazone 150mg, acetaminophen 250mg, caffeine 20mg, thiamine 7.7mg (Soma Compound / CAP) 1 CAP PO ST 1 Day. Diclofenac (CataFlam 25mg / Tab) 1 Tab PO ST 1 Day. Famotidine (Famotidine 20mg / Tab) 1 Tab Po ST 1 day. Sodium chloride (Sodium Chloride 0.9% 500ml / Bag) 500 ml St IVD 1 day. Famotidine (Famotidine 20mg / Tab) 1 Tab PO BID PC 3 days. Chlorzoxazone 150mg, acetaminophen 250mg, caffeine 20mg, thiamine 7.7mg (SOMA Compound / CAP) 1 CAP PO BID PC 3 days. ACETYLCYSTEINE (ACC600 Effervescent Tab 600mg / Tab) 1 Tab PO BID PC 3 days. DICLOFENAC (CataFlam 25mg / Tab) 1 Tab PO TID PC 3 days. Mosapride (MOPRIDE 5 mg / Tab) 1 Tab PO TID PC 3 days. On an unknown date , the patient was stabilized and discharged. On 23-Nov-2021, the patient had improved but still in recovering. Muscle ache, inoculation site red, swelling at the injection site, left rear back pain, cardiac chest pain, chest tightness met the seriousness criterion of caused hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were recovering. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. BNT162B2 (COMIRNATY) is under agreement with BioNTech SE. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1991545 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-07
Onset:2021-11-20
   Days after vaccination:44
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Body temperature, Chills, Cough, Decreased appetite, Discomfort, Dyspnoea, Headache, Nausea, Oropharyngeal pain, Pyrexia, Vertigo, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: Body temperature; Result Unstructured Data: Test Result:39 Centigrade
CDC Split Type: TWPFIZER INC202101854909

Write-up: NAUSEA; VOMIT; LOSS OF APPETITE; SHORTNESS OF BREATH; SORE THROAT; VERTIGO; DRY COUGH; ABDOMINAL PAIN; HEADACHE; CHILLS; FEVER; UNCOMFORTABLE; This is a spontaneous report received from non-contactable healthcare professional from License Party (BioNTech SE) and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014102 (Regulatory authority). Other Case identifier(s): TW-Fosun-2021FOS007233 (RA). This is a spontaneous report received from a non-contactable HCP received via the regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100014102. A 16-year-old female patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: unknown) on 07-Oct-2021 via intramuscular at an unknown dose with unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medications and past product were not reported. The patient experienced fever on 20-Nov-2021, experienced headache, chills, nausea, vomit, loss of appetite, shortness of breath, sore throat, vertigo, dry cough, abdominal pain on 21-Nov-2021 and experienced uncomfortable on unknown date. On 07-Oct-2021, the patient received the 1st dose of BNT vaccine. On 21-Nov-2021, the patient experienced high fever up to 39 centigrade for 1 day, chills, shortness of breath, sore throat, headache, vertigo, dry cough, abdominal pain, nausea, vomiting and decreased appetite. On 25-Nov-2021, the patient was discharged because that the symptoms had been eased and it was reported that the patient currently had uncomfortable. Headache, chills, fever, nausea, vomit, loss of appetite, shortness of breath, sore throat, vertigo, dry cough, abdominal pain and uncomfortable met the seriousness criterion of hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcome of the uncomfortable was unknown, the outcomes of the other events were recovering. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. BNT162B2 (COMIRNATY) is under agreement with BioNTech SE. Causality Assessment: Headache, Chills, Pyrexia, Nausea, Vomiting, Decreased appetite, Dyspnoea, Oropharyngeal pain, Vertigo, Cough, Abdominal pain, Discomfort Per Reporter = Possible Per Company (BioNTech SE) = Possible No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1991553 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20214

Write-up: Skin erythematous papules on upper chest and bilateral dorsal hands; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Dec-2021 and was forwarded to Moderna on 22-Dec-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of RASH ERYTHEMATOUS (Skin erythematous papules on upper chest and bilateral dorsal hands) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. No Medical History information was reported. On 20-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced RASH ERYTHEMATOUS (Skin erythematous papules on upper chest and bilateral dorsal hands) (seriousness criterion medically significant). At the time of the report, RASH ERYTHEMATOUS (Skin erythematous papules on upper chest and bilateral dorsal hands) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was given. After the vaccination of 20-Nov-2021 patient started to have urticaria about half an hour later. It was reported that patient had skin erythematous papules on upper chest and bil. dorsal hands for 3-4 days, partially improved about 2 days after Moderna vaccination. Laboratory data was mentioned as the doctor evaluated the blood test values and diagnosed that the patient had allergic reactions to Moderna. Therefore, the patient was not advised to receive the same brand of vaccine for the second dose. On 25-Nov-2021 and 09-Dec-2021 patient went to outpatient department for treatment. The doctor prescribed oral drugs for the patient and patient conditions improved after that. Since the patient had no urticaria after previous injections, the procedure of applying for RA was explained to the patient. This is a regulatory case concerning a 66-year-old female patient with no reported relevant medical history, who experienced the serious per reported severity unexpected event of rash erythematous. The event occurred on the same day after the first dose of mRNA-1273 vaccine administration. The event was assessed as related, per temporal association with the product administration. The rechallenge was not applicable, as the event recovered and no information available on other vaccinations. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 66-year-old female patient with no reported relevant medical history, who experienced the serious per reported severity unexpected event of rash erythematous. The event occurred on the same day after the first dose of mRNA-1273 vaccine administration. The event was assessed as related, per temporal association with the product administration. The rechallenge was not applicable, as the event recovered and no information available on other vaccinations. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1991566 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Consciousness fluctuating
SMQs:, Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20214

Write-up: Changes in consciousness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Dec-2021 and was forwarded to Moderna on 22-Dec-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of CONSCIOUSNESS FLUCTUATING (Changes in consciousness) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. No Medical History information was reported. On 19-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Nov-2021, the patient experienced CONSCIOUSNESS FLUCTUATING (Changes in consciousness) (seriousness criteria medically significant and life threatening). At the time of the report, CONSCIOUSNESS FLUCTUATING (Changes in consciousness) was resolving. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. The patient was sent to the emergency department due to of consciousness, cold sweat, laboratory details included EKG: Sinus rhythm, Brain CT: Hemorrhage in the left frontal lobe and temporal lobe. The patient was given treatment with Trandate 12.5mg, Transamin 500mg, Vit Kl lamp, RI 10 u SC, Glycerol 100ml stat, followed by craniotomy to remove blood clots, and was admitted to the intensive care unit after surgery. This is a regulatory case concerning a 50-year-old male patient with no reported relevant medical history, who experienced the serious unexpected life-threatening event of consciousness fluctuating. The event occurred approximately 2 days after the second dose of mRNA-1273 vaccine administration. The event was assessed as related, per temporal association with the product administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 50-year-old male patient with no reported relevant medical history, who experienced the serious unexpected life-threatening event of consciousness fluctuating. The event occurred approximately 2 days after the second dose of mRNA-1273 vaccine administration. The event was assessed as related, per temporal association with the product administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1992492 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-20
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101836189

Write-up: Deep vein thrombosis; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 682414. A 49 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DEEP VEIN THROMBOSIS (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Deep vein thrombosis". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1993487 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Chest X-ray, Chest pain, Dyspnoea, Electrocardiogram, Heart rate, Immunisation, Interchange of vaccine products, Myocarditis, Off label use, Palpitations, Pericarditis, Pyrexia, SARS-CoV-2 test, Tachycardia, Troponin
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clot blood; Pacemaker insertion (cardiac)
Allergies:
Diagnostic Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:no heart attack; Comments: I had blood tests which showed no heart attack; Test Name: Fever; Result Unstructured Data: Test Result:Unknown results; Test Name: Chest x ray; Result Unstructured Data: Test Result:Unknown results; Test Name: ecg; Result Unstructured Data: Test Result:Unknown results; Test Name: Racing heart (tachycardia); Result Unstructured Data: Test Result:Unknown results; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: troponin; Result Unstructured Data: Test Result:normal
CDC Split Type: GBPFIZER INC202101805653

Write-up: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from the regulatory authority RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112141848572440-K8XY6 (MHRA). Other Case identifier(s): GB-RA-ADR 26334640 (RA). A 65-year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Pacemaker fitted" (unspecified if ongoing); "Blood clot in leg" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), for COVID-19 Immunisation; Covid-19 vaccine astrazeneca (Dose 2), for COVID-19 Immunisation. The following information was reported: OFF LABEL USE (hospitalization) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (hospitalization) with onset 20Nov2021, outcome "unknown", described as "Booster"; MYOCARDITIS (hospitalization, medically significant), outcome "unknown", described as "myocarditis"; PERICARDITIS (hospitalization, medically significant), outcome "unknown", described as "pericarditis"; CHEST PAIN (hospitalization) with onset 22Nov2021, outcome "recovered" (22Nov2021), described as "Generalised chest pains"; CHEST PAIN (hospitalization), outcome "recovering", described as "Chest pain"; PYREXIA (hospitalization), outcome "unknown", described as "Fever"; DYSPNOEA (hospitalization), outcome "unknown", described as "Shortness of breath"; PALPITATIONS (hospitalization), outcome "unknown", described as "Heart palpitations"; TACHYCARDIA (hospitalization), outcome "unknown", described as "Racing heart (tachycardia)". The patient underwent the following laboratory tests and procedures: blood test: no heart attack, notes: I had blood tests which showed no heart attack; body temperature: unknown results; chest x-ray: unknown results; electrocardiogram: unknown results; heart rate: unknown results; sars-cov-2 test: negative, notes: No - Negative COVID-19 test; troponin: normal. Clinical course: Patient has not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient''s husband called 999 because she was having chest pain. They sent an ambulance and patient went to hospital where she had tests. The pain lessened within the hour. This report relates to the possible inflammation of the heart (myocarditis or pericarditis). The symptoms did not lead to the hospital stay. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1993510 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dizziness postural, Dyspnoea, Fatigue, Palpitations, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101805837

Write-up: exhaustion/fatigue/unusual tiredness; Chest pain; Shortness of breath; Racing heart (tachycardia); Palpitations/Heart palpitations; Dizziness postural; Shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112150916319720-PPJG0. Other Case identifier(s): GB-MHRA-ADR 26338115. A 36 year-old female patient received bnt162b2 (BNT162B2), administration date 18Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history was not reported. Unsure if patient has had symptoms associated with COVID-19. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot number: Not known), for COVID-19 immunisation. The following information was reported: FATIGUE (disability), outcome "recovering", described as "exhaustion/fatigue/unusual tiredness"; PALPITATIONS (disability) with onset 20Nov2021, outcome "not recovered", described as "Palpitations/Heart palpitations"; DIZZINESS POSTURAL (disability) with onset 20Nov2021, outcome "not recovered", described as "Dizziness postural"; DYSPNOEA (disability) with onset 20Nov2021, outcome "recovering", CHEST PAIN (disability), outcome "unknown" and all described as "Chest pain"; DYSPNOEA (disability), outcome "unknown", described as "Shortness of breath"; TACHYCARDIA (disability), outcome "unknown", described as "Racing heart (tachycardia)". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: The patient took no medications, am not on the pill or any hormone replacement therapies. She was active - cycle her daughter to school and herself to work usually however have felt unable to do so regularly since vaccine. Since having the second dose she had been experiencing heart palpitations and significant spells of dizziness with shortness of breath at times. The dizziness can occur at any time and disorients me. Exhaustion at times too. Am usually a very active person however feel rather concerned about going for a jog at the moment. Still experiencing this after almost a month. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report related to possible inflammation of the heart (myocarditis or pericarditis). The symptoms lead to a hospital stay was reported as no. The diagnosis wasn''t made by a medical professional. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1993895 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Menstruation delayed, SARS-CoV-2 test
SMQs:, Fertility disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101813965

Write-up: Booster; Late period; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112162009329970-ABPN8 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26346787 (MHRA). A 45 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunisation; Bnt162b2 (Dose 2, single), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; MENSTRUATION DELAYED (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Late period". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Nov2021) no - negative covid-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1993932 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-20
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ear discomfort, Ear infection, Ear pain, Nasopharyngitis, Rhinorrhoea, SARS-CoV-2 test, Tinnitus
SMQs:, Hearing impairment (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101813602

Write-up: ear infection; cold symptoms; blocked ear; Ear ringing; Ear pain; Runny nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202112162207144620-ERDBE (MHRA). Other Case identifier(s): GB-MHRA-ADR 26347671 (MHRA). A 26 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWNLot Number: UNKNOWN Route of administration: unspecified), for COVID-19 immunisation. The following information was reported: EAR INFECTION (medically significant), outcome "not recovered", described as "ear infection"; NASOPHARYNGITIS (medically significant), outcome "not recovered", described as "cold symptoms"; TINNITUS (medically significant) with onset 05Dec2021, outcome "not recovered", described as "Ear ringing"; EAR PAIN (medically significant) with onset 04Dec2021, outcome "recovering", described as "Ear pain"; RHINORRHOEA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Runny nose"; EAR DISCOMFORT (medically significant), outcome "not recovered", described as "blocked ear". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Clinical courses: The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient had not test positive for COVID-19 since having the vaccine. Cold like symptoms for 2 weeks followed by ear pain leading to an ear infection and blocked ear, with continued cold symptoms and a runny nose No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1994183 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye movement disorder, Seizure like phenomena, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Ocular motility disorders (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101830463

Write-up: Like a fit; Eyes rolling; Shaking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority-WEB. Regulatory number: IE-HPRA-2021-087948 (HPRA). Other Case identifier(s): IE-HPRA-CVARR2021120823139 (HPRA). A 17 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH8469) at the age of 17 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported.The following information was reported: EYE MOVEMENT DISORDER (life threatening) with onset 20Nov2021, outcome "unknown", described as "Eyes rolling"; TREMOR (life threatening) with onset 20Nov2021, outcome "unknown", described as "Shaking"; SEIZURE LIKE PHENOMENA (medically significant, life threatening) with onset 20Nov2021, outcome "unknown", described as "Like a fit".Clinical course: Six hours later, on 20Nov2021, the patient experienced shaking and eyes rolling, reported as being "like a fit". The patient''s symptoms persisted for 5 minutes. The reporter stayed awake with the patient as treatment. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1994357 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-20
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004224 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: C-reactive protein, COVID-19 immunisation, Cerebral haemorrhage, Hemiparesis, International normalised ratio, Investigation, Platelet count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MAREVAN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: C-reactive protein; Result Unstructured Data: 6 milligram per litre; Test Date: 20211120; Test Name: INR; Result Unstructured Data: 1.8; Test Date: 20211120; Test Name: Investigation; Result Unstructured Data: Imaging revealed cerebral hemorrhage in the frontal part of the right cerebral hemisphere.; Test Date: 20211120; Test Name: Thrombocyte count; Result Unstructured Data: 151 billion per litre
CDC Split Type: NOMODERNATX, INC.MOD20214

Write-up: Hemiparesis (left); Cerebral haemorrhage; Revaccination with different COVID-19 vaccine; This case was received via Regulatory Authority (Reference number: NO-NOMAADVRE-E2B_00062257) on 22-Dec-2021 and was forwarded to Moderna on 22-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of HEMIPARESIS (Hemiparesis (left)) and CEREBRAL HAEMORRHAGE (Cerebral haemorrhage) in a 92-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004224) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Vaccination: Comirnaty; for Product used for unknown indication: Influenza vaccine. Past adverse reactions to the above products included No adverse event with Comirnaty and Influenza vaccine. Concomitant products included WARFARIN SODIUM (MAREVAN) for Atrial fibrillation. On 15-Nov-2021, the patient received third dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 20-Nov-2021, the patient experienced HEMIPARESIS (Hemiparesis (left)) (seriousness criteria hospitalization, disability and medically significant) and CEREBRAL HAEMORRHAGE (Cerebral haemorrhage) (seriousness criteria hospitalization, disability and medically significant). On an unknown date, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). At the time of the report, HEMIPARESIS (Hemiparesis (left)) and CEREBRAL HAEMORRHAGE (Cerebral haemorrhage) was resolving and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2021, C-reactive protein: 6 (abnormal) 6 milligram per litre. On 20-Nov-2021, International normalised ratio: 1.8 (abnormal) 1.8. On 20-Nov-2021, Investigation: imaging revealed cerebral hemorrhage (abnormal) Imaging revealed cerebral hemorrhage in the frontal part of the right cerebral hemisphere.. On 20-Nov-2021, Platelet count: 151 (abnormal) 151 billion per litre. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.; Reporter''s Comments: Thank you for notification of suspected side effect after vaccination. Since the vaccine was new, it was subject to particular surveillance to discover new safety information as quickly as possible. It was particularly important that serious and/or unusual side effects be reported. The message was therefore important to increase knowledge of side effects not detected in the studies and was an important contribution to the international cooperation to maintain safe vaccination worldwide. Notices after coronary vaccination in the Database are processed by the Regulatory Authority in collaboration with the Regulatory Authority. We do not have the capacity to send individual assessments of side effect messages at present. The drug plant publwashes weekly summaries of notices of suspected adverse events after vaccination. Causal relationship was assessed according to international criteria (1). If you have additional information related to the event, such as information about outcomes, copy from journal/laboratory responses and/or other extractions, that may be sent in response to that message. The information was processed safely, and that dialogue was automatically deleted after 4 months. Processing and storing personal data occur under the Health Records Act. For up-to-date information and advice on the use of the vaccines and precautions, refer to the Vaccination Supervisor (2). Questions about coronary vaccine that cannot responded to by professional managers locally, can be directed to Regulatory Authority. We request that no special categories of personal data (health information) are sent by email. If it was impossible to ask a question without bringing such information, we recommend calling. References: 1) Adverse reactions: definitions, diagnoswas and management. Sender''s Comments: This case concerns a 92-year-old male patient, with no medical history reported, who experienced the serious (disabling or Incapacitating, medically significant and hospitalization) unexpected event(s) of Hemiparesis and Cerebral haemorrhage and additional non-serious events. The event(s) occurred approximately within 6 days after the 3rd dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered Not applicable. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no sufficient information in the source document supporting that the events resulted in Disabling or Incapacitating.


