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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 414 out of 8,010

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VAERS ID: 1705719 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-24
   Days after vaccination:11
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: Hypokinesia, Myalgia, Pain, Pain in extremity, SARS-CoV-2 test, Vaccination site joint pain
SMQs:, Rhabdomyolysis/myopathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Throbbing pain
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101152179

Write-up: my left arm; Localised muscle pain; Injection site joint pain; Pain upon movement; Movements reduced; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109022123171960-NPSBO. Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25889521. A 32-year-old male patient received second dose of bnt162b2 (Pfizer COVID-19 MRNA VACCINE BIONTECH, Solution for injection, Lot Number not reported) via an unspecified route of administration on 13Aug2021 as single dose for COVID-19 immunisation. The medical history included throbbing pain from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient did not have symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date, the patient experienced left arm, on 24Aug2021 localised muscle pain, injection site joint pain, pain upon movement, movements reduced. Patient left arm, to just below his elbow had a throbbing pain when not moving. When tried to move it in certain ways, or lift shoulder, the pain was sharp and he felt like his shoulder was weaker, which he discovered when trying to lift his child out of his cot, which patient usually had no problem with. Details of any relevant investigations or tests conducted were reported as none. The patient underwent lab tests and procedures which included sars-cov-2 test: No - Negative COVID-19 test on an unspecified date. The outcome of the event left arm was resolving, localised muscle pain, injection site joint pain, pain upon movement, movements reduced was not resolved. No follow-up attempts possible. No further information expected.


VAERS ID: 1705742 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Inappropriate schedule of product administration, Menstruation irregular, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210901; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101153019

Write-up: Irregular periods; I have had an incredibly heavy, painful period.; I have had an incredibly heavy, painful period.; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. The regulatory authority report number GB-MHRA-WEBCOVID-202109031246435870-WBOLW, Safety Report Unique Identifier GB-MHRA-ADR 25893037. A 25-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FF3319), via an unspecified route of administration on 24Aug2021 (at the age of 25-years-old) as dose 2, single and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FC9001), via an unspecified route of administration on 28Jun2021, as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included combined contraceptive pill which was in the middle of the pill strip. Patient did not had symptoms associated with COVID-19. Patient was not pregnant, and not currently breastfeeding. Patient did not test positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 25Aug2021, the patient experienced irregular periods, have had an incredibly heavy, painful period. She took the combined contraceptive pill and was in the middle of a pill strip, so was not due a period for two weeks. she continued to take the pill, which would normally stop a period, but it had no effect. It was now been 10 days and the period were still going irregular periods and had not lessened at all. The events irregular periods and incredibly heavy, painful period were medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: Negative COVID-19 test on 01Sep2021. The outcome of the event inappropriate schedule of vaccine administered was unknown, and other events were not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1705834 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 FF3318 / 2 RA / 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: ARGOTONE [EPHEDRINE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic to cats; Dust allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101135037

Write-up: appearance of vesicular skin lesion with burning pain; The initial safety information received was reporting only non-serious adverse drug reaction, Upon receipt of follow-up information on 06Sep2021, this case now contains serious adverse reaction. Information processed together This is a spontaneous report from a contactable pharmacist downloaded from the Agency WEB. This is a report received from the Agency (RA). Regulatory Authority report number is IT-MINISAL02-777035. A 32-year-old male patient received second dose of BNT162b2 (COMIRNATY; Lot Number: FF3318 and Expiration date: 31Oct2021) via an intramuscular route of administration in right deltoid (right shoulder) on 24Aug2021(at the age of 32-year-old) as dose 2, 30 ug single for COVID-19 immunization. Medical history included dust allergy and allergic to cats both from 01Jan1995 and unknown if ongoing. Concomitant medications included ephedrine (ARGOTONE) for an unknown indication from an unknown date and unknown if ongoing. On 24Aug2021. After a few hours after the administration of the second dose of vaccine, the patient experienced appearance of vesicular skin lesion with burning pain (herpes zoster) (Other medically important condition) on 24Aug2021. The appearance of vesicular skin lesion with burning pain was in the left allemithorax, from the dorsal region to the mammary region. After medical consultation set therapy with antiviral for oral sub ministration and aciclovir cream. Added vitamin B supplement. The outcome of the event was not recovered. Health Authority comment: 01Sep2021, Regulatory Authority: This report sheet was updated from NON-SERIOUS to SERIOUS as the suspected adverse reaction described is an event related to an infection or infestation. No follow-up attempts are needed. No further information is expected. Follow-up (06Sep2021): New information received from a contactable pharmacist downloaded from the Agency WEB IT-MINISAL02-777035 included: The information about event seriousness, treatment, dose, expiry date of suspect, and other clinical information was added. No follow-up attempts are possible. No further information expected.


VAERS ID: 1707889 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-24
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214020 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral venous thrombosis
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

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

Write-up: This case was received via Regulatory Authority (Reference number: ES-AEMPS-984484) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of CEREBRAL VENOUS THROMBOSIS in a 20-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214020) for COVID-19 vaccination. No Medical History information was reported. On 20-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced CEREBRAL VENOUS THROMBOSIS (seriousness criteria hospitalization, medically significant and life threatening). At the time of the report, CEREBRAL VENOUS THROMBOSIS outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company comment: This case concerns a 20-year-old, male patient with no relevant medical history, who experienced the unexpected event of Cerebral venous thrombosis. The event occurred approximately 5 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. Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Translated Document received on 14-SEP-2021. Dosage text translated, includes dose information.; Sender''s Comments: This case concerns a 20-year-old, male patient with no relevant medical history, who experienced the unexpected event of Cerebral venous thrombosis. The event occurred approximately 5 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.


VAERS ID: 1708122 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   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 BE7053 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Vaccination site pain
SMQs:, Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101149653

Write-up: Fatigue; Injection site pain; Shivering; Headache; Arthralgia; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional (non-HCP) downloaded from the Regulatory Authority-WEB, regulatory authority number -FAMHP-DHH-N2021-105925. A 52-year-old female patient received the second dose of BNT162B2 (COMIRNATY; solution for injection; Lot Number: BE7053) via an unspecified route of administration on 23Aug2021 at 11:30 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 24Aug2021, the patient experienced fatigue, injection site pain, shivering, headache and arthralgia. The events were all serious for disability. The course of the events was reported as follows: "2nd dose received on Monday 23Aug2021 at around 11:30 am. Pain at the injection site experienced the next day. Onset of other symptoms in the late afternoon on Tuesday 24Aug2021, beginning with headache followed by chills and joint pain. Took Dafalgan 500 mg; the adverse reactions faded away as the day progressed on Thursday 26Aug2021. I could not go to work these 2 days. On Friday 27Aug2021, I was on my feet and only some fatigue was still present." The clinical outcome of the event fatigue was recovering/resolving, and the clinical outcomes of the events injection site pain, shivering, headache and arthralgia were all recovered/resolved on 26Aug2021 Reporter Comment: Treatment - Outcome of the adverse drug reaction - Recovery: 2 days Situations Other: Immune response No follow-up attempts are possible. No further information expected.; Reporter''s Comments: Treatment - Outcome of the adverse drug reaction - Recovery: 2 days Situations Other: Immune response


VAERS ID: 1709258 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-08-24
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6975 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bacterial test, Facial paresis, Herpes zoster meningoencephalitis, Herpes zoster oticus
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Opportunistic infections (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CSF PCR; Result Unstructured Data: Test Result: varicella positive; Comments: HSV negative
CDC Split Type: DEPFIZER INC202101180615

Write-up: Herpes zoster oticus; Varicella zoster encephalitis; Facial paresis; This is a spontaneous report from a non-contactable consumer or other non-HCP from Germany downloaded from the Medicines Agency (MA) EudraVigilance-WEB [DE-PEI-202100184103]. A 15-years-old patient of an unspecified gender received unknown dose of BNT162B2 (COMIRNATY COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FE6975), via an unspecified route of administration on 13Jul2021 (age at the time of vaccination 15-years-old), as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 24Aug2021, the patient experienced Herpes zoster oticus, Facial paresis, and Varicella zoster encephalitis. On an unspecified date, the patient underwent lab tests and procedures which included CSF PCR, Bacterial test: varicella positive, HSV negative. The patient was hospitalized due to adverse events. The outcome for all the events was not recovered. No follow-up attempts possible. No further information expected.


VAERS ID: 1709822 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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: Influenza, Influenza like illness, Intermenstrual bleeding, Menstruation delayed
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Flu; Menstrual cramps
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101153121

Write-up: Late period; Intermenstrual bleeding/ Unusual menstrual bleeding; Flu; flu like symptoms; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109031829226210-ZYVE3 and Safety Report Unique Identifier GB-MHRA-ADR 25893840. A female patient of unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 24Aug2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included dysmenorrhoea and influenza from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. The patient''s concomitant medications were not reported. Historical vaccine received bnt162b2 (BNT162B2, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On 24Aug2021, the patient experienced flu like symptoms. On 25Aug2021, the patient experienced flu. On 01Sep2021, the patient experienced intermenstrual bleeding/ unusual menstrual bleeding. On an unspecified date, the patient experienced late period. Extreme flu like symptoms starting the following day lasting 24 hours. Unusual menstrual bleeding in the next couple of weeks, before period was due (on combined pill). Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Therapeutic measures were taken as a result of late period. The event (flu like symptoms) was recovered on 25Aug2021, event (Flu) was recovered on 26Aug2021, event (intermenstrual bleeding/ unusual menstrual bleeding) was not recovered and event (late period) was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1709950 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-08
Onset:2021-08-24
   Days after vaccination:16
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: Activated partial thromboplastin time, Asthma, Blood fibrinogen, Cerebral venous sinus thrombosis, Computerised tomogram head, Headache, Platelet count, Prothrombin time, SARS-CoV-2 test, Seizure, Venogram, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (narrow), Systemic lupus erythematosus (broad), Convulsions (narrow), Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Hypoglycaemia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ETHINYLESTRADIOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: Activated Partial Thromboplastin Clotting Time (aPTT); Result Unstructured Data: Test Result:27.6; Test Name: Fibrinogen; Result Unstructured Data: Test Result:3.2; Test Date: 20210902; Test Name: CT head; Result Unstructured Data: Test Result:Rt Temporal lobe hypodenstiy; Test Date: 20210906; Test Name: platelet count; Result Unstructured Data: Test Result:Unknown results; Test Name: PT; Result Unstructured Data: Test Result:10.9; Test Date: 20210903; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 20210903; Test Name: MRV; Result Unstructured Data: Test Result:extensive CVST
CDC Split Type: GBPFIZER INC202101182424

Write-up: vomiting; headache; bg asthma; seizure; Cerebral venous sinus thrombosis; This is a spontaneous report from a contactable physician received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109081415187450-5QYEW, Safety Report Unique Identifier GB-MHRA-ADR 25912330. A 25-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Aug2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included non-smoker. Father had a deep vein thrombosis (DVT) in late 50s. Mother has cerebral arteriovenous malformation (AVM). Patient has not had symptoms associated with COVID-19. Patient is not pregnant and is not currently breastfeeding. Concomitant medication included ethinylestradiol taken for contraception from 08Aug2018 to 04Aug2021. The patient previously took heparin. Drug history (DHx) indicates the patient took combined oral contraceptive pill (COCP). The patient experienced bg asthma on an unspecified date. The patient experienced cerebral venous sinus thrombosis on 24Aug2021. She also developed a mild headache on 24Aug2021 which worsened the following day (25Aug2021) slowly and has associated vomiting and increasing severity. The patient was admitted with headache and vomiting. She had a seizure on 31Aug2021 which was witnessed by the partner. Computerised tomogram (CT) head on 02Sep2021 showed right (rt) temporal lobe hypodenstiy. Magnetic resonance venogram (MRV) on 03Sep2021 showed extensive cerebral venous sinus thrombosis (CVST). The platelet count was measured on 06Sep2021 with unknown results. Prothrombin time (PT) was 10.9, activated partial thromboplastin clotting time (aPTT) was 27.6, and fibrinogen was 3.2; all on an unspecified date. The patient have none of the following: history of, or current, malignancy; previous reactions to medications, especially heparin or anticoagulants; confirmed or suspected autoimmune or inflammatory disease, including vasculitis; history of, or concurrent, intracranial malignancy; concurrent or recent intracranial infections; recent surgical or medical interventions to the central nervous system (including lumbar puncture); recent trauma/head injury. COVID-19 virus test was no - negative COVID-19 test on 03Sep2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the bg asthma and seizure was unknown; of the headache and vomiting was not recovered; while of the remaining events was recovering. All of the events were considered serious due to being medically significant and life threatening. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1710368 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-24
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Body temperature, Cardiac failure, Catheterisation cardiac, Coronary artery stenosis, Echocardiogram, Electrocardiogram, Electrocardiogram ST segment elevation, Myocarditis, Pericardial effusion, Pericarditis, Pyrexia, Ventricular hypokinesia
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: Body temperature; Result Unstructured Data: Test Result:37.5 Centigrade; Comments: pyrexia at 37.5 degrees Centigrade; Test Date: 20210827; Test Name: Emergency catheter test; Result Unstructured Data: Test Result:There was well significant stenosis; Comments: There was well significant stenosis in the coronary artery and the patient was clinically diagnosed as acute myocarditis and pericarditis.; Test Date: 20210827; Test Name: Echocardiography; Result Unstructured Data: Test Result:The patient had diffuse wall motion; Comments: The patient had diffuse wall motion decreased and had 5-11 illegible character of pericardial effusion.; Test Date: 20210827; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:There was a wide range of ST elevated found
CDC Split Type: JPPFIZER INC202101179066

Write-up: a wide range of ST elevated; diffuse wall motion decreased; 5-11 illegible of pericardial effusion; Acute myocarditis/myocarditis; Pericarditis; significant stenosis in the coronary artery; cardiac failure; pyrexia at 37.5 degrees Centigrade; Thoracic back pain; This is a spontaneous report from a contactable physician received from the Agency (RA). Regulatory authority report number is v21126204. The patient was a 40-year and11-month-old male. On 12Aug2021 (the day of vaccination), the patient received the second single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number Unknown, Expiration date Unknown) via an unspecified route of administration as DOSE 2, SINGLE for COVID-19 immunization. On 24Aug2021 (12 days after the vaccination), the patient experienced events. On 27Aug2021 (15 days after the vaccination), the patient was admitted to the hospital. On 04Sep2021 (23 days after the vaccination), the patient was discharged from hospital. On 04Sep2021 (23 days after the vaccination), the outcome of the events was recovering. The course of the events was as follows: From 24Aug2021 (12 days after the vaccination), the patient experienced pyrexia at 37.5 degrees Centigrade, and felt thoracic back pain. On 27Aug2021 (15 days after the vaccination), the patient visited another hospital. There was a wide range of ST elevated found in electrocardiogram and the patient was referred to the department. Echocardiography showed that the patient had diffuse wall motion decreased and had 5-11 illegible character of pericardial effusion. Acute myocarditis and pericarditis were suspected, and an emergency catheter test was performed and showed that there was well significant stenosis in the coronary artery and the patient was clinically diagnosed as acute myocarditis and pericarditis. The wall motion improved without becoming fulminant, and the patient was discharged on 04Sep2021 after the improvement of cardiac failure. The reporting physician classified the events as serious including life-threatening and hospitalization and assessed the causality between the events and BNT162B2 as unassessable. Other possible cause of the events such as any other diseases was also the viral possibility (for clarification). The reporting physician commented as follows: Despite of the viral possibility, there is no denial of vaccine-induced myocarditis and pericarditis. Information about lot/batch number has been requested.


VAERS ID: 1714751 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7053 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Dyspnoea, Dysstasia, Fatigue, Headache, Insomnia, Malaise, Myalgia, Nausea, Pyrexia, Sense of oppression, Sleep disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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 (narrow), Cardiomyopathy (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101155281

Write-up: Sleep disorder; Weakness; Oppression; Nausea; Shivering; Fever; Fatigue; Headache; Myalgia; Malaise; Breathing difficult; inability to get up; inability to sleep; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB with regulatory authority number BE-FAMHP-DHH-N2021-106039. Spontaneous COVID-19 report received by the authorities on 30Aug0821. A 55-year-old female patient received bnt162b2 (COMIRNATY), dose 2 at vaccination age of 55-year-old via an unspecified route of administration on 24Aug2021 (Lot Number: Fe7053) as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 24Aug2021, the patient experienced sleep disorder, weakness, oppression, nausea, shivering, fever, fatigue, headache, myalgia, malaise and breathing difficult which were considered as serious with seriousness criterion of disability. The patient did not received treatment for the adverse events. It was further reported that the Pfizer vaccine is still being tested so the adverse reactions cannot be monitored. She does not have an attending physician because she usually never sick. So, she did not have anyone to consult. If it had been more, she would probably have died in her bed. As far back as she can remember, she has never been as sick as during the 2 days following the vaccine. Headache, tightness, difficulty in breathing, inability to get up, and at the same time inability to sleep (24Aug2021). In addition, given the small decline in the tests carried out, we still have no idea of the long-term effects of the vaccine. The patient requested to be informed on the follow-ups and the procedures that you are going to put in place to monitor the vaccinated population (it seems to the patient that the follow-up should focus at least on the development of cancer, autoimmune disease, increase in winter illnesses, allergies, increase in Alzheimer disease, Parkinsons, for children whose pregnant mothers have been vaccinated: allergies, autism, motor development disorders, delay in learning.-for young people and children: effect on fertility). Another general question to be forwarded to the various experts and political decision-makers: according to them saying that vaccination was the solution to get out of the crisis, since now enough people in the region have been vaccinated, (as the vaccination centers are closing, it is because we achieved the objective) why have they have not lifted all the containment measures and why do we still have to wear a mask. And don''t talk about a variant because we knew from the start that there would be some. If a new wave is in the works as some experts announce, the vaccine will not have been useful in getting out of the crisis. It is time for politicians to show humility and acknowledge this. The vaccine should have been reserved only for people who were afraid of Covid knowing that since we can be a carrier even when vaccinated, we do not protect others. Note for her part I would have really wanted to avoid this vaccine if the constraints imposed by the policies had not forced her to do so. She will be less fearful regarding her long-term health. The outcome of the events was recovering. Follow-up attempt are not possible. No expected further information.


VAERS ID: 1714822 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCKX7 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Headache, Hot flush, Hypersensitivity, Pharyngeal swelling, Pyrexia, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101155252

Write-up: Acute allergic reaction; Pyrexia; Headache; Dizziness; throat started to swell from the inside; I could not breathe anymore; hot flashes; had a reaction again at the hospital; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021172037 with Safety Report Unique Identifiers DE-PEI-202100179901, and DE-CADRPEI-2021172037. A 27-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: SCKX7, expiry date not reported), via an unspecified route of administration on 24Aug2021 (at the age of 27 years old) as dose number unknown, 0.3 mL single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously took cefuroxime and experienced drug allergy. On 24Aug2021 the patient experienced acute allergic reaction, pyrexia, headache, and dizziness. Within 5 minutes of the vaccination, throat started to swell from the inside. Patient could not breathe anymore. In addition, patient suffered from dizziness and hot flashes. Patient was immediately given 250 ml of intravenous cortisone and an ambulance was called. Patient had a reaction again at the hospital (date unspecified in 2021) and received intravenous cortisone for a second time. This report is a serious report per hospitalization from an unspecified date in 2021 due to the events reported. The event could not breathe was also reported as medically significant. Therapeutic measures were taken as a result of the events reported. The outcome of the events was not recovered. Sender''s Comment: Do you or the person concerned have any known allergies? If so, which ones? Cefuroxime // Within 5 minutes of the vaccination, my throat started to swell from the inside. I could not breathe anymore. In addition, patient suffered from dizziness and hot flashes. I was immediately given 250 ml of intravenous cortisone and an ambulance was called. I had a reaction again at the hospital and received intravenous cortisone for a second time. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1714826 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-24
   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 - / UNK - / -

Administered by: Other       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? 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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101155297

Write-up: Myocarditis; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021172498. A 19-year-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 22Aug2021 as dose number unknown, 0.3ml single for COVID-19 immunisation. No medical history and concomitant medications were reported. On 24Aug2021, the patient experienced myocarditis. This report was serious (hospitalization). The outcome of the event was reported as resolved on 26Aug2021. Sender comment: Do you or the person concerned have any known allergies? If so, which ones? None. Details of risk factors or previous illnesses. None/recovered. No follow up attempts are possible. No further information is expected. Information about batch number cannot be obtained.


VAERS ID: 1714860 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cyanosis, Musculoskeletal stiffness
SMQs:, Anaphylactic reaction (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (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: ESJNJFOC20210934436

Write-up: Fingers stiffness; Acrocyanosis; This spontaneous report received from a health care professional via a Regulatory Authority (EVHUMAN Vaccines, ES-AEMPS-999756) on 17-SEP-2021 concerned a 49 year old female with an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE423 expiry: Unknown) .5 ml, with frequency 1 total administered on 23-AUG-2021 for covid-19 immunisation. No concomitant medications were reported. On 24-AUG-2021, the patient experienced fingers stiffness, acrocyanosis. Treatment with Covid-19 vaccine ad26.cov2.s was withdrawn on 23-AUG-2021. The patient recovered from fingers stiffness, and acrocyanosis on 25-AUG-2021. This report was serious (Other Medically Important Condition).


VAERS ID: 1715945 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-24
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005242 / 1 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Ophthalmic migraine, SARS-CoV-2 test
SMQs:, 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.
Allergies:
Diagnostic Lab Data: Test Date: 11/09/2020; Test Name: Test PCR positive; Test Result: Positive; Result Unstructured Data: Positive.
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: This case received via the regulatory authority (reference number: FR-AFSSAPS-BR20213321) on Sep 12, 2021 and forwarded to Moderna, reported by a consumer, describes the occurrence of ophthalmic migraine in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 3005242) for COVID-19 immunization. The patient''s past medical history included COVID-19 on Nov 9, 2020. On Aug 19, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Aug 24, 2021, after the mRNA-1273 (Moderna COVID-19 vaccine), patient experienced ophthalmic migraine (medically significant). At the time of the report, ophthalmic migraine: resolving. Diagnostic results: On Nov 9, 2020, SARS-CoV-2 test: Positive. Concomitant medication and treatment medication not provided. 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. The event assessed serious as per regulatory authority report.


VAERS ID: 1716141 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-08-24
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Postoperative care
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101155311

Write-up: Appendicitis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB (regulatory authority number AT-BASGAGES-2021-043338). A 15-year-old female patient received BNT162B2 (COMIRNATY) intramuscular, on 24Jul2021, as the first single dose, for COVID-19 immunisation. Medical history included good postoperative course. The patient''s concomitant medications were not reported. The patient experienced appendicitis on 24Aug2021 with outcome of recovered on an unspecified date in 2021. On 25Aug2021 the patient experienced appendectomy. The event was reported serious per hospitalization. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1716210 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Echocardiogram, Electrocardiogram, Inappropriate schedule of product administration, Magnetic resonance imaging heart, Myocarditis, Pain, Pyrexia, Troponin
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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 Date: 20210830; Test Name: Echocardiography; Result Unstructured Data: Test Result:Normal LVEF, normal findings; Test Date: 20210827; Test Name: EKG; Result Unstructured Data: Test Result:Elevations of the front wall; Test Date: 20210831; Test Name: Kardio-MRT; Result Unstructured Data: Test Result:Mild myocarditis; Test Date: 20210827; Test Name: Troponin; Result Unstructured Data: Test Result:3.7 ng/ml
CDC Split Type: DEPFIZER INC202101155241

Write-up: Myocarditis; Febrile symptoms; stinging sensation in the thorax; first dose on 13Jul2021, second dose on 24Aug2021; This is a spontaneous report from a physician downloaded from the regulatory authority-WEB. Regulatory authority number DE-PEI-202100180356. A 24-year-old male patient received bnt162b2 (COMIRNATY, solution for injection; Lot Number: Unknown) intramuscular, on 24Aug2021, as dose 2, 0.3 ml single, at the age of 24-year-old, for covid-19 immunization. The patient''s medical history was not reported. The patient''s concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY, solution for injection; Lot Number: not reported) intramuscular, on 13Jul2021, as dose 1, 0.3 ml single, at the age of 23-year-old, for covid-19 immunization and experienced no adverse event. The patient experienced myocarditis on 25Aug2021. In 2021, the patient experienced febrile symptoms and stinging sensation in the thorax. It was also reported that the patient received first dose on 13Jul2021 and second dose on 24Aug2021. The patient underwent lab tests and procedures which included echocardiogram: normal lvef, normal findings on 30Aug2021; electrocardiogram: elevations of the front wall on 27Aug2021; magnetic resonance imaging heart: mild myocarditis on 31Aug2021; and troponin: 3.7 ng/ml on 27Aug2021. The events myocarditis, febrile symptoms and stinging sensation in the thorax were assessed as serious (hospitalization). Outcome of the event myocarditis was not recovered while it was unknown for the other events. Sender comment: Febrile symptoms, no fever recorded the day after vaccination. Still did a 70 km bike tour. Then, in the evening, patient suffered from a stinging sensation in the thorax. The following day: Patient had a consultation with the outpatient cardiologist. Patient was subsequently admitted as an inpatient. Patient was then diagnosed with acute myocarditis. A temporal connection exists with the vaccination. Outpatient treatment was not necessary. No follow up attempts possible, no further information expected. Information about batch number cannot be obtained.


