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From the 10/15/2021 release of VAERS data:

Found 800,916 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 449 out of 8,010

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VAERS ID: 1744812 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-21
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? 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: ATJNJFOC20210954287

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority (AT-BASGAGES-2021-045564)1 was received on 28-SEP-2021 and concerned a 36 year old male of unspecified race and ethnicity. 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: 21C16-04 expiry: UNKNOWN) dose was not reported, 1 total administered on 13-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 21-AUG-2021, the patient experienced sars-cov-2 infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint


VAERS ID: 1746034 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-08-21
   Days after vaccination:80
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 2 - / 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? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 13 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TOUJEO; VICTOZA; FLOSIN [TAMSULOSIN HYDROCHLORIDE]; CO DALNESSA
Current Illness: Chronic renal failure; Diabetes mellitus; Heart failure; Hypertension; Obesity; Prostatic hyperplasia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: EEPFIZER INC202101239784

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number EE-SAM-51282109162. This is the first case for this patient and refers to events after both doses. An 80-year-old male patient received bnt162b2 (COMIRNATY, Solution for Injection, (Batch/Lot Number: EW6126)), dose 2 intramuscularly on 02Jun2021 as dose 2, 0.3 ml single and dose 1 intramuscularly on 21Apr2021 (Batch/Lot Number: ER7449) as dose 1, 0.3 ml single for COVID-19 immunisation. The patient''s medical history included obesity, chronic renal failure, heart failure, prostatic hyperplasia, hypertension and diabetes mellitus; all were ongoing. Concomitant medications included insulin glargine (TOUJEO) 300iU/ml, liraglutide (VICTOZA) 6mg/ml solution for injection in pre-filled pen, tamsulosin hydrochloride (FLOSIN [TAMSULOSIN HYDRO-CHLORIDE]) 0.4mg modified-release capsule, hard, amlodipine besilate, indapamide, perindopril erbumine (CO DALNESSA) tablet; all taken for an unspecified indication from an unknown date. On 21Aug2021, the patient experienced covid-19 (hospitalization, medically significant, life threatening). The course of the disease was severe, the patient was in the intensive care unit due to COVID-19 (as the main disease) between 29Aug2021 and 11Sep2021. The patient underwent sars-cov-2 test resulted in positive on 25Aug2021. The outcome of the event was resolved on 16Sep2021. Sender Comment: Serious vaccine ineffectiveness report. The causal relationship is considered possible. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Serious vaccine ineffectiveness report. The causal relationship is considered possible.; Sender''s Comments: Linked Report(s) : EE-PFIZER INC-202101247292 the same patient, different events: suspect doses: 1and 2 or 2


VAERS ID: 1746293 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-08-21
   Days after vaccination:147
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Hypertension arterial; Nephrectomy; Paralysis; Prostate surgery (at multiple occasions)
Allergies:
Diagnostic Lab Data: Test Date: 20210821; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101215873

Write-up: Vaccination failure; sars-cov-2 test positive; This is a spontaneous report from a contactable Pharmacist downloaded from the regulatory authority-WEB FR-AFSSAPS-LY202110953. A 88-year-old male patient received BNT162B2 (COMIRNATY, Formulation:Solution for injection, lot number: ER9470 and Expiry date: 31Jul2021) via intramuscularly, on 27Mar2021, as Dose 2, Single for COVID-19 immunization and first dose of BNT162B2 (COMIRNATY, Formulation:Solution for injection, Lot number: ER2659 and Expiry date: 30Jun2021), intramuscularly in Arm, on 01Mar2021, as Dose 1, Single for COVID-19 immunization. The patient medical history included hypertension arterial, nephrectomy, prostate surgery, AFib and hemilarynx paralysis opening. Concomitant medications were not reported. It was reported that on 21Aug2021, the patient experienced sars-cov-2 test positive. The patient was hospitalized for sars-cov-2 test positive from 28Aug2021 to 05Sep2021. On 21Aug2021 the patient underwent lab test and procedure which included SARS-CoV-2 test was positive. The outcome of the event sars-cov-2 test positive was recovering. Upon follow up, the investigation included reviewing the involved batch records, deviation investigation and 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 ER9470 and lot ER2659 respectively. 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 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. Follow-up (20Sep2021): New information received from a Product Quality Complaint Group included expiry dates and Complaint record received from the regulatory authority site. Information obtained. No follow-up attempts possible. No further information expected.


VAERS ID: 1746369 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Antiphospholipid syndrome, Ascites, Bacterial test, Biopsy bone marrow, Blood lactate dehydrogenase, Blood potassium, Blood sodium, Blood test, Bronchopneumopathy, Cerebral haematoma, Cerebral venous thrombosis, Chills, Computerised tomogram, Computerised tomogram head, Cytomegalovirus test, Diarrhoea, Epstein-Barr virus test, Fibrin D dimer, Haemodynamic test, Haemoglobin, Haptoglobin, Headache, Hemiplegia, Herpes simplex test, Hydrocephalus, Hypokalaemia, Hyponatraemia, Immunology test, Investigation, Mean cell volume, Nausea, Neck pain, Paresis, Periportal oedema, Platelet count, Pleural effusion, Prothrombin time, Pulmonary function test, Pupils unequal, Renal function test, Somnolence, Thrombocytopenia, Ultrasound Doppler, Vomiting, White blood cell count
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (broad), Chronic kidney disease (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Hypokalaemia (narrow), Immune-mediated/autoimmune 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abstains from alcohol; Non-tobacco user; Phlebitis (Mother suffered from phlebitis aged 20 years old, Aunt and maternal cousin also); Venous (peripheral) insufficiency, unspecified (noted in Doppler ultrasound performed in Jun2020)
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: Activated partial thromboplastin time; Result Unstructured Data: Test Result:0.71; Test Date: 20210907; Test Name: Activated partial thromboplastin time; Result Unstructured Data: Test Result:1.29; Test Date: 20210907; Test Name: Antiphospholipid syndrome under circulating anticoagulant; Test Result: Positive ; Comments: but B2Gp1 and anticardiolipin negative; Test Date: 2021; Test Name: bacterial tests; Result Unstructured Data: Test Result:underway; Test Date: 2021; Test Name: bone marrow differential cell count; Result Unstructured Data: Test Result:underway; Test Date: 20210907; Test Name: lactate dehydrogenase; Result Unstructured Data: Test Result:no evidence; Test Date: 20210907; Test Name: hypokalaemia; Result Unstructured Data: Test Result:3.3 mmol/L; Test Date: 20210907; Test Name: hyponatremia; Result Unstructured Data: Test Result:129 mmol/L; Test Date: 20210907; Test Name: hyponatremia; Result Unstructured Data: Test Result:130 mmol/L; Comments: after recharge; Test Date: 20210907; Test Name: test for schizocytes; Test Result: Negative ; Test Date: 20210908; Test Name: computed tomography; Result Unstructured Data: Test Result:no subdural hemorrhaging; Comments: hemorrhagic with reduction in midline structure deviation, no subdural hemorrhaging, hemoventriculitis; Test Date: 20210907; Test Name: Thoracic-abdominal-pelvic computed tomography scan; Result Unstructured Data: Test Result:hematoma of the perilesional edema; Comments: increase in the right side frontal-parietal-temporal lobar hematoma of the perilesional edema; Test Date: 20210906; Test Name: computed tomography scan of the brain; Result Unstructured Data: Test Result:right temporal lobar hematoma of 7 cm; Comments: with moderate mass effect on the right cerebral hemisphere without falcine or temporal herniation, thrombophlebitis of the right lateral sinus and the lower part of the superior sagittal sinus; Test Date: 2021; Test Name: Cytomegalovirus; Result Unstructured Data: Test Result:underway; Test Date: 2021; Test Name: Epstein-Barr virus; Result Unstructured Data: Test Result:underway; Test Date: 20210906; Test Name: D-dimers; Result Unstructured Data: Test Result:$g 4000; Test Date: 20210821; Test Name: haemodynamic; Result Unstructured Data: Test Result:stable; Test Date: 20210906; Test Name: Haemoglobin; Result Unstructured Data: Test Result:11.7 g/dl; Test Date: 20210907; Test Name: haptoglobin; Result Unstructured Data: Test Result:normal; Test Date: 2021; Test Name: Herpes Simplex Virus; Result Unstructured Data: Test Result:underway; Test Date: 20210907; Test Name: ELISA; Test Result: Negative ; Comments: negative Anti PF4 antibodies; Test Date: 20210907; Test Name: schizocytes; Test Result: Negative ; Test Date: 20210906; Test Name: mean corpuscular volume; Result Unstructured Data: Test Result:113; Test Date: 20210906; Test Name: thrombocytopaenia; Result Unstructured Data: Test Result:64 x10 9/l; Test Date: 20210907; Test Name: thrombocytopaenia; Result Unstructured Data: Test Result:43 x10 9/l; Test Date: 20210906; Test Name: prothrombin time; Test Result: 100 %; Test Date: 20210821; Test Name: respiratory condition; Result Unstructured Data: Test Result:stable; Test Date: 20210908; Test Name: renal function; Result Unstructured Data: Test Result:normal; Test Date: 202006; Test Name: Doppler ultrasound; Result Unstructured Data: Test Result:Lower limb vein insufficiency; Test Date: 20210907; Test Name: Doppler ultrasound of lower limb; Result Unstructured Data: Test Result:no thrombosis; Comments: no evidence to suggest deep vein or superficial thrombosis in lower limbs; Test Date: 20210906; Test Name: white blood cells; Result Unstructured Data: Test Result:9.5 x10 9/l; Test Date: 20210907; Test Name: haptoglobin; Result Unstructured Data: Test Result:normal
CDC Split Type: FRPFIZER INC202101216204

Write-up: Thrombophlebitis cerebral vein; obstructive hydrocephalus in the left lateral ventricle; hypokalaemia at 3.3 mmol/l; intraperitoneal effusion; periportal edema; deficit on the left side of the body; hyponatremia at 129 mmmol/l; bronchopneumopathy; right pleural effusion; anisocoria reactive; paresis discreet; nausea; right temporal lobar hematoma; thrombocytopaeniaie; neck pain; sleepy; headaches; shivers; diarrhoea; vomiting; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-PO20214823. This contactable consumer reported events for the same patient. This is one the of two reports referring to the 2nd dose. A 30-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 20Aug2021 (Batch/Lot Number: Unknown) as DOSE 2, 0.3 ml, SINGLE for COVID-19 immunization. Medical history included lower limb vein insufficiency based on Doppler ultrasound performed in Jun2020. The patient had no known allergies and former chronic thrombocytopaenia. Her mother suffered from phlebitis aged 20 due to cigarettes and pills and no bed rest. Her aunt and maternal cousin also suffered from phlebitis with suspicion of thrombocytopaenia. The patient had no tobacco and no alcohol consumption. Concomitant medications included diosmin, hesperidin (DAFLON) and drospirenone, ethinylestradiol betadex clathrate (JASMINELLE) taken for an unspecified indications and therapy dates. The patient received the first dose of bnt162b2 (COMIRNATY) on 30Jul2021 (Batch/Lot Number: Unknown) for COVID-19 immunization with onset of neck pain immediately after, change under paracetamol. Then, received the 2nd dose on 20Aug2021. Twenty-four hours after (on 21Aug2021), the patient had headaches and neck pain with shivers, diarrhoea and vomiting. On 31Aug2021, she consulted at the emergency room of the hospital center given the persisting headaches. In the emergency room, female patient was sleepy, coherent and oriented, no impairment, cranial nerve included stable haemodynamic and respiratory condition, afebrile. No other information on her trip to the hospital center then transferred on 06Sep2021. Computed tomography scan of the brain on 06Sep2021 showed right temporal lobar hematoma of 7 cm with moderate mass effect on the right cerebral hemisphere without falcine or temporal herniation, thrombophlebitis of the right lateral sinus and the lower part of the superior sagittal sinus (which started on 21Aug2021). The patient was hospitalized in 2021 due to thrombophlebitis . On 06Sep2021, Blood tests: Haemoglobin 11.7 g/dl with mean corpuscular volume at 113; white blood cells at 9.5 G/l; thrombocytopaenia at 64 G/l; Activated partial thromboplastin time at 0.71, prothrombin time 100%, and D-dimers $g 4000. Initiation of treatment with ARGANOVA was provided. On 07Sep2021, onset of signs of altered brain compliance such as anisocoria reactive, paresis discreet, nausea, deficit on the left side of the body, persistent headaches not treated with paracetamol; Activated partial thromboplastin time 1.29 under ARGANOVA, thrombocytopaeniaie at 43 G/l, hyponatremia at 129 mmmol/l then rechecked at 130 mmol/l after recharge, and hypokalaemia at 3.3 mmol/l. Thoracic-abdominal-pelvic computed tomography scan showed increase in the right side frontal-parietal-temporal lobar hematoma of the perilesional edema, increase in the mass effect on the right lateral ventricle and the 3rd ventricle upon the onset of an obstructive hydrocephalus in the left lateral ventricle. Left-sided subfalcine herniation of 17 mm and right internal temporal herniation, hemoventriculitis in the lateral ventricles also no vein thrombosis in the chest, abdomen and pelvis areas but result showed early stafe bronchopneumopathy in both basal segments (upon breathing in?), thin layer of right pleural effusion, small amount of intraperitoneal effusion, periportal edema. Doppler ultrasound of lower limb showed no evidence to suggest deep vein or superficial thrombosis in lower limbs. Anti PF4 antibodies test was negative under ELISA test, no report on ARGANOVA and switch for unfractionated heparin. There was a very little evidence of thrombotic microangiopathies as test for schizocytes negative, normal haptoglobin, and no evidence of lactate dehydrogenase. Antiphospholipid syndrome under circulating anticoagulant positive but B2Gp1 and anticardiolipin negative. Viral (Herpes Simplex Virus, Cytomegalovirus, Epstein-Barr virus), bone marrow differential cell count, and bacterial tests underway (in 2021). On 08Sep2021 (in the operating room), evacuation of haematoma and decompressive craniectomy, active bleeding during surgery with multiple transfusions (4 units of Red Blood Cell concentrates, 2 units of Fresh Frozen Plasma, 2 units of Platelet Concentrate). Post-operative check computed tomography showed hemorrhagic with reduction in midline structure deviation, no subdural hemorrhaging, hemoventriculitis; apyrexia, and normal renal function. Outcome of thrombophlebitis of the right lateral sinus and the lower part of the superior sagittal sinus was not recovered while unknown for the remaining events. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101265712 same drug/patient, different events and dose


VAERS ID: 1746407 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7053 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Crohn's disease, Vaccination site reaction
SMQs:, Gastrointestinal premalignant disorders (narrow), Ischaemic colitis (broad), Immune-mediated/autoimmune 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101222300

Write-up: Injection site reaction; Crohn''s disease acute episode; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority, regulatory authority number BE-FAMHP-DHH-N2021-106450. A 46-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 20Aug2021 (Batch/Lot Number: Fe7053) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 21Aug2021, the patient experienced injection site reaction (medically significant) and Crohn''s disease acute episode (medically significant). Therapeutic measures were taken as a result of injection site reaction and Crohn''s disease acute episode (treatment was reported as yes). The patient was recovering from both events. Reporter''s comments: Treatment: Yes. Medication Evolution of the ADR: Remedial Situations. Others: No idea. ADR description: Crohn''s disease acute episode. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Treatment - Yes Medication Evolution of the ADR - Remedial Situations - Others: No idea ADR description - Crohn''s disease acute episode


VAERS ID: 1746427 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness, Malaise
SMQs:, Torsade de pointes/QT prolongation (broad), 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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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: FRPFIZER INC202101233248

Write-up: Consciousness loss; Malaise; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-PO20214892. A 16-years-old male patient received bnt162b2(COMIRNATY, solution for injection, Batch/Lot Number: FG4493), intramuscular on 21Aug2021 (at the age of 16-year-old) as dose number unknown, 0.3ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 21Aug2021, the patient experienced consciousness loss and malaise. The outcome of the events were recovering. No follow-up attempts possible. No further information expected.