VAERS ID: 1994445 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214029 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FRAGMIN; NATRIUMBIKARBONAT; ESPO [ESOMEPRAZOLE]
Current Illness: Atrial fibrillation; Cardiac failure; Hypertension; Lipids NOS high
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20214

Write-up: PERICARDITIS; This case was received via regulatory authority (Reference number: SE-MPA-2021-095537) on 22-Dec-2021 and was forwarded to Moderna on 22-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of PERICARDITIS (PERICARDITIS) in an 82-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214029) for COVID-19 vaccination. Concurrent medical conditions included Cardiac failure, Hypertension, Lipids NOS high and Atrial fibrillation. Concomitant products included DALTEPARIN SODIUM (FRAGMIN) from 26-Apr-2017 to an unknown date, SODIUM BICARBONATE (NATRIUMBIKARBONAT) from 02-Jun-2021 to an unknown date and ESOMEPRAZOLE (ESPO [ESOMEPRAZOLE]) from 09-Jun-2017 to an unknown date for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Nov-2021, after starting mRNA-1273 (Spikevax), the patient experienced PERICARDITIS (PERICARDITIS) (seriousness criteria hospitalization and medically significant). At the time of the report, PERICARDITIS (PERICARDITIS) had not resolved. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No treatment medications were reported.; Sender''s Comments: This case concerns a 82-year-old male patient, with medical history of Cardiac failure, Hypertension, Lipids NOS high and Atrial fibrillation, who experienced the serious (medically significant and hospitalization) unexpected events(s) of Pericarditis. The event(s) started occurring approximately within 2 days after the 3rd dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered not applicable. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1996017 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Fatigue, Headache, Influenza like illness, Monoparesis, Myalgia, Paraesthesia, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Non-alcoholic fatty liver
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHJNJFOC20211264205

Write-up: TINGLING IN THE LEFT ARM; FEELING OF SWELLING; LOWER LIMBS PAIN; FEELING OF DECREASED STRENGTH IN THE LEFT HAND AND BOTH KNEES; FATIGUE; PARESTHESIA OF THE TOES; TRANSIENT OCCIPITAL HEADACHES; FLU-LIKE SYMPTOMS; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, CH-SM-2021-29313) on 30-DEC-2021 and concerned a 28 year old male. The patient''s height, and weight were not reported. The patient''s past medical history included: non-alcoholic fatty liver. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 20-NOV-2021 for an unspecified indication (Dose number in series 1). The batch number was not reported. Per procedure, no follow-up will be requested for this case No concomitant medications were reported. On 20-NOV-2021, the patient experienced flu-like symptoms. On 23-NOV-2021, the patient experienced tingling in the left arm, feeling of swelling, lower limbs pain, feeling of decreased strength in the left hand and both knees, fatigue, paresthesia of the toes, and transient occipital headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on 22-NOV-2021, and feeling of swelling, feeling of decreased strength in the left hand and both knees, paresthesia of the toes, and transient occipital headaches on 02-DEC-2021, and had not recovered from fatigue, tingling in the left arm, and lower limbs pain. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20211264205-COVID-19 VACCINE AD26.COV2.S- flu-like symptoms, tingling in the left arm, feeling of swelling. This event(s) is considered unassessable. The event(s) 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(s). 20211264205-COVID-19 VACCINE AD26.COV2.S- Lower limbs pain, feeling of decreased strength in the left hand and both knees, fatigue, paresthesia of the toes, transient occipital headaches. This event(s) is labeled per regulatory authority and is therefore considered potentially related.


VAERS ID: 1996500 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-20
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METHOTREXATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis; Psoriatic arthritis; Pustular psoriasis; Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...); Swelling; Tremor
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101869574

Write-up: COVID-19; drug ineffective; booster; This is a spontaneous report received from a contactable Consumer from the Regulatory Authority (RA). The reporter is the patient. A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 20Nov2021 (Lot number: FH4751) as dose 3 (booster), single, (Batch/Lot number not provided) as dose 2, single and (Batch/Lot number not provided) as dose 1, single for covid-19 immunisation. Patient has not had symptoms associated with COVID-19. Relevant medical history included: "Tremor"; "Arthritis"; "Swelling"; "Rheumatoid arthritis", notes: Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...); "pusular psoraris"; "Psoriatic arthritis". Concomitant medication included: METHOTREXATE taken for arthritis. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "not recovered", described as "booster"; COVID-19 (medically significant), outcome "not recovered", described as "COVID-19"; DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "drug ineffective". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : 202101675212 Original Case : 202101675212 same patient/different events


VAERS ID: 1996634 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1012A / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Erythema nodosum, Immunisation
SMQs:, Hypersensitivity (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101817233

Write-up: Erythema nodosum; booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: IT-MINISAL02-821157. A 43 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 20Nov2021 (Lot number: 1F1012A, Expiration Date: 31Dec2021) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, dose 1, single), for covid-19 immunisation; Covid-19 vaccine (MANUFACTURER UNKNOWN, dose 2, single), for covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "booster"; ERYTHEMA NODOSUM (medically significant) with onset 24Nov2021, outcome "not recovered", described as "Erythema nodosum". Reporter Comment: Erythema nodosum POST 3 DOSE PFIZER No follow-up attempts are possible. No further information is expected.


VAERS ID: 1996691 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 072F21A_1101207 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Chest pain, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20214

Write-up: Fever; Chest pain, generalized soreness and weakness; Chest pain, generalized soreness and weakness; Chest pain, generalized soreness and weakness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Dec-2021 and was forwarded to Moderna on 22-Dec-2021. This regulatory authority prospective pregnancy case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever), CHEST PAIN (Chest pain, generalized soreness and weakness), PAIN (Chest pain, generalized soreness and weakness) and ASTHENIA (Chest pain, generalized soreness and weakness) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 072F21A_1101207) for an unknown indication. No Medical History information was reported. On 20-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 20-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion hospitalization), CHEST PAIN (Chest pain, generalized soreness and weakness) (seriousness criterion hospitalization), PAIN (Chest pain, generalized soreness and weakness) (seriousness criterion hospitalization) and ASTHENIA (Chest pain, generalized soreness and weakness) (seriousness criterion hospitalization). At the time of the report, PYREXIA (Fever), CHEST PAIN (Chest pain, generalized soreness and weakness), PAIN (Chest pain, generalized soreness and weakness) and ASTHENIA (Chest pain, generalized soreness and weakness) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication information was not provided by the reporter. 10 hours after vaccination, the patient started developing chest pain, fever (38 �C), and systemic pain. On 21-Nov-2021, the patient sought medical attention at the emergency department of Hospital. Electrocardiography, blood test and urinalysis were carried out. The physician mentioned that white blood cell count was elevated, and the patient was pregnant. Hence, the physician recommended that the patient be hospitalized to observe fetal heart sounds and antibiotics. The patient was discharged on 26-Nov-2021. On 14-Dec-2021 the patient mentioned that she was hospitalized due to adverse reaction after receiving the second dose of the Moderna vaccine on 20-Nov-2021. The patient mentioned that discomfort was absent and prenatal examination results were normal. Treatment information was not provided by the reporter. Company Comment This case concerns a 34-year-old pregnant female patient with no relevant medical history, who experienced the serious unexpected events of Pyrexia, Chest pain, Pain and Asthenia. The events occurred the same day after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting as hospitalization and retained for consistency with the RA report.; Sender''s Comments: This case concerns a 34-year-old pregnant female patient with no relevant medical history, who experienced the serious unexpected events of Pyrexia, Chest pain, Pain and Asthenia. The events occurred the same day after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting as hospitalization and retained for consistency with the RA report.


VAERS ID: 1998359 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-10-10
Onset:2021-11-20
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2022-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Chest pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26367723) on 21-Dec-2021 and was forwarded to Moderna on 21-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 10-Oct-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion hospitalization). At the time of the report, CHEST PAIN (Chest pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided by reporter. No treatment drug was provided by reporter. Patient is not enrolled in clinical trial; Sender''s Comments: This case concerns in a patient of unknown age and gender, with medical history not reported, who experienced the serious (medically significant) unexpected event(s) of Chest pain. The event(s) started occurring approximately within 41 day(s) after the 1st dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered unknown. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 2000628 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-11-20
   Days after vaccination:124
Submitted: 0000-00-00
Entered: 2022-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XE393 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20211266696

Write-up: Vaccination failure; This spontaneous report received from a health care professional by a Regulatory Authority (PT-INFARMED-T202112-1510) on 31-DEC-2021 and concerned a 29 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393, expiry: UNKNOWN) 0.5 ml, 1 total administered on 19-JUL-2021 for covid-19 immunisation (Dose number series 1). Drug start period was 124 Days. No concomitant medications were reported. On 20-NOV-2021, the patient experienced vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccination failure on 23-NOV-2021. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000209726.; Reporter''s Comments: Other information


VAERS ID: 2002460 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Generalised tonic-clonic seizure, Headache
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epileptic fit (2020 allegedly already had epileptic seizures)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101845280

Write-up: 30Nov2021 The patient still complains of a headache; tonic clonic seizures 3 hours after vaccination; This is a spontaneous report received from a contactable reporter (Physician) from the Regulatory Authority-WEB. Regulatory number: AT-BASGAGES-2021-063588. A 55 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 20Nov2021 (Lot number: FF2834) as dose 1, single, at the age of 55-year-old, for covid-19 immunisation. Relevant medical history included: "Epileptic fit", start date: 2020 (not ongoing), notes: 2020 allegedly already had epileptic seizures. The patient''s concomitant medications were not reported. The patient experienced tonic clonic seizures 3 hours after vaccination (hospitalization) with onset 20Nov2021 and outcome recovered in 2021 and the patient still complains of a headache (hospitalization) with onset 30Nov2021 and outcome "recovered in 2021". Relatedness of drug to reactions/events Comirnaty/ all events/ Source of assessment Health Care Professional, Method of assessment Regulatory Authority Assessment/ Possible No follow-up attempts are possible. No further information is expected.


VAERS ID: 2002778 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Electrocardiogram, Electrocardiogram abnormal, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:unknown results
CDC Split Type: AUPFIZER INC202101836059

Write-up: Pericarditis; Chest pain; Electrocardiogram; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 682032. A 24-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), administration date 18Nov2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDITIS (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Pericarditis"; CHEST PAIN (non-serious) with onset 20Nov2021, outcome "not recovered", described as "Chest pain"; ELECTROCARDIOGRAM ABNORMAL (non-serious) with onset 20Nov2021, outcome "not recovered", described as "Electrocardiogram". The patient underwent the following laboratory tests and procedures: electrocardiogram: (20Nov2021) unknown results. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2003199 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC202101828396

Write-up: Stomach pain; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. The reporter is the patient. Regulatory number: CZ-CZSUKL-21013123 (RA). A 29 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 19Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: ABDOMINAL PAIN UPPER (medically significant) with onset 20Nov2021, outcome "recovering", described as "Stomach pain". It was reported that the patient suffered the pain of greater intensity after each meal. Stomach pain lasts for 3 weeks at the time of the reporting, not resolved. Therapeutic measures were taken as a result of abdominal pain upper which included diet, stomach teas, Helicid. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected


VAERS ID: 2003299 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCTJ2 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Electrocardiogram, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:unknown results; Test Name: Long-term ECG; Result Unstructured Data: Test Result:unknown results
CDC Split Type: DEPFIZER INC202101828142

Write-up: Syncope; Atrial fibrillation; This is a spontaneous report received from a non-contactable reporter(s) (Physician) from the regulatory authority-WEB. Regulatory number: DE-PEI-202100277757 (PEI). A 58 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: SCTJ2) at the age of 58 years as dose number unknown, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (hospitalization) with onset 20Nov2021, outcome "recovered" (2021), described as "Atrial fibrillation"; SYNCOPE (hospitalization) with onset 21Nov2021, outcome "recovered" (2021), described as "Syncope". The patient underwent the following laboratory tests and procedures: electrocardiogram: unknown results; unknown results. The PEI assessed the causal relationship between bnt162b2 (COMIRNATY) and Atrial fibrillation and Syncope as D. Unclassifiable. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2004073 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-20
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Hypertension, Loss of consciousness, Pain in extremity, Tension headache
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZMODERNATX, INC.MOD20214

Write-up: Innability to stand; Head tightness; Pain chest; Colapse; Hypertensive crisis; Breathlessness; This case was received via Regulatory Authority (Reference number: CZ-CZSUKL-21012612) on 22-Dec-2021 and was forwarded to Moderna on 22-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of HYPERTENSION (Hypertensive crisis) in a 31-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 20-Nov-2021, the patient experienced TENSION HEADACHE (Head tightness), CHEST PAIN (Pain chest), LOSS OF CONSCIOUSNESS (Colapse), HYPERTENSION (Hypertensive crisis) (seriousness criterion medically significant) and DYSPNOEA (Breathlessness). On 21-Nov-2021, the patient experienced PAIN IN EXTREMITY (Innability to stand). At the time of the report, PAIN IN EXTREMITY (Innability to stand), TENSION HEADACHE (Head tightness), CHEST PAIN (Pain chest), LOSS OF CONSCIOUSNESS (Colapse), HYPERTENSION (Hypertensive crisis) and DYSPNOEA (Breathlessness) outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported by the reporter Treatment information was not provided. Patient was Healthy. Company comment: This regulatory case concerns a 31-year-old female patient, with no medical history reported, who experienced the serious unexpected event of HYPERTENSION. The event occurred after an unknown time interval after the first dose of the mRNA-1273 vaccine. The rechallenge is not applicable since no information about further dosing has been disclosed. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender''s Comments: This regulatory case concerns a 31-year-old female patient, with no medical history reported, who experienced the serious unexpected event of HYPERTENSION. The event occurred after an unknown time interval after the first dose of the mRNA-1273 vaccine. The rechallenge is not applicable since no information about further dosing has been disclosed. The benefit-risk relationship of the mRNA-1273 is not affected by this report.


VAERS ID: 2004134 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test positive, Venous thrombosis limb
SMQs:, Embolic and thrombotic events, venous (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenoidectomy; Deep vein thrombosis leg; Factor V Leiden thrombophilia; Obesity; Phlebitis
Allergies:
Diagnostic Lab Data: Test Date: 20210224; Test Name: SARS-CoV-2 test Positive; Test Result: Positive
CDC Split Type: FRPFIZER INC202101830994

Write-up: Leg venous thrombosis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: FR-AFSSAPS-ST20214760. A 43-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 19Nov2021 (Lot number: Unknown) as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Factor V Leiden thrombophilia" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Phlebitis", start date: 1997 (unspecified if ongoing); "Adenoidectomy" (unspecified if ongoing); "Deep vein thrombosis leg", start date: Oct2001 (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: VENOUS THROMBOSIS LIMB (medically significant) with onset 20Nov2021, outcome "recovering", described as "Leg venous thrombosis". The event "leg venous thrombosis" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: (24Feb2021) positive. Therapeutic measures were taken as a result of venous thrombosis limb. Clinical course: On D1: intense pain in the left calf which intensified over the days. Support: emergency room consultation on 11/22/2021 and angiological consultation on 11/23/2021 which shows phlebitis (2 clots) in the G calf. Established anticoagulant treatment with Xarelto since 11/23/2021 with class III venous contention.Declaration via the reporting portal, medically confirmed. DTA of TVP with evidence of thrombophilia in October 2001: resistance to activated protein C in connection with the Leiden mutation of factor V in the heterozygous state. Partial deficit in ATIII.ATCD Covid: yes, positive PCR test on 02/24/2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2004439 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Abdominal pain, Immunisation, Interchange of vaccine products, Off label use, Pain, Weight decreased
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia; Eczema; Hay fever
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101823024

Write-up: Bloated feeling; Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY; Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY; Patient received the third (booster) dose; Pain; Pain in tummy; Lost a lot of weight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202112170958373850-MPE84 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26350479 (MHRA). A 60 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK0596) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing); "Hay fever" (unspecified if ongoing); "Anemia" (unspecified if ongoing). Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 20Nov2021, outcome "unknown" and all described as "Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Patient received the third (booster) dose"; PAIN (medically significant) with onset 2021, outcome "recovering", described as "Pain"; ABDOMINAL DISTENSION (medically significant) with onset 23Nov2021, outcome "recovering", described as "Bloated feeling"; ABDOMINAL PAIN (medically significant) with onset 2021, outcome "unknown", described as "Pain in tummy"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "Lost a lot of weight". The event "pain in tummy" was evaluated at the physician office visit. Patient with having pain in her tummy went to GP ended up having appendix out, and she was reading about having the appendix out she read that about 4 days later a group people had the same issue and timeline. she still in pain but slowly recovering and lost a lot of weight due to the pain, been taking paracetamol. Patient was not enrolled in clinical trial. Therapeutic measures were taken as a result of pain, abdominal pain included having appendix out and taking paracetamol. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2004459 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-20
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Enuresis, Fall, Headache, Immunisation, Loss of consciousness, Malaise, SARS-CoV-2 test, Vertigo
SMQs:, Torsade de pointes/QT prolongation (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lumbar disc disease
Allergies:
Diagnostic Lab Data: Test Date: 20211124; Test Name: PCR test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101845498

