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

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

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

This is page 522 out of 10,317

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VAERS ID: 1960647 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, SARS-CoV-2 test, Sinus headache, Sinus pain
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: COVID-19 VACCINE ASTRAZENECA; INFLUENZA VIRUS; OESTRODOSE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211206; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: sinus pain; headache; Headache sinus; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 26300862) on 08-Dec-2021 and was forwarded to Moderna on 08-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SINUS PAIN (sinus pain), HEADACHE (headache) and SINUS HEADACHE (Headache sinus) in a 49-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 13-Feb-2021 to an unknown date for COVID-19, ESTRADIOL (OESTRODOSE) from 08-Aug-2019 to an unknown date for HRT, INFLUENZA VACCINE (INFLUENZA VIRUS) from 09-Oct-2021 to an unknown date for Influenza. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced SINUS HEADACHE (Headache sinus) (seriousness criterion medically significant). On an unknown date, the patient experienced SINUS PAIN (sinus pain) (seriousness criterion medically significant) and HEADACHE (headache) (seriousness criterion medically significant). At the time of the report, SINUS PAIN (sinus pain) and HEADACHE (headache) had not resolved and SINUS HEADACHE (Headache sinus) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment information was provided. In the 2.5 weeks since the booster I have experienced a number of migraine-like headaches (latterly over the right eye), dull headaches, and sinus pain. Woolly feeling in head. Unable to concentrate. Eyesight affected (sensitivity to light and also unable to read or look at screens for extended periods). Blood up nose. Generally feeling rough. "Spoke to the GP who prescribed antibiotics in case of infection. Saw a cranial osteopath. " Company comment. This regulatory authority case concerns a 49-year-old, female patient with no reported relevant medical history, who experienced the unexpected serious events of sinus pain, headache, and sinus headache. The event headache is unexpected as it is retained as serious per the source document Authority reporting. The events headache and sinus pain occurred one day after the administration of one dose (booster dosage) of mRNA-1273 vaccine, considered as third dose of COVID-19 vaccine schedule. The patient received previously two doses of AstraZeneca COVID-19 vaccine. The patient was prescribed antibiotics. Regulatory authority reported the rechallenge as unknown, however, no information about additional dosing was disclosed. Concomitant medication OESTRODOSE could be potentially confounder for headache. The benefit-risk relationship of mRNA-1273 is not affected by this report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 49-year-old, female patient with no reported relevant medical history, who experienced the unexpected serious events of sinus pain, headache, and sinus headache. The event headache is unexpected as it is retained as serious per the source document Authority reporting. The events headache and sinus pain occurred one day after the administration of one dose (booster dosage) of mRNA-1273 vaccine, considered as third dose of COVID-19 vaccine schedule. The patient received previously two doses of AstraZeneca COVID-19 vaccine. The patient was prescribed antibiotics. Regulatory authority reported the rechallenge as unknown, however, no information about additional dosing was disclosed. Concomitant medication OESTRODOSE could be potentially confounder for headache. The benefit-risk relationship of mRNA-1273 is not affected by this report. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1960718 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-20
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Asthenia, Chest pain, Headache, Immunisation
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC202101729140

Write-up: headache; weakness; chest pain; abdominal cramps; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. The reporter is the patient. Regulatory number: HU-OGYI-812621. A 32 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (2nd dose , Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "Booster"; HEADACHE (hospitalization) with onset 20Nov2021, outcome "unknown", described as "headache"; ASTHENIA (hospitalization) with onset 20Nov2021, outcome "unknown", described as "weakness"; CHEST PAIN (hospitalization) with onset 20Nov2021, outcome "unknown", described as "chest pain"; ABDOMINAL PAIN (hospitalization) with onset 20Nov2021, outcome "unknown", described as "abdominal cramps". No information regarding the patient''s past vaccines was reported. Sender''s Comment: According to the SmPC of Comirnaty, headache and weakness are listed and therefore expected. The events abdominal cramps and chest pain are not listed and not expected. TTO is unknown. The causal relationship between the suspected drug and the events is considered not assessable per lack of information. The case is considered serious due to hospitalization. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1960841 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-11-20
   Days after vaccination:169
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0785 / 2 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CT scan; Result Unstructured Data: Test Result:Results unknown; Test Name: MRI scan; Result Unstructured Data: Test Result:Results unknown
CDC Split Type: NLPFIZER INC202101753877

Write-up: stroke; Cerebral infarction; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the regulatory authority-WEB. Regulatory number: NL-LRB-00718022 . A 73 year-old female patient received bnt162b2 (COMIRNATY), administration date 04Jun2021 (Lot number: FD0785) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (1st dose, 0.3 mL), administration date: 27Apr2021, for Covid-19 immunization. The following information was reported: CEREBRAL INFARCTION (hospitalization, medically significant, life threatening) with onset 20Nov2021, outcome "recovering", described as "Cerebral infarction"; CEREBROVASCULAR ACCIDENT (hospitalization, medically significant, life threatening), outcome "unknown", described as "stroke". The patient underwent the following laboratory tests and procedures: computerised tomogram: results unknown; magnetic resonance imaging: results unknown. Therapeutic measures were taken as a result of cerebral infarction. Clinical courses: The patient was treated with non specified anticoagulant. Hospitalization information: Recording after stroke, 48 hours. No previous COVID-19 infection. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1960919 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain
SMQs:, Retroperitoneal fibrosis (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: PHMODERNATX, INC.MOD20214

Write-up: Lower Back pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Dec-2021 and was forwarded to Moderna on 10-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BACK PAIN (Lower Back pain) in a 28-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 20-Nov-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 05-Dec-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 20-Nov-2021, the patient experienced BACK PAIN (Lower Back pain) (seriousness criterion disability). On 05-Dec-2021, BACK PAIN (Lower Back pain) had not resolved. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) was unknown. Patient took first vaccine since experienced lower back pain Concomitant product use was not provided Treatment information was not provided Company Comment : This RA case concerns a 28 year old female patient with no medical history reported, who experienced , Serious ( Disability ) , Unexpected event of back pain which occurred on the same day after vaccination with the first dose number of mRNA-1273 vaccine. ( Moderna Covid 19 Vaccine ) . The re-challenge for this case was captured as unknown by this RA report. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender''s Comments: This RA case concerns a 28 year old female patient with no medical history reported, who experienced , Serious ( Disability ) , Unexpected event of back pain which occurred on the same day after vaccination with the first dose number of mRNA-1273 vaccine. ( Moderna Covid 19 Vaccine ) . The re-challenge for this case was captured as unknown by this RA report. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.


VAERS ID: 1961044 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-26
Onset:2021-11-20
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arrhythmia, Shock
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Coronary artery disorder (NOS) (Normal coronary artery with LAD middle bridge formation on July 16, 2021)
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hyperplasia (Benign prostate hyperplasia under control); Hypertension (Hypertension under control); Parkinsonism (Parkinsonism, right side tremor, under anti-parkinsonism with improvement.); Syncope (Syncope, cause to be determined)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20214

Write-up: Shock, arrythmia; Shock, arrythmiia; This regulatory authority case was reported by an other health care professional and describes the occurrence of SHOCK (Shock, arrythmia) and ARRHYTHMIA (Shock, arrythmiia) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The patient''s past medical history included Syncope (Syncope, cause to be determined), Parkinsonism (Parkinsonism, right side tremor, under anti-parkinsonism with improvement.), Hypertension (Hypertension under control) and Benign prostatic hyperplasia (Benign prostate hyperplasia under control). Concurrent medical conditions included Coronary artery disorder (NOS) (Normal coronary artery with LAD middle bridge formation on July 16, 2021) since 16-Jul-2021. On 26-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced SHOCK (Shock, arrythmia) (seriousness criterion life threatening) and ARRHYTHMIA (Shock, arrythmiia) (seriousness criterion life threatening). At the time of the report, SHOCK (Shock, arrythmia) and ARRHYTHMIA (Shock, arrythmiia) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient was found to collapse suddenly on the morning of 20 Nov 2021. Bystander CPCR was performed within one minute by his son. After EMT arrived, CPCR was performed and he arrived at hospital on 20 Nov. Endotracheal tube insertion was arranged. Defibrillation with 200J was performed for three times for VF rhythm. Other medications were used during resuscitation, including Epinephrine x12, Amiodarone x2, and sodium bicarbonate x4, followed by Dopamine pump (4amp in 500ml) 20 ml/hr. Then he was transferred to another hospital branch. Due to pulseless, he received CPCR on the ambulance for five minutes. ROSC was noted after resuscitation for unknown time. Brain CT was done over there, which revealed no ICH. Further catheter lab was activated, which revealed LADm 50% stenosis and RCA p to m 70% stenosis with diffuse coronary spasm. No PCI was done. He ever received Dopamin use but held due to Vf at ICU over there. Due to family''s request, he was AAD to ED. On 26 Oct 2021, he received Moderna vaccine. On 20 Nov, he fainted immediately, the family performed CPCR for 1 minute, and he was sent to the emergency department of hospital. He had out-of-hospital with cardiac arrest (OCHA), and received defibrillation and emergency treatment, respirator intubation, and booster treatment. Brain CT showed no intracranial hemorrhage, and cardiac catheterization showed coronary artery stenosis (LAD-m 50% stenosis and RCA m 70% stenosis), with diffuse coronary artery spasm. He was admitted to the ICU. On 01 Dec 2021: CS: he had E1VTM1, conjunctiva edema and redness in both eyes, a 7.5mm endotracheal tube was indwelt in the mouth and connected to the respirator, a silicone nasogastric tube was indwelt, the left brachial artery catheter and left vein needle was maintained smooth, the right vein needle was connected to Levophed 16 mg in D5W 250 mL, at 4 mL/hr and a urinary catheter was indwelt. He had stable vital signs and was still receiving treatment in ICU. Company comment: This case concerns a 59-year-old, male patient with relevant medical history of Coronary artery disorder, Syncope, and Hypertension, who experienced the unexpected events of Shock and Arryhtmia. The events occurred approximately 25 days after the second dose of mRNA-1273 Vaccine which resulted in a life threatening condition and subsequent ICU admission. Patient had an Out-of-hospital cardiac arrest, was immediately resuscitated, received defibrillation and emergency treatment, respirator intubation, and booster treatment. Brain CT showed no intracranial hemorrhage, and cardiac catheterization showed coronary artery stenosis, with diffuse coronary artery spasm. At the time of report the outcome of the events was not resolved and patient was still receiving treatment in ICU. The patient''s medical history of Coronary artery disorder, Syncope, and Hypertension remain confounders. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 59-year-old, male patient with relevant medical history of Coronary artery disorder, Syncope, and Hypertension, who experienced the unexpected events of Shock and Arryhtmia. The events occurred approximately 25 days after the second dose of mRNA-1273 Vaccine which resulted in a life threatening condition and subsequent ICU admission. Patient had an Out-of-hospital cardiac arrest, was immediately resuscitated, received defibrillation and emergency treatment, respirator intubation, and booster treatment. Brain CT showed no intracranial hemorrhage, and cardiac catheterization showed coronary artery stenosis, with diffuse coronary artery spasm. At the time of report the outcome of the events was not resolved and patient was still receiving treatment in ICU. The patient''s medical history of Coronary artery disorder, Syncope, and Hypertension remain confounders. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1962105 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dysmenorrhoea, Menstruation irregular, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Fertility disorders (broad)

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

Write-up: My menstrual cycle has been the same for 16 years and now it is unusual. I was on my period at the same time I got the vaccine and the next day it had already begun to change. The first experience was my blood had separated from what looked like water on top and blood on the bottom. The next period was on and off , almost like spotting and it was a colour I''d never seen before. 3rd period after vaccine is intense, unbearable cramps like I''ve never experience and an alarming amount of blood clots. (I get the occasional clot but not like this). It was so thick I could barely get it off my clothes under a tap. Very strange and concerning.


VAERS ID: 1962583 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005237 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Chills, Dizziness, Extrasystoles, Headache, Hyperhidrosis, Pain, Pain in extremity, Palpitations, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Heartbeats skipped; Heart racing; Shaking; Sweating; Low back pain; General body pain; Felt faint; severe body ache and lower back pain; Chills; Headache; Pain in arm; This case was received via regulatory authority(Reference number: GB-MHRA-ADR 26253278) on 09-Dec-2021 and was forwarded to Moderna on 09-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of EXTRASYSTOLES (Heartbeats skipped), PALPITATIONS (Heart racing), TREMOR (Shaking), HYPERHIDROSIS (Sweating), BACK PAIN (Low back pain), PAIN (General body pain), PAIN IN EXTREMITY (Pain in arm), DIZZINESS (Felt faint), PAIN IN EXTREMITY (severe body ache and lower back pain), HEADACHE (Headache) and CHILLS (Chills) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005237) for COVID-19 vaccination. No Medical History information was reported. On 20-Nov-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced EXTRASYSTOLES (Heartbeats skipped) (seriousness criterion medically significant), PALPITATIONS (Heart racing) (seriousness criterion medically significant), TREMOR (Shaking) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating) (seriousness criterion medically significant), BACK PAIN (Low back pain) (seriousness criterion medically significant), PAIN (General body pain) (seriousness criterion medically significant), DIZZINESS (Felt faint) (seriousness criterion medically significant), PAIN IN EXTREMITY (severe body ache and lower back pain) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). At the time of the report, EXTRASYSTOLES (Heartbeats skipped), PALPITATIONS (Heart racing), TREMOR (Shaking), HYPERHIDROSIS (Sweating), BACK PAIN (Low back pain), PAIN (General body pain), DIZZINESS (Felt faint), PAIN IN EXTREMITY (severe body ache and lower back pain) and CHILLS (Chills) had resolved and PAIN IN EXTREMITY (Pain in arm) and HEADACHE (Headache) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. The patient''s last menstrual period date was 23-Nov-2021. Patient did not had symptoms associated with COVID-19 and did not had a COVID-19 test Company Comment - This regulatory authority case concerns a 33-year-old female patient with no details on relevant medical history, who experienced the unexpected serious (medically significant) events of extrasystoles, palpitations, tremor, back pain, pain, pain in extremity, headache, chills after mRNA- 1273 Moderna vaccine, first dose of the vaccination schedule. The events pain in extremity and headache occurred on the same day after the dose of mRNA- 1273 vaccine. The events extrasystoles, palpitations, tremor, hyperhidrosis, back pain, pain, dizziness, pain in extremity and chills occurred on an unknown date after the first dose of the mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 33-year-old female patient with no details on relevant medical history, who experienced the unexpected serious (medically significant) events of extrasystoles, palpitations, tremor, back pain, pain, pain in extremity, headache, chills after mRNA- 1273 Moderna vaccine, first dose of the vaccination schedule. The events pain in extremity and headache occurred on the same day after the dose of mRNA- 1273 vaccine. The events extrasystoles, palpitations, tremor, hyperhidrosis, back pain, pain, dizziness, pain in extremity and chills occurred on an unknown date after the first dose of the mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report


VAERS ID: 1962747 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-20
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20211235861

Write-up: FATIGUE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300125413] concerned a 61 year old female of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: Unknown) dose was not reported, 1 total, administered on 30-JUL-2021 for an unspecified indication (dose number series 1). No concomitant medications were reported. On 20-NOV-2021, the patient experienced fatigue and inability to fall asleep for 4 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0-20211235861-Covid-19 vaccine ad26.cov2.s- Fatigue. This event(s) is labeled per RSI and is therefore considered potentially related


VAERS ID: 1964128 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK8911 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Malaise, Pyrexia, Vaccination site reaction
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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 INC202101733981

Write-up: Shivers / Shivering; Reaction at the injection site / Injection site reaction; Feeling unwell / Malaise; Fever; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: BE-FAMHP-DHH-N2021-109618 (FAMHP). A 81 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FK8911) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (disability) with onset 20Nov2021, outcome "not recovered", described as "Shivers / Shivering"; VACCINATION SITE REACTION (disability) with onset 20Nov2021, outcome "not recovered", described as "Reaction at the injection site / Injection site reaction"; MALAISE (disability) with onset 20Nov2021, outcome "not recovered", described as "Feeling unwell / Malaise"; PYREXIA (disability) with onset 20Nov2021, outcome "not recovered", described as "Fever"; FATIGUE (disability) with onset 20Nov2021, outcome "not recovered", described as "Fatigue". Therapeutic measures were not taken as a result of chills, vaccination site reaction, malaise, pyrexia, fatigue. Events were assessed as serious, caused disability by the regulatory authority. Reporter Comment: Treatment - No Evolution of the ADR - No improvement ADR description - Please tick the adverse reaction(s) observed. You can describe these side effect(s) in detail in the "Side effect description" field. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Treatment - No Evolution of the ADR - No improvement ADR description - Please tick the adverse reaction(s) observed. You can describe these side effect(s) in detail in the "Side effect description" field.


