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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 448 out of 8,010

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VAERS ID: 1705795 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Inappropriate schedule of product administration, Lymphadenopathy, SARS-CoV-2 test
SMQs:, Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RIGEVIDON (28)
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Birth control pill
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101151001

Write-up: Painful periods; After both vaccinations a lymph node above my collarbone swelled; dose 1 on 28-JUN-2021, dose 2 on 21-AUG-2021; This is a spontaneous report from a contactable consumer. This is the second of two reports. The first report is a report downloaded from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109010007402750-E8BXM, Safety Report Unique Identifier GB-MHRA-ADR 25877558. A 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Aug2021 (at the ae of 20 years) (Batch/Lot Number: FE3380) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included birth control pill (oral contraception). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Patient is not pregnant Patient is not currently breastfeeding. Concomitant medication included ethinylestradiol, levonorgestrel (RIGEVIDON (28)) taken as birth control pill from 2015 to an unspecified stop date. The patient previously took DOSE 1 of BNT162B2 on 28Jun2021 for COVID-19 immunisation and experienced heavy, painful period. It was reported that the patient was experiencing painful period cramping again after the second dose. After both vaccinations a lymph node above the collarbone swelled, however this is not uncommon for the patient when facing a viral infection + appears to be resolving on its own. 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 event lymph node swelled was recovering, unknown for painful periods. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1705857 (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: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7959 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Troponin
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: Smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210821; Test Name: Troponin; Result Unstructured Data: Test Result:260 ng/L
CDC Split Type: ITPFIZER INC202101149942

Write-up: Left chest pain on 21Aug night, 19Aug second dose of anti covid vaccine now in the emergency room for chest pain. Troponin 260; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB: IT-MINISAL02-778199. A 39-years-old male patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch no: not reported/ Lot Number: FD7959; expiration date: unknown) via unknown route of administration on 19Aug2021 as dose 2, single for covid-19 immunization. The patient medical history included smoker from an unknown date and unknown if ongoing and concomitant medications were not reported. On 21Aug2021 night, the patient experienced left chest pain after second dose of Anti-covid vaccine taken on 19aug2021. Patient was now in the emergency room for the event chest pain and patient was hospitalized due to event. On 21Aug2021, the patient underwent lab tests and procedures which included troponin results 260 ng/l. The outcome of the event was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1706099 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-08-21
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004226 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Haphephobia, Hypoaesthesia, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Numbness in both forearms; Contact difficulty; Chills; Myalgia; Pyrexia; This case was received via Takeda Pharmaceuticals (Reference number: 2021TJP085908) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This case, reported by a physician, was received by Takeda via Moderna''s adverse reaction reporting site (TASK0021229), and this case, initially reported to the Pharmaceuticals and Medical Devices Agency (PMDA) by a physician, was received via the PMDA (Ref, v21124940). On 24-Jul-2021, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before vaccination: 36.2 degrees Celsius. On 21-Aug-2021, at 10:00, the patient received the 2nd dose of this vaccine. Pyrexia developed in the evening. On 22-Aug-2021, the patient slept for a day. Around 14:00, the patient drank tea. Around 20:30, when the patient''s family went to check on the condition of the patient, he/she was trembling with arms bent. Chills, myalgia, and numbness in both forearms were observed, but contact was difficult. At consultation at the vaccine call center, the emergency room (ER) consultation was recommended, and the patient visited emergency and critical care center of a hospital. The patient was unable to eat, so the patient was hospitalized for fluid replacement. On 23-Aug-2021, the symptoms improved, and the patient was discharged from the hospital. The outcome of pyrexia, chills, myalgia, numbness in both forearms, and contact difficulty 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.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1706181 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005241 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, COVID-19 immunisation, General physical health deterioration, Hypotension, Respiratory distress
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AERIUS [DESLORATADINE]
Current Illness: Allergy (Allergy with symptoms from airways.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: This case was received via a regulatory authority (Reference number: NO-NOMAADVRE-E2B_00045409) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION, RESPIRATORY DISTRESS, HYPOTENSION, GENERAL PHYSICAL HEALTH DETERIORATION and COVID-19 IMMUNISATION in a 43-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005241) for COVID-19 vaccination. Previously administered products included for Vaccination: Comirnaty. Past adverse reactions to the above products included No adverse reaction with Comirnaty. Concurrent medical conditions included Allergy (Allergy with symptoms from airways.). Concomitant products included DESLORATADINE (AERIUS [DESLORATADINE]) for Allergy. On 20-Aug-2021, 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 ANAPHYLACTIC REACTION (seriousness criteria hospitalization, medically significant and life threatening), RESPIRATORY DISTRESS (seriousness criteria hospitalization, medically significant and life threatening), HYPOTENSION (seriousness criteria hospitalization and life threatening), GENERAL PHYSICAL HEALTH DETERIORATION (seriousness criteria hospitalization and life threatening) and COVID-19 IMMUNISATION (seriousness criteria hospitalization and life threatening). On 22-Aug-2021, ANAPHYLACTIC REACTION, RESPIRATORY DISTRESS, HYPOTENSION, GENERAL PHYSICAL HEALTH DETERIORATION and COVID-19 IMMUNISATION had resolved. For mRNA-1273 (Spikevax) (Unknown), the reporter considered ANAPHYLACTIC REACTION, RESPIRATORY DISTRESS, HYPOTENSION, GENERAL PHYSICAL HEALTH DETERIORATION and COVID-19 IMMUNISATION to be possibly related. Treatment medications were not reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.


VAERS ID: 1706339 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-21
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF 2832 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Myocardial infarction, X-ray
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210822; Test Name: X-ray; Result Unstructured Data: Test Result:Unknown
CDC Split Type: SEPFIZER INC202101150080

Write-up: Myocardial infarct; chest pain; This is a spontaneous report from a contactable consumer downloaded from the This is a report received from the regulatory authority number SE-MPA-2021-078314. A 63-years-old male patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: FF 2832, Expiration Date: Not reported), dose 1 via an unspecified route of administration on 16Aug2021 as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 21Aug2021, the patient experienced myocardial infarct and chest pain. The events resulted in hospitalization. Reported suspected vaccine was bnt162b2 (Covid-19 vaccines), first dose. Reported suspected adverse reaction was myocardial infarction which occurred 5 days after vaccination. The reporter indicates chest pain, admitted to hospital, surgery for angina x-ray 6 days after vaccination. The patient underwent lab tests and procedures which included x-ray: unknown on 22Aug2021. Therapeutic measures were taken as a result of myocardial infarct (myocardial infarction) and chest pain (chest pain). The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1706341 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-08-21
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4442 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hemiparesis, Ischaemic stroke, Magnetic resonance imaging
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ACETYLSALICYLSYRA
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: magnetic resonance imaging; Result Unstructured Data: Test Result:findings of fresh ischemic lesion; Comments: left putamen area
CDC Split Type: SEPFIZER INC202101150072

Write-up: Ischemic stroke; right-sided, partially persistent, hemisymptom; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority -WEB, regulatory authority number SE-MPA-2021-078338. A 58-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 11Aug2021 (Lot Number: FG4442) as single dose for COVID-19 immunisation. Medical history included hypertension, prophylactically treated with acetylsalicylic acid since 2008 due to great heredity for ischemic heart disease. Concomitant medication included acetylsalicylsyra taken for hypertension from 2008 to an unspecified stop date. On 21Aug2021, the patient experienced ischemic stroke (hospitalization, disability) with outcome of recovering, right-sided, partially persistent, hemisymptom (hemiparesis) (medically significant) on 21Aug2021 with outcome of unknown. The clinical course was reported as follows: Reported suspected adverse reaction was ischemic stroke left putamen (shell nucleus). The patient became ill with right-sided, partially persistent, hemisymptom with magnetic resonance imaging findings of fresh ischemic lesion left putamen area 10 days after dose 2. Course: Recovering/resolving. The case was assessed as serious, hospital care, permanent physical impairment. No follow-up attempts are possible. No further information expected.


VAERS ID: 1709248 (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: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G040A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster
SMQs:, 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: DEPFIZER INC202101155227

Write-up: Herpes zoster; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, company number DE-PEI-202100181896. A 27-year-old male patient received bnt162b2 (COMIRNATY, formulation: solution for injection, Lot Number: 1G040A), via an unspecified route of administration on 20Aug2021, dose number unknown, 0.3 ML as single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced herpes zoster on 21Aug2021. The event was serious (medically significant). The outcome of the event was reported as recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information expected.


VAERS ID: 1709523 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-08-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2832 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Burning sensation, Condition aggravated, Herpes zoster, Pain, Skin injury
SMQs:, Peripheral neuropathy (broad), Accidents and injuries (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101155606

Write-up: went back to the emergency room due to increased pain and the extent of the skin lesion; went back to the emergency room due to increased pain and the extent of the skin lesion; thoracic herpes zoster; Burning sensation; dermal lesion in the right half of the body; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. Regulatory authority number is ES-AEMPS-990928. A 23-years-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FF2832, Expiration date not reported), via intramuscular route on 18Aug2021 as dose 2, 0.3 ml single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FF4213, Expiration date not reported), via unspecified route 28Jul2021 as dose 1, 0.3 ml single for COVID-19 immunization. On 21Aug2021, patient went to the emergency room of a hospital due to a burning sensation and the appearance of a dermal lesion in the right half of the body. Patient was diagnosed with thoracic herpes zoster. Later, on 24Aug2021 he went back to the emergency room due to increased pain and the extent of the skin lesion. Therapeutic measures were taken as a result of events and patient took feverish treatment with amitriptyline 10mg/day. The outcome of events was unknown. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1709560 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-08-21
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest X-ray, Computerised tomogram, Pulmonary embolism, Pulmonary infarction
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: lung imaging; Result Unstructured Data: Test Result:atelectasis; Test Date: 2021; Test Name: ct examination; Result Unstructured Data: Test Result:pulmonary embolism/pulmonary infarction; Comments: several small pulmonary embolisms found, the left lower lung pulmonary infarction
CDC Split Type: FIPFIZER INC202101195281

Write-up: Pulmonary infarction; Pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number FI-FIMEA-20214575. A 53-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 21Jul2021 (Batch/Lot Number unknown) as dose 2, single for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced pulmonary infarction (life threatening) on 21Aug2021, pulmonary embolism (life threatening) on 21Aug2021. The clinical course details reported as follows: Good health, no medications. From 21Aug2021, flank pain in the supine position, preceded by dyspnea for about a week. Applied to occupation health (2021), from which to lung imaging and due to atelectasis transferred to internal medicine emergency. Pulmonary embolism detected in CT examination, several small pulmonary embolisms found. In addition, in the left lower lung pulmonary infarction. The findings explain the patient''s symptoms. novel oral anticoagulants (NOAC) treatment initiated. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected. Batch/Lot number cannot be obtained.


VAERS ID: 1709579 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood electrolytes, Blood pressure measurement, Body temperature, C-reactive protein, Chest discomfort, Dysphagia, Dyspnoea, Electrocardiogram, Globulin, Haemoglobin, Heart rate, Hypersensitivity, Lip oedema, Oxygen saturation, Paraesthesia oral, Physical examination, Platelet count, Respiratory rate, Troponin, White blood cell count
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: Medical History/Concurrent Conditions: Birch pollen allergy; Egg allergy; Haemochromatosis
Allergies:
Diagnostic Lab Data: Test Date: 20210821; Test Name: Creatinine; Result Unstructured Data: Test Result:67 mmol/L; Test Date: 20210821; Test Name: electrolytes; Result Unstructured Data: Test Result:Normal; Test Date: 20210821; Test Name: Blood pressure; Result Unstructured Data: Test Result:116/69 mmHg; Test Date: 20210821; Test Name: Body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Test Date: 20210821; Test Name: C-Reactive protein; Result Unstructured Data: Test Result:Negative; Test Date: 20210821; Test Name: electrocardiogram; Result Unstructured Data: Test Result:76; Comments: 76 bpm, Regular Sinus Rhythm, normoaxed, no pulmonary embolism S1Q3, incomplete Right Bundle Branch Block appearance, no repolarisation disorder; Test Date: 20210821; Test Name: globulin; Result Unstructured Data: Test Result:7.93 g/l; Test Date: 20210821; Test Name: Hemoglobin; Result Unstructured Data: Test Result:12.6 g/dl; Test Date: 20210821; Test Name: pulse; Result Unstructured Data: Test Result:79; Comments: 79 bpm; Test Date: 20210821; Test Name: Saturation; Test Result: 100 %; Comments: In ambient air; Test Date: 20210821; Test Name: Physical examination; Result Unstructured Data: Test Result:no headache no localization sign non-edematous uvu; Comments: No headache no localization sign non-edematous uvula slight swelling of the lips, not of the tongue, not of the eyelids no dysphonia dysphagia, no hypersalivation no pruritus no erythema bilateral upper chest tightness increased on inspiration Regular heart noise, absence of murmurs. no mottling, no sweating clear auscultation no coughing no bronchospasm; Test Date: 20210821; Test Name: Plaq; Result Unstructured Data: Test Result:184 g/l; Test Date: 20210821; Test Name: Respiratory rate; Result Unstructured Data: Test Result:20; Test Date: 20210821; Test Name: Troponin; Result Unstructured Data: Test Result:11.5 pg/mL; Comments: 21:18: troponin h0 negative; Test Date: 20210821; Test Name: Troponin; Result Unstructured Data: Test Result:11.4 pg/mL; Comments: 23:13 troponin 113 11.4 therefore cycle; Test Date: 20210821; Test Name: white blood cells; Result Unstructured Data: Test Result:7.93 g/l
CDC Split Type: FRPFIZER INC202101149735

Write-up: Paresthesia lips; Dyspnea; Edema lip; Allergic reaction; dysphagia; bilateral upper chest tightness increased on inspiration; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number FR-AFSSAPS-CN20212801. A 44-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in left arm on 21Aug2021 09:20 (Batch/Lot Number: FG4493) at the age of 44 years old as dose 1, single for COVID-19 immunisation. Medical history included allergy to egg and birch pollen, and TIA (unspecified) haemochromatosis mites from 2014 to an unknown date and POS (unknown meaning). The patient did not undergo COVID-19 PCR test. The patient''s concomitant medications were not reported. Historical vaccination included hepatitis vaccine received by the patient on an unspecified date for hepatitis immunization and experienced allergic reaction. Adverse reactions after Pfizer vaccine: Onset at 10 minutes of paraesthesia of the lips, dyspnoea, slight oedema of the lips. Emergency department consultation: electrocardiogram and bio normal. Administration of polaramine (dexchlorpheniramine) and 80 MG intravenous corticoids. Discharge with cetirizine and solupred (prednisolone) with progressive decrease. At day 2, still moderate dyspnoea OK, no oedema Emergency department report from 21Aug2021: 9h20 PFIZER vaccine 1st dose. 1h later, feeling dyspnea and dysphagia taking an aerius (desloratadine). 21Aug2021 17:22: 9 am review of the vaccine GLYCAEMIC LOAD 15 physical examination: no headache no localization sign non-edematous uvula slight swelling of the lips, not of the tongue, not of the eyelids no dysphonia, dysphagia, no hypersalivation no pruritus no erythema bilateral upper chest tightness increased on inspiration Regular heart noise, absence of murmurs. no mottling, no sweating clear auscultation no coughing no bronchospasm Saturation 100% in ambient air, respiratory rate 20 and pulse 79 bpm, blood pressure 116/69 mm Hg and temperature 37.7 degrees Celsius. Action to be taken: Scope: polaramine Intravenous + methylprednisolone 80 mg Monitoring 2 h. 21Aug2021 18:43: File transmitted allergic reaction at least after 1st dose of Pfizer. Multi allergic history including hepatitis vaccine immediate post-injection lip oedema pruritus chest tightness radiating into the throat with dyspnoea since 15 hours. Good general condition No rash. no objective mucosal oedema much improved after cortico polaramine. 21Aug2021 Blood test: normal electrolytes creatinine 67 mmol/L (Normal: 45-105 mmol/L) C-Reactive protein negative Haemoglobin [Hb] 12.6 g/dL (Normal: 12-16 g/dL), plaq 184 G/L (Normal: 150-450 G/L), gb (globulin/white blood cell) 7.93 G/L (Normal: 4-10 G/L). Electrocardiogram: 76 bpm, Regular Sinus Rhythm, normoaxed, no pulmonary embolism S1Q3, incomplete Right Bundle Branch Block appearance, no repolarisation disorder. 21Aug2021 21:18: troponin h0 negative 11.5 pg/mL waiting troponin H3. 21Aug2021 23:13: troponin 113 11.4 therefore cycle. Conclusion: Allergy grade 1-2 after 1st injection Pfizer vaccine see an allergist and discuss a second vaccination organised in a hospital with pre-medication ANAPEN at home to be planned. Chest tightness without argument for a cardiac cause Discharge treatment is: ANAPEN Omicrog: 2 pens, intramuscular injection in the thigh if severe allergy (respiratory distress, malaise); call emergency services before/after injection. CETIRIZINE: 10 mg once a day for 10 days. SOLUPRED 80 mg in the morning for 3 days then 40 mg for 2 days: then stop DOLIPRANE (paracetamol) capsule 500 mg: 1 g every 6 hours if pain, 2 boxes. The case was reported as serious with events paresthesia lips, dyspnea and edema lip reported as medically significant events. The patient was recovering from the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1709602 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-21
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster, SARS-CoV-2 test
SMQs:, Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Delivery (Pregnancy and childbirth in 2019); Comments: Vaccin covid Pfizer 1 injection .
Allergies:
Diagnostic Lab Data: Test Date: 20210130; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Positive
CDC Split Type: FRPFIZER INC202101149748

Write-up: Acute posterior ganglionitis; This is a spontaneous report from a contactable consumer or other non-HCP downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-MA20213382. A 32-year-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number was not reported), intramuscular on 29Jul2021 as DOSE 1, SINGLE for covid-19 immunization. Medical history included delivery from 2019 Pregnancy and childbirth in 2019 , covid-19 from Jan2021. The patient''s concomitant medications were not reported. On 21Aug2021, the patient experienced acute posterior ganglionitis and burning sensation. Burning sensation localized on the area of the rash. Shingles on her left hip since 21Aug2021. It still extends around her hip between the back and the pubis. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 30Jan2021. Therapeutic measures were taken as Valaciclovir oral + biseptine locally as a result of acute posterior ganglionitis and burning sensation. The outcome of all events was not recovered. Comments:Approximate time of occurrence of the adverse reaction: 3 weeks No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1709715 (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: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Headache, Influenza like illness, Pyrexia, Renal pain
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? 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 INC202101149824

Write-up: Kidney pain; Gastric pain; Fever; Headache; influenza-like illness; This is a spontaneous report from a contactable consumer or other non-healthcare professional downloaded from a regulatory authority-WEB FR-AFSSAPS-RS20212782. A 32-years-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number, Expiry Date: not reported), intramuscular, administered in right arm on 20Aug2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. History of no COVID-19. On 21Aug2021 (1 day post-vaccination), the patient reported fever, headache, kidney pain ++++ leading to gastric pain. She also had influenza-like illness which required 1 day off work after COMIRNATY vaccination. Evolution: healing in progress on 22Aug2021. Therapeutic measures were taken as a result of kidney pain, gastric pain, fever, headache and influenza-like illness. Sick leave for 3 days, took medication (anti-inflammatory). The outcome of event influenza-like illness was unknown while the outcome of other events was recovering. No follow-up attempts needed. No further information expected.