VAERS ID: 1746684 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380/V1328 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Abortion spontaneous, Back pain, Fatigue, Headache, Menstrual disorder, Menstruation delayed, Nausea, Thrombosis
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Termination of pregnancy and risk of abortion (narrow), 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 INC202101225383

Write-up: bleeding; miscarriage; Clot blood; headaches; nausea; fatigue; stomach cramps; back ache; Late period; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109161109025300-YJNEF, Safety Report Unique Identifier GB-MHRA-ADR 25951831. A 27-year-old female patient (not pregnant, not currently breastfeeding; age at vaccination: 27-year-old) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot FE3380/V1328), via an unspecified route of administration on 21Aug2021 as dose 2, single for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced bleeding, miscarriage on an unspecified date. She had late period on 21Aug2021. She had nausea, fatigue, stomach cramps, back ache and headache on 22Aug2021. On 06Sep2021, she experienced blood clot. The events were serious medically significant. The outcome of stomach cramps, clot blood was recovered on12Sep2021; for late period was recovered on 06Sep2021; for headache was unknown; for other events was not recovered. Clinical course of events: The patient was due on her period on 23Aug2021 but she didn''t actually come on until the 06Sep2021. When she did come on, she was heavily bleeding and was passing blood clots around 4-5 inches long. She had horrific stomach cramps and other period symptoms from the 22Aug2021 right through until around the 12Sep2021, including headaches, nausea, back ache and fatigue. She rang and spoke to her GP and Nurse Practitioner as she was concerned, she was having a miscarriage. They said it was possible, but they couldn''t be sure and if she was still bleeding more than a week, later to contact them back. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1747217 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-08-21
   Days after vaccination:220
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Malaise, Oropharyngeal pain, Pyrexia
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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:
CDC Split Type: LTPFIZER INC202101221329

Write-up: vaccination failure; COVID-19; Malaise; Pyrexia; Sore throat; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number LT-SMCA-5940N. A 41-years-old male patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: EJ6797), via an unspecified route of administration on 04Feb2021 as single dose, first dose via an unspecified route of administration on 13Jan2021 (Batch/Lot Number: EL1491) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 21Aug2021, the patient experienced covid-19, vaccination failure, malaise, pyrexia, sore throat. The outcome of the events were recovered on 30Aug2021. Conclusion for EL1491:The investigation of the referenced RA ID resulted in the following conclusion: Reference RA ID 5616433 (see File attachment in this investigation record) The complaint for LOE of "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and 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 EL1491. 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." Conclusion for EJ6797: The investigation of the referenced RA ID resulted in the following conclusion: Reference RA ID 5570166 (see File attachment in this investigation record): The complaint for "Adverse Event Safety Request" of "PFIZER-BIONTECH COVID-19" was investigated. The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference samples, 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 "EJ6797". 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 a regulatory notification was required. The reported defect could not be confirmed on the reference samples. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected. Vaccine Lot is provided.


VAERS ID: 1747320 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA FD9234 / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Erysipelas, Interchange of vaccine products
SMQs:, Medication errors (broad), Opportunistic infections (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: NOMODERNATX, INC.MOD20213

Write-up: interchange of vaccine products; ERYSIPELAS; This case was received via Agency (Reference number: NO-NOMAADVRE-E2B_00047421) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of ERYSIPELAS (ERYSIPELAS) in a 49-year-old female patient who received mRNA-1273 (Spikevax) (batch no. FD9234) for Vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Vaccination: Comirnaty. On 19-Aug-2021 at 3:00 PM, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced ERYSIPELAS (ERYSIPELAS) (seriousness criterion medically significant). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products). On 30-Aug-2021, ERYSIPELAS (ERYSIPELAS) had resolved. At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter considered ERYSIPELAS (ERYSIPELAS) to be possibly related. No further causality assessment was provided for INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products). No concomitant medication details provided. The patient experienced redness of the skin 2 days after the second COVID-19 vaccination dose of Spikevax. The affected area is approximately 10x15 cm. The patient had redness, swelling, warmth and palpitation tenderness. Suspected erysipelas. No Treatment informations were reported. Company Comment: This case concerns a 49-year-old, female patient with unknown medical history, who experienced the unexpected serious event of erysipelas. The event occurred 2 days after receiving second dose of Moderna mRNA-1273 vaccine (Spikevax). First dose was with Comirnaty (Pfizer mRNA vaccine). The rechallenge is not applicable as the event occurred after the second dose only. The reporter assessed the event as possible. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 49-year-old, female patient with unknown medical history, who experienced the unexpected serious event of erysipelas. The event occurred 2 days after receiving second dose of Moderna mRNA-1273 vaccine (Spikevax). First dose was with Comirnaty (Pfizer mRNA vaccine). The rechallenge is not applicable as the event occurred after the second dose only. The reporter assessed the event as possible. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1750686 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-21
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Tetany
SMQs:, Hypokalaemia (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:
CDC Split Type: FRPFIZER INC202101222817

Write-up: Tetany; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-BR20213417. A 50-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 30Jul2021 (Batch/Lot Number: FE8244) as dose 2, single for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 02Jul2021, first injection of COMIRNATY vaccine lot no. FE1248. On 30Jul2021, second injection of COMIRNATY vaccine lot no. FE8244. On 21Aug2021, occurrence in of a tetany crisis with contraction of the jaws, upper limbs, larynx, preceded by a tingling of the tip of the nose for 30 minutes, regressing 30 minutes after the injection of NO-CHPA . The patient hospitalized on an unspecified date and was monitored for 48 hours; healing without sequelae. The outcome of event was recovered on an unspecified date.


VAERS ID: 1750858 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Immune thrombocytopenia, Laboratory test, Platelet count, Spinal myelogram
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
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: Eczema
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: biological assessment; Result Unstructured Data: Test Result:a deep thrombocytopenia at less than 10 G / l with; Comments: a deep thrombocytopenia at less than 10 G / l without attack of the other lines, there is no argument in favor of disseminated intravascular coagulation.; Test Name: platelet count; Result Unstructured Data: Test Result:6 x10 9/l; Test Date: 20210825; Test Name: platelet count; Result Unstructured Data: Test Result:<3 x10 9/l; Test Date: 20210824; Test Name: myelogram; Result Unstructured Data: Test Result:Presence of quite a number of megakaryocytes embe; Comments: Presence of quite a number of megakaryocytes embedded in the coagula. On the periphery of coagula, a few precursors are observable and show granular and erythroblastic lines balanced at all stages of maturation and without morphological atypia notable. Lymphocytes are polymorphic.
CDC Split Type: FRPFIZER INC202101256656

Write-up: Immune thrombocytopenic purpura; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number FR-AFSSAPS-ST20213211. A 23-year-old male patient received bnt162b2, dose 2 intramuscular on 20Aug2021 as dose 2, 0.3 mL single for covid-19 immunisation. Medical history included eczema. The patient''s concomitant medications were not reported. The patient did no have history of COVID-19. D1 received without notable problem. The patient experienced immune thrombocytopenic purpura on 21Aug2021. Appearance during the night from Saturday to Sunday (21Aug2021), of a petechial purpura of the lower limbs, upper limbs of the abdomen, torso and neck. The patient does not report externalized bleeding: no hematuria, no digestive bleeding, no ENT bleeding. He did not have a fever. He consulted in the emergency room on 24Aug2021. The biological assessment finds a deep thrombocytopenia at less than 10 G / l without attack of the other lines, there is no argument in favor of disseminated intravascular coagulation. Hospitalization. Corticosteroid therapy with 1mg / kg of Methylprednisolone (80mg) was started on 24Aug2021. A myelogram was carried out on 24Aug2021: Presence of quite a number of megakaryocytes embedded in the coagula. On the periphery of coagula, a few precursors are observable and show granular and erythroblastic lines balanced at all stages of maturation and without morphological atypia notable. Lymphocytes are polymorphic. In total, a partially coagulated sample, but the cytological aspects of which are in favor of a peripheral origin of the thrombocytopenia of the ITP type. Platelets evolution <3G / L on 25Aug2021, hemodynamically stable. On 29Aug2021, Stable hemodynamics, afebrile, No bleeding, Slight improvement in lower limb petechiae, no other signs of hemorrhagic syndrome, Very slight improvement in platelets at 6 G / L. The outcome of the event was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1751131 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Influenza like illness, Myalgia, Off label use, Pain in extremity, Product use issue, SARS-CoV-2 test, Tinnitus, Vertigo positional
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Hearing impairment (narrow), Vestibular disorders (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), 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: Breast feeding.
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101226583

Write-up: tiredness/Chronic fatigue; flu like symptoms; bppv; sore arm; tinnitus/Tinnitus aggravated; Headache occurring; Muscle ache; ongoing breast feeding; ongoing breast feeding; bnt162b2 on 08Jun2021 as first dose/on 21Aug2021 as second dose; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109180952470920-H0LIZ, Safety Report Unique Identifier GB-MHRA-ADR 25964497. This consumer reported information for both mother and baby. This is the maternal report. Only this case is serious. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration on 21Aug2021 (Lot number was not reported) at the age of 42 years old, as second dose, single for COVID-19 immunisation. Medical history included ongoing breast feeding, suspected covid-19 from 07Nov2019 to 21Nov2019. Patient is not pregnant. The patient''s concomitant medications were not reported. The patient previously took bnt162b2 on 08Jun2021 (Lot number was not reported) as first dose, single for COVID-19 immunisation. On unspecified date, the patient experienced tiredness, flu like symptoms, benign paroxysmal positional vertigo (bppv), chronic fatigue. On 23Aug2021, the patient experienced muscle ache. On 25Aug2021, the patient experienced headache occurring. On 06Sep2021, the patient experienced tinnitus/tinnitus aggravated. "I have had to be medically treated for BPPV which started approximately two weeks after having the second dose of vaccine. I initially a sore arm, flu like symptoms and tiredness, I am getting recurring headaches, tinnitus and am exhausted all the time. I cannot return to some former activities and am tired out after any physical exertion, including housework." Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient is due for blood test. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. Outcome of the events flu like symptoms, bppv was recovering. Outcome of the events headache, tiredness/chronic fatigue, muscle ache and tinnitus/tinnitus aggravated was not recovered. Outcome of the event sore arm was unknown. 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-202101238405 Baby case


VAERS ID: 1751247 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Fatigue, Feeling hot, Feeling of body temperature change, Headache, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210919; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Feeling hot; Weakness; Headache; Rash; Fatigue; Feeling hot and cold; Headache dull; This case was received via RA (Reference number: GB-MHRA-ADR 25974378) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling hot), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), ASTHENIA (Weakness), RASH (Rash), FATIGUE (Fatigue), HEADACHE (Headache) and HEADACHE (Headache dull) in a 19-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No Medical History information was reported. On 21-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced HEADACHE (Headache dull) (seriousness criteria disability and medically significant). On 22-Aug-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) (seriousness criteria disability and medically significant) and FATIGUE (Fatigue) (seriousness criteria disability and medically significant). On 23-Aug-2021, the patient experienced RASH (Rash) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced FEELING HOT (Feeling hot) (seriousness criteria disability and medically significant), ASTHENIA (Weakness) (seriousness criteria disability and medically significant) and HEADACHE (Headache) (seriousness criteria disability and medically significant). At the time of the report, FEELING HOT (Feeling hot), ASTHENIA (Weakness) and HEADACHE (Headache) was resolving, FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), FATIGUE (Fatigue) and HEADACHE (Headache dull) had not resolved and RASH (Rash) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication were not provided Treatment medication were not reported. Patient had experienced headache same day as the jab, next day patient had headache, fatigue, weakness and feeling hot then cold (but afebrile) and these had persisted 4 weeks and still haven''t resolved. Patient was unable to work and needed help with ADLs because of fatigue ability. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in Clinical trial. Company Comment : This case concerns a 19 year-old, female subject, with a non significant clinical history, who experienced the unexpected events of FEELING HOT, FEELING OF BODY TEMPERATURE CHANGE, ASTHENIA, RASH, FATIGUE, IMPAIRED WORK ABILITY and two events of HEADACHE. The events occurred approximately two days after the second dose of [Moderna CoviD-19 Vaccine] . The rechallenge was not applicable since only information about the second dose was disclosed.The benefit-risk relationship of the mRNA-1273, is not affected by this report.; Sender''s Comments: This case concerns a 19 year-old, female subject, with a non significant clinical history, who experienced the unexpected events of FEELING HOT, FEELING OF BODY TEMPERATURE CHANGE, ASTHENIA, RASH, FATIGUE, IMPAIRED WORK ABILITY and two events of HEADACHE. The events occurred approximately two days after the second dose of [Moderna CoviD-19 Vaccine] . The rechallenge was not applicable since only information about the second dose was disclosed.The benefit-risk relationship of the mRNA-1273, is not affected by this report.