VAERS ID: 1964144 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-20
Onset:2021-11-20
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / -

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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE
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: BRPFIZER INC202101744800

Write-up: facial paralysis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 32 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 20Sep2021 16:15 (Lot number: Unknown) at the age of 31 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient had no covid prior vaccination. The patient was not allergic to any medications, food or other products. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: FACIAL PARALYSIS (medically significant) with onset 20Nov2021 06:00, outcome "not recovered", described as "facial paralysis". Therapeutic measures were not taken as a result of facial paralysis. Since the vaccination, the patient had not been tested for COVID-19. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1964194 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-11-20
   Days after vaccination:86
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, COVID-19, SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Hypersensitivity (broad), Respiratory failure (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: LANTUS; ASPIRIN [ACETYLSALICYLIC ACID]; AMLODIPINE; ATORVASTATINE [ATORVASTATIN CALCIUM]; PALLADON; BELOC [METOPROLOL SUCCINATE]; DAFALGAN; ELIQUIS
Current Illness: Arterial insufficiency (lower limbs); Diabetes mellitus insulin-dependent (insulin-requiring diabetes); Dyslipidaemia; Ischaemic heart disease; Metastasis (ganglionic and bone); Urothelial carcinoma (a high-grade)
Preexisting Conditions: Medical History/Concurrent Conditions: Left ventricular ejection fraction
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: Covid-19 smear; Test Result: Positive
CDC Split Type: CHPFIZER INC202101787668

Write-up: smear for SARS-CoV-2 that is positive; SARS-CoV-2 positive, first dose of Comirnaty vaccine on 29Jul2021 and the second dose on 26Aug2021; Acute hypoxemic respiratory failure; SARS-CoV-2 positive, febrile state, oxygenation; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. A 66 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 26Aug2021 (Lot number: unknown) at the age of 66 years as dose 2, single and intramuscular, administration date 29Jul2021 (Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Transitional cell carcinoma" (ongoing), notes: a high-grade; "Metastasis" (ongoing), notes: ganglionic and bone; "Myocardial ischaemia" (ongoing); "Type 1 diabetes mellitus" (ongoing), notes: insulin-requiring diabetes; "Dyslipidaemia" (ongoing); "Arterial insufficiency" (ongoing), notes: lower limbs; "retained Left ventricular ejection fraction (LVEF)" (unspecified if ongoing). Concomitant medication(s) included: LANTUS; ASPIRIN [ACETYLSALICYLIC ACID]; AMLODIPINE; ATORVASTATINE [ATORVASTATIN CALCIUM]; PALLADON; BELOC [METOPROLOL SUCCINATE]; DAFALGAN; ELIQUIS. The following information was reported: COVID-19 (prolonged hospitalization, medically significant) with onset 20Nov2021, outcome "unknown", described as "SARS-CoV-2 positive, febrile state, oxygenation"; SARS-COV-2 TEST POSITIVE (prolonged hospitalization, medically significant) with onset 21Nov2021, outcome "not recovered", described as "smear for SARS-CoV-2 that is positive"; VACCINATION FAILURE (prolonged hospitalization, medically significant) with onset 20Nov2021, outcome "not recovered", described as "SARS-CoV-2 positive, first dose of Comirnaty vaccine on 29Jul2021 and the second dose on 26Aug2021"; ACUTE RESPIRATORY FAILURE (prolonged hospitalization, medically significant) with onset 20Nov2021, outcome "unknown", described as "Acute hypoxemic respiratory failure". The patient prolonged hospitalization for covid-19, sars-cov-2 test positive, vaccination failure, acute respiratory failure (start date: 16Nov2021). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Nov2021) positive. Therapeutic measures were taken as a result of covid-19, sars-cov-2 test positive, vaccination failure, acute respiratory failure.Clinical course: This 66-year-old patient was known in particular for a high-grade urothelial carcinoma, metastatic to the lymph nodes and bone, ischemic heart disease with retained Left ventricular ejection fraction (LVEF), insulin-requiring diabetes, dyslipidemia and arterial insufficiency of the lower limbs. He was hospitalized on 16Nov2021 with a fractured right humerus, with surgery scheduled for 21Nov2021. In the meantime, the day before the operation, he presented with a feverish state which prompted a smear for SARS-CoV-2, which was found to be positive. Patient was transferred to a COVID unit for further support. There, patient received a dose of tocilizumab, dexamethasone and received oxygenation. Reporter comment: This patient therefore presented with a SARS-CoV-2 infection with acute hypoxemic respiratory failure 3 months after the second injection of the COVID-19 vaccine Comirnaty. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: This patient therefore presented with a SARS-CoV-2 infection with acute hypoxemic respiratory failure 3 months after the second injection of the COVID-19 vaccine Comirnaty; Sender''s Comments: Linked Report(s) : CH-PFIZER INC-202101762216 LOE and another event after 2 doses of Comirnaty


VAERS ID: 1964212 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood potassium, Blood sodium, Body temperature, C-reactive protein, Chest scan, Chills, Dyspnoea, Fatigue, Fibrin D dimer, Glomerular filtration rate, Haemoglobin, Immunisation, Oxygen saturation, Pyrexia, Respiratory rate, SARS-CoV-2 antibody test, SARS-CoV-2 test, Tachypnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic lymphocytic leukemia
Allergies:
Diagnostic Lab Data: Test Date: 20211126; Test Name: creatinine; Result Unstructured Data: Test Result:117; Comments: renal failure; Test Date: 20211126; Test Name: potassium; Result Unstructured Data: Test Result:3.6; Comments: hypokalaemia; Test Date: 20211126; Test Name: sodium; Result Unstructured Data: Test Result:131; Comments: hyponatremia; Test Date: 20211126; Test Name: body temperature; Result Unstructured Data: Test Result:39.3 Centigrade; Test Date: 20211126; Test Name: temperature; Result Unstructured Data: Test Result:39.3 Centigrade; Test Date: 202111; Test Name: chest scanner; Result Unstructured Data: Test Result:not show pulmonary embolism; Comments: Covid pneumonia- 19 range between 25-50%.; Test Date: 20211126; Test Name: CRP; Result Unstructured Data: Test Result:200; Test Date: 20211126; Test Name: D-dimer; Result Unstructured Data: Test Result:1700; Test Date: 20211126; Test Name: e-GFR; Result Unstructured Data: Test Result:57; Comments: renal failure; Test Date: 20211126; Test Name: Hb; Result Unstructured Data: Test Result:117; Test Date: 20211126; Test Name: SpO2; Test Result: 88 %; Comments: in ambient air; Test Date: 20211126; Test Name: respiratory rate; Result Unstructured Data: Test Result:tachypnea; Test Date: 20211128; Test Name: anti-S Ig and anti-N Ig; Test Result: Negative ; Test Date: 20211122; Test Name: Sars-Cov-2 nasal smear; Test Result: Positive
CDC Split Type: CHPFIZER INC202101786305

Write-up: Fatigue; Chills; Febrile state; Tachypnea; Progressive dyspnea; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from a regulatory authority. Regulatory number: CH-SM-2021-29289 (RA). A 73 year-old male patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic lymphocytic leukemia" (unknown if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (dose 1, Lot number: unknown), administration date: 15Feb2021, when the patient was 73 years old, for COVID-19 immunisation, reaction(s): "SARS-CoV-2 infection", "Drug ineffective", "cough"; Comirnaty (dose 2, Lot number: unknown), administration date: 12Apr2021, when the patient was 73 years old, for COVID-19 immunisation, reaction(s): "Drug ineffective", "cough", "SARS-CoV-2 infection". The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; DYSPNOEA (hospitalization, medically significant) with onset 22Nov2021, outcome "not recovered", described as "Progressive dyspnea"; FATIGUE (hospitalization, medically significant) with onset 26Nov2021, outcome "not recovered", described as "Fatigue"; CHILLS (hospitalization, medically significant) with onset 26Nov2021, outcome "not recovered", described as "Chills"; PYREXIA (hospitalization, medically significant) with onset 26Nov2021, outcome "not recovered", described as "Febrile state"; TACHYPNOEA (hospitalization, medically significant) with onset 26Nov2021, outcome "not recovered", described as "Tachypnea". The events "progressive dyspnea", "fatigue", "chills", "febrile state" and "tachypnea" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: creatinine: (26Nov2021) 117, notes: renal failure; potassium: (26Nov2021) 3.6, notes: hypokalaemia; sodium: (26Nov2021) 131, notes: hyponatremia; body temperature: (26Nov2021) 39.3 Centigrade; (26Nov2021) 39.3 Centigrade; chest scanner: (Nov2021) not show pulmonary embolism, notes: Covid pneumonia-19 range between 25-50%; CRP: (26Nov2021) 200; D-dimer: (26Nov2021) 1700; e-GFR: (26Nov2021) 57, notes: renal failure; Hb: (26Nov2021) 117; SpO2: (26Nov2021) 88 %, notes: in ambient air; respiratory rate: (26Nov2021) tachypnea; anti-S Ig and anti-N Ig: (28Nov2021) negative; Sars-Cov-2 nasal smear: (22Nov2021) positive. Therapeutic measures were taken as a result of dyspnoea, fatigue, chills, tachypnoea. Clinical course: A causal relationship between Comirnaty and Tachypnea, Fever, Chills, Fatigue, Dyspnea exacerbated, was assessed as being possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : PFIZER INC-202101766720 different events after 1st and 2nd dose


VAERS ID: 1964288 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-11-20
   Days after vaccination:85
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, COVID-19, Headache, Pyrexia, SARS-CoV-2 test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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? No
Previous Vaccinations:
Other Medications: EUTHYROX
Current Illness: Autoimmune hypothyroidism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211122; Test Name: COVID-19 PCR test positive; Result Unstructured Data: Test Result:COVID-19 PCR test positive
CDC Split Type: CZPFIZER INC202101762653

Write-up: COVID-19; Vaccination failure; Fever; Headache; Back pain; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority. Regulatory number: CZ-CZSUKL-21012563 (CZSUKL). A 39 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 27Aug2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 05Aug2021 (Lot number: FE6208) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autoimmune hypothyroidism" (ongoing). Concomitant medication(s) included: EUTHYROX taken for autoimmune hypothyroidism. The following information was reported: COVID-19 (medically significant) with onset 20Nov2021, outcome "not recovered", described as "COVID-19"; VACCINATION FAILURE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Vaccination failure"; PYREXIA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Fever"; HEADACHE (non-serious) with onset 20Nov2021, outcome "not recovered", described as "Headache"; BACK PAIN (non-serious) with onset 20Nov2021, outcome "not recovered", described as "Back pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: (22Nov2021) covid-19 pcr test positive. Clinical Course: It was reported that the patient did not have any vaccination around the time of the vaccination against COVID-19. Patient was non-smoker. As of the date of this report, the reactions are yet to subside. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1964725 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-11-20
   Days after vaccination:150
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1248 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Artificial cardiac pacemaker user
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: CT thorax; Result Unstructured Data: Test Result:- no pleural or pericardial effusion; Comments: - no pleural or pericardial effusion, - cardiomegaly, - multiple bilateral areas of mixed topography ground glass infiltrate consistent with Covid lung disease with severe involvement of about 60%. - crazy paving-type abnormality extending over almost the entire lower lobe of the right lung, - condensation of almost the entire lower lobe of the left lung with aerated bronchogram and ascending left diaphragm; Test Date: 20211120; Test Name: oxygen saturation; Test Result: 85%; Test Date: 20211120; Test Name: SARS-COV-2 test; Test Result: Positive; Comments: covid+.
CDC Split Type: FRPFIZER INC202101728833

Write-up: covid-19; vaccination failure; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from the Regulatory Authority. The Regulatory Authority number FR-AFSSAPS-LL20217852. A 93 year old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: FE1248, Expiration Date: 31Oct2021), intramuscular, administration date 23Jun2021 as dose 2, single and (COMIRNATY, Formulation: Solution for injection, Lot number: FA4598) intramuscular, administration date 15May2021 as dose 1, single for covid-19 immunization. Relevant medical history included pacemaker (unspecified if ongoing, fall with PCI (initial loss of consciousness). The patient''s concomitant medications were not reported. The following information was reported: COVID-19 (hospitalization, medically significant) with onset 20Nov2021, outcome not recovered; VACCINATION FAILURE (hospitalization, medically significant) with onset 20Nov2021, outcome not recovered. The patient underwent the following laboratory tests and procedures computerised tomogram: (20Nov2021) - no pleural or pericardial effusion, - no pleural or pericardial effusion cardiomegaly. Multiple bilateral areas of mixed topography ground glass infiltrate consistent with Covid lung disease with severe involvement of about 60%. Crazy paving-type abnormality extending over almost the entire lower lobe of the right lung Condensation of almost the entire lower lobe of the left lung with aerated bronchogram and ascending left diaphragm; oxygen saturation: (20Nov2021) 85%; sars-cov-2 test (20Nov2021) positive, covid+ Product. The investigation summary conclusion on 10Dec2021 included 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 FE1248 and FA4598. 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 causes were identified as the complaint was not confirmed. Follow-up on 10Dec2021 included New information reported from product quality complaint team included Product Investigation Summary Conclusion. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1964749 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-11-20
   Days after vaccination:219
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN2246 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Fall, General physical health deterioration, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Accidents and injuries (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: Medical History/Concurrent Conditions: AFib; Thyroiditis; Total knee replacement (x2)
Allergies:
Diagnostic Lab Data: Test Date: 20211111; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101730302

Write-up: Vaccination failure; COVID-19; Deterioration of general condition and fall to the ground in this context of infection; Deterioration of general condition and fall to the ground in this context of infection; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority-WEB. Regulatory number: FR-AFSSAPS-LY202112749 (regulatory authority). A 92 year-old female patient received bnt162b2 (COMIRNATY), administration date 15Apr2021 (Lot number: EN2246) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Thyroiditis" (unspecified if ongoing); "AFib" (unspecified if ongoing); "Total knee replacement" (unspecified if ongoing), notes: x2. The patient''s concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization) with onset 20Nov2021, outcome "recovering", described as "Vaccination failure"; COVID-19 (hospitalization) with onset 20Nov2021, outcome "recovering", described as "COVID-19"; GENERAL PHYSICAL HEALTH DETERIORATION (hospitalization), FALL (hospitalization) all with onset 20Nov2021, outcome "recovering" and all described as "Deterioration of general condition and fall to the ground in this context of infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Nov2021) positive. It was reported that there was no respiratory involvement. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1964845 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Amenorrhoea, Blood pressure measurement, Electrocardiogram, Fatigue, Fibrin D dimer, Heart rate, Oxygen saturation, Palpitations, Pyrexia, SARS-CoV-2 test, Tachycardia, Troponin
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Fertility disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Weight increase
Allergies:
Diagnostic Lab Data: Test Date: 20211126; Test Name: Blood pressure; Result Unstructured Data: Test Result:130/86 mmHg; Test Date: 20211126; Test Name: Electrocardiography; Result Unstructured Data: Test Result:no conduction or repolarisation disorder; Test Date: 20211126; Test Name: D-dimers; Test Result: Negative ; Test Date: 20211126; Test Name: Heart rate; Result Unstructured Data: Test Result:180; Comments: /min; Test Date: 20211126; Test Name: Saturation; Test Result: 96 %; Test Name: SARS-COV-2 test; Result Unstructured Data: Test Result:Unknown results; Test Date: 20211126; Test Name: Troponin; Test Result: Negative
CDC Split Type: FRPFIZER INC202101730832

Write-up: Tachycardia; sudden stop of menstrual cycle; Fatigue; Fever; Nightly palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: FR-AFSSAPS-PS20212657 (RA). A 27 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 27 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Weight increase" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer not provided), for COVID-19 IMMUNISATIONS. The following information was reported: TACHYCARDIA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Tachycardia"; AMENORRHOEA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "sudden stop of menstrual cycle"; FATIGUE (non-serious) with onset 20Nov2021, outcome "not recovered", described as "Fatigue"; PYREXIA (non-serious) with onset 20Nov2021, outcome "not recovered", described as "Fever"; PALPITATIONS (non-serious) with onset 2021, outcome "not recovered", described as "Nightly palpitations". The event "nightly palpitations" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (26Nov2021) 130/86 mmHg; electrocardiogram: (26Nov2021) no conduction or repolarisation disorder; fibrin d dimer: (26Nov2021) negative; heart rate: (26Nov2021) 180, notes: /min; oxygen saturation: (26Nov2021) 96 %; sars-cov-2 test: (unspecified date) unknown results; troponin: (26Nov2021) negative. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1965022 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Shoulder injury related to vaccine administration
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLINE HYDROCHLORIDE; FLUCONAZOLE; LANSOPRAZOLE; NAPROXEN; PROPRANOLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Ill-defined disorder; Vaginal candidiasis
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101732186

Write-up: Shoulder Injury Related to Vaccine Administration; This is a spontaneous report received from a contactable reporter (Physician) from the Agency Regulatory Authority. Regulatory number: GB-MHRA-TPP10348042C5343670YC1638197980502. Other Case identifier(s): GB-MHRA-ADR 26287919. A 33 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid left, administration date 20Nov2021 (Lot number: FK0596) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Ill-defined disorder" (unspecified if ongoing); "Vaginal candidiasis" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medications included: AMITRIPTYLINE HYDROCHLORIDE taken for ill-defined disorder, start date: 18Nov2019; FLUCONAZOLE taken for ill-defined disorder, vulvovaginal candidiasis, start date: 29Nov2021; LANSOPRAZOLE taken for ill-defined disorder, start date: 26Jan2021; NAPROXEN taken for ill-defined disorder, start date: 26Jan2021; PROPRANOLOL taken for ill-defined disorder, anxiety, start date: 22May2019. The following information was reported: SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Shoulder Injury Related to Vaccine Administration"; ARTHRALGIA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "ongoing pain in the shoulder"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 20Nov2021, outcome "unknown", described as "injection was placed high up in left deltoid/site of the injection which was just 1cm below the acromion". Clinical course: Physician reported that it was likely that patient had a shoulder Injury related to vaccine administration from inadvertent injection of vaccine into deltoid bursa. Administered Covid 19 vaccine 20 November 2021. She said that the injection was placed high up in left deltoid and she experienced ongoing pain in the shoulder following the injection with painful reduction in shoulder movement up until and including when she reported the problem 29 November 2021. On examination she was tender over the left deltoid and she pointed to the site of the injection which was just 1cm below the acromion. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1965059 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL1939 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Chest pain, Condition aggravated, Disease recurrence, Dyspnoea, Fatigue, Hypotension, Immunisation, Interchange of vaccine products, Nausea, Neck pain, Off label use, Post viral fatigue syndrome, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Arthritis (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef)); Myalgic encephalomyelitis (Diagnosed with ME 16 years ago, been well for the past 4-5 years)
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: Blood Pressure; Result Unstructured Data: Test Result:Low; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101739513

Write-up: Chest pain; Fever; Shortness of breath; Condition aggravated; Experiencing a reactivation myalgic encephalomyelitis (ME) symptoms; Experiencing a reactivation myalgic encephalomyelitis (ME) symptoms; Neck pain; Low blood pressure; Fatigue; Nausea; The patient received the primary immunization series with AZ vaccine and received a third dose of COMIRNATY vaccine; The patient received the primary immunization series with AZ vaccine and received a third dose of COMIRNATY vaccine; The patient received booster dose of COMIRNATY vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112030907382590-KU9Z6 (RA). Other Case identifier(s): GB-MHRA-ADR 26285543 (RA). A 50 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FL1939) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Myalgic encephalomyelitis" (unspecified if ongoing), notes: Diagnosed with ME 16 years ago, been well for the past 4-5 years; "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef); "Clinical trial participant" (unspecified if ongoing), notes: Study details: School of Tropical Medicine. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Vaccination history included: Astrazenecacovid-19vaccine (DOSE 2, SINGLE Lot number: UNKNOWN; Route of administration: Unspecified), administration date: 17May2021, for COVID-19 immunisation; Astrazeneca covid19 vaccine (DOSE 1, SINGLE Lot number: UNKNOWN; Route of administration: Unspecified), administration date: 01Mar2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (disability, medically significant), INTERCHANGE OF VACCINE PRODUCTS (disability, medically significant) all with onset 20Nov2021, outcome "unknown" and all described as "The patient received the primary immunization series with AZ vaccine and received a third dose of COMIRNATY vaccine"; IMMUNISATION (disability, medically significant) with onset 20Nov2021, outcome "unknown", described as "The patient received booster dose of COMIRNATY vaccine."; NECK PAIN (disability, medically significant) with onset 23Nov2021, outcome "not recovered", described as "Neck pain"; HYPOTENSION (disability, medically significant) with onset 21Nov2021, outcome "not recovered", described as "Low blood pressure"; FATIGUE (disability, medically significant) with onset 21Nov2021, outcome "not recovered", described as "Fatigue"; NAUSEA (disability, medically significant) with onset 21Nov2021, outcome "not recovered", described as "Nausea"; CHEST PAIN (disability, medically significant), outcome "unknown", described as "Chest pain"; PYREXIA (disability, medically significant), outcome "unknown", described as "Fever"; DYSPNOEA (disability, medically significant), outcome "unknown", described as "Shortness of breath"; CONDITION AGGRAVATED (disability, medically significant), outcome "unknown", described as "Condition aggravated"; POST VIRAL FATIGUE SYNDROME (disability, medically significant), DISEASE RECURRENCE (disability, medically significant), outcome "unknown" and all described as "Experiencing a reactivation myalgic encephalomyelitis (ME) symptoms". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (21Nov2021) low; sars-cov-2 test: (unspecified date) no - negative covid-19 test. The patient was experiencing a reactivation myalgic encephalomyelitis (ME) symptoms which the patient had been pretty clear of the past 4-5 years. The report was related to possible inflammation of the heart (myocarditis or pericarditis). The symptoms did not lead to a hospital stay. The patient was happy if the general physician (GP) or treating physician was contacted. No imaging such as, but not limited to, chest X-ray, echocardiogram, cardiac magnetic resonance imagining (MRI), chest computerised tomography (CT) was carried out. No blood tests, such as for certain proteins (called troponin) that signal heart muscle damage were taken. The patient had not tested positive for COVID-19, since having the vaccine.