VAERS ID: 1709985 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-21
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Anaemia, Blood test, Haemorrhage, SARS-CoV-2 test, Smear vagina, Ultrasound scan, Vaginal haemorrhage
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood test; Result Unstructured Data: Test Result:unknown results; Test Date: 20210714; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative COVID-19 test; Test Date: 2021; Test Name: Vaginal swab test; Result Unstructured Data: Test Result:unknown results; Test Date: 2021; Test Name: Ultra sound; Result Unstructured Data: Test Result:unknown results
CDC Split Type: GBPFIZER INC202101196454

Write-up: Vaginal bleeding; Bloating NOS; bleeding; anemia; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Regulatory Authority (RA). Regulatory authority report number -MHRA-WEBCOVID-202109121846412950-DPZKW, Safety Report Unique Identifier -MHRA-ADR 25929323. A 35-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 16Aug2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not pregnant and was not breastfeeding at the time of report. The patient had no symptoms associated with COVID-19. The patient was not enrolled in clinical trial. On 14Jul2021, the patient underwent COVID-19 virus test and the result was negative. On 21Aug2021, 5 days after vaccination, the patient experienced vaginal bleeding and bloating NOS. On an unknown date in 2021, the patient experienced bleeding, and anaemia. The events anaemia, bleeding, vaginal bleeding and bloating NOS were reported as serious for life threatening and causing hospitalization. The clinical course was reported as follows: The patient had been bleeding for a month since her second vaccine; had been to accident and emergency (a&e); booked an ultra sound, blood tests and nothing was found. Every time she exercised, bleed and soiled her pad; that was so frustrating as she was meant to be trying for a baby and her dates made no sense. The patient had been put doing errands three times and had soiled with blood and ruined all her clothes. There was no control over the blood coming out; it came out at a speed as if she had to wet herself. The patient requested someone to help her, as losing that much blood could lead to anaemia. The patient had not tested positive for COVID-19 since having the vaccine. The relevant investigations conducted were ultra sound, vaginal swab and blood test for which the result were unknown. The clinical outcome of the events anaemia, bleeding, vaginal bleeding and bloating NOS was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1710010 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Extrasystoles, Head discomfort, Inappropriate schedule of product administration, Palpitations, SARS-CoV-2 test
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Medication errors (narrow), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Psoriasis
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101187974

Write-up: governmental pressure/ Head pressure; Palpitations are back; My heart seems to be missing beats; received BNT162B2 on 21Aug2021 as dose 2/first dose of BNT162B2 vaccine on 10Jun2021; This is a spontaneous report from a contactable consumer (patient). This is the 2nd of 2 reports. The first report is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109090700327410-AOUI8; Safety Report Unique Identifier GB-MHRA-ADR 25916014. A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 21Aug2021 (at the age of 34 years old) (Batch/Lot Number: Not known) as dose 2 , single for COVID-19 immunisation. Medical history included psoriasis from an unknown date and unknown if ongoing. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient received the first dose of BNT162B2 vaccine on 10Jun2021 and experienced governmental pressure (head pressure) and palpitations. The patient experienced governmental pressure (head pressure) to receive the second dose of vaccine, even when he didn''t want to on an unknown date. The patient''s palpitations are back after the second dose of vaccine, his heart seems to be missing beats on an unspecified date. The patient underwent lab tests and procedures which included covid-19 virus test: No - Negative COVID-19 test on an unspecified date. The seriousness of the events is life threatening and medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event head pressure was recovered on an unknown date, palpitations was not recovered, while the other event was unknown. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101182481 Same patient/drug, different dose/event (DOSE2)


VAERS ID: 1710226 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-14
Onset:2021-08-21
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Coagulation test, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hormone therapy; Mobility decreased; MTHFR gene mutation (homozygous mutation); Smoker; Trauma
Allergies:
Diagnostic Lab Data: Test Name: BLOOD TESTS FOR THROMBOPHILIA; Result Unstructured Data: Test Result:IN PROGRESS; Test Name: coagulation screening; Result Unstructured Data: Test Result:homozygous mutation for the MTHFR gene
CDC Split Type: ITPFIZER INC202101125678

Write-up: LOW RISK PERIPHERAL PULMONARY THROMBOEMBOLIA; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number IT-MINISAL02-775958. A 28-year-old female patient received BNT162B2 (COMIRNATY), intramuscular, administered in the right shoulder (arm) on 14Aug2021 (Batch/Lot Number: FG4493; Expiration Date: 30Nov2021) as dose 1, single for COVID-19 immunization. Medical history included: smoking, estroprogestinics, trauma, reduced mobility, MTHFR gene mutation (homozygous mutation), and travels. The patient''s concomitant medications were not reported. The patient previously took and had an allergy to amoxicillina. The patient entered for a low risk peripheral pulmonary embolia arised with temporal correlation after the first dose of the Pfizer COVID-19 vaccine (14Aug2021 first dose, 21Aug2021 diagnosis of embolia). The event was medically significant. Blood tests for thrombophilia in progress. It was reported that the only anomaly in the coagulation screening was the finding of a homozygous mutation for the MTHFR gene, which however, was officially excluded from "classic" coagulation screening. The patient was discharged on 25Aug2021 (as reported). The outcome of the event was recovering. Reporter comment: Patient entered for a low risk peripheral pulmonary embolia arised with temporal correlation after the first dose of Pfizer COVID-19 VACCINE (14Aug2021 first dose, 21Aug2021 diagnosis of embolia). Unknown risk factors (family history, smoking, estroprogestinics, travels, reduced mobility, trauma, blood tests for thrombophilia in progress. Sender comment: 25Aug2021, a regulatory authority: This report sheet was updated from NON-SERIOUS to SERIOUS as the suspected adverse reaction described is a clinically relevant event on the important medical events list. Sender comment: 01Sep2021 a regulatory authority: the report is updated with the additional information provided by the reporter. Sender comment: 08Sep2021 Regional Pharmacovigilance Centre: the card is updated with the additional information provided by the reporter.; Reporter''s Comments: PATIENT ENTERED FOR A LOW RISK PERIPHERAL PULMONARY EMBOLIA ARISED WITH TEMPORAL CORRELATION AFTER THE FIRST DOSE OF PFIZER COVID-19 VACCINE (14Aug2021 FIRST DOSE, 21Aug2021 EMBOLIA DIAGNOSIS). UNKNOWN RISK FACTORS (FAMILY HISTORY, SMOKING, ESTROPROGESTINICS, TRAVELS, REDUCED MOBILITY,TRAUMA, BLOOD TESTS FOR THROMBOPHILIA IN PROGRESS


VAERS ID: 1710313 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1945 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Depressed level of consciousness, Feeling hot, Heart rate, Hyperhidrosis, Oxygen saturation, Visual impairment
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic sinusitis
Allergies:
Diagnostic Lab Data: Test Date: 20210821; Test Name: Blood pressure; Result Unstructured Data: Test Result:105/70; Comments: 14:15 (10 minutes after vaccination); Test Date: 20210821; Test Name: Pulse rate; Result Unstructured Data: Test Result:66; Comments: 14:15 (10 minutes after vaccination); Test Date: 20210821; Test Name: SPO2; Result Unstructured Data: Test Result:97; Comments: 14:15 (10 minutes after vaccination)
CDC Split Type: JPPFIZER INC202101152603

Write-up: Consciousness decreased; Feeling hot; Feeling of darkness in front of the eyes; Sweaty; This is a spontaneous report from a contactable physician received via Regulatory Authority. The patient was a 46-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included chronic sinusitis. On 21Aug2021 14:05 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FD1945 , Expiration date 31Oct2021) (at the age of 46-years) intramuscular in the arm left as DOSE 1, SINGLE for COVID-19 immunization. On 21Aug2021 at 14:15 (10 minutes after the vaccination), the patient experienced feeling hot, the patient experienced consciousness decreased, feeling of darkness in front of the eyes and sweaty. Then the patient''s consciousness was clear. The patient''s blood pressure was 105/70, pulse rate 66, oxygen saturation 97 on 21Aug2021 14:15 (10 minutes after vaccination). The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered on an unspecified date in 2021. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: A contributory role of BNT162B2 to event consciousness decreased cannot be excluded based on temporal association and available information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1710570 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7053 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Myalgia, Oropharyngeal pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), 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? 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: PTPFIZER INC202101150051

Write-up: Arthralgia; Fever; Throat pain; Myalgia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. This is a report received from Regulatory authority report number [PT-INFARMED-A202108-2954 ] with Safety Report Unique Identifier [PT-INFARMED-A202108-2954 ]. A 27-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 21Aug2021 (Lot Number: FE7053) as DOSE 2, 0.3 ML SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced arthralgia, fever, throat pain and myalgia on 21Aug2021 with outcome of recovered on 23Aug2021. There is no suspicion of drug interactions. Previous reactions to the same drug or to other drugs are not known. Specific treatment for the events was given, Paracetamol, Brufen and Nolotil. The reporter''s assessment of the causal relationship of the events with the COMIRNATY 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. The events were reported as medically significant from health authority. No follow-up attempts are possible. No further information expected.


VAERS ID: 1710659 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2832 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101194051

Write-up: Anaphylaxis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority number is SE-MPA-2021-082182. A 44-year-old female patient received BNT162b2 (COMIRNATY), via an unspecified route of administration on 21Aug2021 (Batch/Lot Number: FF2832) (at the age of 44-years-old) as dose 2, single for COVID-19 immunisation. Medical history included severe allergic reactions. It was reported that she has had previous severe allergic reactions, not specified to what, and she has Epipen because of this. The patient''s concomitant medications were not reported. The patient experienced anaphylaxis which started the same day as the vaccination on 21Aug2021. Shortly after (maximum 10 minutes) the vaccination, the patient reacted with a feeling of discomfort in the mouth. She was given Desloratadine tablet 5 mg x 1. She had increasing cough that went from dry cough to acute shortness of breath in about two-three minutes. She was given Epipen in the right thigh and shortness of breath was reversed in about 1.5 minutes. During the reaction, it was also prepared to give oxygen, 10 tablets of Betapred, 1 Litre of ringer acetate intravenously. Ambulance was called for. She was completely respiratory and circulatory stable after treatment and went to hospital for further observation. It was also stated in the report that the patient reacted to the first vaccination dose, but with milder symptoms (pending clarification). She had then sought hospital care, but it was unclear what symptoms she had. The outcome of the event was unknown. Report assessed as serious, life threatening, and hospitalisation. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1714747 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood test, Fatigue, Headache, Investigation, Malaise, Muscular weakness, Myalgia, Paralysis, Vaccination site paraesthesia, Visual acuity reduced, Vocal cord paralysis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210822; Test Name: blood test; Result Unstructured Data: Test Result:unknown; Test Date: 20210822; Test Name: balance tests; Result Unstructured Data: Test Result:unknown
CDC Split Type: BEPFIZER INC202101155179

Write-up: whole system completely liquefied, without force; Fatigue extreme; temporary unilateral paralysis (injection side); tingling in the right arm; speech paralysis (bug); view reduced by half, it lasted 1 minute; headaches; no strength at all in the arms / the arm completely without strength; Muscular pain; Malaise; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-106019. A 57-year-old female patient received bnt162b2 (COMIRNATY, solution for injection) via an unspecified route of administration, administered to arm Right on 20Aug2021 (Lot Number: Unknown) (at the age of 57 years old) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The day after the injection (on 21Aug2021), temporary unilateral paralysis (injection side) (transient paralysis); tingling in the right arm (tingling of extremity); speech paralysis (bug) (vocal cord paralysis); eyesight reduced to half, it lasted 1 minute (visual acuity reduced) followed by a headache; no strength at all in the arms / the arm completely without strength (weakness of arms), muscular pain (myalgia) and malaise. The following week (on 27Aug2021), patient experienced the whole system completely liquefied, without force (weakness generalized) and intense fatigue (fatigue extreme). Examinations were carried out at the hospital on Sunday the 22Aug2021 at the emergency department: blood test, balance tests (unknown results), making an appointment with the attending physician on 24Aug2021: no stroke, but discomfort and semi-paralysis. It was unknown if treatment was given for the events. The events resulted in an emergency room visit and physician office visit. The events were reported as serious, disability. The outcome of the events ''whole system completely liquefied, without force'' and '' Fatigue extreme'' was recovering at the time of report, for the rest of the events was recovered on 21Aug2021. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1714849 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-08-21
   Days after vaccination:213
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Dyspnoea exertional, Productive cough, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pulmonary hypertension (broad), 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? 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: Gastric ulcer; Polio (In childhood)
Allergies:
Diagnostic Lab Data: Test Date: 20210821; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210821; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: ESPFIZER INC202101155628

Write-up: Vaccination failure; COVID-19 respiratory infection; Dyspnea; Cough with expectoration; Fever up to 38 degrees Celsius; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB. This is a report received from Regulatory authority report number ES-AEMPS-982277 with Safety Report Unique Identifier ES-AEMPS-982277. A 78-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 30Dec2020 (Lot Number: EJ6796; Expiration Date: 30Apr2021) as dose 1, single and on 20Jan2021 (Lot Number: EM0477; Expiration Date: 30Apr2021) as dose 2, single, for COVID-19 immunization. Medical history included gastric ulcer and poliomyelitis in childhood. Concomitant medications were not reported. The patient experienced vaccination failure, COVID-19 respiratory infection, dyspnea, fever and cough on 21Aug2021. The patient was admitted for minimal exertion dyspnea and cough with expectoration and fever taken with thermometer up to 38 degrees Celsius. No headache, or thoracic pain, no precordial oppression. No low in diuresis or perimeter augmentation in lower extremities. No ageusia or anosmia. No alterations in intestinal or urinary habits. No other symptomatology. Patient had a positive COVID-19 antigen test, SARS-CoV-2 respiratory infection after vaccination. Outcome of the events fever and cough was recovered on an unspecified date, while the remaining events was not recovered. Based on investigation conclusion on 08Sep2021 for potential lack of effect with lot numbers EJ6796 and EM0477. The event does not reasonably suggest device malfunction. Severity of harm was not applicable. Investigational report conclusion from the site was: "For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: The complaint for a cardiac arrest (lot EM0477) and fatal vaccine case (lot EJ6796) after vaccination of PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EM0477 and EJ6796. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Agency concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The testing process determined that a regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed."


VAERS ID: 1715973 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-08-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCDN1 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cervical conisation; Piles; Thyroid nodule
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101156002

Write-up: Acute posterior ganglionitis / typical herpes zona on the right half of the chest; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-PC20213468. A 68-years-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection), dose 2 intramuscular, administered in Arm Left on 18Aug2021 (Batch/Lot Number: SCDN1) as dose 2, single (age at vaccination 68-year-old) for covid-19 immunisation. Patient do not have medical history of covid-19. Medical history included thyroid nodule, haemorrhoid treatment, conization from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced acute posterior ganglionitis / typical herpes zona on the right half of the chest (medically significant) on 21Aug2021. The outcome for the event was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1716259 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-08-21
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0932 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC202101155721

Write-up: Numbness facial right-sided. Affected eye, mouth and movement; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DK-DKMA-WBS-0086777. A 17-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 24Jul2021 (Batch/Lot Number: FD0932) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient does not have any other health issues. Additional information on drug: Previously given: no. The patient experienced numbness facial right-sided, affected eye, mouth and movement on 21Aug2021 with outcome of not recovered. The patient was treated with unspecified penicillin. Numbness facial reported as resulting in hospitalisation. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1716262 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5029 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CONCERTA
Current Illness: ADHD
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC202101172594

Write-up: Fever; Vomiting; Abdominal pain; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB. This is the second of two reports. A 16-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 via an unspecified route of administration on 20Aug2021 (Batch/Lot Number: FC5029) as DOSE 2, SINGLE for covid-19 immunisation (at the age of 16). Medical history included ongoing attention deficit hyperactivity disorder. Concomitant medication included methylphenidate hydrochloride (CONCERTA). The patient took previously dose 1 bnt162b2 (COMIRNATY, Solution for injection), (Batch/Lot Number: FD0932) as DOSE 1, SINGLE for covid-19 immunisation on 14Jul2021 with associated headache, monoplegia, sensory loss and conversion disorder. On 21Aug2021, 1 day after vaccination, the patient experienced fever, vomiting and abdominal pain. It was reported that events caused hospitalization. Causality was reported as the physician informs that there was initially a suspicion of apoplexy which got disconfirmed by test. The physician conferred with a neurologist and came to a suspicion of Functional symptoms. The clinical outcome of events was not recovered. Sender''s comments: FOLLOW-UP (version 003): New information received on 24Aug2021 from a third reporter in duplicate case DK-DKMA-WBS-0086212 (DK-DKMA-ADR 25840925), which has been merged with this master case before submission to regulatory authority. No follow up attempts possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DK-PFIZER INC-202101054746 same patient/ vaccine, different dose/ events


VAERS ID: 1716289 (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: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCDD2 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time ratio, Alanine aminotransferase, Angiogram, Antineutrophil cytoplasmic antibody, Antinuclear antibody, Aspartate aminotransferase, Aspartate aminotransferase increased, Beta-2 glycoprotein antibody, Blood bicarbonate, Blood chloride, Blood creatine phosphokinase, Blood creatine phosphokinase increased, Blood creatinine, Blood fibrinogen, Blood glucose, Blood homocysteine, Blood potassium, Blood pressure measurement, Blood sodium, Blood thyroid stimulating hormone, Blood urea, Body mass index, Body temperature, Brain natriuretic peptide, C-reactive protein, C-reactive protein increased, Cardiolipin antibody, Coma scale, Echocardiogram, Ejection fraction, Electrocardiogram, Electrophoresis protein, Haemoglobin, Heart rate, Investigation, Ischaemic stroke, Lipids, Magnetic resonance imaging head, Oxygen saturation, Platelet count, Protein total, Prothrombin level, SARS-CoV-2 test, Treponema test, Troponin I, White blood cell count, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NEBIVOLOL; ELIQUIS; PERINDOPRIL; TAHOR
Current Illness: Smoker (yes quantified at 20 pack years ongoing)
Preexisting Conditions: Medical History/Concurrent Conditions: Anterior myocardial infarction; Pneumothorax; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210821; Test Name: Activated partial thromboplastin time ratio; Result Unstructured Data: Test Result:1.03; Test Date: 20210821; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:40 IU/l; Test Date: 20210824; Test Name: cervical and cephalic angioscan; Result Unstructured Data: Test Result:right fronto-insular ischaemic lesion; Comments: without hemorrhagic transformation and no dissection of the supra-aortic trunks.; Test Date: 20210824; Test Name: anti-myeloperoxidase; Result Unstructured Data: Test Result:pending; Test Date: 20210824; Test Name: anti-polynuclear neutrophil cytoplasmic antibodies; Result Unstructured Data: Test Result:pending; Test Date: 20210824; Test Name: anti-proteinase 3; Result Unstructured Data: Test Result:pending; Test Date: 20210824; Test Name: anti nuclear antibodies; Result Unstructured Data: Test Result:pending; Test Date: 20210821; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result:44 IU/l; Test Date: 20210824; Test Name: b2 glycoprotein I; Result Unstructured Data: Test Result:pending; Test Date: 20210821; Test Name: Bicarbonates; Result Unstructured Data: Test Result:20.6 mmol/L; Test Date: 20210821; Test Name: Chlorides; Result Unstructured Data: Test Result:107 mmol/L; Test Date: 20210821; Test Name: Creatine phosphokinase; Result Unstructured Data: Test Result:494 IU/l; Test Date: 20210821; Test Name: Creatinine; Result Unstructured Data: Test Result:89 umol/l; Test Date: 20210821; Test Name: Fibrinogen; Result Unstructured Data: Test Result:4.2 g/l; Test Date: 20210821; Test Name: blood glucose; Result Unstructured Data: Test Result:0.94 g/l; Test Date: 20210821; Test Name: Glucose; Result Unstructured Data: Test Result:5.1 mmol/L; Test Date: 20210824; Test Name: total plasma homocysteine; Result Unstructured Data: Test Result:9.65 umol/l; Test Date: 20210821; Test Name: Potassium; Result Unstructured Data: Test Result:4.4 mmol/L; Test Date: 20210821; Test Name: blood pressure; Result Unstructured Data: Test Result:114/87 mmHg; Test Date: 20210821; Test Name: Sodium; Result Unstructured Data: Test Result:139 mmol/L; Test Date: 20210824; Test Name: thyroid stimulating hormone; Result Unstructured Data: Test Result:1.81 MiU/L; Test Date: 20210821; Test Name: Urea; Result Unstructured Data: Test Result:5.0 mmol/L; Test Name: Body Mass Index; Result Unstructured Data: Test Result:23.7; Comments: kg/m2; Test Date: 20210821; Test Name: temperature; Result Unstructured Data: Test Result:36.3; Comments: degrees; Test Date: 20210821; Test Name: brain natriuretic peptide; Result Unstructured Data: Test Result:unknown pg/mL; Test Date: 20210824; Test Name: anti-cardiolipin; Result Unstructured Data: Test Result:pending; Test Date: 20210821; Test Name: Glasgow score; Result Unstructured Data: Test Result:15; Test Date: 20210821; Test Name: C-reactive protein; Result Unstructured Data: Test Result:7.3 mg/l; Test Date: 20210824; Test Name: a Trans-oesophageal echocardiography; Result Unstructured Data: Test Result:there was no argument for a cardio embolic; Comments: anteroseptal and apical akinesia but no thrombus seen, dilated non hypertrophied left ventricle. The inter-atrial septum is intact, there is no passage of air bubbles at rest and on Valsalva maneuver.; Test Date: 20210824; Test Name: trans-thoracic echocardiography; Result Unstructured Data: Test Result:there was no argument for a cardio embolic; Comments: anteroseptal and apical akinesia but no thrombus seen, dilated non hypertrophied left ventricle. The inter-atrial septum is intact, there is no passage of air bubbles at rest and on Valsalva maneuver.; Test Date: 20210824; Test Name: left ventricular ejection fraction; Test Result: 39 %; Test Date: 20210821; Test Name: Electrocardiography; Result Unstructured Data: Test Result:regular sinus rhythm with ventricular extrasystole; Comments: Q waves in v2-V3 and negative T waves in V5-V6.; Test Date: 20210824; Test Name: Plasma protein electrophoresis; Result Unstructured Data: Test Result:moderate hypogammaglobulinemia; Comments: with no detectable qualitative abnormality in the gamma area; Test Date: 20210821; Test Name: haemoglobin; Result Unstructured Data: Test Result:16 g/dl; Test Date: 20210821; Test Name: heart rate; Result Unstructured Data: Test Result:103; Comments: beats/min; Test Date: 20210825; Test Name: National Institutes of Health score; Result Unstructured Data: Test Result:0; Comments: that he is not very compliant and continues to smoke but the outcome is favorable; Test Date: 20210824; Test Name: lipid assessment; Result Unstructured Data: Test Result:normal; Test Date: 20210824; Test Name: Lyme; Test Result: Negative ; Test Date: 20210821; Test Name: Brain magnetic resonance imaging; Result Unstructured Data: Test Result:cerebral infarction; Comments: of semi recent appearance in the superficial right sylvian region with stenosis and small appearance of a cortical branch of the M3 portion of the right sylvian artery as well as numerous slow flows in the territory concerned; Test Date: 20210821; Test Name: oxygen saturation; Test Result: 97 %; Comments: on room air; Test Date: 20210821; Test Name: Platelets; Result Unstructured Data: Test Result:229; Comments: 10p9 /L; Test Date: 20210821; Test Name: Total Protein; Result Unstructured Data: Test Result:72 g/l; Test Date: 20210821; Test Name: prothrombin rate; Test Result: 92 %; Test Date: 20210822; Test Name: COVID-19; Test Result: Negative ; Test Date: 20210824; Test Name: syphilis; Test Result: Negative ; Test Date: 20210821; Test Name: Cardiac Troponin I; Result Unstructured Data: Test Result:unknown ug/L; Comments: [0.000-0.034]?g/L; Test Date: 20210821; Test Name: Leukocytes; Result Unstructured Data: Test Result:10.1; Comments: 10p9 /L
CDC Split Type: FRPFIZER INC202101155195