VAERS ID: 1716286 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   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 FG4493 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Discomfort, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Influenza like illness, Loss of consciousness, Presyncope, SARS-CoV-2 test, Sinus bradycardia
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), Disorders of sinus node function (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: trans-thoracic echocardiography; Result Unstructured Data: Test Result:normal; Test Date: 20210824; Test Name: ECG; Result Unstructured Data: Test Result:showing major sinus bradycardia (30 bpm), junction; Comments: showing major sinus bradycardia (30 bpm), junctional escape and sinus pause greater than 6 seconds.; Test Name: Holter ECG; Result Unstructured Data: Test Result:normal; Test Date: 20210824; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101166559

Write-up: Vagal reaction; loss of consciousness; Influenza like illness; arthralgia; Recurrence of discomfort; sinus bradycardia (30 bpm); This is a spontaneous report received from a contactable physician downloaded from the Regulatory Agency-WEB. The regulatory authority report number is FR-AFSSAPS-BR20213320. A 28-years-old male patient received the second dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: FG4493) via intramuscular administered in left arm on 23Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 24Aug2021, the patient experienced appearance of a general reaction with fever and arthralgia accompanied by malaise with loss of consciousness at home. The patient underwent lab tests and procedures which included trans-thoracic echocardiography and Holter ECG: normal on an unspecified date and ECG: recurrence of discomfort in the Emergency Department with percritical ECG showing major sinus bradycardia (30 bpm), junctional escape and sinus pause greater than 6 seconds on 24Aug2021. Malaise whose vagal origin is preferred with severe vagal reaction. The outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts possible. No further information expected.


VAERS ID: 1716471 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7051 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Arthralgia, Blood pressure increased, Blood pressure measurement, Body temperature, Chest pain, Chills, Headache, Inappropriate schedule of product administration, Laryngitis, Palpitations, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Arthritis (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: Blood pressure; Result Unstructured Data: Test Result:195/110 mmHg; Test Date: 202108; Test Name: Body temperature; Result Unstructured Data: Test Result:40.2 Centigrade
CDC Split Type: CZPFIZER INC202101194942

Write-up: Pain head; severe joint pain; Rigoring; Pyrexia; Laryngitis; Inappropriate schedule of vaccine administered; Blood pressure increased; Palpitation; Cardiac arrhythmia; Anginal pain behind the sternum; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. Regulatory authority number is CZ-CZSUKL-21010307. A 38-year-old male patient received the second dose of bnt162b2 (COMIRNATY) intramuscular on 24Aug2021 (at the age of 38 years old) (Lot Number: FE7051) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No allergies, no permanent medications, no health complications, never hospitalized. The patient previously received the first dos of bnt162b2 intramuscular on 09Aug2021 (Batch/Lot Number: Unknown) for COVID-19 immunisation. The patient experienced blood pressure increased (life threatening) on 24Aug2021, palpitation (life threatening) on 24Aug2021, cardiac arrhythmia (life threatening) on 24Aug2021, anginal pain behind the sternum (life threatening) on 24Aug2021, pain head on 25Aug2021, severe joint pain on 25Aug2021, rigoring on 25Aug2021, pyrexia on 25Aug2021, laryngitis on 25Aug2021, inappropriate schedule of vaccine administered on 24Aug2021. The patient underwent lab tests and procedures which included blood pressure: 195/110 mmHg on 24Aug2021, body temperature: 40.2 centigrade in Aug2021. The outcome of the events Pain head, Rigoring, Pyrexia was recovered on 25Aug2021, of the event severe joint pain was recovered on 26Aug2021, of the event Laryngitis was recovering, of the other events was recovered on 24Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1716543 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
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: Angiogram, Cerebral venous sinus thrombosis, Computerised tomogram, Fibrin D dimer, Platelet count
SMQs:, Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: sinus venous CT angiography; Result Unstructured Data: Test Result:unknown results; Test Name: CT without / with contrast; Result Unstructured Data: Test Result:unknown results; Test Date: 20210830; Test Name: D-dimer; Result Unstructured Data: Test Result:241000; Test Date: 20210320; Test Name: Platelet; Result Unstructured Data: Test Result:288000; Test Date: 20210829; Test Name: Platelet; Result Unstructured Data: Test Result:245000
CDC Split Type: ESPFIZER INC202101155765

Write-up: Cerebral venous sinus thrombosis; This is a spontaneous report from a contactable physician downloaded from the WEB. Regulatory authority number ES-AEMPS-989157. A 29-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection; lot number unknown) via an unspecified route of administration, on 24Aug2021, as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient is not pregnant at the time of vaccination. Historical vaccine included (COMIRNATY, Solution for injection; lot number not reported) via an unspecified route of administration, on 03Aug2021, as dose 1, single for covid-19 immunization. The patient previously took oral contraceptives (unspecified). The patient experienced cerebral venous sinus thrombosis (cerebral venous sinus thrombosis) (hospitalization) on 24Aug2021. The patient underwent lab tests and procedures which included sinus venous CT angiography with unknown results on an unspecified date CT without / with contrast with unknown results on an unspecified date, fibrin d dimer: 241000 on 30Aug2021, platelet count: 288000 on 20Mar2021, and platelet count: 245000 on 29Aug2021. It was unknown if the patient has COVID-19 passed. Determination of anti-PF4 antibodies and technique was not performed as there was no thrombopenia. Pending completion of thrombophilia study. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1716680 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-24
   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 - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood creatinine, Blood creatinine increased, Computerised tomogram, Dyspnoea, Fibrin D dimer, Fibrin D dimer increased, Free prostate-specific antigen, Investigation, Occult blood, Pain, Polymerase chain reaction, Pulmonary embolism, Sinus tachycardia, Troponin, Troponin increased, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Anaphylactic reaction (broad), Haemorrhage laboratory terms (broad), Myocardial infarction (narrow), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ingrown toe nail; Meniscus operation
Allergies:
Diagnostic Lab Data: Test Date: 20210828; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:85; Comments: Ui/L; Test Date: 20210828; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result:61; Comments: Ui/L; Test Date: 20210828; Test Name: Creatinine; Result Unstructured Data: Test Result:113; Comments: ?mol/L; Test Date: 20210828; Test Name: Computed tomography angiogram; Result Unstructured Data: Test Result:See below results:; Comments: existence of a left lower lobar pulmonary embolism with downstream pulmonary infarction and a left pleural effusion.; Test Date: 20210828; Test Name: D-dimer; Result Unstructured Data: Test Result:1899 ng/ml; Test Name: Prostate-specific antigen; Result Unstructured Data: Test Result:Normal; Test Date: 20210828; Test Name: liver balance; Result Unstructured Data: Test Result:slightly disturbed; Test Name: Fecal blood test negative; Result Unstructured Data: Test Result:Negative; Test Date: 20210828; Test Name: Polymerase Chain Reaction test; Result Unstructured Data: Test Result:Not reported; Test Date: 20210828; Test Name: Sinus tachycardia; Result Unstructured Data: Test Result:120; Comments: 120/min with orthopnea and left basal crackles.; Test Date: 20210828; Test Name: troponin; Result Unstructured Data: Test Result:22 ng/L; Comments: incresed; Test Date: 20210825; Test Name: Chest radiography; Result Unstructured Data: Test Result:See below results:; Comments: finding a left basal opacity compatible with left lower lobar pneumopathy, prompting the introduction of Augmentin.
CDC Split Type: FRPFIZER INC202101155114

Write-up: Pulmonary embolism; sinus tachycardia; creatinine increased to 113 umol/L; troponin increased to 22 ng/L; D-dimer increased to 1899 ng/mL; left basithoracic pain; dyspnoea; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number FR-AFSSAPS-NT20213620. This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority number FR-AFSSAPS-NT20213620. A 52-years-old male patient received bnt162b2 (COMIRNATY) solution for injection, (Lot Number and expiry date was unknown) dose 1 via intramuscular route of administration at arm left on 19Aug2021 as a single dose for covid-19 immunisation. Medical history included meniscus operation from an unknown date and unknown if ongoing, in growing nail from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient''s concomitant medications were not reported. On 24Aug2021 the patient experienced pulmonary embolism, left basithoracic pain, dyspnoea, sinus tachycardia, creatinine increased to 113 umol/l (blood creatinine increased), troponin increased to 22 ng/l, d-dimer increased to 1899 ng/ml. (The male patient presents with left basithoracic pain associated with dyspnoea since approximately 24Aug2021. He consulted his physician on 25Aug2021 who ordered chest radiography finding a left basal opacity compatible with left lower lobar pneumopathy), prompting the introduction of Augmentin. He attended the Emergency Room on 28Aug2021 due to persistence of symptoms. On arrival, he presented with sinus tachycardia at 120/min with orthopnoea and left basal crackles. The blood test showed creatinine increased to 113 umol/L, a slightly disturbed liver balance with Aspartate aminotransferase 61 Ui/L and Alanine aminotransferase 85 Ui/L, troponin increased to 22 ng/L and D-dimer increased to 1899 ng/mL. The computed tomography angiogram confirmed the existence of a left lower lobar pulmonary embolism with downstream pulmonary infarction and a left pleural effusion. There is no evidence of scenography acute cor pulmonale. The male patient is haemodynamically stable with no need for oxygen. Pneumologist''s advice, pulmonary embolism of low intermediate seriousness to be treated with low molecular weight heparin for 48 hours and then switched to direct oral anticoagulants. Note that the first dose of Comirnaty vaccine was administered on 19Aug2021, bring 5 days before the onset of symptoms. Search for factor II/factor V mutation and lupus circulating anticoagulant (not feasible in the acute phase due to increased fibrinogen) scheduled. Routine Screening Update: Fecal blood test negative and Prostate-specific antigen within normal range. C/S protein and SAPL research in progress. Anticoagulant therapy to be continued for at least six months. Xarelto 15 mg: 1 tablet in the morning and evening until 17Sep2021, Xarelto 20 mg: 1 tablet in the morning from 18Sep2021, Amlodipine 10 mg: 1 tablet in the morning. The patient underwent lab tests and procedures which included, x-ray: see below results: on 25Aug2021 finding a left basal opacity compatible with left lower lobar pneumopathy, on 28Aug2021 alanine aminotransferase: 85 Ui/L, aspartate aminotransferase: 61 Ui/L, blood creatinine: 113 ?mol/L, computerised tomogram: see below results: existence of a left lower lobar pulmonary embolism with downstream pulmonary infarction and a left pleural effusion, fibrin d dimer: 1899 ng/ml on 28Aug2021, occult blood: negative, free prostate-specific antigen: normal on an unspecified date, investigation: slightly disturbed, polymerase chain reaction: not reported on 28Aug2021, sinus tachycardia: 120 on 28Aug2021 120/min with orthopnea and left basal crackles, troponin: 22 ng/l on 28Aug2021 increased, prompting the introduction of Augmentin. Therapeutic measures were taken as a result of pulmonary embolism (pulmonary embolism). Outcome of the event Pulmonary embolism was recovering, all other events was unknown. No follow-up attempts are possible. No further information is expected.?


VAERS ID: 1716748 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Respiratory distress, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (broad), Hypersensitivity (narrow), Respiratory failure (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? 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: Food allergy; Quincke''s edema; Skin rash; Specific allergy (drug) (morphine, hypertensives, primperan)
Allergies:
Diagnostic Lab Data: Test Name: COVID test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101166736

Write-up: Distress respiratory; quincke edema; This is a spontaneous report from a contactable physician downloaded from the Agency WEB FR-AFSSAPS-TO20217277. A 56-year-old female patient received first dose of BNT162B2 (COMIRNATY, solution for injection, lot number: FG6273 and expiry date was not reported), intramuscularly in Arm right, on 24Aug2021(Age at vaccination:56 years), as dose 1, single for COVID-19 immunisation. The patient medical history included Food allergy, Specific allergy (drug): morphine, hypertensives, primperan, Quincke''s oedema and skin rash. Concomitant medications were not reported. On 24Aug2021, 20 minutes after the vaccination the patient had respiratory distress with quincke oedema (glottis and epiglottis). The patient underwent COVID test with the result of negative on an unspecified date. The patient received treatment for the events with Cortisone injection IVD. The outcome of the events were recovered on 24Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1716889 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Headache, Hyperhidrosis, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101160895

Write-up: Runny nose; Pain stomach; Dizzy; Sweating; Sore throat; Exhaustion; Headache; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202109052042030060-A5AZK, Safety Report Unique Identifier GB-MHRA-ADR 25897376. A female patient of an unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: UNKNOWN) via an unspecified route of administration on 24Aug2021, as dose 1, single for COVID-19 immunisation. Medical history was not reported. It was unsure if the patient had symptoms associated with COVID-19. The patient was not enrolled in clinical trial. Concomitant medications were not reported. On 24Aug2021, the patient experienced headache and exhaustion; on 25Aug2021, the patient experienced sweating and sore throat; on 26Aug2021, the patient experienced dizzy; on 30Aug2021, the patient experienced pain stomach; and on 01Sep2021, the patient experienced runny nose; all reported as serious for being medically significant. On an unknown date, the patient underwent COVID-19 virus test and the result was No - Negative COVID-19 test. The clinical outcome of sweating was resolved on 26Aug2021, dizzy was resolved on 28Aug2021, headache was resolved on 31Aug2021 and that of pain stomach was resolved on 02Sep2021. The clinical outcomes of the events exhaustion, sore throat and runny nose was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1716952 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   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: Axillary pain, SARS-CoV-2 test
SMQs:, 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 Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101168449

Write-up: Armpit pain; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109060824528790-MAPWD, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25898432. A 38-years-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 23Aug2021 as DOSE 2, SINGLE for covid-19 immunisation. The patients medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On 24Aug2021, the patient experienced armpit pain. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on No - Negative COVID-19 test. The outcome of the event was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1717037 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-24
   Days after vaccination:11
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: Abdominal pain upper, SARS-CoV-2 test
SMQs:, Acute pancreatitis (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pancreatic pain (Pancreatic pain 10 years ago - none since)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101176241

Write-up: Pancreatic pain; This is a spontaneous report from a contactable other health professional received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109071048484650-KZTPP. Safety Report Unique Identifier GB-MHRA-ADR 25905895. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Aug2021 as single dose for COVID-19 immunization. Medical history included pancreatic pain (pancreatic pain 10 years ago - none since) from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. The patient experienced pancreatic pain on 24Aug2021. The event resulted in hospitalization (on an unknown date in 2021). The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. It was unsure if patient was enrolled in clinical trial. The patient report did not relate to possible blood clots or low platelet counts. The outcome of the event was not resolved at the time of this report. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1717161 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-08-24
   Days after vaccination:80
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1921 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart disease, unspecified (tested before arranged heart surgery)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: CT for E gen; Result Unstructured Data: Test Result:26.33; Test Date: 20210825; Test Name: CT for SarsCov2 gen; Result Unstructured Data: Test Result:25.39; Test Date: 20210825; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: HRPFIZER INC202101156413

Write-up: Vaccination failure/SARS-CoV-2 PCR test: positive; Vaccination failure/SARS-CoV-2 PCR test: positive; Coughing/light cough; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number HR-HALMED-300050630. A 71-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 05May2021 (Lot Number: EX6537, unknown expiration) as dose 1, 0.3 ml single; and intramuscular on 05Jun2021 (Lot Number: FD1921, unknown expiration) as dose 2, 0.3 ml single, for COVID-19 immunisation. Medical history included ongoing chronic heart disease, unspecified (tested before arranged heart surgery). The patient''s concomitant medications were not reported. The patient experienced vaccination failure and coughing on 24Aug2021. Interference developed only one day on 24Aug2021 (light cough), PCR positive on 25Aug2021. The patient underwent lab tests and procedures which included CT for E gen: 26.33, CT for SarsCov2 gen: 25.39, and SARS-CoV-2 PCR test: positive on 25Aug2021. The patient is in isolation at home. The patient recovered from the events on 25Aug2021. As of 07Sep2021, investigation result was received from Product quality complaint team. Conclusion for lot number FD1921: 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: Reference PR ID 6078283 (see File attachment in this investigation record) The complaint for "PFIZERBIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FD1921. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regular. Conclusion for lot number EX6537: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QClab 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: Reference PR ID 6004595 (see File attachment in this investigation record) The complaint for "PFIZERBIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EX6537. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regular. Information on the lot/batch number has been requested.


VAERS ID: 1717222 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   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: Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101155642

Write-up: chest pain, diagnosed as pericarditus; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority. -WEB, regulatory authority number IE-HPRA-2021-083680.Safety Report Unique Identifier: IE-HPRA-2021-083680. A 16-year-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 23Aug2021 at DOSE 2, SINGLE for COVID-19 immunization. The patient did not have any relevant medical history/concurrent conditions. The patient was not taking any concomitant medication. Historical vaccine included first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was unknown) as DOSE 1, SINGLE for COVID-19 immunization. On 23/Aug/2021, the patient was vaccinated with his second dose of Comirnaty, 1.5 days later on 24/Aug/2021, the patient experienced chest pain and was diagnosed with pericarditis. The duration of the reaction was reported as over 4 days (4 days +). The patient was treated with anti-inflammatories (unspecified) and beta blockers (unspecified). At the time of reporting the outcome of the reaction was unknown. No follow-up attempts are needed, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1717251 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-08-24
   Days after vaccination:133
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210828; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101156271

Write-up: Sars-cov-2 vaccination failure. covid pneumonia19. positive pcr test; Sars-cov-2 vaccination failure. covid pneumonia19. positive pcr test; This is a Non-interventional study report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number -MINISAL02-778163. A 88-year-old female subject received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 13Apr2021 (Lot Number: ew2246; Expiration Date: 31Jul2021) as 0.3 ml single dose, dose 1 intramuscular, administered in Arm Left on 23Mar2021 (Lot Number: ET3620) as single dose for COVID-19 immunisation. The subject''s medical history concomitant medications were not reported. The subject experienced sars-cov-2 vaccination failure, covid pneumonia19 on 24Aug2021. The subject underwent lab tests and procedures which included COVID-19 PCR test (positive rapid swab): positive on 28Aug2021. Actions taken (Therapy for suspected covid pneumonia in subject with positive rapid swab with suggestive covid symptoms). The outcome of events was not recovered. Complaint record received with summary investigation, 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 EW2246 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 CAPA were identified as the complaint was not confirmed. The reporter''s assessment of the causal relationship of the event with the suspect product bnt162b2 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.; Sender''s Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to vaccination failure and COVID-19 pneumonia cannot be ruled out


VAERS ID: 1717321 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   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 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Chest pain, Myalgia, Oxygen saturation, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), 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? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: Blood pressure; Result Unstructured Data: Test Result:122/77 mmHg; Test Date: 20210827; Test Name: Body temperature; Result Unstructured Data: Test Result:37 Centigrade; Test Date: 20210827; Test Name: Oxygen saturation; Test Result: 98 %
CDC Split Type: ITPFIZER INC202101155349

Write-up: Sternal pain; Generalised muscle aches; Fever; FARO This is a non-interventional study report from the observational study Faro from a contactable pharmacist from the Regulatory Authority-WEB, regulatory authority number -MINISAL02-779119. A 12-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: FG4686; Expiration Date: 30Nov2021), dose 2 intramuscular on 23Aug2021 11:55 as 0.3mL, single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced generalised muscle aches, fever on 24Aug2021, sternal pain on 26Aug2021. The events were reported as serious due to hospitalization from 27Aug2021 to 28Aug2021. Measures taken (Admitted to Pediatrics for observation and investigation of the case). On 24Aug2021 onset of fever and muscle aches which have regressed. From 26Aug2021 sternal chest pain. She arrived to the emergency room on 27Aug2021 where she was hospitalized for investigating the case. She was sent back to her home on 28Aug2021 for improvement. The patient underwent lab tests and procedures which included blood pressure: 122/77 mmhg, body temperature: 37 centigrade, and oxygen saturation: 98 % on 27Aug2021. The outcome of events was recovering. Reporter comment: No history. 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.; Reporter''s Comments:.; Sender''s Comments: Based on the close temporal relationship, the association between the event chest pain with COMIRNATY use can not be fully excluded. There is a reasonable possibility that the events myalgia and pyrexia were related with COMIRANTY use based on known drug safety profile. 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: 1717467 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-08-24
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8162 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Haemorrhagic diathesis, Platelet count, Platelet count decreased, Thrombocytopenic purpura
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GENINAX; FUROSEMIDE; TAKECAB; ALLOPURINOL; BISOPROLOL FUMARATE; MAGNESIUM OXIDE; ROSUVASTATIN; JARDIANCE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Heart disorder; Polymyalgia rheumatica
Allergies:
Diagnostic Lab Data: Test Date: 20210811; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before the vaccination; Test Date: 20210824; Test Name: Platelets; Result Unstructured Data: Test Result:71000; Test Date: 20210827; Test Name: Platelets; Result Unstructured Data: Test Result:66000; Test Date: 20210906; Test Name: Platelets; Result Unstructured Data: Test Result:77000; Test Date: 20210911; Test Name: Platelets; Result Unstructured Data: Test Result:10000; Test Date: 20210911; Test Name: Platelets; Result Unstructured Data: Test Result:2000
CDC Split Type: JPPFIZER INC202101207376

Write-up: Thrombocytopenic purpura; Bleeding tendency; Platelets decreased (71000)/ Platelets decreased to 10000/ Platelets 2000; This is a spontaneous report from a contactable physician (vaccinator) received from the regulatory authority. Regulatory authority report number is v21127822. The patient was a 79-year and 4-month-old (age at second vaccination) male. Body temperature before vaccination was 36.5 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 Heart disease, Diabetes mellitus and Polymyalgia rheumatica. Concomitant drugs included garenoxacin mesilate (GENINAX), furosemide, vonoprazan fumarate (TAKECAB), allopurinol, bisoprolol fumarate, magnesium oxide, rosuvastatin and empagliflozin (JARDIANCE). On 11Aug2021 at 14:02 (the day of vaccination), the patient received the second 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 24Aug2021 (13 days after the vaccination), the patient experienced Thrombocytopenic purpura. On 11Sep2021 (31 days after the vaccination), the outcome of the event was unknown. The course of the event was as follows: On 24Aug2021 (13 days after the vaccination), there was Bleeding tendency, and the patient went to a hospital, blood test was performed, the patient was introduced to hospital due to Platelets decreased (71000). Platelets 66000 (27Aug2021), 77000 (06Sep2021), during the period, the patient went the hospital and Aspiration bone marrow was performed. On 10Sep2021, the patient visited our hospital regularly, and blood test was performed. On 11Sep2021, there was an urgent contact for outsourcing that the Platelets decreased to 10000, and the patient was introduced to another hospital in the same day. In the same day, the result of blood test was Platelets 2000, the patient was introduce to another hospital as Thrombocytopenic purpura. The reporting physician classified the event as serious (Life-threatening ) 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: Before the vaccination, there was no same symptoms, Platelets decreased Rapidly. Oral medicine Prescribed by our hospital or other hospital was not changed from July on, there was no other reason except the vaccination.