VAERS ID: 1965133 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Arrhythmia, Chest pain, Dyspnoea, Fatigue, Immunisation, Interchange of vaccine products, Neurological symptom, Off label use, Palpitations, Paraesthesia, SARS-CoV-2 test, Tachycardia, Tremor
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Medication errors (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; LOSARTAN POTASSIUM; OMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; GERD; Myocarditis
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101739415

Write-up: abdominal pain; tremor; Fatigue/unusual tiredness; Chest pain; Shortness of breath; Heart palpitations; Racing heart (tachycardia); Paraesthesia; Abnormal heart rhythm; Neurologic symptoms; off label use; interchange of vaccine products; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the the Regulatory Authority. The Regulatory Authority number GB-MHRA-WEBCOVID-202112041534265310-XBJOW, Other Case identifier(s): GB-MHRA-ADR 26289054. A 56 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK9413) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included Myocarditis, start date: 2018 (not ongoing); GERD (unspecified if ongoing); Blood pressure high (unspecified if ongoing). Patient has not had symptoms associated with COVID-19. Concomitant medication(s) included AMLODIPINE taken for hypertension, start date: 2019; LOSARTAN POTASSIUM taken for hypertension, start date: 2019; OMEPRAZOLE taken for gastrooesophageal reflux disease, start date: 2021. Vaccination history included Covid-19 vaccine astrazeneca (Dose 1), administration date: 11Mar2021, for COVID-19 vaccination; Covid-19 vaccine astrazeneca (Dose 2), administration date: 20May2021, for COVID-19 vaccination. The following information was reported OFF LABEL USE (non-serious) with onset 20Nov2021, outcome unknown; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 20Nov2021, outcome unknown; IMMUNISATION (non-serious) with onset 20Nov2021, outcome unknown; ABDOMINAL PAIN (medically significant), outcome recovering; TREMOR (medically significant), outcome recovering; NEUROLOGICAL SYMPTOM (medically significant) with onset 25Nov2021, outcome not recovered; FATIGUE (medically significant), outcome unknown; CHEST PAIN (medically significant), outcome unknown; DYSPNOEA (medically significant), outcome unknown; PALPITATIONS (medically significant), outcome unknown; TACHYCARDIA (medically significant), outcome unknown; PARAESTHESIA (medically significant), outcome unknown; ARRHYTHMIA (medically significant), outcome unknown. Shortness of breath; Fatigue; Extreme tingling and fizzing feeling in whole body; Abdominal pain; Chest pain intermittent; Internal tremor; Rapid heartbeat; Abnormal heart rhythm. The report relate to possible inflammation of the heart (myocarditis or pericarditis). Relevant investigations or tests conducted Currently seeing general practitioner (GP) awaiting blood test appointment. The symptoms did not lead to a hospital stay. A diagnosis was not made by a medical professional. Electrocardiogram (ECG) booked for dec 14. Blood tests, such as for certain proteins (called troponin) that signal heart muscle damage was not taken. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent the following laboratory tests and procedures sars-cov-2 test negative, No - Negative COVID-19 test. Therapeutic measures were taken as a result of abdominal pain, tremor, neurological symptom, fatigue, chest pain, dyspnoea, palpitations, tachycardia, paraesthesia. Treatment given because of the symptoms included medication prescribed Propranolol. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1965193 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751201121 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Blood pressure measurement, Chest pain, Computerised tomogram, Diastolic hypertension, Echocardiogram, Electrocardiogram, Immunisation, Magnetic resonance imaging heart, Myocarditis, Palpitations, SARS-CoV-2 test, X-ray
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Angiogram; Result Unstructured Data: Test Result:Unknown; Test Name: Blood pressure; Result Unstructured Data: Test Result:117/130; Test Name: Blood pressure; Result Unstructured Data: Test Result:180/100; Test Name: CT scan; Result Unstructured Data: Test Result:Unknown; Test Name: Echocardiogram; Result Unstructured Data: Test Result:Unknown; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Unknown; Test Name: cardiac MRI; Result Unstructured Data: Test Result:Unknown; Test Date: 20211122; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: X-ray; Result Unstructured Data: Test Result:Unknown
CDC Split Type: GBPFIZER INC202101739308

Write-up: Chest pain; Heart palpitations; Booster; Hypertension diastolic; possible inflammation of the heart; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112051235250400-MHLKI (regulatory authority). Other Case identifier(s): GB-MHRA-ADR 26291016 (regulatory authority). A 56 year-old male patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH4751201121) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot number: Not known), for COVID-19 immunisation, reaction(s): "it raised bp slightly"; Bnt162b2 (Dose 2, Lot number: Not known), for COVID-19 immunisation, reaction(s): "it raised bp slightly". The following information was reported: IMMUNISATION (hospitalization, medically significant, life threatening) with onset 20Nov2021, outcome "unknown", described as "Booster"; DIASTOLIC HYPERTENSION (hospitalization, medically significant, life threatening) with onset 20Nov2021, outcome "not recovered", described as "Hypertension diastolic"; CHEST PAIN (hospitalization, medically significant, life threatening), outcome "unknown", described as "Chest pain"; PALPITATIONS (hospitalization, medically significant, life threatening), outcome "unknown", described as "Heart palpitations"; MYOCARDITIS (hospitalization, medically significant, life threatening) with onset 2021, outcome "unknown", described as "possible inflammation of the heart (myocarditis or pericarditis)". The events "hypertension diastolic", "chest pain", "heart palpitations" and "possible inflammation of the heart (myocarditis or pericarditis)" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: angiogram: (unspecified date) unknown; blood pressure measurement: (unspecified date) 117/130; (unspecified date) 180/100; computerised tomogram: (unspecified date) unknown; echocardiogram: (unspecified date) unknown; electrocardiogram: (unspecified date) unknown; magnetic resonance imaging heart: (unspecified date) unknown; sars-cov-2 test: (22Nov2021) negative, notes: No - Negative COVID-19 test; x-ray: (unspecified date) unknown. Therapeutic measures were taken as a result of diastolic hypertension. Clinical course: Patient not had symptoms associated with COVID-19. It was stated that after booster had to attend accident and emergency (A and E). Had spent 24 hours in hospital, still had high blood pressure 180/100 even though they prescribed Amlodipine 10mg. Patient was not tested positive for COVID-19 since the vaccination. Patient was not enrolled in clinical trial. The reporter considered this report as related to possible inflammation of the heart (myocarditis or pericarditis). The symptoms lead to a 24 hours hospital stay and diagnosis made by a medical professional and detail of the diagnosis given as reacting to booster. Blood tests such as for certain proteins (called troponin) that signal heart muscle damage was taken and it was unknown troponin normal or raised. No any recent or ongoing illness. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1965269 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Breast pain, Chills, Dyspnoea, Headache, Immunisation, Interchange of vaccine products, Off label use, Paralysis, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Lipodystrophy (broad), Arthritis (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101738975

Write-up: Off label use; Interchange of vaccine products; booster; Chronic fever; Breast pain female; Generalised joint pain; Breathlessness; Chronic headaches; move; shortness of breath; chills; severe headache; severe fever; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Agency (MHRA). Regulatory number: GB-MHRA-WEBCOVID-202112060821308320-7A7T5 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26294324 (MHRA). A 68 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: FLUCLOXACILLIN, administration date 11Nov2021. Vaccination history included: Covid-19 vaccine (Dose 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (Dose 2; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "booster"; PARALYSIS (medically significant) with onset 2021, outcome "unknown", described as "move"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "shortness of breath"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "severe headache"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "severe fever"; PYREXIA (non-serious) with onset 20Nov2021, outcome "recovered with sequelae" (25Nov2021), described as "Chronic fever"; BREAST PAIN (non-serious) with onset 20Nov2021, outcome "recovering", described as "Breast pain female"; ARTHRALGIA (non-serious) with onset 20Nov2021, outcome "recovering", described as "Generalised joint pain"; DYSPNOEA (non-serious) with onset 20Nov2021, outcome "recovering", described as "Breathlessness"; HEADACHE (non-serious) with onset 20Nov2021, outcome "recovering", described as "Chronic headaches". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course:The patient was not enrolled in clinical trial .Patient had not had symptoms associated with COVID-19.Patient had not tested positive for COVID-19 since having the vaccine It was reported that fever, pain in all joints, pain in left breast severe, mild in right breast, unable to stand up straight. severe headache, chills. shortness of breath when able to move. The report was not related to possible myocarditis or pericarditis and blood clots or low platelet counts. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1965343 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Electrocardiogram, Extrasystoles, Fatigue, Immunisation, Myocarditis, Palpitations, SARS-CoV-2 test, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (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: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder cancer (surgery to remove tumour/ pre-cancerous cells. BCG treatment over a year ago. No chemo and radio); Tumour excision (surgery to remove tumour/ pre-cancerous cells)
Allergies:
Diagnostic Lab Data: Test Name: electrocardiogram; Result Unstructured Data: Test Result:Unknown results; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101758534

Write-up: Fatigue/unusual tiredness; Heart palpitations; Racing heart (tachycardia); Myocarditis; Ectopic beats; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory number: GB-MHRA-WEBCOVID-202112061410376500-RYGRN (MHRA). Other Case identifier(s): GB-MHRA-ADR 26295685 (MHRA). A 71 year-old male patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "Bladder cancer" (unspecified if ongoing), notes: surgery to remove tumour/ pre-cancerous cells. BCG treatment over a year ago.; "Tumour excision" (unknown if ongoing), notes: surgery to remove tumour/ pre-cancerous cells. Concomitant medication(s) included: INFLUENZA VIRUS taken for immunisation. Vaccination history included: Bnt162b2, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; EXTRASYSTOLES (medically significant) with onset 30Nov2021, outcome "recovering", described as "Ectopic beats"; FATIGUE (medically significant), outcome "unknown", described as "Fatigue/unusual tiredness"; PALPITATIONS (medically significant), outcome "unknown", described as "Heart palpitations"; TACHYCARDIA (medically significant), outcome "unknown", described as "Racing heart (tachycardia)"; MYOCARDITIS (medically significant), outcome "unknown", described as "Myocarditis". The patient underwent the following laboratory tests and procedures: electrocardiogram: unknown results; sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: Patient has not had symptoms associated with COVID-19. Ectopic beats, fatigue or unusual tiredness, myocarditis, heart palpitations and (racing heart) tachycardia. Heart missing a beat. Patient has not tested positive for covid 19 since having the vaccine. Patient is not enrolled in clinical trial. Report related to possible inflammation of the heart (myocarditis or pericarditis). Please provide details of any relevant investigations or tests conducted: "electrocardiogram". Symptoms not leaded to a hospital stay and diagnosis made by a medical professional (Nurse practitioner and general practitioner). No blood tests, such as for certain proteins (called troponin) that signal heart muscle damage taken. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1965750 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Multiple sclerosis (Primary Progressive MS and taking medicines for multiple sclerosis)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Seizure; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26319011) on 12-Dec-2021 and was forwarded to Moderna on 12-Dec-2021. This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26319011) on 12-Dec-2021 and was forwarded to Moderna on 12-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of SEIZURE (Seizure) in a 73-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. Concurrent medical conditions included Multiple sclerosis (Primary Progressive MS and taking medicines for multiple sclerosis). On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant). On 20-Nov-2021, SEIZURE (Seizure) had resolved. 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 relevant concomitant and treatment medications were reported Patient had First seizure day after COVID booster COMPANY COMMENT: This is a regulatory case concerning a 73-year-old female patient with clinical history of Multiple sclerosis who experienced the unexpected event of SEIZURE The event occurred 2 days after third dose of mRNA-1273. The rechallenge was not applicable since only information about third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: COMPANY COMMENT: This is a regulatory case concerning a 73-year-old female patient with clinical history of Multiple sclerosis who experienced the unexpected event of SEIZURE The event occurred 2 days after third dose of mRNA-1273. The rechallenge was not applicable since only information about third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1965965 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Immunisation, Interchange of vaccine products, Nausea, Off label use, Temperature regulation disorder, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (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: IEPFIZER INC202101734043

Write-up: NAUSEA; Tiredness; unable to stay warm / lack of warmth; Chills; uncontrollable shaking; Dose 3 booster; Chimpanzee Adenovirus encoding the SARS CoV 2 Spike glycoprotein (ChAdOx1-S); Chimpanzee Adenovirus encoding the SARS CoV 2 Spike glycoprotein (ChAdOx1-S); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: IE-HPRA-2021-087145 (HPRA). A 57 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH8469) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Vaxzevria (astrazeneca), for COVID-19 immunization; Covid-19 vaccine (manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Dose 3 booster"; OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 20Nov2021, outcome "unknown" and all described as "Chimpanzee Adenovirus encoding the SARS CoV 2 Spike glycoprotein (ChAdOx1-S)"; NAUSEA (medically significant) with onset 21Nov2021 03:00, outcome "not recovered", described as "NAUSEA"; FATIGUE (medically significant) with onset 21Nov2021 03:00, outcome "recovered" (22Nov2021), described as "Tiredness"; TREMOR (medically significant) with onset 21Nov2021, outcome "recovered" (21Nov2021), described as "uncontrollable shaking"; TEMPERATURE REGULATION DISORDER (medically significant) with onset 21Nov2021 03:00, outcome "recovered" (22Nov2021), described as "unable to stay warm / lack of warmth"; CHILLS (medically significant) with onset 21Nov2021 03:00, outcome "recovered" (22Nov2021), described as "Chills". Therapeutic measures were taken as a result of nausea, fatigue, tremor, temperature regulation disorder, chills. Clinical course: The patient was not taking any concomitant medication. The patient did not have any relevant medical history or concurrent conditions. On 21Nov2021 at 3 am, the patient experienced uncontrollable shaking lasting 6 hours, tiredness, chills and lack of warmth, lasting 24 hours. The patient also experienced nausea, which was still present at the time of reporting. The patient was treated with paracetamol every 4 hours. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1966034 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, C-reactive protein, Ecchymosis, Emergency care examination, Fibrin D dimer, Neurological examination, Paraesthesia, Tremor, Visual impairment
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: C-Reactive Protein; Result Unstructured Data: Test Result:13; Test Date: 20211122; Test Name: Emergency care; Result Unstructured Data: Test Result:UNKNOWN RESULTS; Test Date: 20211125; Test Name: Emergency care; Result Unstructured Data: Test Result:UNKNOWN RESULTS; Test Name: D-Dimer; Result Unstructured Data: Test Result:0.4; Test Date: 20211125; Test Name: Neurological examination; Result Unstructured Data: Test Result:UNKNOWN RESULTS
CDC Split Type: ITPFIZER INC202101730315

Write-up: Visual disturbance; Shakiness; Ecchymosis; Strength loss of; Paraesthesia; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority-WEB. Regulatory number: IT-MINISAL02-815878. A 19 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 20Nov2021 (Lot number: unknown) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VISUAL IMPAIRMENT (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Visual disturbance"; TREMOR (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Shakiness"; ECCHYMOSIS (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Ecchymosis "; ASTHENIA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Strength loss of"; PARAESTHESIA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Paraesthesia". The patient underwent the following laboratory tests and procedures: c-reactive protein: (unspecified date) 13; emergency care: (22Nov2021) unknown results; (25Nov2021) unknown results; fibrin d dimer: (unspecified date) 0.4; neurological examination: (25Nov2021) unknown results. Actions taken (Emergency Room assessment, neurological consultation, awaiting brain Magnetic Resonance Imaging scan results). Suggested therapy: Brain Magnetic Resonance Imaging scan at the Neurology Department in PRIVACY; Neurological consultation at the Emergency Room; Test results within normal limits. The patient was referred to an immunologist for a specialized assessment at the privacy Emergency Room. Sender comment: Pharmacovigilance Centre 29Nov: The missing information was requested. Pharmacovigilance Centre 30Nov: The neurological report was to attach to the Pharmacovigilance Network. Awaiting the Magnetic Resonance Imaging scan results No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1966253 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-11-20
   Days after vaccination:274
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Disease risk factor
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101730845

Write-up: Miscarriage at 5 weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: NL-LRB-00721494. A 21 year-old female patient received bnt162b2 (COMIRNATY) strength: 0.3 mL, administration date 19Feb2021 (Lot number: Unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Disease risk factor" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, SINGLE 0.3 ML), administration date: 29Jan2021, for COVID-19 immunization. No previous COVID-19 infection. The following information was reported: ABORTION SPONTANEOUS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Miscarriage at 5 weeks". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1966262 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Body temperature increased, Chills, Fatigue, Headache, Malaise, Maternal exposure during pregnancy
SMQs:, Neuroleptic malignant syndrome (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (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: ACARIZAX
Current Illness: Disease risk factor; Maternal vaccine exposure (vaccine exposure during pregnancy week: 5)
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: Body temperature increased; Result Unstructured Data: fever
CDC Split Type: NLJNJFOC20211236402

Write-up: Maternal exposure during pregnancy; Miscarriage; Malaise; Headache; Body temperature increased; Fatigue; Chills; This spontaneous pregnancy report received from a consumer by a Regulatory Authority (EVHUMAN Vaccines, NL-LRB-00727206) on 16-DEC-2021 was received on 16-DEC-2021 and concerned a 36 year old female of unknown race and ethnic origin. The patient''s weight was 53 kilograms, and height was 158 centimeters. The patient''s concurrent conditions included: disease risk factor, and maternal vaccine exposure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 dosage forms, 0.5 ml total dose, 1 total, administered on 20-NOV-2021 for covid-19 immunisation (Dose number in series 1). The batch number was not reported. Per procedure, no follow-up will be requested for this case. Drug Star Period was 1 days. Gestation period was 5 weeks. Concomitant medications included allergens, house dust & mite for unknown indication. On 20-NOV-2021, the patient experienced chills. On 21-NOV-2021, the patient experienced headache, body temperature increased, malaise, and fatigue. Laboratory data included: Body temperature increased (NR: not provided) Fever: 37.5 to 38 degrees Celsius. On 07-DEC-2021, the patient experienced miscarriage. On an unspecified date, the patient experienced maternal exposure during pregnancy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 20-NOV-2021, and malaise on 25-NOV-2021, was recovering from body temperature increased, and fatigue, had not recovered from headache, and the outcome of miscarriage and maternal exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1966343 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Dyspnoea
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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101729015

Write-up: pain in the chest; pressure in the chest; Shortness of breath; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: NO-NOMAADVRE-PASRAPP-2021-U4e8yw. Other Case identifier(s): NO-NOMAADVRE-E2B_00062365. A 32-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 18Nov2021 17:00 (Lot number: Unknown, expiration date unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (hospitalization) with onset 20Nov2021, outcome "not recovered", described as "pain in the chest"; CHEST DISCOMFORT (hospitalization) with onset 20Nov2021, outcome "not recovered", described as "pressure in the chest"; DYSPNOEA (hospitalization) with onset 20Nov2021, outcome "not recovered", described as "Shortness of breath". Due to this the patient was picked up by ambulance. the physician did not find out what caused the dyspnoea and chest pain. The events "pain in the chest", "pressure in the chest" and "shortness of breath" were evaluated at the physician office visit and emergency room visit. Reporter Comment: Contact with healthcare professionals: Physician. The patient was picked up by ambulance. The physician did not find out what caused the dyspnoea and chest pain. The patient reported sick leave due to the ADR''s. Contact with healthcare professionals: Physician. The patient was picked up by ambulance. The physician did not find out what caused the DYSPNOEA and CHEST PAIN. The patient reported sick leave due to the ADR''s. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Contact with healthcare professionals: Physician. The patient was picked up by ambulance. The physician did not find out what caused the dyspnoea and chest pain. The patient reported sick leave due to the ADR''s. Contact with healthcare professionals: Physician. The patient was picked up by ambulance. The physician did not find out what caused the DYSPNOEA and CHEST PAIN. The patient reported sick leave due to the ADR''s.