Write-up: Ischemic stroke; Aspartate aminotransferase increase; Creatine phosphokinase increase; C-reactive protein increase; Leukocytes increase; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. Regulatory authority number FR-AFSSAPS-BS20211672. A 40-year-old male patient received bnt162b2 (COMIRNATY; Solution for injection, Lot Number: SCDD2), dose 2 intramuscularly administered in left arm on 20Aug2021 as a dose 2, single for covid-19 immunisation. The patient medical history included Anterior myocardial infarction in 2012, stroke in 2017, pneumothorax in 2011 and ongoing smoking (quantified at 20 pack years). Drinking and others were not reported. The patient did not have medical history of COVID-19. Concomitant medications included nebivolol, apixaban (ELIQUIS), perindopril and atorvastatin calcium (TAHOR) all were taken for an unspecified indication, start and stop date were not reported. The patient received bnt162b2 (COMIRNATY; Solution for injection, Batch/Lot Number: FE2296), dose 1 intramuscularly administered in arm left on 24Jul2021 as a dose 1, single for covid-19 immunisation. On 21Aug2021, the patient had ischemic stroke, aspartate aminotransferase increase, creatine phosphokinase increase, C-reactive protein increase and leukocytes increase. The patient had been tested for covid: negative on 22Aug2021. The patient underwent lab tests and procedures on 21Aug2021, which included activated partial thromboplastin time ratio which was 1.03, alanine aminotransferase which was 40 iu/l, aspartate aminotransferase which was 44 iu/l, blood bicarbonate which was 20.6 mmol/l, blood chloride which was 107 mmol/l, blood creatine phosphokinase which was 494 iu/l, blood creatinine which was 89 umol/l, blood fibrinogen which was 4.2 g/l and blood glucose which was 0.94 g/l. On 24Aug2021, the patient was tested for angiogram which was right fronto-insular ischaemic lesion, without hemorrhagic transformation and no dissection of the supra-aortic trunks and patient test for antineutrophil cytoplasmic antibody, antineutrophil cytoplasmic antibody, antineutrophil cytoplasmic antibody, antinuclear antibody and beta-2 glycoprotein antibody for which the results were pending. At Day 1, on 21Aug2021 at 4:15 pm the patient presented with dysarthria with word finding difficulties and comprehension disorder and sensation of numbness in the face with symptoms resolving in 2 to 3 minutes. On admission to the emergency room, vital signs were included, temperature that was 36.3 degrees, blood pressure that was 114/87 mmHG, heart rate that was 103beats/min, Glasgow score that was 15, oxygen saturation that was 97% on room air and blood glucose that was 0.94g/L. Blood test on admission was unremarkable, Sodium that was 139[136-145] mmol/L, Potassium that was 4.4 [3.5-4.8] mmol/L, Chlorides that was 107 [98-107] mmol/L, Bicarbonates that was 20.6 [23.0-31.0] mmol/L, Total Protein that was 72 [58-74] g/L, Glucose that was 5.1 [4.44-6.38] mmol/L, Urea that was 5.0 [2.9-8.2] mmol/L, Creatinine that was 89 [64.0-104] umol/L, Aspartate aminotransferase that was 44 [5-34] IU/L, Alanine aminotransferase that was 40[0-55] IU/L, Creatine phosphokinase that was 494 [30-200] IU/L, brain natriuretic peptide that was [0-100] pg/mL, Cardiac Troponin I that was [0.000-0.034]ug/L, C-reactive protein that was 7.3[0.0 -5.0]mg/L, Fibrinogen that was 4, 2 g/L [1.9 -4.3], Leukocytes that was 10.1 10p9 /L [3.8 -9.5], haemoglobin that was 16g/dL [12.9 -16.7], Platelets that was 229 10p9 /L [210 -326], prothrombin rate that was 92% and Activated partial thromboplastin time ratio that was 1.03. The Electrocardiography was in regular sinus rhythm with ventricular extrasystoles, Q waves in v2-V3 and negative T waves in V5-V6. No bacteriological test was done. Brain magnetic resonance imaging showed cerebral infarction, of semi recent appearance in the superficial right sylvian region with stenosis and small appearance of a cortical branch of the M3 portion of the right sylvian artery as well as numerous slow flows in the territory concerned. At Day 4, on 24Aug2021, the patient underwent, a cervical and cephalic angioscan in search of a dissection of the supra-aortic trunks. The conclusion was a right fronto-insular ischaemic lesion without hemorrhagic transformation and no dissection of the supra-aortic trunks. A trans-thoracic echocardiography and a Trans-oesophageal echocardiography were performed and the conclusion was that there was no argument for a cardio embolic cause on that day. Note however a left ventricular ejection fraction of 39%, anteroseptal and apical akinesia but no thrombus seen, dilated non hypertrophied left ventricle. The inter-atrial septum is intact, there is no passage of air bubbles at rest and on Valsalva maneuver. Complementary blood test that included, Immunoallergological assessment with anti-nuclear antibodies, anti-cardiolipin, anti-polynuclear neutrophil cytoplasmic antibodies, anti-myeloperoxidase, anti-proteinase 3, b2 glycoprotein I for which results pending,total plasma homocysteine that was 9.65 umol/L [5.5-16.2], Normal lipid and hormonal assessments with thyroid stimulating hormone that was 1.81 mIU/L, Plasma protein electrophoresis, moderate hypogammaglobulinemia with no detectable qualitative abnormality in the gamma area and serologies that was Lyme ongoing, syphilis and Lyme negative. At Day 5, on 25Aug2021, the reporting physician reported that the patient has National Institutes of Health score of 0, that he is not very compliant and continues to smoke but the outcome is favorable. Summary done on the basis of the additional observations collected by the regional pharmacovigilance centre. Conclusion was reported as, Sylvian ischaemic stroke on day 1 of a COMIRNATY vaccine booster in a patient with a history of cardiovascular disease. Outcome of the event ischemic stroke was recovering whereas outcome of the aspartate aminotransferase increase, creatine phosphokinase increase, c-reactive protein increase and leukocytes increase were unknown.


VAERS ID: 1716503 (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: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase, Chest pain, Dyspnoea, Investigation, Myocarditis, Troponin increased
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210821; Test Name: creatine kinase; Result Unstructured Data: Test Result: elevated Creatine Kinase-MB; Test Date: 20210821; Test Name: Investigation; Result Unstructured Data: Test Result: hypertroponinemia.
CDC Split Type: DEPFIZER INC202101155245

Write-up: Myocarditis/elevated Creatine Kinase-MB; Dyspnoea; hypertroponinemia; retrosternal pain; This is a spontaneous report from a non-contactable consumer from the Regulatory Authority. The regulatory authority number DE-PEI-CADR2021172456. A 16-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 19Aug2021 (Lot Number: Unknown) as dose 2, 0.3 ml, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 21Aug2021, two days after the second vaccination, the patient suffered from dyspnea, retrosternal pain, and myocarditis. Laboratory results at the hospital showed elevated Creatine Kinase-MB and hypertroponinemia in 21Aug2021. The patient was hospitalized on Aug2021 due to the events. The outcome of the event retrosternal pain was unknown while the outcome of the rest of the events was not recovered. None, second vaccination was carried out on 19Aug2021, two days later, patient suffered from dyspnoea and retrosternal pain. Laboratory results at the hospital showed elevated Creatine Kinase and hypertroponinemia. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1716694 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-21
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Ovarian cyst ruptured
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MIRENA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Eosinophilic myocarditis (post parasitose); Ovarian cyst functional (right; discovered in 2019 because of pain after insertion of MIRENA IUD, no signs hereafter)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101166872

Write-up: sudden acute abdominal pain: hemorrhagic rupture of an ovarian cyst; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-PB20215992. A 55-year-old female patient received first dose of bnt162b2 (COMIRNATY; Solution for injection; Lot Number: FG4493), via intramuscular route as dose 1, single on 16Aug2021 for covid-19 immunisation. Medical history included post-parasitosis eosinophilic myocarditis with favorable evolution on an unknown date in 2018; discovery of a functional cyst of the right ovary on an unknown date in 2019, asymptomatic since; contraception by Mirena IUD. Concomitant medication included levonorgestrel (MIRENA) taken for contraception, start and stop date were not reported. The patient experienced sudden acute abdominal pain: hemorrhagic rupture of an ovarian cyst (hospitalization) during the night of 20Aug2021 / 21Aug2021 which led to emergency surgical management. Therapeutic measures were taken as a result of event. The outcome of event was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1716962 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-08-21
   Days after vaccination:44
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH KE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dermatitis, Disturbance in attention, Influenza, Palpitations, SARS-CoV-2 test
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic sinusitis (I had chronic sinusitis when I was about 17); Palpitations
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101168466

Write-up: Flu; concentration became very cloudy; beyond the flu; palpitations; 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-202109061020230070-GSE10 and Safety Report Unique Identifier is GB-MHRA-ADR 25899454. A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Ke3380), via an unspecified route of administration on 08Jul2021 as dose 2, single for COVID-19 immunization. Medical history included palpitations from an unknown date and unknown if ongoing and chronic sinusitis, patient had chronic sinusitis when he was about 17. Patient has not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW3143), via an unspecified route of administration on 06Jun2021 as dose 1, single for COVID-19 immunization and experienced flu from 21Jun2021 to 01Jul2021. The patient experienced beyond the flu and palpitations on an unspecified date in 2021, flu on 21Aug2021. Patient further reported that, he was one of the fittest people, patient knew and the only time he had been sick was about 2 to 3 weeks after the vaccine, which was he understands the time it started kicking in. His assumption was the symptoms were connected. Beyond the flu, his concentration became very cloudy (2021). In addition, the first bout of flu kept him bedridden and he had severe heart palpitations. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date in 2021. The clinical outcome for the events was unknown except recovered for flu on 01Sep2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1717220 (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: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac flutter, Chest discomfort, Headache, Joint stiffness, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Tachyarrhythmia terms, nonspecific (narrow), Arthritis (broad), 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic fatigue syndrome; Chronic pain; Ehlers-Danlos syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101160582

Write-up: HEART FEELS FLUTTERY; PAIN; PLUS TYPICAL HEADACHE; FEVER; TIGHT CHEST; JOINT STIFFNESS; This is a spontaneous report from a contactable consumer downloaded from a regulatory authority-WEB. This is a report received, regulatory authority number IE-HPRA-2021-083113, IE-HPRA-CVARR2021082118300. A 29-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 20Aug2021 as dose 2, single for COVID-19 immunisation. Medical history included pain (chronic), chronic fatigue syndrome, Ehlers-Danlos syndrome. The patient was not taking any concomitant medications. On 27Jul2021, the patient was previously vaccinated with the first dose of Comirnaty (batch number unknown) for COVID-19 immunization. The patient experienced heart feels fluttery, plus typical headache fever and pain on an unspecified date then joint stiffness and tight chest on 21Aug2021. On 20Aug2021, the patient was vaccinated with the second dose of COMIRNATY (batch number unknown). One day later, the patient experienced a tight chest and joint stiffness. The patient described that her heart felt fluttery on an unknown date. The patient also experienced a typical headache, fever, and pain on an unknown date. The events were reported as medically significant. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1717241 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Choking, Dyspnoea, Type I hypersensitivity
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Hypersensitivity (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101155347

Write-up: Choking; Immediate hypersensitivity reaction; Agitated; dyspnea; This is a spontaneous report from a contactable other HCP downloaded from theregulatory authority , regulatory authority number IT-MINISAL02-777789. A 55-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Deltoid Left on 21Aug2021 16:59 at the age of 55 years old (Lot Number: FG4493; Expiration Date: 30Nov2021) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 21Aug2021 17:09, the patient experienced choking, immediate hypersensitivity reaction, agitated, dyspnea. The outcome of events was recovered on 21Aug2021. Events were serious as other relevant clinical condition. Treatment included half a vial of adrenaline intramuscular called the emergency service (access to emergency room and self-discharge on the same day). Description of the reaction: in 10 minutes, appears to be purple and shaken, brings hands to the throat, dyspnea, does not talk even if stimulated. Looks like suffocating. Half a vial of adrenaline, called the emergency service. Subjective improvement after 10 minutes. Arrival at the emergency room without symptoms. Sender comment: 31Aug2021 RA: follow-up information requested to the reporter regarding medical records. 31Aug2021 RA: the form is updated with the additional information provided by the reporter/attached clinical report provided by the reporter. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1717244 (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: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood test, Chest pain, Fibrin D dimer, Hypoaesthesia, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:everything in the norm; Test Name: d-dimer; Result Unstructured Data: Test Result:everything in the norm
CDC Split Type: ITPFIZER INC202101155181

Write-up: Numbness in the right arm; Asthenia; Muscle pain; Chest pain; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number -MINISAL02-777835. A 28-years-old male patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: FG4493; Expiration Date: 30Nov2021), via intramuscularly in Arm Left on 20Aug2021 at 11:12 as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 21Aug2021, the patient experienced chest pain, numbness in the right arm, asthenia, muscle pain. The patient underwent lab tests and procedures which included blood test: everything in the norm on, fibrin d dimer: everything in the norm on. The outcome of the events was recovering. Actions taken (performed general visit and blood test, including d-dimer: everything in the norm) - Ethnic origin (PRIVACY) - COVID 19 VACCINE COMIRNATY (PFIZER): Site of administration (left shoulder) Booster dose number (1) Time of administration (11:12) Batch expiration (30Nov2021). No follow-up attempts are possible, information about batch number cannot be obtained.


VAERS ID: 1717312 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-08-21
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2707 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye oedema, Macular oedema, Retinal vein occlusion
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Embolic and thrombotic events, venous (narrow), Retinal disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? 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: ITPFIZER INC202101155388

Write-up: central macular edema RIGHT EYE; central macular edema RIGHT EYE; Branch retinal vein occlusion (BRVO); This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-779007. A 58-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 21Jul2021 (Lot Number: FE2707; Expiration Date: 30Sep2021) as 0.3ml single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced central macular edema right eye (disability) on 21Aug2021 with outcome of not recovered, Branch retinal vein occlusion (BRVO) (disability) on 21Aug2021 with outcome of not recovered. Reporter comment: The patient shall be assessed by the haematologist as indicated by the ophthalmologist. I need to inform you that I will be on holiday until 12Sep2021, therefore I will not be able to reply to any emails until that date! Reporter''s Comments: The patient shall be assessed by the haematologist as indicated by the ophthalmologist. I need to inform you that I will be on holiday until 12Sep2021, therefore I will not be able to reply to any emails until that date!


VAERS ID: 1717314 (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: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Gait disturbance, Malaise, Musculoskeletal stiffness, Myalgia, Pulmonary embolism
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Arthritis (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101155399

Write-up: thromboembolism of pulmonary artery; Myalgia; Difficulty in walking; stiffness of the lower limb; Malaise; Asthenia; FARO This is a non-interventional study report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-779040. A 48-year-old male patient received bnt162b2 (COMIRNATY, Lot Number: FG4686), dose 1 intramuscular in left shoulder on 20Aug2021 as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced myalgia, difficulty in walking, stiffness of the lower limb, malaise, asthenia on 21Aug2021. The events were reported as serious due to hospitalization. After the 1st dose of the vaccine, the patient felt generalized malaise, asthenia, muscle pain, difficulty in walking and stiffness of the lower limbs. Admitted to the emergency room diagnosed with thromboembolism of pulmonary artery (TEPA). The outcome of events was unknown. The reporter''s 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. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Considering a temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate


VAERS ID: 1717339 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Confusional state, Dyspnoea, Pallor, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210821; Test Name: body temperature; Result Unstructured Data: Test Result:below 38; Comments: below 38
CDC Split Type: ITPFIZER INC202101195212

Write-up: pallor; slight fever; respiratory difficulty; sudden fainting; momentary absence of lucidity; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-782411. A 24-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Deltoid Right on 20Aug2021 16:21 (Lot Number: FG4493, at age of 24 years old) as 0.3 mL single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced manifested sudden fainting, with pallor, slight fever, momentary lack of lucidity and respiratory difficulty on 21Aug2021 (18 hours after administration of the vaccine). Events sudden fainting, with pallor, slight fever and respiratory difficulty were reported as Life-threatening, event momentary lack of lucidity was reported as non-serious. Emergency medical assistance was requested and the reaction resolved completely. The outcome of event Confusional state was recovered on unknown date. The outcome of rest events was recovered on 22Aug2021. The emergency physician suggested taking antipyretic medication (not taken by the patient as fever was below 38). The reaction resolved spontaneously the following day. Sender''s comments: The reporter will be contacted for the date of full resolution of the ADR. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1717422 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Facial paralysis, Imaging procedure, Paraesthesia oral
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Convulsion (occurred while the patient was a child.)
Allergies:
Diagnostic Lab Data: Test Date: 20210820; Test Name: body temperature; Result Unstructured Data: Test Result:36.1; Comments: Before vaccination.; Test Date: 20210820; Test Name: Imaging procedure; Result Unstructured Data: Test Result:no problem
CDC Split Type: JPPFIZER INC202101162916

Write-up: Facial palsy/Facial palsy peripheral; Tingling sensation on the right side of the mouth; This is a spontaneous report from a contactable physician received from the RA. Regulatory authority report number is v21125948. A 50-year-old male patient received BNT162B2 (COMIRNATY), first dose via an unspecified route of administration on 20Aug2021 (Batch/Lot Number: FF3620; Expiration Date: 30Nov2021, at age 50-year-old at vaccination) as a single dose for COVID-19 immunisation. Medical history included seizure occurred while the patient was a child. Concomitant medications were not reported. On 20Aug2021, body temperature before vaccination was 36.1 degrees Centigrade. On 20Aug2021, (in the afternoon the day of vaccination), the patient received the first dose of the BNT162B2 vaccine. On 21Aug2021 (the next day of vaccination), the patient experienced tingling sensation on the right side of the mouth and facial palsy/facial palsy peripheral. On 23Aug2021 (3 days after the vaccination), the patient visited the hospital and was diagnosed as right facial palsy/ facial palsy peripheral. On the same day, the patient was introduced to another hospital. No problem was found after the imaging procedure on 20Aug2021. The patient received outpatient treatment for a while. The reporting physician classified the event as non-serious and assessed that the causality between the event and BNT162B2 was unassessable. The outcome of event facial palsy/facial palsy peripheral and tingling sensation on the right side of the mouth was unknown.


VAERS ID: 1717591 (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: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4213 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Mood swings, Postmenopausal haemorrhage, Vaginal haemorrhage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (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: EUTHYROX.
Current Illness: Allergy multiple (doxicycline, contrast fluid.)
Preexisting Conditions: Medical History/Concurrent Conditions: Contrast media allergy; Diethylstilboestrol syndrome; Heavy menstrual bleeding (at older age); Menstrual disorder (menstrual complaints including heavy menstrual bleeding at older age); Postmenopause (last menstruation: 3 years prior); Uterine myoma (fibroids in uterus.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101157657

Write-up: vaginal bleeding/ Postmenopausal haemorrhage; vaginal bleeding; Abdominal bloating; Mood swings; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00674959, with Safety Report Unique Identifier NL-LRB-00676355. A 60-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 30Jul2021 (Batch/Lot Number: FF4213) as dose 2, single for COVID-19 immunisation. Medical history included allergy multiple: doxicycline, contrast fluid; postmenopause (last menstruation: 3 years prior), diethylstilboestrol syndrome; uterine myoma (fibroids in uterus); menstrual disorder (patient described menstrual complaints including heavy menstrual bleeding at older age). Concomitant medication included levothyroxine sodium (EUTHYROX) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of COMIRNATY 0.3 ml for COVID-19 immunisation with no adverse event. The patient experienced vaginal bleeding/postmenopausal haemorrhage, abdominal bloating and mood swings on 21Aug2021 (also reported as 21 days after start). Started a little bit few weeks ago, since a week bleeding like she was on her period. Patient is 60 and haven''t had a period since about 3 years prior. Patient was very late in the transition. She has a medical file with complaints about menstruation and bleeding. On 01Sep2021 follow-up, it was reported that the blood loss was over. She had it for 10 days. A few weeks earlier, she had very light bleeding, almost nothing. Now quite intense, bloated stomach, mood swings. Patient was going to have X-ray next week for further investigation. The patient recovered from the events 10 days after onset. Summary of Reporter Comment: BioNTech/Pfizer vaccine (Comirnaty), Past drug therapy: yes, ADRs: no, Date: 25Jun2021. Additional information ADR: available. Previous COVID-19 infection: No. Follow up (01Sep2021): The blood loss is now over. I''ve had it for 10 days. A few weeks earlier I had very light bleeding, almost nothing. Now quite intense, bloated stomach, mood swings. No follow-up attempts are needed. No further information is expected. Reporter''s Comments: Summary of Reporter Comment: BioNTech/Pfizer vaccine (Comirnaty), Past drug therapy: yes, ADRs: no, Date: 25Jun2021. Additional information ADR: available. Previous COVID-19 infection: No. Follow up (01Sep2021): The blood loss is now over. I''ve had it for 10 days. A few weeks earlier I had very light bleeding, almost nothing. Now quite intense, bloated stomach, mood swings.