VAERS ID: 1717480 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-08-24
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: JPMODERNATX, INC.MOD20213

Write-up: COVID-19 infection; This case was received via regulatory authority (Reference number: JP-TAKEDA-2021TJP086941) on 07-Sep-2021 and was forwarded to Moderna on 18-Sep-2021. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 infection) in a 21-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 26-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced COVID-19 (COVID-19 infection) (seriousness criterion medically significant). At the time of the report, COVID-19 (COVID-19 infection) had resolved. This case was reported by a family member of a vaccine recipient via the Drug Information Center. COVID-19 infection was assessed as serious by the MAH. On 26-Jul-2021, in the morning, the patient received the 1st dose of this vaccine. On 24-Aug-2021, the patient visited a medical institution and was found positive for COVID-19 infection. The patient healed him/herself at home. On an unknown date, COVID-19 infection resolved. The outcome of COVID-19 infection was reported as resolved. Follow-up investigation is impossible due to the reporters non-cooperation. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. This case concerns a 21-year-old male patient with no relevant medical history, who experienced the unexpected event of COVID-19. The event occurred approximately 30 days after the first dose of Spikevax. The event was considered related to the product per the reporter''s assessment. The rechallenge was not appliable. There is no information about the second dose. The benefit-risk relationship of Spikevax in not affected by this report.; Sender''s Comments: This case concerns a 21-year-old male patient with no relevant medical history, who experienced the unexpected event of COVID-19. The event occurred approximately 30 days after the first dose of Spikevax. The event was considered related to the product per the reporter''s assessment. The rechallenge was not appliable. There is no information about the second dose. The benefit-risk relationship of Spikevax in not affected by this report.


VAERS ID: 1717605 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 FG3716 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Paraesthesia oral, Pharyngeal paraesthesia
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101155615

Write-up: PARESTHESIA TONGUE; PHARYNGEAL PARESTHESIA; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Uaxjzg. A 54-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 24Aug2021 (Batch/Lot Number: FG3716) as DOSE 2, SINGLE, at the age of 54-year-old for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously took comirnaty for immunisation and experienced no adverse event. The patient experienced paresthesia tongue on 24Aug2021 with outcome of recovered, pharyngeal paresthesia on 24Aug2021 with outcome of recovered. Therapeutic measures were taken as a result of paresthesia tongue, pharyngeal paresthesia. The clinical course as follow: The patient was administered the second dose of Comirnaty and developed after about 25 minutes tingling (paresthesia) in his tongue and pharynx. He was first treated with EpiPen (adrenaline), which gave some improvement but the symptoms returned after a few minutes. He was then given 20 mg cetirizine which revealed the symptoms, but again the symptoms returned and he was administered another dose of cetirizine. After that he had no symptoms but was hospitalized for further observation. Relatedness of drug to reaction(s)/event: Source of assessment: Center. Result of Assessment: Possible. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1717612 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 FG 3716 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Paraesthesia oral, Pharyngeal hypoaesthesia, Tremor, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101155534

Write-up: NUMBNESS THROAT; BREATHING DIFFICULT; URTICARIA; SHAKING OF LOWER EXTREMITIES; tingling sensation of the tongue; This is a spontaneous report from a contactable Health Care Professional downloaded from the regulatory authority-WEB. This is a report received from regulatory authority. Regulatory authority report number NO-NOMAADVRE-FHI-2021-Uqjg3p with Safety Report Unique Identifier NO-NOMAADVRE-E2B_00045871. A 39-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Right on 24Aug2021 (Lot Number: FG 3716) at age of 39 years old as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient was administered the first dose of Comirnaty under increased surveillance in an Intensive Care Unit due to a previous reaction to vaccination in 2009. She developed urticaria, feeling of numbness in her throat/ numbness throat, tingling sensation of the tongue, shaking of lower extremities and breathing difficult on 24Aug2021. She was treated with half a dose of adrenaline and an antihistamine, and was hospitalized for further observation. The outcome was recovering. Reporter comment: Reporter''s qualification: Nurse Sender comment: This case has been linked to case FHI-2009-9376 regarding the same patient.; Reporter''s Comments: Reporter''s qualification: Nurse


VAERS ID: 1720590 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-24
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Facial paralysis (facial paralysis on the right side that lasted approximately 18 months.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101166553

Write-up: Facial palsy; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authorirty. WEB. This is a report received Regulatory authority report number FR-AFSSAPS-BR20213325 with Safety Report Unique Identifier FR-AFSSAPS-BR20213325. A 62-year-old male patient received BNT162B2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 19Aug2021 (Batch/Lot Number: FG4493) as single dose for COVID-19 immunization. Medical history included facial paralysis from an unknown date and unknown if ongoing facial paralysis on the right side that lasted approximately 18 months. The concomitant medications were not reported. On 20Aug2021-21Aug2021 and 22Aug2021, slight difficulty swallowing one the left side of the throat. On 24Aug2021, started feeling numbness on the left side (cheek) and left eye, slightly tearing up. On 25Aug2021, stronger numbness on the left side, and left side of the mouth. Difficult speaking and inability to completely close the left eye. The patient experienced Facial palsy (facial paralysis) on 24Aug2021. The patient was hospitalized for facial palsy from 25Aug2021 to 26Aug2021. Consultation with the Ear, Nose, Throat doctor: corticoids perfusion the whole time while being hospitalised then discharged under corticoids treatment for 5 days; therapeutic measures were taken as a result of facial palsy (facial paralysis). The patient did not recover from the event.


VAERS ID: 1720598 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Adenovirus test, Antinuclear antibody, C-reactive protein, C-reactive protein increased, Chlamydia test, Coxiella test, Cytomegalovirus test, DNA antibody, Ejection fraction decreased, Electrocardiogram, Electrocardiogram ST segment elevation, Enterovirus test, Epstein-Barr virus test, HIV test, Hepatitis C virus test, Herpes simplex test, Human herpes virus 6 serology, Leptospira test, Leptospirosis, Lyme disease, Magnetic resonance imaging heart, Myocarditis, Parvovirus B19 test, Rubella, Toxoplasmosis, Troponin I, Troponin I increased, Varicella virus test, Ventricular hypokinesia
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Cardiomyopathy (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (narrow), 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? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: adenovirus; Test Result: Negative ; Test Date: 20210825; Test Name: anti-nuclear antibodies; Test Result: Negative ; Test Date: 20210825; Test Name: soluble anti-nuclear; Test Result: Negative ; Test Date: 20210825; Test Name: Chlamydia pneumoniae; Result Unstructured Data: Test Result:pending; Test Date: 20210825; Test Name: Chlamydia psittaci; Result Unstructured Data: Test Result:pending; Test Date: 20210825; Test Name: Chlamydia trachomatis; Test Result: Negative ; Test Date: 20210825; Test Name: Coxiella burnetii; Result Unstructured Data: Test Result:pending; Test Date: 20210824; Test Name: C-reactive protein; Result Unstructured Data: Test Result:69.3 mg/l; Test Date: 20210825; Test Name: C-reactive protein; Result Unstructured Data: Test Result:76.8 mg/l; Test Date: 20210826; Test Name: C-reactive protein; Result Unstructured Data: Test Result:44.4 mg/l; Test Date: 20210825; Test Name: Cytomegalovirus; Test Result: Negative ; Test Date: 20210825; Test Name: cytomegalovirus Polymerase Chain Reaction; Test Result: Negative ; Test Date: 20210825; Test Name: anti-double stranded deoxyribonucleic acid; Test Result: Negative ; Test Date: 20210824; Test Name: Electrocardiography; Result Unstructured Data: Test Result:diffuse ST above shift detected; Test Date: 20210825; Test Name: enterovirus; Test Result: Negative ; Test Date: 20210825; Test Name: Epstein-Barr virus; Result Unstructured Data: Test Result:compatible with old infections; Test Date: 20210825; Test Name: Epstein-Barr virus; Test Result: Negative ; Test Date: 20210825; Test Name: Hepatitis C Virus; Test Result: Negative ; Test Date: 20210825; Test Name: Herpes Simplex Virus 1; Test Result: Negative ; Test Date: 20210825; Test Name: Herpes Simplex Virus 2; Test Result: Negative ; Test Date: 20210825; Test Name: Human Immunodeficiency Virus; Test Result: Negative ; Test Date: 20210825; Test Name: human herpesvirus 6; Test Result: Negative ; Test Date: 20210825; Test Name: Leptospiroses; Test Result: Negative ; Test Date: 20210825; Test Name: Leptospirosis; Test Result: Negative ; Test Date: 20210825; Test Name: Lyme borreliosis; Test Result: Negative ; Test Date: 20210825; Test Name: cardiac magnetic Resonance Imaging; Result Unstructured Data: Test Result:appearance of myocarditis; Comments: with two of the 3 Lake Louise criteria detected, complicated by global left ventricular hypokinesia with altered ejection fraction at 49%; Test Date: 20210825; Test Name: Parvovirus; Result Unstructured Data: Test Result:compatible with old infections; Test Date: 20210825; Test Name: rubella; Result Unstructured Data: Test Result:compatible with old infections; Test Date: 20210825; Test Name: Toxoplasmosis; Test Result: Negative ; Test Date: 20210824; Test Name: troponin I cardiac; Result Unstructured Data: Test Result:34.271 ug/L; Test Date: 20210825; Test Name: troponin I cardiac; Result Unstructured Data: Test Result:30.098 ug/L; Test Date: 20210826; Test Name: troponin I cardiac; Result Unstructured Data: Test Result:13.255 ug/L; Test Date: 20210825; Test Name: varicella zoster virus; Test Result: Negative
CDC Split Type: FRPFIZER INC202101166532

Write-up: Myocarditis; C-reactive protein 69.3 mg/l; troponin I cardiac 34.271 ug/l; diffuse ST above shift detected; global left ventricular hypokinesia with altered ejection fraction at 49%; global left ventricular hypokinesia with altered ejection fraction at 49%; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, number FR-AFSSAPS-BS20211685. A 16-year-old male patient received the second dose of bnt162b2 (COMIRNATY; lot number: FG4493), intramuscularly in the left arm on 21Aug2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had not medical history of COVID and had not a COVID test. The patient received the first dose of BNT162B2 (lot number: FE7051) in the left arm intramuscularly on 31Jul2021 for COVID-19 immunisation. The patient experienced myocarditis, C-reactive protein 69.3 mg/l, troponin I cardiac 34.271 ug/l, diffuse ST above shift detected on 24Aug2021 and global left ventricular hypokinesia with altered ejection fraction at 49% on 25Aug2021. The patient was hospitalized from 24Aug2021 to 27Aug2021 for myocarditis, C-reactive protein 69.3 mg/l, troponin I cardiac 34.271 ug/l, diffuse ST above shift detected. The clinical course was reported as follows: day 3, on 24Aug201, onset of a sudden fever-related constrictive pain. The patient consulted the emergency department. On 24Aug2021, C-reactive protein 69.3 mg/l (normal range less than 5); troponin I cardiac: 34.271 ug/l (normal range: 0.000-0.034); electrocardiography: diffuse ST above shift detected. On day 4, 25Aug2021, cardiac magnetic resonance imaging: appearance of myocarditis with two of the 3 Lake Louise criteria detected, complicated by global left ventricular hypokinesia with altered ejection fraction at 49%; C-reactive protein 76.8 mg/l; troponin I cardiac 30.098 mg/l; plasma serology was as follows: negative soluble anti-nuclear, anti-double stranded deoxyribonucleic acid and anti-nuclear antibodies; toxoplasmosis, human immunodeficiency virus, hepatitis C virus, cytomegalovirus: negative; parvovirus, rubella, Epstein-Barr virus compatible with old infections; chlamydia pneumoniae pending, chlamydia psittaci pending, chlamydia trachomatis negative; leptospirosis negative, lyme borreliosis negative; coxiella burnetii pending; polymerase chain reaction: negative for cytomegalovirus, Epstein-Barr virus, human herpesvirus 6, adenovirus, leptospiroses, enterovirus; negative herpes simplex virus 1, herpes simplex virus 2 and varicella zoster virus. Day 5, on 26Aug2021: C-reactive protein 44.4 mg/l; troponin I cardiac 13.255 ug/l. The patient no longer had pain. Cardiologists conclusion: post-vaccine myocarditis. The patient was released from the hospital on 27Aug2021 with treatment with BISOCE 1.25 mg and perindopril 2 mg. A transthoracic cardiac ultrasound was scheduled in 3 months. In conclusion: myocarditis, on day 3 after the COMIRNATY vaccine booster. The patient had recovered from the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1720619 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-24
   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 UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Alanine aminotransferase, Aspartate aminotransferase, Blood alkaline phosphatase, Blood bilirubin, Blood calcium, Blood triglycerides, Chest X-ray normal, Computerised tomogram, Electrocardiogram, Full blood count normal, Gamma-glutamyltransferase, Hypotension, Investigation, Lipase, Liver function test, Magnetic resonance imaging, Pancreatitis acute, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (COVID symptomatic in Oct2020: anosmia, ageusia, asthenia lasting 2 weeks-no hospitalisation); Fracture bone
Allergies:
Diagnostic Lab Data: Test Date: 20210828; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:60; Test Date: 20210828; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result:101; Test Date: 20210828; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:75; Test Date: 20210828; Test Name: total bilirubin; Result Unstructured Data: Test Result:40; Test Date: 20210828; Test Name: Calcium levels; Result Unstructured Data: Test Result:2.13; Comments: mM; Test Date: 20210828; Test Name: blood count; Result Unstructured Data: Test Result:nothing to report; Test Date: 20210828; Test Name: Triglycerides; Result Unstructured Data: Test Result:2 g/l; Comments: Triglycerides at 2.3 mM (approximately 2g/l); Test Date: 20210828; Test Name: Chest X-Ray; Result Unstructured Data: Test Result:nothing to report; Test Date: 20210828; Test Name: pelvic abdominal computed tomography; Result Unstructured Data: Test Result:acute Balthazar E pancreatitis; Comments: biologically confirmed acute Balthazar E pancreatitis - No dilation of the bile ducts eliminating lithiasis pancreatitis; Test Date: 20210828; Test Name: Electrocardiography; Result Unstructured Data: Test Result:nothing to report; Test Date: 20210828; Test Name: gamma-glutamyltranspeptidase; Result Unstructured Data: Test Result:32; Test Name: biological check-up; Result Unstructured Data: Test Result:inflammatory syndrome; Comments: 1st consultation with the general practitioner: gastro enteric diagnosis Because of the persistence, a new consultation with prescription of a biological check-up which shows an inflammatory syndrome.; Test Date: 20210828; Test Name: lipasemia; Result Unstructured Data: Test Result:306; Test Date: 20210828; Test Name: Liver function test; Result Unstructured Data: Test Result:BC 15; Test Date: 20210828; Test Name: Liver function test; Result Unstructured Data: Test Result:BL 25; Test Date: 20210828; Test Name: magnetic resonance imaging; Result Unstructured Data: Test Result:pending; Comments: A magnetic resonance imaging of the bile is pending in order to eliminate a malformative cause The patient is hospitalised due to her low blood pressure and abdominal pain
CDC Split Type: FRPFIZER INC202101166909

Write-up: Acute pancreatitis; abdominal pain; iterative vomiting; low blood pressure; This is a spontaneous report from a contactable pharmacist and a physician downloaded from the Regulatory Agency-WEB, regulatory authority number FR-AFSSAPS-PA20211455. A 16-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 05Aug2021 (Batch/Lot Number: Unknown) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation . Medical history included COVID symptomatic in Oct2020: anosmia, ageusia, asthenia lasting 2 weeks-no hospitalisation , fracture of the right thumb.The patient''s concomitant medications were not reported. The patient experienced acute pancreatitis (hospitalization) on 24Aug2021 with outcome of recovering , abdominal pain (hospitalization) on 24Aug2021 with outcome of unknown , iterative vomiting (hospitalization) on 24Aug2021 with outcome of unknown , low blood pressure (hospitalization) on 24Aug2021 with outcome of unknown.Therapeutic measures were taken as a result of the events.The follwing clinical course was reported : On 05Aug2021: Dose 1 COMIRNATY batch unknown.On 24Aug2021: abdominal pain with iterative vomiting in what looks like eating disorders according to the mother 1st consultation with the general practitioner: gastro enteric diagnosis Because of the persistence, a new consultation with prescription of a biological check-up which shows an inflammatory syndrome.On 28Aug2021: the patient consulted the emergency department. pelvic abdominal computed tomography: biologically confirmed acute Balthazar E pancreatitis - No dilation of the bile ducts eliminating lithiasis pancreatitis.A magnetic resonance imaging of the bile is pending in order to eliminate a malformative cause.The patient is hospitalised due to her low blood pressure and abdominal pain Electrocardiography nothing to report.Chest X-Ray nothing to report.Liver function test findings: Aspartate aminotransferase 101, Alanine aminotransferase 60, lipasemia 306, total bilirubin 40, unknown(BC) 15 unknown (BL )25, alkaline phosphatase 75, gamma-glutamyltranspeptidase 32.Complete blood count nothing to report.Calcium levels at 2.13 mm.Triglycerides at 2.3 mM (approximately 2g/l).EVOLUTION: Significant improvement of the pain after setting up multimodal analgesia with Patient-Controlled Analgesia morphine, neopam and paracetamol, No follow-up attempts are needed. No further information expected. Information about batch number cannot be obtained. On 05Aug2021: Dose 1 COMIRNATY batch unknown.On 24Aug2021: abdominal pain with iterative vomiting in what looks like eating disorders according to the mother 1st consultation with the general practitioner: gastro enteric diagnosis Because of the persistence, a new consultation with prescription of a biological check-up which shows an inflammatory syndrome.On 28Aug2021: the patient consulted the emergency department. pelvic abdominal computed tomography: biologically confirmed acute Balthazar E pancreatitis - No dilation of the bile ducts eliminating lithiasis pancreatitis.A magnetic resonance imaging of the bile is pending in order to eliminate a malformative cause.The patient is hospitalised due to her low blood pressure and abdominal pain Electrocardiography nothing to report.Chest X-Ray nothing to report.Liver function test findings: Aspartate aminotransferase 101, Alanine aminotransferase 60, lipasemia 306, total bilirubin 40, unknown(BC) 15 unknown (BL )25, alkaline phosphatase 75, gamma-glutamyltranspeptidase 32.Complete blood count nothing to report.Calcium levels at 2.13 mm.Triglycerides at 2.3 mM (approximately 2g/l).EVOLUTION: Significant improvement of the pain after setting up multimodal analgesia with Patient-Controlled Analgesia morphine, neopam and paracetamol No follow-up attempts are needed. No further information expected. Information about batch number cannot be obtained.


VAERS ID: 1720855 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-24
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Migraine with aura, Migraine without aura, SARS-CoV-2 test
SMQs:, 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: Migraine with aura
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101190745

Write-up: normally get migraine without aura; Migraine aura; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109092215008370-RL7UW, Safety Report Unique Identifier GB-MHRA-ADR 25920940. A female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection; Batch/ Lot Number: FF3319) via an unspecified route of administration on 16Aug2021 as dose number unknown, single for COVID-19 immunisation. Medical history included patient had 5-6 aura attacks in 18 years. Concomitant medication was not reported. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date, patient normally get migraine without aura (medically significant). On 24Aug2021 (after 8 days of vaccination), patient experienced migraine aura (medically significant). Patient had 6-7 aura attacks in 4 days between the 24Aug2021 and 28Aug2021. The patient underwent lab tests and procedures which included COVID-19 test: negative on an unspecified date. The outcome of event normally get migraine without aura was unknown and for event migraine aura was resolved on 28Aug2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1720935 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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: Body temperature, Body temperature increased, Inappropriate schedule of product administration, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Back pain; Headache
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: temperature; Result Unstructured Data: Test Result:elevation; Test Date: 20210619; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101232826

Write-up: Muscle pain; Temperature elevation; Inappropriate schedule of vaccine administered; This is a solicited report from the regulatory authority from a contactable consumer. This is the second of two reports. The first report is a report downloaded from the regulatory authority with regulatory authority report number GB-MHRA-YCVM-202106212134097730-JWNZ0, and Safety Report Unique Identifier GB-MHRA-ADR 25637481. A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FE3380), via an unspecified route of administration on 24Aug2021 as dose 2, single (at the age of 19 years old) for COVID-19 immunization. Medical history included back pain and headache. Last menstrual period was reported as 04Jul2021. Patient has not had symptoms associated with COVID-19. Patient was not pregnant and was not currently breastfeeding. Concomitant medication included paracetamol taken for headache. The patient previously took hyoscine butylbromide (BUSCOPAN) from 31May2021 to 02Jun2021 for menstrual cramp; and dose 1 of BNT162B2, received on 10Jul2021 for COVID-19 immunization where patient experienced painful arm on 11Jul2021. The patient experienced muscle pain and temperature elevation, both on 25Aug2021 and reported as serious per other medically important condition. The patient experienced inappropriate schedule of vaccine administered, as first dose was received on 10Jul2021, and second dose was received on 24Aug2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent a COVID-19 virus test on 19Jun2021 with the following result: No - Negative COVID-19 test. The outcome of the events muscle pain and temperature elevation was recovered on 26Aug2021. The outcome of the remaining event 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 needed. No further information is expected.; Sender''s Comments: Based on plausible dose- event relationship post-vaccination the causal role of BNT162B2 vaccine cannot be excluded for the reported events 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 ,Linked Report(s) : GB-PFIZER INC-2021886459 Same patient and product, different dose and event


VAERS ID: 1721019 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-24
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7053 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Carditis, Chest pain, Cold sweat, Dyspnoea, Pericarditis, Skin discolouration
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No Relevant Medical History/Underlying Conditions.
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101180565

Write-up: acs; Pericarditis; Carditis; was playing gaa / acute chest pain with sob, clamy, grey / relieved on lying down; was playing gaa / acute chest pain with sob, clamy, grey / relieved on lying down; was playing gaa / acute chest pain with sob, clamy, grey / relieved on lying down; was playing gaa / acute chest pain with sob, clamy, grey / relieved on lying down; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. Regulatory authority number IE-HPRA-2021-083319 with Safety Report Unique Identifier: IE-HPRA-2021-083319. Initial report received by the RA on 25Aug2021 from a healthcare professional. A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: FE7053), dose 1 via an unspecified route of administration on 15Aug2021 as 1st dose, single for COVID-19 immunization. Patient''s medical history and concomitant medications were not reported. The patient experienced was playing gaa/ acute chest pain with sob, clamy, grey/ relieved on lying down, carditis, pericarditis, and acs (acute coronary syndrome) on 24Aug2021. Also, he had acute chest pain with shortness of breath while playing sport (GAA) on 24Aug2021 after 9 days from 1st dose. It was outlined in the report that the patient was clammy and grey in colour. All the events were reported as medically significant. His symptoms were relieved on lying down. The duration of the reaction was reported as less than 1 hour. 9 days later on 24Aug2021, the patient experienced acute chest pain with shortness of breath while playing sport (GAA). It was outlined in the report that the patient was clammy and grey in colour. Symptoms were relieved on lying down. The duration of the reaction was reported as less than 1 hour. The reporter queried carditis, acute coronary syndrome or pericarditis. The patient was treated with rest and ibuprofen. The outcome of carditis, acs and pericarditis was unknown, while outcome of other events was recovered on an unspecified date No follow-up attempts are possible. No further information is expected.