VAERS ID: 1968307 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-20
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness, Migraine, Nausea, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? 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 INC202101740690

Write-up: Loss of consciousness; Migraine; Nausea; Visual impairment; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 675615 Regulatory Authority. A 24 year-old patient (unspecified gender) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 20Nov2021, outcome "recovered", described as "Loss of consciousness"; MIGRAINE (non-serious) with onset 20Nov2021, outcome "recovered", described as "Migraine"; NAUSEA (non-serious) with onset 20Nov2021, outcome "recovered", described as "Nausea"; VISUAL IMPAIRMENT (non-serious) with onset 20Nov2021, outcome "recovered", described as "Visual impairment". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1968421 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-20
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Anosmia, Fatigue, Headache, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Taste and smell disorders (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101753679

Write-up: Sudden loss of smell; Sudden loss of taste; Fatigue; Headache; Myalgia; This is a spontaneous report received from a contactable consumer from the Regulatory Authority-WEB. Regulatory number: BE-FAMHP-DHH-N2021-109698 (FAMHP). A 27-year-old female patient received BNT162B2 (COMIRNATY), administration date 17Nov2021 (Lot number: Unknown) as dose number unknown, single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: ANOSMIA (disability) with onset 20Nov2021, outcome "recovered" (22Nov2021), described as "Sudden loss of smell"; AGEUSIA (disability) with onset 20Nov2021, outcome "recovered" (22Nov2021), described as "Sudden loss of taste"; FATIGUE (disability) with onset 20Nov2021, outcome "recovered" (22Nov2021), described as "Fatigue"; HEADACHE (disability) with onset 20Nov2021, outcome "recovered" (22Nov2021), described as "Headache"; MYALGIA (disability) with onset 20Nov2021, outcome "recovered" (22Nov2021), described as "Myalgia". Therapeutic measures were not taken as a result of anosmia, ageusia, fatigue, headache, myalgia. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1968541 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-01
Onset:2021-11-20
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Application site reaction, Oedema peripheral, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC202101762471

Write-up: Oedema extremity upper; conspicuous local reaction; swelling of the upper limb for 14 days; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from the regulatory authority. Regulatory number: CZ-CZSUKL-21012598. A 57 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm, administration date Nov2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1, Single, intramuscular), administration date: 2021, for COVID-19 immunisation. The following information was reported: OEDEMA PERIPHERAL (medically significant) with onset 20Nov2021, outcome "unknown", described as "Oedema extremity upper"; APPLICATION SITE REACTION (medically significant) with onset 20Nov2021, outcome "unknown", described as "conspicuous local reaction"; PERIPHERAL SWELLING (non-serious) with onset 20Nov2021, outcome "unknown", described as "swelling of the upper limb for 14 days". The events "oedema extremity upper", "conspicuous local reaction" and "swelling of the upper limb for 14 days" were evaluated at the physician office visit. Therapeutic measures were taken as a result of oedema peripheral, application site reaction, peripheral swelling. Clinical course: conspicuous local reaction with swelling of the upper limb for 14 days (according to a patient''s description the vaccine was injected to the lower edge of deltoid muscle), without rash, without breathing difficulties. This adverse reactions started on 20.11.2021. Treatment of the adverse reaction: from allergologist 20 mg Prednison, 1 tablet Zyrtec. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1969086 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-12
Onset:2021-11-20
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1010A / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bed rest, Chest discomfort, Impaired work ability, Limb discomfort, Myocarditis, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101734262

Write-up: Pain in the limbs; Myocarditis; Fever; pressure on the chest; 4 weeks unable to work, bed rest; 4 weeks unable to work, bed rest; This is a spontaneous report received from a non-contactable reporter(s) (Physician) from a regulatory authority. Regulatory number: DE-PEI-CADR2021204843 (PEI). Other Case identifier(s): DE-CADRPEI-2021204843, DE-PEI-202100230923. A 25 year-old male patient received bnt162b2 (COMIRNATY (mRNA Tozinameran)), administration date 12Nov2021 (Lot number: 1F1010A) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Pain in the limbs"; MYOCARDITIS (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Myocarditis"; PYREXIA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Fever"; CHEST DISCOMFORT (non-serious) with onset 20Nov2021, outcome "not recovered", described as "pressure on the chest"; BED REST (non-serious), IMPAIRED WORK ABILITY (non-serious) all with onset 2021, outcome "unknown" and all described as "4 weeks unable to work, bed rest". Health authority comment: Are allergies known to you or the affected person? If so, which ones? No information on risk factors or diseases No / 4 weeks unable to work, bed rest. Source of assessment: PEI. Result of assessment for events Myocarditis, Limb discomfort, Fever: Unclassifiable. Are you or the person affected by allergy? If so, what? No. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1969420 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis, Headache, Herpes zoster, Herpes zoster oticus, Immunisation, Neck pain, SARS-CoV-2 test, Vertigo
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Vestibular disorders (narrow), Arthritis (broad), Opportunistic infections (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: CLOPIDOGREL; INFLUENZA VIRUS; RAMIPRIL; SIMVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Facial palsy; Prediabetes; Shingles; TIA; Vertigo; White coat hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20211129; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101731462

Write-up: facial paralysis; pain/ pain in her neck and base of her head; pain/ pain in her neck and base of her head; vertigo; Ramsay-Hunt syndrome; Shingles; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112041722492210-EEEXB. Other Case identifier(s): GB-MHRA-ADR 26289150. A 55 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation; medroxyprogesterone acetate (SAYANA PRESS) (Batch/Lot number: unknown) for contraception, vertigo. Relevant medical history included: "Facial paralysis" (unspecified if ongoing); "Shingles" (unspecified if ongoing); "Vertigo" (unspecified if ongoing); "TIA", start date: Jun2012 (unspecified if ongoing); "White coat hypertension", start date: Jun2012 (unspecified if ongoing); "Pre diabetic" (unspecified if ongoing). The patient has not had symptoms associated with COVID-19, was not currently breastfeeding. Patient was not enrolled in clinical trial. Concomitant medication(s) included: CLOPIDOGREL taken for transient ischaemic attack, start date: Jun2012; INFLUENZA VIRUS, start date: Oct2021; RAMIPRIL taken for white coat hypertension, start date: Jun2012; SIMVASTATIN taken for transient ischaemic attack, start date: Jun2012. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; FACIAL PARALYSIS (hospitalization, medically significant), outcome "not recovered", described as "facial paralysis"; NECK PAIN (hospitalization, medically significant), HEADACHE (hospitalization, medically significant), outcome "not recovered" and all described as "pain/ pain in her neck and base of her head"; VERTIGO (hospitalization, medically significant), outcome "not recovered", described as "vertigo"; HERPES ZOSTER (hospitalization, medically significant) with onset 01Dec2021, outcome "not recovered", described as "Shingles"; HERPES ZOSTER OTICUS (hospitalization, medically significant) with onset 02Dec2021, outcome "not recovered", described as "Ramsay-Hunt syndrome". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Nov2021) negative, notes: No - Negative COVID-19 test. The action taken for medroxyprogesterone acetate was unknown. Therapeutic measures were taken as a result of facial paralysis, vertigo, herpes zoster, herpes zoster oticus. The patient described that 2 weeks after her third dose she started to get vertigo. Two days later she was experiencing pain in her neck and base of her head. The following morning she awoke with facial paralysis. She had been diagnosed with shingles in the ear and facial palsy. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Nov2021) negative, notes: No - Negative COVID-19 test. The action taken for medroxyprogesterone acetate was unknown. Therapeutic measures were taken as a result of immunisation, facial paralysis, vertigo, herpes zoster, herpes zoster oticus, and included steroids and anti viral medication. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Patient is not enrolled in clinical trial. Reaction-Does your report relate to possible inflammation of the heart (myocarditis or pericarditis)? If yes, we will ask you some additional questions at the end of this report: "No" Suspect Reactions-Please provide details of any relevant investigations or tests conducted: "Long term affects not yet known".


VAERS ID: 1969421 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Condition aggravated, Dyspnoea, Fatigue, Immunisation, Infection, Interchange of vaccine products, Magnetic resonance imaging, Musculoskeletal pain, Myocarditis, Off label use, Pain, Palpitations, Troponin
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN; SUMATRIPTAN; TRANEXAMIC ACID
Current Illness: Myopericarditis (Previous, following covid infection in Mar2020. Diagnosed by MRI in Dec2020, MRI clear Jul2021)
Preexisting Conditions: Medical History/Concurrent Conditions: Frequent headaches; Heavy periods; Long COVID-19; Migraine; Suspected COVID-19 (Unsure when symptoms stopped, covid infection in Mar2020)
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: magnetic resonance imaging; Result Unstructured Data: Test Result:MRI clear; Test Date: 202012; Test Name: Magnetic resonance imaging; Result Unstructured Data: Test Result:Myopericarditis diagnosed.; Test Name: Troponin; Result Unstructured Data: Test Result:Not provided
CDC Split Type: GBPFIZER INC202101739526

Write-up: Myopericarditis/myocarditis; Myopericarditis; Patient received first, second dose of non-Pfizer vaccine and booster dose of COMIRNATY; Patient received first, second dose of non-Pfizer vaccine and booster dose of COMIRNATY; The patient received booster dose of COMIRNATY; infection; Fatigue/unusual tiredness; Chest pain, Sore chest on left side, Some stabbing chest pain to left of breastbone.; Shortness of breath; Heart palpitations; shoulder blade pain/Pain under left shoulder blade; Pain on lying down and wakes me in the night; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112041804259620-FVHKR. Other Case identifier(s): GB-MHRA-ADR 26289216. A 54 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH4751) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Heavy periods" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "Frequent headaches" (unspecified if ongoing); "Long COVID-19" (unknown if ongoing); "Myopericarditis", start date: Dec2020 (ongoing), notes: Previous, following covid infection in Mar2020. Diagnosed by MRI in Dec2020, MRI clear Jul2021; "Suspected COVID-19", start date: 14Mar2020 (not ongoing), notes: Unsure when symptoms stopped, covid infection in Mar2020. Patient was not enrolled in clinical trial. "General practitioner (GP) diagnosed (had myopericarditis previously following covid infection in Mar2020. Magnetic resonance imaging (MRI) diagnosis Dec2020 and follow up clear in Jul2021. 7 months colchicine treatment." Concomitant medication included: IBUPROFEN taken for headache; INFLUENZA VIRUS taken for influenza immunisation, administration date 15Nov2021; SUMATRIPTAN taken for migraine, start date: 01Feb2021; TRANEXAMIC ACID taken for heavy menstrual bleeding, start date: 01Mar2021. Past drug history included: Colchicine for Myopericarditis. Vaccination history included: Covid-19 vaccine (DOSE 2, manufacturer unknown), for COVID-19 vaccination; Covid-19 vaccine (DOSE 1, manufacturer unknown), for COVID-19 vaccination. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 20Nov2021, outcome "unknown" and all described as "Patient received first, second dose of non-Pfizer vaccine and booster dose of COMIRNATY"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "The patient received booster dose of COMIRNATY"; INFECTION (medically significant) with onset 2021, outcome "recovering", described as "infection"; MYOCARDITIS (medically significant) with onset 24Nov2021, outcome "not recovered", described as "Myopericarditis/myocarditis"; CONDITION AGGRAVATED (medically significant) with onset 24Nov2021, outcome "not recovered", described as "Myopericarditis"; FATIGUE (medically significant) with onset 2021, outcome "unknown", described as "Fatigue/unusual tiredness"; CHEST PAIN (medically significant) with onset 2021, outcome "unknown", described as "Chest pain, Sore chest on left side, Some stabbing chest pain to left of breastbone."; DYSPNOEA (medically significant) with onset 2021, outcome "unknown", described as "Shortness of breath"; PALPITATIONS (medically significant) with onset 2021, outcome "unknown", described as "Heart palpitations"; MUSCULOSKELETAL PAIN (medically significant) with onset 2021, outcome "unknown", described as "shoulder blade pain/Pain under left shoulder blade"; PAIN (medically significant) with onset 2021, outcome "unknown", described as "Pain on lying down and wakes me in the night". The events "infection", "myopericarditis/myocarditis", "myopericarditis", "fatigue/unusual tiredness", "chest pain, sore chest on left side, some stabbing chest pain to left of breastbone.", "shortness of breath", "heart palpitations", "shoulder blade pain/pain under left shoulder blade" and "pain on lying down and wakes me in the night" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: (Jul2021) MRI clear; (Dec2020) myopericarditis diagnosed.; troponin: (unspecified date) not provided. Patient did not have a COVID-19 test. Therapeutic measures were taken as a result of infection, myocarditis, condition aggravated, chest pain, musculoskeletal pain, pain; including Colchicine. Clinical course: The report was related to possible inflammation of the heart (myocarditis or pericarditis). The symptoms did not lead to a hospital stay. A diagnosis was made by a medical professional General Practitioner and consultant cardiologist on symptoms and previous history. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1969440 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Enuresis, Erectile dysfunction, Immunisation, Interchange of vaccine products, Nightmare, Off label use, Pain in extremity, Product use issue, Vertigo
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), Sexual dysfunction (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:
CDC Split Type: GBPFIZER INC202101739052

Write-up: Vertigo; The patient received influenza vaccine on same day of comirnaty; The patient received influenza vaccine on same day of comirnaty; The patient received the primary immunization series with at least one non-Pfizer vaccine (AZ) and received a third dose of COMIRNATY vaccine; The patient received the primary immunization series with at least one non-Pfizer vaccine (AZ) and received a third dose of COMIRNATY vaccine; The patient received booster dose of COMIRNATY vaccine.; Erectile dysfunction; hand pain; Nightmares; Dizziness; Bed wetting; This is a spontaneous report from a contactable consumer (patient) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112061336518880-G4YOY. Other Case identifier: GB-MHRA-ADR 26295565. A 68-year-old female patient received BNT162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK0596) as dose 3 (booster), single for COVID-19 immunisation. The patient also received INFLUENZA VACCINE (MANUFACTURER UNKNOWN), administration date 20Nov2021 for immunization. The patient''s concomitant medications were not reported. It was reported that the patient had no other health issues. The patient had no symptoms associated with COVID-19 and was not enrolled in the clinical trial. The patient had not had a COVID-19 test. Vaccination history included: Covid-19 vaccine AstraZeneca (DOSE NUMBER UNKNOWN, SINGLE Lot number: UNKNOWN), administration date: 23Feb2021, for COVID-19 immunisation and Covid-19 vaccine (DOSE NUMBER UNKNOWN, unknown manufacturer), for COVID-19 immunisation. The following information was reported: On an unknown date in 2021, the patient experienced erectile dysfunction, hand pain, nightmare, dizziness and bed wetting. On 25Nov2021, 5 days after vaccination, the patient experienced vertigo. It was reported that the patient experienced dizziness when she moves her head, turning over in bed and when getting up from lying down. The patient had not tested positive for COVID-19, since having the vaccine. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). The clinical outcome of the events erectile dysfunction, hand pain, nightmare, dizziness, bed wetting and vertigo was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1969503 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Complex regional pain syndrome, Disease recurrence, Gait inability, Immunisation, Interchange of vaccine products, Off label use, Product use issue
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Arthritis (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: C-reactive protein increased; Complex regional pain syndrome; Joint inflammation (but no current medication)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101758701

Write-up: CRPS relapse left foot and ankle; CRPS relapse left foot and ankle; unable to walk without aid; severe left hip pain/joint pain; Off label use; Interchange of vaccine products; Booster; COVID vaccine was administered on the same date as another vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory number: GB-MHRA-WEBCOVID-202112081246112940-V7XAT (MHRA). Other Case identifier(s): GB-MHRA-ADR 26307112 (MHRA). A 67 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH4751) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Joint inflammation", notes: but no current medication; "C-reactive protein increased"; "CRPS remission left ankle". Patient has not had symptoms associated with COVID-19 and did not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medication(s) included: FLUAD taken for immunisation, administration date 20Nov2021. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; PRODUCT USE ISSUE (medically significant) with onset 20Nov2021, outcome "unknown", described as "COVID vaccine was administered on the same date as another vaccine"; ARTHRALGIA (medically significant) with onset 21Nov2021, outcome "recovering", described as "severe left hip pain/joint pain"; COMPLEX REGIONAL PAIN SYNDROME (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "CRPS relapse left foot and ankle"; GAIT INABILITY (medically significant), outcome "unknown", described as "unable to walk without aid". Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1969597 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Fatigue, Hypoaesthesia, Immunisation, Influenza like illness, Malaise, Pyrexia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef)); Neutropenia (Cyclic Neutropenia - no treatment and generally no impact since diagnosed); Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211201; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101770252

Write-up: Hypoaesthesia; unwell; flu like after effects; Fever chills; Fatigue; Chest pain; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112101023174580-W2TZJ. Other Case identifier(s): GB-MHRA-ADR 26317432. A female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH4751) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Neutropenia" (unspecified if ongoing), notes: Cyclic Neutropenia - no treatment and generally no impact since diagnosed; "Suspected COVID-19", start date: 30Nov2021, stop date: 07Dec2021; "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef). The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; HYPOAESTHESIA (medically significant), outcome "recovering", described as "Hypoaesthesia"; MALAISE (medically significant), outcome "recovering", described as "unwell"; CHEST PAIN (medically significant) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Chest pain"; PYREXIA (medically significant) with onset 21Nov2021, outcome "recovered" (24Nov2021), described as "Fever chills"; FATIGUE (medically significant) with onset 21Nov2021, outcome "recovered" (29Nov2021), described as "Fatigue"; INFLUENZA LIKE ILLNESS (medically significant), outcome "unknown", described as "flu like after effects". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Dec2021) no - negative covid-19 test. Clinical information: Vaccine was thursday midday, then during that afternoon she experienced shooting pains in her chest, which made worry. She stayed calm and they seemed to dissipate later on that evening thankfully. Although the next day She became unwell with flu like after effect which seen her in bed for 2 solid days. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Details of relevant investigations or tests conducted was reported as none. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1969709 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Hypersensitivity, SARS-CoV-2 test
SMQs:, Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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; Allergic to dogs; Allergic to horses; Asthmatic; Dust allergy; Immunodeficiency; Pollen allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20200703; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: headache; chills; allergic reaction; Chronic headaches; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26323632) on 12-Dec-2021 and was forwarded to Moderna on 12-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (chills), HYPERSENSITIVITY (allergic reaction) and HEADACHE (Chronic headaches) in a 51-year-old patient of an unknown gender who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 18-Mar-2020 to 22-Apr-2020. Concurrent medical conditions included Asthmatic, Allergic to horses, Immunodeficiency, Allergic to dogs, Allergic to cats, Dust allergy and Pollen allergy. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced HEADACHE (Chronic headaches) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criterion medically significant), CHILLS (chills) (seriousness criterion medically significant) and HYPERSENSITIVITY (allergic reaction) (seriousness criterion medically significant). On 27-Nov-2021, HEADACHE (Chronic headaches) had resolved. At the time of the report, HEADACHE (headache), CHILLS (chills) and HYPERSENSITIVITY (allergic reaction) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2020, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No Concomitant medications were reported. The patient was on Ventolin, Spiriva and Ciclesonide medication. The patient had severe all over body chills for 4 hours from Midnight on Friday 19 Nov 2021. The patient was sick. The patient had a severe headache for two days. This required me to stay in bed. The patient slept for most of the first day after the vaccine. The patient then had a milder headache every morning for 5 days after that. The patient also felt sick every morning. The patient would classify the effect of the booster as an allergic reaction. No treatment medications were reported Company comment: This case concerns a 51-year-old female patient, with medical history of asthma and allergic, who experienced the serious unexpected events of headache (reported as headache and chronic headaches), chills and hypersensitivity after third dose of mRNA-1273. The events occurred the same day after vaccination. The re-challenge is not applicable since further dose is not expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.; Sender''s Comments: This case concerns a 51-year-old female patient, with medical history of asthma and allergic, who experienced the serious unexpected events of headache (reported as headache and chronic headaches), chills and hypersensitivity after third dose of mRNA-1273. The events occurred the same day after vaccination. The re-challenge is not applicable since further dose is not expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.