Write-up: headache; head spinning; had wet herself; Drug ineffective; SARS-CoV-2 infection; Transient loss of consciousness and was out for about 30 seconds; felt unwell; she lay back down on bed and had fallen out of bed; Booster; This is a spontaneous report received from contactable reporter(s) (Physician) from the regulatory authority-WEB and product quality group. Regulatory number: GB-MHRA-WEBCOVID-202112171052538820-ZPRYV (regulatory authority). Other Case identifier(s): GB-MHRA-ADR 26350822 (regulatory authority). A 53 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FF8288) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "L5/S1 disc protrusion", start date: 12Feb2019 (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Gabapentin, notes: Repeat Gabapentin 300mg capsules Last issued: 12Nov2021 take 1 daily; Atorvastatin, notes: Repeat Atorvastatin 40mg tablets Last issued: 14Dec2021 tablet 1 tablet once a day. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant) with onset 24Nov2021, outcome "unknown", described as "Drug ineffective"; COVID-19 (medically significant) with onset 24Nov2021, outcome "recovering", described as "SARS-CoV-2 infection"; HEADACHE (medically significant), outcome "unknown", described as "headache"; VERTIGO (medically significant), outcome "unknown", described as "head spinning"; LOSS OF CONSCIOUSNESS (medically significant) with onset 21Nov2021, outcome "recovered" (21Nov2021), described as "Transient loss of consciousness and was out for about 30 seconds"; MALAISE (medically significant) with onset 21Nov2021, outcome "recovered" (2021), described as "felt unwell"; FALL (medically significant) with onset 21Nov2021, outcome "recovered" (2021), described as "she lay back down on bed and had fallen out of bed"; ENURESIS (medically significant), outcome "unknown", described as "had wet herself". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Nov2021) positive. Clinical course: Patient was not enrolled in clinical trial Patient did not had symptoms associated with COVID-19 previously. Not had a COVID-19 test before vaccination. Patient on morning after her vaccination, woke with head spinning and felt unwell, she lied back down on bed. Her husband heard a thud and she had fallen out of bed and was a bad colour and was out for about 30 seconds, had wet herself, no injuries, no confusion were there. She had headache in following days and then got PCR test on 24Nov2021 which was positive. This report was not related to possible blood clots or low platelet counts, myocarditis and pericarditis. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2004497 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ear pain, Headache, Immunisation, Neuralgia, Pain of skin, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM; RAMIPRIL; PROPRANOLOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211217; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101824369

Write-up: neuralgia; Intermittent head pain right side; Booster; soreness and stinging on scalp; ear pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112171249041070-YCLY3. Other Case identifier(s): GB-MHRA-ADR 26351618. A 62 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH4751) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Concomitant medication(s) included: CITALOPRAM; RAMIPRIL; PROPRANOLOL. Vaccination history included: Bnt162b2 (first dose), for COVID-19 Immunization; Bnt162b2 (second dose), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 07Dec2021, outcome "not recovered", described as "Intermittent head pain right side"; PAIN OF SKIN (medically significant) with onset 2021, outcome "unknown", described as "soreness and stinging on scalp"; EAR PAIN (medically significant) with onset 2021, outcome "unknown", described as "ear pain"; NEURALGIA (medically significant) with onset 16Dec2021, outcome "not recovered", described as "neuralgia". The patient had negative COVID-19 virus test on 17Dec2021. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2004690 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood test, Contusion, Decreased appetite, Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CABERGOLINE; TAMSULOSIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Enlarged prostate; Prolactinoma
Allergies:
Diagnostic Lab Data: Test Date: 20211214; Test Name: Blood test; Result Unstructured Data: Test Result:showed my platelets & clotting were fine.; Test Date: 20211214; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101821488

Write-up: fever; Enlargement of lymph nodes; Shoulder pain; Bruise; Vomiting; Appetite lost; off label use; interchange of vaccine products; Booster; Feverish; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (MHRA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112180009532440-D3J1R (MHRA). Other Case identifier(s): GB-MHRA-ADR 26355754 (MHRA). A 69 year-old male patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH3220) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Prolactinoma" (unspecified if ongoing); "Enlarged prostate" (unspecified if ongoing). Unsure if patient has had symptoms associated with COVID-19. Concomitant medication(s) included: CABERGOLINE taken for prolactin-producing pituitary tumour; TAMSULOSIN taken for prostatomegaly. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1, Patient had similar AE after dose 1), administration date: 06Feb2021, for COVID-19 immunisation, reaction(s): "vomiting"; Covid-19 vaccine astrazeneca (Dose 2), administration date: 01May2021, for Vaccination. The following information was reported: OFF LABEL USE (disability) with onset 21Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability) with onset 20Nov2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (disability) with onset 20Nov2021, outcome "unknown", described as "Booster"; PYREXIA (disability), outcome "recovering", described as "fever"; PYREXIA (disability) with onset 20Nov2021, outcome "recovered" (27Nov2021), described as "Feverish"; VOMITING (disability) with onset 21Nov2021, outcome "recovered" (21Nov2021), described as "Vomiting"; DECREASED APPETITE (disability) with onset 21Nov2021, outcome "recovered" (24Nov2021), described as "Appetite lost"; LYMPHADENOPATHY (disability), outcome "recovered", described as "Enlargement of lymph nodes"; ARTHRALGIA (disability), outcome "recovered", described as "Shoulder pain"; CONTUSION (disability), outcome "recovered", described as "Bruise". The patient underwent the following laboratory tests and procedures: blood test: (14Dec2021) showed my platelets & clotting were fine.; sars-cov-2 test: (14Dec2021) negative, notes: No - Negative COVID-19 test. Clinical course: Fever for a few days starting about 8hr after the injection. Unable move without vomitting for 13hr from about 12hr after the injection. Almost exactly the same reaction as patient had to 1st AZ injection. I had no siginificant reaction to my 2nd AZ injection. Noticed a bruise 6" below injection site about 8 days after the injection. Went to A&E for checks. Blood test results showed platelets and clotting were fine. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial Reaction. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2004807 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HYDROXYQUINOLINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...); Sjogren''s syndrome
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101823837

Write-up: interchange of vaccine products; Pain stomach; off label use; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112181248514630-EDN3L. Other Case identifier: GB-MHRA-ADR 26357599. A 51 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK9413) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Sjogren''s syndrome" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing), notes: Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr... Concomitant medication included: HYDROXYQUINOLINE taken for Sjogren''s syndrome. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; ABDOMINAL PAIN UPPER (medically significant) with onset 22Nov2021, outcome "recovered with sequelae", described as "Pain stomach". Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2004982 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL1939 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Tinnitus
SMQs:, Hearing impairment (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211205; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101824043

Write-up: loud continual buzzing in ears; Tinnitus, unspecified; OFF LABEL USE; INTERCHANGE OF VACCINE PRODUCTS; BOOSTER; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112190706289980-DW4UW (RA). Other Case identifier: GB-MHRA-ADR 26359321 (RA). A 70 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FL1939) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VIRUS taken for immunisation, administration date 12Oct2021. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1), administration date: 04Feb2021, for COVID-19 IMMUNISATION; Covid-19 vaccine astrazeneca (DOSE 2), administration date: 11May2021, for COVID-19 IMMUNISATION. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "OFF LABEL USE"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "INTERCHANGE OF VACCINE PRODUCTS"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "BOOSTER"; TINNITUS (medically significant), outcome "not recovered", described as "loud continual buzzing in ears"; TINNITUS (medically significant) with onset 01Dec2021, outcome "not recovered", described as "Tinnitus, unspecified". Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Dec2021) negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of tinnitus, tinnitus which included microsuction. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2005148 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Pulmonary pain, SARS-CoV-2 test
SMQs:, Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210113; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101829430

Write-up: Lung pain; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202112191640217910-ZHLO8 (RA). Other Case identifier(s): GB-MHRA-ADR 26360080 (RA). A 63-year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH3220) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 13Jan2021, stop date: 23Jan2021. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; PULMONARY PAIN (medically significant) with onset 22Nov2021, outcome "recovered with sequelae" (12Dec2021), described as "Lung pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (13Jan2021) positive, notes: Yes - Positive COVID-19 test. Clinical course: GP gave antibiotics. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Report not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2007165 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1022A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram thorax, Echocardiogram, Interchange of vaccine products, Off label use, Pneumonia, Pulmonary embolism, Right ventricular hypertrophy
SMQs:, Embolic and thrombotic events, venous (narrow), Pulmonary hypertension (narrow), Eosinophilic pneumonia (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CT chest; Result Unstructured Data: Test Result:result unknown; Comments: Diagnostics; Test Name: echocardiography; Result Unstructured Data: Test Result:result unknown; Comments: Diagnostics
CDC Split Type: DEPFIZER INC202101845011

Write-up: Infarct pneumonia; Pulmonary artery embolism (main stem); Right heart strain; Interchange of vaccine products; off label use; This is a spontaneous report received from a non-contactable reporter(s) (Physician) from the Regulatory Authority. Regulatory number: DE-202100281853. A 29 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: 1F1022A) at the age of 29 years as dose 2 (initial pfizer dose), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine janssen injektionssuspension (1st dose), administration date: 30Aug2021, for Prophylactic vaccination. The following information was reported: PNEUMONIA (hospitalization, life threatening) with onset 02Dec2021, outcome "not recovered", described as "Infarct pneumonia"; PULMONARY EMBOLISM (hospitalization, life threatening) with onset 02Dec2021, outcome "not recovered", described as "Pulmonary artery embolism (main stem)"; RIGHT VENTRICULAR HYPERTROPHY (hospitalization, life threatening) with onset 02Dec2021, outcome "not recovered", described as "Right heart strain"; INTERCHANGE OF VACCINE PRODUCTS (life threatening) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; OFF LABEL USE (life threatening) with onset 20Nov2021, outcome "unknown", described as "off label use". The patient underwent the following laboratory tests and procedures: computerised tomogram thorax: result unknown, notes: Diagnostics; echocardiogram: result unknown, notes: Diagnostics.The reporter''s assessment of the causal relationship of the Pulmonary embolism, Right ventricular hypertrophy, Pneumonia following pulmonary infarction was: [Source of assessment: Method of assessment: unknown, Result of Assessment: D. Unclassifiable]. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2007295 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-25
Onset:2021-11-20
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E024A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Craniocerebral injury, Diplopia, Dizziness, Fall, Headache, Nausea, Pain assessment, Syncope, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Ocular motility disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchial asthma; Dissociative motor disorder; Motor polyneuropathy.
Allergies:
Diagnostic Lab Data: Test Date: 20211202; Test Name: Pain scale; Result Unstructured Data: Test Result:5-6; Comments: for severe headache
CDC Split Type: DEPFIZER INC202101831251

Write-up: Severe headaches; Double image; Fell on the floor; Traumatic brain injury; Syncope; Dizziness; suffered from "black in front of her eyes"/ seeing dull; Nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: DE-CADR2021224303. Other Case identifier(s): DE-CADR-2021224303, DE-202100278545. A 17 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), administration date 25Oct2021 (Lot number: 1E024A) as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Bronchial asthma" (unspecified if ongoing); "Dissociative movement disorder" (unspecified if ongoing). Family history included: "Familial burden of Dejerine Sottas disease (Hereditary motor-sensitive neuropathy type III)" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: SYNCOPE (hospitalization) with onset 20Nov2021, outcome "recovering", described as "Syncope"; DIZZINESS (hospitalization) with onset 20Nov2021, outcome "recovering", described as "Dizziness"; HEADACHE (hospitalization) with onset 02Dec2021, outcome "unknown", described as "Severe headaches"; DIPLOPIA (hospitalization) with onset 02Dec2021, outcome "unknown", described as "Double image"; FALL (hospitalization) with onset 02Dec2021, outcome "unknown", described as "Fell on the floor"; CRANIOCEREBRAL INJURY (hospitalization) with onset 02Dec2021, outcome "unknown", described as "Traumatic brain injury"; VISUAL IMPAIRMENT (hospitalization) with onset 2021, outcome "unknown", described as "suffered from "black in front of her eyes"/ seeing dull"; NAUSEA (hospitalization) with onset 2021, outcome "unknown", described as "Nausea". The patient was hospitalized for headache, diplopia, fall, craniocerebral injury, visual impairment, nausea (start date: 02Dec2021). The clinical course was described as follows: Since one month, episodes with syncope had occurred spontaneously 4 times. The patient does not remember the first syncope: She was found by her boyfriend and after that she was fine. The second episode occurred 2-3 days later. The patient did not go to the doctor. Before the syncope she was dull and suffered from "black in front of her eyes" with nausea. The third episode was on 02Dec2021 in the morning on a school trip to the city. The patient had severe headache, magnitude 5-6 /10 on the Pain scale, nausea, dizziness and she was "black in front of her eyes". As a result, the patient had syncope for one minute. After that she was seeing dull and had a double image. Then she bumped against a wall. After 30 minutes, the patient had the fourth episode of syncope and also fell on the floor. The teacher called an ambulance. The patient was admitted to the hospital with traumatic brain injury and syncope. The patient underwent the following laboratory tests and procedures: pain assessment (normal high range 10): (02Dec2021) 5-6, notes: for severe headache. Therapeutic measures were taken as a result of syncope, dizziness, headache, diplopia, fall, craniocerebral injury, visual impairment, nausea. She was given paracetamol, ibuprofen and dimenhydrinate (VOMEX) in the hospital. The patient denies having engaged in smoking, drugs and alcohol.


VAERS ID: 2007458 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G047A / 3 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Electrocardiogram, Electrocardiogram ST segment elevation, Exercise tolerance decreased, Fatigue, Immunisation, Myocarditis, Pyrexia, Somnolence, Troponin T
SMQs:, Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VACCINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pneumonia
Allergies:
Diagnostic Lab Data: Test Name: electrocardiogram; Result Unstructured Data: Test Result:ST - 1 -2 mm increase in thoracic connections; Comments: no ST elevation on control scan after one month; Test Date: 20211130; Test Name: electrocardiogram; Result Unstructured Data: Test Result:ST elevation of 0.5-1 mm; Test Name: Troponin-T; Result Unstructured Data: Test Result:increased to 108; Test Date: 20211130; Test Name: Troponin-T; Result Unstructured Data: Test Result:Troponin-T was a normal 6
CDC Split Type: FIPFIZER INC202101845284

Write-up: Myocarditis; Exercise tolerance decreased; Somnolence; Fatigue; Pyrexia; Electrocardiogram ST segment elevation; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Physician) from the regulatory authority-WEB. The reporter is the patient. Regulatory number: FI-FIMEA-20217885 (FIMEA). A 37 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid right, administration date 20Nov2021 (Lot number: 1G047A) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "pneumonia", start date: Dec2020 (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE, administration date 20Nov2021. Vaccination history included: Covid-19 vaccine (Dose 2. Manufacturer unknown. have no specific symptoms), for covid-19 immunization; Covid-19 vaccine (Dose 1. Manufacturer unknown. have no specific symptoms), for covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; MYOCARDITIS (medically significant) with onset 21Nov2021, outcome "recovering", described as "Myocarditis"; EXERCISE TOLERANCE DECREASED (medically significant) with onset 21Nov2021, outcome "recovering", described as "Exercise tolerance decreased"; SOMNOLENCE (medically significant) with onset 21Nov2021, outcome "recovering", described as "Somnolence"; FATIGUE (medically significant) with onset 21Nov2021, outcome "recovering", described as "Fatigue"; PYREXIA (medically significant) with onset 21Nov2021, outcome "recovering", described as "Pyrexia"; ELECTROCARDIOGRAM ST SEGMENT ELEVATION (medically significant) with onset 21Nov2021, outcome "recovering", described as "Electrocardiogram ST segment elevation". The patient underwent the following laboratory tests and procedures: electrocardiogram: (unspecified date) st - 1 -2 mm increase in thoracic connections, notes: no ST elevation on control scan after one month; (30Nov2021) st elevation of 0.5-1 mm; troponin t: (unspecified date) increased to 108; (30Nov2021) troponin-t was a normal 6. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2007856 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Conjunctivitis, Cough, Cough variant asthma, Dry skin, Gait disturbance, Inappropriate schedule of product administration, Joint swelling, Lower respiratory tract infection, SARS-CoV-2 test, Skin exfoliation
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20211020; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101829406

Write-up: cough; joint pain; walking difficult; skin around my eyes is peeling; asthma like cough; Dry skin; Conjunctivitis; Chest infection; Ankle swelling; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112192338091230-ONVWI (Agency). Other Case identifier(s): GB-MHRA-ADR 26360946 (Agency). A 26 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK0596) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 19Oct2021 (unspecified if ongoing), notes: Unsure when symptoms stopped. Date of last menstrual period: 2015. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 02Sep2021, for COVID-19 immunisation. The following information was reported: COUGH (medically significant), outcome "not recovered", described as "cough"; ARTHRALGIA (medically significant), outcome "not recovered", described as "joint pain"; CONJUNCTIVITIS (medically significant) with onset 04Dec2021, outcome "not recovered", described as "Conjunctivitis"; JOINT SWELLING (medically significant) with onset 24Nov2021, outcome "recovered" (02Dec2021), described as "Ankle swelling"; LOWER RESPIRATORY TRACT INFECTION (medically significant) with onset 03Dec2021, outcome "not recovered", described as "Chest infection"; DRY SKIN (medically significant) with onset 15Dec2021, outcome "not recovered", described as "Dry skin"; GAIT DISTURBANCE (medically significant), outcome "unknown", described as "walking difficult"; SKIN EXFOLIATION (medically significant), outcome "unknown", described as "skin around my eyes is peeling"; COUGH VARIANT ASTHMA (medically significant), outcome "not recovered", described as "asthma like cough"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 20Nov2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Oct2021) negative, notes: No - Negative COVID-19 test. Clinical course: The patient had been on antibiotics and she had finished the course but she had a very persistent/ asthma like cough and reoccurring conjunctivitis causing sensitivity and redness to eyes and the skin around her eyes was peeling. she had ankle joint pain/swelling just after the vaccine was given, and she found walking difficult. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2008001 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Headache, Immunisation, Interchange of vaccine products, Kidney infection, Malaise, Nephrolithiasis, Off label use, Product use issue, Renal pain, SARS-CoV-2 test
SMQs:, Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: CT scan; Result Unstructured Data: Test Result:Kidney stones ruled out; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101839683