VAERS ID: 1721053 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 UNKNOWN / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Hyperpyrexia, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101163450

Write-up: hyperpyrexia; myalgia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-779687. A 34-year-old female patient received BNT162B2 (COMIRNATY) at the age of 34-years-old, via an unspecified route of administration, administered in Deltoid Left on 24Aug2021 14:30 (Batch/Lot Number: unknown) as dose 2, single for COVID-19 immunization. Medical history included allergy. The patient''s concomitant medications were not reported. The patient experienced hyperpyrexia and myalgia on 24Aug2021 23:20. The outcome of the event was recovering. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reporter''s Comments: Reaction time: 23:20 -


VAERS ID: 1721077 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Varicella zoster virus infection
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101174648

Write-up: Varicella zoster after innoculation with first dose Pfizer Comirnaty vaccine; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority, regulatory authority number IT-MINISAL02-780014. A 12-years-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: FG4686, Expiry date: 30Nov2021), via intramuscular route of administration on 21Aug2021 18:58 in Arm Left as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On 24Aug2021, the patient experienced varicella zoster after innoculation with first dose pfizer comirnaty vaccine.The Patient received treatment for the event. The event is serious and medically significant. Therapeutic measures were taken as a result of varicella zoster after innoculation with first dose pfizer comirnaty. The outcome for the event was unknown. No follow-up attempts possible. No further information expected


VAERS ID: 1721149 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 FF0843 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blister, Body temperature, Pruritus, Rash, Toxic skin eruption
SMQs:, Severe cutaneous adverse reactions (narrow), 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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101164024

Write-up: Other possible cause(s) of the event such as any other diseases was toxicoderma.; Itching; Blister; rash started on the right forearm and then spread to the whole body; This is a spontaneous report from a contactable physician received from the regulatory Agency. Regulatory authority report number is v21125961. This physician reported the same events for two patients. This is the first of two reports. A 50-year-old (also reported as 50-year and 7-month-old) female patient received bnt162b2 (COMIRNATY; Batch/Lot Number: FF0843; Expiration Date: 31Oct2021) via an unspecified route of administration on 24Aug2021 11:10 (the day of vaccination)(at the age of 50-year-old) as dose 2, single for COVID-19 immunisation. Body temperature before vaccination was 36.6 degrees centigrade on 24Aug2021. 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 02Sep2021 (9 days after the vaccination), the patient experienced blister and itching. The course of the event was as follows: on 24Aug2021, after the second vaccination, the rash started on the right forearm and then spread to the whole body. The reporter classified the event as non-serious and assessed that the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was toxicoderma on an unspecified date. On 06Sep2021 (13 days after the vaccination), the outcome of the events was not recovered Reporter comment:The patient''s husband also had this injection and experienced the same symptoms. Follow-up attempts are completed. No further information is expected.; Reporter''s Comments: The patient''s husband also had this injection and experienced the same symptoms.; Sender''s Comments: Linked Report(s) : JP-PFIZER INC-202101207533 same reporter/event/drug, different patient


VAERS ID: 1721161 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-08-24
   Days after vaccination:162
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: JPPFIZER INC202101165669

Write-up: COVID-19 antigen test positive; COVID-19 antigen test positive; GENERAL INVESTIGATION TARGETING THE VACCINES (HEALTH CARE PROVIDERS HCPS) WHO ARE VACCINATED IN EARLY POST-APPROVAL PHASE (FOLLOW-UP STUDY) This is a report from a Non-Interventional Study source for Protocol C4591006. The subject was a 42-year-old male (age at vaccination was 42 years old). On 22Feb2021, the subject received the first dose of BNT162b2 (COMIRNATY, Lot number EP2163, Expiration date 31May2021), on 15Mar2021 (the day of vaccination), the subject received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EP2163, Expiration date 31May2021), both via an unspecified route of administration in left upper arm as a single dose for COVID-19 immunization. The subject had no medical history or concomitant medication. The subject did not receive any other vaccines. There was no complication (prevaccination screening questionnaire), no allergy, no complication (medical questionnaire), no medical history, no treatment drug which the subject was orally taking. On 24Aug2021 (5 months 9 days after the vaccination), the subject had COVID-19 antigen test positive. It was reported serious adverse event did not occur. The subject did not have COVID-19. The outcome of the event was not provided. 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.; Sender''s Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.


VAERS ID: 1721183 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-08-24
   Days after vaccination:155
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Heart rate, Ovarian cyst, Oxygen saturation, Respiratory rate
SMQs:

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: BP; Result Unstructured Data: Test Result:132/62; Test Date: 20210825; Test Name: HR; Result Unstructured Data: Test Result:83; Comments: /min; Test Date: 20210825; Test Name: SpO2; Test Result: 100 %; Comments: During post operative oxygen administration; Test Date: 20210825; Test Name: SpO2; Test Result: 99 %; Comments: after oxygen administration; Test Date: 20210825; Test Name: R; Result Unstructured Data: Test Result:17; Comments: /min
CDC Split Type: JPPFIZER INC202101180208

Write-up: Bilateral ovarian cystoma; GENERAL INVESTIGATION TARGETING THE VACCINES (HEALTH CARE PROVIDERS HCPS) WHO ARE VACCINATED IN EARLY POST-APPROVAL PHASE (FOLLOW-UP STUDY) This is a report from a Non-Interventional Study source for Protocol C4591006, reported from 2 contactable investigators. A 25-year-old (at the event onset) female subject received second dose of BNT162b2 (COMIRNATY), intramuscular, administered in arm left on 22Mar2021 at 14:00 (Lot Number: EP2163; Expiration Date: 31May2021) (at the age of 24-year-old) as 0.3 mL single dose for COVID-19 immunisation. Medical history including family history was not reported. The subject did not receive any concomitant medication. The subject previously received the first dose of BNT162b2 (COMIRNATY, Lot Number: EP2163, Expiration date: 31May2021) intramuscularly in the left arm at 0.3 mL single dose for COVID-19 immunization on 25Feb2021 at the age of 24 years. On 24Aug2021, the subject experienced bilateral ovarian cystoma. On 28Aug2021, the outcome of the event was recovered. The investigator classified the event as serious (hospitalization). The investigator considered that the event was not a reasonable possibility to the study drug. The subject required to visit examination at a medical institution for bilateral ovarian cystoma. The subject admitted to the hospital for 5 days. The clinical course was as follows: on 13Jun2021, when the subject admitted to the hospital for infective gastroenteritis, right bilateral ovarian cystoma and left chocolate cyst were suspected thus recommended to visit gynecology. On 17Aug2021, the subject visited to gynecology and diagnosed as bilateral ovarian cystoma. On 24Aug2021, the subject admitted to the hospital. On 25Aug2021, laparoscope bilateral adnexal tumor extirpative surgery was performed. Intraoperative bleeding was 200ml. Administrated acelio from 10 minutes before the end of the surgery. Administrated PRIDION 200 mg (as reported), after awaking and spontaneous respiration were confirmed and extubation. After 2 minutes, the subject complained dyspnoea and airway stenosis sounds was found. Confirmed redness form anterior chest to both arms. Took care as anaphylaxis. 6L oxygen was administrated. The subject gradually recovered after administrated ATARAX-P 1A and SOLU-MEDROL 250mg. Redness was disappeared. 3L oxygen was administrated. SPO2: 100%, Respiration(R): 17/min, Blood pressure (BP) 132/62 and Heart rate (HR) 83/min. Oxygen was stopped, 4 hours after returned room. SPO2: 99%. On 26Aug2021, there was no abnormality for after surgery examination at anesthesiologists. On 28Aug2021, the subject was discharged. The cause of anaphylaxis was possibly related to PRIDION (as reported) thus the subject scheduled to visit dermatology for further examination.; Sender''s Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event Ovarian Cyst and the administration of the vaccine cannot be 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: 1721348 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   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 FE4721 / 2 - / OT

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: HARMONET
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101190410

Write-up: Faint; This is a spontaneous report from a contactable consumer reporting for herself. This is the second of two reports. The first was from the Regulatory Authority. This is a report received from the Regulatory authority report number [PT-INFARMED-B202107-4956] with Safety Report Unique Identifier [PT-INFARMED-B202107-4956]. A 24-year-old female patient received on 23Aug2021 the second dose of BNT162B2 (COMIRNATY, lot FE4721) at 0.3 ml single intramuscular for Covid-19 immunization. Concomitant medications included HARMONET. Medical history was not reported. The patient had first dose of BNT162B2 (COMIRNATY, lot number unknown) on 26Jul2021 for Covid-19 immunization and experienced vaccination site pain. On 24Aug2021, the morning after the administration of the 2nd dose, the patient fainted. The faint lasted approximately 5 minutes. The patient denies previous fainting episodes and a history of adverse reactions to other medications. She said she was healthy and undergoes exams regularly, as she was an athlete. Due to the clinical significance of ADR at the 2nd dose, the severity level of the case was considered severe. Outcome was recovered on 24Aug2021. No follow-up attempts are possible. No further information is expected. Linked Report(s): PT-PFIZER INC-202101025792 Same patient and product, different event and dose.


VAERS ID: 1722356 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
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: 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 INC202101170201

Write-up: Pericarditis; This is a spontaneous report from a contactable other health professional via the Regulatory Authority (TGA). Regulatory authority report number is 615156. A 31-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced pericarditis on 24Aug2021. 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: 1723469 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
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: Abdominal pain, Lethargy, Myocarditis
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101170527

Write-up: Myocarditis; Abdominal pain; Lethargy; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 616467. A 48-yeaer-old female patient received BNT162B2 (COMIRNATY) at single dose on an unknown date via an unknown route for COVID-19 immunisation. Medical history and concomitant drug were not provided. Patient experienced abdominal pain, lethargy, myocarditis on 24Aug2021. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724239 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-24
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4592 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Echocardiogram, Electrocardiogram, Myocarditis, Physical examination, Troponin, Ventricular internal diameter
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? 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: 20210823; Test Name: BP; Result Unstructured Data: Test Result:58%; Test Date: 20210823; Test Name: TAPSE; Result Unstructured Data: Test Result:22mm; Test Date: 20210823; Test Name: Transthoracic echocardiography; Result Unstructured Data: Test Result:Not delated left ventricule, not hypertrophic with; Comments: Not delated left ventricule, not hypertrophic with normal systolic function. absence of segmental alterations. no significant valvulopathies. no pericardial effusion; Test Date: 20210823; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:sinus rhythm with ST elevation in infero-lateral l; Comments: sinus rhythm with ST elevation in infero-lateral leads; Test Date: 20210823; Test Name: aortic root; Result Unstructured Data: Test Result:32 mm; Test Date: 20210823; Test Name: Left auricula; Result Unstructured Data: Test Result:38 mm; Test Date: 20210823; Test Name: mitral valve; Result Unstructured Data: Test Result:Normal; Test Date: 20210823; Test Name: Troponin; Result Unstructured Data: Test Result:4174; Test Date: 20210823; Test Name: LVEDD; Result Unstructured Data: Test Result:50 mm; Test Date: 20210823; Test Name: LVESD; Result Unstructured Data: Test Result:35 mm
CDC Split Type: ESPFIZER INC202101166284

Write-up: Myopericarditis; This is a spontaneous report from a contactable physician downloaded from the (Regulatory Authority report number: ES-AEMPS-989218). A 32-year-old male patient received BNT162B2 (COMIRNATY, Lot Number: FG4592; Expiration date was not reported) on 19Aug2021 as dose number unknown, single, with route of administration unspecified, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 24Aug2021, the patient had myopericarditis; assessed as serious (medically significant). The patient underwent laboratory tests and procedures on 23Aug2021 which included blood pressure measurement of 58%; TAPSE (echocardiogram) showed 22 mm; transthoracic echocardiography showed not delated left ventricule, not hypertrophic with normal systolic function, absence of segmental alterations, no significant valvulopathies and no pericardial effusion; electrocardiogram showed sinus rhythm with ST elevation in infero-lateral leads; aortic root was 32 mm; left auricula was 38 mm; mitral valve was normal; troponin was 4174; LVEDD was 50 mm; and LVESD was 35 mm. IV was not dilated, not hypertrophic with function normal systolica; absence of segmental alterations; no significant valvulopathies in the stroke pericardial. The outcome of the event was recovered on 27Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1724368 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Decreased appetite, Dizziness, Hyperhidrosis, Influenza like illness, Loss of consciousness, Muscle spasms, Nausea, Pyrexia, SARS-CoV-2 test, Tinnitus, Vaccination site pain
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: Abscess; Acute posterior ganglionitis; Behcet-like symptom; Bipolar aphthosis; Uveitis
Allergies:
Diagnostic Lab Data: Test Date: 20210819; Test Name: FEVER; Result Unstructured Data: Test Result:flu-like syndrome with fever; Test Date: 20210819; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Negative
CDC Split Type: FRPFIZER INC202101186007

Write-up: The patient also reports tinnitus and loss of consciousness; The patient also reports tinnitus and loss of consciousness; pain in the left shoulder (ipsilateral to the injection); spasm in the arm and hand; flu-like syndrome with sweating, fever, dizziness, asthenia, nausea, loss of appetite; flu-like syndrome with sweating, fever, dizziness, asthenia, nausea, loss of appetite; flu-like syndrome with sweating, fever, dizziness, asthenia, nausea, loss of appetite; flu-like syndrome with sweating, fever, dizziness, asthenia, nausea, loss of appetite; flu-like syndrome with sweating, fever, dizziness, asthenia, nausea, loss of appetite; flu-like syndrome with sweating, fever, dizziness, asthenia, nausea, loss of appetite; flu-like syndrome with sweating, fever, dizziness, asthenia, nausea, loss of appetite; pain in the left shoulder (ipsilateral to the injection); This is a spontaneous report from a contactable consumer or other non hcp downloaded from the RA- FR-AFSSAPS-LY202110447. A 32-year-old patient received bnt162b2 (Comirnaty, Formulation: Solution for injection, Batch/Lot number: Not reported) via an Intramuscular route of administration , administered in left arm on 23Aug2021. The patient''s medical history include Suspicion of Behcets disease (Bipolar aphthosis), Acute posterior ganglionitis, Abscess and Uveitis. Concomitant medications were not reported. There is no medical history of Covid seen. On 24Aug2021 , patient reports the appearance of pain in the left shoulder (ipsilateral to the injection) accompanied by spasm in the arm and hand, as well as a flu-like syndrome with sweating, fever, dizziness, asthenia, nausea, loss of appetite. The patient also reports tinnitus and loss of consciousness. The patient consulted a doctor without specifying the management. Patient underwent laboratory test include SARS-CoV-2 test: Negative on 19Aug2021. Treatment received for the adverse event were not reported. Outcome of the events flu syndrome, unconsciousness and tinnitus was recovering as of 26Aug2021 and not recovered with regard to shoulder pain on 26Aug2021. No additional information available. No follow-up attempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.


VAERS ID: 1724934 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-24
   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 FF3622 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Hypertension, Physical deconditioning
SMQs:, Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Hypertension (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: Anxiety (the patient had strong anxiety)
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: BP; Result Unstructured Data: Test Result:150/s; Comments: morning; Test Date: 20210824; Test Name: BP; Result Unstructured Data: Test Result:160s; Test Date: 20210825; Test Name: BP; Result Unstructured Data: Test Result:190/s; Comments: midnight; Test Date: 20210825; Test Name: BP; Result Unstructured Data: Test Result:140/s; Comments: after some drugs were taken orally by the patient, BP became 140/s.; Test Date: 20210825; Test Name: BP; Result Unstructured Data: Test Result:150/s; Comments: When the patient woke up, BP was 150/s.; Test Date: 20210830; Test Name: BP; Result Unstructured Data: Test Result:120/s; Comments: morning
CDC Split Type: JPPFIZER INC202101172090

Write-up: Hypertension; BP was 150/s/160/s/BP was 190/s/BP became 140/s/BP was 150/s/Blood pressure increased; Physical deconditioning; This is a spontaneous report from a contactable pharmacist received from the regulatory authority. Regulatory authority report number is v21127150. A 65-year-old (age at the vaccination) male patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF3622, Expiration date 30Nov2021) via an unspecified route of administration on 21Aug2021 at 09:30 (at the age of 65-year-old) as a single dose for COVID-19 immunization. Medical history included the patient had strong anxiety. 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). The concomitant medications were not reported. On 24Aug2021 at 07:00 (3 days after the vaccination), the patient experienced Hypertension. The course of the event was as follows: From 24Aug2021 morning (3 days after the vaccination), the patient experienced Physical deconditioning. BP was 150/s, although it went down once, but it became 160/s again. Nifedipine was prescribed. On 25Aug2021 midnight (4 days after the vaccination), BP was 190/s, and after some drugs were taken orally by the patient, BP became 140/s. When the patient woke up, BP was 150/s. On 27Aug2021 (6 days after the vaccination), an additional prescription for nifedipine was requested. On 30Aug2021 morning (9 days after the vaccination), BP was 120/s. It seemed to be taking orally every 6 hours. On 07Sep2021 (17 days after the vaccination), the patient received a medical examination. And since 04Sep2021 (14 days after the vaccination), the patient has not been taking antihypertensive drugs. The patient would this to be reported as side reactions. On 04Sep2021 (14 days after the vaccination), the outcome of the event was recovering. The reporter classified the event as non-serious and assessed the causality between the event and bnt162b2 as unassessable. Other possible cause of the event such as any other diseases was that since the patient had strong anxiety, there was a possibility of Blood pressure increased due to anxiety. Reporter Comment: There was a possibility that Physical deconditioning of the patient after the vaccination caused Blood pressure increased. And it was also possible that the patient''s anxiety was strong, so the tendency for Blood pressure increased continued for a long time.; Reporter''s Comments: There was a possibility that Physical deconditioning of the patient after the vaccination caused Blood pressure increased. And it was also possible that the patient''s anxiety was strong, so the tendency for Blood pressure increased continued for a long time.


VAERS ID: 1725086 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-08-24
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE9174 / 1 - / OT

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101166897

Write-up: Pericarditis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Uy2514. A 34-year-old male patient received BNT162B2 (COMIRNATY, Lot Number: FE9174), intramuscular on 21Jul2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient developed pericarditis on 24Aug2021. The patient was hospitalized and was effectively treated with ibuprofen. He improved greatly after one day of treatment. The outcome of the event was recovering. Reporter comment: 03Sep2021 Additional information received from the primary reporter by phone. The following fields have been updated: therapy start date, event description. No follow-up attempts are possible. No further information expected.


VAERS ID: 1725108 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA FE4721 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Duodenogastric reflux, Pyrexia, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific dysfunction (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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: PTMODERNATX, INC.MOD20213

Write-up: Biliary vomiting; Tachycardia; Fever; This case was initially received via the RA (Reference number: PT-INFARMED-B202108-3338) on 12-Sep-2021. The most recent information was received on 12-Sep-2021 and was forwarded to Moderna on 15-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of DUODENOGASTRIC REFLUX (Biliary vomiting), TACHYCARDIA (Tachycardia) and PYREXIA (Fever) in a 19-year-old female patient who received mRNA-1273 (Spikevax) (batch no. FE4721) for COVID-19 immunisation. No Medical History information was reported. On 23-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 milliliter. On 24-Aug-2021, the patient experienced DUODENOGASTRIC REFLUX (Biliary vomiting) (seriousness criterion medically significant), TACHYCARDIA (Tachycardia) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 24-Aug-2021, DUODENOGASTRIC REFLUX (Biliary vomiting), TACHYCARDIA (Tachycardia) and PYREXIA (Fever) had resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered DUODENOGASTRIC REFLUX (Biliary vomiting), TACHYCARDIA (Tachycardia) and PYREXIA (Fever) to be possibly related. No concomitant and treatment information was provided. Reporter''s comment included: No concomitant medication. No medication error. Other information- Leukocytosis with neutrophilia. Fever 37.6?C. Intense biliary vomiting and diarrhoea. Tachycardia 139 bpm. This report concerns a 19 year old female patient with no relevant medical history who experienced unexpected serious events of duodenogastric reflex (biliary vomiting), tachycardia and pyrexia. Additionally, the patient also experienced non-serious event of diarrhea, and was found to have leukocytosis with neutrophilia. The events occurred approximately one day after vaccination with mRNA-1273. The re-challenge was not applicable, as the events happened after the first dose. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 is not affected by this report. No concomitant medication. No medication error. Other information- Leukocytosis with neutrophilia. Fever 37.6?C. Intense biliary vomiting and diarrhoea. Tachycardia 139 bpm. Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2021: translation was received on 15-Sep-2021 and event verbatim, dosage form,additional information on drug, reporter''s causality, reporter''s coment translated; Sender''s Comments: This report concerns a 19 year old female patient with no relevant medical history who experienced unexpected serious events of duodenogastric reflex (biliary vomiting), tachycardia and pyrexia. Additionally, the patient also experienced non-serious event of diarrhea, and was found to have leukocytosis with neutrophilia. The events occurred approximately one day after vaccination with mRNA-1273. The re-challenge was not applicable, as the events happened after the first dose. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1725136 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Chest discomfort, Dyspnoea, Electrocardiogram, Heart rate, Inappropriate schedule of product administration, Myocarditis, Ultrasound scan
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ELVANSE
Current Illness: Eating disorder, unspecified
Preexisting Conditions: Medical History/Concurrent Conditions: Anorexia nervosa
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:unknown; Test Name: blood samples; Result Unstructured Data: Test Result:possible heart damage; Comments: One abnormal result showed a possible heart damage; Test Name: ECG; Result Unstructured Data: Test Result:unknown; Test Name: pulse; Result Unstructured Data: Test Result:unknown; Test Name: ultrasound; Result Unstructured Data: Test Result:normal, but diagnosed with perimyocarditis; Comments: normal, but has been diagnosed with perimyocarditis
CDC Split Type: SEPFIZER INC202101167012

Write-up: Perimyocarditis/heart damage; difficulty breathing; tightness in her chest; The patient received the first dose on 06Jul2021, and the second dose was given on 24Aug2021.; This is a spontaneous report from a contactable consumer, downloaded from the regulatory authority-WEB, Regulatory authority number: SE-MPA-2021-078462. A 29-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 24Aug2021 (Batch/Lot Number: unknown) as dose 2, single (at the age of 29-years-old) for Covid-19 immunisation. Medical history included anorexia nervosa and ongoing eating disorder, unspecified in 2004. Concomitant medication included lisdexamfetamine mesilate (ELVANSE) taken for an unspecified indication from 01May2018 to an unspecified stop date. The patient previously received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 06Jul2021 (Batch/Lot Number: unknown) as dose 1, single for Covid-19 immunisation. The patient received the first dose on 06Jul2021, and the second dose was given on 24Aug2021. The patient experienced perimyocarditis on 27Aug2021 which was 3 days after the second dose. The patient woke up on 27Aug2021 with difficulty breathing and tightness in her chest. This continued the whole day. She contacted the public health consultancy after 6PM and was recommended to go to the emergency clinic. In the emergency clinic, pulse, blood pressure, electrocardiogram (ECG) and blood samples were taken. One abnormal result showed a possible heart damage, and the patient was admitted and transferred to cardiology ward and stayed overnight. The next day an ultrasound was done. The result of ultrasound was normal, but the patient has been diagnosed with perimyocarditis. The patient received Ipren as treatment. The outcome of the event "Perimyocarditis/heart damage" was not resolved, while the outcome of the rest of the events was unknown. This report was assessed as serious: hospitalisation. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1725927 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-08-24
   Days after vaccination:45
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: Echocardiogram, 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? 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: 20210416; Test Name: Echocardiogram; Result Unstructured Data: LVEF= 46%; Test Date: 20210824; Test Name: Echocardiogram; Result Unstructured Data: LVEF= 26%
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Myocarditis; This regulatory authority case was reported by a pharmacist and describes the occurrence of MYOCARDITIS (Myocarditis) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Echocardiogram: abnormal (abnormal) LVEF= 46%. On 24-Aug-2021, Echocardiogram: abnormal (abnormal) LVEF= 26%. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant product information were provided by the reporter. No treatment information was provided by the reporter. Company Comment: This case concerns a 74 year old male patient with no relevant medical history, who experienced the expected event of Myocarditis. The event Myocarditis occurred approximately 14 days after the first 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 Moderna COVID-19 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 74 year old male patient with no relevant medical history, who experienced the expected event of Myocarditis. The event Myocarditis occurred approximately 14 days after the first 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 Moderna COVID-19 vaccine is not affected by this report