VAERS ID: 1969744 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Nausea, 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? 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: 20211209; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Nausea; This case was received via RA (Reference number: GB-MHRA-ADR 26324271) on 12-Dec-2021 and was forwarded to Moderna on 12-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for an unknown indication. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). On 27-Nov-2021, NAUSEA (Nausea) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product was not provided. Treatment medication was not reported. It was reported that patient had no symptoms associated with COVID-19 .Post vaccination patient not tested positive for COVID-19.Also patient was not enrolled in any clinical trials. Company Comment This case concerns a female patient of unknown age, with no relevant medical history reported, who experienced the unexpected event of nausea. The event occurred 1 day after the third dose of mRNA-1273. The rechallenge was unknown since no information regarding the first and second dose was disclosed and as was reported by regulatory Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the event meets the criteria to be medically significant.; Sender''s Comments: This case concerns a female patient of unknown age, with no relevant medical history reported, who experienced the unexpected event of nausea. The event occurred 1 day after the third dose of mRNA-1273. The rechallenge was unknown since no information regarding the first and second dose was disclosed and as was reported by regulatory Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the event meets the criteria to be medically significant.


VAERS ID: 1969982 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0114 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Breast pain, Headache, Immunisation, Lymphadenitis, Lymphadenopathy, Nausea, Tenderness
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Lipodystrophy (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101753851

Write-up: Booster; Swollen and inflammed lymph nodes under armpit of arm vaccine administered; Nausea; Headache; Tenderness and pain to left side of breast; Swollen and inflammed lymph nodes under armpit of arm vaccine administered; tenderness; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Agency WEB. Regulatory number: IE-HPRA-2021-087161 (RA). A 29 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH0114) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. The patient relevant medical history was reported as none.. There were no concomitant medications. Vaccination history included: Comirnaty (Dose 1, On 12Jan2021, the patient was vaccinated with the first dose of Comirnaty (batch details:EM0477)), administration date: 12Jan2021, for COVID-19 immunization; Comirnaty (Dose 2, on 04Feb2021, the patient was vaccinated with the second dose of Comirnaty (batch details: EJ6789).), administration date: 04Feb2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (disability) with onset 20Nov2021, outcome "unknown", described as "Booster"; LYMPHADENITIS (disability), LYMPHADENOPATHY (disability) all with onset 20Nov2021, outcome "not recovered" and all described as "Swollen and inflammed lymph nodes under armpit of arm vaccine administered"; NAUSEA (disability) with onset 20Nov2021, outcome "not recovered", described as "Nausea"; HEADACHE (disability) with onset 20Nov2021, outcome "not recovered", described as "Headache"; BREAST PAIN (disability) with onset 20Nov2021, outcome "not recovered", described as "Tenderness and pain to left side of breast"; TENDERNESS (disability) with onset 20Nov2021, outcome "not recovered", described as "tenderness". Therapeutic measures were taken as a result of lymphadenitis, nausea, headache, breast pain, lymphadenopathy, tenderness. Clinical course: It was reported that 12 hours later on 20Nov2021, the patient experienced swollen and inflamed lymph nodes under armpit of arm vaccine was administered, tenderness and pain to left side of breast, nausea and headache, which were ongoing at the time of reporting.The patient was not taking any concomitant medication. The patient did not have any relevant medical history/concurrent conditions. It was noted that the patient did not have any surgical history and had no history of COVID-19 infection. The patient was treated with paracetamol (brand unspecified) and Nurofen. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1969994 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0114 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Lip swelling, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN [ACETYLSALICYLIC ACID]; CRESTOR
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101762730

Write-up: Swollen lips / lip swelling; Myalgia; Fever; Patient received third dose on 20Nov2021; This is a spontaneous report received from a contactable reporter (Physician) from the regulatory authority-WEB. Regulatory number: IE-HPRA-2021-087271 (regulatory authority). Other Case identifier(s): IE-HPRA-CVARR2021112422840 (regulatory authority). A 61 year-old male patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH0114) as dose 3 (booster), single for COVID-19 immunisation. Information regarding the patient''s medical history/concurrent conditions was not provided in the report. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; CRESTOR. Vaccination history included: Comirnaty (DOSE 1, SINGLE, Batch/Lot number: Unknown), administration date: 25May2021, for COVID-19 immunisation; Comirnaty (DOSE 2, SINGLE, Batch/Lot number: FC2336), administration date: 18Jun2021, for COVID-19 immunisation, reaction(s): "Myalgia", "Fever". The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Patient received third dose on 20Nov2021"; LIP SWELLING (medically significant) with onset 24Nov2021, outcome "unknown", described as "Swollen lips / lip swelling"; MYALGIA (non-serious) with onset 24Nov2021, outcome "unknown", described as "Myalgia"; PYREXIA (non-serious) with onset 24Nov2021, outcome "unknown", described as "Fever". Therapeutic measures were taken as a result of lip swelling with prednisolone (brand unspecified) at a dose of 30 mg daily for 3 days and cetirizine (brand unspecified) at a dose of 10 mg daily. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : IE-PFIZER INC-202101780916 Same patient/Drug/Reporter, different dose number and event.


VAERS ID: 1970038 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-20
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005698 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Computerised tomogram head, Ischaemic stroke
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (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: 20211120; Test Name: Brain CT; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Date: 20211121; Test Name: Brain CT; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: ITMODERNATX, INC.MOD20214

Write-up: cardioembolic ischemic stroke; This case was received via Agency (Reference number: IT-MINISAL02-816721) on 14-Dec-2021 and was forwarded to Moderna on 14-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of ISCHAEMIC STROKE (cardioembolic ischemic stroke) in a 70-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005698) for COVID-19 immunisation. No Medical History information was reported. On 17-Nov-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 20-Nov-2021, the patient experienced ISCHAEMIC STROKE (cardioembolic ischemic stroke) (seriousness criteria hospitalization and medically significant). At the time of the report, ISCHAEMIC STROKE (cardioembolic ischemic stroke) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2021, Computerised tomogram head: inconclusive (Inconclusive) Inconclusive. On 21-Nov-2021, Computerised tomogram head: negative (Negative) Negative. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Relevant concomitant product usage were not reported by the reporter. Patient experienced Embolic ischemic stroke 3 days after the third dose of Moderna COVID-19 Vaccine. No treatment details were added. Most recent FOLLOW-UP information incorporated above includes: On 14-Dec-2021: Translation Received on 18-Dec-21 contains translated event verbatim and Narrative.; Reporter''s Comments: Embolic ischemic stroke occurred after 3 days from the 3rd dose COVID vaccine (Moderna in this case). During the admission of FA; Sender''s Comments: This case concerns a 59-year-old female patient, with o medical history reported, who experienced the serious (medically significant and hospitalization) unexpected event of ischaemic stroke. The event occurred 3 days after the 1st dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered Not applicable. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1970054 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005698 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blindness, Eye oedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? 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: ITMODERNATX, INC.MOD20214

Write-up: I did the third dose booster of Moderna on 19/11, the next day my right eye inflated and it deflated on Sunday. On Monday 22/11 I started losing sight to my right eye; I did the third dose booster of Moderna on 19/11, the next day my right eye inflated and it deflated on Sunday. On Monday 22/11 I started losing sight to my right eye; This case was received via regulatory authority (Reference number: IT-MINISAL02-817088) on 14-Dec-2021 and was forwarded to Moderna on 14-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BLINDNESS (I did the third dose booster of Moderna on 19/11, the next day my right eye inflated and it deflated on Sunday. On Monday 22/11 I started losing sight to my right eye) and EYE OEDEMA (I did the third dose booster of Moderna on 19/11, the next day my right eye inflated and it deflated on Sunday. On Monday 22/11 I started losing sight to my right eye) in a 26-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005698) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 20-Nov-2021, the patient experienced BLINDNESS (I did the third dose booster of Moderna on 19/11, the next day my right eye inflated and it deflated on Sunday. On Monday 22/11 I started losing sight to my right eye) (seriousness criterion disability) and EYE OEDEMA (I did the third dose booster of Moderna on 19/11, the next day my right eye inflated and it deflated on Sunday. On Monday 22/11 I started losing sight to my right eye) (seriousness criterion disability). At the time of the report, BLINDNESS (I did the third dose booster of Moderna on 19/11, the next day my right eye inflated and it deflated on Sunday. On Monday 22/11 I started losing sight to my right eye) and EYE OEDEMA (I did the third dose booster of Moderna on 19/11, the next day my right eye inflated and it deflated on Sunday. On Monday 22/11 I started losing sight to my right eye) had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant medication were reported. No treatment medication were reported. Company Comment: This case concerns a 26-year-old, female patient with no medical history reported, who experienced the unexpected serious event of eye oedema on the next day after the booster (third) dose of mRNA-1273 vaccine. The event eye oedema resolved one day after and on the third day after vaccination the patient experienced the unexpected serious event of blindness, reported as started losing sight to my right eye, which had not recovered at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority�s report due to Disability.; Sender''s Comments: This case concerns a 26-year-old, female patient with no medical history reported, who experienced the unexpected serious event of eye oedema on the next day after the booster (third) dose of mRNA-1273 vaccine. The event eye oedema resolved one day after and on the third day after vaccination the patient experienced the unexpected serious event of blindness, reported as started losing sight to my right eye, which had not recovered at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority�s report due to Disability.


VAERS ID: 1970110 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1008A / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Immunisation, Pain in extremity, Ultrasound Doppler
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: echo; Result Unstructured Data: Test Result:complete, left popliteal DVT
CDC Split Type: ITPFIZER INC202101762476

Write-up: ECHO: complete left popliteal DVT; onset of pain and swelling of the left calf 10 days after the vaccination; booster; This is a spontaneous report received from a contactable Physician from a Regulatory Authority. Regulatory number: IT-MINISAL02-817980. A 83 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 20Nov2021 13:22 (Lot number: 1F1008A) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication included: FLUAD TETRA taken for influenza immunisation, administration date 20Nov2021 13:20. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for covid-19 immunization; Covid-19 vaccine (dose 2, manufacturer unknown), for covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "booster"; DEEP VEIN THROMBOSIS (medically significant) with onset 27Nov2021, outcome "not recovered", described as "ECHO: complete left popliteal DVT"; PAIN IN EXTREMITY (medically significant) with onset 27Nov2021, outcome "not recovered", described as "onset of pain and swelling of the left calf 10 days after the vaccination". The patient underwent the following laboratory tests and procedures: ultrasound doppler: complete, left popliteal dvt. Therapeutic measure was taken as a result of deep vein thrombosis, pain in extremity with low molecular weight heparin. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1970210 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Body temperature, Body temperature increased, Fatigue, Headache, Malaise, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: body temperature; Result Unstructured Data: Test Result:37.5 to 38 Centigrade
CDC Split Type: NLPFIZER INC202101744263

Write-up: pain in heart area; Nausea; Myalgia; Headache; Fatigue; Malaise; body temperature increased: 37.5 to 38 degrees Celcius; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Agency Regulatory Authority-WEB. Regulatory number: NL-LRB-00721299 Regulatory Authority. A 35-year-old male patient received bnt162b2 (COMIRNATY, 0.3 ml), administration date 20Nov2021 (Lot number: FG6273) at the age of 35 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient had no previous COVID-19 infection. The following information was reported: ANGINA PECTORIS (medically significant) with onset 22Nov2021, outcome "not recovered", described as "pain in heart area"; NAUSEA (non-serious) with onset 21Nov2021, outcome "recovering", described as "Nausea"; MYALGIA (non-serious) with onset 21Nov2021, outcome "recovering", described as "Myalgia"; HEADACHE (non-serious) with onset 20Nov2021, outcome "recovered" (22Nov2021), described as "Headache"; FATIGUE (non-serious) with onset 20Nov2021, outcome "not recovered", described as "Fatigue"; MALAISE (non-serious) with onset 20Nov2021, outcome "not recovered", described as "Malaise"; BODY TEMPERATURE INCREASED (non-serious) with onset 20Nov2021, outcome "recovering", described as "body temperature increased: 37.5 to 38 degrees Celcius". The patient underwent the following laboratory tests and procedures: body temperature: (21Nov2021) 37.5 to 38. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1970251 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Computerised tomogram, Echocardiogram, Fibrin D dimer, Pericarditis, Troponin I, Troponin T
SMQs:, Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: Computerised tomogram; Result Unstructured Data: Test Result:no alterations; Test Date: 20211120; Test Name: Echocardiogram; Result Unstructured Data: Test Result:normal; Test Date: 20211120; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:8000; Test Date: 20211120; Test Name: Troponin I; Result Unstructured Data: Test Result:normal; Test Date: 20211120; Test Name: Troponin T; Result Unstructured Data: Test Result:normal
CDC Split Type: PTPFIZER INC202101734203

Write-up: Pericarditis; Chest pain with progressive worsening; chest pain with progressive worsening; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Agency WEB. Regulatory number: PT-INFARMED-J202111-1795 (RA). A 34 year-old female patient received bnt162b2 (COMIRNATY, Pharmaceutical form: Concentrate for injectable dispersion), intramuscular, administration date 19Nov2021 (Lot number: EL1491) as dose 3 (booster) (also reported as: Dose number 0.9 mL), 0.3 ml single for COVID-19 immunisation. The patient''s relevant medical history was not reported. No history of allergies. The patient has no previous major disease, no cardiac history, no autoimmune or inflammatory disease, no acute myocardial infarction or oncological history, patient was healthy to date. No history of infections (bacterial, fungal or viral). A history of adverse reaction to any drug is unknown. Concomitant medications was none. Vaccination history included: COMIRNATY(First dose Lot EJ6797), administration date: 30Dec2020, for COVID-19 immunization and experienced no adverse event; and then COMIRNATY(Second dose EL1491), administration date: 20Jan2021, for COVID-19 immunization and experienced reactions myalgia and asthenia, mild reaction after second dose of vaccine. The following information was reported: The adverse reaction referred to in this notification (pericarditis) appeared the next day (20Nov2021) after taking the third dose of the suspected vaccine. Patient had to go the emergency department and specific treatment with ibuprofen 600 mg and colchicine was administered (Under Ibuprofen 600 3i and colchicine 1/2+0+1/). The patient took the 3rd dose of the vaccine in the morning and the day after, by the end of the afternoon, had chest pain with progressive worsening, so she went to the emergency department, and pericarditis was diagnosed. The patient underwent the following laboratory tests and procedures: computerised tomogram with result no alterations; echocardiogram with result normal and fibrin D dimer with result 8000; Troponin I with result normal; Troponin T with result normal; all on 20Nov2021. The suspected pericarditis remains in recovery. Outcome of event: In recovery. The reporter''s assessment of the causal relationship of the events Pericarditis, Chest pain and Chest pain aggravated with the suspect product was: Source of assessment: Reporter, Method of assessment: Unknown, Result of Assessment: Probable. Reporter Comment: Concomitant-no Medication Medication Error occurred?-no Other Information-Healthy, No history of Allergies Mild reaction after second dose of vaccine 3rd dose COVID vaccine on 19Nov2021 in the morning. Late afternoon of the 20, chest pain with progressive worsening. She went to the Emergency Unit and diagnosed with pericarditis. Under Ibuprofen 600 3i and colchicine 1/2+0+1/ No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Concomitant-no Medication Medication Error occurred?-no Other Information-Healthy, No history of Allergies Mild reaction after second dose of vaccine 3rd dose COVID vaccine on 19Nov2021 in the morning. Late afternoon of the 20, chest pain with progressive worsening. She went to the Emergency Unit and diagnosed with pericarditis. Under Ibuprofen 600 3i and colchicine 1/2+0+1/


VAERS ID: 1970308 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-12
Onset:2021-11-20
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214029 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis, Seizure, Wrong product administered
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Epilepsy (Convulsive disease after OP tumor Cerebri); Glioma (Cytostaticabeh for Glioma)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20214

Write-up: RECEIVED VACCINATION WITH MODERN ACCIDENTALLY INSTEAD OF PFIZER (BORN AFTER WHEN MODERN SHOULD NOT BE GIVEN).; CONVULSIONS; MYOCARDITIS; This case was received regulatory authority (Reference number: SE-MPA-2021-095399) on 13-Dec-2021 and was forwarded to Moderna on 13-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of SEIZURE (CONVULSIONS), MYOCARDITIS (MYOCARDITIS) and WRONG PRODUCT ADMINISTERED (RECEIVED VACCINATION WITH MODERN ACCIDENTALLY INSTEAD OF PFIZER (BORN AFTER WHEN MODERN SHOULD NOT BE GIVEN). ) in a 28-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214029) for COVID-19 vaccination. Concurrent medical conditions included Epilepsy (Convulsive disease after OP tumor Cerebri) and Glioma (Cytostaticabeh for Glioma). On 12-Nov-2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced SEIZURE (CONVULSIONS) (seriousness criteria medically significant and life threatening) and MYOCARDITIS (MYOCARDITIS) (seriousness criteria medically significant and life threatening). On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (RECEIVED VACCINATION WITH MODERN ACCIDENTALLY INSTEAD OF PFIZER (BORN AFTER WHEN MODERN SHOULD NOT BE GIVEN). ) (seriousness criterion life threatening). At the time of the report, SEIZURE (CONVULSIONS), MYOCARDITIS (MYOCARDITIS) and WRONG PRODUCT ADMINISTERED (RECEIVED VACCINATION WITH MODERN ACCIDENTALLY INSTEAD OF PFIZER (BORN AFTER WHEN MODERN SHOULD NOT BE GIVEN). ) was resolving. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. No treatment medication was provided.; Sender''s Comments: This case concerns a 28-year-old, female patient with relevant medical history of epilepsy and glioma, who experienced the unexpected events of Seizure and Wrong Product Administered, and expected event of Myocarditis. The events occurred approximately 9 days after the third dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as events occurred after third dose. This patient''s underlying medical conditions remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.