Write-up: kidney stones; Feeling ill; Kidney pain; Acute kidney infection; Off label use; interchange of vaccine products; Product use for unapproved combination; Booster; headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112201123477640-06PAW (RA). Other Case identifier(s): GB-MHRA-ADR 26362960 (RA). A 50 year-old patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK9413) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. No history of UTI''s, kidney problems or pain. General good health. Concomitant medication(s) included: INFLUENZA VIRUS, administration date 20Nov2021. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1), administration date: 26Feb2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (DOSE 2), administration date: 17May2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "interchange of vaccine products"; PRODUCT USE ISSUE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Product use for unapproved combination"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; NEPHROLITHIASIS (medically significant), outcome "unknown", described as "kidney stones"; RENAL PAIN (medically significant) with onset 23Nov2021, outcome "recovering", described as "Kidney pain"; KIDNEY INFECTION (medically significant) with onset 23Nov2021, outcome "recovered" (30Nov2021), described as "Acute kidney infection"; MALAISE (medically significant), outcome "recovered", described as "Feeling ill"; HEADACHE (medically significant), outcome "recovered", described as "headache". Patient experienced feeling ill post vaccination (booster) with a headache for 3 days. Severe pain in the right kidney area on the 23rd of November in the afternoon. Ambulance called and A&E admission. Kidney stones suspected but ruled out by CT scan on 25Nov2021. The event "kidney pain" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (25Nov2021) kidney stones ruled out; sars-cov-2 test: (unspecified date) negative. Patient had not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. This report was not related to possible blood clots or low platelet counts, was not related to possible myocarditis or pericarditis. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2008041 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-20
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anti-platelet factor 4 antibody test, Fall, Fibrin D dimer, Platelet count, SARS-CoV-2 test, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Accidents and injuries (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MEMANTINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: Anti platelet factor 4 antibody test; Result Unstructured Data: Test Result:unknown; Test Name: D-dimer; Result Unstructured Data: Test Result:Unknown; Comments: $g4000; Test Name: platelet count; Result Unstructured Data: Test Result:unknown; Comments: <150 A- 109/L; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101838056

Write-up: Clot blood; falling; This is a spontaneous report received from a contactable reporter (Other HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112201230469280-4CCRM. Other Case identifier: GB-MHRA-ADR 26363410. A 80 year-old female patient received bnt162b2 (COMIRNATY), administration date 15Nov2021 (Lot number: FH4751) as dose number unknown,single for covid-19 immunisation. Relevant medical history included: "Non-smoker" (unspecified if ongoing); "Alzheimer''s" (unspecified if ongoing). Concomitant medication included: MEMANTINE. Patient has not had symptoms associated with COVID-19. The following information was reported: THROMBOSIS (hospitalization, medically significant, life threatening) with onset 03Dec2021, outcome "not recovered", described as "Clot blood"; FALL (hospitalization, medically significant, life threatening) with onset 20Nov2021, outcome "unknown", described as "falling ". Patient was hospitalized on an specified date. The events were reported as serious (medically significant, life threatening). The clinical course was reported as follows: Patient was sent into hospital after falling on 20Nov2021 and returned to residential and then return. The patient does not have history of, or current, malignancy; does not have confirmed or suspected autoimmune or inflammatory disease, including vasculitis; does not have additional medical history, not already provided, that relates to previous venous or arterial thromboses and does not have previous reactions to medications, especially heparin or anticoagulants. The report relate to possible blood clots or low platelet counts but does not relate to possible myocarditis or pericarditis. Patient was diagnosed with thrombosis by hospital last 03Dec2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent the following laboratory tests and procedures: anti-platelet factor 4 antibody test: unknown; fibrin d dimer (normal high range 4000): unknown, notes: $g4000; platelet count (109-150): unknown, notes: <150 A- 109/L; sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of thrombosis which included blood transfusion and reported that patient was still in hospital. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2008278 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Night sweats, SARS-CoV-2 test
SMQs:, Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101838961

Write-up: Night sweat; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112202024199510-LABUE (RA). Other Case identifier(s): GB-MHRA-ADR 26366838 (RA). A 52 year-old female patient (not pregnant) received BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), administration date on 20Nov2021 (Batch/Lot number: unknown) at the age of 52 years as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included: "Suspected COVID-19", start date: 02Nov2020, stop date: 20Jan2021. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), administration date: 13Mar2021; Covid-19 vaccine astrazeneca (Dose 2), administration date: 08May2021. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (disability) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (disability) with onset 20Nov2021, outcome "unknown", described as "Booster"; NIGHT SWEATS (disability) with onset 21Nov2021, outcome "not recovered", described as "Night sweat". The patient stated that she realized that she was of menopausal age but found it highly coincidental that her symptoms started the day after the injection & were quite severe. The patient''s last menstrual period was on 20Oct2021. She had her window open at night & still felt the need to have a fan blasting her all night. The patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in a clinical trial. It was reported that the reaction did not relate to possible inflammation of the heart (myocarditis or pericarditis). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: No - Negative COVID-19 test. The patient received no treatment for the event. No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2008287 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Muscle spasms, SARS-CoV-2 test
SMQs:, Dystonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Idiopathic intracranial hypertension; Stent insertion NOS (stents placed)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101838563

Write-up: booster; Spasm muscle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112202031457080-RWIDR. Other Case identifier(s): GB-MHRA-ADR 26366787. A 35-year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "iih" (unspecified if ongoing); "stents" (unspecified if ongoing), notes: stents placed. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunisation; Bnt162b2 (DOSE 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (disability, medically significant) with onset 20Nov2021, outcome "unknown", described as "booster"; MUSCLE SPASMS (disability, medically significant) with onset 20Nov2021, outcome "not recovered", described as "Spasm muscle". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Clinical course: It was reported that patient now needed to go to physio for the damage caused. The patient last menstrual period date was 17Dec2021. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. was is not enrolled in clinical trial. This report not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2009293 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-20
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthritis reactive, SARS-CoV-2 test
SMQs:, Conjunctival disorders (narrow), Ocular infections (broad), Arthritis (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Reactive arthritis; Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Arthritis reactive; This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRITIS REACTIVE (Arthritis reactive) in a 65-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Previously administered products included for Drug use for unknown indication: HYDROXYCHLOROQUINE (2x200mg daily). Past adverse reactions to the above products included No adverse event with HYDROXYCHLOROQUINE. Concurrent medical conditions included Reactive arthritis and Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...). On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced ARTHRITIS REACTIVE (Arthritis reactive) (seriousness criterion medically significant). At the time of the report, ARTHRITIS REACTIVE (Arthritis reactive) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medications were reported. Patient was not enrolled in clinical trial. This is a regulatory authority case concerning a 65-year-old, male patient with Concurrent medical conditions of Reactive arthritis and Rheumatoid arthritis, who experienced the unexpected serious events of Arthritis reactive. The events occurred approximately 3 days after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events were reported as not resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 65-year-old, male patient with Concurrent medical conditions of Reactive arthritis and Rheumatoid arthritis, who experienced the unexpected serious events of Arthritis reactive. The events occurred approximately 3 days after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events were reported as not resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.


VAERS ID: 2009557 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-30
Onset:2021-11-20
   Days after vaccination:294
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER AB0004 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Condition aggravated, Epilepsy, Fatigue, Loss of consciousness, Muscular weakness, Pain in extremity, Respiration abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADCAL D3; CARBAMAZEPINE; CETIRIZINE; CETRABEN [LIGHT LIQUID PARAFFIN;WHITE SOFT PARAFFIN]; DICYCLOVERINE; DULCOLAXO; GLYCEROL SUPPOSITORIES B.P.; IBUPROFEN; LACTULOSE; LAXIDO; MEPTAZINOL; MICRALAX [SODIUM CITRATE ACID;SODIUM LAURYL SULFOACE
Current Illness: Multiple sclerosis (Taking medicines for multiple sclerosis); Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy; Meningioma (Removal of occipital meningioma.); Osteoporosis; Sciatica
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Condition worsened; Unconscious; Abnormal breathing; Epileptic fit; Weariness; Weakness of limbs; Leg pain; Back pain; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 26371662) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of EPILEPSY (Epileptic fit), FATIGUE (Weariness), MUSCULAR WEAKNESS (Weakness of limbs), PAIN IN EXTREMITY (Leg pain), BACK PAIN (Back pain), CONDITION AGGRAVATED (Condition worsened), LOSS OF CONSCIOUSNESS (Unconscious) and RESPIRATION ABNORMAL (Abnormal breathing) in a 71-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for COVID-19 vaccination. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination. The patient''s past medical history included Epilepsy, Sciatica, Meningioma (Removal of occipital meningioma.) and Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)) since an unknown date. Concurrent medical conditions included Multiple sclerosis (Taking medicines for multiple sclerosis) and Osteoporosis. Concomitant products included BUDESONIDE (RHINOCORT AQUA) for Allergic rhinitis, CETIRIZINE for Allergy, BISACODYL (DULCOLAXO), GLYCEROL (GLYCEROL SUPPOSITORIES B.P.), LACTULOSE, MACROGOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE (LAXIDO) and SODIUM CITRATE ACID, SODIUM LAURYL SULFOACETATE, SORBIC ACID (MICRALAX [SODIUM CITRATE ACID;SODIUM LAURYL SULFOACETATE;SORBIC ACID]) for Constipation, TEMAZEPAM for Difficulty sleeping, PROCHLORPERAZINE for Dizzy spells, CARBAMAZEPINE for Epilepsy, WHITE SOFT PARAFFIN for Eyes dry, OMEPRAZOLE for Indigestion, DICYCLOVERINE for Muscle spasm, CALCIUM CARBONATE, COLECALCIFEROL (ADCAL D3) and RISEDRONATE SODIUM (RISEDRONATE) for Osteoporosis, IBUPROFEN, MEPTAZINOL and PARACETAMOL for Pain, CINCHOCAINE HYDROCHLORIDE, HYDROCORTISONE (UNIROID HC) for Piles, LIGHT LIQUID PARAFFIN, WHITE SOFT PARAFFIN (CETRABEN [LIGHT LIQUID PARAFFIN;WHITE SOFT PARAFFIN]) for Skin dry. On 30-Jan-2021, the patient received first dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced EPILEPSY (Epileptic fit) (seriousness criterion life threatening), FATIGUE (Weariness) (seriousness criterion life threatening), MUSCULAR WEAKNESS (Weakness of limbs) (seriousness criterion life threatening), PAIN IN EXTREMITY (Leg pain) (seriousness criterion life threatening) and BACK PAIN (Back pain) (seriousness criterion life threatening). On an unknown date, the patient experienced CONDITION AGGRAVATED (Condition worsened) (seriousness criterion life threatening), LOSS OF CONSCIOUSNESS (Unconscious) (seriousness criterion life threatening) and RESPIRATION ABNORMAL (Abnormal breathing) (seriousness criterion life threatening). On 20-Nov-2021, EPILEPSY (Epileptic fit) had resolved. On 27-Nov-2021, FATIGUE (Weariness) had resolved. On 03-Dec-2021, MUSCULAR WEAKNESS (Weakness of limbs), PAIN IN EXTREMITY (Leg pain) and BACK PAIN (Back pain) had resolved. At the time of the report, CONDITION AGGRAVATED (Condition worsened), LOSS OF CONSCIOUSNESS (Unconscious) and RESPIRATION ABNORMAL (Abnormal breathing) outcome was unknown. No treatment medication details was reported. All side effects listed were because the effect was worse than patient''s normal problems. The Epileptic Fit was the worst Patient would ever had leaving her unconscious for over an hour with abnormal breathing. It was obviously life-threatening. Patient said she will not accept the Moderna Vaccine again. Patient is not enrolled in clinical trial. Company Comment: This case concerns a 71-year-old, female patient, with reported medical history of Multiple sclerosis, Steroid therapy, Epilepsy, Osteoporosis, Sciatica and Meningioma who experienced the serious unexpected events of Epilepsy, Fatigue, Muscular Weakness, Pain in Extremity, Back Pain, Condition Aggravated, Loss of Consciousness and Respiration Abnormal. The event Epilepsy occurred one day after the administration of the 3rd dose of the mRNA-1273 vaccine and the outcome at the time of the report was Recovered/Resolved. The events Epilepsy, Fatigue, Muscular weakness, Pain in extremity and Back pain, occurred one day after the administration of the 3rd dose of the mRNA-1273 vaccine and the outcome at the time of the report was Recovered/Resolved. The events Condition Aggravated, Loss of Consciousness and Respiration Abnormal, occurred in an unknown date and the outcome at the time of the report was Unknown. The rechallenge is not applicable since the events occurred after the 3rd dose of the of the mRNA-1273 vaccine and another dose will not be administered. The reported medical history remains as a confounder for the events. The events of Epilepsy and Loss of consciousness, were reported as serious by the RA. The seriousness Criteria was: Life-threatening. Seriousness was automatically upgraded per IME list for these events as Medically Significant, in accordance with the RA criteria, this severity was manually downgraded to mirror with SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 71-year-old, female patient, with reported medical history of Multiple sclerosis, Steroid therapy, Epilepsy, Osteoporosis, Sciatica and Meningioma who experienced the serious unexpected events of Epilepsy, Fatigue, Muscular Weakness, Pain in Extremity, Back Pain, Condition Aggravated, Loss of Consciousness and Respiration Abnormal. The event Epilepsy occurred one day after the administration of the 3rd dose of the mRNA-1273 vaccine and the outcome at the time of the report was Recovered/Resolved. The events Epilepsy, Fatigue, Muscular weakness, Pain in extremity and Back pain, occurred one day after the administration of the 3rd dose of the mRNA-1273 vaccine and the outcome at the time of the report was Recovered/Resolved. The events Condition Aggravated, Loss of Consciousness and Respiration Abnormal, occurred in an unknown date and the outcome at the time of the report was Unknown. The rechallenge is not applicable since the events occurred after the 3rd dose of the of the mRNA-1273 vaccine and another dose will not be administered. The reported medical history remains as a confounder for the events. The events of Epilepsy and Loss of consciousness, were reported as serious by the RA. The seriousness Criteria was: Life-threatening. Seriousness was automatically upgraded per a regulatory authority list for these events as Medically Significant, in accordance with the RA criteria, this severity was manually downgraded to mirror with a regulatory authority. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2009677 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Malaise, Migraine, Nasopharyngitis, Rhinorrhoea, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Comments: No Medical History information was reported.
Allergies:
Diagnostic Lab Data: Test Date: 20211221; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Runny nose; Chronic migraine; Generally unwell; Head cold; This case was received (Reference number: GB-MHRA-ADR 26377272) on 23-Dec-2021 and was forwarded to Moderna on 23-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), MIGRAINE (Chronic migraine), MALAISE (Generally unwell) and NASOPHARYNGITIS (Head cold) in a 59-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. No Medical History information was reported. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 05-Mar-2021 to an unknown date and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for Immunisation. On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced MALAISE (Generally unwell) (seriousness criterion disability) and NASOPHARYNGITIS (Head cold) (seriousness criterion disability). On an unknown date, the patient experienced RHINORRHOEA (Runny nose) (seriousness criterion disability) and MIGRAINE (Chronic migraine) (seriousness criterion disability). At the time of the report, RHINORRHOEA (Runny nose), MIGRAINE (Chronic migraine), MALAISE (Generally unwell) and NASOPHARYNGITIS (Head cold) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had CFS and chronic migraine. Since booster she felt worse and generally unwell, it was like having a permanent cold. Patient got hot and cold and have excess catarrh or runny nose or sneezing. Patient had not been able to go out for exercise. No treatment information was provided. Company Comment - This case concerns a 59 year old female patient with no relevant medical history, who experienced the serious (disability) unexpected events of rhinorrhea, migraine, malaise and nasopharyngitis. The event malaise occurred on the same day after the third dose of mRNA-1273 vaccine, the other events occurred on an unknown date after the dose of mRNA-1273 vaccine. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 59 year old female patient with no relevant medical history, who experienced the serious (disability) unexpected events of rhinorrhea, migraine, malaise and nasopharyngitis. The event malaise occurred on the same day after the third dose of mRNA-1273 vaccine, the other events occurred on an unknown date after the dose of mRNA-1273 vaccine. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2009811 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Babinski reflex test, Blood cholesterol, Blood cholesterol increased, Feeling abnormal, Full blood count, Hypoaesthesia, Paraesthesia, Romberg test, Vaccination site haemorrhage
SMQs:, Dyslipidaemia (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Dementia (broad), Guillain-Barre syndrome (broad), Lipodystrophy (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Kyphosis; Migraine; Spondylosis
Preexisting Conditions: Medical History/Concurrent Conditions: Flu
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Babinski reflex test; Test Result: Negative ; Test Date: 2021; Test Name: cholesterol; Result Unstructured Data: Test Result:slightly increased; Test Date: 2021; Test Name: Complete blood count; Result Unstructured Data: Test Result:normal; Test Date: 2021; Test Name: Romberg test; Test Result: Negative
CDC Split Type: HRPFIZER INC202101869622