VAERS ID: 1717654 (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: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4442 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Fatigue, Headache, Myalgia, Nausea, Pyrexia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), 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: IMPLANON NXT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Mitral valve prolapse
Allergies:
Diagnostic Lab Data: Test Date: 20210821; Test Name: Body temperature; Result Unstructured Data: Test Result:37,6 Centigrade
CDC Split Type: PTPFIZER INC202101155745

Write-up: Febricula (37,6 C); Headache; Nausea; Tiredness; Myalgia; Vomiting; This is a spontaneous report from a contactable physician downloaded. This is a report received from INFARMED Regulatory authority report number, PT-INFARMED-B202108-2989. A 29-year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), dose 2 intramuscular on 20Aug2021 (Lot Number: FG4442) as 0.3 ml single for COVID-19 immunization. Medical history included mitral valve prolapse (unknown if ongoing). Concomitant medication included etonogestrel (IMPLANON NXT). The patient previously received bnt162b2 (COMIRNATY), dose 1 intramuscular on 23Jul2021 (Lot Number: unknown) as 0.3 ml single for COVID-19 immunization. The patient experienced febricula (37,6 C), headache, nausea, tiredness, myalgia, vomiting on 21Aug2021. Spontaneous notification refers to a case sent by a doctor for an adult, female, 29 years old, who presented myalgia, febricula (37.6 C), headache, tiredness, vomiting and nausea associated with the use of the vaccine of mRNA against COVID-19 (with modified nucleoside) (Comirnaty), concentrate for injectable dispersion, 30 mcg/0.3 ml, lot: FG4442, CAUL: 43221-A, two doses of 0.3 ml, 28 days apart, per intramuscular route, indicated for immunization to prevent COVID-19 caused by the SARS-CoV-2 virus. Adverse drug reactions (ADR) started 1 day after the administration of the 2nd dose of the suspected vaccine and caused temporary incapacity to work for at least 2 days. As a treatment for ADR, paracetamol was administered orally. At the date of notification (1 day after the start of ADRs), reactions were recovering. Its evolution is unknown. The final outcome of the ADRs was unknown. The events were considered as serious (Disability). The reporter''s assessment of the causal relationship of pyrexia, headache, nausea, fatigue, myalgia, vomiting with the suspect product was: Source of assessment: reporter, Method of assessment: unknown, Result of Assessment: probable Reporter''s Comment: Concomitant Medication: Implanon Medication Error Occurred: No. Other Information: Personal history: mitral valve prolapse. The adverse reactions described caused temporary incapacity to work for at least 2 days. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Concomitant Medication: Implanon Medication Error Occurred: No. Other Information: Personal history: mitral valve prolapse. The adverse reactions described caused temporary incapacity to work for at least 2 days.


VAERS ID: 1717655 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-21
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4442 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual 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: DAYLETTE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101155915

Write-up: Formation of large clots during menstruation; This is a spontaneous report from a consumer (patient) downloaded from the WEB. This is a report received from INFARMED Regulatory authority report number [PT-INFARMED-B202108-3026] with Safety Report Unique Identifier [PT-INFARMED-B202108-3026]. A 27-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 13Aug2021 (Batch/Lot Number: FG4442) as DOSE NUMBER UNKNOWN, 0.3 ML SINGLE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing (take medication with inhaled corticosteroids). Concomitant medication included drospirenone, ethinylestradiol (DAYLETTE) taken as hormonal contraceptive, start and stop date were not reported. The patient experienced formation of large clots during menstruation (reported as medically significant) on 21Aug2021 with outcome of unknown. It was not known whether the administration corresponds to the 1st or 2nd dose. The adverse drug reaction (ADR) started 8 days after administration of the suspected vaccine. It is unknown whether treatment to reverse ADR was administered. The evolution of ADR was unknown. The patient is asthmatic and completed a course of treatment with inhaled corticosteroids 2 months prior to vaccine administration. Reporter''s Comment: Concomitant Medicine- Hormonal Contraceptive (Daylette 3mg/0.02mg drospirenone/ethinylestradiol) Further information-I am an asthmatic patient and I take medication with inhaled corticosteroids. I finished the treatment cycle about 2 months before the first dose of vaccine. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Concomitant Medicine- Hormonal Contraceptive (Daylette 3mg/0.02mg drospirenone/ethinylestradiol) Further information-I am an asthmatic patient and I take medication with inhaled corticosteroids. I finished the treatment cycle about 2 months before the first dose of vaccine


VAERS ID: 1717661 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4442 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Tonic convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (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: PTPFIZER INC202101160613

Write-up: Tonic seizure with 10 seconds long with spontaneous recovery; This is a spontaneous report from a contactable other hcp (nurse) downloaded from the regulatory authority-WEB, regulatory authority number PT-INFARMED-F202108-2915. A 13-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 21Aug2021 (Batch/Lot Number: FG4442) at age of 13-year-old as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced tonic seizure with 10 seconds long with spontaneous recovery on 21Aug2021 with outcome of recovered on 21Aug2021. Event was assessed serious as medically significant. The drug was of single administration. There is no suspected interaction between medications. Previous reactions to the same drug or other drugs are unknown. There was no specific treatment of ADR, and only the maneuver of elevation of LL (lower limbs) was elaborated. The patient received dose 2 bnt162b2 intramuscular at 0.3 ml single with an interval of at least 21 days between each dose. The reporter''s assessment of the causal relationship of the event with the suspect product was possible. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1720545 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004730 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Burning sensation, Discomfort, Dizziness exertional, Epigastric discomfort, Frequent bowel movements, Hypersensitivity, Nausea, Palpitations, Peripheral coldness, Pollakiuria, Tremor
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: EPIPEN; SERETIDE; VENTOLINE [SALBUTAMOL SULFATE]; SELO-ZOK; TEVA PANTOPRAZOLE; DOLOPROCT COMP; TELFAST
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKMODERNATX, INC.MOD20213

Write-up: Nausea; Dizziness when walking (not on rest); Discomfort; Informs about epigastric pressure; Shaking all over the body; Informs about frequent urination; Informs about increased frequency of defecation; Cold hands; Allergic reaction; Burning sensation in the whole body; Slight palpitations; This case was received via regulatory authority (Reference number: DK-DKMA-ADR 25879991) on 13-Sep-2021 and was forwarded to Moderna on 13-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of NAUSEA (Nausea), DIZZINESS EXERTIONAL (Dizziness when walking (not on rest)), DISCOMFORT (Discomfort), EPIGASTRIC DISCOMFORT (Informs about epigastric pressure), TREMOR (Shaking all over the body), POLLAKIURIA (Informs about frequent urination), FREQUENT BOWEL MOVEMENTS (Informs about increased frequency of defecation), PERIPHERAL COLDNESS (Cold hands), HYPERSENSITIVITY (Allergic reaction), BURNING SENSATION (Burning sensation in the whole body) and PALPITATIONS (Slight palpitations) in a 34-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004730) for COVID-19 immunisation. Concomitant products included BENZYL ALCOHOL, FLUOCORTOLONE PIVALATE, LIDOCAINE HYDROCHLORIDE (DOLOPROCT COMP) from 25-Sep-2020 to an unknown date for Anal fissure, EPINEPHRINE (EPIPEN) from 22-Jan-2018 to an unknown date for Anaphylactic shock, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (SERETIDE) from 22-Jan-2018 to an unknown date and SALBUTAMOL SULFATE (VENTOLINE [SALBUTAMOL SULFATE]) from 11-Jul-2017 to an unknown date for Asthma, PANTOPRAZOLE SODIUM SESQUIHYDRATE (TEVA PANTOPRAZOLE) from 20-Feb-2018 to an unknown date for Esophageal acid reflux, METOPROLOL SUCCINATE (SELO-ZOK) from 17-Jan-2020 to an unknown date for Hypertension, FEXOFENADINE HYDROCHLORIDE (TELFAST) from 15-Jul-2021 to an unknown date for Urticaria. 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 NAUSEA (Nausea) (seriousness criteria hospitalization and life threatening), DIZZINESS EXERTIONAL (Dizziness when walking (not on rest)) (seriousness criteria hospitalization and life threatening), DISCOMFORT (Discomfort) (seriousness criteria hospitalization and life threatening), EPIGASTRIC DISCOMFORT (Informs about epigastric pressure) (seriousness criteria hospitalization and life threatening), TREMOR (Shaking all over the body) (seriousness criteria hospitalization and life threatening), POLLAKIURIA (Informs about frequent urination) (seriousness criteria hospitalization and life threatening), FREQUENT BOWEL MOVEMENTS (Informs about increased frequency of defecation) (seriousness criteria hospitalization and life threatening), PERIPHERAL COLDNESS (Cold hands) (seriousness criteria hospitalization and life threatening), HYPERSENSITIVITY (Allergic reaction) (seriousness criteria hospitalization and life threatening), BURNING SENSATION (Burning sensation in the whole body) (seriousness criteria hospitalization and life threatening) and PALPITATIONS (Slight palpitations) (seriousness criteria hospitalization and life threatening). In 2021, NAUSEA (Nausea), DIZZINESS EXERTIONAL (Dizziness when walking (not on rest)), DISCOMFORT (Discomfort), EPIGASTRIC DISCOMFORT (Informs about epigastric pressure), TREMOR (Shaking all over the body), POLLAKIURIA (Informs about frequent urination), FREQUENT BOWEL MOVEMENTS (Informs about increased frequency of defecation), PERIPHERAL COLDNESS (Cold hands), BURNING SENSATION (Burning sensation in the whole body) and PALPITATIONS (Slight palpitations) had resolved. On 26-Aug-2021, HYPERSENSITIVITY (Allergic reaction) had resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided. Company comment: This case concerns a 34-year-old, female patient with a history of Anaphylactic shock, urticaria and asthma (as suggested by concomitant medication indication), who experienced the unexpected events of nausea, dizziness exertional, discomfort, epigastric discomfort, tremor, pollakiuria, frequent bowel movements, peripheral coldness, hypersensitivity, burning sensation and palpitations. The events occurred approximately on the same day after the first dose of Spikevax. The rechallenge was not applicable as the events happened after the first dose. The medical history of Anaphylactic shock, urticaria and asthma remain a confounder for the events. Use of concomitant medication adrenaline, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE and SALBUTAMOL, remain confounders for palpitations. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Translation document received contains No new information. However updated dosage text of mRNA-1273 and added concomitant products - Teva, Ventolin, missed in earlier workflow.; Sender''s Comments: This case concerns a 34-year-old, female patient with a history of Anaphylactic shock, urticaria and asthma (as suggested by concomitant medication indication), who experienced the unexpected events of nausea, dizziness exertional, discomfort, epigastric discomfort, tremor, pollakiuria, frequent bowel movements, peripheral coldness, hypersensitivity, burning sensation and palpitations. The events occurred approximately on the same day after the first dose of Spikevax. The rechallenge was not applicable as the events happened after the first dose. The medical history of Anaphylactic shock, urticaria and asthma remain a confounder for the events. Use of concomitant medication adrenaline, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE and SALBUTAMOL, remain confounders for palpitations. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1720797 (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: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Cold sweat, Disturbance in attention, Dizziness, Fatigue, Myalgia, Nausea, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210822; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101182431

Write-up: Joint pain; Pain muscle; Fainting; Nausea; Cold sweat; Fatigue; Dizzy spells; Concentration loss; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number: GB-MHRA-WEBCOVID-202109081559459760-BU6CO; Safety Report Unique Identifier: GBMHRA-ADR 25912994. A 29-year-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: FE3380; Expiry date: Not reported), dose 2 via an unspecified route of administration on 20Aug2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Patient was not pregnant, patient was not currently breastfeeding. The patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number and Expiry date was Not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. On 21Aug2021 the patient experienced joint pain, pain muscle, fainting, nausea, cold sweat, fatigue, dizzy spells, concentration loss. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The events were assessed as medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test was no negative COVID-19 test on 22Aug2021. Patient had recovered from (fainting, nausea, cold sweat) on 21Aug2021 and event of (join pain, pain muscle) was recovered on 26Aug2021, (fatigue, dizzy spells, concentration loss) on 31Aug2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1720874 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-08-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ageusia, Cough, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Taste and smell disorders (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: BOOTS PHARMACEUTICALS PARACETAMOL; BOOTS COLD & FLU RELIEF; STREPSILS ORIGINAL
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: constant; persistent cough; Persistent dry cough; This case was received via RA (Reference number: -MHRA-ADR 25929029) on 13-Sep-2021 and was forwarded to Moderna on 13-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of COUGH (Persistent dry cough), AGEUSIA (constant) and COUGH (persistent cough) in a 30-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. Concurrent medical conditions included Suspected COVID-19 since 21-Aug-2021. Concomitant products included AMYLMETACRESOL, DICHLOROBENZYL ALCOHOL (STREPSILS ORIGINAL) from 21-Aug-2021 to an unknown date for Coughing, PARACETAMOL (BOOTS PHARMACEUTICALS PARACETAMOL) from 21-Aug-2021 to an unknown date for Headache, CAFFEINE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (BOOTS COLD & FLU RELIEF) from 21-Aug-2021 to an unknown date for Persistent cough. On 18-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 COUGH (Persistent dry cough) (seriousness criterion medically significant). On an unknown date, the patient experienced AGEUSIA (constant) (seriousness criterion medically significant) and COUGH (persistent cough) (seriousness criterion medically significant). At the time of the report, COUGH (Persistent dry cough) had not resolved and AGEUSIA (constant) and COUGH (persistent cough) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient underwent Lateral Flow test and PCR test, results were not provided. Company Comment: This case concerns a 30-year-old, male patient with no relevant medical history, who experienced the unexpected events of cough, ageusia and cough. The event Cough (reported as persistent dry cough) occurred 3 days after the second dose of Spikevax. For ageusia and cough, the time to onset from vaccination was not reported. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Event term, onset date, outcome and seriousness captured per from Regulatory Authority reporting.; Sender''s Comments: This case concerns a 30-year-old, male patient with no relevant medical history, who experienced the unexpected events of cough, ageusia and cough. The event Cough (reported as persistent dry cough) occurred 3 days after the second dose of Spikevax. For ageusia and cough, the time to onset from vaccination was not reported. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Event term, onset date, outcome and seriousness captured per from Regulatory Authority reporting.


VAERS ID: 1720936 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Pain, SARS-CoV-2 test
SMQs:, Medication errors (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: NAPROXEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pain menstrual; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20201228; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101234056

Write-up: Ache; Patient received BNT162B2 Vaccine Dose 1 on 13Jun2021, Dose 2 on 21Aug2021;This is the second of two reports. The first report is a report downloaded from the Regulatory Authority. . The regulatory authority report number is GB-MHRA-YCVM-202106202059453900-PLIW6. A 30-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 VACCINE), via an unspecified route of administration on 21Aug2021, at the age of 30 years, (Batch/Lot Number: FE3380) as dose 2, single for COVID-19 vaccination. Medical history included suspected covid-19 from 25Dec2020 to an unknown date (Unsure when symptoms stopped), pain menstrual. Patient is not pregnant; Patient is not currently breastfeeding. Patient : 03Aug2021. Historical vaccine included bnt162b2 on 13Jun2021 (Dose 1, batch/lot number FC8289), at the age of 30 years, for COVID-19 vaccination and experienced tenderness. Concomitant medications included naproxen for pain menstrual. On 22Aug2021, patient experienced ache. The second vaccine appointment has been brought forward to 22Aug2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The case is serious (medically significant). It was also reported that the patient received the 2nd dose of bnt162b2 on 21Aug2021 and the 1st dose on 13Jun2021 which was considered inappropriate schedule of vaccine administered. The patient had COVID-19 Virus Test (28Dec2020): Yes - Positive COVID-19 test. The outcome for the event ache is recovered on 23Aug2021. The reporter''s assessment of the causal relationship of the event 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. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : GB-MHRA-YCVM-202106202059453900-PLIW6 MHRA


VAERS ID: 1721018 (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: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Chest discomfort, Chest pain, Fatigue, Headache, Influenza like illness, Respiration abnormal, Tenderness
SMQs:, Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Respiratory failure (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: IEPFIZER INC202101180518

Write-up: CHEST PAIN/PRESSURE; BACK ACHES; CHEST PAIN/PRESSURE / PERSISTENT CHEST PAIN; HEAVY BREATHING; HEADACHE; FATIGUE; FLU SYMPTOMS; TENDERNESS; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number IE-HPRA-2021-083215, Safety Report Unique Identifier IE-HPRA-2021-083215. Initial report received by the HPRA on 23Aug2021 from a member of the public reporting on behalf of herself. A 17-years-old female patient received bnt162b2 (COMIRNATY, Formulation; Solution for injection, Batch/Lot number: not reported), dose 2 via an unspecified route of administration on 20Aug2021 as dose 2, single for covid-19 immunisation. The patient medical history/concurrent conditions was not reported. The patient concomitant medications was not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number :Not reported), via an unknown route of administration on 23Jul2021 as dose 1, single for covid-19 immunization. On 21Aug2021,the patient experienced chest pain/pressure; back aches; chest pain/pressure / persistent chest pain; heavy breathing; headache; fatigue; flu symptoms and tenderness. The patient received treatment for events chest pain/pressure, back aches, chest pain/pressure / persistent chest pain, heavy breathing, headache, flu symptoms and tenderness. The patient stated that they had to visit their general practitioner in relation to persistent chest pain and might have to attend Accident and Emergency (A and E). The patient was treated with anti-inflammatories (unspecified) and pain relievers (unspecified). At the time of reporting the patient''s symptoms were persisting for 2 days and were continuing. The clinical outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1721109 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-21
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF7481 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Neck pain, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101174576

Write-up: Pain in the neck and back. Tingling in the fingers and toes. Feeling of legs asleep. The patient had no trauma, no accidents; Pain in the neck and back. Tingling in the fingers and toes. Feeling of legs asleep. The patient had no trauma, no accidents; Pain in the neck and back. Tingling in the fingers and toes. Feeling of legs asleep. The patient had no trauma, no accidents; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-780340. A 42-years-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: FF7481, Expiry date: Unknown) via intramuscularly, administered in Arm Left on 02Aug2021 12:29 as dose 2, single and dose 1 (Lot number: FE7010) administered on 03Jul2021 at 9:14 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 21Aug2021 the patient experienced pain in the neck and back. tingling in the fingers and toes. feeling of legs asleep. the patient had no trauma, no accidents. Therapeutic measures were taken as a result adverse events. The outcome of the event was not recovered. Description: 2nd dose: batch and expiry date of the physiological solution not available, vaccine reconstitution time not available, 03Sep2021 the patient was contacted and stated that he was going to hospital for urgent admission and stated that he suspected the cause of the symptoms: vaccination. - Measures taken (Prescribed Sirdalud 2, Toradol and Palexia 50 Slight benefit for pain, no change for other symptoms). - Ethnic origin (PRIVACY) - COVID 19 COMIRNATY VACCINE (PFIZER): Administration site (left shoulder) Booster dose number (2) Time of administration (12:29 pm) Sender comment: 1st dose: batch FE7010 administered on 03Jul2021 at 9:14 am, batch and expiry date of the physiological solution not available, vaccine reconstitution time not available, no ADRs. No follow-up attempts possible. No further information expected.