VAERS ID: 1972433 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCKX7 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Myocarditis, Pericardial effusion
SMQs:, Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: DEPFIZER INC202101753818

Write-up: Perimyocarditis; Pericardial effusion; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: DE-PEI-CADR2021209194 (RA). Other Case identifier(s): DE-CADRPEI-2021209194 (RA Webportal), DE-PEI-202100260369 (RA). A 52 year-old male patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: SCKX7) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1. Primary Immunization series complete but unknown manufacturer.), for COVID-19 immunisation; Covid-19 vaccine (Dose 2. Primary Immunization series complete but unknown manufacturer.), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; MYOCARDITIS (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Perimyocarditis"; PERICARDIAL EFFUSION (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Pericardial effusion". Additional information: Dose number 3, unit DF. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1972589 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Hypertension, Immunisation, Interchange of vaccine products, Malaise, Off label use, Palpitations
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Cardiomyopathy (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: KARDEGIC; DOLIPRANE; MONO TILDIEM; ALDACTONE [SPIRONOLACTONE]; OESTRODOSE; MAGNESIUM; UTROGESTAN
Current Illness: Allergy (Allergy to product of cardiac scintigraphy); Anginal syndrome; Arterial hypertension; Carotid artery atheroma; Nickel sensitivity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: Blood pressure increased; Result Unstructured Data: Test Result:20
CDC Split Type: FRPFIZER INC202101762149

Write-up: Off label use; Interchange of vaccine products; Booster; Arterial hypertension; Palpitations; Malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. The reporter is the patient. Regulatory number: -AFSSAPS-LY202113026. A 66 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arterial hypertension" (ongoing); "Allergy" (ongoing), notes: Allergy to product of cardiac scintigraphy; "Carotid artery atheroma" (ongoing); "Anginal syndrome" (ongoing); "Nickel sensitivity" (ongoing). The patient had no history of COVID-19. Concomitant medication(s) included: KARDEGIC; DOLIPRANE; MONO TILDIEM; ALDACTONE [SPIRONOLACTONE]; OESTRODOSE; MAGNESIUM; UTROGESTAN. Vaccination history included: Vaxzevria (DOSE 1), administration date: Mar2021, for COVID-19 immunization; Vaxzevria (DOSE 2), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; HYPERTENSION (medically significant) with onset 20Nov2021, outcome "recovered", described as "Arterial hypertension"; PALPITATIONS (medically significant) with onset 20Nov2021, outcome "recovered", described as "Palpitations"; MALAISE (medically significant) with onset 20Nov2021, outcome "recovered" (22Nov2021), described as "Malaise". The patient reported having presented shortly after injection: hypertension, palpitations, malaise for 2 days. Hypertension at 20 (as reported), despite treatment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1972769 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Chest pain, Dyspnoea, Fatigue, Inappropriate schedule of product administration, Palpitations, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101758862

Write-up: Chest pain; First dose of COMIRNATY on 14Aug2021, second dose on 20Nov2021; Heart and chest pain every day; Fatigue/unusual tiredness; Shortness of breath; Heart palpitations; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112070937443580-XQJNI (RA). Other Case identifier(s): GB-MHRA-ADR 26297858 (RA). A 31 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK9413) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, SINGLE), administration date: 14Aug2021, for COVID-19 immunisation. The patient was not pregnant and was not breastfeeding at the time of this report and her last menstrual period was on 03Dec2021. The patient not had symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient had not been tested positive for COVID-19 since having the vaccine. The following information was reported: CHEST PAIN (medically significant) with onset 27Nov2021, outcome "not recovered", described as "Chest pain"; ANGINA PECTORIS (medically significant) with onset 2021, outcome "unknown", described as "Heart and chest pain every day"; FATIGUE (medically significant) with onset 2021, outcome "unknown", described as "Fatigue/unusual tiredness"; DYSPNOEA (medically significant) with onset 2021, outcome "unknown", described as "Shortness of breath"; PALPITATIONS (medically significant) with onset 2021, outcome "unknown", described as "Heart palpitations"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 20Nov2021, outcome "unknown", described as "First dose of COMIRNATY on 14Aug2021, second dose on 20Nov2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. The report of the patient was related to possible inflammation of the heart (myocarditis or pericarditis). The symptoms did not lead to hospital stay. It was unknown whether any blood tests conducted for symptoms but no imaging like X-ray, echocardiogram were carried out. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1972958 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster, Immunisation, Interchange of vaccine products, Off label use, Pain, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response)); Pulmonary fibrosis; Rheumatoid arthritis; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101758683

Write-up: Shingles; Skin rash; Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY; Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY; Booster: dose number 3; Sore; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112081510356950-T1DOV (MHRA). Other Case identifier(s): GB-MHRA-ADR 26308498 (MHRA). A 68 year-old male patient received bnt162b2 (COMIRNATY, reported as COVID-19 MRNA VACCINE BIONTECH), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Immunodeficiency" (unspecified if ongoing), notes: Taking other treatments or medicines, not listed above, known to lower the immune response); "Steroid therapy" (unspecified if ongoing), notes: Taking regular steroid treatment (e.g. orally or rectally); "Pulmonary fibrosis" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 2, SINGLELot number: Unknown Route of Administration: Unspecified,Non-Pfizer manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, SINGLELot number: Unknown Route of Administration: Unspecified,Non-Pfizer manufacturer), for COVID-19 immunisation. The patient had no symptoms associated with COVID-19. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 20Nov2021, outcome "unknown" and all described as "Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster: dose number 3"; HERPES ZOSTER (medically significant) with onset 27Nov2021, outcome "recovering", described as "Shingles"; RASH (medically significant) with onset 27Nov2021, outcome "recovering", described as "Skin rash"; PAIN (medically significant) with onset 2021, outcome "unknown", described as "Sore". The events "shingles", "skin rash" and "sore" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Sep2021) no - negative covid-19 test. Therapeutic measures were taken as a result of herpes zoster, rash, pain. The clinical course was reported as follows: after having the booster of Pfizer, on 27Nov2021, the patient had a rash which came out around the injection site, which then started to spread down his arm and was very angry and sore. The patient contacted the GP who diagnosed him with shingles. The patient also added that he asked GP if it was a result of the booster and the GP replied that it could be just a coincidence, the GP put the patient on drugs for it and slowly began to feel better and it had been 2 weeks. The patient had not tested positive for COVID-19 since having the vaccine, Patient is not enrolled in clinical trial. It was reported that the relevant investigations included that the doctor had asked the patient to see him at the surgery. Therapeutic measure were taken as a result of skin rash, shingles and sore. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1973004 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary mass, Hypokinesia, Immunisation, Influenza like illness, Interchange of vaccine products, Off label use, Pain
SMQs:, Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Flu
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101768508

Write-up: flu like symptoms; Ache; Off label use; interchange of vaccine product; booster; lump; This increased in size to be large enough to inhibit movement maybe as large as a golf ball.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202112082007037320-COHMA (MHRA). Other Case identifier(s): GB-MHRA-ADR 26310727 (MHRA). A 62 year-old male patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH4751) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Influenza" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VIRUS. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE: 01), administration date: 03Mar2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (DOSE: 02), administration date: 19May2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant, medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant, medically significant) with onset 20Nov2021, outcome "unknown", described as "interchange of vaccine product"; IMMUNISATION (medically significant, medically significant) with onset 20Nov2021, outcome "unknown", described as "booster"; INFLUENZA LIKE ILLNESS (medically significant, medically significant) with onset 21Nov2021, outcome "recovered" (22Nov2021), described as "flu like symptoms"; PAIN (medically significant, medically significant) with onset 21Nov2021, outcome "recovered" (22Nov2021), described as "Ache"; AXILLARY MASS (medically significant, medically significant) with onset 2021, outcome "recovered" (2021), described as "lump"; HYPOKINESIA (medically significant) with onset 2021, outcome "recovered" (2021), described as "This increased in size to be large enough to inhibit movement maybe as large as a golf ball.". Therapeutic measures were taken as a result of axillary mass, hypokinesia. Clinical course as By next day these symptoms had cleared but then had a notable underarm lump. This increased in size to be large enough to inhibit movement maybe as large as a golf ball. Took loratadine, swelling started reducing within a couple of hours and was gone in two days. No reaction at all to AstraZeneca vaccinations or indeed flu vaccine. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No reaction at all to astrazenica vaccinations or indeed flu vaccine. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis).Details of any relevant investigations or tests conducted as None. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1973038 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Myalgia, Psoriasis, SARS-CoV-2 test, Skin disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN [ACETYLSALICYLIC ACID]; ETODOLAC; LEVOCETIRIZINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101768933

Write-up: Patient received third dose of Comirnaty on 20Nov2021; Skin condition/patch came back behind my ear, noticed it on my eyelid; Within a week or two/muscle pain; Psoriasis; This is a spontaneous report received from a contactable reporter (Consumer) from The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112082348597230-1POBS (MHRA). Other Case identifier(s): GB-MHRA-ADR 26311040 (MHRA). A 36 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH4751) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history was not reported. Date of last menstrual period: 28Nov2021. Patient had not tested positive for COVID-19 since having the vaccine, was not enrolled in clinical trial, not had symptoms associated with COVID-19. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] taken for limb injury; ETODOLAC taken for dysmenorrhoea; LEVOCETIRIZINE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot number: Unknown), administration date: 19Jan2021, for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE, Batch/Lot number: Unknown), administration date: 31Mar2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Patient received third dose of Comirnaty on 20Nov2021"; SKIN DISORDER (medically significant) with onset 2021, outcome "unknown", described as "Skin condition/patch came back behind my ear, noticed it on my eyelid"; MYALGIA (medically significant) with onset 2021, outcome "unknown", described as "Within a week or two/muscle pain"; PSORIASIS (medically significant) with onset 2021, outcome "recovered with sequelae" (2021), described as "Psoriasis". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, no - negative COVID-19 test. Clinical course: The patient first received the vaccine in January 2021. She had developed some skin condition on the back of my ears, but since she thought she had a reaction to shampoo change she didn''t think about it much. But it didn''t go away and then she noticed some patches on her eyelid. She was not exactly sure whether the back of her ear happened before or after the first dose, but on her eye it was definitely after the vaccine. She was seen by dermatology and prescribed medication (cream) which cleared it. It was completely gone. She received her booster dose less than 20 days ago. Within a week or two, the patch came back behind her ear and noticed it on her eyelid. She strongly believed that the vaccine triggered it. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis) No follow-up attempts are possible. No further information is expected.


VAERS ID: 1973039 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac flutter, Immunisation, Interchange of vaccine products, Myocarditis, Off label use, Pericarditis, SARS-CoV-2 test
SMQs:, Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Chronic kidney disease (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101768931

Write-up: Patient received third dose of Comirnaty on 20Nov2021; Patient received third dose of Comirnaty on 20Nov2021; Patient received third dose of Comirnaty on 20Nov2021; Heart fluttering; Myocarditis; Pericarditis; This is a spontaneous report received from a contactable reporter (Consumer) from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202112090009542490-G6L4O (MHRA). Other Case identifier(s): GB-MHRA-ADR 26311039 (MHRA). A female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient had not tested positive for COVID-19 since having the vaccine, was not enrolled in clinical trial, not had symptoms associated with COVID-19. Vaccination history included: COVID-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; COVID-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 20Nov2021, outcome "unknown" and all described as "Patient received third dose of Comirnaty on 20Nov2021"; CARDIAC FLUTTER (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Heart fluttering"; MYOCARDITIS (medically significant) with onset 2021, outcome "unknown", described as "Myocarditis"; PERICARDITIS (medically significant) with onset 2021, outcome "unknown", described as "Pericarditis". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative COVID-19 test. The report relates to possible inflammation of the heart (myocarditis or pericarditis) No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1973108 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Hypoaesthesia oral, Immunisation, Interchange of vaccine products, Nausea, Off label use, Pharyngeal swelling, Rash, SARS-CoV-2 test, Swelling face
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FEXOFENADINE; LETROZOLE; ZOLADEX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer; Fatigue; Immune system disorder; Uveitis
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101768626

Write-up: Off label use; Interchange of vaccine products; Booster; Rash; Throat swelling NOS; Numb lips; Swelling face; Nausea; Shoulder pain; Lightheadedness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202112091611229040-BFSSN (MHRA). Other Case identifier(s): GB-MHRA-ADR 26313760 (MHRA). A 48 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing); "Fatigue" (unspecified if ongoing); "overactive immune system" (unspecified if ongoing); "chronic Bi-lateral Uveitis" (unspecified if ongoing). Concomitant medication(s) included: FEXOFENADINE; INFLUENZA VIRUS, administration date 21Oct2021; LETROZOLE; ZOLADEX. Past drug history included: Dtpa ipv vaccine. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1, Lot number: Not known), administration date: 11Feb2021, for Covid-19 immunization; Covid-19 vaccine astrazeneca (Dose 2, Lot number: Not known), administration date: 06May2021, for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; RASH (medically significant) with onset 20Nov2021, outcome "recovered" (2021), described as "Rash"; PHARYNGEAL SWELLING (medically significant) with onset 20Nov2021, outcome "recovered with sequelae", described as "Throat swelling NOS"; HYPOAESTHESIA ORAL (medically significant) with onset 20Nov2021, outcome "recovered", described as "Numb lips"; SWELLING FACE (medically significant) with onset 20Nov2021, outcome "recovered" (2021), described as "Swelling face"; NAUSEA (medically significant) with onset 20Nov2021, outcome "recovered with sequelae", described as "Nausea"; ARTHRALGIA (medically significant) with onset 20Nov2021, outcome "recovered with sequelae", described as "Shoulder pain"; DIZZINESS (medically significant) with onset 20Nov2021, outcome "recovered" (2021), described as "Lightheadedness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of rash, pharyngeal swelling, swelling face, nausea. Clinical course: Patient last menstrual period date was provided as 10Jan20217. Patient did not had symptoms associated with COVID-19 and was unsure if enrolled in clinical trial, not pregnant and was not currently breastfeeding. Patient had a history of breast cancer. Patient have an overactive immune system which means her body can react from anything including oranges, and fatigue. Patient had chronic Bi-lateral Uveitis. It was reported that patient had Immediate reaction to the vaccine booster, Rash and swelling in throat area. Saw medic at the booster centre. Patient was on permanent antihistamines and was told this may have kept the reaction down. After half an hour light-headedness, swelling in face and numb lips. This went down over the course of the day. Pain in right shoulder and nausea was present for over 10 days. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1973124 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Agitation, Back pain, Immunisation, Interchange of vaccine products, Lymphadenopathy, Malaise, Off label use, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Medication errors (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: Acid reflux (esophageal); Stomach ulcer
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101768558

Write-up: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority RA). Regulatory number: GB-MHRA-WEBCOVID-202112091848086130-1Q69J (RA). Other Case identifier(s): GB-MHRA-ADR 26314011 (RA). A 54 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Stomach ulcer" (unspecified if ongoing); "various acid reflux issues" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; MALAISE (medically significant), outcome "unknown", described as "unwell"; LYMPHADENOPATHY (medically significant) with onset 22Nov2021, outcome "recovered", described as "Glands swollen"; AGITATION (medically significant) with onset 22Nov2021, outcome "recovered", described as "Agitation"; ABDOMINAL PAIN (medically significant) with onset 22Nov2021, outcome "recovered with sequelae", described as "Tummy ache"; BACK PAIN (medically significant) with onset 22Nov2021, outcome "recovered with sequelae", described as "Backache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: Patient felt very unwell for about a week with lasting pains in tummy and back. Patient was not currently breastfeeding. Patient has not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected..


VAERS ID: 1973144 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-20
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Liver function test, Off label use, Pruritus, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS; OMEGA-3 FISH OIL; VITAMIN B12; VITAMIN D; VITAMIN D3; ZOLPIDEM TARTRATE
Current Illness:
Preexisting Conditions: Chronic fatigue syndrome
Allergies:
Diagnostic Lab Data: Test Name: liver tested; Result Unstructured Data: Test Result: Unknown result; Comments: Had liver tested since booster; Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101768417

Write-up: Off label use; Interchange of vaccine products; booster; Itching/ Chronic itching in the night only for over 2 weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The Regulatory Authority number GB-MHRA-WEBCOVID-202112092041177520-XOQLA, Other Case identifier(s) GB-MHRA-ADR 26314357. A 51 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included ME/CFS (unspecified if ongoing). Concomitant medication(s) included INFLUENZA VIRUS taken for immunisation; OMEGA-3 FISH OIL; VITAMIN B12; VITAMIN D; VITAMIN D3; ZOLPIDEM TARTRATE. Vaccination history included Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization. Patient had not symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. The following information was reported OFF LABEL USE (medically significant), outcome unknown; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome unknown; IMMUNISATION (medically significant), outcome unknown; PRURITUS (medically significant) with onset 20Nov2021, outcome recovering. The patient underwent the following laboratory tests and procedures liver tested unknown result, Had liver tested since booster; COVID-19 virus test No - Negative COVID-19 test. Reporter that chronic itching in the night only for over 2 weeks after Pfizer booster. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1973374 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Hypertension, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Vestibular disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101734009

Write-up: numbness to face, hands and feet / numbness of hands, feet and face; feeling faint; hypertension; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority-WEB. Regulatory number: IE-HPRA-2021-087097 (HPRA). A 56 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH8469) at the age of 56 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (hospitalization, medically significant) with onset 20Nov2021, outcome "not recovered", described as "numbness to face, hands and feet / numbness of hands, feet and face"; DIZZINESS (hospitalization, medically significant) with onset 20Nov2021, outcome "not recovered", described as "feeling faint"; HYPERTENSION (hospitalization, medically significant) with onset 20Nov2021, outcome "not recovered", described as "hypertension". Clinical course: The patient was not taking any concomitant medication. Information regarding the patient''s medical history/concurrent conditions was not provided in the report. The patient was observed as treatment and transferred to hospital by ambulance, where she was admitted due to hypertension. At the time of reporting, the patient had not recovered. No follow-up attempts are possible. No further information is expected. Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.


VAERS ID: 1973388 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005294 / 2 - / OT

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

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

Write-up: Chest pain in the front and back exacerbated by the inspiration. The day before treated with 2 doses of Moderna COVID vaccine. Clinical diagnosis of suspected pericarditis.; Chest pain in the front and back exacerbated by the inspiration. The day before treated with 2 doses of Moderna COVID vaccine. Clinical diagnosis of suspected pericarditis.; Chest pain in the front and back exacerbated by the inspiration. The day before treated with 2 doses of Moderna COVID vaccine. Clinical diagnosis of suspected pericarditis.; This case was received via regulatory authority (Reference number: IT-MINISAL02-816790) on 14-Dec-2021 and was forwarded to Moderna on 14-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of CHEST PAIN (Chest pain in the front and back exacerbated by the inspiration. The day before treated with 2 doses of Moderna COVID vaccine. Clinical diagnosis of suspected pericarditis.), PAIN (Chest pain in the front and back exacerbated by the inspiration. The day before treated with 2 doses of Moderna COVID vaccine. Clinical diagnosis of suspected pericarditis.) and PERICARDITIS (Chest pain in the front and back exacerbated by the inspiration. The day before treated with 2 doses of Moderna COVID vaccine. Clinical diagnosis of suspected pericarditis.) in a 28-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005294) for COVID-19 immunisation. No Medical History information was reported. On 19-Nov-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced CHEST PAIN (Chest pain in the front and back exacerbated by the inspiration. The day before treated with 2 doses of Moderna COVID vaccine. Clinical diagnosis of suspected pericarditis.) (seriousness criterion medically significant), PAIN (Chest pain in the front and back exacerbated by the inspiration. The day before treated with 2 doses of Moderna COVID vaccine. Clinical diagnosis of suspected pericarditis.) (seriousness criterion medically significant) and PERICARDITIS (Chest pain in the front and back exacerbated by the inspiration. The day before treated with 2 doses of Moderna COVID vaccine. Clinical diagnosis of suspected pericarditis.) (seriousness criterion medically significant). At the time of the report, CHEST PAIN (Chest pain in the front and back exacerbated by the inspiration. The day before treated with 2 doses of Moderna COVID vaccine. Clinical diagnosis of suspected pericarditis.), PAIN (Chest pain in the front and back exacerbated by the inspiration. The day before treated with 2 doses of Moderna COVID vaccine. Clinical diagnosis of suspected pericarditis.) and PERICARDITIS (Chest pain in the front and back exacerbated by the inspiration. The day before treated with 2 doses of Moderna COVID vaccine. Clinical diagnosis of suspected pericarditis.) was resolving. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided Treatment information was not provided; Reporter''s Comments: pericarditis is only suspected and not confirmed. Not hospitalized patient.; Sender''s Comments: This case concerns a 28-year-old, male patient with no relevant medical history, who experienced the unexpected events of Chest Pain and .Pain; and expected event of Pericarditis. The events occurred approximately 2 days after the second dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as events occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.