VAERS ID: 1751259 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-08-21
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Inappropriate schedule of product administration
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Medication errors (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: GBMODERNATX, INC.MOD20213

Write-up: Prolonged heavy periods; Inappropriate schedule of vaccine administration; This case was received via regulatory authority(Reference number: GB-MHRA-ADR 25977129) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Prolonged heavy periods) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration). On 24-Aug-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Prolonged heavy periods) (seriousness criterion medically significant). On 21-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration) had resolved. At the time of the report, HEAVY MENSTRUAL BLEEDING (Prolonged heavy periods) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported . Treatment information was not provided. Patient reported that she don''t have any periods normally because she use the contraceptive implant. She had an extraordinarily heavy period from 24/08/2021 which lasted for ten days and made me feel very ill. A second very heavy period has started today on 21/09/2021. She have never had heavy periods like this and prior to the vaccine she had not had any period for over a year. She is very anxious and upset about why this has happened and why it was not listed as a symptom on the vaccine information booklets. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Company comment - This case concerns a 26 year-old, female subject, with a non significant clinical history, who experienced the unexpected events of MENSTRUAL BLEEDING, MALAISE and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION. The events occurred approximately 3 days after the second dose of [Spikevax] The rechallenge was not applicable. The events were considered related to the study drug per the reporter''s assessment The events are consistent with the current understanding of the mechanism of action of the study medication The benefit-risk relationship of the vaccine is not affected by this report; Sender''s Comments: This case concerns a 26 year-old, female subject, with a non significant clinical history, who experienced the unexpected events of MENSTRUAL BLEEDING, MALAISE and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION. The events occurred approximately 3 days after the second dose of [Spikevax] The rechallenge was not applicable. The events were considered related to the study drug per the reporter''s assessment The events are consistent with the current understanding of the mechanism of action of the study medication The benefit-risk relationship of the vaccine is not affected by this report


VAERS ID: 1751443 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Biopsy heart, Body temperature, Loss of consciousness, Myocarditis, Ventricular fibrillation, Viral myocarditis
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac disorder; Hypercholesterolaemia
Allergies:
Diagnostic Lab Data: Test Date: 20210830; Test Name: myocardial biopsy; Result Unstructured Data: Test Result:inflammatory cell infiltrate with lymphocyte; Comments: inflammatory cell infiltrate with lymphocyte antibodies; Test Date: 20210819; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101229452

Write-up: Myocarditis; Loss of consciousness; Ventricular fibrillation; Viral myocarditis; This is a spontaneous report from a contactable physician received from the RA. Regulatory authority report number is v21127100. A 65-year and 1-month-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 19Aug2021 15:16 (Batch/Lot Number: FF0843; Expiration Date: 31Oct2021) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Hypercholesterolaemia, heart disease. The patient had a family history of Ischaemic heart disease (patient father) and hypertension (patient mother). Body temperature before vaccination was 36.3 degrees Centigrade. The patient''s concomitant medications were not reported. On 21Aug2021 at 17:18 (2 days after the vaccination), the patient experienced Myocarditis. On 21Aug2021 (2 days after the vaccination), the patient was admitted to the hospital. The course of the event was as follows: On 21Aug at 17:18, loss of consciousness. Requested emergency transport. The patient was ROSC(Return of spontaneous circulation) as defibrillation was performed for ventricular fibrillation. The patient was admitted to Hospital and hypothermia therapy was performed. On 22nd night, ventricular fibrillation occurred and defibrillation. On 23Aug2021, the patient was transported to Hospital. On 30Aug2021, myocardial biopsy was performed. The patient was diagnosed with myocarditis as there was an inflammatory cell infiltrate with lymphocyte antibodies. The patient experienced myocarditis (hospitalization) on 21Aug2021 17:18 with outcome of recovering, loss of consciousness (hospitalization) on 21Aug2021 17:18 with outcome of recovering, ventricular fibrillation (hospitalization) on 21Aug2021 17:18 with outcome of recovering, viral myocarditis (hospitalization) on 21Aug2021 17:18 with outcome of recovering. The patient was hospitalized from 21Aug2021 to an unknown date. Therapeutic measures were taken as a result of events. The reporting physician classified the event as serious (Hospitalized since 21Aug2021) and assessed that the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was Viral myocarditis. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1751477 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-08-21
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003653 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Neuropathy peripheral, Pyrexia
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (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:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Peripheral nerve disorder; Pyrexia; This case was received via Takeda Pharmaceuticals (Reference number: 2021TJP096439) on 17-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case, reported by a physician, was received by via Moderna''s adverse reaction reporting site (TASK0021773), and reported to the Pharmaceuticals and Medical Devices Agency (PMDA) by a physician, was received via the PMDA (Ref, v21127171). Peripheral nerve disorder was assessed as serious by the MAH. On 16-Jul-2021, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before the vaccination: 36.4 degrees Celsius. On 20-Aug-2021, at 09:00, the patient received the 2nd dose of this vaccine. There was no pain when the needle was inserted, and there was pain when the drug solution was injected. On 21-Aug-2021, peripheral nerve disorder developed. Pyrexia, arm pain, and numbness up to the ulnar side little finger developed. Grip strength in the left vaccinated side decreased. Pain and numbness persisted for 1 month. On 17-Sep-2021, symptoms had not resolved yet. The outcome of peripheral nerve disorder was reported as ongoing and unchanged. The outcome of pyrexia was unknown. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Since adverse reaction was prolonged, this case was reported.; Sender''s Comments: This case concerns a 40 year old male patient with no medical history reported, who experienced the unexpected serious event of Peripheral nerve disorder, within 1 day after the second dose of mRNA-1273 vaccine. Limited information regarding the event have been provided at this time. Rechallenge is not applicable. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1753114 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-21
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? 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: ATJNJFOC20210960325

Write-up: SARS-CoV-2 infection; Vaccination failure; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-045985) on 30-SEP-2021 and concerned a 28 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C11-01 expiry: UNKNOWN) dose was not reported, 1 total administered on 10-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 21-AUG-2021, the patient experienced SARS-COV-2 infection. (severe acute respiratory syndrome coronavirus 2) and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.


VAERS ID: 1754410 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Paraesthesia, Vaccination site swelling
SMQs:, Peripheral neuropathy (broad), Guillain-Barre 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC202101228759

Write-up: Paresthesia of fingers; Puncture site swelling; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number CZ-CZSUKL-21010562. A 21-years-old female patient received bnt162b2 (COMIRNATY, Formulation: solution for injection, Lot Number: unknown), dose 2 via an intramuscular route of administration on 21Aug2021 (at the age of 21-years-old) as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included bnt162b2 (COMIRNATY, Formulation: solution for injection, Lot Number: unknown), dose 1 via an intramuscular route of administration on 31Jul2021 as DOSE 1, SINGLE for covid-19 immunization. The patient''s medical history was not reported. The patient was healthy. The patient''s concomitant medications were not reported. The patient experienced paresthesia of fingers and puncture site swelling on 21Aug2021. The outcome of the events was not recovered (persist for 2 months). No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.


VAERS ID: 1754415 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-21
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / IM

Administered by: Other       Purchased by: ?
Symptoms: Anal pap smear, Blood glucose, Blood glucose decreased, Blood pressure fluctuation, Dizziness, Full blood count, Neurogenic bowel, Ultrasound abdomen, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypoglycaemia (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: 08/2021; Test Name: Pap smear; Result Unstructured Data: Test Result: Normal, no finding; Test Date: 08/2021; Test Name: Blood count; Result Unstructured Data: Test Result: Normal, no finding; Test Name: Sugar blood; Result Unstructured Data: Test Result: Decreased; Test Date: 08/2021; Test Name: Abdomen ultrasound; Result Unstructured Data: Test Result: Normal, no finding.
CDC Split Type: CZPFIZER INC202101228703

Write-up: This is a spontaneous report from a contactable consumer or other non-HCP (patient), downloaded via the regulatory authority (CZ-CZSUKL-21010608). A 24-year-old female patient received the 2nd dose of BNT162B2 (Comirnaty, solution for injection, batch/lot# not reported), intramuscularly, on Aug 10, 2021, single dose, for COVID-19 immunization. No medical history or concomitant medications. The patient previously received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), intramuscularly, on Jul 21, 2021, single dose, for COVID-19 immunization. It was reported after receiving the second dose of vaccine, patient vomited (medically significant) on Aug 21, 2021. She experienced lightheadedness/dizziness (medically significant), defecation urgency, blood pressure fluctuation and sugar blood decreased on an unknown date in Aug 2021. The patient underwent lab tests and procedures, which included pap smear; blood count; abdomen ultrasound (results were normal), no finding on an unknown date in Aug 2021; and decreased blood glucose on an unspecified date. The outcome of vomiting: not recovered (the vomiting lasted 3 weeks); while outcome of rest all the events: unknown. No follow-up attempts possible. No further information expected. Batch/lot numbers cannot be obtained.


VAERS ID: 1754603 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-08-21
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7011 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea exertional, Pulmonary embolism, Venous thrombosis limb
SMQs:, Embolic and thrombotic events, venous (narrow), Pulmonary hypertension (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101228728

Write-up: - Pulmonary artery embolism bilaterally; - Leg vein thrombosis of the V. femoralis communis and superficialis on the left side; Sudden unusual onset of breathlessness on physical exertion.; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority, regulatory authority number DE-PEI-CADR2021178902, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100189320. A 58-year-old male patient received bnt162b2 (strength: 0.3ML), via an unspecified route of administration on 27Jul2021 (Batch/Lot Number: FE7011) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (strength: 0.3ML) on unspecified date for covid-19 immunization. On 21Aug2021, the patient experienced "- pulmonary artery embolism bilaterally" and "- leg vein thrombosis of the V. femoralis communis and superficialis on the left side." The events caused hospitalization on unspecified date. On unspecified date, the patient experienced sudden unusual onset of breathlessness on physical exertion. The outcome of events pulmonary embolus and leg venous thrombosis was recovering while outcome of the other event was unknown. Result of Assessment for bnt162b2 and events pulmonary embolus and leg venous thrombosis was D. Unclassifiable. Regulatory Authority Comment: Are you or the person concerned aware of any allergies? If so, which ones? None Information on risk factors or previous illnesses None / Sudden unusual onset of breathlessness on physical exertion. Because of this, presentation to the family doctor. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1754663 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Breast enlargement, Breast pain, Intermenstrual bleeding
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Lipodystrophy (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: URBASON [METHYLPREDNISOLONE ACETATE]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20213

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of BREAST PAIN (Mastodynia), INTERMENSTRUAL BLEEDING and BREAST ENLARGEMENT (Breast enlargement) in a 31-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Concomitant products included METHYLPREDNISOLONE ACETATE from 14-Aug-2021 to 14-Aug-2021 for Wasp sting. On 21-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced BREAST PAIN (Mastodynia) (seriousness criterion medically significant), INTERMENSTRUAL BLEEDING (seriousness criterion medically significant) and BREAST ENLARGEMENT (Breast enlargement) (seriousness criterion medically significant). At the time of the report, BREAST PAIN (Mastodynia), INTERMENSTRUAL BLEEDING and BREAST ENLARGEMENT (Breast enlargement) had not resolved. No treatment information was provided. Company Comment: This case concerns a 31 year-old, female subject, with medical no relevant medical history, who experienced the unexpected events of Breast pain, Intermenstrual bleeding, and Breast enlargement. The events occurred approximately the same day after the first dose of Spikevax. The rechallenge was unknown since no information about the second dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Seriousness was assessed as per Regulatory Authority report. Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Translation received on 27 Sep 21, Dosage text Updated, anatomical location of vaccination updated; Sender''s Comments: This case concerns a 31 year-old, female subject, with medical no relevant medical history, who experienced the unexpected events of Breast pain, Intermenstrual bleeding, and Breast enlargement. The events occurred approximately the same day after the first dose of Spikevax. The rechallenge was unknown since no information about the second dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Seriousness was assessed as per Regulatory Authority report.