Write-up: occasional numbness in certain parts of the body; There was a bigger bloodstain at the injection site; strange sensations occurred in the body; Neurological symptoms of paresthesia; slightly increased cholesterol; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. This is the second of two reports. The first report is a report downloaded from the regulatory authority -HALMED-300052825. A 62 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm right, administration date 20Nov2021 (Lot number: FE6208) at the age of 62 years as dose 2, 0.3ml, single for covid-19 immunisation. Relevant medical history included: "Migraine" (ongoing); "Flu", start date: 2018, stop date: 2018; "begin kyphosis" (ongoing); "Spondylosis" (ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (1 st dose, Lot: FD6840), administration date: 16Oct2021, for COVID-19 immunisation, reaction(s): "numbness", "burning sensation", "headache", "inflammation of the Bartolini''s gland". The following information was reported: VACCINATION SITE HAEMORRHAGE (disability) with onset 20Nov2021, outcome "recovered" (2021), described as "There was a bigger bloodstain at the injection site"; FEELING ABNORMAL (disability) with onset 20Nov2021, outcome "not recovered", described as "strange sensations occurred in the body"; PARAESTHESIA (disability) with onset 20Nov2021, outcome "not recovered", described as "Neurological symptoms of paresthesia"; HYPOAESTHESIA (disability) with onset 21Nov2021, outcome "unknown", described as "occasional numbness in certain parts of the body"; BLOOD CHOLESTEROL INCREASED (non-serious) with onset 2021, outcome "unknown", described as "slightly increased cholesterol". The events "strange sensations occurred in the body", "neurological symptoms of paresthesia" and "occasional numbness in certain parts of the body" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: babinski reflex test: (2021) negative; blood cholesterol: (2021) slightly increased; full blood count: (2021) normal; romberg test: (2021) negative. Therapeutic measures were taken as a result of feeling abnormal, paraesthesia, hypoaesthesia. Clinical course: Immediately after receiving the 2nd dose, strange sensations occurred in the body. There was a bigger bloodstain at the site of the needle prick. After 45 minutes of receiving 2 doses, paresthesias began to occur, which increased as time passed. After 24 hours of receiving the 2nd dose, the paresthesias became stronger and unbearable: tingling, pricking needle-like stings, stronger and weaker, numbness in the muscles of the legs and arms. Feeling like stings of needles or electric currents gripped the whole body, reaching the left side of the cheek and returning again through the whole body without any simultaneous rotation, they would appear in the leg, soles and suddenly in the cheeks, chest or back. After two days, she went to the doctor, who let her do laboratory tests and referred her to a neurologist. Complete blood count tests returned to normal. The neurologist did the Babinski and Romberg tests which were negative and referred her for an magnetic resonance imaging of the head which has not been done yet, gave her paresthesia medications. The symptoms are still going on, she had been on sick leave for the second week, she can''t stand on her feet for a long time because her toes and the front parts of her soles had started to tingle. She felt the stings on the fingers still in the body as well as the feeling of occasional numbness in certain parts of the body. Slightly increased cholesterol on the last lab findings after the 2nd dose. Sender''s comments: Causality assessment is based on HALMED-CNIPH meeting held on 14Dec2021 No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : -PFIZER INC-202101817330 The same patient, different vaccine dose, different events


VAERS ID: 2011348 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Carditis, Chest pain, Dyspnoea, Fatigue, Immunisation, Interchange of vaccine products, Myocardial infarction, Myocarditis, Off label use, Palpitations, Pericarditis, Tachycardia, Thrombosis, Troponin, X-ray
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DESOGESTREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception; Comments: Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding.
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:Unknown Results; Test Name: Troponin; Result Unstructured Data: Test Result:Normal; Test Name: X-ray; Result Unstructured Data: Test Result:Unknown Results
CDC Split Type: GBPFIZER INC202101847120

Write-up: Carditis; Fatigue/unusual tiredness; Chest pain; Shortness of breath; Racing heart (tachycardia); Palpitations/Heart palpitations; blood clot in the lung; myocarditis; pericarditis; Attack heart (NOS); Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112201130194540-N12NU (MHRA). Other Case identifier(s): GB-MHRA-ADR 26362977 (MHRA). A 49 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Contraception" (unspecified if ongoing). Concomitant medication(s) included: DESOGESTREL taken for contraception. Vaccination history included: Covid-19 vaccine astrazeneca (Dose-Unknown, Primary Immunization series complete), for COVID-19 immunisation; Covid-19 vaccine (Dose-Unknown, Primary Immunization series complete , Unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (hospitalization) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (hospitalization) with onset 20Nov2021, outcome "unknown", described as "Booster"; MYOCARDIAL INFARCTION (hospitalization, medically significant) with onset 21Nov2021, outcome "recovered with sequelae" (20Dec2021), described as "Attack heart (NOS)"; CARDITIS (hospitalization, medically significant), outcome "unknown", described as "Carditis"; FATIGUE (hospitalization), outcome "unknown", described as "Fatigue/unusual tiredness"; CHEST PAIN (hospitalization), outcome "unknown", described as "Chest pain"; DYSPNOEA (hospitalization), outcome "unknown", described as "Shortness of breath"; TACHYCARDIA (hospitalization), outcome "unknown", described as "Racing heart (tachycardia)"; PALPITATIONS (hospitalization), outcome "unknown", described as "Palpitations/Heart palpitations"; THROMBOSIS (hospitalization), outcome "unknown", described as "blood clot in the lung"; MYOCARDITIS (hospitalization), outcome "unknown", described as "myocarditis"; PERICARDITIS (hospitalization), outcome "unknown", described as "pericarditis". Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Report relate to possible inflammation of the heart (myocarditis or pericarditis). Diagnosis made by a medical professional. Treatment given because of Carditis (anti inflammatory). Sudden onset of chest pain, heart attack or blood clot in the lung, put down to inflammation of the heart. The patient underwent the following laboratory tests and procedures: blood test: unknown results; troponin: normal; x-ray: unknown results. Therapeutic measures were taken as a result of carditis. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2011466 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-07
Onset:2021-11-20
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Lymph node pain, Lymphadenopathy, Menstrual disorder
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESCITALOPRAM; ESTRADOT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety disorder; Menopausal
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101846715

Write-up: menstrual cramps; lymph nodes under my arms have been sore and swollen; lymph nodes under my arms have been sore and swollen; menstrual clotting; Menstrual flooding/bleeding heavily; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112210947122110-LQ6QL (RA). Other Case identifier(s): GB-MHRA-ADR 26370038 (RA). A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 07Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Menopausal" (unspecified if ongoing); "Anxiety disorder" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM taken for anxiety disorder; ESTRADOT taken for menopause, start date: 01Aug2021. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 Immunisation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The following information was reported: DYSMENORRHOEA (disability, medically significant), outcome "not recovered", described as "menstrual cramps"; HEAVY MENSTRUAL BLEEDING (disability, medically significant) with onset 20Nov2021, outcome "not recovered", described as "Menstrual flooding/bleeding heavily"; LYMPHADENOPATHY (disability, medically significant), LYMPH NODE PAIN (disability, medically significant), outcome "unknown" and all described as "lymph nodes under my arms have been sore and swollen"; MENSTRUAL DISORDER (disability, medically significant), outcome "unknown", described as "menstrual clotting". Since having the vaccine the monthly cycle has turned into a permanent cycle patient was bleeding heavily on a daily basis with menstrual cramps and clotting. The lymph nodes under patient arms have been sore and swollen ever since patient had the vaccine so nearly 7 weeks now. The report not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2011582 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chest discomfort, Chest pain, Dizziness, Dyspnoea, Immunisation, Interchange of vaccine products, Off label use, Pyrexia, SARS-CoV-2 test, Thrombocytopenia, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CEFALEXIN; PENICILLIN V [PHENOXYMETHYLPENICILLIN]; PREDNISOLONE; TRAMADOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Immunocompromised; Osteoarthritis; Splenectomy (Spleen has been removed); Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Test Date: 2021; Test Name: body temperature; Result Unstructured Data: Test Result:high Centigrade; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101846529

Write-up: Off label use; Interchange of vaccine products; Booster; thrombocytopenia; wheeze; dizziness; high temperature; difficulty breathing; chest tight; pain in back of chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112211421501720-UWLQE (RA). Other Case identifier(s): GB-MHRA-ADR 26372072 (RA). A 70 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Steroid therapy" (unspecified if ongoing), notes: Taking regular steroid treatment (e.g. orally or rectally); "Splenectomy" (unspecified if ongoing), notes: Spleen has been removed; "Immunocompromised" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing). Concomitant medication(s) included: CEFALEXIN taken for immunodeficiency, start date: 01Jan1988; PENICILLIN V [PHENOXYMETHYLPENICILLIN] taken for immunodeficiency, start date: 01Jan1980; PREDNISOLONE taken for asthma, start date: 03Mar2021; TRAMADOL taken for osteoarthritis, start date: 01Jan2010. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), administration date: 20Jan2021, for COVID-19 immunisation, reaction(s): "thrombocytopenia", "wheeze", "dizziness", "high temperature", "difficulty breathing", "Rash purpuric", "Head pain", "Pyrexia", "Dizzy spells", "Respiratory symptom", "Asthmatic symptoms exaggerated", "Nosebleed"; Bnt162b2 (Dose 2), administration date: Apr2021, for COVID-19 immunisation, reaction(s): "chest tight", "pain in back of chest", "dizziness", "difficulty breathing", "Palpitations", "high temperature", "Thrombocytopenia", "wheeze". The following information was reported: OFF LABEL USE (disability, medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability, medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (disability, medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; THROMBOCYTOPENIA (disability, medically significant) with onset 2021, outcome "not recovered", described as "thrombocytopenia"; WHEEZING (disability, medically significant) with onset 2021, outcome "not recovered", described as "wheeze"; DIZZINESS (disability, medically significant) with onset 2021, outcome "not recovered", described as "dizziness"; PYREXIA (disability, medically significant) with onset 2021, outcome "not recovered", described as "high temperature"; DYSPNOEA (disability, medically significant) with onset 2021, outcome "not recovered", described as "difficulty breathing"; CHEST DISCOMFORT (disability, medically significant) with onset 2021, outcome "not recovered", described as "chest tight"; CHEST PAIN (disability, medically significant) with onset 2021, outcome "not recovered", described as "pain in back of chest". Clinical course: Spleen was removed, the first vaccine triggered past signs and symptoms which were severe. Asthmatic symptoms have been exaggerated. Asthma had become unstable all since the first vaccine. The second dose of Pfizer Vac, symptoms were severe but not as much as the first dose of the vaccine or the third full dose of Pfizer. Symptoms were much more severe and long-lasting, possible because none were ever resolved. It was not unsure if patient had had symptoms associated with COVID-19. After first vaccine all signs and symptoms of thrombocytopenia returned. Headaches and head pains were severe and ongoing, occasionally associated with severe dizziness. Palpitations often associated with very high temperature 38.5C and higher- occurring several peaks per day. Respiratory symptoms included difficulty breathing, audible expiratory wheeze, chest tight and pain in back of chest. Four weeks after the third full vaccine, symptoms were still ongoing, some less severe but none have cleared completely. The patient underwent the following laboratory tests and procedures: body temperature: (2021) 38.5 Centigrade; (2021) high; sars-cov-2 test: (unspecified date) no - negative covid-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200005421 same patient, different dose and events.


VAERS ID: 2011840 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Immunisation, SARS-CoV-2 test
SMQs:, Hearing impairment (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101847671

Write-up: Palsy Bells; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112220640139830-I6UZD. Other Case identifier(s): GB-MHRA-ADR 26375880. A 53 year-old male patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Lot number unknown), for COVID-19 immunization; Bnt162b2 (Dose: 2, Lot number unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 20Nov2021, outcome "unknown", described as "booster"; BELL''S PALSY (hospitalization, medically significant), outcome "recovering", described as "Palsy Bells". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2011870 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Aching in limb; This case was received via the RA (Reference number: GB-MHRA-ADR 26376915) on 23-Dec-2021 and was forwarded to Moderna on 23-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Aching in limb) in a 67-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for COVID-19 vaccination. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 20-Feb-2021 to an unknown date for Vaccination. On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced PAIN IN EXTREMITY (Aching in limb) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Aching in limb) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information mentioned. Patient also had soreness of injection site (leg). Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment This case concerns a 67-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of pain in extremity. The events occurred the same day after the third dose of mRNA-1273. The rechallenge was unknown since no information regarding the first and second dose was disclosed and as was reported by regulatory Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events meet the criteria to be medically significant.; Sender''s Comments: This case concerns a 67-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of pain in extremity. The events occurred the same day after the third dose of mRNA-1273. The rechallenge was unknown since no information regarding the first and second dose was disclosed and as was reported by regulatory Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events meet the criteria to be medically significant.


VAERS ID: 2012246 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Muscle spasms, Off label use, Spinal compression fracture
SMQs:, Dystonia (broad), Accidents and injuries (narrow), Osteoporosis/osteopenia (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Leukemia (had no symptoms or medicine since 2016); Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101856534

Write-up: Vertebral collapse; Leg spasm; off label use; interchange of vaccine products; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112231421068810-IKOW7. Other Case identifier(s): GB-MHRA-ADR 26386034. A 76 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Leukaemia" (unspecified if ongoing), notes: had no symptoms or medicine since 2016 ; "Neoplasm" (unspecified if ongoing), notes: Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy). Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (dose 1, single), administration date: 2021, for COVID-19 immunization; Covid-19 vaccine astrazeneca (dose 2, single), administration date: 2021, for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "booster"; SPINAL COMPRESSION FRACTURE (medically significant) with onset 21Nov2021, outcome "recovered" (21Nov2021), described as "Vertebral collapse"; MUSCLE SPASMS (medically significant) with onset 21Nov2021, outcome "recovered" (21Nov2021), described as "Leg spasm". Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. The patient stated she laid on the floor unable to move her legs for over an hour unable to get up. After this time she crawled into another room and hauled herself onto the sofa. She stayed there for another half hour. Then she was able to get up and walk. She was unable to get medical help in spite of the fact she tried to ring her doctor. Patient has not tested positive for COVID-19 since having the vaccine. The report relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2012620 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-11-20
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Obesity; Recovered smoker
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: FRMODERNATX, INC.MOD20214

Write-up: NA/Vaccination failure; This case was received via Regulatory Agency (Reference number: FR-AFSSAPS-TO20219361) on 25-Dec-2021 and was forwarded to Moderna on 25-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of VACCINATION FAILURE (NA/Vaccination failure) in a 53-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214011) for COVID-19 vaccination. The patient''s past medical history included Obesity and Recovered smoker. On 25-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 20-Nov-2021, after starting mRNA-1273 (Spikevax), the patient experienced VACCINATION FAILURE (NA/Vaccination failure) (seriousness criterion hospitalization). At the time of the report, VACCINATION FAILURE (NA/Vaccination failure) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Nov-2021, SARS-CoV-2 test: negative (Negative) Negative. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not provided. Company comment. This regulatory authority case concerns a 53 � year � old, male patient with no reported relevant medical history, who experienced the unexpected serious event of vaccination failure. The event occurred 56 days after the administration of a dose of mRNA-1273 vaccine. No information about previous vaccination schedule was provided. At the time of the report the outcome of the events was resolving. Three days after the onset of vaccination failure, SARS-CoV-2 test was performed, and it was reported as negative. The case was assessed as serious as per Regulatory Authority�s report due to hospitalization; however, no details on hospitalization dates and/or clinical course were provided in the source document. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 53 � year � old, male patient with no reported relevant medical history, who experienced the unexpected serious event of vaccination failure. The event occurred 56 days after the administration of a dose of mRNA-1273 vaccine. No information about previous vaccination schedule was provided. At the time of the report the outcome of the events was resolving. Three days after the onset of vaccination failure, SARS-CoV-2 test was performed, and it was reported as negative. The case was assessed as serious as per Regulatory Authority�s report due to hospitalization; however, no details on hospitalization dates and/or clinical course were provided in the source document. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2013104 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3739 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Headache, Hypoaesthesia, Immunisation, Lymphadenopathy, Myalgia, Oropharyngeal pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: GABAPENTIN; BLUEBERRY; METHYLSULFONYLMETHANE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blepharoconjunctivitis (chronic blepharoconjunctive); Bronchial asthma; Headache (chronic daily headache); Ileocolitis (chronic ileocolitis); Mite allergy; Muscular dystrophy (Myofibrillar muscular dystrophy)
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:unknown; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade
CDC Split Type: ITPFIZER INC202101830524