VAERS ID: 1973644 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blindness, Vision blurred, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202101760413

Write-up: Vision blurred; Visual impairment; loss of central vision left eye; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: AEFI-A-051124. A 38 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VISION BLURRED (medically significant) with onset 20Nov2021 01:00, outcome "not recovered", described as "Vision blurred"; VISUAL IMPAIRMENT (medically significant) with onset 20Nov2021 01:00, outcome "not recovered", described as "Visual impairment"; BLINDNESS (medically significant) with onset 20Nov2021 01:00, outcome "not recovered", described as "loss of central vision left eye". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1973697 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-20
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: 20211129; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:180/100
CDC Split Type: PHPFIZER INC202101759121

Write-up: Increased Blood Pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300122891 (PHFDA). A 16 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 20Nov2021, outcome "recovered" (29Nov2021), described as "Increased Blood Pressure". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (29Nov2021) 180/100. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1974613 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood pressure decreased, Chills, Dizziness, Eating disorder, Fatigue, Headache, Malaise, Nausea, Pyrexia, Sleep disorder, Vaccination site pain, Vaccination site reaction
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Drug allergy (allergy to amoxycillin); Dust allergy; Lactose intolerance
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101762246

Write-up: Arthralgia; Blood pressure dropped; Injection site reaction; pain in injection arm; Shivering; Fever; Sleep disturbed; Headache; Fatigue; difficulty eating due to nausea; Nausea; Malaise; Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority-WEB. Regulatory number: BE-FAMHP-DHH-N2021-109693 Regulatory Authority. A 17-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), administration date 20Nov2021 (Lot number: FH8469) at the age of 17 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "dust mite allergy" (unspecified if ongoing); "lactose intolerance" (unspecified if ongoing); "drug allergy" (unspecified if ongoing), notes: allergy to amoxycillin. The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (first dose, lot/batch FG9019), administration date: 30Oct2021, for COVID-19 immunisation. The following information was reported: ARTHRALGIA (disability) with onset 20Nov2021, outcome "recovering", described as "Arthralgia"; BLOOD PRESSURE DECREASED (disability) with onset 20Nov2021, outcome "unknown", described as "Blood pressure dropped"; VACCINATION SITE REACTION (disability) with onset 20Nov2021, outcome "recovering", described as "Injection site reaction"; VACCINATION SITE PAIN (disability) with onset 20Nov2021, outcome "recovering", described as "pain in injection arm"; CHILLS (disability) with onset 20Nov2021, outcome "recovering", described as "Shivering"; PYREXIA (disability) with onset 20Nov2021, outcome "recovering", described as "Fever"; SLEEP DISORDER (disability) with onset 20Nov2021, outcome "unknown", described as "Sleep disturbed"; HEADACHE (disability) with onset 20Nov2021, outcome "recovering", described as "Headache"; FATIGUE (disability) with onset 20Nov2021, outcome "recovering", described as "Fatigue"; EATING DISORDER (disability) with onset 20Nov2021, outcome "recovering", described as "difficulty eating due to nausea"; NAUSEA (disability) with onset 20Nov2021, outcome "recovering", described as "Nausea"; MALAISE (disability) with onset 20Nov2021, outcome "recovering", described as "Malaise"; DIZZINESS (disability) with onset 20Nov2021, outcome "unknown", described as "Dizziness". Therapeutic measures were taken as a result of arthralgia, blood pressure decreased, vaccination site reaction, vaccination site pain, chills, pyrexia, sleep disorder, headache, fatigue, eating disorder, nausea, malaise, dizziness. Reporter Comment: Treatment: Dafalgan. Evolution of the ADR: Recovering ADR time relationship: The adverse effects started mostly on the night of Saturday 20 to Sunday 21. They are slowly fading. Absence from school Monday 22 and Tuesday 23. ADR description: Very disturbed sleep, fever flares, pain in injection arm, difficulty eating due to nausea, very severe fatigue, unable to attend class, drop in blood pressure, dizziness, No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Treatment: Dafalgan. Evolution of the ADR: Recovering ADR time relationship: The adverse effects started mostly on the night of Saturday 20 to Sunday 21. They are slowly fading. Absence from school Monday 22 and Tuesday 23. ADR description: Very disturbed sleep, fever flares, pain in injection arm, difficulty eating due to nausea, very severe fatigue, unable to attend class, drop in blood pressure, dizziness,


VAERS ID: 1974623 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Fatigue, Headache, Migraine, Myalgia, Nausea, Pain in extremity, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101762502

Write-up: Pain in the arm; Fatigue; Muscle pain; severe migraines; Fever; Joint pain; Stomach cramps; Headache; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority-WEB. Regulatory number: BE-FAMHP-DHH-N2021-109780 Regulatory Authority. A female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH8469) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, manufacturer unknown), for COVID-19 immunisation. The following information was reported: ABDOMINAL PAIN UPPER (disability) with onset 20Nov2021, outcome "recovered" (23Nov2021), described as "Stomach cramps"; HEADACHE (disability) with onset 20Nov2021, outcome "recovered" (23Nov2021), described as "Headache"; NAUSEA (disability) with onset 20Nov2021, outcome "recovered" (23Nov2021), described as "Nausea"; PAIN IN EXTREMITY (disability) with onset 21Nov2021, outcome "recovering", described as "Pain in the arm"; FATIGUE (disability) with onset 21Nov2021, outcome "recovering", described as "Fatigue"; MYALGIA (disability) with onset 21Nov2021, outcome "recovering", described as "Muscle pain"; MIGRAINE (disability) with onset 21Nov2021, outcome "recovering", described as "severe migraines"; PYREXIA (disability) with onset 21Nov2021, outcome "recovering", described as "Fever"; ARTHRALGIA (disability) with onset 21Nov2021, outcome "recovering", described as "Joint pain". Therapeutic measures were not taken as a result of abdominal pain upper, headache, nausea, pain in extremity, fatigue, myalgia, migraine, pyrexia, arthralgia. Reporter Comment: Evolution of the ADR - In the process of recovery ADR description - severe headache, stomach cramps, nausea for 3 days after the second dose Pain in the arm the first night No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Evolution of the ADR - In the process of recovery ADR description - severe headache, stomach cramps, nausea for 3 days after the second dose Pain in the arm the first night


VAERS ID: 1974797 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7369 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure abnormal, Blood pressure measurement, Chills, Headache, Hot flush, Immunisation, Migraine, Musculoskeletal stiffness, Myalgia, Nausea, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: Blood pressure; Result Unstructured Data: Test Result:not provided
CDC Split Type: BEPFIZER INC202101761971

Write-up: booster; Nausea; Shivering; Migraines; Stiffness; hot flashes; Headache; Myalgia; body aches; blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority-WEB. Regulatory number: BE-FAMHP-DHH-N2021-109818 Regulatory Authority. A 68 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FG7369) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (2nd dose, single, batch/lot number: EW4811), administration date: 09Apr2021, for COVID-19 immunisation; Covid-19 vaccine (1st dose, manufacturer unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (disability, medically significant) with onset 20Nov2021, outcome "unknown", described as "booster"; NAUSEA (disability, medically significant) with onset 20Nov2021, outcome "recovered" (23Nov2021), described as "Nausea"; CHILLS (disability, medically significant) with onset 20Nov2021, outcome "recovered" (23Nov2021), described as "Shivering"; MIGRAINE (disability, medically significant) with onset 20Nov2021, outcome "recovered" (23Nov2021), described as "Migraines"; MUSCULOSKELETAL STIFFNESS (disability, medically significant) with onset 20Nov2021, outcome "recovered" (23Nov2021), described as "Stiffness"; HOT FLUSH (disability, medically significant) with onset 20Nov2021, outcome "recovered" (23Nov2021), described as "hot flashes"; HEADACHE (disability, medically significant) with onset 20Nov2021, outcome "recovered" (23Nov2021), described as "Headache"; MYALGIA (disability, medically significant) with onset 20Nov2021, outcome "recovered" (23Nov2021), described as "Myalgia"; PAIN (disability, medically significant) with onset 20Nov2021, outcome "recovered" (23Nov2021), described as "body aches"; BLOOD PRESSURE ABNORMAL (disability, medically significant) with onset 20Nov2021, outcome "recovered" (23Nov2021), described as "blood pressure". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (20Nov2021) not provided. Therapeutic measures were taken as a result of nausea, chills, migraine, musculoskeletal stiffness, hot flush, headache, myalgia, pain, blood pressure abnormal. Reporter Comment: Treatment Yes Mint essential oil, dafalgan, Evolution of the ADR Recovered: 2 days, Situations Other: Composition of the vaccine ADR description - Migraines, blood pressure, nausea, body aches No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Treatment Yes Mint essential oil, dafalgan Evolution of the ADR Recovered: 2 days Situations Other: Composition of the vaccine ADR description - Migraines, blood pressure, nausea, body aches


VAERS ID: 1977685 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Headache, Injection site pain, Pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (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: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: pain; Light headedness; Pain injection site; Pain in arm; Headache; This case was received via RA (Reference number: GB-MHRA-ADR 26326934) on 14-Dec-2021 and was forwarded to Moderna on 14-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (pain), DIZZINESS (Light headedness), INJECTION SITE PAIN (Pain injection site), PAIN IN EXTREMITY (Pain in arm) and HEADACHE (Headache) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 21-Oct-2021 to 27-Oct-2021. On 20-Nov-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced DIZZINESS (Light headedness) (seriousness criterion medically significant), INJECTION SITE PAIN (Pain injection site) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (pain) (seriousness criterion medically significant). At the time of the report, PAIN (pain), PAIN IN EXTREMITY (Pain in arm) and HEADACHE (Headache) was resolving and DIZZINESS (Light headedness) and INJECTION SITE PAIN (Pain injection site) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Patient''s symptoms were pain in left arm (immediate) and rounds of light-headedness (later on 20/11). Pain in left arm spread from injection site to entire arm pain level was 7/10 for first three days and has now been at 4-5/10 up until now (the next 20 days). Light-headedness was quite severe for first three days, but still happens around twice a day at random. Headaches sometimes follow these rounds, regardless of level of stress or hydration. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Company comment This case concerns a 26-year-old patient of an unknown gender, with no reported medical history, who experienced the unexpected serious events of PAIN, DIZZINESS, INJECTION SITE PAIN, PAIN IN EXTREMITY and HEADACHE. The events occurred on the same day of the administration of the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 26-year-old patient of an unknown gender, with no reported medical history, who experienced the unexpected serious events of PAIN, DIZZINESS, INJECTION SITE PAIN, PAIN IN EXTREMITY and HEADACHE. The events occurred on the same day of the administration of the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1978280 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Electrocardiogram, Myocarditis, Pericarditis, Troponin
SMQs:, Anaphylactic reaction (broad), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:changes consistent with myopericarditis; Test Name: Troponin; Result Unstructured Data: Test Result:up to 192
CDC Split Type: NZPFIZER INC202101760416

Write-up: Myocarditis; Pericarditis; Chest discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Regulatory number: AEFI-A-051485 (AEFI Case Number). A 21 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (1st single dose), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (hospitalization, medically significant) with onset 20Nov2021 13:49, outcome "recovering", described as "Myocarditis"; PERICARDITIS (hospitalization, medically significant) with onset 20Nov2021 13:49, outcome "recovering", described as "Pericarditis"; CHEST DISCOMFORT (hospitalization) with onset 20Nov2021 13:49, outcome "recovering", described as "Chest discomfort". The patient underwent the following laboratory tests and procedures: electrocardiogram: changes consistent with myopericarditis; troponin: up to 192. Clinical course: It was reported that patient experienced pleuritic chest pain one day after getting his second COVID vaccination. He has been diagnosed with myopericarditis, requiring hospital admission. Troponin up to 192 with ECG changes consistent with myopericarditis. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1978317 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Cerebrovascular accident, Chest discomfort, Eye pain, Headache, Hypoaesthesia, Lethargy, Nausea, Palpitations, Paraesthesia, Speech disorder, Transient ischaemic attack, Vaccination site pain, Vision blurred
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Arthritis (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: stroke; Result Unstructured Data: Test Result:all clear; Test Name: tia red out; Result Unstructured Data: Test Result:all clear
CDC Split Type: NZPFIZER INC202101760470

Write-up: Hypoaesthesia; Injection site pain; Lethargy; Nausea; Paraesthesia/tingling in hand; Chest discomfort; heart racing; Speech disorder/complete loss of words/Couldn''t speak/struggling to put sentences together; complete Vision blurred; right eye pain; pain in elbow; Headache/sudden pain in head like when had vaccine /Instant headache 20 seconds after injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the patient. Regulatory number: AEFI-A-052558 (MedSafe AEFI Case Number). A 44 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: CHEST DISCOMFORT (medically significant), outcome "not recovered", described as "Chest discomfort"; HEADACHE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Headache/sudden pain in head like when had vaccine /Instant headache 20 seconds after injection"; HYPOAESTHESIA (medically significant), outcome "not recovered", described as "Hypoaesthesia"; VACCINATION SITE PAIN (medically significant), outcome "not recovered", described as "Injection site pain"; LETHARGY (medically significant), outcome "not recovered", described as "Lethargy"; NAUSEA (medically significant), outcome "not recovered", described as "Nausea"; PARAESTHESIA (medically significant), outcome "not recovered", described as "Paraesthesia/tingling in hand"; SPEECH DISORDER (medically significant) with onset 26Nov2021, outcome "not recovered", described as "Speech disorder/complete loss of words/Couldn''t speak/struggling to put sentences together"; VISION BLURRED (medically significant) with onset 26Nov2021, outcome "not recovered", described as "complete Vision blurred"; EYE PAIN (medically significant) with onset 20Nov2021, outcome "not recovered", described as "right eye pain"; ARTHRALGIA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "pain in elbow"; PALPITATIONS (medically significant) with onset 26Nov2021, outcome "not recovered", described as "heart racing". The patient underwent the following laboratory tests and procedures: cerebrovascular accident: all clear; transient ischaemic attack: all clear. Clinical course: The patient stated she had Instant headache 20 seconds after injection, right eye pain, tingling in hand, pain in elbow which disappeared but not fully by next day. 6 days after heart racing, complete blurred vision, sudden pain in head like when had vaccine and complete loss of words. Couldn''t speak. Now 3 days after that episode and struggling to put sentences together. Many tests. Stroke, tia red out, heart and armies checked all clear. Never had before. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1978383 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1015A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Breast pain, Chest pain, Computerised tomogram thorax, Inappropriate schedule of product administration, Pain in extremity, Paraesthesia, Pulmonary thrombosis, Ultrasound scan
SMQs:, Peripheral neuropathy (broad), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Lipodystrophy (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: EVRA; NUVARING
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: DT of the thorax; Result Unstructured Data: Test Result:confirmed 3-4 blood clots in the left lung; Test Name: ultrasound of the right arm; Result Unstructured Data: Test Result:confirmed 3-4 blood clots in the left lung
CDC Split Type: SEPFIZER INC202101776660

Write-up: buzzing; pressing sensations in the right forearm; The woman got terrible pain on the left side of her chest; terrible pain in her left side breasts; Blood clots (in left lung); Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare proefssional) from the WEB. Regulatory number: SE-MPA-2021-095960. Other Case identifier(s): SE-VISMA-1638634577704. A 28 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: 1F1015A) as DOSE 2, SINGLE for covid-19 immunization. The patient''s relevant medical history was not reported. Concomitant medication(s) included: EVRA, start date: 10Jun2021, stop date: 03Dec2021, 0.120 mg/0.015 mg per 24 hours 1 ring at 3 week intervals. Fourth week ring-free exactly 7 days via Vaginal; NUVARING, start date: 27Oct2020, stop date: 03Jun2021, 1 plaster was changed once a week for 3 weeks. Week 4 patch free exactly 7 days before menstruation via Cutaneous. Vaccination history included: Comirnaty (DOSE 1, batch/lot# FE4721), administration date: 21Sep2021, for COVID-19 immunisation. The following information was reported: PULMONARY THROMBOSIS (life threatening) with onset 27Nov2021, outcome "not recovered", described as "Blood clots (in left lung)"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (life threatening) with onset 20Nov2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; PARAESTHESIA (non-serious) with onset 27Nov2021, outcome "unknown", described as "buzzing"; PAIN IN EXTREMITY (non-serious) with onset 27Nov2021, outcome "unknown", described as "pressing sensations in the right forearm"; CHEST PAIN (non-serious) with onset 27Nov2021, outcome "unknown", described as "The woman got terrible pain on the left side of her chest"; BREAST PAIN (non-serious) with onset 27Nov2021, outcome "unknown", described as "terrible pain in her left side breasts". The events "blood clots (in left lung)" and "the woman got terrible pain on the left side of her chest" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram thorax: confirmed 3-4 blood clots in the left lung; ultrasound scan: confirmed 3-4 blood clots in the left lung. Therapeutic measures prescribed anticoagulants were taken as a result of pulmonary thrombosis, breast pain. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1978391 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-27
Onset:2021-11-20
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7898 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Spinal fluid sample; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: SEPFIZER INC202101785865

Write-up: Bell''s palsy; This is a spontaneous report received from a contactable consumer from the regulatory authority-WEB. Regulatory number: SE-MPA-2021-096944 (regulatory authority). Other Case identifier: SE-VISMA-1639007965527 (regulatory authority). A 14-year-old female patient received BNT162B2 (COMIRNATY), administration date 27Oct2021 (Lot number: FG7898) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Asthma" (ongoing). The patient''s concomitant medications were not reported. The following information was reported: BELL''S PALSY (hospitalization) with onset 20Nov2021, outcome "recovering", described as "Bell''s palsy". The patient underwent the following laboratory tests and procedures: csf test: unknown results. Therapeutic measures were taken as a result of bell''s palsy. Clinical course: a sudden half-sided facial paralysis occurred. Spinal fluid sample was taken to rule out lyme disease. The girl was put on cortisone treatment for 10 days. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1979671 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-20
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (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: FIPFIZER INC202101774505

Write-up: Palpitations/pounding heartbeat; This is a spontaneous report received from a contactable reporter (Consumer) from the WEB. The reporter is the patient. Regulatory number: FI-FIMEA-20217400. A 27 year-old male patient received BNT162B2 (COMIRNATY), administration date 17Nov2021 (Lot number: UNKNOWN) as dose number unknown, single for COVID-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (disability) with onset 20Nov2021, outcome "recovered with sequelae", described as "Palpitations/pounding heartbeat". According to the patient, he received the vaccine on the vaccination bus. Approximately 3?-4 days after the vaccination, He started having episodes of pounding heartbeat. The symptom appeared randomly, including when he was fully at rest. The episodes lasted from 5 minutes to 30 minutes. The patient stated that he''d never experienced similar symptoms before. No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1979831 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-11-20
   Days after vaccination:89
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, COVID-19 pneumonia, Chest X-ray, Oxygen saturation, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Chest x-ray; Result Unstructured Data: Test Result: abnormalities suggestive of COVID 19; Test Name: oxygen saturation; Result Unstructured Data: Test Result: between 88 and 91%; Test Date: 20211128; Test Name: oxygen saturation; Test Result: 95%; Test Date: 20211123; Test Name: Sars-Cov2 PCR test; Test Result: Positive; Comments: Delta variant positive.
CDC Split Type: FRPFIZER INC202101773486