VAERS ID: 1754838 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101229241

Write-up: Pregnancy loss <20 weeks gestation; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB [FR-AFSSAPS-LY202110983]. A 29-year-old female patient, pregnant received the first dose of BNT162B2 (COMIRNATY; Lot Number: FF2834), intramuscular, administered in left arm on 19Aug2021 as single dose for COVID-19 immunisation. The patient''s medical history included asthma. The patient''s history of COVID-19 was unknown and it was unknown if the person has been tested for COVID-19. The patient''s concomitant medications were not reported. The patient experienced pregnancy loss <20 weeks gestation on 21Aug2021. The event resulted in emergency room visit. The patient''s date of last menstrual period was 14Jul2021. The patient reported she became pregnant while taking bnt162b2. The patient was 6 weeks pregnant at the onset of the event. The patient was due to deliver on 20Apr2022. The pregnancy resulted in spontaneous abortion. The outcome of the event was recovered on an unspecified date in 2021. The clinical course was reported as follows: 21Aug2021: visit to the emergency room given the metrorrhagia revealing a miscarriage at 6 weeks. The patient did not have an influenza-like illness / fever between the vaccination and the miscarriage. The reporter is in doubt as to the accountability for the vaccine and the event. Evolution: healing without complications. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1754859 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-21
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG9428 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood thyroid stimulating hormone, Hypothyroidism
SMQs:, Hypothyroidism (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: Test Date: 20210820; Test Name: TSH; Result Unstructured Data: Test Result:11.38 MiU/L
CDC Split Type: FRPFIZER INC202101232977

Write-up: Hypothyroidism; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority. -WEB, regulatory authority number FR-AFSSAPS-MP20217499. A 48-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 12Aug2021 (Batch/Lot Number: FG9428) as DOSE 2, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced hypothyroidism on 21Aug2021 with outcome of recovering. The patient underwent lab tests and procedures which included blood thyroid stimulating hormone on 20Aug2021: 11.38 miu/l = rebalancing of treatment. It was reported that on 21Aug2021, there was onset of hypothyroidism. Evolution: in process of recovery/resolution. Accountability made "without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1754937 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCEL5 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea at rest, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Respiratory failure (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: FRPFIZER INC202101232377

Write-up: Dyspnea at rest; Paresthesia of 4 limbs; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-TS20214303. A 56-year-old female patient received the second dose of BNT162b2 (COMIRNATY), intramuscular on 20Aug2021 (Batch/Lot Number: SCEL5) as single dose for Covid-19 immunisation. The patient medical history was not reported. The first dose of BNT162b2 (COMIRNATY) was administered on 30Jul2021 via intramuscular injection in left arm (lot number: FE8244) for Covid-19 immunisation. The patient''s concomitant medications were not reported. After the second dose, the patient experienced dyspnea at rest and paresthesia of 4 limbs on 21Aug2021. Outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1755032 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myalgia, Pain, Pain in extremity, Seizure, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101226604

Write-up: pain; stomach vomiting convulsions; Aches & pains in legs; Generalised muscle aches; Vomiting; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-WEBCOVID-202109171759446610-HMXMP, Safety Report Unique Identifier GB-ADR 25960855. A 22-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: unknown) via an unspecified route of administration on 20Aug2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient experienced pain, stomach vomiting convulsions on an unspecified date; aches & pains in legs, generalised muscle aches and vomiting on 21Aug2021. After waking up day after vaccine patient stated that, I had to stop myself from vomiting as I was overwhelmed with stomach vomiting convulsions. I needed paracetamol to even cope with aches and pains throughout my limbs as I could barely walk. When at work the painkillers wore off in the last hour of my shift and could barely walk as the pain was so overwhelming. Therapeutic measures were taken as a result of pain, aches & pains in legs and generalised muscle aches. Outcome of the event pain recovered on an unspecified date, event vomiting was recovered on 21Aug2021, events aches & pains in legs, generalised muscle aches was recovered on 22Aug2021 and outcome of the event stomach vomiting convulsions was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1755103 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Limb injury, SARS-CoV-2 test
SMQs:, Accidents and injuries (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 INC202101233784

Write-up: Arm injury; This is a spontaneous report from a contactable consumer. This is a report received from theregulatory authority. Regulatory authority report number (GB-MHRA-WEBCOVID-202109192319594450-KO1TI). Safety Report Unique Identifier (GB-MHRA-ADR 25966440). A 22-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection), via an unspecified route of administration on left arm 21Aug2021 (Lot number and expiry date: not reported, at the age of 22-year-old) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. Patient was not had symptoms associated with COVID-19. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection), via an unspecified route of administration on an unknown date (Lot number and expiry date: not reported) as single dose for COVID-19 immunization. On 21Aug2021, the patient experienced arm injury. The event considered as medically significant. It was reported as he got his first and second vaccination on his left arm, after getting his 2nd vaccination he started to feel pain the arm, he left it for couple of days he thought its normal but now it was a month but he was getting worst he could not function his fingers properly. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date, the patient underwent lab tests and procedures which included sars-cov-2 test: negative COVID-19 test. The outcome of the event was not recovered. No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1755177 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Intermenstrual bleeding, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Medication errors (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 Date: 20210321; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101240554

Write-up: irregular light spotting; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer. This is the second of 2 reports. The first report is a report received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109191441212460-MUVBC. Safety Report Unique Identifier GB-MHRA-ADR 25966091. A 26-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number, Expiry date was not reported), via an unspecified route of administration on 21Aug2021 as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously took PROVERA, MIRENA, on an unknown date. Previously, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ET8885, Expiry date was not reported), via an unspecified route of administration on 09Jun2021 as single dose for COVID-19 immunization and experienced intermenstrual bleeding. The patient experienced inappropriate schedule of vaccine administered on 21Aug2021, irregular light spotting on an unspecified date. The events caused medically significant. The patient underwent lab tests and procedures which included SARS-CoV-2 test was positive (Yes - Positive COVID-19 test) on 21Mar2021. The patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. The reporter stated that my period was on 03Jul2021 as regular, she had a baby in January and her cycle was back into a regular routine also had 3 regular periods up until this point. Her period was on 03Jul2021 lasted for 9 weeks and she still have a regular bleed again. She had her second COVID vaccine on 21st August 2021 and after 10 days her bleeding stop and began irregular light spotting. She also had the Mirena coil fitted on the 19th June however this hormone usually stops bleeding and when she was prescribed Provera to stop the bleeding this did not work, she went back and had it checked and they could not understand why she had bleeding constantly for over 8 weeks. The patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the events was unknown. No follow-up attempts were possible; information about lot/batch number cannot be obtained. No further information was expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101233727 Same patient/product, different dose/event


VAERS ID: 1755256 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7053 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Feeling of body temperature change, Headache, Lymphadenopathy, Menstrual disorder, Pain
SMQs:, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101229383

Write-up: Bad body ache; Period starting early; Bad headache; Hot and cold feelings; Tiredness / Fatigue; Swollen lymph; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB received IE HPRA. Regulatory authority report number is IE-HPRA-2021-083367 with Safety Report Unique Identifier is IE-HPRA-2021-083367. A 31-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: FE7053, Expiry date not reported), via an unspecified route of administration on 21Aug2021 (at the age of 31-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (COMIRNATY, Batch/Lot number: FC5029, Expiry date not reported), via an unspecified route of administration on 27Jul2021 as dose 1, single for COVID-19 immunization. The patient experienced bad body ache on 21Aug2021 with outcome of not recovered, period starting early on 21Aug2021 with outcome of not recovered, bad headache on 21Aug2021 with outcome of not recovered, hot and cold feelings on 21Aug2021 with outcome of not recovered, tiredness/fatigue on 21Aug2021 with outcome of not recovered, and swollen lymph on 21Aug2021 with outcome of not recovered. The events were reported as serious, disabling by the health authority. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1755277 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Interchange of vaccine products, Off label use, Painful respiration, Pneumothorax, Taste disorder
SMQs:, Anaphylactic reaction (broad), Taste and smell disorders (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ISPFIZER INC202101228891

Write-up: Pneumothorax on the right side; pain above the right side of chest to the back; Taste of blood in mouth; Dyspnea; Inhalation pain; off label use; Interchange of vaccine products; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number IS-IMA-4713. A 41-year-old female patient received BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: Unknown), dose 2 via an unspecified route of administration on 19Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included COVID-19 VACCINE JANSSEN (AD26.COV2. S) administered on unknown date. It was reported that two days after the vaccination the patient started experiencing painful respiration, pain above the right side of chest to the back , dyspnea and blood taste in her mouth, inhalation pain on 21Aug2021. On 23Aug2021 the patient was diagnosed with pneumothorax and was hospitalized for 2 nights. On an unspecified date, patient had off label use, interchange of vaccine products. The patient was still under observation and has a follow-up x-ray scheduled on 09.09.2021. Outcome of all the events was reported as not recovered at this time of the report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1755464 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Hyperthyroidism, Loss of consciousness, Pyrexia, Silent thyroiditis, Thyroiditis subacute
SMQs:, Torsade de pointes/QT prolongation (broad), 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), Hypothyroidism (broad), Hyperthyroidism (narrow), Vestibular disorders (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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? 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:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Loss of consciousness; Hyperthyroidism; Pyrexia; Lightheadedness; Suspected subacute thyroiditis; Suspected painless Thyroiditis; This case was received via the regulatory authority (Reference number: 2021TJP098015) on 23-Sep-2021 and was forwarded to Moderna on 30-Sep-2021. This case, initially reported to the regulatory authority by a physician, was received via the RA (Ref, v21127514). On an unknown date, the patient received the 1st dose of this vaccine. On 20-Aug-2021, the patient received the 2nd dose of this vaccine. On 21-Aug-2021, the patient had pyrexia of 40 degrees Celsius in the early evening. At 21:33, the patient lost consciousness after urination. The patient was transported by ambulance to the hospital. Intravenous drip infusion was performed, and the patient went home. On 22-Aug-2021, the patient visited a neurology department. The patient had pyrexia of 38 degrees Celsius and lightheadedness. There were no abnormalities on head CT, and CRP elevated to 2.30. Hyperthyroidism was noted with TSH 0.004, FT3 4.09, and FT4 1.84. Subacute thyroiditis or silent thyroiditis is suspected based on pyrexia and other symptoms. After that, thyroid hormone gradually improved. The resolution of symptoms was confirmed. The outcome of pyrexia, loss of consciousness, lightheadedness, hyperthyroidism, suspected subacute thyroiditis, and suspected painless thyroiditis was reported as recovered. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Although subacute thyroiditis or silent thyroiditis was suspected based on pyrexia and other symptoms, the causality with loss of consciousness was unknown. It cannot be determined that the vaccine is unrelated to the thyroid gland.; Sender''s Comments: This case concerns a 52-year-old female patient with no relevant medical history, who experienced serious, ADR, unlisted, event of subacute thyroiditis, among other serious events. The event occurred 3 days after 2nd dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the events occurred after the 2nd dose of Moderna COVID-19 Vaccine. -Some vaccines have been found to trigger or induce some abnormal activation of immune responses in genetic predisposed individuals. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1755560 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-21
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (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? No
Previous Vaccinations:
Other Medications: CETIRIZINE HCL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHMODERNATX, INC.MOD20213

Write-up: Itching with whole body; This regulatory authority case was reported by a consumer and describes the occurrence of PRURITUS (Itching with whole body) in a 51-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. Concomitant products included CETIRIZINE HCL from 25-Aug-2021 to 11-Sep-2021 for Itching all over. On an unknown date, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) dosage was changed to at an unspecified dose. On 21-Aug-2021, the patient experienced PRURITUS (Itching with whole body) (seriousness criterion medically significant). On 19-Sep-2021, PRURITUS (Itching with whole body) had not resolved. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown Route) and mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown) was unknown. Treatment information was not provided. Company comment: This case concerns a 51 year old female patient with no relevant medical history ,who experienced the serious unexpected event of Pruritus .The event occurred on 21-AUG-2021 after first dose of Spikevax ,the onset latency was unknown since date of administration of the vaccine was not reported . The rechallenge was not applicable since only information about the first dose was disclosed.The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 51 year old female patient with no relevant medical history ,who experienced the serious unexpected event of Pruritus .The event occurred on 21-AUG-2021 after first dose of Spikevax ,the onset latency was unknown since date of administration of the vaccine was not reported . The rechallenge was not applicable since only information about the first dose was disclosed.The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1755590 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-08-21
   Days after vaccination:113
Submitted: 0000-00-00
Entered: 2021-10-02
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? 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: Chronic obstructive lung disease
Allergies:
Diagnostic Lab Data: Test Date: 20210821; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Iu international unit(s)
CDC Split Type: PTPFIZER INC202101229091

Write-up: PCR positive; COVID-19; This is a spontaneous report from a contactable nurse downloaded from the Authority-WEB. This is a report received from regulatory authority report number PT-INFARMED-T202109-262 with Safety Report Unique Identifier PT-INFARMED-T202109-262. A 70-year-old male patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: EY2172, Expiry Date: Not Reported), via intramuscular route of administration on 30Apr2021 as dose 2, 0.3 ml single covid-19 immunisation and patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: EW2239, Expiry Date: Not Reported), via intramuscular route of administration on 02Apr2021 as dose 1, 0.3ml single for covid-19 immunisation. The interval between the two doses was 28 days. The patient medical history included chronic obstructive pulmonary disease (CPOD). The patient concomitant medications were not reported. On 21Aug2021, the patient experienced COVID-19. No information about previous SARS-CoV-2 infection. Adverse drug reaction (ADR) was detected 141 and 113 days after administration, respectively, of the 1st and 2nd dose of the suspected drug, with unknown duration. The ADR was accompanied by symptoms, coughing and respiratory distress, which led to hosp, which was prolonged by worsening of her COPD (Chronic obstructive pulmonary disease). The sick person is now cured. The suspected drug was not suspended once the vaccine schedule was complete. There is no suspicion of drug interactions. There are no data on the history of previous drug/vaccine reactions or allergies, on having specific treatment for the reaction, or on the use of usual medication. The patient was hosp for COVID-19. The patient''s hosp was prolonged as a result of covid-19. The patient received two doses for covid-19 immunization but was covid-19 positive so vaccination failure captured. Other information-cough + difficulty breathing; patient already negative, improved, but still in hospital, p worsening of his COPD (Chronic obstructive pulmonary disease). The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 21Aug2021 Iu international unit(s). Outcome of the event covid-19 was unknown. Conclusion from Puurs division was: The complaint for PFIZERBIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product 5887986 5887714 type. The final scope was determined to be the associated lot(s) of the reported lot EW2239and EY2172. 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. Site 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 needed. No further information is expected.