VAERS ID: 1725952 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-08-24
   Days after vaccination:83
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 2 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Chills, Headache, Interchange of vaccine products, Muscular weakness, Nausea, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), 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? 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: 20210824; Test Name: BODY TEMPERATURE; Result Unstructured Data: 39 degree Celsius
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Syncope; Nausea; Headache; 06/02/2021-Received Covid-19 AstraZeneca vaccine; Limb weakness; Chills; Fever; This regulatory authority case was reported by a pharmacist and describes the occurrence of SYNCOPE (Syncope) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination. No Medical History information was reported. On 02-Jun-2021, the patient started COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced MUSCULAR WEAKNESS (Limb weakness), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and INTERCHANGE OF VACCINE PRODUCTS (06/02/2021-Received Covid-19 AstraZeneca vaccine). On an unknown date, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant) and NAUSEA (Nausea). The patient was treated with ACETAMINOPHEN (oral) at a dose of 1 dosage form. On 24-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (06/02/2021-Received Covid-19 AstraZeneca vaccine) had resolved. At the time of the report, SYNCOPE (Syncope), MUSCULAR WEAKNESS (Limb weakness), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Aug-2021, Body temperature: 39 degree celsius (abnormal) 39 degree Celsius. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided by the reporter. The reporter reported that patient received Covid-19 AstraZeneca vaccine on 06/02/202. Patient was admitted in emergency and was not having any cough, sputum, SOB, N/V or abdominal pain. TOCC(-) Company Comment : This case concerns a 51 Y/O F with serious unexpected syncope, and non-serious muscular weakness, chills, pyrexia, nausea, headache, and interchange of vaccine products (Covid-19 AstraZeneca vaccine). Latency within 1 day after 2nd dose mRNA-1273. Outcomes unknown. Rechallenge not applicable. Reporter causality not provided. Causality possible from temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 51 Y/O F with serious unexpected syncope, and non-serious muscular weakness, chills, pyrexia, nausea, headache, and interchange of vaccine products (Covid-19 AstraZeneca vaccine). Latency within 1 day after 2nd dose mRNA-1273. Outcomes unknown. Rechallenge not applicable. Reporter causality not provided. Causality possible from temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1726154 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
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: Abscess, Influenza like illness, Sepsis
SMQs:, Sepsis (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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210943065

Write-up: SEPSIS; ABSCESS; FLU LIKE SYMPTOMS; This spontaneous report received from a consumer via Regulatory Authority (EVHUMAN Vaccines, DE-PEI-CADR2021179205) on 22-SEP-2021 concerned a 72 year old male of an unspecified race and ethnic origin. The patient''s weight was 82 kilograms, and height was 167 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: unknown and expiry: unknown) dose was not reported, 1 total administered on 24-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 24-AUG-2021, the patient experienced sepsis, abscess, had flu like symptoms and was hospitalized (on date unspecified) for unspecified number of days. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sepsis, abscess, and flu like symptoms. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1728863 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
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: ATJNJFOC20210942841

Write-up: VACCINATION FAILURE; SARS-CoV-2 infection; This spontaneous report received from a physician by a Regulatory authority (AT-BASGAGES-2021-044709) on 22-SEP-2021 and concerned a 23-year-old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD955 expiry: unknown) dose was not reported, 1 total administered on 10-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 24-AUG-2021, the patient had vaccination failure and severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1728881 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       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? 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 INC202101212534

Write-up: Myocarditis; This is a spontaneous report from a contactable other health professional via the Regulatory authority. Regulatory authority report number is 618461. A 32-year-old male patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced myocarditis on 24Aug2021 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: 1729410 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris
SMQs:, Other ischaemic heart disease (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: IEPFIZER INC202101193790

Write-up: pain in heart area / heart pain for 5 plus hours / never had pain here before; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number IE-HPRA-2021-083292, Safety Report Unique Identifier IE-HPRA-2021-083292. A 24-year-old male patient received the second dose of BNT162B2 (COMIRNATY, solution for injection, batch/lot number was unknown), via an unspecified route of administration, on 23Aug2021, as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (COMIRNATY, solution for injection, batch/lot number was unknown), via an unspecified route of administration, on an unspecified date in 2021, as dose 1, single for COVID-19 immunization. On 24Aug2021, at 03:45 am, the patient experienced pain in heart area / heart pain for 5 plus hours / never had pain here before. The patient reported that he never experienced similar pain before. At the time of reporting, the patient''s symptoms were continuing. 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: 1729416 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 FE7053 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Bradycardia, Dizziness
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101195265

Write-up: Arrhythmia; Bradycardia; Dizziness; This is a spontaneous report from a contactable other health care professional downloaded from the regulatory authority-WEB, regulatory authority number IE-HPRA-2021-083542. Safety Report Unique Identifier IE-HPRA-2021-083542. Initial report received by the HPRA on 28Aug2021 from a healthcare professional. A 17-year-old male patient received second dose of bnt162b2 (Comirnaty, solution for injection, Lot Number: FE7053), via an unspecified route of administration on 24Aug2021 (at the age of 17 years old) as dose2, 0.3ml single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient''s historical vaccine included bnt162b2 (Comirnaty, solution for injection, Lot Number: was not reported), via an unspecified route of administration on an unspecified date as dose1, single for COVID-19 immunization. The patient experienced arrhythmia, bradycardia, and dizziness on 24Aug2021. The patient was transferred to the emergency department (ED) for assessment. The outcome of all events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1729421 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 FE7053 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Eye swelling, Headache, Lethargy, Mass, Subperiosteal abscess, Swelling face, Venous thrombosis
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Osteonecrosis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Computerised tomogram; Result Unstructured Data: Test Result:CT confirmed Potty puffy tumour and venous saggita
CDC Split Type: IEPFIZER INC202101195053

Write-up: Ct confirmed potty puffy tumour; Pus drained in theatre; Significant frontal facial swelling; Venous saggital thrombosis; Eye swelling; Headache; Headache progressed to lethargy; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) EudraVigilance-WEB, regulatory authority number IE-HPRA-2021-084093, Safety Report Unique Identifier IE-HPRA-2021-084093. A 12-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number FE7053), dose 1 via an unspecified route of administration on 24Aug2021 (at the age of 12-years-old) as dose 1, single for COVID-19 immunization. The patient no relevant medical history/underlying conditions and concomitant medications were not reported. On 24Aug2021, the patient experienced ct confirmed potty puffy tumour, pus drained in theatre, significant frontal facial swelling, venous saggital thrombosis, eye swelling, headache and headache progressed to lethargy. It was stated that 2 hours later on 24Aug2021, the patient developed a headache which progressed to lethargy. The patient experienced significant frontal face and eye swelling. Computerised tomogram (CT) confirmed pott puffy tumour and venous sagittal thrombosis. Pus was drained in theatre. The events were serious (medically significant, hospitalization). The patient underwent lab tests and procedures which included computerised tomogram ct confirmed potty puffy tumour and venous saggita on unspecified date. Treatment included 1 month of Intravenous (IV) antibiotics (unspecified) and anticoagulation therapy (subcutaneous antithrombotic, unspecified). Outcome of the events was not recovered. No follow up attempts are possible. No further information is expected.


VAERS ID: 1729539 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7010 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, Overdose, SARS-CoV-2 test, SARS-CoV-2 test positive, Severe acute respiratory syndrome
SMQs:, Lack of efficacy/effect (narrow), Drug abuse and dependence (broad), Medication errors (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: 20210824; Test Name: Covid-19 molecular test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101187840

Write-up: Covid-19 molecular test positive; drug ineffective; overdose; positive molecular test for sars cov2 with asymptomatic course; This is a spontaneous report from a contactable other healthcare professional downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-781807. A 44-years-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: FE7010, Expiration date: 31Oct2021), via intramuscularly, administered in Left Arm (left shoulder) on an unspecified date as dose 2, 3 ml, single for COVID-19 immunization. The patient''s medical history and concomitant medications were unknown. On 24Aug2021, the patient experienced positive molecular test for sars cov2 with asymptomatic course. On an unspecified date the patient experienced covid-19 molecular test positive, drug ineffective and overdose. The patient underwent lab tests and procedures which included sars-cov-2 test which showed positive result on 24Aug2021. The outcome of the events was unknown. 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 FE7010. 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. The regulatory authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible, no further information is expected.


VAERS ID: 1729593 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 FE8206 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Feeling cold, Sensory disturbance, Vaccination site warmth
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (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: Food allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101179720

Write-up: Feeling hot of the vaccination site (left arm); feeling cold of the opposite arm; Abnormal sensation; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126246. The patient was a 22-year-old male (age at vaccination). Body temperature before vaccination was 36.7 degrees Centigrade. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) include ALLERGY TO RAW VEGETABLES AND FRUIT. On 24Aug2021 at 14:39 (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 administered in left arm as dose 1, single for COVID-19 immunization. On 24Aug2021 at 14:54 (15 minutes after the vaccination), the patient experienced Abnormal sensation. On 24Aug2021 (the day of vaccination), the outcome of the events was recovered. The course of the events was reported as follows: Feeling hot of the vaccination site (left arm), feeling cold of the opposite arm on 24Aug2021 at 14:54. No other allergic symptoms were present. A route was kept, and took POLARAMINE by intravenous injection. The reporting physician classified the event as non-serious and assessed the causality between the event and bnt162b2 as unassessable. Other possible cause of the event such as any other diseases was not provided. The reporting physician commented as follows: The symptoms were probably psychological.


VAERS ID: 1729869 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-08-24
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4213 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Deep vein thrombosis, Electrocardiogram, Ultrasound scan, X-ray
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Obesity (BMI 40.3)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: blood test; Result Unstructured Data: Test Result:no results specified; Test Date: 2021; Test Name: ECG; Result Unstructured Data: Test Result:no results specified; Test Date: 2021; Test Name: ultrasound; Result Unstructured Data: Test Result:no results specified; Test Date: 2021; Test Name: chest X ray; Result Unstructured Data: Test Result:no results specified
CDC Split Type: NLPFIZER INC202101186142

Write-up: Thrombosis in foot/Deep vein thrombosis; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Authority-WEB. The regulatory authority report number is NL-LRB-00675950. This consumer reported different events for the same patient vaccinated with different doses of Comirnaty. This report is for the second dose. A 42-year-old female patient received the second dose BNT162b2 (COMIRNATY, solution for injection, lot number FF4213), via an unspecified route of administration on 24Jul2021 as dose 2, single for covid-19 immunisation. Medical history included ongoing obesity (BMI 40.3). The patient was previously vaccinated with the first dose of BNT162b2 (COMIRNATY, lot number unknown) on 19Jun2021 for covid-19 immunisation and experienced neck pain, pain in arm and, fatigue. The patient''s concomitant medications were not reported. The patient previously took amoxicillin, clavulanic acid (AUGMENTIN) and experienced drug allergy (still ongoing). The patient had no previous corona infection. 32 days (as reported) after start, on 24Aug2021, the patient experienced thrombosis in foot/deep vein thrombosis. The deep vein thrombosis was treated with anticoagulants and compression stocking. Diagnostics on an unspecified date in 2021 included blood test, ultrasound, chest X ray, ECG - all with no results specified. The patient has not recovered from the event. Reporter''s Comment: BioNTech/Pfizer vaccine (Comirnaty). Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): Yes. ADRs: Painful arm and neck, tired Date: 19Jun2021. Confounding factors: Confounding factors, allergy: Augmentin. COVID-19: Previous COVID-19 infection: No. Other: diagnostic procedures: blood test, ultrasound, lung X-ray, ECG. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty). Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): Yes. ADRs: Painful arm and neck, tired Date: 19Jun2021. Confounding factors: Confounding factors, allergy: Augmentin. COVID-19: Previous COVID-19 infection: No. Other: diagnostic procedures: blood test, ultrasound, lung X-ray, ECG.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101231947 same patient, different vaccine dose/events


VAERS ID: 1729897 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-08-24
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Drug ineffective, Nasopharyngitis, Oropharyngeal pain, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: COVID-19 test; Test Result: Positive ; Comments: COVID-19 confirmed
CDC Split Type: PHPFIZER INC202101183142

Write-up: Drug ineffective; COVID-19 confirmed by positive COVID-19 test; cold; cough; sore throat; This is a spontaneous report from a contactable other health professional. The regulatory authority report number is PH-PHFDA-300103472. A 30-year-old female patient received BNT162B2 (COMIRNATY Solution for injection), intramuscular, on 16Jul2021 (Batch/Lot Number: FD5996), at age 30 years old, as dose number unknown, single, for COVID-19 immunisation. It was unknown if the patient was pregnant at the time of vaccination. Relevant medical history and concomitant medications were not reported. On 24Aug2021 21:50, the patient experienced drug ineffective, COVID-19 confirmed by positive COVID-19 test, cold, cough, and sore throat. The patient recovered from the events on an unspecified date. On 18Sep2021, investigation results for batch/lot number FD5996 was provided. The investigation results were as follows: 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: Reference PR ID 6168537 The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FD5996. 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. They conclude that the reported defect is not representative of the quality of the batch and the batch remains acceptable. They process determined that no regulatory notification was required The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed No follow-up attempts are possible. No further information is expected.


VAERS ID: 1729903 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-08-24
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9309 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: SARS-CoV-2 RT-PCR test; Test Result: Positive
CDC Split Type: PTPFIZER INC202101180474

Write-up: COVID-19 after vaccine failure of the mRNA vaccine against COVID-19; COVID-19 after vaccine failure of the mRNA vaccine against COVID-19; This is a spontaneous report from a contactable other hcp downloaded from the WEB, regulatory authority number PT-INFARMED-B202108-3498. A 48-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 via intramuscular route on 17Jun2021 (Batch/Lot Number: FC5435; (CAUL: 31521), Expiration Date: 30Sep2021) as dose 1, 0.3 ml single and dose 2 via intramuscular route on 15Jul2021 (Batch/Lot Number: FD9309; (CAUL: 38021), Expiration Date: 31Oct2021) as dose 2, 0.3 ml single, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Approximately 6 weeks after completing the Comirnaty vaccine schedule, on 24Aug2021, the patient presented with COVID-19, confirmed by a positive PCR test for SARS-CoV-2 infection. The patient manifested symptoms associated with COVID-19, namely nasal congestion. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 24Aug2021. The reporter''s assessment of the causal relationship of the [COVID-19 and vaccination failure] 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. The outcome of Covid-19 was unknown. Reporter comment: Further information: RT PCR test positive on 24Aug2021. Nasal congestion. As per information from product quality complaint team on 10Sep2021, from RA (lot number: FC5435, expiration date: 30Sep2021): For this lot Adverse Event Safety Request for Investigation and/or Lack of Effect was previously investigated. A sample was not sent to the lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: The complaint for PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FC5435. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. Concludes that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Conclusion also provided for dose 2 (lot number: FD9309, expiration date: 31Oct2021): The complaint for PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FD9309. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. RA concludes that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1729904 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005696 / UNK - / OT

Administered by: Unknown       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: PTMODERNATX, INC.MOD20213

Write-up: Sincope vasovagal; This case was received via Agency (Reference number: PT-INFARMED-F202108-3469) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Sincope vasovagal) in a 20-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005696) for COVID-19 vaccination. No Medical History information was reported. On 24-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 24-Aug-2021, the patient experienced SYNCOPE (Sincope vasovagal) (seriousness criterion medically significant). On 24-Aug-2021, SYNCOPE (Sincope vasovagal) had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant product information were provided by the reporter. No treatment information was provided by the reporter. Company Comment: This case refers to a 20-year-old male patient with no known medical history who experienced the unexpected event of Syncope on the same day the first dose of Spikevax was administered. No causality assessment was provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Translation Received on 20-sep-2021 includes dosage information was updated; Sender''s Comments: This case refers to a 20-year-old male patient with no known medical history who experienced the unexpected event of Syncope on the same day the first dose of Spikevax was administered. No causality assessment was provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1729921 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210824; Test Name: SARS-CoV-2 test; Result Unstructured Data: Positive Iu international unit(s)
CDC Split Type: PTJNJFOC20210943202

Write-up: COVID-19 VACCINE VACCINE FAILURE USER WITH COMPLETE VACCINATION SCHEDULE FOR 2 WEEKS HAD COVID-19; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, PT-INFARMED-T202109-112) on 22-SEP-2021 and concerned a 24 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C17-05 expiry: UNKNOWN) 0.5 ml, 1 total administered on 24-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 24-AUG-2021, the patient experienced covid-19 vaccine vaccine failure user with complete vaccination schedule for 2 weeks had covid-19. Laboratory data included: SARS-CoV-2 test (NR: not provided) Positive Iu international unit (s). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 vaccine vaccine failure user with complete vaccination schedule for 2 weeks had covid-19 was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.; Reporter''s Comments: Other information- Asymptomatic Test performed on 24-Aug-2021


VAERS ID: 1729960 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 FE8235 / 2 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Anovulatory cycle, Genital discharge, Genital haemorrhage, Inappropriate schedule of product administration
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad), Medication errors (narrow), 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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101193114

Write-up: Bleeding / colored discharge from genitals daily; colored discharge from genitals daily; Probably absence of ovulation; Dose 1: 06Jul2021; Dose 2: 24Aug2021; This is a spontaneous report from a non-contactable consumer (reporting for herself). A 25-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration, administered in arm right on 24Aug2021 (at the age of 25 years old) (Lot Number: FE8235) as single dose for covid-19 immunization. Medical history and concomitant medications were none. No known allergies. Historical vaccine included bnt162b2 (COMIRNATY) dose 1 on 06Jul2021 (at the age of 24 years old) (lot number: FD6840) in Right arm for Covid-19 immunisation. Patient was not pregnant at time of vaccination. The patient had not received any other vaccine within 4 weeks. The patient experienced bleeding / colored discharge from genitals daily on 28Aug2021, colored discharge from genitals daily on 28Aug2021, probably absence of ovulationon on 28Aug2021. Patient had not received treatment for the events. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of bleeding / colored discharge from genitals daily, colored discharge from genitals daily, probably absence of ovulationon was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1729982 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-08-24
   Days after vaccination:46
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: Deafness unilateral
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: hearing loss in the left ear; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEAFNESS UNILATERAL (hearing loss in the left ear) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced DEAFNESS UNILATERAL (hearing loss in the left ear) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 10-Aug-2021 to 14-Aug-2021 due to DEAFNESS UNILATERAL. At the time of the report, DEAFNESS UNILATERAL (hearing loss in the left ear) outcome was unknown. 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 drug details not provided. Today the patient paid a return visit (Cardiology Department) to take a long-term prescription and mentioned hearing loss to Physician. Company comment: This case concerns a female patient with no relevant medical history, who experienced the unexpected event of hearing loss in the left ear. The event occurred approximately 1 month 16 days after the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a female patient with no relevant medical history, who experienced the unexpected event of hearing loss in the left ear. The event occurred approximately 1 month 16 days after the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1729989 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-24
   Days after vaccination:11
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: Blood bilirubin, Blood pressure measurement, Body temperature, C-reactive protein, Diarrhoea, Haemoglobin, Heart rate, Nausea, Oxygen saturation, Respiratory rate, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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:
Current Illness: Cachexia; Gastric ulcer; Hepatitis B (chronic viral hepatitis B with hepatitis D); Hepatitis D; Hepatocellular carcinoma; Liver cirrhosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: T-Bil; Result Unstructured Data: 3.35 mg/dL; Test Date: 2021; Test Name: Blood pressure; Result Unstructured Data: 151/88 mm/hg; Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: 35?C; Test Date: 2021; Test Name: CRP; Result Unstructured Data: 90.57mg/L; Test Date: 2021; Test Name: Haemoglobin; Result Unstructured Data: 10.1 g/dL; Test Date: 2021; Test Name: Heart rate; Result Unstructured Data: 64 beats/min; Test Date: 2021; Test Name: Oxygen saturation; Result Unstructured Data: 99%; Test Date: 2021; Test Name: Respiratory rate; Result Unstructured Data: 20 breaths/ min
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Diarrhea; Vomiting; Nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Sep-2021 and was forwarded to Moderna on 15-Sep-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of DIARRHOEA (Diarrhea), VOMITING (Vomiting) and NAUSEA (Nausea) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hepatocellular carcinoma, Cachexia, Hepatitis B (chronic viral hepatitis B with hepatitis D), Liver cirrhosis, Gastric ulcer and Hepatitis D. On 13-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion hospitalization), VOMITING (Vomiting) (seriousness criterion hospitalization) and NAUSEA (Nausea) (seriousness criterion hospitalization). The patient was treated with METOCLOPRAMIDE HYDROCHLORIDE (PRIMPERAN) (intravenous) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), VOMITING (Vomiting) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood bilirubin: 3.35 (High) 3.35 mg/dL. In 2021, Blood pressure measurement: 151/88 (High) 151/88 mm/hg. In 2021, Body temperature: 35 (normal) 35?C. In 2021, C-reactive protein: 90.57 (High) 90.57mg/L. In 2021, Haemoglobin: 10.1 (Low) 10.1 g/dL. In 2021, Heart rate: 64 (normal) 64 beats/min. In 2021, Oxygen saturation: 99 (normal) 99%. In 2021, Respiratory rate: 20 (normal) 20 breaths/ min. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered DIARRHOEA (Diarrhea), VOMITING (Vomiting) and NAUSEA (Nausea) to be possibly related. Concomitant product use was not provided by the reporter. On 24 Aug 2021, the patient had diarrhea and vomiting for 3 days. The patient sought medical attention at the Emergency Department of the hospital as the symptoms persisted. After consultation, injection Primperan 1amp ST IVP was administered for treatment. The physician advised that the patient be hospitalized for treatment. The nurse reported a suspected vaccine-related adverse reaction. The patient was transferred to the Division of Gastroenterology for inpatient treatment. This case concerns a 60-year-old, male patient with relevant medical history of Hepatocellular carcinoma, Cachexia, Chronic viral hepatitis B with hepatitis D, Liver cirrhosis and Gastric ulcer, who experienced the unexpected events of diarrhoea, vomiting and nausea. The events occurred approximately 12 days after the patient received an unspecified dose of Moderna COVID-19 Vaccine. The rechallenge was assessed as not applicable since it was not specified which dose of the prodct the patient actually received. The medical history of Hepatocellular carcinoma, Cachexia, Chronic viral hepatitis B with hepatitis D, Liver cirrhosis and Gastric ulcer remains a confounder for all reported events. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Moderna COVID-19 Vaccine in not affected by this report.; Sender''s Comments: This case concerns a 60-year-old, male patient with relevant medical history of Hepatocellular carcinoma, Cachexia, Chronic viral hepatitis B with hepatitis D, Liver cirrhosis and Gastric ulcer, who experienced the unexpected events of diarrhoea, vomiting and nausea. The events occurred approximately 12 days after the patient received an unspecified dose of Moderna COVID-19 Vaccine. The rechallenge was assessed as not applicable since it was not specified which dose of the prodct the patient actually received. The medical history of Hepatocellular carcinoma, Cachexia, Chronic viral hepatitis B with hepatitis D, Liver cirrhosis and Gastric ulcer remains a confounder for all reported events. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Moderna COVID-19 Vaccine in not affected by this report.