Write-up: booster; large lymph node/lymph node at the level of the neck; Throat pain; half face asleep/spordal feeling of numbness in the left cheek; severe headache; fluctuating fever with Temp max 39 � C; muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: IT-MINISAL02-822050 (MINISAL02). A 33 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 18Nov2021 (Lot number: FG3739) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Myofibrillar muscular dystrophy" (unknown if ongoing), notes: Myofibrillar muscular dystrophy; "ileocolitis" (unknown if ongoing), notes: chronic ileocolitis; "headache" (unknown if ongoing), notes: chronic daily headache; "allergy to mites" (unspecified if ongoing); "blepharoconjunctive" (unspecified if ongoing), notes: chronic blepharoconjunctive; "Bronchial asthma" (unknown if ongoing). Concomitant medication(s) included: GABAPENTIN taken for headache, start date: 25Oct2021; BLUEBERRY; METHYLSULFONYLMETHANE. Vaccination history included: Comirnaty (dose 1, single, batch EX0893), administration date: 22Apr2021, for covid-19 immunisation; Comirnaty (dose 2, single, batch EY7065), administration date: 16May2021, for covid-19 immunisation. The following information was reported: IMMUNISATION (hospitalization), outcome "unknown", described as "booster"; LYMPHADENOPATHY (hospitalization) with onset 20Nov2021, outcome "recovered with sequelae", described as "large lymph node/lymph node at the level of the neck"; OROPHARYNGEAL PAIN (hospitalization) with onset 20Nov2021, outcome "recovered with sequelae", described as "Throat pain"; HYPOAESTHESIA (hospitalization) with onset 20Nov2021, outcome "recovered with sequelae", described as "half face asleep/spordal feeling of numbness in the left cheek"; HEADACHE (hospitalization) with onset 20Nov2021, outcome "recovered with sequelae", described as "severe headache"; PYREXIA (hospitalization) with onset 20Nov2021, outcome "recovered with sequelae", described as "fluctuating fever with Temp max 39 degree C"; MYALGIA (hospitalization) with onset 20Nov2021, outcome "recovered with sequelae", described as "muscle pain". The events "large lymph node/lymph node at the level of the neck", "throat pain", "half face asleep/spordal feeling of numbness in the left cheek", "severe headache", "fluctuating fever with temp max 39 degree c" and "muscle pain" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: unknown; body temperature: 39 Centigrade.Impact on quality of life was reported as 8/10 Reporter Comment: Myofibrillar muscular dystrophy, chronic ileocolitis, chronic daily headache, allergy to mites, chronic blepharoconjunctiva No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Myofibrillar muscular dystrophy, chronic ileocolitis, chronic daily headache, allergy to mites, chronic blepharoconjunctiva


VAERS ID: 2013122 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1020A / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure abnormal, Blood pressure diastolic, Blood pressure systolic, Heart rate, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: diastolic blood pressure; Result Unstructured Data: Test Result:118; Test Date: 20211120; Test Name: systolic blood pressure; Result Unstructured Data: Test Result:175; Test Date: 20211120; Test Name: Heart rate; Result Unstructured Data: Test Result:131; Comments: unit: bpm
CDC Split Type: ITPFIZER INC202101831321

Write-up: Tachycardia (Heart rate 131bpm)_systolic blood pressure 175_ diastolic blood pressure 118; Tachycardia (Heart rate 131bpm)_systolic blood pressure 175_ diastolic blood pressure 118; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from the regulatory authority-WEB. Regulatory number: IT-MINISAL02-822223. A 55 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 20Nov2021 14:52 (Lot number: 1F1020A) at the age of 55 years as dose 1, 0.3 ml single for covid-19 immunization. Relevant medical history included: "Covid infection" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: TACHYCARDIA (medically significant) with onset 20Nov2021, outcome "recovered" (2021), BLOOD PRESSURE ABNORMAL (medically significant) with onset 20Nov2021, outcome "unknown" and all described as "Tachycardia (Heart rate 131bpm)_systolic blood pressure 175_ diastolic blood pressure 118". The patient underwent the following laboratory tests and procedures: blood pressure diastolic: (20Nov2021) 118; blood pressure systolic: (20Nov2021) 175; heart rate: (20Nov2021) 131, notes: unit: bpm. Reporter Comment: Adverse reaction 1 dose of vaccine after Covid infection. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Adverse reaction 1 dose of vaccine after Covid infection


VAERS ID: 2013451 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood test, Condition aggravated, Erysipelas, Fatigue, Headache, Malaise, Neuralgia, Paraesthesia, Vaccination site erythema, Vaccination site inflammation, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Arthritis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral hemorrhage
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:Not reported
CDC Split Type: NLPFIZER INC202101834367

Write-up: Headache; Malaise; Erysipelas; Fatigue; Tingling of extremity; Neuralgia; Condition aggravated; Vaccination site erythema; Vaccination site pain; Vaccination site warmth; Vaccination site inflammation; Vaccination site swelling; Generalized joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: NL-LRB-00728767. A 72 year-old male patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: FG6273) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cerebral hemorrhage" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (Dose number 1, single, start date: 28Oct2021, batch/lot number: Unspecified, route of administration: Unspecified, strength: Unspecified., Reaction: Neck pain), administration date: 28Oct2021, for Covid-19 Immunization, reaction(s): "Neck pain", "Tingling of extremity". The following information was reported: ERYSIPELAS (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Erysipelas"; FATIGUE (non-serious) with onset 21Nov2021, outcome "not recovered", described as "Fatigue"; PARAESTHESIA (non-serious) with onset 21Nov2021, outcome "not recovered", described as "Tingling of extremity"; VACCINATION SITE WARMTH (non-serious) with onset 20Nov2021, outcome "recovered" (23Nov2021), described as "Vaccination site warmth"; VACCINATION SITE INFLAMMATION (non-serious) with onset 20Nov2021, outcome "recovered" (23Nov2021), described as "Vaccination site inflammation"; NEURALGIA (non-serious) with onset 21Nov2021, outcome "not recovered", described as "Neuralgia"; CONDITION AGGRAVATED (non-serious) with onset 21Nov2021, outcome "not recovered", described as "Condition aggravated"; VACCINATION SITE ERYTHEMA (non-serious) with onset 20Nov2021, outcome "recovered" (23Nov2021), described as "Vaccination site erythema"; VACCINATION SITE PAIN (non-serious) with onset 20Nov2021, outcome "recovered" (23Nov2021), described as "Vaccination site pain"; MALAISE (non-serious) with onset 21Nov2021, outcome "not recovered", described as "Malaise"; HEADACHE (non-serious), outcome "recovering", described as "Headache"; VACCINATION SITE SWELLING (non-serious) with onset 20Nov2021, outcome "recovered" (23Nov2021), described as "Vaccination site swelling"; ARTHRALGIA (non-serious) with onset 20Nov2021, outcome "not recovered", described as "Generalized joint pain". The patient underwent the following laboratory tests and procedures: blood test: not reported. Therapeutic measures were taken as a result of erysipelas, fatigue, paraesthesia, vaccination site warmth, vaccination site inflammation, neuralgia, condition aggravated, vaccination site erythema, vaccination site pain, malaise, headache, vaccination site swelling, arthralgia. Clinical course: There was no Extensive swelling of vaccinated limb. The patient was not having Previous COVID-19 infection. Sender''s comment: Since the nature of the reported reaction does not imply seriousness according to one of the CIOMS critera, the reaction was considered as non-serious by the Regulatory Authority. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2015764 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Menstrual disorder, Oligomenorrhoea
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101857731

Write-up: Period after 11 months of no period - bleeding 2 days after booster vaccine and still bleeding one month later; Period after 11 months of no period - bleeding 2 days after booster vaccine and still bleeding one month later; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-EYC 00269772 (RA). Other Case identifier(s): GB-MHRA-ADR 26375952 (RA). A 51 year-old female patient received bnt162b2 (COMIRNATY), parenteral, administration date 20Nov2021 (Lot number: FK9413) as dose number unknown (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, MANUFACTURER UNKNOWN), for covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; MENSTRUAL DISORDER (medically significant), OLIGOMENORRHOEA (medically significant) all with onset 22Nov2021, outcome "unknown" and all described as "Period after 11 months of no period - bleeding 2 days after booster vaccine and still bleeding one month later". The outcome of the events was unknown. Reporter comment- The other outcome for Period after 11 months of no period - bleeding 2 days after booster vaccine and still bleeding one month later was: still bleeding No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: The other outcome for Period after 11 months of no period - bleeding 2 days after booster vaccine and still bleeding one month later was: still bleeding


VAERS ID: 2015908 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH475I / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Dehydration, Ear pain, Headache, Lethargy, Muscle spasms, Nausea, Paraesthesia, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HYDROXYCHLOROQUINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef)); Lethargy; Pain; Systemic lupus erythematosus (had been manageable over the years); Tingling
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101857736

Write-up: Paresthesia; Cramp legs; Generalised joint pains; Lethargic tendency; Cramp of limb; Dehydration; Nauseous; Headache; Earache; Fever; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112241049140430-5A5WZ (RA). Other Case identifier(s): GB-MHRA-ADR 26391429 (RA). A female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH475I) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Systemic lupus erythematosus" (unspecified if ongoing), notes: had been manageable over the years; "Tingling" (unspecified if ongoing); "Lethargy" (unspecified if ongoing); "Pain" (unspecified if ongoing); "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef). Concomitant medication(s) included: HYDROXYCHLOROQUINE taken for systemic lupus erythematosus, start date: 01Apr2005. The following information was reported: MUSCLE SPASMS (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Cramp of limb"; MUSCLE SPASMS (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Cramp legs"; NAUSEA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Nauseous"; HEADACHE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Headache"; EAR PAIN (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Earache"; PYREXIA (medically significant) with onset 20Nov2021, outcome "recovered with sequelae" (2021), described as "Fever"; ARTHRALGIA (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Generalised joint pains"; DEHYDRATION (medically significant) with onset 20Nov2021, outcome "recovered with sequelae" (2021), described as "Dehydration"; LETHARGY (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Lethargic tendency"; PARAESTHESIA (medically significant) with onset 25Nov2021, outcome "not recovered", described as "Paresthesia". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of muscle spasms, muscle spasms, nausea, headache, ear pain, pyrexia, arthralgia, dehydration, lethargy, paraesthesia.The patient received treatment of IV therapy due to dehydration, analgesic drug therapy and hydrotherapy for adverse events. Clinical course: Systemic lupus erythematosus (SLE) - had been manageable over the years, since having covid vaccine, the patient had become less active, in more pain, tingling and cramp sensations (new) and lethargy. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016025 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; ATENOLOL; FLUOXETINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101857612

Write-up: Off label use; interchange of vaccine products; Booster; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112242249227880-JFALY. Other Case identifier(s): GB-MHRA-ADR 26393953. A 50 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE; ATENOLOL; FLUOXETINE; INFLUENZA VIRUS taken for influenza immunisation, administration date 01Oct2021. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1, Lot number: Not known), administration date: 16Mar2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (Dose 2, Lot number: Not known, Fatigue onset date: 16May2021, not recovered), administration date: 08May2021, for COVID-19 immunisation, reaction(s): "Fatigue". The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; FATIGUE (medically significant) with onset 2021, outcome "not recovered", described as "Fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: Patient had no symptoms associated with COVID-19. The patient was not currently breastfeeding. The patient was not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2016118 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Deep vein thrombosis, Erythema, Inappropriate schedule of product administration, Pain in extremity, SARS-CoV-2 test, Scan, Thrombosis
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:DVT; Comments: had a thromboses vein; Test Name: Bloods; Result Unstructured Data: Test Result:Unknown results; Comments: Bloods taken waiting for referral; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: scan; Result Unstructured Data: Test Result:no clot was found; Comments: Referred for a scan no clot was found on the scan
CDC Split Type: GBPFIZER INC202101857575

Write-up: dvt/ thromboses vein/ clotting on vein; leg pain/pain in left leg thigh/leg pain in calf; redness & pain in left leg thigh; Thrombosis; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112252312483000-LVXIK. Other Case identifier(s): GB-MHRA-ADR 26395244. A 46-year-old male patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: Fk9413) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE NUMBER 1), administration date: 21Sep2021, for COVID-19 immunisation, reaction(s): "felt unwell", "leg was swollen", "slight bruising", "redness where the pain was in left calf", "pain in calf". The following information was reported: DEEP VEIN THROMBOSIS (medically significant), outcome "not recovered", described as "dvt/ thromboses vein/ clotting on vein"; THROMBOSIS (medically significant) with onset 05Dec2021, outcome "not recovered", described as "Thrombosis"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "leg pain/pain in left leg thigh/leg pain in calf"; ERYTHEMA (non-serious), outcome "unknown", described as "redness & pain in left leg thigh"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 20Nov2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The events "dvt/ thromboses vein/ clotting on vein", "thrombosis", "leg pain/pain in left leg thigh/leg pain in calf" and "redness & pain in left leg thigh" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: dvt, notes: had a thromboses vein; unknown results, notes: Bloods taken waiting for referral; sars-cov-2 test: negative, notes: No - Negative COVID-19 test; scan: no clot was found, notes: Referred for a scan no clot was found on the scan. Clinical course: Patient had his first vaccine felt unwell doctor suspected a clot in left leg. Referred for a scan no clot was found on the scan my leg was swollen and slight bruising & redness where the pain was in his left calf. He had second vaccine in late November still had leg pain in calf then developed redness & pain in left leg thigh with a lump at the end of a vein in my inner thigh. After a few calls to doctor''s surgery, he was advised to go to AE was seen his doctor that advised he had a thromboses vein/ clotting on vein & bloods where taken to see if he had DVT. The results where DVT was unluckily but he had a thromboses vein in his thigh, now waiting for referral for scan/ treatment. Patient has not had symptoms associated with COVID-19. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016367 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Dizziness, Dyspnoea, Exercise tolerance decreased, Feeling abnormal, Hemianaesthesia, Impaired work ability, Inflammation, Loss of personal independence in daily activities, Pain, Palpitations, Rash, Tinnitus, Tremor, Vertigo
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Other ischaemic heart disease (narrow), Hearing impairment (narrow), Vestibular disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenomyosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101859309

Write-up: Heart pain/Heart hurts; Inflammation in body; Tinnitus; Can''t do daily normal things; Numbness one side body; Can''t work with pain and shakes; Can''t work with pain and shakes; Tremors/shakes; Couldn''t breathe; Dizzy; Palpitations; Can''t walk far out of breath; Brain fog; Vertigo; Rash; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority-WEB. The reporter is the patient. Regulatory number: IE-HPRA-2021-088430. Other Case identifier(s): IE-HPRA-CVARR2021121623316. A 44 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH8469) at the age of 44 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Adenomyosis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: ANGINA PECTORIS (hospitalization, disability, life threatening) with onset 20Nov2021, outcome "not recovered", described as "Heart pain/Heart hurts"; INFLAMMATION (hospitalization, disability, life threatening) with onset 20Nov2021, outcome "not recovered", described as "Inflammation in body"; TINNITUS (hospitalization, disability, life threatening) with onset 20Nov2021, outcome "not recovered", described as "Tinnitus"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hospitalization, disability, life threatening) with onset 20Nov2021, outcome "not recovered", described as "Can''t do daily normal things"; HEMIANAESTHESIA (hospitalization, disability, life threatening) with onset 20Nov2021, outcome "not recovered", described as "Numbness one side body"; PAIN (hospitalization, disability, life threatening), IMPAIRED WORK ABILITY (hospitalization, disability, life threatening) all with onset 20Nov2021, outcome "not recovered" and all described as "Can''t work with pain and shakes"; TREMOR (hospitalization, disability, life threatening) with onset 20Nov2021, outcome "not recovered", described as "Tremors/shakes"; DYSPNOEA (hospitalization, disability, life threatening) with onset 20Nov2021, outcome "not recovered", described as "Couldn''t breathe"; DIZZINESS (hospitalization, disability, life threatening) with onset 20Nov2021, outcome "not recovered", described as "Dizzy"; PALPITATIONS (hospitalization, disability, life threatening) with onset 20Nov2021, outcome "not recovered", described as "Palpitations"; EXERCISE TOLERANCE DECREASED (hospitalization, disability, life threatening) with onset 20Nov2021, outcome "not recovered", described as "Can''t walk far out of breath"; FEELING ABNORMAL (hospitalization, disability, life threatening) with onset 20Nov2021, outcome "not recovered", described as "Brain fog"; VERTIGO (hospitalization, disability, life threatening) with onset 20Nov2021, outcome "not recovered", described as "Vertigo"; RASH (hospitalization, disability, life threatening) with onset 20Nov2021, outcome "not recovered", described as "Rash". The patient was hospitalized for angina pectoris, inflammation, tinnitus, loss of personal independence in daily activities, hemianaesthesia, pain, impaired work ability, tremor, dyspnoea, dizziness, palpitations, exercise tolerance decreased, feeling abnormal, vertigo, rash (start date: 2021). Therapeutic measures (Difene 50 mg) were taken as a result of angina pectoris, inflammation, tinnitus, loss of personal independence in daily activities, hemianaesthesia, pain, impaired work ability, tremor, dyspnoea, dizziness, palpitations, exercise tolerance decreased, feeling abnormal, vertigo, rash. Clinical course: It was reported that 5 minutes later on the 20Nov2021, the patient experienced inflammation in body (as reported by "cardiac doctors"). The patient also couldn''t breathe, had rash, tremors, vertigo, tinnitus, numbness on one side of the body, palpitations and heart pain. The patient stated she had to close her business, as she could not work with the pain, shakes, brain fog and vertigo. The patient reported she could not do daily normal things like walking far, reporting being out of breath, heart hurting and dizziness. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016698 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1014A / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Erythema multiforme, Immunisation
SMQs:, Severe cutaneous adverse reactions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101839945

Write-up: Erythema multiforme; Booster; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from the regulatory authority. Regulatory number: PT-INFARMED-E202112-2004 (INFARMED). A 71 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 20Nov2021 (Lot number: 1F1014A) as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1), for COVID-19 immunisation, reaction(s): "no adverse event"; Comirnaty (DOSE 2), for COVID-19 immunisation, reaction(s): "No adverse event". The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; ERYTHEMA MULTIFORME (medically significant) with onset 14Dec2021, outcome "recovering", described as "Erythema multiforme". The reporter''s assessment of the causal relationship of the Erythema multiforme was possible. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016875 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-11-20
   Days after vaccination:205
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2172 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101866627