VAERS ID: 1757942 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-21
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? 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: ATJNJFOC20211001802

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046248) on 01-OCT-2021 and concerned a 19 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD985 expiry: UNKNOWN) dose was not reported, 1 total, administered on 05-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-AUG-2021, the patient experienced vaccination failure, sars-cov-2 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1757955 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-08-21
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5029 / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis, Coagulopathy, Decreased appetite, Headache, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage laboratory terms (broad), Embolic and thrombotic events, venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (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: BEPFIZER INC202101228735

Write-up: thrombosis in the confluent sinus and the proximal sinus right; Blood clotting problem; Headache aggravated; Vomiting; do not eat or drink; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [BE-FAMHP-DHH-N2021-106227]. A 17-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Lot Number: FC5029) at single dose on 21Jul2021 for covid-19 immunisation; desogestrel/ethinylestradiol (DESORELLE) at an unspecified dosage from 10Aug2021 for an unspecified indication. Medical history and concomitant medications were not reported. The patient experienced headache aggravated, vomiting and do not eat or drink on 21Aug2021; thrombosis in the confluent sinus and the proximal sinus right and blood clotting problem on 22Aug2021. Therapeutic measures were taken for the events. The action taken in response to the events for desogestrel/ethinylestradiol was permanently withdrawn. The outcome of events was recovering. This report was serious - hospitalization. Reporter comment: Treatment - Yes hospitalization, Fraxiparin was initiated at 2 x 5700 units per day and switched to Pradaxa. Evolution of the adverse drug reaction - Recovering. Conditions - Other: not known. Examinations - admitted until today. Adverse drug reaction description - thrombosis of the confluent sinus into the proximal sinus right ; Reporter''s Comments: Treatment - Yes hospitalization, Fraxiparin was initiated at 2 x 5700 units per day and switched to Pradaxa. Evolution of the adverse drug reaction - Recovering. Conditions - Other: not known. Examinations - admitted until today. Adverse drug reaction description - thrombosis of the confluent sinus into the proximal sinus right


VAERS ID: 1758020 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-21
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Laboratory test, Venous thrombosis limb
SMQs:, Embolic and thrombotic events, venous (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: Test Date: 20210823; Test Name: examinations; Result Unstructured Data: Test Result:found that there was venous thrombosis in the leg
CDC Split Type: FIPFIZER INC202101228669

Write-up: Leg venous thrombosis; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Authority, regulatory authority number FI-FIMEA-20214764. A 57-year-old male patient received bnt162b2, intramuscular on 13Aug2021 (lot number and expiry date: unknown) as dose 2, single for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2, for Covid-19 immunisation. On 21Aug2021, the patient experienced leg venous thrombosis. The clinical course was reported as follows: One week after the second vaccination, the base of the left leg became sore and the pain gradually worsened. Patient went on 23Aug2021 to a doctor and underwent examinations and found that there was venous thrombosis in the leg. Patient stated he had no creatures or risk factors that usually cause similar blood clots. This brought to mind the suspicion that the blockage could be due to the vaccine. The vaccine was given in the left upper arm. Left lower extremity vein: Actual deep thrombosis venous trunks appear to be open, but in the middle and distal thirds of the calf in the gastrocnemius and soleus muscle sites abundantly thrombotic and partially thickened venous trunks in an area about 20 cm in diameter. Calf shaft in widespread muscular venous thrombosis. Outcome of the event was not recovered. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1758044 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-21
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Erythema, Feeling hot, Peripheral swelling, Thrombophlebitis, Ultrasound Doppler
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Prostate cancer
Allergies:
Diagnostic Lab Data: Test Date: 20210821; Test Name: doppler ultrasound; Result Unstructured Data: Test Result:see below; Comments: Doppler ultrasound echocardiography of the lower limb veins: -No image of deep vein thrombosis -Distal periphlebitis of the left internal saphenous is the cause of the symptomatology.
CDC Split Type: FRPFIZER INC202101228672

Write-up: Thrombophlebitis; Sensitive, swollen, red and hot calf; Sensitive, swollen, red and hot calf; Sensitive, swollen, red and hot calf; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority number FR-AFSSAPS-NC20214176. A 60-year-old male patient received bnt162b2 (COMIRNATY, solution for injection, Batch number-unknown) via intramuscular, administered in Arm Right on 05Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. Patient medical history included prostate cancer from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 21Aug2021 patient experienced thrombophlebitis, sensitive, swollen, red and hot calf. The patient underwent lab tests and procedures which included ultrasound doppler: see below on 21Aug2021 Doppler ultrasound echocardiography of the lower limb veins: -No image of deep vein thrombosis -Distal periphlebitis of the left internal saphenous is the cause of the symptomatology. Therapeutic measures were taken as a result of thrombophlebitis, sensitive, swollen, red and hot calf with Arixtra 2.5 mg/0.5 ml: an injection/day for 15 days. The outcome of all events were recovering. Patient notes: prostate cancer (surveillance active) No follow-up attempts possible. No further information expected. Batch/Lot numbers can not be obtained.


VAERS ID: 1758249 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Bedridden, Influenza like illness, Nausea, Weight, Weight decreased
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Test Date: 20210821; Test Name: weight loss; Test Result: 4 kg; Comments: weight loss of 4 kg
CDC Split Type: FRPFIZER INC202101229442

Write-up: Abdominal pain; Loss of weight; Nausea; Influenza like illness; 8 days off work and partially bedridden; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority number FR-AFSSAPS-ST20213429. A 33-years-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm on 20Aug2021 (Lot number was not reported) as dose 2, 0.3 ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY) received on 30Jul2021 for covid-19 immunisation. The patient experienced influenza-like syndrome on 21Aug2021 with associating headache, dizziness and strong asthenia. Headache subsided with doliprane as treatment with duration about 3 days. The patient experienced abdominal pain with nausea and weight loss of 4 kg on 21Aug2021, which were considered medically significant. Patient had no vomiting. These pains led the patient to consult the general practitioner. Patient was 8 days off work and partially bedridden in 2021, she recovered. The patient had fully recovered from influenza-like syndrome on 24Aug2021; fully recovered from abdominal pain and nausea on 28Aug2021; recovered from bedridden on unspecified date in 2021; recovering from weight loss. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1759840 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-21
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? 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: ATJNJFOC20211002544

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority (AT-BASGAGES-2021-046254) on 01-OCT-2021 and concerned a 55 year old female 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) dose was not reported, 1 total administered on 04-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 21-AUG-2021, the patient experienced sars-cov-2 infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.


VAERS ID: 1759896 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation reaction
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 INC202101238812

Write-up: Immunization reaction; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number DE-PEI-CADR2021177066. A 16-year-old male patient received BNT162B2 (COMIRNATY) via an unspecified route of administration on 21Aug2021 (at 16-year-old) (Batch/Lot Number: Unknown) as unknown dose, 0.3 ml single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. On 21Aug2021, the patient experienced Immunization reaction. The case was reported as serious as hospitalization. The outcome of the event was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1760097 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myalgia, Pericarditis, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Systemic lupus erythematosus (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Tendinopathies and ligament disorders (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:
CDC Split Type: AUPFIZER INC202101243236

Write-up: Pericarditis; Injection site pain; Myalgia; This is a spontaneous report from a contactable healthcare professional via the Regulatory Authority The regulatory authority report number is 624353. A 38-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 21Aug2021 (Batch/Lot number was not reported) (at the age of 38-year-old) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 21Aug2021, the patient experienced pericarditis, injection site pain, and myalgia. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1760575 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body mass index, 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: Medical History/Concurrent Conditions: Smoker (Stopped smoking one month ago (7 to 8 cigarettes per day for 8 years))
Allergies:
Diagnostic Lab Data: Test Name: body Mass Index; Result Unstructured Data: Test Result:27; Test Name: Emergency Doppler ultrasound; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: FRPFIZER INC202101239618

Write-up: right peroneal deep vein thrombosis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB FR-AFSSAPS-NT20213888. A 25-years-old male patient received second dose of bnt162b2 (COMIRNATY), intramuscular, administered in left arm on 20Aug2021 (Lot Number: FG6273) as single dose for covid-19 immunisation. Medical history included smoking from 2013 to Jul2021 (Stopped smoking one month ago, 7 to 8 cigarettes per day for 8 years). The patient didn''t have medical history of Covid-19. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY), intramuscular, administered in left arm on 23Jul2021 (Lot Number: FF4213) as single dose for covid-19 immunisation. The patient experienced right peroneal deep vein thrombosis on 21Aug2021. The patient underwent lab tests and procedures which included emergency Doppler ultrasound: unknown results; body mass index 27. Therapeutic measures were taken as a result of the event including emergency anticoagulation management for at least 2 months. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1760864 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-08-21
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, Pain in extremity, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), 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? 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 INC202101249267

Write-up: Arm still extremely painful; Swollen arm; Swollen glands; This is a spontaneous report from a contactable consumer. This is the second of two reports. The first report is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109202210401130-NFVBM. Safety Report Unique Identifier GB-MHRA-ADR 25971863. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jul2021 (Batch/Lot Number: FF3319) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were 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. The patient experienced excessive swollen arm where injection was administered, excessive swollen gland under arm on 21Aug2021 and arm still extremely painful at times on an unspecified date. The events were assessed as serious (medically significant). Lab data includes COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. The outcome of the events swollen arm was not recovered; swollen glands on 02Sep2021; and arm still extremely painful was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1760904 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-08-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hepatitis acute
SMQs:, Hepatitis, non-infectious (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: Medical History/Concurrent Conditions: Adenoidectomy; Anxiodepressive syndrome; Attempted suicide; Ingrowing nail; Psychiatric disorder NOS; Road traffic accident; Sexual assault victim; Tonsillectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Hepatitis acute; This case was received via the Regulatory Agency (Reference number: FR-AFSSAPS-RS20212791) on 27-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of HEPATITIS ACUTE (Hepatitis acute) in a 23-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient''s past medical history included Ingrowing nail, Attempted suicide, Anxiodepressive syndrome, Road traffic accident, Psychiatric disorder NOS, Sexual assault victim, Adenoidectomy and Tonsillectomy. On 18-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 21-Aug-2021, the patient experienced HEPATITIS ACUTE (Hepatitis acute) (seriousness criteria hospitalization and medically significant). At the time of the report, HEPATITIS ACUTE (Hepatitis acute) was resolving. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter. No treatment information was provided by the reporter. This case concerns a 23-year-old, male patient with no relevant medical history, who experienced the unexpected event of hepatitis acute. The event hepatitis acute occurred 4 days after the first dose of mRNA-1273 vaccine administration. The rechallenge was unknown as there''s no information available about the second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 23-year-old, male patient with no relevant medical history, who experienced the unexpected event of hepatitis acute. The event hepatitis acute occurred 4 days after the first dose of mRNA-1273 vaccine administration. The rechallenge was unknown as there''s no information available about the second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1761071 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-21
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? 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: ATJNJFOC20211001784

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory authority (EVHUMAN Vaccines, AT-BASGAGES-2021-046251) on 01-OCT-2021 and concerned a 20 year old female of unspecified race and ethnic origin. The patient''s weight, height, and medical history 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) dose was not reported, 1 total administered on 11-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 21-AUG-2021, the patient experienced vaccination failure, and sars-cov-2 (Severe acute respiratory syndrome coronavirus 2) infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000195774.


VAERS ID: 1761072 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-21
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? 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: ATJNJFOC20211001962

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046253) on 01-OCT-2021 and concerned a 59 year old male. The patient''s height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 expiry: unknown) dose was not reported, frequency time 1 total was administered on 04-JUL-2021 for drug used for an unknown indication. No concomitant medications were reported. On 21-AUG-2021, the patient experienced severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the SARS-CoV-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). The case was associated with product quality complaint (PQC).


VAERS ID: 1762799 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-08-21
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Intermenstrual bleeding
SMQs:, Haemorrhage terms (excl laboratory terms) (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: GBPFIZER INC202101258889

Write-up: effected menstual cycle; This is a spontaneous report from a contactable consumer or other non hcp (patient) received from the Agency Regulatory . The regulatory authority report number is GB-MHRA-EYC 00260790. Safety Report Unique Identifier [GB-MHRA-ADR 25950793]. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Formulation: Solution for injection, Lot Number: FA1027), via parenteral on 20Jul2021 as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. It was reported that on 21Aug2021, the patient experienced effected menstrual cycle. Effected patient menstrual cycle. Patient have had periods from age 11 always regular, never any spotting or missed. On day 1 of patient cycle, patient had spotting for 4 hours and then 3 weeks later patient started period. The outcome of event was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1763283 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-08-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea at rest, Fatigue, Lactic acidosis, Office visit, Paraesthesia, Pericarditis
SMQs:, Lactic acidosis (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Chronic kidney disease (broad), Respiratory failure (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 Name: Cardiac examination; Result Unstructured Data: Test Result:Unknown
CDC Split Type: ITPFIZER INC202101250352

Write-up: Evidence of pericarditis on echocardium; Prolonged fatigue/Exhaustion; Dyspnoea at rest with lactic acidosis; Dyspnoea at rest with lactic acidosis; Alteration of diffuse sensitivity/Disturbance of skin sensation; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-788167. A 57-year-old patient of an unspecified gender received BNT162B2 (COMIRNATY, solution for injection, lot number: FG4686, expiry date: 30Nov2021), intramuscularly administered in right arm (reported as right shoulder) on 18Aug2021 13:30 as dose 1, 0.3 mL single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced evidence of pericarditis on echocardium, prolonged fatigue/exhaustion, dyspnoea at rest with lactic acidosis and alteration of diffuse sensitivity/disturbance of skin sensation on 21Aug2021. The reporter assessed all events as serious (medically significant). The patient underwent lab tests and procedures which included cardiac examination: unknown results on an unspecified date. The outcome of all events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1763436 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Anxiety, Arthralgia, Body temperature, Cough, Diarrhoea, Discomfort, Fatigue, Feeling abnormal, Feeling hot, Head discomfort, Headache, Heart rate, Hyperhidrosis, Hypoaesthesia, Malaise, Muscular weakness, Pain, Pain in extremity, Toothache, Vaccination site induration, Vaccination site mass, Vaccination site pain, Vaccination site scar
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Sexual dysfunction (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: Urticaria (mackerel and contrast agent); Vertebral hernia (Cervical spine, lumbar spine, thoracic spine (A Plastic Surgery))
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: morning; Test Date: 20210827; Test Name: Pulse; Result Unstructured Data: Test Result:around 80; Test Date: 20210828; Test Name: Pulse; Result Unstructured Data: Test Result:around 80; Test Date: 20210829; Test Name: Pulse; Result Unstructured Data: Test Result:84; Test Date: 20210831; Test Name: Pulse; Result Unstructured Data: Test Result:95; Test Date: 20210901; Test Name: Pulse; Result Unstructured Data: Test Result:92; Test Date: 20210902; Test Name: Pulse; Result Unstructured Data: Test Result:87; Comments: A clinic 80; Test Date: 20210903; Test Name: Pulse; Result Unstructured Data: Test Result:88; Test Date: 20210904; Test Name: Pulse; Result Unstructured Data: Test Result:84; Test Date: 20210905; Test Name: Pulse; Result Unstructured Data: Test Result:83; Test Date: 20210906; Test Name: Pulse; Result Unstructured Data: Test Result:81; Test Date: 20210907; Test Name: Pulse; Result Unstructured Data: Test Result:98; Test Date: 20210908; Test Name: Pulse; Result Unstructured Data: Test Result:99; Test Date: 20210821; Test Name: Body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Comments: before vaccination; Test Date: 20210822; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: morning; Test Date: 20210823; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: morning; Test Date: 20210824; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: morning; Test Date: 20210825; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: morning; Test Date: 20210826; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: morning; Test Date: 20210827; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: morning; Test Date: 20210828; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: morning; Test Date: 20210829; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: morning; Test Date: 20210830; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: morning; Test Date: 20210831; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: morning; Test Date: 20210901; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: morning; Test Date: 20210902; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: morning; Test Date: 20210903; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: morning; Test Date: 20210903; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Test Date: 20210904; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: morning; Test Date: 20210905; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: morning; Test Date: 20210906; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: morning; Test Date: 20210907; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: morning
CDC Split Type: JPPFIZER INC202101243444