VAERS ID: 1721112 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Pain in extremity, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101171240

Write-up: Dizziness; Tachycardia; Arm pain; Exhaustion; This is a spontaneous report received from a contactable consumer or other non-healthcare professional downloaded from the Regulatory Authority. -WEB. This is a report received from the Regulatory Authority , Regulatory authority report number IT-MINISAL02-780346. A 39-years-old female patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: FG7387), via an intramuscular route of administration on 21Aug2021 (at the age of 39-years-old) as dose 1, 0.3 ml single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tachycardia on 23Aug2021, dizziness on 29Aug2021, arm pain and exhaustion on 21Aug2021. Reporter stated arm pain, exhaustion only on the first day. On the third day tachycardia for 24 h and on the ninth day (after 8 days) dizziness (strong dizziness from sitting for 10 min then intermittent) lasting about 1 hour. The event tachycardia assessed as serious (medically significant) and while other events was non-serious. The outcome of the events was reported as recovered on Aug2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1721145 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3622 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cerebral haematoma, Cerebral haemorrhage, Coma scale, Computerised tomogram, Haemorrhage subcutaneous, Investigation, Pupils unequal, Vasculitis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Vasculitis (narrow), Immune-mediated/autoimmune disorders (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210819; Test Name: body temperature; Result Unstructured Data: Test Result:36 Centigrade; Comments: before vaccination; Test Date: 20210821; Test Name: Jcs; Result Unstructured Data: Test Result:20; Test Date: 20210821; Test Name: CT; Result Unstructured Data: Test Result:Haemorrhage subcutaneous of right Temporal; Test Date: 20210821; Test Name: image; Result Unstructured Data: Test Result:haematoma of approximately 60ml in the right tempo; Comments: haematoma of approximately 60ml in the right temporal lobe subcortically
CDC Split Type: JPPFIZER INC202101163900

Write-up: Cerebral haemorrhage of right Temporal lobe; Haemorrhage subcutaneous of right Temporal lobe; haematoma of approximately 60ml in the right temporal lobe subcortically; Pupils unequal; it was suspected that it might be Vasculitis; This is a spontaneous report from a contactable physician received from the Agency (A). Regulatory authority report number is v21125931. A 48-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 19Aug2021 11:00 (Batch/Lot Number: FF3622; Expiration Date: 30Nov2021) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history was none. The patient''s concomitant medications were not reported. The patient was a 48-year and 10-month-old female (Age at Vaccination). Body temperature before vaccination was 36 degrees Centigrade. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 19Aug2021 at 11:00 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Lot number FF3622, Expiration date 30Nov2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 21Aug2021 at 06:30 (2 days after vaccination), the patient experienced Cerebral haemorrhage of right Temporal lobe. On 21Aug2021 (2 days after the vaccination), the patient was admitted to the hospital. On 03Sep2021 (15 days after vaccination), the outcome of the event was recovering. The course of the event was as follows: On 21Aug2021 around 06:30 (2 days after vaccination), the patient wanted to go to the toilet, she was unable to move by herself. After observation, because no change of the state was seen, and the patient visited the Hospital. The CT showed Haemorrhage subcutaneous of right Temporal lobe, the patient was introduced to this hospital. When came to this hospital, level of consciousness was Jcs20. She was also considered as Pupils unequal. The image showed haematoma of approximately 60ml in the right temporal lobe subcortically. Therefore, craniotomy for removal of hematoma was performed emergently. Part of the brain tissue was extracted; it was suspected that it might be Vasculitis. The reporter classified the event as serious (hospitalized) 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: 1721212 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fall, Loss of consciousness, Neck pain, Presyncope
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), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Vasovagal reflex; Loss of consciousness; Fall; Neck pain; This case was received via the regulatory authority (Reference number: JP-TAKEDA-2021TJP088193) on 08-Sep-2021 and was forwarded to Moderna on 20-Sep-2021. This case was reported by an administrative agency via a medical representative. Loss of consciousness was assessed as serious by the RA. A patient with 3 episodes of loss of consciousness in the past. On 21-Aug-2021, the patient received the 1st dose of this vaccine. At 15:58, loss of consciousness developed. The patient fell off a chair and fell backward, hitting the left side of head hard. Neck pain developed. BP: 135/84 mmHg, pulse rate: 60 beats/min, and Sp02: 97%. At 16:46, the symptoms stabilized, and a physician allowed the patient to return home. At 17:25, on the way home, the patient experienced abdominal discomfort and facial pallor and came to the first-aid room again. The patient felt poorly in a standing or sitting position. Vasovagal reflex was considered. The condition was settled in a decubitus position. BP in the sitting position was 93/61 mmHg. At 18:25, the patient was intermittently checked for poorly feeling in a sitting position. Taking sitting and standing positions was considered difficult in the end, and the patient was thus rushed to a hospital. Blood test, cervical and chest X-ray, transthoracic echocardiography, and electrocardiogram were performed, and acetated ringer''s solution was infused intravenously. Around 23:00, the symptoms resolved, and the patient returned home. The outcome of loss of consciousness, fall, neck pain, and vasovagal reflex was reported as resolved. 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: The symptoms are considered as vasovagal reflex. The patient had a history of 3 episodes of loss of consciousness, which may be causally related to the events, but there is also a possibility that the symptoms are adverse reactions. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a male patient with medical history of 3 episodes of loss of consciousness in the past, who experienced the unexpected events of loss of consciousness and presyncope. The events occurred on the same day after the first dose of Spikevax. The rechallenge was not applicable, as the events happened after the first dose. The reporter assessed the events as related to the product. Patient''s medical history of 3 episodes of loss of consciousness in the past remains a confounder. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1721225 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004666 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Contusion, Fall, Headache, Loss of consciousness, Neck pain, Presyncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Loss of consciousness; Fall from a chair; Smash on the back of the left side of the head; Vasovagal reflex; Headache; Pain in the neck; This case was received via Takeda Pharmaceuticals (Reference number: JP-TAKEDA-2021TJP092441 ) on 09-Sep-2021 and was forwarded to Moderna on 20-Sep-2021. This case, initially reported to the Regulatory Authority by an administrative agency, was received via the RA (Ref, v21126200). The patient had experienced 3 episodes of loss of consciousness and underwent detailed examinations at a medical institution, which revealed no etiologies. On an unknown date, body temperature before the vaccination: 36.8 degrees Celsius. On 21-Aug-2021, at 15:44, the patient received the 1st dose of the vaccine. At 15:58, vasovagal reflex developed, and the patient lost consciousness. The patient fell backward from a chair and smashed the back of the left side of the head. BP: 135/84 mmHg, pulse rate: 60 bpm, and SpO2: 97%. The patient had headache and pain in the back of the neck. At 16:46, as the symptoms were stabilized, the patient was allowed to return home by a physician. At 17:25, the patient noticed abdominal discomfort and facial pallor and returned to the first-aid room. The patient felt sick when standing or sitting, which subsided in a supine position. BP was 93/61 mmHg in a sitting position. At 18:25, the patient was confirmed of having intermittent sick feeling in a sitting position. It was concluded that the patient was unable to take sitting and standing position. The patient was urgently transported to a hospital. Blood test, cervical spine and chest X-ray, transthoracic echocardiography, and electrocardiography were performed. Intravenous drip injection of acetate Ringer''s solution was administered. Around 23:00, the symptoms resolved, and the patient returned home. The outcome of vasovagal reflex, loss of consciousness, fall from a chair, smash on the back of the left side of the head, headache, and pain in the neck was reported as resolved. 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: The patient is considered to have experienced vasovagal reflex. The patient had previously experienced 3 episodes of loss of consciousness, which may have been causally related to the event. However, it is also possible that adverse reactions developed, so this case was reported. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 36-year-old male patient, with a history of loss of consciousness (NAD), who developed the unexpected events of presyncope, loss of consciousness, fall, contusion, headache, and neck pain, approximately 15 minutes after receiving the first dose of Moderna COVID-19 vaccine. The rechallenge was not applicable. The events were considered as possibly related to the suspect drug per the reporter''s assessment. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1723461 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-21
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy
SMQs:, Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101169976

Write-up: Bell''s palsy; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 613924. A 44-year-old female patient received BNT162B2 (COMIRNATY) at single dose via an unknown route on an unknown date in Aug2021 for COVID-19 immunisation. Medical history and concomitant drug were not provided. On 21Aug2021, patient experienced Bell''s palsy. Onset Time in Days with COMIRNATY was 1 day. 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: 1724269 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-08-21
   Days after vaccination:184
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Fatigue, Nasal congestion, 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:
Allergies:
Diagnostic Lab Data: Test Date: 20210821; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ESPFIZER INC202101171202

Write-up: PCR test for COVID-19: positive; PCR test for COVID-19: positive; Congestion nasal; Tiredness; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number is ES-AEMPS-993076. A 37-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 18Feb2021 (Batch/Lot Number: EL0725; Expiration Date: 31Mar2021) as SINGLE DOSE, dose 1 intramuscular on 28Jan2021 (Batch/Lot Number: EJ6134; Expiration Date: 30Apr2021) as SINGLE DOSE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Close contact with positive patient. On 21Aug2021 polymerase chain reaction (PCR) test for COVID-19: positive. On 23Aug2021, patient experienced Nasal congestion, and tiredness. The outcome of the events was recovering. Investigation results received on 09Sep2021: Conclusion: 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 EJ6134. 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. 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 were identified as the complaint was not confirmed. Investigation results received on 10Sep2021: Conclusion: 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 EL0725. 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. 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 were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1724397 (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: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3318 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Arthritis, Biopsy skin, Bronchoalveolar lavage, Cough, Eosinophilic granulomatosis with polyangiitis, Erysipelas, Erythema, Oedema peripheral, Pain, Purpura, Vasculitis
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (narrow), Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (narrow), Vasculitis (narrow), Hypersensitivity (narrow), Arthritis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AERIUS [DESLORATADINE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy multiple (taking AERIUS); Dry cough; Fever (between 38 and 39?); Haemoptysis; Sputum; Thoracic pain
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: Cutaneous biopsy; Result Unstructured Data: Test Result:Vasculitis of the small vessels; Comments: The polymorphic character of the infiltrate with eosinophils is more suggestive of Churg-Strauss syndrome granulomatosis [Eosinophilic granulomatosis with polyangiitis] (more so than Wegener).; Test Date: 20210822; Test Name: bronchoalveolar lavage; Result Unstructured Data: Test Result:polynuclear eosinophils
CDC Split Type: FRPFIZER INC202101166714

Write-up: Vasculitis NOS; suspicion of erysipelas; Churg-Strauss syndrome granulomatosis; Pain; cough; an erythematous patch that spread up to the arms; oedema on both hands/ significant left lower limb oedema; pain in the ankles; inflammatory arthritis; Purpuric marks; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority, regulatory authority number FR-AFSSAPS-TO20217250. A 33-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 20Jul2021 (Batch/Lot Number: FF3318) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included multiple allergies from an unknown date and unknown if ongoing (taking AERIUS). It was also reported that on 10Jul2021, the female patient presented with a dry slightly hacking cough, with intermittent temperature surges to between 38 and 39?, associated with right basi-thoracic pains and with yellowish haemoptoic and sometimes emetogenic sputum. She was therefore put on anti-inflammatory medication. Concomitant medication included desloratadine (AERIUS [DESLORATADINE]) taken multiple allergies, start and stop date were not reported. On 21Aug2021, onset of intense pain in the ankles, with walking impeded by inflammatory arthritis. Purpuric marks appeared on the ankles opposite the bone protrusions, as well as on the hands, with very painful bilateral oedema on both hands, which led her to consult at the Emergency Room on 22Aug2021. The bronchoalveolar lavage found numerous polynuclear eosinophils. On 24Aug2021, extensive purpura on the lower and upper limbs, which were almost bullous, with significant left lower limb oedema and an erythematous patch that spread up to the arms. Pains and a cough. Cutaneous biopsy of the right heel. =$g Vasculitis (also reported as Vasculitis NOS) of the small vessels with fibrin-cruoric thromboses. The polymorphic character of the infiltrate with eosinophils is more suggestive of Churg-Strauss syndrome granulomatosis [Eosinophilic granulomatosis with polyangiitis] (more so than Wegener). The patient was hospitalized due to vasculitis. It was added that treatment and care with corticosteroids and antibiotics (suspicion of erysipelas). The outcome of the event vasculitis was recovering; for all other events was unknown. No follow-up attempts are possible. No further information expected.


VAERS ID: 1724591 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-21
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Coital bleeding, Haemorrhage, Heavy menstrual bleeding, 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 INC202101182398

Write-up: Prolonged periods/ heavy period; Spotting; bleeding during sex; bleeding; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202109082319527000-UV4QB, Safety Report Unique Identifier GB-MHRA-ADR 25915256. A female patient of an unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: not reported) via an unspecified route of administration on 01Aug2021, as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included unspecified pill. The patient had no symptoms associated with COVID-19 and not had a COVID-19 test. The patient was not enrolled in clinical trial. On 21Aug2021, 20 days after vaccination the patient experienced prolonged periods/ heavy period. On an unknown date in 2021, the patient experienced bleeding, spotting and bleeding during sex. The clinical course was reported as follows: It was reported that the patient was on the pill (unspecified). After five days, spotting occurred while still on the same pill. She had heavy period while on normal pill break (normally bleeding last 4-5 days) which was for 8 days. She also reported that spotting continued and had bleeding during sex. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the events bleeding, prolonged periods/ heavy period and spotting was not resolved and while that of bleeding during sex was unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724858 (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: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Diarrhoea, Migraine, Nausea, Palpitations, Tachycardia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Dehydration (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: Test Name: blood test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC202101174719

Write-up: nausea; diarrhoea; heart palpitation; migraine; tachycardia; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority number IT-MINISAL02-780090. A 36-year-old patient of an unspecified gender received bnt162b2 (COMIRNATY, Batch/Lot Number: Unknown), dose 1 intramuscular, administered in arm left (left shoulder) on 18Aug2021 as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced nausea, diarrhoea, heart palpitation, migraine, and tachycardia on 21Aug2021. This case was reported as serious due to hospitalization. The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date. Actions taken (cardiology visit - blood tests - and etc.) - Impact on quality of life (7/10). The outcome of events was not recovered. Reporter''s comment: no problem before 1st dose. no previous heart attack. no anxiety as doctors call it - perfect condition Sender''s comment: 06Sep2021 Regional Pharmacovigilance Center: requests for follow-up information from the reporter regarding severity criterion, clinical documentation, suspect vaccine batch number and outcome to date. Waiting. No follow-up attempts possible, information about lot/batch numbers cannot be obtained. No further information expected.; Reporter''s Comments: no problem before 1st dose. no previous heart attack. no anxiety as doctors call it - perfect condition


VAERS ID: 1726051 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-21
Submitted: 0000-00-00
Entered: 2021-09-23
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: ATJNJFOC20210942867

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via Regulatory authority (AT-BASGAGES-2021-044708) was received on 22-SEP-2021 and concerned a 20 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 and expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-JUL-2021 for drug used for unknown indication. No concomitant medications were reported. On 21-AUG-2021, the patient experienced vaccination failure and SARS-COV-2 infection (severe acute respiratory syndrome coronavirus 2). 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: 1727550 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-08-21
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Myocarditis, Pyrexia, Troponin I
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Pollen allergy; Smoker
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210821; Test Name: Troponin I; Result Unstructured Data: 1889.6 nanogram per litre
CDC Split Type: ESMODERNATX, INC.MOD20213

Write-up: This case was received (Reference number: ES-AEMPS-986512) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of CHEST PAIN (DOLOR TORACICO), PYREXIA (Fever) and MYOCARDITIS (Miocarditis aguda) in a 27-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214020) for COVID-19 vaccination. Concurrent medical conditions included Pollen allergy and Smoker since 2017. On 20-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Aug-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, the patient experienced CHEST PAIN (DOLOR TORACICO) (seriousness criterion hospitalization) and PYREXIA (Fever) (seriousness criterion hospitalization). On 25-Aug-2021, the patient experienced MYOCARDITIS (Miocarditis aguda) (seriousness criteria hospitalization and medically significant). At the time of the report, CHEST PAIN (DOLOR TORACICO), PYREXIA (Fever) and MYOCARDITIS (Miocarditis aguda) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Aug-2021, Troponin I: 1889.6 nanogram per litre (abnormal) 1889.6. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported by reporter No treatment medications provided by the reporter This case concerns 27 year-old, male subject with no relevant medical history, who experienced the expected event of MYOCARDITIS and the unexpected events of CHEST PAIN and PYREXIA. The events of Chest pain and Pyrexia occurred approximately 33 days after the first dose of Spikevax and 5 days after subsequent second dose of Spikevax. Event of Myocarditis occurred approximately 37 days after the first dose of Spikevax and 9 days after subsequent second dose of Spikevax. The rechallenge was unknown as there is no information about first dose. The event on myocarditis is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Spikevax is not affected by this report Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Translation document received on 15-Sep-2021. Added Anatomical location of the doses.; Sender''s Comments: This case concerns 27 year-old, male subject with no relevant medical history, who experienced the expected event of MYOCARDITIS and the unexpected events of CHEST PAIN and PYREXIA. The events of Chest pain and Pyrexia occurred approximately 33 days after the first dose of Spikevax and 5 days after subsequent second dose of Spikevax. Event of Myocarditis occurred approximately 37 days after the first dose of Spikevax and 9 days after subsequent second dose of Spikevax. The rechallenge was unknown as there is no information about first dose. The event on myocarditis is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Spikevax is not affected by this report


VAERS ID: 1728648 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-21
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Atrial fibrillation
SMQs:, Supraventricular tachyarrhythmias (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: Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Emphysema pulmonary
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: fibrillation auriculaire paroxystique; This case was received via regulatory authority (Reference number: FR-AFSSAPS-MP20217062) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of ATRIAL FIBRILLATION (fibrillation auriculaire paroxystique) in a 54-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient''s past medical history included Emphysema pulmonary. Concurrent medical conditions included Hypertension arterial. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 21-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced ATRIAL FIBRILLATION (fibrillation auriculaire paroxystique) (seriousness criteria hospitalization prolonged and medically significant). At the time of the report, ATRIAL FIBRILLATION (fibrillation auriculaire paroxystique) had not resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant Informations were reported. No treatment Informations were reported. Patient developed paroxysmal atrial fibrillation. This case concerns a 54-year-old, female patient with relevant medical history of hypertension, who experienced the unexpected event of atrial fibrillation. The event occurred approximately 19 days after the first dose of Spikevax. The patient''s medical history remains a confounding factor to the event. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Translation received on 14 Sep 2021 and verbatim was translated.; Sender''s Comments: This case concerns a 54-year-old, female patient with relevant medical history of hypertension, who experienced the unexpected event of atrial fibrillation. The event occurred approximately 19 days after the first dose of Spikevax. The patient''s medical history remains a confounding factor to the event. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1729661 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8162 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dyslalia, Lumbar puncture, Magnetic resonance imaging head, Movement disorder
SMQs:, Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210820; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination; Test Date: 20210820; Test Name: spinal tap; Result Unstructured Data: Test Result:no abnormality; Comments: No abnormality in Cerebrospinal puncture; Test Date: 20210820; Test Name: head MRI; Result Unstructured Data: Test Result:no abnormality
CDC Split Type: JPPFIZER INC202101192037

Write-up: Dyslalia/the patient was hard to speak and vocalization can not be done well; movement disorder of upper and lower limbs/the body always hit here and there when walking/Symptoms of staggering appeared/fingers can not move well when working; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126407. The patient was a 25-year and 8-month-old male. Body temperature before vaccination was 36.8 degrees Centigrade. There were no special matters in family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 20Aug2021 at 09:00 (at age of 25 years old, the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FE8162, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 21Aug2021 at 19:00 to 20:00 (1 day after the vaccination), the patient experienced movement disorder of upper and lower limbs and Dyslalia. On 10Sep2021 (21 days after the vaccination), the outcome of the event was not recovered and recovered with sequela of movement disorder of upper and lower limbs and Dyslalia (as source reported). The course of the event was as follows: On 21Aug2021 (Saturday, 1 day after the vaccination), from evening, the patient went to bed while thinking the body always hit here and there when walking. On 22Aug2021 (Sunday, 2 days after the vaccination) in the morning, the patient was hard to speak and vocalization could not be done well. Symptoms of Gait stumbling appeared. On 23Aug2021 (Monday, 3 days after the vaccination), fingers could not move well when working, so the patient went to hospital with his father. The patient was asked to go to see a doctor in midbrain neurology department of a privacy place. Head MRI was no abnormality. Anesthetic drug reaction was negative. On 25Aug2021 (Wednesday,5 days after the vaccination), symptoms did not deteriorate, and not improve as well, so the patient went to see doctor of a privacy place again. No abnormality in Cerebrospinal puncture. After that, considering of situation of observation, 2nd dose was planed to terminate. The reporting physician classified the event as serious (risk of disability) and assessed that the causality between the event and bnt162b2 as unassessable. Whether there was other possible cause of the event such as any other diseases was unknown. The reporting physician commented as follows: 3 weeks later, Dyslalia and movement disorder of upper and lower limbs were still continuing now. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1729930 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PE3380 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Chest pain, Dyspnoea, Fatigue, Muscle spasms, Palpitations
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC202101195039

Write-up: Difficulty breathing; Chest pain; Palpitations; Stomach pain; Muscular spasm; Fatigability; This is a spontaneous report from a contactable consumer or other non-health care professional downloaded from the regulatory authority-WEB, regulatory authority number is RO-NMA-2021-SPCOV12358. A 22-years-old female patient received first dose of bnt162b2 (COMIRNATY, Formulation: solution for injection, Lot number: PE3380), via an intramuscular route on 21Aug2021 (at the age of 22-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced difficulty breathing, chest pain, palpitations, stomach pain, muscular spasm and fatigability on 21Aug2021. The events were assessed as serious (hospitalization). The outcome of events was not resolved. Health authority comments: No consent obtained for contacting the treating physician for obtaining additional information regarding this case.