Write-up: Vaccine failure; covid-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-292. A 66 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 29Apr2021 (Lot number: EY2172) as dose 1, 0.3ml, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Vaccine failure"; COVID-19 (medically significant) with onset 20Nov2021, outcome "unknown", described as "covid-19". The reporter''s assessment of the causal relationship of the [Drug ineffective, COVID-19] with the suspect product was: Source of assessment: Reporter, Method of assessment: Unknown, Result of Assessment: Possible No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016879 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-11-20
   Days after vaccination:129
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4632 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101867504

Write-up: Vaccination failure; Vaccination failure; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-299. A 45 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 14Jul2021 (Lot number: FA4632) as dose 1, 0.3 ml single for covid-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Nov2021, outcome "unknown" and all described as "Vaccination failure". This report was considered as non-serious. The reporter''s assessment of the causal relationship of the event Drug ineffective with the suspect product was: Source of assessment: Reporter, Method of assessment: Unknown, Result of Assessment: Possible. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016880 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-11-20
   Days after vaccination:95
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: PTPFIZER INC202101839656

Write-up: This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority and product quality group. Regulatory number: PT-INFARMED-T202112-301 (RA). A 41-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Aug2021 (Lot number: FF0688) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Nov2021, outcome "unknown" and all described as "Vaccination failure". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Nov2021) positive. The product quality complaint team regarding complaint for PFIZERBIONTECH COVID-19 VACCINE Was investigated. The Investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FF0688. A Complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016881 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-11-20
   Days after vaccination:135
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1921 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: PTPFIZER INC202101839667

Write-up: Vaccine failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-304 (regulatory authority). A 49 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 08Jul2021 (Lot number: FD1921, Expiration Date: 30Sep2021) as dose 1, 0.3 ml, single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Vaccine failure"; COVID-19 (medically significant) with onset 20Nov2021, outcome "unknown", described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Nov2021) positive. Clinical course: The reporter''s assessment of the causal relationship of the [Drug ineffective, COVID-19] with the suspect product was: Source of assessment: Reporter, Method of assessment: Unknown, Result of Assessment: Possible. Physician reported case not serious. Investigational results reported from product quality complaint team regarding complaint received for bnt162b2 (COMIRNATY, Batch/Lot Number: FD1921, expiration date: 30Sep2021). Conclusion from agency division was: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced ID resulted in the following conclusion: Reference ID 6078283 (see File attachment in this investigation record) The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FD1921 A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Agency concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016883 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-11-20
   Days after vaccination:129
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4632 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: SARS-CoV-2 test; Test Result: Positive; Comments: Positive IU international unit(s).
CDC Split Type: PTPFIZER INC202101839692

Write-up: This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority and product quality group. Regulatory number: PT-INFARMED-T202112-309 (RA). A 40-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 14Jul2021 (Lot number: FA4632) as dose 1, 0.3 ml, single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Nov2021, outcome "unknown" and all described as "Vaccination Failure". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Nov2021) positive, notes: Positive IU international unit(s). The reporter''s assessment of the causal relationship of the [Drug ineffective, COVID-19] with the suspect product was Source of assessment: Notifier, Method of assessment: Unknown, Result of Assessment: Possible the complaint for PFIZERBIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FA4632. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016894 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-11-20
   Days after vaccination:126
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5435 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Positivo Iu international unit(s)
CDC Split Type: PTPFIZER INC202101867823

Write-up: Vaccination failure; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Agency Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-530 (INFARMED). A 53 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Jul2021 (Lot number: FC5435) as dose 1, 0.3 ml single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Vaccination failure"; COVID-19 (medically significant) with onset 20Nov2021, outcome "unknown", described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Nov2021) positive, notes: Positivo Iu international unit(s). The reporters assessment of the casual relationship of the (All events) with the suspect product was: Source of assessment: reporter, Method of assessment: Unknown, Result of Assessment: Possible. Additional information: case not serious. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016928 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-11-20
   Days after vaccination:113
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: PTPFIZER INC202101846952

Write-up: Vaccination failure; Vaccination failure; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-939. A 44-year-old male patient received BNT162B2 (COMIRNATY), intramuscular, administration date 30Jul2021 (Lot number: FE8235, Expiration Date: 30Nov2021) as dose 2, 0.3 ml single and intramuscular, administration date 02Jul2021 (Lot number: FD8274) as dose 1, 0.3 ml single for covid-19 immunization. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Nov2021, outcome "recovered" (29Nov2021) and all described as "Vaccination failure". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Nov2021) positive. Clinical course: The reporters assessment of the casual relationship of the (Vaccination failure) with the suspect product was: Source of assessment: reporter, Method of assessment: Unknown, Result of Assessment: Possible. Investigation results from product quality group: The complaint for "Pfizer-Biontech COVID-19 vaccine" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FE8235/FD8274. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The RA process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Reporter Comment: Other information-no records No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Other information-no records


VAERS ID: 2016929 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-11-20
   Days after vaccination:121
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4728 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic rhinitis; Colitis ulcerative; Depressive disorder; Goiter; Obesity; Tachycardia paroxysmal (Isolated ventricular extrasystole)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101875040

Write-up: This is a spontaneous report received from a contactable reporter (Other HCP) from Regulatory Authority. Regulatory number: PT-INFARMED-T202112-940 (RA). A 33-year-old female patient received BNT162B2 (COMIRNATY), intramuscular, administration date 22Jul2021 (Lot number: FE4728) as dose 2, 0.3 ml single and intramuscular, administration date 24Jun2021 (Lot number: FC5435) as dose 1, 0.3 ml single for COVID-19 immunisation. Relevant medical history included: "Colitis ulcerative", start date: 2020 (unknown if ongoing); "Allergic rhinitis" (unknown if ongoing); "Tachycardia paroxysmal", start date: 26Sep2018 (unknown if ongoing), notes: Isolated ventricular extrasystole; "Goiter", start date: 2019 (unknown if ongoing); "Depressive disorder", start date: 2019 (unknown if ongoing); "Obesity", start date: 2019 (unknown if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Nov2021, outcome "recovered" (29Nov2021) and all described as "Covid-19". No follow-up attempts are possible. No further information is expected.


VAERS ID: 2022155 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1006A / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, Paraesthesia, Swelling face, Vertigo
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Vestibular disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PREDNISON
Current Illness: Allergy to feathers; Allergy to molds; Alveolitis extrinsic allergic (therapy: corticosteroids (corticotherapy)); Dust allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC202101866049

Write-up: Cheek swelling; Head spinning; Tingling of the cheek; Lymph nodes cervical swollen; This is a spontaneous report received from a contactable reporter (Physician) from the regulatory authority. Regulatory number: CZ-CZSUKL-21013378. A 55 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 20Nov2021 (Lot number: 1F1006A) at the age of 55 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Dust allergy" (ongoing); "Alveolitis extrinsic allergic", start date: May2021 (ongoing), notes: therapy: corticosteroids (corticotherapy); "Allergy to molds" (ongoing); "Allergy to feathers" (ongoing). Concomitant medication(s) included: PREDNISON taken for hypersensitivity pneumonitis, start date: May2021. The following information was reported: PARAESTHESIA (medically significant) with onset 20Nov2021, outcome "recovering", described as "Tingling of the cheek"; LYMPHADENOPATHY (medically significant) with onset 20Nov2021, outcome "recovering", described as "Lymph nodes cervical swollen"; VERTIGO (non-serious) with onset 20Nov2021, outcome "recovering", described as "Head spinning"; SWELLING FACE (medically significant) with onset 21Nov2021, outcome "recovering", described as "Cheek swelling". No follow-up attempts are possible. No further information is expected.


VAERS ID: 2022552 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7898 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Amenorrhoea, Heart rate increased, Mass, Palpitations, Pregnancy test
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Fertility disorders (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: pregnancy test; Result Unstructured Data: Test Result:Negative
CDC Split Type: ESPFIZER INC202101865558

Write-up: I have not had my period again. Date of the last period on 03Nov2021. Negative pregnancy test.; Palpitations, discontinuous and sometimes elevated heart rate even at rest.; Palpitations, discontinuous and sometimes elevated heart rate even at rest.; Lumps under my chest (I couldn not put my bra on because it hurt) and a big lump on my neck that hurt to touch.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from The Regulatory Authority WEB. The reporter is the patient. Regulatory number: ES-AEMPS-1070261 (AEMPS). A 43 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm right, administration date 19Nov2021 (Lot number: FG7898) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: AMENORRHOEA (medically significant) with onset 03Dec2021, outcome "not recovered", described as "I have not had my period again. Date of the last period on 03Nov2021. Negative pregnancy test."; PALPITATIONS (non-serious), HEART RATE INCREASED (non-serious) all with onset 20Nov2021, outcome "recovered" (30Nov2021) and all described as "Palpitations, discontinuous and sometimes elevated heart rate even at rest."; MASS (non-serious) with onset 20Nov2021, outcome "recovered" (28Nov2021), described as "Lumps under my chest (I couldn not put my bra on because it hurt) and a big lump on my neck that hurt to touch.". The patient underwent the following laboratory tests and procedures: pregnancy test: negative. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2022794 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0114 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anosmia, Axillary pain, Blood test, Chest pain, Condition aggravated, Dyspnoea, Fatigue, Gait disturbance, Inappropriate schedule of product administration, Investigation, Malaise, Pain in extremity, Paraesthesia, Pelvic pain, SARS-CoV-2 test, Troponin
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:Unknown result; Test Name: Chest sounding; Result Unstructured Data: Test Result:Unknown result; Test Date: 20210812; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Positive; Comments: Yes - Positive COVID-19 test; Test Name: certain protein; Result Unstructured Data: Test Result:Unknown result.
CDC Split Type: GBPFIZER INC202101862808

Write-up: loss of smell; felt increasingly unwell; long covid symptoms had worsened; no longer unable to run and struggle to climb stairs or walk to her car; extreme shortness of breath; tingling and pain in her extremities/ sharp pains in her legs; sharp pains in chest underarm side & pelvic area; sharp pains in chest underarm side & pelvic area; Fatigue/unusual tiredness; Chest pain; tingling and pain in her extremities; inappropriate schedule of vaccine administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from The Regulatory Authority WEB. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112192231593640-QTIDR (MHRA). Other Case identifier(s): GB-MHRA-ADR 26360876 (MHRA). A 47 year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH0114) as dose 2, single for covid-19 immunisation. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Batch/lot number: FE3380. reaction from 12Aug2021 and not recovered (ongoing).), administration date: 31Jul2021, for COVID-19 immunization, reaction(s): "SARS-CoV-2 infection"; Bnt162b2 (Dose 1, Batch/lot number: FE3380. reaction from 06Sep2021 and not recovered (ongoing)), administration date: 31Jul2021, for COVID-19 immunisation, reaction(s): "Tingling feet/hands", "Light sensitivity to eye"; Bnt162b2 (Dose 1, Batch/lot number: FE3380. reaction from 01Aug2021 and not recovered (ongoing)), administration date: 31Jul2021, for covid-19 immunisation, reaction(s): "Cough increased", "Headaches cluster"; Bnt162b2 (Dose 1, Batch/lot number: FE3380. reaction from 13Aug2021 and not recovered (ongoing)), administration date: 31Jul2021, for Covid-19 immunisation, reaction(s): "Breathing difficult". COVID-19 virus test positive on 12Aug2021. No other illness other than long covid symptoms and adverse affects from vaccine. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. The following information was reported: FATIGUE (hospitalization, medically significant), outcome "unknown", described as "Fatigue/unusual tiredness"; CHEST PAIN (hospitalization, medically significant) with onset 09Dec2021, outcome "not recovered", described as "Chest pain"; ANOSMIA (hospitalization), outcome "unknown", described as "loss of smell"; MALAISE (hospitalization), outcome "unknown", described as "felt increasingly unwell"; CONDITION AGGRAVATED (hospitalization), outcome "unknown", described as "long covid symptoms had worsened"; GAIT DISTURBANCE (hospitalization), outcome "unknown", described as "no longer unable to run and struggle to climb stairs or walk to her car"; DYSPNOEA (hospitalization, medically significant), outcome "unknown", described as "extreme shortness of breath"; PARAESTHESIA (hospitalization, medically significant) with onset 26Nov2021, outcome "not recovered", described as "tingling and pain in her extremities"; PAIN IN EXTREMITY (hospitalization), outcome "unknown", described as "tingling and pain in her extremities/ sharp pains in her legs"; AXILLARY PAIN (hospitalization), PELVIC PAIN (hospitalization), outcome "unknown" and all described as "sharp pains in chest underarm side & pelvic area"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 20Nov2021, outcome "unknown", described as "inappropriate schedule of vaccine administered". The patient was hospitalized for fatigue, chest pain, anosmia, malaise, condition aggravated, gait disturbance, dyspnoea, paraesthesia, pain in extremity, axillary pain, pelvic pain (hospitalization duration: 1 day(s)). Patient was not enrolled in clinical trial. She was extremely concerned for her health. The reporter considered the report was related to possible inflammation of the heart (myocarditis or pericarditis). The details of any relevant investigations or tests conducted included: "GP sent her to A&E on the 17Oct2021 & She had a private consultation on 06Jan2021: as she had lost faith in the NHS". The symptoms lead to a hospital stay for one day. No diagnosis made by a medical professional. Performed "Chest sounding". Had taken blood tests, such as for certain proteins (called troponin) that signal heart muscle damage. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2023080 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Medication errors (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fibromyalgia; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Piriformis syndrome; Spinal stenosis
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101870147

Write-up: Shingles; Booster; Interchange of vaccine products; Off label use; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority; GB-MHRA-WEBCOVID-202112271846478010-FBQXI. Other Case identifier(s): GB-MHRA-ADR 26400244. A 52 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK9413) as dose 3 (booster), single for covid-19 immunisation. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Relevant medical history included: "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...; "Fibromyalgia" (unspecified if ongoing); "Piriformis Syndrome" (unspecified if ongoing); "Spinal stenosis (congenital)" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1, Lot number-PW40037, Arthralgia on 01Apr2021 with the outcome of NOT RECOVERED), administration date: 02Mar2021, for COVID-19 Immunisation, reaction(s): "Arthralgia"; Covid-19 vaccine astrazeneca (Dose 2, Lot number- DU46691, Arthralgia on 14Jul2021 with the outcome of NOT RECOVERED), administration date: 20May2021, for COVID-19 Immunisation, reaction(s): "Arthralgia". The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; HERPES ZOSTER (medically significant) with onset 21Dec2021, outcome "not recovered", described as "Shingles". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2023253 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Injection site pain; This case was received (Reference number: GB-RA-ADR 26416888) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injection site pain) in a 52-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced INJECTION SITE PAIN (Injection site pain) (seriousness criteria disability and medically significant). At the time of the report, INJECTION SITE PAIN (Injection site pain) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No Concomitant medication provided. Patient last menstrual period was on an unknown date in 2018. Patient was not pregnant, Patient was not currently breastfeeding Patient''s arm was swollen, with a stretch under her arm, around her shoulder, bruising in her elbow and wrist. Tingling in patients first two fingers and thumb, and later in whole hand. This increased dramatically and patient booked an private physiotherapist as a coping measure for the pain and recovery. The patient''s doctor asked her to wear a splint and to take pain killers. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). Company comment: This regulatory case concerns a 52-year-old female patient, with no medical history reported, who experienced the serious unexpected event of INJECTION SITE PAIN. The event occurred on the same day of the third dose of the mRNA-1273 vaccine. The rechallenge is unknown, but it could be considered not applicable since no information about further dosing has been disclosed. The benefit-risk relationship of the mRNA-1273 is not affected by this report. The seriousness was assessed as per regulatory authority report.; Sender''s Comments: This regulatory case concerns a 52-year-old female patient, with no medical history reported, who experienced the serious unexpected event of INJECTION SITE PAIN. The event occurred on the same day of the third dose of the mRNA-1273 vaccine. The rechallenge is unknown, but it could be considered not applicable since no information about further dosing has been disclosed. The benefit-risk relationship of the mRNA-1273 is not affected by this report. The seriousness was assessed as per regulatory authority report.


VAERS ID: 2023904 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ8372 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Borrelia test, Facial paresis, Immunisation, Malaise, Muscle spasms
SMQs:, Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Borrelia serology and radiology; Result Unstructured Data: Test Result:without remark
CDC Split Type: SEPFIZER INC202101869449

Write-up: Palsy Bells; (Covid-19 vaccines) third dose administered; muscle spasm on her right side of the neck; peripheral facial paresis on her right side; felt ill; This is a spontaneous report received from a contactable reporter(s) (Physician) from the WEB. Regulatory number: SE-MPA-2021-099010 (MPA). Other Case identifier(s): SE-VISMA-1640075731596 (MPA). A 67 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FJ8372) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Unknown manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (hospitalization, disability, medically significant) with onset 20Nov2021, outcome "unknown", described as "(Covid-19 vaccines) third dose administered"; BELL''S PALSY (hospitalization, disability, medically significant) with onset 02Dec2021, outcome "not recovered", described as "Palsy Bells"; MUSCLE SPASMS (hospitalization, disability) with onset 2021, outcome "not recovered", described as "muscle spasm on her right side of the neck"; FACIAL PARESIS (non-serious) with onset 2021, outcome "not recovered", described as "peripheral facial paresis on her right side"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "felt ill". The patient underwent the following laboratory tests and procedures: borrelia test: (2021) without remark. Clinical course: The woman felt ill with muscle spasm on her right side of the neck. She has since had a persistent peripheral facial paresis on her right side which has not regressed in 3 weeks. The case was assessed as serious, hospital care, permanent physical impairment. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2025788 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-11-20
   Days after vaccination:129
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7011 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, Suspected COVID-19
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101866331

Write-up: COVID-19; Vaccination failure; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: DE-202100281864 (RA). A 20 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 14Jul2021 (Lot number: FE7011) at the age of 20 years as dose 2, single and intramuscular, administration date 11Jun2021 (Lot number: FC3095) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 20Nov2021, outcome "unknown", described as "COVID-19"; DRUG INEFFECTIVE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Vaccination failure". No follow-up attempts are possible. No further information is expected.