Write-up: feeling of hot in the body; body feels heavy; slight sweating; Feeling uneasy; downward feeling in stomach; muscle weakness and numbness in my left arm; muscle weakness and numbness in my left arm; feel unusually tired; Coughed; Diarrhea smell; root of the upper right back tooth was treated/toothache; head always feels heavy; felt poorly in the morning; Strong headache; scar on my left arm from the injection was painful; left arm from the injection was painful/dull pain around the injection mark on the left arm/Vaccination site pain; lump around the injection mark; Vaccination site induration; The left arm was pain and only goes up to the shoulders; left side body was pain; malaise; Painful L arm; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21127266. A 58-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number: FF3620, Expiration date: 30Nov2021) via an unspecified route of administration, administered in the left arm on 21Aug2021 at 15:00 (at the age of 58-years-old) as dose 1, single for COVID-19 immunization. Body temperature before vaccination was 35.8 degrees Centigrade on 21Aug2021. The patient had a history of cervical spine, thoracic spine, lumbar spine hernia (A Plastic Surgery) and had urticaria to mackerel and contrast agent. Concomitant medications were not reported. On 23Aug2021 (2 days after the vaccination), the patient experienced Vaccination site induration and Vaccination site pain. The course of the event was as follows: On 21Aug2021 Saturday, Vaccination. At 3:00 PM Body was malaise and had painful L arm. On 22Aug2021 Sunday, the patient slept without getting up for 8 hours. The left arm was pain and only goes up to the shoulders, and the left side body was pain. Body temperature (morning) 36.6 degrees Centigrade. On 23Aug2021 Monday, the patient the afternoon, the patient was able to lift the left arm little by little, but the scar on my left arm from the injection was painful. Body temperature (morning) 36.6 degrees Centigrade. On 24Aug2021 Tuesday, the patient felt poorly in the morning, had headache in the afternoon, and felt like the head was cracking in the evening. The patient took half tablet of Paracetamol 500 which was the internal medicine prescription for headache and slept. The body temperature at the time was just 36.5 degrees Centigrade, so took half a tablet at own discretion. The left arm went up to the shoulder, but there was a dull pain around the injection mark on the left arm. Body temperature (morning) 36.5 degrees Centigrade. On 25Aug2021 Wednesday, Strong headache subsides in the morning, but the head always feels heavy. Occasional headache but did not seem to be enough to take medication. There was still a dull ache on left arm around the injection scar. Body temperature (morning) 36.5 degrees Centigrade. On 26Aug2021 Thursday, occasional headaches, but nothing that would require medication. The patient still had a dull ache on left arm around the vaccination scar. Body temperature (morning) 36.6 degrees Centigrade. On 27Aug2021 Friday, the patient went to Dental Clinic for treatment. The root of the upper right back tooth was treated, and the patient was prescribed an anti-inflammatory (Cefaclor 250) and an analgesic (Voltaren 25), which took after dinner. The patient still had a dull ache on left arm around the injection mark. Body temperature (morning) 36.7 degrees Centigrade. On 28Aug2021 Saturday, the patient had a toothache that treated yesterday, so took anti-inflammatory and analgesic and three times a day, morning, noon and night. Sometimes got headaches, but the patient did not think will be able to take the medicine. The patient still had a dull ache around the injection mark on left arm. Body temperature (morning) 36.7 degrees Centigrade. Patient''s pulse rate was around 90 until 27Aug2021, when it dropped to around 80 and the patient stopped feeling well. the patient took Cymbalta 20 x 1 tablet. On 29Aug2021 Sunday, took anti-inflammatory and analgesic three times a day, morning, afternoon and night, for toothache as yesterday. Coughed a little and felt like diarrhea smell. Occasional headaches, but nothing that would require medication. There was still a dull ache around the injection mark on left arm. Body temperature (morning) 36.7 degrees Centigrade. Pulse 84 (Cymbalta 20x1 tablet has been taken again since then). On 30Aug2021 Monday, toothache recovered, and the patient stopped taking anti-inflammatory and analgesics. The patient had occasional headaches, but the patient did not think need to take any medication. The patient had a slight cough and diarrhea smell, so took over-the-counter cold remedies (Pavlon) after dinner. Around 10:00 p.m., the patient started to feel unusually tired and sat down on a chair to take a tablet. the patient fell asleep spontaneously and continued to fall asleep as soon as the patient regained consciousness. Body temperature (morning) 36.6 degrees Centigrade. On 31Aug2021 Tuesday, the patient was coughing a little, and diarrhea smell, so the patient stopped taking the cold medicine because of last night. The headache was still there. The patient held off on taking the medicine. There was still a dull ache around the injection mark on his left arm. The patient drank a large beer with dinner, and between 9:00 and 10:00, the patient drank barbecued rice wine three times with soda water. About half an hour later, the patient felt a strange sense of malaise, sat down on a chair and looked at tablet. The patient fell asleep spontaneously and continued to fall asleep as soon as the patient regained consciousness. When the patient bought a pair of battery-powered hair clippers, the patient lowered them with left arm and saw that it weighed less than three kilograms, and the patient thought changed. Body temperature (morning) 36.6 degrees Centigrade. Pulse 95. On 01Sep2021 Wednesday, the patient was still coughing a little, and diarrhea smell, and the patient had a headache, but the patient held off on taking medication. the patient drank a large beer at dinner, and between 9:00 and 10:00, the patient drank 0.5 barbecued rice wine, divided into two portions, with soda water. The patient was still worried about the dull pain around the injection scar on left arm. Body temperature (morning) 36.7 degrees Centigrade. Pulse 92. On 02Sep2021 Thursday, the patient still had a slight cough, diarrhea smell, the patient had a strong headache today, and the patient felt poorly. Feeling uneasy, the patient went to the clinic and consulted the doctor. Three days after the vaccination, the patient had a strong headache that started at noon, and the patient took the prescription Paracetamol. The patient took prescription dental medication (anti-inflammatory and analgesic) for two days, morning, noon and night. The patient took an over-the-counter cold medicine once a night for a mild cough and a downward feeling in stomach. Explain to the doctor how the body felt after taking the above medications. After considering current condition, such as felt poorly, muscle weakness and numbness in left arm, dull pain around the injection mark on left arm that would not go away, and the symptoms of body after the vaccination, the doctor decided to stop the vaccination for the second time (9/11). After the vaccination, the patient noticed that there was still a lump around the injection mark. Body temperature (morning) 36.7 degrees Centigrade. Pulse 87. (A clinic determination 80). On 03Sep2021 Friday, today, the patient didn''t have a cough or a diarrhea smell. the patient did have a headache and heaviness, but the patient held off on taking the medicine. The patient had been resting all day. the patient felt hot, but his body temperature was around 36.5 degrees Centigrade. The patient had numbness in left arm, a dull ache around the injection mark on his left arm, and a lump that has not gone away. The body feels heavy and malaise all day long. Body temperature (morning) 36.6 degrees Centigrade. Pulse 88. On 04Sep2021 Saturday, there was a dull ache around the injection scar on the left arm and numbness in the left arm. Body temperature (morning) 36.6 degrees Centigrade. Pulse 84.On 05Sep2021 Sunday, numbness in left arm. Headache in the morning, shifting from weak to strong. Heaviness in the body, coughing a little, feeling like diarrhea smell, in the evening he couldn''t stand the headache and took medicine (half a tablet of Paracetamol 500) and felt better. The lump on left arm has not gone away. Body temperature (morning) 36.6 degrees Centigrade. Pulse 83. On 06Sep2021 Monday, there was a dull ache around the injection scar on the left arm and numbness in the left arm. Heaviness in the body. A little coughing and a diarrhea smell. The lump in the injection scar on left arm was not going away. Body temperature (morning) 36.7 degrees Centigrade. Pulse 81. On 07Sep2021 Tuesday, feeling of hot in the body, slight sweating. Heaviness, coughing a little, and a diarrhea smell. Dull pain around the injection mark on the left arm, and the lump has not disappeared. Body temperature (morning) 36.6 degrees Centigrade. Pulse 98. On 08Sep2021 Wednesday, feeling of hot in the body, slight sweating. Heaviness, coughing a little, and a diarrhea smell. Dull pain around the injection mark on the left arm, and the lump has not disappeared. Body temperature (morning) 36.6 degrees Centigrade. Pulse 99. Outcome of event toothache was recovered on 30Aug2021, while remaining events was not recovered. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1771308 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-21
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? 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: ATJNJFOC20211012706

Write-up: Vaccination failure; SARS-CoV-2 infection; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046243) on 07-OCT-2021 concerned a 27 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD985, expiry: unknown) dose was not reported, 1 total administered on 30-JUN-2021 for an unknown indication. No concomitant medications were reported. On 21-AUG-2021, the patient experienced severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection and had vaccination failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1775888 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-21
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? 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: ATJNJFOC20211015583

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via Regulatory Authority (AT-BASGAGES-2021-046285) on 08-OCT-2021 and concerned a 54 year old male with unknown race and ethnicity. 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: XD975 expiry: UNKNOWN) dose was not reported, 1 total administered on 02-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 21-AUG-2021, the patient experienced vaccination failure and sars-cov-2 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1776193 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-21
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? 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: ATJNJFOC20211016591

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician by a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046273) on 08-OCT-2021 and concerned a 23 year old female. 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: XD985 expiry: UNKNOWN) dose was not reported,1 total administered on 08-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 21-AUG-2021, the patient experienced sars-cov-2 infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint.


VAERS ID: 1776194 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-21
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? 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: ATJNJFOC20211016509

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician by a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046276) on 08-OCT-2021 concerned a 25 year old male patient. 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: XD974 expiry: unknown) dose was not reported, 01 total (first dose), administered on 24-JUN-2021 for drug use for unknown indication. No concomitant medications were reported. On 21-AUG-2021, the patient experienced severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection and vaccination failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.


VAERS ID: 1776195 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-21
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? 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: ATJNJFOC20211016473

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046278) on 08-OCT-2021 concerned a 46 year old female. 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: XD974 and expiry: Unknown) dose was not reported, 1 total administered on 12-JUN-2021 for drug used for unknown indication. No concomitant medications were reported. On 21-AUG-2021, the patient experienced SARS-COV-2 (severe acute respiratory syndrome coronavirus) infection and vaccination failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the SARS-COV-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint.


VAERS ID: 1780069 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, Condition aggravated, Pain in extremity, Pyrexia, SARS-CoV-2 test, Sickle cell anaemia with crisis, Visual analogue scale
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SIKLOS
Current Illness: Sickle cell disease
Preexisting Conditions: Medical History/Concurrent Conditions: Transfusion (for post-viral haemolytic crises); Transfusion (for post-viral haemolytic crises); Vaso-occlusive crisis (2 years ago)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Fever; Result Unstructured Data: Test Result:40 Centigrade; Test Date: 2021; Test Name: C-reactive protein; Result Unstructured Data: Test Result:77 mg/l; Test Date: 2021; Test Name: COVID-19 test; Test Result: Negative ; Test Date: 2021; Test Name: Visual Analogue Scale; Result Unstructured Data: Test Result:up to 7; Test Date: 2021; Test Name: Visual Analogue Scale; Result Unstructured Data: Test Result:stationary at 4
CDC Split Type: FRPFIZER INC202101278883