VAERS ID: 1730000 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-08-21
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Itchy skin; Skin rash (non-injection site); This regulatory authority case was reported by a physician and describes the occurrence of PRURITUS (Itchy skin) and RASH (Skin rash (non-injection site)) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 21-Aug-2021, the patient experienced PRURITUS (Itchy skin) (seriousness criterion medically significant) and RASH (Skin rash (non-injection site)) (seriousness criterion medically significant). At the time of the report, PRURITUS (Itchy skin) and RASH (Skin rash (non-injection site)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medication provided. No treatment information mentioned. Company comment: This case concerns a 72-year-old female patient with no relevant medical history, who experienced the unexpected events of Pruritus and Rash.The events occurred 1 month 18 days after first dose of Spikevax. The rechallenge was not applicable, as the events happened after the first dose.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 72-year-old female patient with no relevant medical history, who experienced the unexpected events of Pruritus and Rash.The events occurred 1 month 18 days after first dose of Spikevax. The rechallenge was not applicable, as the events happened after the first dose.The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting


VAERS ID: 1730012 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-08-21
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal distension, Abdominal pain upper, Blood test, Computerised tomogram, Thrombocytopenia, Venous thrombosis
SMQs:, Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, venous (narrow), 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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: High level of D-dimer; Test Name: CT scan; Result Unstructured Data: Suspected mesenteric venous thrombosis
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Thrombocytopenia; Abdominal distention; Pain in upper abdomen/Stomachache; Mesenteric venous thrombosis; This regulatory authority case was reported by a pharmacist and describes the occurrence of THROMBOCYTOPENIA (Thrombocytopenia), ABDOMINAL DISTENSION (Abdominal distention), ABDOMINAL PAIN UPPER (Pain in upper abdomen/Stomachache) and VENOUS THROMBOSIS (Mesenteric venous thrombosis) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced ABDOMINAL DISTENSION (Abdominal distention) (seriousness criterion hospitalization), ABDOMINAL PAIN UPPER (Pain in upper abdomen/Stomachache) (seriousness criterion hospitalization) and VENOUS THROMBOSIS (Mesenteric venous thrombosis) (seriousness criterion medically significant). On 22-Aug-2021, the patient experienced THROMBOCYTOPENIA (Thrombocytopenia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in August 2021 due to ABDOMINAL DISTENSION, ABDOMINAL PAIN UPPER and THROMBOCYTOPENIA. At the time of the report, THROMBOCYTOPENIA (Thrombocytopenia), ABDOMINAL DISTENSION (Abdominal distention), ABDOMINAL PAIN UPPER (Pain in upper abdomen/Stomachache) and VENOUS THROMBOSIS (Mesenteric venous thrombosis) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) High level of D-dimer. On an unknown date, Computerised tomogram: abnormal (abnormal) Suspected mesenteric venous thrombosis. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Age of the patient reported that 52.2 Reported that the patient received the Moderna vaccine on July, reported that high level of D-dimer discovered in the blood test, a CT scan was conducted, and suspected mesenteric venous thrombosis was found. Reported that the physician suspected that the severe stomachache was caused by thrombi. Given the state of the disease, hospitalization was required for treatment and the patient was informed of the information Company comment: This case concerns a 52-year-old, male patient with no relevant medical history reported, who experienced the unexpected events of thrombocytopenia, abdominal distension, abdominal pain upper and venous thrombosis. The events occurred approximately 1 month after the first dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 in not affected by this report.; Sender''s Comments: This case concerns a 52-year-old, male patient with no relevant medical history reported, who experienced the unexpected events of thrombocytopenia, abdominal distension, abdominal pain upper and venous thrombosis. The events occurred approximately 1 month after the first dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 in not affected by this report.


VAERS ID: 1730029 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-08-21
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal neoplasm, Abdominal pain, Appendicitis, Computerised tomogram abdomen, 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), Non-haematological tumours of unspecified malignancy (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: Abdominal computed tomography; Result Unstructured Data: thrombosis
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Appendicitis; Intra-abdominal tumor; Thrombus; Abdominal pain; This regulatory authority case was reported by an other and describes the occurrence of THROMBOSIS (Thrombus), ABDOMINAL PAIN (Abdominal pain), APPENDICITIS (Appendicitis) and ABDOMINAL NEOPLASM (Intra-abdominal tumor) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced THROMBOSIS (Thrombus) (seriousness criterion medically significant) and ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant). On 24-Aug-2021, the patient experienced APPENDICITIS (Appendicitis) (seriousness criterion medically significant) and ABDOMINAL NEOPLASM (Intra-abdominal tumor) (seriousness criterion medically significant). The patient was treated with Surgery (Appendectomy) for Appendicitis. At the time of the report, THROMBOSIS (Thrombus), ABDOMINAL PAIN (Abdominal pain), APPENDICITIS (Appendicitis) and ABDOMINAL NEOPLASM (Intra-abdominal tumor) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Aug-2021, Computerised tomogram abdomen: abnormal (abnormal) thrombosis. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. They have planned to perform blood sampling for thrombosis. Concomitant medications was not provided by the reporter. Company Comment: This case concerns a 25-year-old, male patient with no relevant medical history, who experienced the unexpected events of Thrombosis, Abdominal pain, Appendicitis and Abdominal neoplasm. The events occurred more than a month after the first dose of vaccine. The rechallenge was unknown since no information about the second dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of vaccine in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 25-year-old, male patient with no relevant medical history, who experienced the unexpected events of Thrombosis, Abdominal pain, Appendicitis and Abdominal neoplasm. The events occurred more than a month after the first dose of vaccine. The rechallenge was unknown since no information about the second dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of vaccine in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1730066 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004729-CDC / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cellulitis, Lymphangitis, Pyrexia, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site rash, Vaccination site swelling
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Induration at injection site; Pain at the vaccination site; Itchy rash at the vaccination site; Cellulitis; Acute neck lymphangitis; Fever; Redness at the vaccination site; Swelling at the vaccination site; This regulatory authority case was reported by an other health care professional and describes the occurrence of CELLULITIS (Cellulitis) and LYMPHANGITIS (Acute neck lymphangitis) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3004729-CDC) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 21-Aug-2021, the patient experienced PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Redness at the vaccination site) and VACCINATION SITE SWELLING (Swelling at the vaccination site). On 23-Aug-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant) and LYMPHANGITIS (Acute neck lymphangitis) (seriousness criterion medically significant). On 26-Aug-2021, the patient experienced VACCINATION SITE INDURATION (Induration at injection site), VACCINATION SITE PAIN (Pain at the vaccination site) and VACCINATION SITE RASH (Itchy rash at the vaccination site). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 1 dosage form four times per day. At the time of the report, CELLULITIS (Cellulitis), LYMPHANGITIS (Acute neck lymphangitis), VACCINATION SITE INDURATION (Induration at injection site), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Redness at the vaccination site), VACCINATION SITE SWELLING (Swelling at the vaccination site), VACCINATION SITE PAIN (Pain at the vaccination site) and VACCINATION SITE RASH (Itchy rash at the vaccination site) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant information was provided. Patient Received AZ vaccine on 28. Patient experienced Fever, neck lymphatic swelling, arm redness and swelling on 21-08-2021 and visited medical care on 23-08-2021 diagnosed: 1. Acute neck lymphangitis, 2. Cellulitis. patient was Prescribed with ephalexin monhydrate 500mg 1cap QID 3day , 500mg Acetaminophen 1tab QID 3 days. This is a case of interchange of vaccine regarding a 43-year-old female patient ,with no reported medical history of who experienced the unexpected serious event of cellulitis and lymphangitis and nonserious expected events of vaccination site induration, pyrexia, vaccination site erythema, vaccination site swelling, vaccination site pain and vaccination site rash. The events occurred 1 day after the second dose of mRNA-1273. The rechallenge was not unknown as details of first dose was not disclosed. events of vaccination site induration, pyrexia, vaccination site erythema, vaccination site swelling, vaccination site pain and vaccination site rash are consistent with the current understanding of the mechanism of action of mRNA-1273. Causality for the reported events was not provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. Cellulitis and lymphangitis are considered important medical events..; Sender''s Comments: This is a case of interchange of vaccine regarding a 43-year-old female patient ,with no reported medical history of who experienced the unexpected serious event of cellulitis and lymphangitis and nonserious expected events of vaccination site induration, pyrexia, vaccination site erythema, vaccination site swelling, vaccination site pain and vaccination site rash. The events occurred 1 day after the second dose of mRNA-1273. The rechallenge was not unknown as details of first dose was not disclosed. events of vaccination site induration, pyrexia, vaccination site erythema, vaccination site swelling, vaccination site pain and vaccination site rash are consistent with the current understanding of the mechanism of action of mRNA-1273. Causality for the reported events was not provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. Cellulitis and lymphangitis are considered important medical events.


VAERS ID: 1730607 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8871 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Arteriospasm coronary, Back pain, Hypoaesthesia, Migraine, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Other ischaemic heart disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clotting disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: VNPFIZER INC202101192518

Write-up: mild continuous heart pain; twitching of veins around heart; Recurring numbing of right leg and right arm; fever; migraine; 30 minutes after injection a burning / paralyzing pain in left side of back.; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old female patient received bnt162b2 (COMIRNATY) dose 1 via an unspecified route of administration administered in left arm on 21Aug2021 16:15 (at age of 32-year-old) (Lot Number: FF8871) as single dose for COVID-19 immunisation. Medical history included high risk of blood clotting. The patient''s concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced mild continuous heart pain, twitching of veins around heart, recurring numbing of right leg and right arm, fever, migraine on 21Aug2021 21:00, 30 minutes after injection a burning / paralyzing pain in left side of back on 21Aug2021 16:45. The events resulted in Emergency room/department or urgent care and Doctor or other healthcare professional office/clinic visit. No treatment was received for events. The outcome of events was recovered with sequelae. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1732461 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-21
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101193489

Write-up: Lung embolism; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority. -WEB, regulatory authority number DE-PEI-202100184773. A 60-year-old female patient received BNT162B2 (COMIRNATY, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced lung embolism on 21Aug2021 with outcome of unknown. Relatedness of the vaccine BNT162B2 to the event Lung embolism was assessed as unclassifiable. No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1732468 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-21
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101193377

Write-up: Pulmonary embolism; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, number DE-PEI-202100185504. A 60-year-old female patient received BNT162B2 (COMIRNATY 0.3 mL), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) 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 pulmonary embolism. The patient''s outcome was unknown for pulmonary embolism. This report is serious - other. Result of assessment for Pulmonary embolism/RA / D. Unclassifiable No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1732787 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCEL5 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Activated partial thromboplastin time prolonged, Blood test, Headache, Hypoferritinaemia, Magnetic resonance imaging, Microcytic anaemia, Motor dysfunction, Paraesthesia, Thrombocytopenia, Transient ischaemic attack, Vision blurred
SMQs:, Haematopoietic erythropenia (narrow), Haematopoietic thrombocytopenia (narrow), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Sarcoidosis
Allergies:
Diagnostic Lab Data: Test Date: 20210821; Test Name: partial thromboplastin time; Result Unstructured Data: Test Result:1.34; Comments: ratio; Test Date: 20210821; Test Name: Blood test; Result Unstructured Data: Test Result:Moderate microcytic anemia; Comments: Hypoferritinemia Lack of thrombocytopenia; Test Date: 20210821; Test Name: MRI; Result Unstructured Data: Test Result:could not confirm the TIA
CDC Split Type: FRPFIZER INC202101228394

Write-up: Lack of thrombocytopenia; brief left occipital headaches; Elongated partial thromboplastin time; Transient ischemic attack; Hypoferritinemia; Moderate microcytic anemia; a deficit in the upper and lower left limbs; tingling in the left half of the body; left sight problems with central scotoma associated with blurred vision / visual disturbances; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-PC20213362. A 31-year-old female patient received the first dose of BNT162B2 (COMIRNATY) via intramuscular on the left arm on 19Aug2021 (Lot Number: SCEL5) at the age of 31-year-old as 0.3 ml dose for COVID-19 immunization. Medically history included sarcoidosis. The patient was not considered in risk of developing a severe form of COVID-19. COVID-19 history was none. COVID-19 test was not performed. Concomitant medication was not reported. On 21Aug2021, the patient experienced transient ischemic attack, hypoferritinemia and moderate microcytic anemia, a deficit in the upper and lower left limbs, tingling in the left half of the body, left sight problems with central scotoma associated with blurred vision. The deficit of the left limbs lasted 1 hour and the visual disturbances 5 minutes. They were accompanied by brief left occipital headaches. Faced with this clinical picture, the patient went to the emergency room for suspicion of a Transient Ischemic Attack. The MRI (magnetic resonance image) performed in the emergency room could not confirm the TIA(Transient Ischemic Attack). Her blood test performed int he emergency room shows: Moderate microcytic anemia, Hypoferritinemia, Lack of thrombocytopenia, Elongated partial thromboplastin time (ratio = 1.34). On 25Aug2021, the pateint has a consulation with a neurologist who does not seem to accept the TIA diagnosis Prescribed, however, Kardegic as a preventive treatment and a thrombophilia assessment to be carried out. Her neurologist will also present the case at the unit meeting. To sum up, suspicion of the TIA happened in 3 days after first dose of the COMIRNATY vaccine. The outcome of transient ischemic attack, motor dysfunction and blurred vision was recovered on 21Aug2021. The outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1732872 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Fall, Limb discomfort, Seizure, Stress
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101241803

Write-up: Convulsion; traumatic fall; limb clonia; context of stress; anxiety; This is the second of two reports. The first report is a report from the FR-AFSSAPS-LL20216011. A 14-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscularly on 21Aug2021 (Batch/Lot number was not reported) at age of 14-years-old as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No history of COVID. Historical vaccine included bnt162b2 (COMIRNATY), dose 1 on 03Jul2021 (Batch/Lot number was not reported) for COVID-19 immunisation and experienced a tonic focal convulsion occurred on 09Jul2021 (Day 6) with electroencephalogram showing abnormalities suggesting the onset of an epileptic disease. The second dose took place on 21Aug2021 followed 90 minutes later by a convulsion with a traumatic fall and limb clonia, all in a context of stress and anxiety. Outcome of the events was unknown. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101194397 same patient, drug/ different AE, dose (first dose)


VAERS ID: 1732948 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-21
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101196401

Write-up: Prolonged heavy periods; This is a spontaneous report from a contactable consumer. This is a report received from a regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109120935575430-QS4SG with Safety Report Unique Identifier GB-MHRA-ADR 25928975. A patient of an unknown gender and age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no symptoms associated with COVID-19 and not had COVID-19 test. The patient was not enrolled in clinical trial. On 21Aug2021, the patient experienced prolonged heavy periods which was reported as serious for causing disability. The patient had not been tested positive for COVID-19 since having the vaccine. The clinical outcome of the event prolonged heavy periods was not resolved at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1733347 (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: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Bone pain, Chest pain, Fatigue, Gait disturbance, Investigation, Pain
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Osteonecrosis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Impact on quality of life; Result Unstructured Data: Test Result:5/10; Test Date: 20210904; Test Name: several examinations; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC202101193406

Write-up: chest pain when breathing deeply; The first week pains everywhere; difficulty walking; fatigue; Bone pain; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-780671. A 33-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), intramuscular, administered in left arm (reported as left shoulder) on 20Aug2021 (Batch/Lot Number: FG7387) as dose 1, 0.3 mL single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced chest pain when breathing deeply, the first week pains everywhere, difficulty walking, fatigue and bone pain on 21Aug2021. Measures taken (on the night of 03Sep2021 the patient was brought to the hospital, her pain was unbearable. She was discharged on 04Sep2021 after several examinations). The events were reported as serious (hospitalization). Impact on quality of life was 5/10 on an unspecified date. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1733417 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3622 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Pruritus, Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MONTELUKAST
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Chronic eosinophilic rhinosinusitis
Allergies:
Diagnostic Lab Data: Test Date: 20210820; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101100250

Write-up: pyrexia; Urticaria/Itching strong Generalised urticaria/Generalised urticaria; Itching strong Generalised urticaria; The initial safety information received was reporting only non-serious adverse drug reaction(s). Upon receipt of follow-up information on 13Sep2021, this case now contains serious adverse reaction(s). Information processed together. This is a spontaneous report from a contactable pharmacist received from the Regulatory Agency (RA). Regulatory authority report number is v21124746. The patient was a 43-year and 1-month-old female. Body temperature before vaccination was 36.6 degrees Centigrade. Patient''s history according to the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) included Asthma, eosinophilic rhinosinusitis and MONTELUKAST (also reported as Medical history was unknown). Concomitant drug was MONTELUKAST via oral route for Asthma and eosinophilic rhinosinusitis, it was ongoing. No relevant tests. Whether the patient received any recent vaccines for any other conditions prior to the event being reported was unknown. The patient recently did not receive SARS-CoV2 vaccinations other than the vaccination of Pfizer-BioNTech COVID-19 vaccine. Whether the patient received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination was unknown. On 20Aug2021 in the afternoon (the day of vaccination), the patient received the second dose of bnt162b2(COMIRNATY, Solution for injection, Lot number: FF3622, Expiration date 30Nov2021) via Intramuscular route of administration as a single dose at 43 years old for COVID-19 immunization. On 21Aug2021 at 10:00 (1 day after the vaccination), the patient experienced Urticaria. The course of the event was as follows: the next day of the vaccination, from the morning, the patient experienced Itching strong Generalised urticaria. On 21Aug2021 at about 10:00 (1 day after vaccination), generalised urticaria occurred. Generalised urticaria recovered on unspecified time and the treatment was unknown (as reported). All the signs and symptoms of the adverse events included that generalised urticaria. The time course of the adverse events included that from the morning the next day of the vaccination. The patient required medical intervention, which included: DIV) saline 100ml, Solu-Cortef 100mg IV, POLARAMINE 1A PO) Levocetirizine(5). Information on organ involvement: The patient had no Multiorgan involvement. The patient had no Respiratory. The patient had no Cardiovascular. The patient had Dermatological/Mucosal included Generalized urticaria (hives) .(Details: Generalised urticaria appeared in the morning of the next day after vaccination. The patient had no Gastrointestinal. Had Pyrexia and took Calonal 300mg orally on unspecified date. The outcome of the event urticaria was recovered on an unspecified date, for itching was recovering, while for pyrexia was unknown. The reporting pharmacist classified the events as non-serious and assessed that the events were related to BNT162B2. There was no other possible cause of the event such as any other diseases. The reporting pharmacist commented as follows: Suspected of causality with the vaccine. Follow-up attempts are completed. No further information is expected.; Reporter''s Comments: Suspected of causality with the vaccine.


VAERS ID: 1733509 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-08-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis
SMQs:, Cardiomyopathy (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 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: Myocarditis; This case was received via Takeda Pharmaceuticals (Reference number: JP-TAKEDA-2021TJP092127) on 11-Sep-2021 and was forwarded to Moderna on 11-Sep-2021. This case, initially reported to the Pharmaceuticals and Medical Devices Agency (PMDA) by a physician, was received via the PMDA (Ref, v21126442). On an unknown date, the patient received the 1st dose of this vaccine. on 18-Aug-2021, the patient received the 2nd dose of this vaccine. At night, pyrexia of 38.0 degrees Celsius developed and persisted up until 20-Aug-2021. On 21-Aug-2021, at the time of awakening, chest pain developed. The patient visited the reporting hospital. Electrocardiogram showed ST elevation in a wide range of lead, and Trop 1 was also positive (0.985 ng/mL). The patient was hospitalized with suspected pericarditis and myocarditis. Subsequent cardiac MRI showed LGE in the side of the epicardium. Myocarditis was diagnosed because there was also a high signal at 92 W. On 26-Aug-2021, the patient was discharged from the hospital. On 08-Sep-2021, it was confirmed the symptoms were resolving. The outcome of myocarditis was reported as resolving. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Considering the timing of vaccination, myocarditis due to this vaccine is suspected.; Sender''s Comments: This case concerns a 22 year old male patient with no relevant medical history, who experienced the expected event of Myocarditis. The event occurred on the same day after the second dose of the Moderna COVID-19 vaccine.The rechallenge was not applicable. The event is considered related to the product per the reporter''s assessment. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1736078 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-21
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Influenza like illness, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210945568

Write-up: FLU LIKE SYMPTOMS; MYALGIA; NAUSEA; This spontaneous report received from a consumer by a Regulatory authority (EVHUMAN Vaccines, DE-PEI-CADR2021167849) on 23-SEP-2021 and concerned a 30-year-old female of unspecified race and ethnicity. The patient''s weight was 56 kilograms, and height was 165 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on 20-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 21-AUG-2021, the patient experienced flu like symptoms, myalgia, nausea (Limb pain, chills, fever, dizziness, nausea and headache) and was hospitalized (date unspecified). Number of days hospitalized and discharge information was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from myalgia, nausea, and flu like symptoms. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1736515 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-21
Submitted: 0000-00-00
Entered: 2021-09-27
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: ATJNJFOC20210947450

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-044618) on 24-SEP-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: 21C10-03 expiry: UNKNOWN) dose was not reported,1 total, administered on 12-MAY-2021 for product use for unknown 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 a product quality complaint.