VAERS ID: 2025853 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-20
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Appendicitis
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101874045

Write-up: Appendicitis with necessary surgery; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from The Regulatory Authority WEB. Regulatory number: DE-PEI-CADR2021203547 (PEI). Other Case identifier(s): DE-CADRPEI-2021203547 (PEI Webportal), DE-PEI-202100229155 (PEI). A 33 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: APPENDICITIS (hospitalization, medically significant) with onset 20Nov2021, outcome "unknown", described as "Appendicitis with necessary surgery". Clinical course: Sender Comment: The patient did not concerned of any known allergies. There was no Information on risk factors or previous illnesses. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2025856 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-04
Onset:2021-11-20
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SDEH4 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Circulatory collapse, Dermatitis allergic, Heavy menstrual bleeding, Hypersensitivity, Pruritus
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylactic shock (a severe allergic reaction/anaphylactic shock two years earlier)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101874326

Write-up: Allergic reaction; Itching/severe itching in the kidney area, on the inside of the wrists and in the shoulder area; Allergic rash on the patient''s lower shin; Circulatory collapse; angioedema in both palms; heavy periods; This is a spontaneous report received from a non-contactable reporter (Consumer) from the regulatory authority-WEB. Regulatory number: DE-PEI-CADR2021203812 . Other Case identifier(s): DE-CADRPEI-2021203812 (Webportal), DE-PEI-202100229302 . A 41 year-old female patient received bnt162b2 (COMIRNATY), administration date 04Nov2021 (Lot number: SDEH4) as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "anaphylactic shock", start date: 2019 (unspecified if ongoing), notes: a severe allergic reaction/anaphylactic shock two years earlier. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN. After the first vaccination, Angioedema in both palms of the hands.), for COVID-19 Immunisation, reaction(s): "Angioedema"; Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 Immunisation, reaction(s): "heavy periods". After the first vaccination: angioedema in both palms of the hands. Duration approximately 30 minutes (she had already reported here). The following information was reported: HYPERSENSITIVITY (hospitalization) with onset 20Nov2021, outcome "recovering", described as "Allergic reaction"; PRURITUS (hospitalization) with onset 2021, outcome "unknown", described as "Itching/severe itching in the kidney area, on the inside of the wrists and in the shoulder area"; DERMATITIS ALLERGIC (hospitalization) with onset 2021, outcome "unknown", described as "Allergic rash on the patient''s lower shin"; CIRCULATORY COLLAPSE (medically significant) with onset 2021, outcome "unknown", described as "Circulatory collapse"; ANGIOEDEMA (medically significant) with onset 2021, outcome "unknown", described as "angioedema in both palms"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 2021, outcome "unknown", described as "heavy periods". The events "allergic reaction", "itching/severe itching in the kidney area, on the inside of the wrists and in the shoulder area", "allergic rash on the patient''s lower shin", "circulatory collapse" and "angioedema in both palms" were evaluated at the emergency room visit. On the 16th day after the second vaccination, the patient suffered from a severe allergic reaction. It started with angioedema in both palms (she had never had it before, except after the first vaccination). This was followed by violent and complete emptying of the bowels. Circulatory collapse. An ambulance was called as she could not tell whether her airways were also swelling up. Paramedic arranged fluid equalization. Emergency doctor insisted on hospitalisation. The doctor in the emergency room of the hospital confirmed an allergic reaction. Meanwhile, she suffered from severe itching in the kidney area, on the inside of the wrists and in the shoulder area when she was at hospital. The doctor at the hospital also uncovered an allergic rash on the patient''s lower shin. The patient was given cortisone and antihistamine. What is particularly interesting was the connection with the hormonal status. The reaction occurred on both occasions when the patient was having heavy periods. Both times, she took a sachet of Aspirin Complex on the same day. Therapeutic measures were taken as a result of hypersensitivity, pruritus, dermatitis allergic, heavy menstrual bleeding. Sender comment: Do the person concerned have any known allergies? If so, what are they? Patient had a severe allergic reaction/anaphylactic shock two years earlier. Her airways were also affected at the time. The paramedic was funnily the same person again this time. She could remember the violence of the reaction. The cause was unclear at the time. She suspected a combination of several factors (reaction to milk protein in connection with exercise, severe stress, aspirin intake and hormonal status = period). All of the factors (in moderation) could not cause such a reaction on their own. Details of risk factors or previous illnesses: No further/previous history. [Both times she was physically active and both times she was exposed to psychological stress (looking at horses for sale, which would have a massive financial and temporal impact on the rest of life). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2025871 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E021A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101874073

Write-up: Apoplectic fit; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: DE-PEI-CADR2021205085. Other Case identifier(s): DE-CADRPEI-2021205085, DE-PEI-202100230700. A 82 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Formulation: solution for injection, Lot number: 1E021A) as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization) with onset 20Nov2021, outcome "not recovered", described as "Apoplectic fit". No follow-up attempts are possible. No further information is expected.


VAERS ID: 2025878 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-14
Onset:2021-11-20
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdomen scan, Chest X-ray, Colonoscopy, Deep vein thrombosis, Endoscopy upper gastrointestinal tract, Ultrasound scan
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: abdomen check; Result Unstructured Data: Test Result:UNKNOWN; Test Name: chest X-ray; Result Unstructured Data: Test Result:UNKNOWN; Test Name: colonoscopy; Result Unstructured Data: Test Result:UNKNOWN; Test Name: gastroscopy; Result Unstructured Data: Test Result:UNKNOWN; Test Name: sonography; Result Unstructured Data: Test Result:UNKNOWN
CDC Split Type: DEPFIZER INC202101874027

Write-up: Deep vein thrombosis leg; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from The Regulatory Authority WEB. Regulatory number: DE-PEI-CADR2021205761 (PEI). Other Case identifier(s): DE-CADRPEI-2021205761 (PEI Webportal), DE-PEI-202100231298 (PEI). A 75 year-old male patient received bnt162b2 (COMIRNATY), administration date 14Nov2021 (Lot number: Unknown) as dose number unknown, 0.3ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DEEP VEIN THROMBOSIS (hospitalization) with onset 20Nov2021, outcome "recovering", described as "Deep vein thrombosis leg". The patient underwent the following laboratory tests and procedures: abdomen scan: unknown; chest x-ray: unknown; colonoscopy: unknown; endoscopy upper gastrointestinal tract: unknown; ultrasound scan: unknown. Clinical course: Patient had no known allergy. The patient had deep vein thrombosis in the right leg 11 years ago, Currently no immobilization. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2026720 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haematocrit, Haematocrit decreased, Haemoglobin, Haemoglobin decreased, Immunisation, Interchange of vaccine products, Off label use
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202110; Test Name: Haematocrit; Result Unstructured Data: Test Result:34.6; Comments: Units:/100; Test Date: 202112; Test Name: Haematocrit; Result Unstructured Data: Test Result:22.8; Comments: Units:/100; Test Date: 202110; Test Name: Haemoglobin; Result Unstructured Data: Test Result:11.6; Test Date: 202112; Test Name: Haemoglobin; Result Unstructured Data: Test Result:7.2
CDC Split Type: GRPFIZER INC202101873409

Write-up: Haemoglobin decreased; Haematocrit decreased; Off label use; Interchange of vaccine products; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GR-GREOF-202110064. A 19 year-old female patient received BNT162B2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen (SINGLE DOSE), COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, described as "booster"; HAEMOGLOBIN DECREASED (medically significant) with onset 02Dec2021, outcome "recovering", described as "Haemoglobin decreased"; HAEMATOCRIT DECREASED (medically significant) with onset 02Dec2021, outcome "recovering", described as "Haematocrit decreased". The patient underwent the following laboratory tests and procedures: haematocrit: (Oct2021) 34.6 per 100; (Dec2021) 22.8 per 100; haemoglobin: (Oct2021) 11.6; (Dec2021) 7.2. She underwent a series of tests but a pathological cause could not be found. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2026721 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diabetic ketoacidosis
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC202101873543

Write-up: Diabetic ketoacidosis - type 1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: GR-GREOF-202110129. A 24 year-old male patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 24 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DIABETIC KETOACIDOSIS (medically significant, life threatening) with onset 20Nov2021, outcome "recovered with sequelae" (2021), described as "Diabetic ketoacidosis - type 1". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2026739 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4509 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Asthenia, Body temperature, Diarrhoea, Dry throat, Dyspnoea, Erythema, Fatigue, Flatulence, Nausea, Oropharyngeal pain, Paraesthesia, Pyrexia, Sensation of foreign body, Tinnitus, Tongue oedema
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hearing impairment (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy NOS; Articular calcification; Spinal disorder NOS
Preexisting Conditions: Medical History/Concurrent Conditions: Anal fissure (Operated anal fissure); Cyst breast; Hypothalamic hamartoma (Cerebral vascular hamartoma); Meningioma; Mitral valve prolapse
Allergies:
Diagnostic Lab Data: Test Date: 202111; Test Name: Body temperature; Result Unstructured Data: Test Result:37.7 Centigrade
CDC Split Type: HRPFIZER INC202101866278

Write-up: swelling of the tongue; Tingling; Sore throat; Abdominal pain; Lump feeling in throat; facial redness; Flatulence; Fatigue; Nausea; Weakness; Dry throat; increased temperature/ body temperature 37.7; constant tinnitus; Diarrhea; heavy breathing; This is a spontaneous report received from a contactable consumer Regulatory number: HR-HALMED-300052991. Other Case identifier(s): 11-240-697-031. A 50-year-old female patient received BNT162B2 (COMIRNATY; Lot number: FG4509), intramuscular on 20Nov2021 (at the age of 50-years-old) as dose number unknown, single for COVID-19 immunization. Relevant medical history included: "Hypothalamic hamartoma" (unknown if ongoing), notes: Cerebral vascular hamartoma; "Anal fissure" (not ongoing), notes: Operated anal fissure; "Cyst breast" (unknown if ongoing); "Problems with cervical spine" (ongoing); "Meningioma" (unknown if ongoing); "Mitral valve prolapse" (unknown if ongoing); "Shoulder calcifications" (ongoing); "allergies" (ongoing). The patient''s concomitant medications were not reported. The following information was reported: TONGUE OEDEMA (medically significant) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "swelling of the tongue"; PARAESTHESIA (non-serious) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "Tingling"; OROPHARYNGEAL PAIN (non-serious) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "Sore throat"; ABDOMINAL PAIN (non-serious) with onset 20Nov2021, outcome "recovered" (24Nov2021), described as "Abdominal pain"; SENSATION OF FOREIGN BODY (non-serious) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "Lump feeling in throat"; ERYTHEMA (non-serious) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "facial redness"; FLATULENCE (non-serious) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "Flatulence"; FATIGUE (non-serious) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "Fatigue"; NAUSEA (non-serious) with onset 20Nov2021, outcome "recovered" (24Nov2021), described as "Nausea"; ASTHENIA (non-serious) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "Weakness"; DRY THROAT (non-serious) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "Dry throat"; PYREXIA (non-serious) with onset 20Nov2021, outcome "recovered" (24Nov2021), described as "increased temperature/ body temperature 37.7"; TINNITUS (non-serious) with onset 20Nov2021, outcome "not recovered", described as "constant tinnitus"; DIARRHOEA (non-serious) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "Diarrhea"; DYSPNOEA (non-serious) with onset 20Nov2021, outcome "recovering", described as "heavy breathing". The patient underwent the following laboratory tests and procedures: body temperature (36-37): (Nov2021) 37.7 Centigrade. Reaction(s) / Event(s) Assessed: Ear buzzing/Result of Assessment: Probable/Likely. Reaction(s) / Event(s) Assessed: Tongue oedema, Tingling, Sore throat, Abdominal pain, Lump feeling in throat, Redness facial, Flatulence, Fatigue, Nausea, Asthenia, Dry throat, Pyrexia, Diarrhea, Shortness of breath/Result of Assessment: Probable/Likely. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2026748 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-14
Onset:2021-11-20
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Epilepsy, Loss of consciousness, Myocardial infarction
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DEPAKIN CHRONO [VALPROATE SODIUM;VALPROIC ACID]
Current Illness: Alcohol use; Deaf; Smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy
Allergies:
Diagnostic Lab Data:
CDC Split Type: HRPFIZER INC202200008754

Write-up: heart attack; in the hospital he gets another heart attack; Epileptic seizure; unconscious; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: HR-HALMED-300053198. A 36 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 14Nov2021 (Lot number: unknown) as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Alcohol use" (ongoing); "Smoker" (ongoing); "Deaf" (ongoing); "Epilepsy" (unspecified if ongoing). Concomitant medication(s) included: DEPAKIN CHRONO [VALPROATE SODIUM;VALPROIC ACID] taken for epilepsy, start date: 10Feb2006. The following information was reported: MYOCARDIAL INFARCTION (hospitalization, medically significant) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "heart attack; in the hospital he gets another heart attack"; EPILEPSY (medically significant) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Epileptic seizure"; LOSS OF CONSCIOUSNESS (medically significant) with onset 20Nov2021, outcome "not recovered", described as "unconscious". Therapeutic measures were taken as a result of myocardial infarction. The patient received the first dose of Pfizer Covid-19 vaccine on 14Nov2021. Shortly after that, on 20Nov2021, during a game he became unwell, he collapsed and had heart attack, and later in hospital he had epileptic attack + heart. The patient was resuscitated twice, and they were able to stabilize him, although he was still unconscious. Relatedness of drug (Source of assessment: regulatory authority; Method of assessment: WHO Causality) to all reaction(s)/event(s): Unassessable/Unclassifiable. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2026874 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0115 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Pruritus, Rash, Syncope, Tinnitus, Vertigo
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hearing impairment (narrow), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: LVPFIZER INC202101873609

Write-up: Syncope; Tinnitus aggravated; Vertigo; Generalised pruritus; Generalised rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: LV-SAM-2021127333. A 36 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 20Nov2021 (Lot number: FK0115) at the age of 36 years as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "allergy" (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Zirtec; Tavigil. Vaccination history included: Comirnaty (1st dose), for Covid-19 immunisation, reaction(s): "generalised puritus", "generalised rash". The following information was reported: PRURITUS (medically significant) with onset 20Nov2021, outcome "recovering", described as "Generalised pruritus"; RASH (medically significant) with onset 20Nov2021, outcome "recovering", described as "Generalised rash"; SYNCOPE (medically significant) with onset 25Nov2021, outcome "recovered" (2021), described as "Syncope"; TINNITUS (medically significant) with onset 25Nov2021, outcome "recovering", described as "Tinnitus aggravated"; VERTIGO (non-serious) with onset 25Nov2021, outcome "recovering", described as "Vertigo". Additional Information: The patient was scheduled to have more medical testing. The reporter has been contacted in order to gather follow-up information. For medical history the patient reported; patient had an unspecified allergy several years ago when patient had to drink a prescription drug, because zirtec and tavigil didn''t help. The cause of the allergy was not identified at the time. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : LV-SAM-2021127333


VAERS ID: 2026985 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-11-20
   Days after vaccination:108
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atopic eczema; Overweight
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: PTPFIZER INC202200005626

Write-up: Vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-1487. A 41 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 07Jul2021 (Lot number: FE6029) as dose 1, 0.3 ml, single and intramuscular, administration date 04Aug2021 (Lot number: FE8235) as dose 2, 0.3 ml, single for covid-19 immunisation. Relevant medical history included: "Atopic eczema" (unknown if ongoing); "Overweight", start date: 25Oct2019 (unknown if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Vaccination failure"; COVID-19 (medically significant) with onset 20Nov2021, outcome "recovered" (30Nov2021), described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Nov2021) positive. Clinical course: The reporter''s assessment of the causal relationship of Vaccination failure with the suspect product was: Source of assessment: reporter, Method of assessment: unknown, Result of Assessment: possible. Seriousness was reported as non serious. Reporter Comment: Other information-OVERWEIGHT 25Oct2019S87 DERMATITIS / ATOPIC ECZEMA No follow-up attempts are possible. No further information is expected. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2026990 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-07
Onset:2021-11-20
   Days after vaccination:197
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2172 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20211122; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: International unit(s)
CDC Split Type: PTPFIZER INC202200006189

Write-up: Vaccine failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from The Regulatory Authority WEB and product quality group. Regulatory number: PT-INFARMED-T202112-1547 (INFARMED). A 71 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 07May2021 (Lot number: EY2172) as dose 2, 0.3ml single and intramuscular, administration date 09Apr2021 (Lot number: EW2243) as dose 1, 0.3ml single for covid-19 immunisation. Relevant medical history included: "Hypertension arterial" (unknown if ongoing). The patient''s concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 20Nov2021, outcome "recovered" (30Nov2021), described as "Vaccine failure"; COVID-19 (medically significant) with onset 20Nov2021, outcome "recovered" (30Nov2021), described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Nov2021) positive, notes: International unit(s). Reporter Comment: Other information-Female user, 71 years old. AP: Hypertension arterial. Positive test for COVID19 to 22Nov2021 after family risk contact. Symptoms (onset 20Nov): dry cough, odynophagia, headache, nasal congestion. Healing criteria at 30Nov, with symptomatic improvement. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Other information-Female user, 71 years old. AP: Hypertension arterial. Positive test for COVID19 to 22Nov2021 after family risk contact. Symptoms (onset 20Nov): dry cough, odynophagia, headache, nasal congestion. Healing criteria at 30Nov, with symptomatic improvement.


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