Write-up: Sickle cell anaemia with crisis; Sickle cell anaemia with crisis; Fever 40?C maximum; pain in the lower limbs; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-GR20214234 with Sender''s (Case) Safety Report Unique Identifier FR-AFSSAPS-2021132730. An 18-year-old male patient received bnt162b2 (COMIRNATY; Batch/Lot Number: Unknown) via intramuscular, on 21Aug2021 (at the age of 18 years old) as dose 2, 0.3 mL single for COVID-19 immunisation. Medical history included ongoing major sickle cell disease/ syndrome SS, on background treatment with hydroxycarbamide (SIKLOS) 1250 mg in the evening, fairly well balanced (usually 1 transfusion per year). The patient also had a differential diagnostic: last transfusion was on 03Aug2021 to 04May2021 (previous Aug2020) for post-viral haemolytic crises and last vaso-occlusive crisis with painful presentation which was 2 years ago (2019). Concomitant medication included hydroxycarbamide (SIKLOS) taken for sickle cell disease, start and stop date were not reported. On 21Aug2021, during the night, the patient experienced pain in the lower limbs typical of his previous vaso-occlusive attacks, accompanied by fever the next morning. During the night of 22Aug2021 to 23Aug2021, it was also reported that the patient experienced a unifocal vaso-occlusive crisis (reported as sickle cell anaemia with crisis), with a Visual Analogue Scale of 7. Transient improvement at home and Visual Analogue Scale of 4 after paracetamol. On 23Aug21, hospitalisation due to bilateral signs of vaso-occlusive crisis, and pain only in the lower limbs. No thoracic signs. Fever was 40?C maximum, C-reactive protein 77 mg/L but no inflammatory or infectious findings. The patient had a negative COVID-19 test. No other inflammatory triggers, unusual clinical presentation with initial pain (haemolysis in the foreground, pain usually delayed or not observed during the usual attacks). Visual Analogue Scale up to 7, no vital distress or acute chest syndrome but ineffective first line management: Visual Analogue Scale stationary at 4. Recourse to transfusion (exchange of 2 Radial Glia Cells). Pain relief with morphine. Increase in background treatment with SIKLOS to 1500 mg per day from Monday to Saturday inclusive and 1000 mg on Sunday. Addition of FOLIC ACID 5 mg, 1 pill per day and CYANOCOBALAMINE 1 mg per day for 4 months. On 26Aug2021, discharge from hospital. The outcome of the event Sickle cell anaemia with crisis was recovered on 26Aug2021, for the event pain in the lower limbs was recovered on unspecified date in 2021, while for the other event was unknown. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1780213 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-21
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abortion spontaneous, Back pain, Haemorrhage, Maternal exposure during pregnancy
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (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: FRPFIZER INC202101291442

Write-up: Early miscarriage; maternal exposure during pregnancy, first trimester; bleedings; Pain over the back; Pain abdominal; This is a spontaneous report from a contactable other HCP downloaded from the Regulatory Agency (RA)-WEB FR-AFSSAPS-NT20214298. A 34-year-old female pregnant patient received bnt162b2 (COMIRNATY, formulation: Solution for injection, Lot number: FE8235), intramuscularly administered in arm left on 10Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient''s last menstrual period on 09Jul2021. The patient did not had COVID-19 and not tested for COVID-19. On an unspecified date, the patient experienced maternal exposure during pregnancy, first trimester. The mother was 6 Weeks pregnant at the onset of the event. On 21Aug2021, the pregnant patient presents pain in the back and stomach. She was hospitalized for a miscarriage following bleedings. The mother reported she became pregnant while taking bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE). The mother was due to deliver on 15Apr2022. The pregnancy resulted in spontaneous abortion. The events spontaneous abortion, miscarriage following bleedings and maternal exposure during pregnancy, first trimester assessed as medically significant. On an unspecified date, the patient recovered with sequelae from early miscarriage and recovered from pain over the back and pain abdominal. The outcome of all other events was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1783865 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Drug ineffective, SARS-CoV-2 test, Suspected COVID-19, Vaccination site pain
SMQs:, Lack of efficacy/effect (narrow), Arthritis (broad), 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: LEVETIRACETAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy (well controlled with medication)
Allergies:
Diagnostic Lab Data: Test Date: 20210630; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101126244

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; Joint pain; Vaccination site pain; This is a solicited report from the regulatory authority program from a contactable consumer. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-YCVM-202108201903042080-CUAXN, Safety Report Unique Identifier GB-MHRA-ADR 25865669. A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FF3319) via an unspecified route of administration on 21Aug2021 (at the age of 17-year-old) as single dose for covid-19 immunization. The patient''s medical history included epilepsy well controlled with medication. The concomitant medication included levetiracetam from 09Mar2020. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient did not have symptoms associated with COVID-19. On 21Aug2021 the patient experienced vaccination site pain on 21Aug2021, joint pain on 22Aug2021, sars-cov-2 infection on 19Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 30Jun2021 (No -Negative COVID-19 test). The outcome of the events for vaccination site pain and joint pain was resolved on 24Aug2021, for sars-cov-2 infection was resolved on 23Sep2021. The reporter assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Follow-up (26Sep2021): New information received from a contactable consumer Via regulatory authority included: New event (sars-cov-2 infection) and event details. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, the causal relationship between the events Joint pain, Vaccination site pain, Covid-19 and suspect drug BNT162B2 cannot be excluded.


VAERS ID: 1787213 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-21
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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? 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: 20210821; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Positive Iu international unit(s)
CDC Split Type: PTJNJFOC20210941927

Write-up: VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority (regulatory authority, PT-INFARMED-T202109-176) on 22-SEP-2021 concerned a 50 year old female. 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: XD986 expiry: unknown) 0.5 ml, 1 total administered on 09-JUN-2021 for covid-19 immunization (Drug start period- 73 days). No concomitant medications were reported. On 21-AUG-2021, the patient experienced vaccination failure. Laboratory data included: SARS-CoV-2 PCR test (NR: not provided) Positive Iu international unit (s). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccination failure on 01-SEP-2021. This report was serious (Other Medically Important Condition).; Reporter''s Comments: Other information-23-Aug -Possibility of positive contact being false, so far all asymptomatics; High Risk Contact of user considered NOT CASE, THERE WAS A PROBLEM WITH THE BATCH OF TESTS AND THERE WAS A SERIES OF FALSE POSITIVES. USER WAS CALLED TO REPEAT THE TEST AND IT WAS NEGATIVE. THE PHARMACY CALLED THE USER.


VAERS ID: 1584228 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Missouri  
Vaccinated:2021-08-12
Onset:2021-08-20
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site mass, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (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: None
Current Illness: None
Preexisting Conditions: Allergies and asthma
Allergies: Tree nuts
Diagnostic Lab Data: None
CDC Split Type:

Write-up: A small knot developed on the bicep of the same arm injected. It appears to be on/near a large bicep vein. It is slightly painful. It is still present 1 week after vaccination


VAERS ID: 1587278 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-08-13
Onset:2021-08-20
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain lower, Seizure
SMQs:, Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (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: Celexa and Zyrtec
Current Illness: none
Preexisting Conditions: had seizure the day after receiving Maderna vaccine +1 . also has had intermittent, sharp central lower abd pain lasting 15-30 minutes since the day after the vaccine. Abd pain started before the seizure. No hx of seizures in the past
Allergies: NKDA
Diagnostic Lab Data: none
CDC Split Type:

Write-up: seizure and midline lower abd pain


VAERS ID: 1589070 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-19
Onset:2021-08-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 035C21A / 1 LA / SYR

Administered by: Military       Purchased by: ?
Symptoms: Chills, Cold sweat, Gait disturbance, Sleep disorder
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre 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: Birth control, oral contraceptive
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Woke up several time the following night. When I officially woke up the next morning I had cold chills with clammy skin. I felt so hazy walking, almost like vertigo.


VAERS ID: 1589094 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-12
Onset:2021-08-20
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Military       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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:

Write-up: Moderna COVID-19 Vaccine EUA


VAERS ID: 1590068 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: California  
Vaccinated:2021-06-16
Onset:2021-08-20
   Days after vaccination:65
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
SMQs:, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Acetaminophen (Mapap) 325 mg Oral Tab Takes Occasionally Atenolol (TENORMIN) 25 mg Oral Tab Takes Regularly Atorvastatin (LIPITOR) 40 mg Oral Tab Takes Regularly Calcitriol (ROCALTROL) 0.25 mcg Oral Cap Takes Regularly Clopidogrel (PLAVIX)
Current Illness: None
Preexisting Conditions:
Allergies: Lisinopril
Diagnostic Lab Data:
CDC Split Type:

Write-up: Breakthrough infection despite vaccination


VAERS ID: 1591132 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-12
Onset:2021-08-20
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Polymenorrhoea, Vaccine positive rechallenge
SMQs:, Haemorrhage terms (excl laboratory terms) (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: Same adverse affect with 1st vaccine
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Mentrual period started today and is excessively heavy bloody flow compared to normal. Same occurred with my first jab of the same vaccine.


VAERS ID: 1591162 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-08-10
Onset:2021-08-20
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (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: Topamax, loestrin, multi-vitamin, vitamin d, vitamin a, evening primrose, magnesium, melatonin
Current Illness: anal fistula
Preexisting Conditions: none
Allergies: contact dermatitis, bee venom, preparation H, ciprofloxacin, sumatriptin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Itching, red, swelling, rash-like at injection site (very similar to a bug bite) 10 days after 1st shot.


VAERS ID: 1591166 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-08-17
Onset:2021-08-20
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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? No
Previous Vaccinations:
Other Medications: Aptensio XR
Current Illness: NO
Preexisting Conditions: NO
Allergies: NO
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever of 102 next morning after dose


VAERS ID: 1591196 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Iowa  
Vaccinated:2021-08-19
Onset:2021-08-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? 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:

Write-up: Patient reports very high fever (104 Degrees self-reported) with chills and nausea starting approximately 18 hours after third dose of Pfizer vaccine. I encouraged patient to contact his prescriber. At time of reporting, I am unsure of resolution of symptoms.


VAERS ID: 1591281 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-08-20
Onset:2021-08-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Dysphagia, Lip pruritus, Paraesthesia oral
SMQs:, Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Flu vaccine-hypotension and fever
Other Medications: unknown
Current Illness: no
Preexisting Conditions: depression
Allergies: flu vaccine, iodinated contrast, codeine
Diagnostic Lab Data: pending
CDC Split Type:

Write-up: 0930: Patient reporting "tingling" in tongue after J&J COVID vaccine. 0933 Patient reports difficulty swallowing. Epi 0.3mg given IM R thigh. 0937 Patient reporting continued tingling, feels as though tongue is "thick". Reports swallowing has improved. Itching on bottom lip. 0946 Patient taken to ED by ED RNs via stretcher.


VAERS ID: 1591283 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-08-19
Onset:2021-08-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0183 / 1 LA / IM

Administered by: Military       Purchased by: ?
Symptoms: Fatigue, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Child noticed he was having fever at around 4am. Child also felt fatigued. Took his temp at around 10am reading 102.9?F. Initial Treatment: Cold Shower & Tylenol 2x325mg, temp dropped to 98.5?F.


VAERS ID: 1591338 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-07-30
Onset:2021-08-20
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Extra dose administered, Interchange of vaccine products
SMQs:, Medication errors (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:

Write-up: Administration error - mixed vaccine product Patient received Janssen vaccine in March 2021. Patient also recieved 1 dose of Pfizer 7/30/21. This was not caught at time of service. Voicemail was left with patient with notice of 2nd Pfizer appointment cancelation due to CDC guidelines.


VAERS ID: 1591342 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-08-20
Onset:2021-08-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 053E21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Extra dose administered
SMQs:, Medication errors (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: na
Current Illness: na
Preexisting Conditions: na
Allergies: na
Diagnostic Lab Data: na
CDC Split Type:

Write-up: Patient Received double the required dose, she got 1 ml instead of 0.5ml


VAERS ID: 1591343 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-08-20
Onset:2021-08-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017C21A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: No adverse event
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? No
Previous Vaccinations:
Other Medications: Tylenol Aspirin Nitroglycerin Lasix Aldactone Senna Metoprolol Succinate
Current Illness: Chest Pain HTN w/ heart failure Acute Kidney failure
Preexisting Conditions: BPH HTN CAD GERD Hyperlipidemia Anxiety Peripheral Neuropathy Vitamin D Deficiency Anemia Weakness AAA w/o rupture
Allergies: PCN
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: No adverse reaction noted after 15min.


VAERS ID: 1591346 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-08-03
Onset:2021-08-20
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EC3180 / 1 AR / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dysmenorrhoea, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (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: Spirlactone Celexa
Current Illness: None
Preexisting Conditions: Migraines
Allergies: Sulfa meds
Diagnostic Lab Data:
CDC Split Type:

Write-up: Major cramping and breakthrough vaginal bleeding on day 18 of cycle.


VAERS ID: 1591353 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-02-13
Onset:2021-08-20
   Days after vaccination:188
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1284 / 1 RA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9262 / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Tinnitus
SMQs:, Hearing impairment (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: losartan, omepraszole, meloxicam, vitamin D, rosuvastatin
Current Illness: None
Preexisting Conditions: HTN, GERD, Increased cholesterol, bursitis-hips
Allergies: NKDA
Diagnostic Lab Data: None yet
CDC Split Type:

Write-up: Received 1st dose, 02/27/2020. Received 2nd dose: 02/12/2021. I noticed moderate worsening of tinnitus a few(3 maybe) after 2nd dose. I have inquired with an ENT doctor whom I work with about being worked up about condition. I''m working in state for summer and hope to have an appointment in the fall some time. I wanted to let CDC know about the symptom in case others have noticed it as well. It''s a difficult symptom to make a definitive diagnosis. But I have definately noticed an increase in the tinnitus. Wonder if the vaccine could play a role.


VAERS ID: 1591355 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: North Carolina  
Vaccinated:2021-08-20
Onset:2021-08-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 028L20A / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Fatigue, Oligomenorrhoea
SMQs:, Fertility disorders (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: Vitamin D, Viibryd, Acyclovir, L-Lysine
Current Illness: n/a
Preexisting Conditions: I''ve had my period once since my second shot. My second shot was on 2/15/2021.
Allergies: n/a
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: The first shot I had no issues. The second shot I was tired for the next two days, no other symptoms.


VAERS ID: 1591367 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Missouri  
Vaccinated:2021-08-19
Onset:2021-08-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Headache; sore at injection site.