VAERS ID: 1737734 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1EO28A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101202372

Write-up: Syncope; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100184061. A 37-year-old male patient received BNT162B2 (COMIRNATY, solution for injection, lot number: 1EO28A), via an unspecified route of administration on 21Aug2021 (at the age of 37 years old) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced syncope on 21Aug2021. The outcome of the event was recovered on an unspecified date in 2021. Causal relationship between the event(s) and the administration of CORMINATY was assessed as " Unclassifiable (D)" by the RA. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1737880 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-21
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101212631

Write-up: Pericarditis; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 619232. A 27-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced pericarditis on 21Aug2021 with outcome of recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1737944 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-08-21
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7011 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101194256

Write-up: Pericarditis; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021174523. Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100183098. A 46-years-old male patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 23Jul2021 (Lot Number: FE7011) as 0.3mL single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY) as single dose for covid-19 immunisation. The patient experienced pericarditis on 21Aug2021. The patient was hospitalized for pericarditis from 21Aug2021 to 01Sep2021. The outcome of the event was recovered on 31Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1737952 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-07
Onset:2021-08-21
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Myocarditis, Troponin, Troponin increased
SMQs:, Myocardial infarction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210821; Test Name: troponin; Result Unstructured Data: Test Result:increased
CDC Split Type: DEPFIZER INC202101194641

Write-up: Acute perimyocarditis; Troponin increased/raised Troponin; Chest pain/thoracic pain; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021175550, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100184222. A 20-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 07Aug2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had no known allergies. On 21Aug2021, the patient experienced acute peri myocarditis, troponin increased/raised troponin and chest pain/thoracic pain. The patient was hospitalized on an unspecified date due to the events. Outcome of events was recovering (but stop date was reported as 03Sep2021). Relatedness of drug to reaction(s)/event(s) Troponin increased, Myocarditis, Chest pain Source of assessment Result of Assessment D. Unclassifiable No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1737961 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-21
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Movement disorder
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (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: Diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Infarct myocardial
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101194654

Write-up: Movement disorder; Stroke, massively thickened blood; This is a spontaneous report from a non-contactable consumer downloaded from a Regulatory Authority [DE-PEI-CADR2021176094]. Safety Report Unique Identifier: [DE-PEI-202100185335]. A 72-year-old male patient received bnt162b2 (COMIRNATY, strength: 0.3 mL), intramuscular on 31Jul2021 (Lot Number was not reported) as dose number unknown, 0.3 mL single for COVID-19 immunization. Medical history included Infarct myocardial and ongoing diabetes mellitus. The patient''s concomitant medications were not reported. On 21Aug2021 the patient experienced stroke, massively thickened blood/accident cerebrovascular and movement disorder. The patient was hospitalized on unspecified date in 2021 due to the reported the events. Therapeutic measures were taken as a result of the evens which included blood thinning, phlebotomy and unspecified medication. The outcome of the events was not recovered. The PEI assessed the causality of the events Movement disorder, Accident cerebrovascular with bnt162b2 (COMIRNATY) as D. Unclassifiable. Sender Comment: Do you or the person concerned have any known allergies? If yes, which ones? No Information on risk factors or previous illnesses Condition after heart attack, diabetes / blood thinning, phlebotomy, medication No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1738211 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-08-21
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0680 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood potassium, Blood pressure measurement, Blood sodium, Body temperature, C-reactive protein, Chest X-ray, Chest pain, Electrocardiogram, Haemoglobin, Heart rate, Myocarditis, Oxygen saturation, Platelet count, Respiratory rate, Troponin T, Ultrasound scan, White blood cell count
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abstains from alcohol; Non-smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210831; Test Name: potassium; Result Unstructured Data: Test Result:3.6 mmol/L; Test Date: 20210831; Test Name: Blood pressure; Result Unstructured Data: Test Result:130/83; Test Date: 20210831; Test Name: natrium; Result Unstructured Data: Test Result:142 mmol/L; Test Date: 20210831; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Test Date: 20210831; Test Name: Lung X-ray; Result Unstructured Data: Test Result:the heart is normal in size; Comments: the heart is normal in size, the blood volume is not prominent, no inflammation can be seen; Test Date: 20210831; Test Name: C-reactive protein; Result Unstructured Data: Test Result:<4 mg/l; Test Date: 20210831; Test Name: Electrocardiography; Result Unstructured Data: Test Result:sinus rhythm, ventricular rate about 60/min,; Comments: sinus rhythm, ventricular rate about 60/min, PQ time 160 ms, QRS duration 90 ms. T-waves on a large scale slowly rise from the beginning, clear ST rises or falls I do not really distinguish, but especially in chest connections The V2-V6 T-waves are, in my opinion, different in morphology.; Test Date: 20210831; Test Name: haemoglobin; Result Unstructured Data: Test Result:148 g/l; Test Date: 20210831; Test Name: pulse; Result Unstructured Data: Test Result:63; Test Date: 20210831; Test Name: SpO2; Test Result: 99 %; Test Date: 20210831; Test Name: thrombocyte count; Result Unstructured Data: Test Result:308 10*9/L; Test Date: 20210831; Test Name: respiratory rate; Result Unstructured Data: Test Result:21; Test Date: 20210831; Test Name: troponin T; Result Unstructured Data: Test Result:199; Test Date: 20210831; Test Name: Ultrasound; Result Unstructured Data: Test Result:calmly contracting heart; Comments: calmly contracting heart, cannot distinguish pathological amount of pericardial fluid.; Test Date: 20210831; Test Name: leukocyte count; Result Unstructured Data: Test Result:7.3 10*9/L
CDC Split Type: FIPFIZER INC202101195284

Write-up: myocarditis; chest pains on the left side of the thorax; This is a spontaneous report from a contactable nurse downloaded from the REGULATORY AUTHORITY-WEB, regulatory authority number FI-FIMEA-20214571. A 16-year-old male patient received bnt162b2 (COMIRNATY, lot number: FF0680), dose 1 intramuscular on 26Jul2021 as dose 1, single for covid-19 immunisation. Medical history included non smoker, abstains from alcohol. The patient''s concomitant medications were not reported. The patient was no diseases, no medications, no smoking, no alcohol, no drugs. Healthy siblings, no cardiovascular disease at parents'' side, no underlying diseases, allergies. About 3 weeks ago (26Jul2021), the patient received his 1st covid vaccine. About a week ago a little sore in some way, no measurable fever. No obvious cough, no flushing, no urinary tract infection symptoms or any other focal symptoms. On 28Aug2021, the patient started chest pains on the left side of the thorax. The stingings occur mainly during exercise, but also while at rest. General condition good. Thoracic diaphragm is diffusely scarified. The steady, murmurless rhythm of the auscultating heart. On 31Aug2021. blood -Hemoglobin was 148 g/1; Blood -leucocytes was 7.3 E9/I; B -thrombocytes was 308 E9/I; Plasma -Natrium was 142 mmol/I; Potassium was 3.6 mmol/I; Plasma - Creatinine 65 umol/I; Plasma -C-reactive protein<4 mg/1, Troponin T was 199, Blood pressure was 130/83, pulse was 63, body temperature was 36.5 ?C, respiratory rate (!) 21, SpO2 99 %. Electrocardiography shows sinus rhythm, ventricular rate about 60/min, PQ time 160 ms, QRS duration 90 ms. T-waves on a large scale slowly rise from the beginning, clear ST rises or falls cannot really distinguish, but especially in chest connections. The V2-V6 T-waves are, in the opinion, different in morphology. On lung x-ray the heart is normal in size, the blood volume is not prominent, no inflammation can be seen. Seen on ultrasound, calmly contracting heart, cannot distinguish pathological amount of pericardial fluid. Suspected myocarditis (on 21Aug2021). Doesn''t really fit as an acute coronary event considering age and habitus, not think coronary dissection etc. is likely either. Ibuprofen 600 mg 1x3 will be initiated orally. Tomorrow lab tests, bed rest, so Clexane 40 mg 1x1 subcutaneous. On 01Sep2021, the patient went to emergency room for chest pains. Previously about a week ago over the weekend had already been feeling a bit sore/warm in some ways, no allergies, no medical conditions. No fever. No obvious cough, abdominal pain, urinary tract infection symptoms or any other focal symptoms. However, for a week feeling a little dehydrated. Last Saturday, August 28, started having chest pains on the left side of the chest. The stingings are mainly coming from the left side of the chest. mainly during sports, but also at rest a few times. Numerical Rating Scale 6 during stingings, passes by itself, during swimming training could not swim properly, contractions came constantly. Troponin 199, elevated. No clear changes in ECG, V2-V6 T waves slightly different no T-inversions. Cardiac echo done in ward, normal. Myocarditis found. No infection found in etiological investigations. Inpatient stay in internal medicine 01Sep2021-03Sep2021. Burana cure for myocarditis. Discharged 03Sep2021. On 01Sep2021 in good health, troponin had been decreasing. Symptoms started about 3-4 weeks after receiving first dose of coronary vaccine. The outcome of the events was resolving.


VAERS ID: 1738370 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-08-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Blood test, Deep vein thrombosis, Electrocardiogram, Gait disturbance, Muscle spasms, Pain, Pain in extremity, Platelet count, Superficial vein thrombosis, Ultrasound Doppler, Vena cava thrombosis, Venous thrombosis limb, X-ray limb
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Dystonia (broad), Parkinson-like events (broad), Thrombophlebitis (broad), Guillain-Barre syndrome (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Widal syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: chest-abdominal computer tomography angiography; Result Unstructured Data: Test Result:Venous thrombosis superficial (limbs); Comments: thrombosis of the saphenous vein and permeability of the deep veins of the right lower limb, especially the common femoral vein and the inferior vena cava; Test Date: 20210826; Test Name: blood test; Result Unstructured Data: Test Result:unknown result; Test Date: 20210826; Test Name: electrocardiogram; Result Unstructured Data: Test Result:unknown result; Test Date: 20210826; Test Name: platelet count; Result Unstructured Data: Test Result:283,000; Comments: mm3; Test Date: 20210826; Test Name: venous doppler ultrasound of the right lower limb; Result Unstructured Data: Test Result:Venous thrombosis superficial (limbs); Comments: thrombosis of the saphenous vein and permeability of the deep veins of the right lower limb, especially the common femoral vein and the inferior vena cava; Test Date: 20210826; Test Name: X-ray of the right knee; Result Unstructured Data: Test Result:unknown result
CDC Split Type: FRPFIZER INC202101194384

Write-up: Venous thrombosis superficial (limbs); thrombosis of the saphenous vein and permeability of the deep veins of the right lower limb, especially the common femoral vein and the inferior vena cava; Venous thrombosis superficial (limbs); thrombosis of the saphenous vein and permeability of the deep veins of the right lower limb, especially the common femoral vein and the inferior vena cava; Venous thrombosis superficial (limbs); thrombosis of the saphenous vein and permeability of the deep veins of the right lower limb, especially the common femoral vein and the inferior vena cava; Venous thrombosis superficial (limbs); thrombosis of the saphenous vein and permeability of the deep veins of the right lower limb, especially the common femoral vein and the inferior vena cava; unbearable pain with very great difficulty in walking; great difficulty in walking; moderate pain in the right calf (like a small permanent cramp); moderate pain in the right calf (like a small permanent cramp); This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-LL20216021. A 34-year-old male patient received bnt162b2 (COMIRNATY), intramuscular in left arm on 18Aug2021 (Lot Number: FG4493, unknown expiration) as dose 2, single for COVID-19 immunisation. Medical history included Widal syndrome. Concomitant medication included levocetirizine dihydrochloride (LEVOCETIRIZINE MYLAN). The patient previously received first dose of COMIRNATY in Jul2021 for COVID-19 immunisation. No medical history of COVID-19 and has not been tested for COVID-19. On 21Aug2021 (Day 3), the patient experienced moderate pain in the right calf (like a small permanent cramp). On 25Aug2021, the patient had unbearable pain with very great difficulty in walking. On 26Aug2021, the patient reported to the emergency room, examinations carried out: blood test (unknown result), X-ray of the right knee (unknown result), electrocardiogram (unknown result), a venous doppler ultrasound of the right lower limb and a chest-abdominal computer tomography angiography. Result: Venous thrombosis superficial (limbs); thrombosis of the saphenous vein and permeability of the deep veins of the right lower limb, especially the common femoral vein and the inferior vena cava. The pain in the right leg requires immobilization, very great difficulty in moving around, treatment with Xarelto and compression stockings. The patient has not yet recovered from the events. The events "venous thrombosis superficial (limbs); thrombosis of the saphenous vein and permeability of the deep veins of the right lower limb, especially the common femoral vein and the inferior vena cava" were assessed as serious (hospitalization). Reporter''s comment: information obtained by the Regulatory Authority on 30Aug2021. Absence of thrombocytopaenia. Platelets at 283,000/mm3 on 26Aug2021. Note: Accountability without prejudice to the elements of investigation which could be carried out in the context of legal or amicable compensation procedures. No follow-up attempts are possible; information about batch number was already obtained.


VAERS ID: 1738412 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Epistaxis
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:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101194721

Write-up: Epistaxis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-MA20213476. A 17-year-old female patient received BNT162B2 (COMIRNATY; lot/batch number and expiration date not reported) intramuscular on 21Aug2021 (at the age of 17-year-old) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 21Aug2021 the patient experienced had epistaxis every night for 4 days. Event was considered serious, medically significant. Outcome of the event was recovered on 25Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1738565 (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: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Echocardiogram, Paraesthesia, Pericarditis
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
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: Smoker
Allergies:
Diagnostic Lab Data: Test Name: Cardiac ultrasound; Result Unstructured Data: Test Result:Pericarditis
CDC Split Type: FRPFIZER INC202101194630

Write-up: chest pain; dyspnea; Pericarditis; Appearance of tingling in the arm.; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority number FR-AFSSAPS-RE20212486. A 37-years-old male patient received the second dose of bnt162b2 (COMIRNATY) intramuscular on 19Aug2021 (Lot Number: FG6273) as dose 2, single for covid-19 immunisation. Medical history included Smoker. The patient''s concomitant medications were not reported. The patient experienced pericarditis on 21Aug2021, appearance of tingling in the arm on 21Aug2021, chest pain on 22Aug2021, dyspnea on 22Aug2021. On 21Aug2021, Appearance of tingling in the arm. On 22Aug2021, Appearance of chest pain and dyspnea. On 23Aug2021, the pains become more intense with a sensation of "dagger in the heart". The patient consults in the emergency room, diagnosed with pericarditis on the advice of a cardiologist. The patient is hospitalized. Aspirin initiation. On 30Aug2021, the patient is getting better but remains dyspneic. Therapeutic measures were taken as a result of all events, usual treatments, not specified. All events with seriousness criteria of hospitalized and resulted in emergency room visit and physician office visit. The patient underwent lab tests and procedures which included Cardiac ultrasound: Pericarditis. Outcome of the events was recovering. No follow-up attempts possible. No further information expected.


VAERS ID: 1738640 (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: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Echocardiogram, Ejection fraction, Electrocardiogram, Fibrin D dimer, Magnetic resonance imaging, Myocarditis, Troponin
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Obesity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: C-reactive protein; Result Unstructured Data: Test Result:90 mg/l; Test Date: 2021; Test Name: Echocardiogram; Result Unstructured Data: Test Result:Sub-normal left ventricular ejection fraction..; Comments: ..No vasculopathy; Test Date: 2021; Test Name: Left ventricular ejection fraction; Test Result: 67 %; Test Date: 2021; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Sinus rhythm..; Comments: ..ST-segment a little steep concave laterally and inferiorly; Test Date: 2021; Test Name: D dimers; Test Result: Negative ; Test Date: 2021; Test Name: Cardiac magnetic resonance imaging; Result Unstructured Data: Test Result:no disturbance of kinetics. Hypersignal of the..; Comments: ..lateral subepicardial wall. Myocarditis extended to the entire lateral wall, mainly bifocal, associating edema and contrast of subepicardial topography.; Test Date: 20210821; Test Name: Troponin; Result Unstructured Data: Test Result:16000 ng/L; Test Date: 2021; Test Name: Troponin; Result Unstructured Data: Test Result:814 pg/mL
CDC Split Type: FRPFIZER INC202101194539

Write-up: Myocarditis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority number is FR-AFSSAPS-ST20213353. A 27-year-old male patient received BNT162B2 (COMIRNATY; solution for injection), intramuscularly on 19Aug2021 (lot number was not reported) as dose number unknown, 0.3 ml single for COVID-19 immunization. Medical history included ongoing obesity. The patient''s concomitant medications were not reported. On 21Aug2021, the patient arrived at the hospital with chest pain associated with troponin 16000 ng/l. Coronary artery disease was suspected. Electrocardiogram showed sinus rhythm. ST-segment a little steep concave laterally and inferiorly. D-dimers were negative. C-reactive protein was at 90 mg/L and troponin was at 814 pg/ml. Cardioprotective treatment combined with ramipril 2.5 mg/day and bisoprolol 1.25 mg/day was started. Aspirin was started 1 g x 3 on 21Aug2021 and stopped on 23Aug2021. Cardiac magnetic resonance imaging showed left ventricular ejection fraction: 67%, no disturbance of kinetics. Hypersignal of the lateral subepicardial wall. Diagnosis of myocarditis extended to the entire lateral wall, mainly bifocal, associating oedema and contrast of subepicardial topography. The outcome of the event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1738715 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Cough, Heart rate, Inappropriate schedule of product administration, Physical examination, Respiratory rate, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), 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: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Heart rate; Result Unstructured Data: Test Result:tachycardia; Test Date: 202108; Test Name: Clinical examination; Result Unstructured Data: Test Result:widespread wheeze; Test Date: 202108; Test Name: Respiratory rate; Result Unstructured Data: Test Result:Raised resp rate
CDC Split Type: GBPFIZER INC202101196420

Write-up: Asthma/ Asthma aggravated; wheeze; cough; Patient received first dose of BNT162B2 in 26Jun2021 and second dose on 21Aug2021; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109121123153280-CPPED, Safety Report Unique Identifier of GB-MHRA-ADR 25929040. A 20-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF3319) via an unspecified route of administration on 21Aug2021 at the age of 20 years old as a single dose for COVID-19 immunisation. Medical history included asthma from 2003 to 2013. The patient had no symptoms associated with COVID-19 and not had a COVID-19 test. It was unsure if the patient was enrolled in clinical trial. The patient was currently not breastfeeding. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Jun2021 as a single dose for COVID-19 immunisation. On 23Aug2021, 2 days after vaccination, the patient experienced asthma (also reported as asthma aggravated), wheeze and cough; all the events were reported as serious for being medically significant. The patient received second dose of BNT162B2 on 21Aug2021 which is an inappropriate schedule of vaccine administered. The clinical course was reported as follows: the patient had PMH (past medical history) of asthma, but was off all treatment since 2013 and was presented to physician with a 15 days with history of cough and wheeze which were started 2 days after second Pfizer vaccination. Unclear if that was a trigger. It was reported that the adverse event did not relate to possible blood clots or low platelet counts. Relevant investigations included clinical examination: raised respiratory rate and tachycardia, widespread wheeze. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the events asthma aggravated, wheeze and cough was not resolving at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1738962 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-08-21
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bedridden, Dry mouth, Fatigue, Inappropriate schedule of product administration, Influenza, Influenza like illness, Migraine, Movement disorder, Nausea, Pain in extremity, Rash, SARS-CoV-2 test, Somnolence
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Slept most of the day; Bedridden; unable to move arm; flu like symptoms; Rash over arms; Nausea; Flu symptoms; Migraine; Dry mouth; Painful arm; Inappropriate schedule of vaccine administered; Fatigue; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 25951904) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), FATIGUE (Fatigue), RASH (Rash over arms), NAUSEA (Nausea), INFLUENZA (Flu symptoms), MIGRAINE (Migraine), DRY MOUTH (Dry mouth) and PAIN IN EXTREMITY (Painful arm) in a 28-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 25-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 FATIGUE (Fatigue) (seriousness criteria disability and medically significant), NAUSEA (Nausea) (seriousness criteria disability and medically significant), INFLUENZA (Flu symptoms) (seriousness criteria disability and medically significant), MIGRAINE (Migraine) (seriousness criteria disability and medically significant), DRY MOUTH (Dry mouth) (seriousness criteria disability and medically significant) and PAIN IN EXTREMITY (Painful arm) (seriousness criteria disability and medically significant). 21-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 22-Aug-2021, the patient experienced RASH (Rash over arms) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) (seriousness criteria disability and medically significant), SOMNOLENCE (Slept most of the day), BEDRIDDEN (Bedridden) and MOVEMENT DISORDER (unable to move arm). On 21-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. On 22-Aug-2021, FATIGUE (Fatigue), NAUSEA (Nausea), INFLUENZA (Flu symptoms), MIGRAINE (Migraine) and DRY MOUTH (Dry mouth) had resolved. On 23-Aug-2021, PAIN IN EXTREMITY (Painful arm) had resolved. On 25-Aug-2021, RASH (Rash over arms) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) was resolving and SOMNOLENCE (Slept most of the day), BEDRIDDEN (Bedridden) and MOVEMENT DISORDER (unable to move arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative covid-19 test (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by reporter. No treatment medications provided by the reporter. Patient was not enrolled in clinical trial. Company comment: This case concerns a 28-year-old, female patient with no relevant medical history, who experienced the unexpected events of fatigue, nausea, influenza, migraine, dry mouth, and pain in extremity. The events occurred between the same day and one day after the second dose of Spikevax. The rechallenge was unknown as there''s no information available about the first dose. The benefit-risk relationship of Spikevax is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 28-year-old, female patient with no relevant medical history, who experienced the unexpected events of fatigue, nausea, influenza, migraine, dry mouth, and pain in extremity. The events occurred between the same day and one day after the second dose of Spikevax. The rechallenge was unknown as there''s no information available about the first dose. The benefit-risk relationship of Spikevax is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1738968 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Haemorrhage, Polymenorrhoea, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (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: 20210914; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: This case was received via the regulatory authority (Reference number: GB-MHRA-ADR 25953577) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding) in a 28-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 19-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced POLYMENORRHOEA (Frequent periods). On an unknown date, the patient experienced HAEMORRHAGE (Bleeding) (seriousness criterion medically significant) and FATIGUE (Tiredness). On 25-Aug-2021, POLYMENORRHOEA (Frequent periods) had resolved. At the time of the report, HAEMORRHAGE (Bleeding) and FATIGUE (Tiredness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication were not given. Treatment information is not given. It was reported that after second vaccine, patient experienced a very light early period accompanied by strong period like pains. Company Comment: This case concers a 28 year-old female patient with no medical history reported, who experience the unexpected events of polymenorhoea, dysmenorrhoea, haemorrhage after second dose of mRNA-1273. The events occurred aproximately 3 days after second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Covid19 Moderna in not affected by this report.; Sender''s Comments: This case concers a 28 year-old female patient with no medical history reported, who experience the unexpected events of polymenorhoea, dysmenorrhoea, haemorrhage after second dose of mRNA-1273. The events occurred aproximately 3 days after second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Covid19 Moderna in not affected by this report.