VAERS ID: 1730072 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-08-24
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939599-CDC / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Chest discomfort, Cold sweat, Computerised tomogram, Deep vein thrombosis, Dyspnoea, Fibrin D dimer, Heart rate, Hypokalaemia, Nausea, Oxygen saturation, Pulmonary embolism, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypoglycaemia (broad), Hypokalaemia (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Back pain
Preexisting Conditions: Medical History/Concurrent Conditions: Pulmonary embolism
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: BP; Test Result: Inconclusive ; Result Unstructured Data: 120/72 mmHg; Test Date: 20210824; Test Name: Thoracic tomography; Result Unstructured Data: bilateral pulmonary embolism, suspected deep venous embolism in the right leg and hypokalemia; Test Date: 20210824; Test Name: D-dimer test; Test Result: Inconclusive ; Result Unstructured Data: 45100 ng/ml; Test Date: 20210827; Test Name: Heartbeat; Result Unstructured Data: regular; Test Date: 20210824; Test Name: SPO2; Test Result: Inconclusive ; Result Unstructured Data: 90%; Test Date: 20210827; Test Name: SPO2; Test Result: Inconclusive ; Result Unstructured Data: 100%; Test Date: 20210824; Test Name: COVID-19 antigen; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Shortness of breath; chest discomfort; deep vein thrombosis in the right leg; hypokalemia; bilateral pulmonary embolism; cold sweat; nausea; This regulatory authority case was reported by a pharmacist and describes the occurrence of DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (chest discomfort), DEEP VEIN THROMBOSIS (deep vein thrombosis in the right leg), HYPOKALAEMIA (hypokalemia) and PULMONARY EMBOLISM (bilateral pulmonary embolism) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939599-CDC) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Pulmonary embolism. Concurrent medical conditions included Back pain. On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Aug-2021, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization prolonged), CHEST DISCOMFORT (chest discomfort) (seriousness criterion hospitalization prolonged), DEEP VEIN THROMBOSIS (deep vein thrombosis in the right leg) (seriousness criteria hospitalization and medically significant), HYPOKALAEMIA (hypokalemia) (seriousness criteria hospitalization and medically significant), PULMONARY EMBOLISM (bilateral pulmonary embolism) (seriousness criteria hospitalization and medically significant), COLD SWEAT (cold sweat) and NAUSEA (nausea). The patient was treated with ENOXAPARIN for Adverse event, at a dose of 1 dosage form. At the time of the report, DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (chest discomfort), DEEP VEIN THROMBOSIS (deep vein thrombosis in the right leg), HYPOKALAEMIA (hypokalemia), PULMONARY EMBOLISM (bilateral pulmonary embolism), COLD SWEAT (cold sweat) and NAUSEA (nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Aug-2021, Computerised tomogram: abnormal (abnormal) bilateral pulmonary embolism, suspected deep venous embolism in the right leg and hypokalemia. On 24-Aug-2021, Fibrin D dimer: 45100 ng/ml (Inconclusive) 45100 ng/ml. On 24-Aug-2021, Oxygen saturation: 90% (Inconclusive) 90%. On 24-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. On 27-Aug-2021, Blood pressure measurement: 120/72 mmhg (Inconclusive) 120/72 mmHg. On 27-Aug-2021, Heart rate: normal (normal) regular. On 27-Aug-2021, Oxygen saturation: 100% (Inconclusive) 100%. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Bilateral pulmonary embolism was diagnosed through examination and the patient was admitted to the hospital (in the ICU) and the sample was sent for anti-PF4 antibody testing. On 27 Aug 2021, vital signs included limb muscle strength with 5 points, TPR: 37.4?C, 101 beats/min, 17 breaths/min, O2 nasal cannula 2 L/min. The breathing pattern was stable and the bilateral breathing sounds were clear. Then the patient was transferred out to a general ward. After TPA medication for one day, antithrombotic drugs were continued for Q12H. At present, the vital signs are stable, O2 2L/min is in use, SpO2 was 90% and the observation is continuing. Laboratory details included on 24 Aug 2021, D-dimer test was done and value was 45100 ng/ml. Concomitant medications were not reported. Company comment This case concerns a 72-year-old, female patient with previous relevant medical history of pulmonary embolism, who experienced the unexpected events of pulmonary embolism, dyspnoea, chest discomfort, deep vein thrombosis and hypokalemia. The events occurred 1 month and 19 days after the second dose of mRNA-1273. The rechallenge was not applicable, as the events happened after the first dose. The medical history of pulmonary embolism remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 72-year-old, female patient with previous relevant medical history of pulmonary embolism, who experienced the unexpected events of pulmonary embolism, dyspnoea, chest discomfort, deep vein thrombosis and hypokalemia. The events occurred 1 month and 19 days after the second dose of mRNA-1273. The rechallenge was not applicable, as the events happened after the first dose. The medical history of pulmonary embolism remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1731055 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101213124

Write-up: Myocarditis; Pericarditis; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 619840. A 32-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced myocarditis (medically significant) on 24Aug2021, pericarditis (medically significant) on 24Aug2021. 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: 1732442 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-08-24
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004218 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Herpes zoster, Influenza like illness
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: Allergic to cats (cat hair); Grass allergy; Pollen allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: Body temperature; Result Unstructured Data: 38.4 degree Celsius
CDC Split Type: CZMODERNATX, INC.MOD20213

Write-up: This case was received via Medicines Agency (Reference number: CZ-CZSUKL-21010404) 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 HERPES ZOSTER in a 44-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004218) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Grass allergy, Pollen allergy and Allergic to cats (cat hair). On 26-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 24-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced INFLUENZA LIKE ILLNESS. On 25-Aug-2021, the patient experienced HERPES ZOSTER (seriousness criterion medically significant). At the time of the report, HERPES ZOSTER had not resolved and INFLUENZA LIKE ILLNESS had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Aug-2021, Body temperature: 38.4 (High) 38.4 degree Celsius. Concomitant medication was not provided. Treatment information was not provided. rechallenge was done, reaction did not reoccur. Company Comment: This case concerns a 44-year-old male with a medical history of environmental allergies, who experienced the unexpected event of herpes zoster and influenza like illness, 2 days after the second dose of Spikevax. The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 44-year-old male with a medical history of environmental allergies, who experienced the unexpected event of herpes zoster and influenza like illness, 2 days after the second dose of Spikevax. The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1732508 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Deafness, Dizziness, Loss of consciousness
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), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: DEJNJFOC20210942898

Write-up: LOSS OF CONSCIOUSNESS; DEAFNESS; LIGHT HEADEDNESS; This spontaneous report received from a consumer via a Regulatory Authority (Regulatory Authority, DE-PEI-CADR2021169169) on 22-SEP-2021 and concerned a 19 year old male. The patient''s weight was 55 kilograms and height was 172 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 24-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 24-AUG-2021, the patient experienced loss of consciousness, deafness and light headedness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from loss of consciousness, deafness and light headedness. This report was serious (Other Medically Important Condition).; Reporter''s Comments: sender comment- After waking up very strong heartbeat, laid down in bed, measured BP, was normal again.


VAERS ID: 1733135 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Pain, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LORATADINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hay fever; Seasonal allergy
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101105224

Write-up: Headache; Dizzy spells; Ache; This is a solicited report from a non-Pfizer-sponsored program from a contactable consumer. This is a report received from a regulatory authority. The regulatory authority report number is GB-MHRA-YCVM-202108232107222640-6IOKS, Safety Report Unique Identifier GB-MHRA-ADR 25842417. A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot unknown; unknown if first or second dose) intramuscular on 24Aug2021 (at the age of 16 years) as a single dose for COVID-19 vaccination. Medical history included hay fever and seasonal allergy. Concomitant medication included loratadine for hay fever and seasonal allergy. Unsure if patient has had symptoms associated with COVID-19. The patient was not pregnant and date of last menstrual period was 19Aug2021. The patient was not currently breastfeeding. The patient was not enrolled in clinical trial. On 24Aug2021, the patient experienced ache (medically significant) and considered related to the vaccine. On 28Aug2021, the patient had dizzy spells. On 30Aug2021, the patient experienced headache. Lab test included COVID-19 virus test: no - negative covid-19 test in 2021. The outcome of the events ache and headache was not recovered. The outcome of the event dizzy spells was recovered on 02Sep2021. The patient has not tested positive for COVID-19 since having the vaccine. The reporter''s assessment of the causal relationship of the events (dizzy spells and headache) 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; information about lot/batch number cannot be obtained. No further information is expected. Follow-up (05Sep2021): New information reported from a contactable consumer via a regulatory authority includes: new adverse event (dizziness). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Follow-up (09Sep2021): New information reported from a contactable consumer via a regulatory authority includes: medical history, additional adverse event (headache) and seriousness criteria (medically significant). This case is now serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the reported information, a causal relationship between the events of pain, dizziness and headache and suspected drug BNT162B2 cannot be excluded. There is limited information provided in this report. This consumer report lacks confirmation from a healthcare professional. Confirmation from the patient''s treating physician would be helpful. This case will be reassessed once additional information is 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1733385 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiovascular function test, Impaired quality of life, Paraesthesia, Tachycardia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to molds; Dust allergy; Pollen allergy
Allergies:
Diagnostic Lab Data: Test Name: cardiological examination; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC202101228406

Write-up: Impact on quality of life (9/10); diffuse face paraesthesia; tachycardia; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority number IT-MINISAL02-785921. A 37-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included allergies to pollen, dust, mould and brufen, moment act (unknown). The patient''s concomitant medications were not reported. The patient experienced diffuse face paraesthesia (life threatening) on 24Aug2021, tachycardia (life threatening) on 24Aug2021. Therapeutic measures were taken as a result of diffuse face paraesthesia and achycardia. Actions taken: cardiological examination, tachypirine and vitamin B. Impact on quality of life (9/10). The outcome of diffuse face paraesthesia and achycardia was not recovered, of the other event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1733420 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   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 FF0843 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Arthritis, Aspartate aminotransferase, Blood creatinine, Blood urea, Blood uric acid, C-reactive protein, C-reactive protein increased, Gamma-glutamyltransferase, Gamma-glutamyltransferase increased, Haematocrit, Haematocrit increased, Haemoglobin, Joint range of motion decreased, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Pain in extremity, Platelet count, Red blood cell count, Vaccination site swelling, White blood cell count
SMQs:, Liver related investigations, signs and symptoms (narrow), Systemic lupus erythematosus (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension; Lumbar disc herniation
Preexisting Conditions: Medical History/Concurrent Conditions: Epidural anaesthesia
Allergies:
Diagnostic Lab Data: Test Date: 20210830; Test Name: alanine aminotransferase/ Glutamic pyruvic transaminase; Result Unstructured Data: Test Result:28 IU/l; Test Date: 20210830; Test Name: aspartate aminotransferase/ Glutamic-oxaloacetic transaminase; Result Unstructured Data: Test Result:23 IU/l; Test Date: 20210830; Test Name: Creatinine; Test Result: 0.61 mg/dl; Test Date: 20210830; Test Name: Urea nitrogen; Test Result: 15.7 mg/dl; Test Date: 20210830; Test Name: Uric acid; Test Result: 5.1 mg/dl; Test Date: 20210830; Test Name: CRP quantitative; Result Unstructured Data: Test Result:1.75 H mg/dl; Test Date: 20210830; Test Name: ?-glutamyl transpeptidase; Result Unstructured Data: Test Result:61 H IU/l; Test Date: 20210830; Test Name: Hematocrit; Result Unstructured Data: Test Result:45.8 H %; Test Date: 20210830; Test Name: Hemoglobin; Result Unstructured Data: Test Result:14.5 g/dl; Test Date: 20210830; Test Name: mean corpuscular hemoglobin; Test Result: 31.0 pg; Test Date: 20210830; Test Name: mean corpuscular hemoglobin concentration; Test Result: 31.7 %; Test Date: 20210830; Test Name: Mean Corpuscular Volume; Result Unstructured Data: Test Result:97.9; Comments: unit: fl; Test Date: 20210830; Test Name: Platelet; Result Unstructured Data: Test Result:35.5; Comments: unit x104/?L; Test Date: 20210830; Test Name: Red blood cell count; Result Unstructured Data: Test Result:468; Comments: unit x104/?L; Test Date: 20210830; Test Name: White blood cell count; Result Unstructured Data: Test Result:5800; Comments: unit /?L
CDC Split Type: JPPFIZER INC202101121274

Write-up: left shoulder Arthritis; gamma-glutamyl transpeptidase 61 H; CRP quantitative 1.75 H; Hematocrit 45.8 H; strong pain occurred in the arm which was vaccinated; swelling occurred in the arm which was vaccinated; could not stretch up of shoulders; 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 physician received via Pfizer sales representative. A 57-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: FF0843; Expiration Date: 31Oct2021), intramuscular, administered in Arm (also reported as left deltoid muscle) on 23Aug2021 10:00 (at the age of 57 years old) as does 1, single for COVID-19 immunisation. Medical history included hypertension from 16Sep2014 and ongoing, lumbar disc herniation from 10Oct2000 and ongoing, lumbar epidural block. There was no family history. The patient''s concomitant medications were not reported. There was no other vaccination within 4 weeks. The patient did not receive the second dose of vaccination. On 23Aug2021, the patient received the first dose of vaccination (COMIRNATY). On 24Aug2021, the patient experienced strong pain and swelling occurred in the arm which was vaccinated. The patient visited hospital due to could not stretch up of shoulders. Paracetamol (CALONAL) was prescribed. On 28Aug2021, symptoms did not improve. Since the fingers could move, it seemed that there was no effect to the nerves, and follow-up. Diclofenac (VOLTAREN) was prescribed. After vaccination, on an unspecified date, left shoulder arthritis occurred. Considered that it was a side effect of moderate disease. Because Paracetamol 1000 mg did not have effect, so changed to use Diclofenac. Twice trigger point block, NEO VITACAIN 2ml used. The symptoms were recovering (as reported), and the patient went back to work. Relevant tests on 30Aug2021 included the following: aspartate aminotransferase/ glutamic-oxaloacetic transaminase 23, Reference value:10-40, unit U/L; alanine aminotransferase/ glutamic pyruvic transaminase 28, Reference value: 5-40, unit U/L; gamma-glutamyl transpeptidase 61 H, Reference value: male less than 70, female less than 30. unit U/L; Urea nitrogen 15.7, Reference value: 8.0-22.0, unit mg/dl; Creatinine 0.61, Reference value: male 0.61-1.04, female 0.47-0.79, unit mg/dl; Uric acid 5.1, Reference value: male 3.7-7.0, female 2.5-7.0, unit mg/dl; CRP quantitative 1.75 H, Reference value: less than 0.14, unit mg/dl; White blood cell count 5800, Reference value: male 3900-9800, female 3500-9100 unit /?L; Red blood cell count 468, Reference value: male 427-570, female 376-500 unit x104/?L; Hemoglobin 14.5, Reference value: male 13.5-17.5, female 11.3-15.2, unit g/dl; Hematocrit 45.8 H, Reference value: male 39.8-51.8, female 33.4-44.9, unit %; Mean Corpuscular Volume 97.9, Reference value: male 82.7-101.6, female 79.0-100.0, unit fl; mean corpuscular hemoglobin 31.0, Reference value: male 28.0-34.6, female 26.3-34.3, unit pg; mean corpuscular hemoglobin concentration 31.7, Reference value: male 31.6-36.6 female 30.7-36.6 unit %; Platelet 35.5, Reference value: male 13.1-36.2, female 13.0-35.9 x104/?L. Outcome of event left shoulder arthritis was recovering, while other events was unknown. Follow-up attempts are completed. No further information is expected.; Sender''s Comments: There is a reasonable possibility that the events pain in arm and vaccination site swelling were related to comirnaty use based on known drug safety profile. Based on the temporal relationship, the association between the event could not stretch up shoulder and arthritis with comirnaty use can not be fully 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: 1733424 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   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 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Haemoptysis, Pneumonia, Pulmonary alveolar haemorrhage, Pyrexia
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: Cerebral infarction; IgA vasculitis
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal pain (Visited dermatological department due to Abdominal pain and Purpura, diagnosed as IgA vasculitis.); Atrial flutter; Cardiac failure; Hypertension; Purpura (Visited dermatological department due to Abdominal pain and Purpura, diagnosed as IgA vasculitis.); Renal impairment; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101184398

Write-up: respiratory situation deteriorated/bilateral pneumonia; Dyspnoea; Sputum bloody; Pulmonary alveolar haemorrhage; the patient had Pyrexia; This is a spontaneous report from a contactable pharmacist received from a regulatory authority. Regulatory authority report number: v21127568. A 75-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 via an unspecified route of administration on 23Aug2021 at 18:00 (Batch/Lot Number: FF3622; Expiration Date: 30Nov2021) as dose 2, single for Covid-19 immunisation. Medical history included ongoing Cerebral infarction (in hospital at present), ongoing IgA vasculitis (appeared in hospital), high renal impairment, hypertension, atrial flutter, cardiac failure, type 2 diabetes mellitus, and abdominal pain. The patient saw a doctor in dermatological department due to appearance of abdominal pain and purpura, diagnosed as IgA vasculitis. The patient''s concomitant medications were not reported. On 25Aug2021 at 00:00 (2 days after the vaccination), the patient experienced Dyspnoea, Sputum bloody and Pulmonary alveolar haemorrhage. The course of the event was as follows: On 19Jul2021, the patient was admitted to hospital due to Cerebral infarction. The patient saw a doctor in dermatological department due to appearance of Abdominal pain and Purpura, diagnosed as IgA vasculitis. On 23Aug2021 at 18:00 (the day of vaccination), the patient received vaccination of Comirnaty. On 24Aug2021 (1 day after the vaccination), the patient had Pyrexia. On 25Aug2021 (2 days after the vaccination), the patient had Sputum bloody and Dyspnoea. On 26Aug2021 (3 days after the vaccination), the respiratory situation deteriorated. The patient was introduced to Respiratory medicine and was taken IPPV management due to Bilateral pneumonia. MEPM and mPSL pulse was begun. On 30Aug2021 (7 days after the vaccination), extubation was done. Therapeutic measures were taken as a result of the events. On 08Sep2021 (16 days after the vaccination), the outcome of the events was recovering. The reporting pharmacist classified the event as serious (hospitalization) and assessed that the event was related to bnt162b2. Other possible cause of the event such as any other diseases was that the patient was taking DAPT via oral. The reporting pharmacist commented as follows: no special comments from pharmacist. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1733522 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2083 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Condition aggravated, Vaccination site pain
SMQs:

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: Levetiracetam Accord; Lexotanil; Lamotrix; Elicea
Current Illness: Allergy to metals; Depression; Focal seizures (Focal seizures with dissociative seizures).
Preexisting Conditions: Medical History/Concurrent Conditions: Adverse drug reaction NOS (Adverse reactions after neuroleptic use, sumatriptan use and nootropic medication use).
Allergies:
Diagnostic Lab Data:
CDC Split Type: LVPFIZER INC202101195523

Write-up: Patient had a focal seizure; Axillary pain; Injection site pain; This is a spontaneous report from a contactable consumer or other non HCP downloaded from the Regulatory Authority-WEB, regulatory authority number LV-SAM-2021096589. A 31-years-old female patient had received bnt162b2 (COMIRNATY solution for injection), (Batch/Lot Number: FE2083) via intramuscular on 24Aug2021 (at the age of 31-years-old) as dose 1, 0.3ML single for covid-19 immunisation. The patient medical history included ongoing allergy to metals, adverse drug reaction from an unknown date and unknown if ongoing (adverse reactions after neuroleptic use, sumatriptan use and nootropic medication use), ongoing focal seizures with dissociative seizures, ongoing depression. Concomitant medications included levetiracetam (LEVETIRACETAM ACCORD) taken for partial seizures from 23Sep2019 to ongoing; bromazepam (LEXOTANIL) taken for partial seizures, depression from 01Feb2021 to ongoing; lamotrigine (LAMOTRIX) taken for partial seizures from 01Feb2021 to ongoing; escitalopram oxalate (ELICEA) taken for depression from 01Feb2021 to ongoing. The patient previously took sumatriptan and experienced adverse drug reaction. On 24Aug2021, the patient experienced patient had a focal seizure, axillary pain and injection site pain. Patient was hospitalized for the event focal seizure. Both other events were considered as non-serious. The clinical outcome of the events was resolved on an unspecified date of 2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1733526 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8838 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Irritability, Laryngeal oedema, Nausea, Pain, Panic reaction, Paraesthesia, Sensitive skin, Vital signs measurement, Wrong product administered
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Medication errors (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: Medical History/Concurrent Conditions: Otitis media (In treatment by private doctor)
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: Vital Signs; Result Unstructured Data: Test Result:normal
CDC Split Type: MXPFIZER INC202101190306

Write-up: Headache; Irritability; Pain/Sensitivity; Pain/Sensitivity; Dizziness; Nausea; Lower extremity paresthesia; Epiglottis edema; Panic; AstraZeneca had been applied in its first dose; This is a spontaneous report from a non-contactable other health professional. This is a report received from a regulatory authority via email. Regulatory authority report number is 17550-9. A non-pregnant 35-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 intramuscular, administered in Arm Left, at age 35 years, on 24Aug2021 (Batch/Lot Number: FF8838; Expiration Date: 01Dec2021) as DOSE 2, SINGLE for COVID-19 immunisation. Relevant medical history includes long-standing otitis media in treatment by private doctor. No infectious disease in the last 15 days prior to vaccination. Patient had no allergies.The patient''s concomitant medications were not reported. Patient historically received the first dose of COVID-19 Vaccine Astrazeneca on an unspecified date for COVID-19 immunisation. On 24Aug2021, vaccine application error occurred. Error on the part of the personnel that is in the filter that allows the entry of people for their application of the biological, without realizing that AstraZeneca had been applied in its first dose, therefore it was not appropriate to apply Pfizer, as the documentation was not properly verified of their proof of vaccination they allowed their entry so that the biological Pfizer could be applied, it is worth mentioning that the health center staff does not have said documentation since the welfare staff does not allow it. On 24Aug2021, 30 mins after vaccination, the patient experienced headache, irritability, pain, sensitive skin, dizziness, nausea, paresthesia lower limb, aryepiglottis edema/epiglottis edema, and panic reaction. Clinical course: 3:37 hours apply biological 13:57 refers the patient to present headache, nausea, lower extremities paresthesia, epiglottis edema, 14:05 dexamethasone 8 mg ampoule is applied intramuscular (IM), refers adequate response, relatives arrive and panic, goes to the municipality ambulance, is apply oxygen with nasal tips at 3 liters per minute and intravenous (IV) saline solution with an adequate response, 3:00 pm, she withdraws from observation accompanied by family members with stable vital signs. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1733598 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Delirium, Investigation
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Investigations; Result Unstructured Data: Test Result: unremarkable.
CDC Split Type: NZPFIZER INC202101204989

Write-up: This is a spontaneous report from a contactable consumer, via the regulatory authority (report number: AEFI-A-012954). A 68-year-old male patient received the 2nd dose of BNT162B2 (Comirnaty), via an unspecified route of administration, on Aug 21, 2021, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications not reported. The patient experienced delirium (medically significant) on Aug 24, 2021. This led to hospitalization; with outcome of recovered. The patient underwent lab tests and procedures, which included investigation: unremarkable. Reporter''s description: Delirium/acute confusion. Felt generally unwell 1 day after. On Tuesday (2 days after) was noted to be significantly muddled by partner - called partner wrong name, verbally aggressive, convinced partner had done something she hadn''t. Ongoing Wed morning partner advised by GP to call ambulance. Admitted for 2 days - not oriented to place, person, or time. Difficult to engage with. Resolved by Friday morning and cleared for discharge. Investigations unremarkable - no other significant medical concerns. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1733678 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210824; Test Name: SARS-CoV-2 test; Result Unstructured Data: Positive Iu international unit(s)
CDC Split Type: PTJNJFOC20210941741

Write-up: VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, PT-INFARMED-T202109-88) on 22-SEP-2021 concerned a 51 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: XD986 expiry: UNKNOWN) 0.5 ml,1 total, administered on 07-JUN-2021 for covid-19 immunisation. No concomitant medications were reported. On 24-AUG-2021, the patient experienced vaccination failure. Laboratory data included: SARS-CoV-2 test (NR: not provided) Positive Iu international unit (s). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccination failure was not reported. This report was serious (Other Medically Important Condition). The case is associated with Product quality complaint.


VAERS ID: 1736312 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-08-24
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214010 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Tooth abscess
SMQs:, Osteonecrosis (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: ESMODERNATX, INC.MOD20213

Write-up: Dental phlegmon; This case was received via regulatory authority (Reference number: ES-AEMPS-988232) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of TOOTH ABSCESS (Dental phlegmon) in a 26-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3005244 and 214010) for COVID-19 vaccination. No Medical History information was reported. On 26-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced TOOTH ABSCESS (Dental phlegmon) (seriousness criterion medically significant). At the time of the report, TOOTH ABSCESS (Dental phlegmon) was resolving. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 26-Jul-2021. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment information was provided by the reporter. Company Comment: This case concerns a 26-year-old, female patient with no relevant medical history, who experienced the unexpected event of tooth abscess. The event occurred approximately 2 days after the second dose of Spikevax. The rechallenge was not applicable since event occurred after second dose. The reporter assessed the event as related to the product. The benefit-risk relationship of Spikevax in not affected by this report.; Sender''s Comments: This case concerns a 26-year-old, female patient with no relevant medical history, who experienced the unexpected event of tooth abscess. The event occurred approximately 2 days after the second dose of Spikevax. The rechallenge was not applicable since event occurred after second dose. The reporter assessed the event as related to the product. The benefit-risk relationship of Spikevax in not affected by this report.