VAERS ID: 1591371 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-08-19
Onset:2021-08-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW 0198 / 2 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Dizziness, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (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: Valtrex cimetidine sertraline bupropion
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: DOSE 1 SIDE EFFECT IS CONTINOUS DIZZINESS, DOSE 2 SIDE EFFECTS IS TINGLING ALL OVER BODY AND CONTINOUS DIZZINESS, VERY SORE RIGHT ARM


VAERS ID: 1591374 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: New York  
Vaccinated:2021-08-20
Onset:2021-08-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL3183 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Electrocardiogram, Headache, Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), 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), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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? Yes
Hospitalized? No
Previous Vaccinations: significant arm swelling after meningitis vaccine
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: NKA
Diagnostic Lab Data: EKG 8/20/2021
CDC Split Type:

Write-up: Patient developed a headache and passed out (vasovagal syncope)


VAERS ID: 1591397 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-08-19
Onset:2021-08-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Hypoaesthesia, Hypoaesthesia oral, Illusion
SMQs:, Peripheral neuropathy (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Arthritis (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: Vitamin D, benidryl, baby asprin, Aderol XR 20
Current Illness: N/A
Preexisting Conditions: Fatty Liver Disease
Allergies: N/A
Diagnostic Lab Data:
CDC Split Type:

Write-up: Right arm going numb, but pain in right wrist. Lips feel like they are numb, numbing sensation in lips. Also, I have periodic feeling of shrinking. Kinda like vertigo but more of a shrinking sensation


VAERS ID: 1591412 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: New York  
Vaccinated:2021-08-20
Onset:2021-08-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EWO165 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Dyspnoea, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Infective pneumonia (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? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Bronchitis
Preexisting Conditions: Asthma
Allergies: Environmental
Diagnostic Lab Data: Client sent to hospital for observation
CDC Split Type:

Write-up: 10 minutes after vaccine, client c/o difficulty breathing. EMT on site, auscultated wheezing in upper lobes, administered nebulizer treatment. Client discloses recent bronchitis, and history of asthma.


VAERS ID: 1591414 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Utah  
Vaccinated:2021-08-18
Onset:2021-08-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 1 AR / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Loss of consciousness, Nausea, Pain in extremity, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), 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), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Sertraline 50mg, Concerta 54mg
Current Illness:
Preexisting Conditions: Anxiety
Allergies:
Diagnostic Lab Data: None thus far
CDC Split Type:

Write-up: Patient received first dose of Pfizer COVID-19 vaccine on 8/18/21. On the morning of 8/20/21 patient complained of nausea but still went to school. When arrived at school, went straight to restroom and vomited. Remained near toilet, vomited again and passed out for unknown amount of time. Patient returned home, and parent contacted pediatrician''s office who then instructed her to contact the vaccinating pharmacy. She detailed the vomiting/syncope symptoms, also noted that when she is lying down she feels better but when she attempts to stand or remain upright the feelings of nausea return. Patient also noted pain in her legs when she was vomiting at school. Instructed parent to continue monitoring the patient and to notify healthcare provider and vaccinating pharmacy of any further developments.


VAERS ID: 1591418 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-08-20
Onset:2021-08-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Incorrect dose administered
SMQs:, Medication errors (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: none
Preexisting Conditions:
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Diluent was not used, patient recieved undiluted vaccine


VAERS ID: 1591422 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-08-18
Onset:2021-08-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0181 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Ear congestion, Feeling hot, Full blood count normal, Metabolic function test, Pharyngeal swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: anaphylaxis during unknown chemo 20 years ago
Other Medications: Atorvastatin Amlodipine Pantoprazole
Current Illness: None Significant stress
Preexisting Conditions: High blood pressure High cholesterol Gastric ulcers
Allergies: Bactrim DS 800-160 Levoquin Indocin Lortab Tree and grass pollens mold mildew
Diagnostic Lab Data: Per client, CBC and CMP were both normal.
CDC Split Type:

Write-up: Received a call from patient on 8/20/21 at 1145h; patient stated that she received Pfizer vaccine at 12PM on 08/18/2021 and stayed in the office for 30 minutes without event. While driving home, client states she started experiencing throat swelling and her ears felt like they were closing up so she took a benadryl. She states she got really hot. She stopped at ER and they noted nothing in her throat, client states labs were normal, and they looked up an ingredient of Pfizer and informed client that there was a cross-reactivity to one of the ingredients and her sulfa allergy. The ER administered solumedrol and pepcid. They prescribed prednisone 20mg, take three pills, x5days.


VAERS ID: 1591442 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-08-17
Onset:2021-08-20
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Lymphadenopathy, Pain in extremity, Petechiae
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Tendinopathies and ligament disorders (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? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Day 1 - sore left arm (anticipated) Day 2 - enlarged left axillary lymph nodes (anticipated) Day 3 - area of petechiae measuring 3 X 3 cm to medial aspect of right forearm (not anticipated) Note - Both parents experienced petechia which resolved on its own, following second dose of the Moderna vaccine.


VAERS ID: 1591447 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-08-09
Onset:2021-08-20
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PAA165969 / 1 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: No adverse event, Product administered to patient of inappropriate age
SMQs:, Medication errors (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: n/a
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: n/a
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Patient only 5 days from turning 12 when vaccine given, had no adverse reaction


VAERS ID: 1591458 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Nebraska  
Vaccinated:2021-08-20
Onset:2021-08-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0173 / 3 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 575HC / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
SMQs:, Medication errors (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: none
Current Illness: none
Preexisting Conditions: adhd
Allergies: nka
Diagnostic Lab Data: none
CDC Split Type:

Write-up: child received covid #3 and Tdap #2 today. had already gotten tdap on 6-15 and covid 6-15 and 7-6-21. PCP notified.


VAERS ID: 1591460 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-19
Onset:2021-08-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939902 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Injection site pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (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? No
Previous Vaccinations:
Other Medications: Vitamins A, C, D, E, Biotin, Melatonin, Iron, Omega-3 Fish Oil, Atvorstatin, Losartin, Fluticosone, Adapaleine (nasal sprays)
Current Illness:
Preexisting Conditions: Covid diagnosed on June 14
Allergies: Latex
Diagnostic Lab Data: None to date
CDC Split Type:

Write-up: Low Grade fever, joint soreness, soreness at injection site.


VAERS ID: 1591472 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-08-20
Onset:2021-08-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0173 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Paraesthesia, Swollen tongue
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), 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? No
Previous Vaccinations:
Other Medications: ?
Current Illness: ?
Preexisting Conditions: ?
Allergies: ?
Diagnostic Lab Data: ?
CDC Split Type:

Write-up: AT 9:20 PATIENT STATE FACE TINGLING NO APPARENT DISTRESS. NO TROUBLE SWALLOWING. AT 9:25 PATIENT NOW STATES THAT TONGUE FAT. AGREES TO GO TO URGENT CARE ASAP.


VAERS ID: 1591483 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-08-20
Onset:2021-08-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 41B21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fall, Loss of consciousness, Seizure
SMQs:, Torsade de pointes/QT prolongation (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), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (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? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: none reported
Preexisting Conditions: none reported
Allergies: none reported
Diagnostic Lab Data: none
CDC Split Type:

Write-up: patient received vaccine, was fine, about 4 minutes later she lost consciousness and fell out of her chair and began having a seizure. at this point I rushed to her to turn her on her side and monitored pulse, breathing until she regained consciousness about 30 seconds later.


VAERS ID: 1591491 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-08-19
Onset:2021-08-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 007D21A / 2 LA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Back pain, Confusional state, Lethargy, Movement disorder, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: magnesium, folic acid, thiamine, acetaminophen
Current Illness: critical dilantin level 8/19 with changes of condition observed over the past couple of weeks
Preexisting Conditions: tobacco use, wernicke''s encephalopathy, alcoholic hepatitis, epilepsy
Allergies: none
Diagnostic Lab Data: sent to hospital on 8/20
CDC Split Type:

Write-up: confusion, lethargy, fever 100, couldnt turn neck, severe back pain


VAERS ID: 1591492 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-08-12
Onset:2021-08-20
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 048C21A / 2 - / SYR

Administered by: Private       Purchased by: ?
Symptoms: Erythema, Incorrect route of product administration, Induration
SMQs:, Anaphylactic reaction (broad), Drug abuse and dependence (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Medication errors (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: unknown. Med list not updated since 2018.
Current Illness: None listed.
Preexisting Conditions: None listed.
Allergies: None listed.
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Pt vaccine site lower than intended. As a result patient received vaccine subcutaneously and because of this the patient has a red bump on their arm.


VAERS ID: 1591501 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-08-20
Onset:2021-08-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: No adverse event
SMQs:

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: N/A
Current Illness: NKDA
Preexisting Conditions: NA
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Person got vaccination answered no to questions on contraindications. Witnesses mentioned he went around the corner and may or may not have been doing drugs. He walked down the street 15 minutes later and had someone call 911. We were not present at the time of the call.


VAERS ID: 1591523 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-05-17
Onset:2021-08-20
   Days after vaccination:95
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
SMQs:, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: SARS CoV2 PCR PositiveAbnormal
CDC Split Type:

Write-up: COVID infection breakthrough


VAERS ID: 1591529 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-08-20
Onset:2021-08-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Altered state of consciousness, Dizziness, Pallor
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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? No
Previous Vaccinations:
Other Medications: not known
Current Illness: not known
Preexisting Conditions: not known
Allergies: not known
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received the vaccine and was asked to take a sit for 15 minutes. Approximately 10 mins later his girlfriend approached us stating he felt dizzy. When I got to him, he was becoming pale. I called 911, and returned to the patient who was in and count of consciousness. Myself and a second pharmacist assisted him to the floor and checked is blood pressure and awaited EMT''s to arrive. The fire department and EMT''s assessed the patient who was now feeling better and he refused to be transported to the hospital.. He left the pharmacy with his girlfriend.


VAERS ID: 1591530 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-08-20
Onset:2021-08-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0183 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Feeling hot, Loss of consciousness, Nervousness, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: none
Preexisting Conditions: none
Allergies: none listed
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Patient received the vaccine at 9:30am. Approximately 10 minutes after receiving the vaccine she notified us that she was feeling hot and dizzy, and she may pass out. I gave her a cool pack to put on her back, she was sitting down, and breathing heavy. She stated that she was feeling very nervous and has a history of panic attacks. She slumped into her chair and started shaking, her head fell backwards. I held her head up , kept her head to the side, and removed her mask for air. Her entire body shook, including her legs. She came to about a minute later, and was very calm. She knew she had passed out, and that EMT''s were en route. The EMT suggested that she may have had a vasovagal reaction, and was not convinced it was a seizure. She did not go to the hospital , but she did have a friend pick her up and drive her to her primary care.


VAERS ID: 1591543 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-20
Onset:2021-08-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Hyperventilation
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Eosinophilic pneumonia (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: multivitamin, asa 81mg
Current Illness:
Preexisting Conditions: Anxiety
Allergies: morphine, codeine, darvocet
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt. observed hyperventilating after vaccine. per daughter she has anxiety issues. Pt. is alert and oriented and refused emergency care. Pt. recovered on her own. She is alert and oriented. No distress noted at this time.


VAERS ID: 1591544 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Mississippi  
Vaccinated:2021-08-20
Onset:2021-08-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Interchange of vaccine products, No adverse event
SMQs:, 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:
CDC Split Type:

Write-up: Patient arrived at the pharmacy to receive a second dose of Moderna COVID19 vaccine and received a Pfizer dose instead. There has been no adverse event since receiving the vaccine, and the patient was okay when leaving the pharmacy after the required wait time (15-30 minutes).


VAERS ID: 1591546 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-08-20
Onset:2021-08-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 052E21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dysarthria, Fear of injection, Head titubation, Hyperhidrosis, Hypotension, Loss of consciousness, Seizure like phenomena, Tension, Unresponsive to stimuli
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), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (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: Lisinopril (per patient)
Current Illness: no known
Preexisting Conditions: High blood pressure/heart; prediabetes
Allergies: nka
Diagnostic Lab Data: Blood pressure/pulse/pulse ox was checked multiple times on site, pt was transported by EMS for further monitoring at the hospital
CDC Split Type:

Write-up: Patient received his first dose of the Moderna vaccine on the morning of 8/20/21. The patient had told me he was nervous about needles. Approximately 15 minutes later, the patient passed out in the floor. A code white was called as I went to the patient. He was sweaty, but responsive. He told me he had not eaten yet today and that he had taken his blood pressure medicine right before leaving the house. I was told the patient takes medication for his blood pressure and that he is prediabetic. I gave him a water and some candy, he did not want either. We offered other things, such as juice, and the patient declined. I checked his blood pressure. His blood pressure was low, but he continued being responsive, and he did not want me to call EMS. The person he was with had a 30 minute wait post-vaccine, so I agreed to wait and recheck his blood pressure. I rechecked his blood pressure 5 minutes later, and it was going back up. They still had time left, so I told him I would check his blood pressure again before they left. When I went to check his blood pressure for a third time, approximately 30 minutes after the vaccine, the patient tensed up and was unresponsive for about 10-15 seconds. He threw his head back, made a few noises, and seemed to have more a seizure this time instead of passing out. I was able to keep him from falling out of his chair (he refused to stay in the floor). I had my techs call another code white and 911. EMS responded. Patient was once again coherent, he did not want to go to the ER, and was responsive enough that EMS could not force him to go. We did finally convince the patient to go with EMS to be checked further. I will be following up later in the day with the patient.


VAERS ID: 1591550 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-08-19
Onset:2021-08-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Incorrect dose administered, Product preparation issue
SMQs:, Medication errors (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: butalbital-APAP-caffiene 50-325-40, PO PRN Q4 Norvasc 5mg, 1 tab PO QD
Current Illness: UNKNOWN
Preexisting Conditions: prediabetes, mild hypercholesterolemia, essential hypertension, non-compliance, chronic tension-type headache not intractable
Allergies: NKA
Diagnostic Lab Data: non
CDC Split Type:

Write-up: Pfizer improperly diluted with only 0.8ml diluent. Nurse gave 0.3ml of the vaccine mixutre.


VAERS ID: 1591560 (history)  
Form: Version 2.0  
Age: 10.0  
Sex: Male  
Location: Maryland  
Vaccinated:2021-06-09
Onset:2021-08-20
   Days after vaccination:72
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: No adverse event, Product administered to patient of inappropriate age
SMQs:, Medication errors (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:

Write-up: No adverse results - patient was 10 yrs old at time of vaccine, administration error


VAERS ID: 1591562 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Mississippi  
Vaccinated:2021-08-20
Onset:2021-08-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Interchange of vaccine products, No adverse event
SMQs:, 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:
CDC Split Type:

Write-up: Patient arrived at the pharmacy to receive a second dose of Moderna COVID19 vaccine and received a Pfizer dose instead. There has been no adverse event since receiving the vaccine, and the patient was okay when leaving the pharmacy after the required wait time (15-30 minutes).


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