VAERS ID: 1738973 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-21
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Amenorrhoea, COVID-19, Drug ineffective, Heavy menstrual bleeding, Menstruation delayed, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210823; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Positive-Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101224769

Write-up: This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109162025057740-UTMCI, safety report unique identifier is GB-MHRA-ADR 25955205. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FF3319), via an unspecified route of administration on 03Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not enrolled in clinical trial. The patient had menstruation delayed, missed period by 3 weeks and heavy periods on an unspecified date in 2021, SARS-CoV-2 infection/suspected covid-19 on 23Aug2021. It was reported that missed period by 3 weeks, heavier than usual bleeding, previously had regular and light cycles for many years. The patient underwent lab tests and procedures which included SARS-COV-2 test positive (Yes - Positive COVID-19 test) on 23Aug2021. The outcome of event SARS-CoV-2 infection/suspected covid-19 recovered on 31Aug2021, event missed period by 3 weeks was unknown, event heavy periods was not resolved, and event menstruation delayed was resolving. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1739020 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-08-21
   Days after vaccination:63
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (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; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Neck swelling; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 25965038) on 19-Sep-2021 and was forwarded to Moderna on 19-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SWELLING (Neck swelling) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-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 SWELLING (Neck swelling) (seriousness criterion medically significant). At the time of the report, SWELLING (Neck swelling) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The concomitant medications were not reported. The treatment information was not provided. The patient stated that, Since her second dose occasionally I have had one side of my neck swell up seemingly randomly. It resolves itself after a couple of hours but since it has happened again twice. This has never happened before in my life. I suspect this may be food related however, not fully sure as these were foods I never reacted to before either. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment : This case concerns a 27-year-old female patient with no relevant medical history, who experienced the unexpected event of Swelling .The event occurred 4 days after second dose of Spikevax. The rechallenge was unknown since limited 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 27-year-old female patient with no relevant medical history, who experienced the unexpected event of Swelling .The event occurred 4 days after second dose of Spikevax. The rechallenge was unknown since limited 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: 1739412 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9942 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Body temperature, Gamma-glutamyltransferase, Hepatic function abnormal, Pyrexia, SARS-CoV-2 test, White blood cell count
SMQs:, Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 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: Hyperlipidaemia; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: GPT; Result Unstructured Data: Test Result:69; Test Date: 20210826; Test Name: GPT; Result Unstructured Data: Test Result:139; Test Date: 20210831; Test Name: GPT; Result Unstructured Data: Test Result:161; Test Date: 20210906; Test Name: GPT; Result Unstructured Data: Test Result:65; Test Date: 20210825; Test Name: GOT; Result Unstructured Data: Test Result:37; Test Date: 20210826; Test Name: GOT; Result Unstructured Data: Test Result:58; Test Date: 20210831; Test Name: GOT; Result Unstructured Data: Test Result:58; Test Date: 20210906; Test Name: GOT; Result Unstructured Data: Test Result:22; Test Date: 20210820; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210821; Test Name: body temperature; Result Unstructured Data: Test Result:37 to 40 Centigrade; Comments: From 21Aug2021 to 24Aug2021; Test Date: 20210825; Test Name: body temperature; Result Unstructured Data: Test Result:40 Centigrade; Test Date: 20210831; Test Name: body temperature; Result Unstructured Data: Test Result:40 Centigrade; Test Date: 20210825; Test Name: Gamma-GTP; Result Unstructured Data: Test Result:406; Test Date: 20210826; Test Name: Gamma-GTP; Result Unstructured Data: Test Result:509; Test Date: 20210831; Test Name: Gamma-GTP; Result Unstructured Data: Test Result:512; Test Date: 20210906; Test Name: Gamma-GTP; Result Unstructured Data: Test Result:394; Comments: high value; Test Date: 20210825; Test Name: COVID-19 antigen; Test Result: Negative ; Test Date: 20210826; Test Name: COVID-19 PCR; Test Result: Negative ; Test Date: 20210825; Test Name: W; Result Unstructured Data: Test Result:7430
CDC Split Type: JPPFIZER INC202101199248

Write-up: Hepatic function disorder; Pyrexia with 37 to 40 degrees Centigrade/40 degrees Centigrade; This is a spontaneous report from a physician received from the regulatory authority report number is v21126597. This is the first of two reports. This report concerns events occurred after the second dose of BNT162B2. A 55-year-old female patient received the second dose of bnt162b2 (COMIRNATY intramuscular injection, Lot number FF9942, Expiration date 30Nov2021) via an unspecified route of administration on 20Aug2021 at 16:30 (the day of vaccination, at the age of 55-years-old) as dose 2, single for COVID-19 immunization. Patient''s history according to the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) included hypertension and hyperlipidaemia. Concomitant medications included ongoing amlodipine besilate, irbesartan (ILUAMIX) taken orally for hypertension and ongoing pitavastatin taken orally for hyperlipidaemia. The patient received the first dose of bnt162b2 (COMIRNATY intramuscular injection, Lot Number FF0843, Expiration date 31Oct2021) on 30Jul2021 for COVID-19 immunization and experienced painful arm and pyrexia with 37 degrees Centigrade. Body temperature before vaccination, on 20Aug2021, was 36.5 degrees Centigrade. On 21Aug2021, the patient experienced pyrexia with 37 to 40 degrees Centigrade/40 degrees Centigrade. On 25Aug2021 at 09:00 (5 days after vaccination), the patient experienced hepatic function disorder. The course of the event was as follows: on 20Aug2021 (the day of vaccination), the patient received the second dose of vaccination. From 21Aug2021 (1 day after vaccination) to 24Aug2021 (4 days after vaccination), pyrexia with 37 to 40 degrees Centigrade. On 25Aug2021 (5 days after vaccination), visited to department. Body temperature was 40 degrees Centigrade. Hepatic function disorder (white blood cell count (W) 7430, glutamic-oxaloacetic transaminase (GOT) 37, glutamic-pyruvic transaminase (GPT) 69, Gamma-glutamyltransferase (Gamma-GTP) 406), COVID-19 antigen was negative. On 26Aug2021 (6 days after vaccination), the patient visited hospital outpatient, COVID-19 PCR was negative, GOT 58, GPT 139, Gamma-GTP 509. On 30Aug2021 (10 days after vaccination), pyrexia had no improvement. Visited hospital. Requested to be hospitalized at our department. On 31Aug2021 (11 days after vaccination), the patient was hospitalized at our department. Body temperature was 40 degrees centigrade; GOT 58, GPT 161, Gamma-GTP 512. From 03Sep2021 (10 days after vaccination), pyrexia improved. On 06Sep2021 (reported as 06Aug2021), the patient was discharged from the hospital. After discharged, GOT 22, GPT 65, Gamma-GTP 394 high value. On 03Sep2021, the patient had recovered from pyrexia with 37 to 40 degrees Centigrade/40 degrees Centigrade. On 06Sep2021(17 days after vaccination), the outcome of hepatic function disorder was not recovered. The reporter classified the event as serious (hospitalized) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: pyrexia appeared from the day after second vaccination. Hepatic function disorder was observed on the fifth day. For 14 days, pyrexia with 40 degrees Centigrade and hepatic function disorder persisted, considered it was caused by vaccine.; Sender''s Comments: Linked Report(s) : JP-PFIZER INC-202101216544 Same reporter,same patient, different dose,different event


VAERS ID: 1739701 (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: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4728 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dizziness, Headache, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: PTPFIZER INC202101195564

Write-up: Dizziness; Faint; Loss of strenght; Strong headache; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Authority-WEB. This is a report received from Regulatory authority report number PT-INFARMED-T202108-3657. A 27-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 20Aug2021 (Lot Number: FE4728) as 0.3ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. There was no information on clinical history. Previous known infection with the SARS-CoV-2 virus was unknown. The patient presented a picture of fainting, loss of strength, dizziness, severe headache on 21Aug2021. All events were disability. According to the reporter, the reaction was communicated to a health professional. Information on compliance with the planned scheme was unknown. There was no suspicion of drug interactions. There was no information on the history of previous reactions to other drugs, or identified allergies. Events was treated with ibuprofen and betahistine 24mg. The outcome of events was recovered on 26Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1739712 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-21
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache
SMQs:

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: COZAAR; PITAVASTATIN CALCIUM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210942991

Write-up: FATIGUE; HEADACHE; This spontaneous report received from a consumer via Regulatory Authority (EVHUMAN Vaccines, PT-INFARMED-T202109-344) on 22-SEP-2021 and concerned a 42 year old male with unknown race and ethnicity. The patient''s weight was 88 kilograms, and height was 174 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE423 expiry: UNKNOWN) 0.5 ml, 1 total administered on 20-AUG-2021 for covid-19 immunisation. Concomitant medications included losartan potassium, and pitavastatin calcium. On 21-AUG-2021, the patient experienced fatigue and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue and headache was not reported. This report was serious (Disability Or Permanent Damage).


VAERS ID: 1740689 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-21
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dizziness, Dyspnoea, Feeling abnormal, Pericarditis
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101213018

Write-up: Pericarditis; chest pain; dizziness; Dyspnoea; Feeling abnormal; This is a spontaneous report from a contactable HCP via the Regulatory Authority. Regulatory authority report number is 619530. A 25-year-old female patient received an unknown dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On 21AUg2021, the patient experienced chest pain, dizziness, dyspnoea, feeling abnormal and pericarditis. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1740735 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-21
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101213673

Write-up: Pericarditis; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 621308. A 26-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose number unknown, single, for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced pericarditis on 21Aug2021. The event was considered serious, medically significant. 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: 1742640 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-08-21
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Menstrual disorder, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Medical History/Concurrent Conditions: Abdominal pain; Tiredness
Allergies:
Diagnostic Lab Data: Test Date: 20210911; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101224735

Write-up: abdominal cramps; Menstrual cycle abnormal; This is a spontaneous report from a contactable consumer or other non HCP. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202109161336435390-F5LY9, Safety Report Unique Identifier GB-MHRA-ADR 25953183. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: FF3319, Expiration date was not reported), dose 2 via an unspecified route of administration on 11Aug2021 as dose 2, single for covid-19 immunisation. Medical history included abdominal pain, fatigue. The patient''s concomitant medications were not reported. Generally in good health and exercise/workout daily; but she had to rest more due to the abdominal pain and tiredness. Patient has not had symptoms associated with COVID-19. The patient experienced abdominal cramps on an unspecified date, menstrual cycle abnormal on 21Aug2021. it was reported that Changes to the menstrual cycle August period was due around 15th August which didn''t come, and September period was very light, a couple of drops of blood for the first couple of days, then it stopped, but came back again a couple of days later, very light or just pinkish discharge. But the abdominal cramps has been very painful and pro-longed, she still experience the cramps everyday for almost 2 weeks straight, which makes her very tired and sleepless. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (No - Negative COVID-19 test) on 11Sep2021. The outcome of the event abdominal cramps was recovered on an unspecified date and outcome of the other event was reported as not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1742705 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-21
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chillblains, Dizziness postural, Migraine, Myalgia, Nausea, Rash, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BECLOMETASONE; MONTELUKAST; TOPIRAMATE; ZOLMITRIPTAN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Migraine; Dizzy on standing; Nausea; Muscular pain; Facial rash; Vaccination site pain; Chilblains; This case was received via Regulatory Authority RA (Reference number: GB-MHRA-ADR 25966086) on 20-Sep-2021 and was forwarded to Moderna on 20-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLBLAINS (Chilblains), MIGRAINE (Migraine), DIZZINESS POSTURAL (Dizzy on standing), VACCINATION SITE PAIN (Vaccination site pain), NAUSEA (Nausea), MYALGIA (Muscular pain) and RASH (Facial rash) in an 18-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concomitant products included BECLOMETASONE for Asthma, MONTELUKAST for Asthmatic, TOPIRAMATE and ZOLMITRIPTAN for Migraine. In 2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, the patient experienced CHILLBLAINS (Chilblains) (seriousness criterion medically significant), VACCINATION SITE PAIN (Vaccination site pain) (seriousness criterion medically significant), MYALGIA (Muscular pain) (seriousness criterion medically significant) and RASH (Facial rash) (seriousness criterion medically significant). On 22-Aug-2021, the patient experienced MIGRAINE (Migraine) (seriousness criterion medically significant), DIZZINESS POSTURAL (Dizzy on standing) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 22-Aug-2021, CHILLBLAINS (Chilblains), DIZZINESS POSTURAL (Dizzy on standing) and NAUSEA (Nausea) had resolved. On 23-Aug-2021, MIGRAINE (Migraine), VACCINATION SITE PAIN (Vaccination site pain) and MYALGIA (Muscular pain) had resolved. On 29-Aug-2021, RASH (Facial rash) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medication use information was not provided by reporter. The patient was not enrolled in clinical trial nor tested positive for COVID-19, after vaccination. The patient was not breastfeeding nor was pregnant. After 5 hours of vaccination, the patient were experienced fingers and toes turned into blue. This case concerns a 18-year-old, female patient with medical history of Asthma, and Migraine who experienced the unexpected events of Chilblains, Vaccination site pain, Myalgia, Rash, Migraine, Postural Dizziness, and Nausea. The events occurred on an unknown date after the second dose of Moderna Covid -19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Moderna covid -19, is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 18-year-old, female patient with medical history of Asthma, and Migraine who experienced the unexpected events of Chilblains, Vaccination site pain, Myalgia, Rash, Migraine, Postural Dizziness, and Nausea. The events occurred on an unknown date after the second dose of Moderna Covid -19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Moderna covid -19, is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1742874 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
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 FG4686 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Loss of control of legs, Vaccination site erythema, Vaccination site joint swelling
SMQs:, Haemodynamic oedema, effusions and fluid overload (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: ITPFIZER INC202101199735

Write-up: After the time of 25 minutes, loss of leg control; at the point where the puncture was made, the arm swelled from the shoulder to the elbow; at the point where the puncture was made, the arm swelled from the shoulder to the elbow; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB:IT-MINISAL02-782267. A 43-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FG4686; Expiration Date: 30Nov2021), intramuscular on 21Aug2021 at 09:35 (age at vaccination 43-year-old) as dose 1, 0.3 mL single for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medication included Eutirox used for unknown indication. After the time of 25 minutes, the patient experienced loss of leg control, at the point where the puncture was made, the arm swelled from the shoulder to the elbow on 21Aug2021. Seriousness criteria of the event loss of leg control was reported as medically significant. The arm from shoulder to elbow has a skin burn as if it were a burn, impact on quality of life is (7/10). The outcome of the events was not recovered. No follow-up attempts possible. No further information expected.


VAERS ID: 1742925 (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: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Bradycardia, Cardiac fibrillation, Chest discomfort, Dyspnoea, Echocardiogram, Eye pruritus, Gait disturbance, Limb discomfort, Lymphadenopathy, Overdose, Periorbital swelling, Quality of life decreased, Swelling face
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (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), Parkinson-like events (broad), Drug abuse and dependence (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Medication errors (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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Drug allergy (PENICILLIN AND CEPHALOSPORIN ALLERGIES); Penicillin allergy (PENICILLIN AND CEPHALOSPORIN ALLERGIES)
Allergies:
Diagnostic Lab Data: Test Name: echocardiogram; Result Unstructured Data: Test Result:PRESENTS ASPECIFIC ANOMALIES; Test Name: Impact on quality of life; Result Unstructured Data: Test Result:9/10
CDC Split Type: ITPFIZER INC202101209343

Write-up: slow heartbeat with fibrillation; slow heartbeat with fibrillation; itchy eyes; difficulty walking; swollen lymphatic glands; itchy eyes; shortness of breath; swollen face; heavy legs; chest heaviness; 0.45 ml vaccine administered; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB IT-MINISAL02-784182 A 48-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, batch/lot number was not reported), intramuscular, administered in arm right (right shoulder) on 21Aug2021 as dose 1, 0.45 ml, single for covid-19 immunisation. The patient''s medical history included penicillin and cephalosporin allergies. The patient''s concomitant medications were not reported. The patient experienced after vaccination with first dose of Comirnaty shortness of breath, walking difficulties, slow heartbeat with fibrillation, chest heaviness, heavy legs, itchy eyes, swollen face and swollen lymphatic glands on 22Aug2021. Adverse events resulted into hospitalization. She received treatment for adverse events. Since 21aug, the day of the vaccine, she had taking anthistamines and acetametaphen morning and evening. The patient underwent lab test and procedure included echocardiography presented aspecific anomalies. Impact on quality of life (9/10). The outcome of event overdose was unknown, and outcome of other events was not recovered. Health authority comment: PENICILLIN AND CEPHALOSPORIN ALLERGIES. Sender comment: REQUESTED BATCH TO REPORTER. No follow-up attempts were possible. No further information was expected.


VAERS ID: 1743088 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
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 FE8206 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Heart rate, Loss of consciousness, Oxygen saturation, Presyncope
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210821; Test Name: blood pressure; Result Unstructured Data: Test Result:108/69; Test Date: 20210821; Test Name: P; Result Unstructured Data: Test Result:68; Test Date: 20210821; Test Name: SpO2; Result Unstructured Data: Test Result:98
CDC Split Type: JPPFIZER INC202101208763

Write-up: Vasovagal reflex; loss of consciousness; This is a spontaneous report from a contactable other healthcare professional received from the regulatory authority. Regulatory authority report number is v21126708. The patient was a 15-year-old female (also age at vaccination). On 21Aug2021 at 14:34 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number FE8206, expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 21Aug2021 at 14:35 (1 minute after the vaccination), the patient experienced vasovagal reflex. The course of the event was as follows: After vaccination, dizziness occurred, went to the observation area. While sitting, Loss of consciousness occurred and fell from chair, a few seconds later consciousness recovered, answered the call. Cold sweat occurred, no queasy. Carried on a stretcher into the emergency room. Stayed on the bed for a while, got the permission, went home with mother. BP 108/69, P 68, SpO2 98. On 21Aug2021 (the day of vaccination), the outcome of the event was recovering. No serious criteria was provided. The causality between the event and the vaccine was not provided.


VAERS ID: 1743115 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
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 FE8162 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure increased, Blood pressure measurement, Body temperature, Dyspnoea, Erythema, Oxygen saturation, Pruritus
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210821; Test Name: Blood pressure; Result Unstructured Data: Test Result:141/95 mmHg; Test Date: 20210821; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: before vaccination; Test Date: 20210821; Test Name: Body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Test Date: 20210821; Test Name: SpO2; Test Result: 99 %
CDC Split Type: JPPFIZER INC202101212326

Write-up: Anaphylaxis; difficulty in breathing; redness on back of both hands, wrist, and anterior neck region; Blood pressure 141/95 mmHg; itching of the anterior neck region, back of both hands, and abdomen; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126833. The patient was a 24-year and 11-month-old female (age at vaccination). Body temperature before vaccination was 36.9 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 21Aug2021 at 09:29 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FE8162, Expiration date 30Nov2021) via an unspecified route of administration, as a single, dose for COVID-19 immunization. On 21Aug2021 at 09:50 (the day of vaccination), the patient experienced anaphylaxis. On 21Aug2021 (the day of vaccination), the outcome of the event was recovering. The course of the event was as follows: after the vaccination, the patient experienced difficulty in breathing with redness on back of both hands, wrist, and anterior neck region, and was emergently transferred to hospital. At hospital arrival, SpO2 99%, Blood pressure 141/95 mmHg, Body temperature 37.0 degrees centigrade, and consciousness level was clear. The patient was treated with drip infusion. For the itching of the anterior neck region, back of both hands, and abdomen, an ointment was applied. The symptoms subsequently alleviated and the patient went home. The reporting physician classified the events as serious (Medically significant) and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: it is considered consistent with an adverse reaction to vaccine.


VAERS ID: 1744789 (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: ATJNJFOC20210942869

Write-up: Vaccination failure; SARS-CoV-2 infection; This spontaneous report received from a physician via regulatory authority (Regulatory Authority, AT-BASGAGES-2021-044560) on 22-SEP-2021 and concerned a 24 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: 21C10-03 and expiry: unknown) dose was not reported, 1 total was administered on 12-MAY-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 2) infection (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).


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