VAERS ID: 1736413 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005697 / 2 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: C-reactive protein, Chest pain, Dyspnoea, Electrocardiogram, General physical health deterioration, Influenza like illness, Oxygen saturation, Troponin T, Vital signs measurement
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), 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: 20210827; Test Name: CRP; Result Unstructured Data: 14 mg/L; Test Date: 20210827; Test Name: ECG; Result Unstructured Data: Normal; Test Date: 20210827; Test Name: SpO2; Result Unstructured Data: 99 percent; Test Date: 20210827; Test Name: Troponin T; Result Unstructured Data: (Normal range <14), at hospital admission 1 hour later the value was normalized.ng/L; Test Date: 20210827; Test Name: Vital signs; Result Unstructured Data: Normal
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: This case was received via a regulatory authority (Reference number: NO-NOMAADVRE-E2B_00046962) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of in a 40-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005697) for Vaccination. No Medical History information was reported. On 23-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, C-reactive protein: 14 (High) 14 mg/L. On 27-Aug-2021, Electrocardiogram: normal (normal) Normal. On 27-Aug-2021, Oxygen saturation: 99 (normal) 99 percent. On 27-Aug-2021, Troponin T: 20 (High) (Normal range <14), at hospital admission 1 hour later the value was normalized.ng/L. On 27-Aug-2021, Vital signs measurement: normal (normal) Normal. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Laboratory investigation which was performed on 27-Aug-2021 showed that patient was awake, alert, oriented and tired. No concomitant medications was reported. No treatment drug details was reported. Action taken was not applicable. Company comment - This case concerns a 40-year-old, female patient with no relevant medical history, who experienced the unexpected events dyspnea, general physical health deterioration, chest pain and influenza like illness. The events dyspnea, general physical health deterioration, chest pain occurred 5 days after the second dose of mRNA-1273 vaccine administration and the event influenza like illness occurred 2 days after the second dose of mRNA-1273 vaccine administration. The rechallenge was unknown as there''s no information available about the first dose. The events were considered possibly related to the product per the reporter''s assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation document received on 22-Sep-2021 included patient''s laboratory data details (C-reactive protein, electrocardiogram, oxygen saturation, Troponin T).; Reporter''s Comments: Thank you for reporting a suspected side effect after vaccination. Since the vaccine is new, it is subject to special monitoring in order to detect new safety information as quickly as possible. It is especially important that serious and / or unusual side effects are reported. Your message is therefore important to increase knowledge about side effects that have not been discovered in the studies, and is an important contribution to international cooperation to maintain safe vaccination worldwide. Reports after coronary vaccination in the Adverse Reaction Register are processed by a regulatory authority in collaboration with a regulatory authority. We do not currently have the capacity to send individual adverse reaction reports. A regulatory authority Agency publishes weekly summaries of reports of suspected side effects after vaccination: Causality is assessed according to international criteria (1). If you have further information related to the incident, such as information about the outcome, a copy of the medical record / epicrisis / laboratory answer and / or other reports, this can be sent in response to this message. The information is processed securely, and this dialog is automatically deleted after 4 months. Processing and storage of personal data takes place in accordance with the a regulatory authority. We request that no special categories of personal information (health information) be sent by e-mail. If it is impossible to ask a question without including such information, we recommend calling the vaccine telephone. Sender''s Comments: This case concerns a 40-year-old, female patient with no relevant medical history, who experienced the unexpected events dyspnea, general physical health deterioration, chest pain and influenza like illness. The events dyspnea, general physical health deterioration, chest pain occurred 5 days after the second dose of mRNA-1273 vaccine administration and the event influenza like illness occurred 2 days after the second dose of mRNA-1273 vaccine administration. The rechallenge was unknown as there''s no information available about the first dose. The events were considered possibly related to the product per the reporter''s assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1736421 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214020 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Diarrhoea, Lymphadenopathy, Malaise, Myalgia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (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: EFFIPLEN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTMODERNATX, INC.MOD20213

Write-up: This case was received via a regulatory authority (Reference number: PT-INFARMED-B202108-3633) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYALGIA, VACCINATION SITE PAIN, MALAISE, LYMPHADENOPATHY, CHILLS and DIARRHEA in a 23-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214020) for COVID-19 vaccination. Concomitant products included BUSPIRONE HYDROCHLORIDE (EFFIPLEN) for Hormonal contraception. On 24-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced MYALGIA (seriousness criterion medically significant), VACCINATION SITE PAIN (seriousness criterion medically significant), MALAISE (seriousness criterion medically significant), LYMPHADENOPATHY (seriousness criterion medically significant), CHILLS (seriousness criterion medically significant) and DIARRHEA (seriousness criterion medically significant). On 26-Aug-2021, LYMPHADENOPATHY had resolved. At the time of the report, MYALGIA, VACCINATION SITE PAIN, MALAISE, CHILLS and DIARRHOEA had resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered MYALGIA, VACCINATION SITE PAIN , MALAISE, LYMPHADENOPATHY, CHILLS and DIARRHOEA to be probably related. Treatment medication was not provided. The week after inoculation, I had muscle aches, diarrhoea and somnolence, malaise and chills on the first day. Pain in my left arm began later and lasted for 4 days. On 24-Aug, Patient noticed that his cervical lymph nodes were sore (nowbetter) and this morning (today). Patient had swelling in his arm. This case concerns a 23 year-old female patient with no relevant history, who experienced the unlisted events of myalgia, vaccination site pain, malaise, axillary adenopathy, chills, somnolence and diarrhea. The events occurred on the same day as the first dose of mRNA-1273 vaccine. But in the narrative vaccination site pain is referred began later. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The seriousness criteria of Medically significant is maintained for consistency with the RA report, however the source document does not include information supporting the seriousness criteria. There is a reported overdose with no specified reason that was captured. This case concerns a 23 year-old female patient with no relevant history, who experienced the unlisted events of myalgia, vaccination site pain, malaise, axillary adenopathy, chills, somnolence and diarrhea. The events occurred on the same day as the first dose of mRNA-1273 vaccine. But in the narrative vaccination site pain is referred began later. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The seriousness criteria of Medically significant is maintained for consistency with the RA report, however the source document does not include information supporting the seriousness criteria. There is a reported overdose with no specified reason that was captured. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation document received on 22-Sep-2021, Concomitant medication formulation updated, all event reporter causality changed and narrative updated.; Sender''s Comments: This case concerns a 23 year-old female patient with no relevant history, who experienced the unlisted events of myalgia, vaccination site pain, malaise, axillary adenopathy, chills, somnolence and diarrhea. The events occurred on the same day as the first dose of mRNA-1273 vaccine. But in the narrative vaccination site pain is referred began later. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The seriousness criteria of Medically significant is maintained for consistency with the RA report, however the source document does not include information supporting the seriousness criteria. There is a reported overdose with no specified reason that was captured.


VAERS ID: 1736627 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA9099 / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Computerised tomogram, Feeling abnormal, Headache, Hypoaesthesia, Magnetic resonance imaging, Migraine, Pain, Paraesthesia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: SYNTHROID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism
Allergies:
Diagnostic Lab Data: Test Name: CT SCAN; Result Unstructured Data: Test Result:unknown; Comments: to check for neurological issues; Test Name: MRI; Result Unstructured Data: Test Result:unknown; Comments: to check for neurological issues
CDC Split Type: CAPFIZER INC202101191461

Write-up: Extreme brain fog and eating causes stomach pains; Left side of my body is numb including face.; Pins and needles all over left side; pain when touched or move a lot; Constant migraines and ice pick headaches; Constant migraines and ice pick headaches; eating causes stomach pains; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA9099, Expiration date: Not reported), via an unspecified route of administration in left arm, on 23Aug2021 at 13:00 (at the age of 38-years-old) as unknown dose, single for COVID-19 immunization in a public health clinic/ administration facility. Medical history included hypothyroidism. There were no known allergies reported. Concomitant medications/other medications received within 2 weeks of vaccination included levothyroxine sodium (SYNTHROID). No relevant past drug history was reported. The patient was not pregnant at the time of vaccination and didn''t receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination (post-vaccination), the patient had not been tested for COVID-19. On 24Aug2021, the patient''s left side of the body was numb including face, pins and needles all over left side that causes pain when touched or moved a lot, constant migraines and ice pick headaches, extreme brain fog and eating causes stomach pains. The patient was not hospitalized for these events but resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received unspecified treatment for these events. On an unspecified date, the magnetic resonance imaging (MRI) and computerized tomogram (CT) scans were done to check for neurological issues. The outcome of the events was not recovered at the time of report.


VAERS ID: 1737760 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-24
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: CSF test, Magnetic resonance imaging head, Magnetic resonance imaging neck, Multiple sclerosis, Neurological examination
SMQs:, Optic nerve disorders (broad), Demyelination (narrow), Immune-mediated/autoimmune disorders (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CSF examination; Result Unstructured Data: Test Result:Unknown result; Test Name: mri skull; Result Unstructured Data: Test Result:Unknown result; Comments: MRI of the skull, with administration of contrast medium; Test Name: cervical region mri; Result Unstructured Data: Test Result:unknown result; Comments: with administration of contrast medium; Test Name: CSF (Cerebrospinal fluid) neurophysiology; Result Unstructured Data: Test Result:Unknown result
CDC Split Type: DEPFIZER INC202101194332

Write-up: Multiple sclerosis; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-202100184945. A 26-year-old male patient received BNT162B2 (COMIRNATY; lot/batch number and expiration date not reported) via an unspecified route of administration on 10Aug2021 as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received first dose of Comirnaty on 06Jul2021 (lot number unknown) for COVID-19 immunisation. On 24Aug2021 the patient experienced multiple sclerosis. Event was considered serious due to hospitalization and disability. Outcome of the event was not recovered. Relatedness of drug to reaction/event was considered B. Indeterminate by regulatory authority. Senders comment: Diagnosis: MRI of the skull and cervical region with administration of contrast medium, CSF (Cerebrospinal fluid) examination and neurophysiology, complaints since 09Jul2021 Exclusion: Acute disseminated encephalomyelitis. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1737761 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-24
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Ophthalmic herpes zoster
SMQs:, Ocular infections (narrow), Opportunistic infections (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 INC202101202294

Write-up: Herpes zoster keratoconjunctivitis; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the regulatory authority, regulatory authority number DE-PEI-202100184964. A 13-years-old male patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 17Aug2021 (Batch/Lot Number: Unknown) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 24Aug2021, after 7 days of vaccination, the patient experienced herpes zoster keratoconjunctivitis (ophthalmic herpes zoster). At the time of this report, the outcome of event was unknown. Regulatory authority comments included Corneal specks, signs of herpes zoster Comirnaty/ Herpes zoster keratoconjunctivitis/ B. Indeterminate. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1737900 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
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: COVID-19, Computerised tomogram, Computerised tomogram abnormal, Drug ineffective
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Multiple sclerosis
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: CT thorax; Result Unstructured Data: Test Result:abnormal; Comments: Frosted glass and subpleural compacts especially in the right lung lobes, limited similar findings in the left lung lobes: suspected primarily for infectious changes in the context of COVID. Total CT Severity Score:7 /25.
CDC Split Type: BEPFIZER INC202101194429

Write-up: CT scan abnormal; COVID-19 infection after vaccination; COVID-19 infection after vaccination; This is a spontaneous report from a contactable other healthcare professional downloaded from a Regulatory Authority BE-FAMHP-DHH-N2021-106392. A 54-year-old female patient received a dose of BNT162B2 (COMIRNATY, solution for injection, lot number and expiry date was not reported), via an unspecified route of administration, on an unspecified date, as single dose for COVID-19 immunisation. The patient medical history included multiple sclerosis. Concomitant medications included OCRELIZUMAB(OCREVUS), ESCITALOPRAM OXALATE(SIPRALEXA), AMITRIPTYLINE HYDROCHLORIDE(REDOMEX). On 24Aug2021, the patient experienced COVID-19 infection after vaccination, CT scan abnormal on an unspecified date and hospitalized on 31Aug2021. The patient was received treatment with antibiotics, cortisone and oxygen therapy. The patient underwent lab test and procedures included Computerised tomogram (CT thorax) with the result of Frosted glass and subpleural compacts especially in the right lung lobes, limited similar findings in the left lung lobes: suspected primarily for infectious changes in the context of COVID. Total CT Severity Score:7 /25 on 24Aug2021. The patient was discharged on 03Sep2021. Outcome of the events COVID-19 infection after vaccination, CT scan abnormal and drug ineffective were recovering. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reporter''s Comments: Treatment - Yes hospitalization and treated with antibiotics, cortisone and oxygen therapy Evolution of the ADR - Recovering Examinations - CT thorax: Frosted glass and subpleural compacts especially in the right lung lobes, limited similar findings in the left lung lobes: suspected primarily for infectious changes in the context of COVID. Total CT Severity Score:7 /25. ADR description - Patient admitted with a covid infection.


VAERS ID: 1738144 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dermatitis, Psoriasis
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gout; Psoriasis.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101194795

Write-up: Exacerbation of psoriasis; Dermatitis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-997054. A 14-years-old male patient received bnt162b2 (COMIRNATY), intramuscular on 22Aug2021 (Batch/Lot Number: FG4686) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. Medical history included previous suspicion of gout psoriasis of mild severity from Mar2020. No basic treatment only topical serum therapy in outbreaks. The patient''s concomitant medications were not reported. After vaccination 3 days later, a skin outbreak compatible with psoriasis is triggered, a little more intense than the previous ones that subsides without medication. The patient experienced exacerbation of psoriasis on 24Aug2021 with outcome of recovered on 04Sep2021, dermatitis on 24Aug2021 with outcome of recovered on 04Sep2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1738303 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-08-24
   Days after vaccination:145
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: COVID-19, Drug ineffective, Polymerase chain reaction
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: PCR; Test Result: Positive
CDC Split Type: FRPFIZER INC202101194011

Write-up: drug ineffective; COVID-19; This is a spontaneous report received from a contactable Physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number FR-AFSSAPS-BR20213374. A 82-year-old male patient received second dose of bnt162b2 (COMIRNATY, formulation: solution for injection, lot number: unknown) via an unspecified route of administration on an unknown date of Apr2021 as dose 2, single; also received dose 1 of bnt162b2 (COMIRNATY, formulation: solution for injection, lot number: unknown) via an unspecified route of administration on an unknown date of Mar2021 as dose 1, single both for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. On 24Aug2021, the patient experienced COVID-19 and Drug ineffective. On 30Aug2021, hospitalization for acute respiratory failure, patient put on hypnovel. The patient underwent lab test PCR: positive on 24Aug2021. Screening and sequencing not provided. The clinical outcome of events were not recovered. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.


VAERS ID: 1738330 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-24
   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 - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Muscular weakness, Neuropathy peripheral, Pain in extremity, Paraesthesia, Peripheral swelling, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210821; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101194546

Write-up: Neuropathy; swelling in the palm of the hand and a slight sensation of pain; swelling in the palm of the hand and a slight sensation of pain; tingling in the hand and arm on the vaccinated side; accompanied by a loss of strength in this limb; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-BX20218377. A 31-year-old female patient received bnt162b2 (COMIRNATY), intramuscular Arm on 21Aug2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient''s medical history was not reported. Concomitant medication included cyproterone acetate (ANDROCUR) taken for an unspecified indication, start and stop date were not reported. On 24Aug2021, the patient experienced neuropathy, swelling in the palm of the hand and a slight sensation of pain, tingling in the hand and arm on the vaccinated side accompanied by a loss of strength in this limb. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 21Aug2021. The patient was treated with a prescription of gabapentin 100 mg x 3/day. 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: 1738356 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-08-24
   Days after vaccination:196
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Respiratory failure (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:
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: variant delta
CDC Split Type: FRPFIZER INC202101194940

Write-up: Vaccination failure; PCR is positive for SARS-CoV-2, variant delta.; On 24Aug2021, hospitalization for desaturation; On 24Aug2021, hospitalization for desaturation plus fever; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB FR-AFSSAPS-GR20213908. An 88-year-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection), intramuscular on 09Feb2021 (Batch/Lot Number: EJ6788, expiration date: 30Apr2021) as dose 2, 0.3 mL single for COVID-19 immunisation, single, dose 1 via intramuscular, on 19Jan2021 (Batch/Lot Number: EG6788; Expiration Date: 30Apr2021) as dose 1, 0.3 mL single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had vaccination failure, PCR is positive for SARS-CoV-2, variant delta, hospitalization for desaturation plus fever on 24Aug2021. Seriousness criteria of the event was reported as hospitalization and medically significant. The patient laboratory investigation included SARS-CoV-2 PCR test was positive for variant delta on 24Aug2021. Product Complaint Team confirmed that the lot EG6788 is not a valid lot number for Comirnaty. Summary Investigation from RA for compound BNT 162 COVID-19 vaccine suspension for intramuscular 2ml multiple dose vial X 1 lot number EJ6788 with expiration date 30Apr2021. The complaint did not suggest a device malfunction. For this lot Adverse Event Safety Request for Investigation and/or Lack Of Effect was previously investigated. TA sample was not sent to the RA-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 RA ID resulted in the following conclusion: Reference RA ID 5674032 (see File attachment in this investigation record) The complaint for adverse event/LOE of PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot EJ6788 of the reported lot EJ6788. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The RA process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. On 30Aug2021, the outcome of the events was recovery in progress. Reporter comment: Hospitalization of a resident of residential establishments for dependent elderly people with a complete vaccination schedule due to desaturation plus fever. Covid plus variant delta. Follow-up attempts completed. No further information expected.; Reporter''s Comments: Hospitalization of a resident of residential establishments for dependent elderly people with a complete vaccination schedule due to desaturation plus fever. Covid plus variant delta.


VAERS ID: 1738436 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-24
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7051 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Amnesia, Blood glucose, Blood pressure increased, Blood pressure measurement, Body temperature, Bradykinesia, Computerised tomogram head, Confusional state, Disorientation, Electrocardiogram, Heart rate, Investigation, Oxygen saturation, Physical examination
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart valve operation
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: Capillary blood glucose; Result Unstructured Data: Test Result:1 g/l; Test Date: 20210824; Test Name: Blood pressure; Result Unstructured Data: Test Result:132/82 mmHg; Test Date: 20210824; Test Name: Temperature; Result Unstructured Data: Test Result:36 Centigrade; Test Date: 20210824; Test Name: Cerebral computerised tomography scan; Result Unstructured Data: Test Result:No abnormality found; Test Date: 20210824; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Normal; Test Date: 20210824; Test Name: heart rate; Result Unstructured Data: Test Result:92; Comments: beats per minutes; Test Date: 20210824; Test Name: Standard biological findings; Result Unstructured Data: Test Result:Normal; Test Date: 20210824; Test Name: oxygen saturation; Test Result: 96 %; Test Name: Clinical examination; Result Unstructured Data: Test Result:Ideomotor slowdown; Comments: clinical examination did not find any abnormality except for an ideomotor slowdown
CDC Split Type: FRPFIZER INC202101193972

Write-up: Amnesia transient/ amnesic ictus; confusion with spatio-temporal disorientation; confusion with spatio-temporal disorientation; ideo-motor slowdown; Blood pressure: 132/82 mmHg; This is a spontaneous report from a contactable consumer or other non-healthcare professional downloaded from the Agency Regulatory Authority-WEB; the Regulatory Authority report number is FR-AFSSAPS-NC20214024. A 37-year-old male patient received the second dose of BNT162B2 (COMIRNATY) intramuscular, administered in the left arm on 19Aug2021 (batch/lot number: FE7051) as DOSE 2, SINGLE for COVID-19 vaccination. The patient''s medical history included cardiac valve plasty on an unknown date. Patient had no significant neurological history. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on an unspecified date (batch/lot number: unknown) as DOSE 1, SINGLE for COVID-19 vaccination. On 24Aug2021, the patient experienced amnesia transient/ amnesic ictus, confusion with spatio-temporal disorientation, ideo-motor slowdown, and Blood pressure: 132/82 mmHg. It was reported that the patient was referred to the emergency room on 24Aug2021 due to an episode of confusion with spatio-temporal disorientation without sensory-motor deficit or associated head trauma. The clinical examination did not find any abnormality except for an ideomotor slowdown. Blood tests/ additional tests / aetiological tests were as follows: Clinical findings of 24Aug2021: Blood pressure: 132/82 mmHg / heart rate 92 beats per minute / oxygen saturation 96% / Temperature 36 Celsius (C) / capillary blood glucose: 1.00 g/L. Electrocardiogram was normal, standard biological findings were normal, and no abnormality was found in the Cerebral computerised tomography scan. Patient was prescribed magnetic resonance imaging to be done by private health professionals for clinical monitoring. Conclusion: A 37-year-old patient with no significant neurological history experiencing amnesic ictus 5 days after his 2nd injection of the Comirnaty vaccine, which resolved spontaneously the same day. The patient recovered from the events amnesia transient/ amnesic ictus and confusion with spatio-temporal disorientation. Outcome of the other events was unknown. The events amnesia transient/ amnesic ictus and confusion with spatio-temporal disorientation were reported as medically significant.


VAERS ID: 1738531 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Fatigue, Headache, Neck pain, Tachycardia, Vomiting
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), Arthritis (broad), Noninfectious diarrhoea (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101194812

Write-up: Diarrhea; Vomiting; Tachycardia; fatigue; Cervicalgia; Headache NOS aggravated; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-PB20216158. A 45-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 21Aug2021 (Lot Number: FF0688) as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously took first dose bnt162b2 (batch/lot number: FF0688) on 27Jul2021 for covid-19 immunization. The patient presented on day 3 (24Aug2021) of his vaccination (dose 2) very intense headaches with neck pain. Rapid rise in symptoms with very intense headaches (emergency room consultation on 25Aug2021) then persistence of headaches with an episode of vomiting and tachycardia on 26Aug2021, doctor on 26Aug2021. Since then, significant fatigue and persistence of less intense but permanent headaches to this day + diarrhea on 26Aug2021. Symptoms have lasted for 3 weeks with ongoing improvement. Management / severity consultation: complete check-up at the hospital on 25Aug2021 in front of the intensity of the symptoms. Onset date for all events was 21Aug2021. Seriousness criteria was medically significant. Outcome of the events was recovering. No follow-up attempts possible. No further information expected.


VAERS ID: 1738559 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214009 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza like illness, Loss of consciousness, Malaise, SARS-CoV-2 test, Urticaria
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210823; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Urticaria; Influenza like illness; Feeling sick; Consciousness loss; This case was received via regulatory authority (Reference number: FR-AFSSAPS-PV20212630) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Consciousness loss) in a 46-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214009) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 24-Aug-2021, the patient experienced LOSS OF CONSCIOUSNESS (Consciousness loss) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Influenza like illness) and MALAISE (Feeling sick). On 26-Aug-2021, the patient experienced URTICARIA (Urticaria). At the time of the report, LOSS OF CONSCIOUSNESS (Consciousness loss) and MALAISE (Feeling sick) had resolved and URTICARIA (Urticaria) and INFLUENZA LIKE ILLNESS (Influenza like illness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. No relevant concomitant medications were reported. No treatment information was reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Company comment: This case concerns a 46-year-old female with a serious unexpected event of loss of consciousness, and non-serious urticaria, influenza like illness, and malaise. Latency 2 days after second dose mRNA-1273. Events resolved or resolving. No rechallenge. Reporter causality not provided. Causal relationship possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2021: Translation received on 15 Sep 2021 contains no new information.; Sender''s Comments: This case concerns a 46-year-old female with a serious unexpected event of loss of consciousness, and non-serious urticaria, influenza like illness, and malaise. Latency 2 days after second dose mRNA-1273. Events resolved or resolving. No rechallenge. Reporter causality not provided. Causal relationship possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1738584 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-24
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Brain natriuretic peptide, Computerised tomogram, Computerised tomogram thorax, Deep vein thrombosis, Disease risk factor, Echocardiogram, Electrocardiogram, Electrocardiogram QRS complex prolonged, Prostatic specific antigen increased, Pulmonary embolism, Troponin, Ultrasound Doppler, Ultrasound scan
SMQs:, Conduction defects (narrow), Embolic and thrombotic events, venous (narrow), Tumour markers (narrow), Thrombophlebitis (broad), Prostate tumours of unspecified malignancy (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: Hypertension arterial.
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: echocardiogram; Result Unstructured Data: Test Result: Normal global left ventricular systolic function; Comments: Normal global left ventricular systolic function (left ventricular ejection fraction = 74% in Simpson) without parietal kinetic disorder with undilated left ventricle (left ventricular end diastolic diameter = 47 mm; telesystolic diameter of the left ventricle = 35 mm) and without left ventricular hypertrophy (left ventricular posterior wall 5 mm interventricular septum 5 mm) 21 mm left ventricular outflow tract and 14 cm Sub-Aortic Integral Time Speed cardiac insufficiency 2.7L/min/m2. Left ventricle relaxation disorder with E/A (acronym unknown) = 0.7 and TdecelM (acronym unknown)= 242 ms. Normal left filling pressures with E/Elat (acronym unknown) 6.6. Lack of significant valvular anomaly, Left atrium non-dilated (20 ml/m2); Right atrium non-dilated (15 cm?), Non-dilated right ventricle with good kinetics (STDVD [acronym not known] 6 cm?/m? and STS [acronym not known] 3cm2/m2 and right ventricular shortening fraction 49%; St DTI [acronym not known] 12.6 cm/s), Systolic Pulmonary Artery Pressure (tricuspid insufficiency flow) = 35-40 mmHg (i.e. Vmax = 2.8 m/s) for a Right atrial pressure = 5 mmHg). Pulmonary tachycardia 57 ms (milliseconds) absence of hypervolemia. Absence of pericardial effusion.; Test Name: electrocardiography; Result Unstructured Data: Test Result: regular sinus rhythm; Comments: Sinus rhythm, regular sinus rhythm, normal axis (17 degrees), incomplete right bundle branch block, no repolarization disorders, cardiac axis 17 degrees. intra-ventricular conduction: right branch block incomplete, repolarization: normal; Test Name: QRS width; Result Unstructured Data: Test Result:96; Comments: ms (milliseconds); Test Date: 20210827; Test Name: prostate- specific antigen; Result Unstructured Data: Test Result:9; Test Name: troponin; Result Unstructured Data: Test Result: not increased; Test Date: 20210830; Test Name: Venous Doppler ultrasound of the lower limbs; Result Unstructured Data: Test Result: venous thrombosis; Comments: Recent left femoral-popliteal venous thrombosis and right superficial femoral sequelae, segmental (presence of a small-caliber permeable 2nd superficial femoral vein, without thrombus); Test Name: venous ultrasound of the lower limbs; Result Unstructured Data: Test Result: thrombosis; Comments: thrombosis of the external iliac/common femoral vein to the left popliteal; Test Name: Brain natriuretic peptide; Result Unstructured Data: Test Result: not increased; Test Name: computed tomography angiography; Result Unstructured Data: Test Result: bilateral pulmonary embolism; Comments: finding a bilateral pulmonary embolism with a pulmonary heart, associated with two foci of pulmonary infarction; Test Date: 20210830; Test Name: Computerised tomography chest scan; Result Unstructured Data: Test Result: Bilateral proximal pulmonary embolism; Comments: Bilateral proximal pulmonary embolism, with moderate dilatation of the right heart chambers. Two foci of right lower lobe infarction.; Test Name: simplified pulmonary embolism index; Result Unstructured Data: Test Result: 0.
CDC Split Type: FRPFIZER INC202101194560

Write-up: Embolism pulmonary; Thrombosis venous deep; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-ST20213302. A 53-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 13Aug2021 (Batch/Lot Number: Unknown) as Dose 2, single for covid-19 immunisation. Medical history included Hypertension arterial. The patient''s concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date for covid-19 immunisation. The patient experienced thrombosis venous deep on 24Aug2021 and embolism pulmonary on 27Aug2021. Clinical course details: Onset of syncope while pulling a door. The male patient reports two similar episodes in recent weeks associated with exertional dyspnea and the recent onset (24Aug2021) of left calf cramp-type pain. Given this picture, a descrambling venous ultrasound of the lower limbs is carried out finding a thrombosis of the external iliac/common femoral vein to the left popliteal. In this context, a Computed Tomography angiography is performed finding a bilateral pulmonary embolism with a pulmonary heart, associated with two foci of pulmonary infarction. Patient was hospitalized in cardiac intensive care unit. Additional tests: Electrocardiography: Rhythm: Sinus rhythm, regular sinus rhythm, normal axis (17 degrees), incomplete right bundle branch block, no repolarization disorders, cardiac axis 17 degrees, QRS width (in milliseconds): 96, intra-ventricular conduction: right branch block incomplete, repolarization: normal. Venous Doppler ultrasound of the lower limbs on 30Aug2021: Recent left femoral-popliteal venous thrombosis and right superficial femoral sequelae, segmental (presence of a small-caliber permeable 2nd superficial femoral vein, without thrombus). Computerised tomography chest scan on 30Aug2021: Bilateral proximal pulmonary embolism, with moderate dilatation of the right heart chambers. Two foci of right lower lobe infarction. Echocardiogram on 27Aug2021: Normal global left ventricular systolic function (left ventricular ejection fraction = 74% in Simpson) without parietal kinetic disorder with undilated left ventricle (left ventricular end diastolic diameter = 47 mm; telesystolic diameter of the left ventricle = 35 mm) and without left ventricular hypertrophy (left ventricular posterior wall 5 mm interventricular septum 5 mm), 21 mm left ventricular outflow tract and 14 cm Sub-Aortic Integral Time Speed cardiac insufficiency 2.7L/min/m2, Left ventricle relaxation disorder with E/A = 0.7 and Tdece lM [acronym not known]= 242 ms, Normal left filling pressures with E/Elat [acronym not known] 6.6. Lack of significant valvular anomaly. Left atrium non-dilated (20 ml/m2); Right atrium non-dilated (15 cm?). Non-dilated right ventricle with good kinetics (STDVD [acronym not known] 6 cm?/m? and STS [acronym not known] 3cm2/m2 and right ventricular shortening fraction 49%; St DTI [acronym not known] 12.6 cm/s), Systolic Pulmonary Artery Pressure (tricuspid insufficiency flow) = 35-40 mmHg (i.e. Vmax = 2.8 m/s) a Right atrial pressure = 5 mmHg). Pulmonary tachycardia 57 ms (milliseconds) absence of hypervolemia. Absence of pericardial effusion. Conclusion: Left ventricular ejection fraction preserved. No acute pulmonary heart. Portal hypertension. Ongoing medical care of pulmonary embolism complicating deep vein thrombosis of lower left limbs. At Day 15th of a 2nd injection of Pfizer vaccine on 27Aug2021, Regarding the etiological findings, prostate-specific antigen is increased to 9. We advise the male patient to resume contact with his urologist and also with his gastroenterologist. The etiological assessment includes computed tomography. Abdomino-pelvic that will be performed on an outpatient basis. A curative anticoagulation with APIXABAN has been introduced and will be maintained for 6 months. The wearing of elastic venous compression class III of the lower limbs is indicated for a minimum period of 6 months in order to prevent the risk of onset of post thrombotic syndrome. Conclusion: Low risk unprovoked pulmonary embolism (simplified pulmonary embolism index 0; troponin and Brain natriuretic peptide not increased; no sign of acute pulmonary heart) complicating deep vein thrombosis of the lower left limbs. 1st event. Complicated by superinfection of Laennec infarction treated with AUGMENTIN (AMOXICILYN + CLAVULANIC ACID). Indication of curative anticoagulation with ELIQUIS (APIXABAN) for at least 6 months, Prostate-specific antigen increased to 9, Abdomino-pelvic computed tomography will be performed on an outpatient basis. Therapeutic measures were taken as a result of thrombosis venous deep and embolism pulmonary. The outcome of the events was recovering. Serious criteria for the events was hospitalization. The lot number for BNT162b2 was not provided and will be requested during follow up.


VAERS ID: 1738649 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-08-24
   Days after vaccination:124
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Bacteriuria, Blood alkaline phosphatase, Blood bicarbonate, Blood bilirubin, Blood calcium, Blood creatinine, Blood culture, Blood lactate dehydrogenase, Blood lactic acid, Blood pH, Blood pressure measurement, Body temperature, C-reactive protein, COVID-19, Cardiovascular examination, Chlamydia test, Computerised tomogram, Drug ineffective, Dyspnoea, Gamma-glutamyltransferase, Gastrointestinal examination, Glomerular filtration rate, Haemoglobin, Heart rate, Legionella test, Lymphocyte count, Mean cell volume, Mycoplasma test, N-terminal prohormone brain natriuretic peptide, Neutrophil count, Oxygen consumption, Oxygen saturation, PCO2, PO2, Pneumonitis, Polymerase chain reaction, Pulmonary physical examination, Pyrexia, Respiratory rate, SARS-CoV-2 test, Serum ferritin, Sputum test, Transaminases, White blood cell count
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (narrow), Hypersensitivity (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib (Persistent); Cancer of prostate
Allergies:
Diagnostic Lab Data: Test Date: 20210829; Test Name: Thoracic computed tomography angiography; Result Unstructured Data: Test Result:not showing any endoluminal defect; Comments: in the proximal, segmental and subsegmental pulmonary arteries; Test Date: 20210829; Test Name: Cytobacteriological urine examination; Result Unstructured Data: Test Result:38 nucleated elements, sterile.; Test Date: 20210829; Test Name: Alkaline phosphatase; Result Unstructured Data: Test Result:146 IU/l; Test Date: 20210829; Test Name: bicarbonates; Result Unstructured Data: Test Result:20 mmol/L; Test Date: 20210829; Test Name: bilirubin; Result Unstructured Data: Test Result:7 umol/l; Test Date: 20210829; Test Name: Calcium; Result Unstructured Data: Test Result:2.2 mmol/L; Test Date: 20210829; Test Name: creatinine; Result Unstructured Data: Test Result:117 umol/l; Test Date: 20210829; Test Name: Blood culture; Result Unstructured Data: Test Result:in progress; Test Date: 20210829; Test Name: lactate dehydrogenase; Result Unstructured Data: Test Result:226 IU/l; Test Date: 20210829; Test Name: lactic acid; Result Unstructured Data: Test Result:1.5 mmol/L; Test Date: 20210829; Test Name: potential hydrogen; Result Unstructured Data: Test Result:7.5; Test Date: 20210829; Test Name: Blood pressure; Result Unstructured Data: Test Result:128/61 mmHg; Test Date: 20210829; Test Name: temperature; Result Unstructured Data: Test Result:38.6 Centigrade; Test Date: 20210829; Test Name: temperature; Result Unstructured Data: Test Result:38.3 Centigrade; Test Date: 20210829; Test Name: Cardiovascular examination; Result Unstructured Data: Test Result:Regular heart sounds with slight systolic murmur; Comments: no sign of right or left incompetence, no sign of deep vein thrombosis; Test Date: 20210829; Test Name: Polymerase Chain Reaction test for chlamydia pneumoniae; Result Unstructured Data: Test Result:in progress; Test Date: 20210829; Test Name: Chest computed tomography report; Result Unstructured Data: Test Result:Absence of pulmonary embolism; Comments: at the proximal, segmental and sub-segmental level demonstrated on this quality examination. Probable focus of superinfection in the lower right lobe.; Test Date: 20210829; Test Name: C-reactive protein; Result Unstructured Data: Test Result:358.4 mg/l; Test Date: 20210829; Test Name: gamma-glutamyltranspeptidase; Result Unstructured Data: Test Result:104 IU/l; Test Date: 20210829; Test Name: Gastrointestinal examination; Result Unstructured Data: Test Result:soft and yielding abdomen; Comments: painless, no organomegaly; Test Date: 20210829; Test Name: glomerular filtration rate; Result Unstructured Data: Test Result:50 ml/min; Test Date: 20210829; Test Name: Haemoglobulin; Result Unstructured Data: Test Result:14 g/dl; Test Date: 20210829; Test Name: heart rate; Result Unstructured Data: Test Result:75 beats/min; Test Date: 20210829; Test Name: Legionella antigenuria; Test Result: Negative ; Test Date: 20210829; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.7 g/l; Test Date: 20210829; Test Name: mean corpuscular volume; Result Unstructured Data: Test Result:90 fl; Test Date: 20210829; Test Name: nasopharyngeal mycoplasma pneumoniae; Result Unstructured Data: Test Result:in progress; Test Date: 20210829; Test Name: neutrophil polynuclear; Result Unstructured Data: Test Result:2.4 g/l; Test Date: 20210829; Test Name: N-terminal pro b-type natriuretic peptide; Result Unstructured Data: Test Result:469 pg/mL; Test Date: 20210829; Test Name: oygenorequence; Result Unstructured Data: Test Result:2 L/min; Test Date: 20210829; Test Name: saturation; Test Result: 95 %; Test Date: 20210829; Test Name: partial pressure of CO2; Result Unstructured Data: Test Result:25 mmHg; Test Date: 20210829; Test Name: partial oxygen pressure; Result Unstructured Data: Test Result:70.3 mmHg; Test Date: 20210825; Test Name: Polymerase Chain Reaction; Test Result: Positive ; Comments: Serious Acute Respiratory Syndrome COV2 delta variant (L452R mutation).; Test Date: 20210829; Test Name: Pulmonary examination; Result Unstructured Data: Test Result:Systematised crackling focus on the right base; Comments: with dullness, on a background of diffuse course crackling, no sign of struggle, no cyanosis; Test Date: 20210829; Test Name: respiratory rate; Result Unstructured Data: Test Result:23/min; Test Date: 20210825; Test Name: SARS-CoV-2 test; Test Result: Positive ; Test Date: 20210829; Test Name: Ferritin; Result Unstructured Data: Test Result:293 ug/L; Test Date: 20210829; Test Name: Sputum Cytology Examination; Result Unstructured Data: Test Result:+25 cells; Test Date: 20210829; Test Name: normal glutamate-oxaloacetate-transaminase; Result Unstructured Data: Test Result:normal; Test Date: 20210829; Test Name: white blood cells; Result Unstructured Data: Test Result:10.9 g/l
CDC Split Type: FRPFIZER INC202101194298

Write-up: Dyspnoea; Drug ineffective; Covid; hypoxemic pneumonitis; Febrile syndrome; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number FR-AFSSAPS-TO20217581. A 81-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 22Apr2021 (Batch/Lot Number: Unknown) as dose 2, single for COVID-19 immunisation. Medical history included atrial fibrillation (Persistent) and prostate cancer. Concomitant medication(s) included lamotrigine (LAMICTAL) taken for an unspecified indication, start and stop date were not reported; apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported; flecainide acetate (FLECAINE) taken for an unspecified indication, start and stop date were not reported; dutasteride, tamsulosin hydrochloride (COMBODART) taken for an unspecified indication, start and stop date were not reported. On 24Aug2021 the patient experienced Febrile syndrome, hypoxemic pneumonitis and Dyspnoea on 28Aug2021. It was reported that the patient hospitalised on 29Aug2021 for Covid, with hypoxemic pneumonitis requiring oxygenotherapy with nasal cannula (for the moment 3.5L/min), date of onset of symptoms on 24Aug2021, Polymerase Chain Reaction positive on 25Aug2021 at for Serious Acute Respiratory Syndrome COV2 delta variant (L452R mutation), SARS-CoV-2 test was Positive. Ongoing medical care at home: put on AMOXICILLIN by the general practitioner. The patient was visited to Emergency Room on 29Aug2021, sent to the emergency department by his general practitioner due to 93% desaturation at home. Vital signs upon admission on 29Aug2021: temperature: 38.6 ?C, saturation: 95%, respiratory rate: 23/min, oygenorequence: 2 L/min. Chest computed tomography report: Absence of pulmonary embolism at the proximal, segmental and sub-segmental level demonstrated on this quality examination. Pulmonary parenchymal involvement compatible with moderate Covid pneumonia (approximately 25% of lung parenchyma). Probable focus of superinfection in the lower right lobe. Arterial gas measurement: potential hydrogen = 7.5, partial oxygen pressure 70.3 mmHg, partial pressure of CO2 25 mmHg, bicarbonates 20 mmol/L, lactic acid 1.5 mmol/L. Episode of shivering with mottling up to the waist in the emergency department, rapidly regressive when the shivering stopped with blood pressure retained throughout, placed on AUGMENTIN due to the absence of other clinical signs, notably urinary, transfer for ongoing medical care. Clinical examination on admission: Blood pressure 128/61 mmHg, heart rate 75 beats/min, temperature 38.3C, oxygen saturation 96% under 2L, respiratory rate 32/min. Cardiovascular examination: Regular heart sounds with slight systolic murmur, no sign of right or left incompetence, no sign of deep vein thrombosis. Pulmonary examination: Systematised crackling focus on the right base with dullness, on a background of diffuse course crackling, no sign of struggle, no cyanosis. Gastrointestinal examination: soft and yielding abdomen, painless, no organomegaly. No functional urinary symptoms or pain from kidney punch. Blood panel: Normal blood electrolytes. Renal function: creatinine 117 ?mol/L, glomerular filtration rate 50 ml/min. Calcium 2.2 mmol/L. Liver function assessment: Alkaline phosphatase 146 IU/L, gamma-glutamyltranspeptidase 104 IU/L, bilirubin 7 ?mol/L, normal glutamate-oxaloacetate-transaminase, lactate dehydrogenase 226 IU/L. C-reactive protein 358.4 mg/L. Complete blood count platelets: Haemoglobulin 14 g/dl, mean corpuscular volume 90 fl, white blood cells 10.9 g/l including neutrophil polynuclear 2.4 g/l and lymphocytes 0.7 g/l. N-terminal pro b-type natriuretic peptide 469 pg/ml. Ferritin 293 ?g/L. Infectious assessment: Polymerase Chain Reaction test for chlamydia pneumoniae and nasopharyngeal mycoplasma pneumoniae: in progress. Legionella antigenuria: negative. Blood culture of 29Aug2021: in progress. Sputum Cytology Examination: + 25 epithelial cells. Cytobacteriological urine examination: 38 nucleated elements, sterile. Additional tests: Thoracic computed tomography angiography on 29Aug2021: Quality assessment not showing any endoluminal defect in the proximal, segmental and subsegmental pulmonary arteries. No dilation of the pulmonary arterial trunk or the right heart chambers. No pleural-pericardial effusion. Numerous mediastino-hilar ganglia, some of which are juxta-centimetric. No supraclavicular, axillary adenomegaly. Predominantly sub-pleural ground glass condensation ranges with alveolar condensations of the posterior segments, compatible with moderate Covid pneumonia (approximately 20% of the lung parenchyma). Focus of alveolar condensation with bronchial syndrome of the lower right lobe, compatible with a focus of a secondary infection. No suspicious lesion at the sub-diaphragmatic level and in the bone window. For the record, hiatus hernia. Conclusion: Absence of pulmonary embolism at the proximal, segmental and sub-segmental level demonstrated on this quality examination. Pulmonary parenchymal involvement compatible with moderate Covid pneumonia (approximately 25% of lung parenchyma). Probable focus of superinfection in the lower right lobe. Outcome on the ward: At the infectious disease level: Corticosteroid treatment: DEXAMETHASONE increased 8 mg/day (as of 31Aug2021. Antibiotic therapy: AUGMENTIN (as of 29Aug2021). Preventive anticoagulation: LOVENOX 4,000 UIX 2 per day due to OPTIFLOW, stopped on discharge from hospital after resumption of complete ambulation). High flow oxygen therapy maximum flow: 50-50 on 31Aug2021. It was reported that the patient was still hospitalized on 08Sep2021. The outcome of the events were not recovered. No follow up attempts are possible. No further information is expected.


VAERS ID: 1738670 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 FG6273 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Myalgia, Nausea, Pain in extremity, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (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: Drug allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Angioedema; Hypersensitivity; Milk protein allergy (Patient notes); Renal failure (Patient notes)
Allergies:
Diagnostic Lab Data: Test Date: 20210820; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101194547

Write-up: Lumbago; Myalgia; Nausea; Pain in the arm from the injection; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-TS20214055. A 37-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 24Aug2021 (Batch/Lot Number: FG6273) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included angioedema, ongoing drug allergy, hypersensitivity, renal failure and allergy lactose and cow''s milk protein. The patient''s concomitant medications were not reported. The patient previously took clamoxyl [amoxicillin] and experienced hypersensitivity and angioedema, aspirin [acetylsalicylic acid] and experienced hypersensitivity and angioedema. The patient experienced lumbago (disability) on 24Aug2021 with outcome of recovering, myalgia (disability) on 24Aug2021 with outcome of recovering , nausea on an unspecified date with outcome of recovered within 48 hours, pain in the arm from the injection on an unspecified date with outcome of recovered within 48 hours. Currently on sick leave. Cannot sit for long and walk too long. Nausea healed in 48 hours. Pain in the arm from the injection also healed within 48 hours. Serious lumbar myalgia which occurred a few hours after the vaccine. Impossible to get up, blocked in the lower back in any sudden movements and without malposition. After 48 hours of pain, patient went to the doctor who diagnosed she with lumbago. Sick leave because impossible to work with this pain. Rest and analgaesics as well as cortisone. He told the patient that it could be a side effect of the vaccine that would have triggered the myalgia. The patient was still treated with cortisone with a little less pain but still embarrassed. She could not sit for long or walk too long. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 20Aug2021. Therapeutic measures were taken as a result of lumbago and myalgia. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1738761 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 FF3314 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest X-ray, Chest pain, Computerised tomogram, Dizziness, Dysarthria, Dyskinesia, Headache, Inappropriate schedule of product administration, Loss of personal independence in daily activities, Neck pain, Paralysis, Photophobia, SARS-CoV-2 test, Seizure, Tremor, Trismus, Vision blurred
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Dyskinesia (narrow), Dystonia (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Medication errors (narrow), Hypoglycaemia (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: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder pain
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:Unknown results; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Unknown results; Test Name: CT scan; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210822; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101205488

Write-up: Headache; Tremor; Blurred vision; Dizziness; Paralysis; Eyes sensitive to sunlight; Neck pain; Chest pain; Fit (non-epileptic)/convulsing; Inappropriate schedule of vaccine administered; shaking; My jaw locks; I cannot communicate; jerk uncontrollably; I am unable to work or be unsupervised; This is a spontaneous report from a contactable consumer (patient) received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109132303513870-PMUJT and Safety Report Unique Identifier GB-MHRA-ADR 25935507. This is the first of two reports (second dose). A 29-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: FF3314) via an unspecified route of administration on 24Aug2021 (at the age of 29-years-old) as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date in Jun2021 as DOSE 1, SINGLE for covid-19 immunization and experienced one seizure and covid symptoms. She was advised that this was normal. Medical history included bladder pain from an unknown date and unknown if ongoing. Concomitant medication included hydroxyzine taken for bladder pain, start and stop date were not reported. Patient had 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. On 24Aug2021, the patient had inappropriate schedule of vaccine administered, as the second dose was administered on 24Aug2021, which was beyond the appropriate schedule of 42 days from first dose (Jun2021). The patient reported that, on 24Aug2021, she experienced fit (non-epileptic)/convulsing, headache, tremor, blurred vision, dizziness, paralysis, eyes sensitive to sunlight, neck pain and chest pain. On unspecified dates in 2021, she experienced shaking, jaw locks, could not communicate, jerk uncontrollably, unable to work or be unsupervised (loss of personal independence in daily activities). The case was reported as serious with seriousness criteria as hospitalization, disabling/incapacitating and other medically important condition. As per the additional details, patient stated that, on evening of 24Aug2021 after second vaccine her whole body became paralyzed and she could not move. Her boyfriend carried her to bed and she began shaking and convulsing. This had continued up until this day. Sometimes she had up to 12 fits per day and they could last from a few minutes to a few hours. She was taken to hospital in an ambulance on 26Aug2021 and was also in hospital on 29Aug2021 and kept in overnight. Also been to hospital twice and she was awaiting further neurological testing. The fits were very painful sometimes. Her body violently convulses and shakes and she had no control. Her jaw locks and she could not communicate or open eyes. Sometimes, she just shakes and jerk uncontrollably. She was unable to work or be unsupervised. On an unspecified date, the patient underwent lab tests and procedures which included computerised tomogram, chest X-rays and blood tests for which results were unknown. She also underwent sars-cov-2 test with negative result (No - Negative COVID-19 test) on 22Aug2021. The outcome for the event eyes sensitive to sunlight was recovering; outcome for the event shaking was recovered on unspecified date in 2021; outcome for the events jaw locks, cannot communicate, jerk uncontrollably and unable to work or be unsupervised was unknown and the outcome for the rest of the events was reported as not recovered, at the time of report. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101218435 same patient, different dose/event.


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