Write-up: Vaccination failure; COVID-19 confirmed by positive COVID-19 test; COVID-19 pneumonitis; asthenia; fever; This is a spontaneous report received from a contactable reporter (Pharmacist) from the Regulatory Authority. The Regulatory Authority number FR-AFSSAPS-PB20217154. A 52-year-old female patient received bnt162b2 (COMIRNATY), administration date 23Aug2021 (Lot number: FF0688, Expiration Date: 31Oct2021) as dose 2, single, and administration date 02Aug2021 (Lot number: FE8235, Expiration Date: 30Nov2021) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported VACCINATION FAILURE (hospitalization, medically significant) with onset 23Nov2021, outcome not recovered; COVID-19 (hospitalization, medically significant) with onset 23Nov2021, outcome not recovered; COVID-19 PNEUMONIA (hospitalization) with onset 23Nov2021, outcome not recovered; ASTHENIA (medically significant) with onset 20Nov2021, outcome unknown; PYREXIA (medically significant) with onset 20Nov2021, outcome unknown. The patient was hospitalized for vaccination failure, covid-19, covid-19 pneumonia (start date: 24Nov2021). The events vaccination failure, covid-19 confirmed by positive covid-19 test, and covid-19 pneumonitis were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures chest x-ray (unspecified date) abnormalities suggestive of covid 19; oxygen saturation (unspecified date) between 88 and 91; (28Nov2021) 95%; sars-cov-2 test: (23Nov2021) positive, Delta variant positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, covid-19 pneumonia. Admission to the emergency room, the chest x-ray shows abnormalities suggestive of COVID 19 (frosted glass image), crazy paving, 25/30% impairment of the lung parenchyma. No pulmonary embolism. Put under oxygen 2 l/min. Initiation of treatment with dexamethasone 6 mg/day and lovenox 4000 IU/day. On 28Nov2021, increase in oxygen intake (4L/min) and Sa02 95%. In total, COVID19 pneumonia with oxygen frequency at 4L/min in a patient with no particular history with a complete vaccination schedule. On 15Dec2021, the Regulatory Authority provided the following results that included the investigation 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 lots FF0688 and FE8235. 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. Concluded that the reported defect was 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 causes were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1979885 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-20
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1006A / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Blood pressure measurement, Blood test, Deep vein thrombosis, Dyspnoea, Heart rate, Immunisation, Pulmonary embolism, Ultrasound Doppler
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211124; Test Name: Angiography; Result Unstructured Data: Test Result:bilateral pulmonary embolism in lobar branches; Comments: without signs of acute pulmonary heart disease.; Test Date: 20211120; Test Name: blood pressure; Result Unstructured Data: Test Result:170/80.; Test Date: 20211122; Test Name: Blood test; Result Unstructured Data: Test Result:D-DIMERS POSITIVE $g 0.60 ug/ml; Test Date: 20211122; Test Name: Blood test; Result Unstructured Data: Test Result:Troponin T (hyper-sensitive) 16 pg/mL; Test Date: 20211122; Test Name: Blood test; Result Unstructured Data: Test Result:N-Terminal pro-brain natriuretic peptide; Comments: (Brain Natriuretic Peptide) 383 pg/mL less than 125 pg/mL; Test Date: 20211120; Test Name: heart rate; Result Unstructured Data: Test Result:75 per minute; Test Name: Ultrasound Doppler; Result Unstructured Data: Test Result:deep sural and left femoral-popliteal thrombophleb; Comments: deep sural and left femoral-popliteal thrombophlebitis, accompanied by a probable pulmonary embolism; Test Name: Venous Doppler ultrasound of the lower limbs; Result Unstructured Data: Test Result:good patency and good respiratory modulation; Comments: good patency and good respiratory modulation of the proximal deep veins, the inferior vena cava and the bilateral iliac network
CDC Split Type: FRPFIZER INC202101773543

Write-up: Booster; Deep thrombophlebitis of the leg; Embolism pulmonary; dyspnoea; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: FR-AFSSAPS-RS20214072 (RA). A 81 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 15Nov2021 (Lot number: 1F1006A) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Past drug history included: Eliquis. Vaccination history included: Comirnaty (Left arm, Intramuscular injection, batch number: EP2166. No indication of poor tolerance.), administration date: 10Mar2021, for COVID-19 IMMUNISATION; Comirnaty (Left arm, Intramuscular injection, batch number: EW2239. No indication of poor tolerance.), administration date: 07Apr2021, for COVID-19 IMMUNISATION. The following information was reported: DEEP VEIN THROMBOSIS (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Deep thrombophlebitis of the leg"; PULMONARY EMBOLISM (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Embolism pulmonary"; DYSPNOEA (non-serious) with onset 20Nov2021, outcome "unknown", described as "dyspnoea"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster". The patient underwent the following laboratory tests and procedures: angiogram: (24Nov2021) bilateral pulmonary embolism in lobar branches, notes: without signs of acute pulmonary heart disease; blood pressure measurement: (20Nov2021) 170/80.; blood test: (22Nov2021) d-dimers positive greater than 0.60 ug/ml; (22Nov2021) troponin t (hyper-sensitive) 16 pg/ml; (22Nov2021) n-terminal pro-brain natriuretic peptide, notes: (Brain Natriuretic Peptide) 383 pg/mL less than 125 pg/mL; heart rate: (20Nov2021) 75 per minute; ultrasound doppler: (unspecified date) deep sural and left femoral-popliteal thrombophleb, notes: deep sural and left femoral-popliteal thrombophlebitis, accompanied by a probable pulmonary embolism; (unspecified date) good patency and good respiratory modulation, notes: good patency and good respiratory modulation of the proximal deep veins, the inferior vena cava and the bilateral iliac network. Clinical information: On 20Nov2021, 5 days after the booster injection 1, he described a swollen, painful left leg. Recent obstructive thrombophlebitis beginning in the lower third of the left leg on the fibulars at 2.5 mm calibre, the posterior tibials at 4.5 mm, the soleus at 6.5 mm, the medial gastrocnemius veins at 4 mm, the popliteus at 8.5 mm, the entire superficial femoral at 7.5 mm, thrombus slightly overflowing into the lumen of the common femoral at 10 mm. Good patency and compressibility of the common femoral, superficial femoral, popliteal, posterior tibial, fibular, anterior tibial, gastrocnemius and soleus veins, with good Doppler flow. The superficial venous network is permeable. Given the concomitant dyspnoea. Prescribed ELIQUIS at full dose for six months, combined with class III elastic compression. The recently taken blood test sample will be checked as regards the kidney and liver. A chest computed tomography angiography will be performed in the next few days and an ultrasound follow-up is planned for around 07Dec. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1979959 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4571 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Chest pain, Diarrhoea, Disease recurrence, Dizziness, Dyspnoea, Electrocardiogram, Fatigue, Immunisation, Interchange of vaccine products, Myocarditis, Off label use, Palpitations, Panic attack, Pericarditis, Troponin
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Chronic kidney disease (broad), Noninfectious diarrhoea (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; EVOREL CONTI
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Myocarditis (Patient previously was hospitalised with myocarditis)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood pressure; Result Unstructured Data: Test Result:normal; Test Date: 2021; Test Name: ECG; Result Unstructured Data: Test Result:normal; Test Date: 2021; Test Name: Troponin; Result Unstructured Data: Test Result:Awaiting results
CDC Split Type: GBPFIZER INC202101788927

Write-up: Diarrhoea; Panic attacks; Dizziness; Heart pounding; Dose 1 and Dose 2: AstraZeneca COVID vaccine and Dose 3: Pfizer COVID vaccine; Dose 1 and Dose 2: AstraZeneca COVID vaccine and Dose 3: Pfizer COVID vaccine; The patient received third (booster) dose of bnt162b2; myocarditis; myocarditis; possible inflammation of the heart (myocarditis or pericarditis); Fatigue/unusual tiredness; Chest pain; Shortness of breath; This is a spontaneous report received from a contactable reporter (Consumer) from the United Kingdom''s Medicines and Healthcare products Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112110826425360-LXB9B. Other Case identifier(s): GB-MHRA-ADR 26323082. A 56 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH4571) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "myocarditis" (unspecified if ongoing), notes: Patient previously was hospitalised with myocarditis. Patient did not have symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medications included: AMLODIPINE taken for hypertension; estradiol, norethisterone acetate (EVOREL CONTI), start date: 14Aug2021. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 2, SINGLE; Lot number: unknown), administration date: 20May2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (DOSE 1, SINGLE; Lot number: unknown), administration date: 14Mar2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 20Nov2021, outcome "unknown" and all described as "Dose 1 and Dose 2: AstraZeneca COVID vaccine and Dose 3: Pfizer COVID vaccine"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "The patient received third (booster) dose of bnt162b2"; MYOCARDITIS (medically significant), DISEASE RECURRENCE (medically significant) all with onset 2021, outcome "recovered" (2021) and all described as "myocarditis"; PERICARDITIS (medically significant) with onset 2021, outcome "unknown", described as "possible inflammation of the heart (myocarditis or pericarditis)"; DIZZINESS (medically significant) with onset 24Nov2021, outcome "recovering", described as "Dizziness"; PALPITATIONS (medically significant) with onset 24Nov2021, outcome "recovering", described as "Heart pounding"; PANIC ATTACK (medically significant) with onset 26Nov2021, outcome "recovered" (03Dec2021), described as "Panic attacks"; DIARRHOEA (medically significant) with onset 29Nov2021, outcome "recovered" (06Dec2021), described as "Diarrhoea"; FATIGUE (medically significant) with onset 2021, outcome "unknown", described as "Fatigue/unusual tiredness"; CHEST PAIN (medically significant) with onset 2021, outcome "unknown", described as "Chest pain"; DYSPNOEA (medically significant) with onset 2021, outcome "unknown", described as "Shortness of breath". The events "myocarditis", "possible inflammation of the heart (myocarditis or pericarditis)", "dizziness", "heart pounding", "panic attacks", "diarrhoea", "fatigue/unusual tiredness", "chest pain" and "shortness of breath" were evaluated at the physician office visit and emergency room visit. Patient previously was hospitalised with myocarditis, and both the ''acute'' symptoms and gradual recovery was very similar, although not as severe this time. Patient never previously experienced panic attacks, and they often had no obvious trigger; they seemed to have stopped as abruptly as they started. The report was related to possible inflammation of the heart (myocarditis or pericarditis). "An electrocardiogram (ECG) was performed by an ambulence crew but was normal. Blood pressure was normal." The symptoms did not lead to a hospital stay. There was a diagnosis made by a medical professional general practitioner (GP); believed symptoms were related to Covid vaccine booster, commented that she had had a number of patients experience reactions. Advice was given: "Just rest." The patient underwent the following laboratory tests and procedures: blood pressure in 2021: normal; electrocardiogram in 2021: normal; troponin in 2021: awaiting results. Patient did not have a COVID-19 test. Patient did not test positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1980208 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bone pain, Dehydration, Headache, Hyperhidrosis, Illness, Immunisation, Interchange of vaccine products, Muscle spasticity, Nausea, Off label use, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Osteonecrosis (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210921; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101788632

Write-up: The patient received the primary immunization series with non-Pfizer vaccine and received a third dose of bnt162b2; The patient received the primary immunization series with non-Pfizer vaccine and received a third dose of bnt162b2; The patient received booster dose of bnt162b2 vaccine; Fluid loss; Arm seized up; Achey bones; Sweats; Nausea; Headache; Sickness; Feverish; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112131544478650-BR1FE. Other Case identifier(s): GB-MHRA-ADR 26328581. A female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK0596) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient did not have symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Vaccination history included: Covid-19 vaccine (DOSE 2, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, manufacturer unknown), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 20Nov2021, outcome "unknown" and all described as "The patient received the primary immunization series with non-Pfizer vaccine and received a third dose of bnt162b2"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "The patient received booster dose of bnt162b2 vaccine"; NAUSEA (medically significant) with onset 2021, outcome "not recovered", described as "Nausea"; HEADACHE (medically significant) with onset 2021, outcome "not recovered", described as "Headache"; ILLNESS (medically significant) with onset 2021, outcome "not recovered", described as "Sickness"; PYREXIA (medically significant) with onset 2021, outcome "not recovered", described as "Feverish"; DEHYDRATION (medically significant) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "Fluid loss"; MUSCLE SPASTICITY (medically significant) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "Arm seized up"; BONE PAIN (medically significant) with onset 2021, outcome "unknown", described as "Achey bones"; HYPERHIDROSIS (medically significant) with onset 2021, outcome "unknown", described as "Sweats". When needle was taken out of her arm, she felt fluid run down her arm (inside) then her arm seized up and then within a few seconds it seemed to return to normal. She then had the usual illness she had after each jab, which was nausea, headache, sickness, achey bones, feverish. Then later she got sweats. She was usually like this for three days. she hoped she didn''t have to keep going through these illnesses caused by the jab and that had other ways of solving the problem. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Sep2021) no - negative covid-19 test. Patient did not test positive for COVID-19 since having the vaccine. Clinical course: The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1980464 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-20
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Lethargy, Myocarditis, Pericarditis, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202101760417

Write-up: Myocarditis; Pericarditis; Chest discomfort; Woke up 3 days after vaccine with chest pain.; Lethargy; Pyrexia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: AEFI-A-051514. A 30 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (1st single dose), for COVID-19 immunization. The following information was reported: MYOCARDITIS (hospitalization) with onset 20Nov2021 23:48, outcome "recovered" (2021), described as "Myocarditis"; PERICARDITIS (hospitalization) with onset 20Nov2021 23:48, outcome "recovered" (2021), described as "Pericarditis"; CHEST DISCOMFORT (hospitalization) with onset 20Nov2021 23:48, outcome "recovered" (2021), described as "Chest discomfort"; LETHARGY (hospitalization) with onset 20Nov2021 23:48, outcome "recovered" (2021), described as "Lethargy"; PYREXIA (hospitalization) with onset 20Nov2021 23:48, outcome "recovered" (2021), described as "Pyrexia". Clinical course: Date first reported on 25Nov2021. Seriousness was reported as Hospitalization. Reporter stated that: Woke up 3 days after vaccine with chest pain. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1981508 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004730 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: headache; Muscle pain; Fatigue; Rillingen; Joint Pain; Nausea; Feeling unwell; This case was received via regulatory authority (Reference number: BE-FAMHP-DHH-N2021-109613) on 14-Dec-2021 and was forwarded to Moderna on 14-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (headache), MYALGIA (Muscle pain), FATIGUE (Fatigue), CHILLS, ARTHRALGIA (Joint Pain), NAUSEA (Nausea) and MALAISE (Feeling unwell) in a 44-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004730) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced HEADACHE (headache) (seriousness criterion disability), MYALGIA (Muscle pain) (seriousness criterion disability), FATIGUE (Fatigue) (seriousness criterion disability), CHILLS (seriousness criterion disability), ARTHRALGIA (Joint Pain) (seriousness criterion disability), NAUSEA (Nausea) (seriousness criterion disability) and MALAISE (Feeling unwell) (seriousness criterion disability). At the time of the report, HEADACHE (headache), MYALGIA (Muscle pain), FATIGUE (Fatigue), CHILLS, ARTHRALGIA (Joint Pain), NAUSEA (Nausea) and MALAISE (Feeling unwell) had not resolved. No relevant medical history provided. Patient had taken paracetamol/ ibuprofen as treatment medication. No relevant concomitant medication information provided. This case concerns a 44-year-old male patient with no medical history, who experienced the unexpected serious events of Headache, Myalgia, Fatigue, Chills, Arthralgia, Nausea, and Malaise. The events were disabling to the patient as reported by the regulatory authority. The events occurred approximately one day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was reported as not applicable by the regulatory authority. No clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 44-year-old male patient with no medical history, who experienced the unexpected serious events of Headache, Myalgia, Fatigue, Chills, Arthralgia, Nausea, and Malaise. The events were disabling to the patient as reported by the regulatory authority. The events occurred approximately one day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was reported as not applicable by the regulatory authority. No clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1981533 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure decreased, Blood pressure measurement, Chills, Decreased appetite, Delirium febrile, Fatigue, Headache, Malaise, Myalgia, Nausea, Pain in extremity, Pyrexia, Vaccination site reaction
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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: DAFALGAN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: Blood pressure; Result Unstructured Data: Test Result:dropped
CDC Split Type: BEPFIZER INC202101779548

Write-up: Blood pressure dropped; Chills; Reaction at the injection site; Loss of appetite; Pain in the arm from the injection; Nausea; Headache; Muscle aches; Fever; Fatigue; Malaise; Energy loss; Delirium; This is a spontaneous report received from a contactable reporter (Consumer) from the Agency Regulatory Authority-WEB. Regulatory number: BE-FAMHP-DHH-N2021-110144 Regulatory Authority. Spontaneous COVID-19 report received by the Regulatory Authority on 29Nov2021. A 17-year-old male patient received BNT162B2 (COMIRNATY), administration date 20Nov2021 11:15 (Lot number: FH8469) at the age of 17 years as dose 2, single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication included: DAFALGAN. Vaccination history included: Comirnaty (1st dose, lot number: FG9019), administration date: 30Oct2021, for COVID-19 immunisation. The following information was reported: BLOOD PRESSURE DECREASED (disability) with onset 20Nov2021, outcome "unknown", described as "Blood pressure dropped"; CHILLS (disability) with onset 20Nov2021, outcome "unknown", described as "Chills"; VACCINATION SITE REACTION (disability) with onset 20Nov2021, outcome "unknown", described as "Reaction at the injection site"; DECREASED APPETITE (disability) with onset 20Nov2021, outcome "unknown", described as "Loss of appetite"; PAIN IN EXTREMITY (disability) with onset 20Nov2021, outcome "unknown", described as "Pain in the arm from the injection"; NAUSEA (disability) with onset 20Nov2021, outcome "unknown", described as "Nausea"; HEADACHE (disability) with onset 20Nov2021, outcome "unknown", described as "Headache"; MYALGIA (disability) with onset 20Nov2021, outcome "unknown", described as "Muscle aches"; PYREXIA (disability) with onset 20Nov2021, outcome "unknown", described as "Fever"; FATIGUE (disability) with onset 20Nov2021, outcome "unknown", described as "Fatigue"; MALAISE (disability) with onset 20Nov2021, outcome "unknown", described as "Malaise"; ASTHENIA (disability) with onset 20Nov2021, outcome "unknown", described as "Energy loss"; DELIRIUM FEBRILE (disability) with onset 20Nov2021, outcome "unknown", described as "Delirium". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (20Nov2021) dropped. Therapeutic measures were taken as a result of blood pressure decreased, chills, vaccination site reaction, decreased appetite, pain in extremity, nausea, headache, myalgia, pyrexia, fatigue, malaise, asthenia, delirium febrile. Reporter Comment: Treatment: Dafalgan 1g, Buscopan, Motilium, Vitamins and energizing ampoules (not specified). Evolution of the adverse drug reaction: Not reported. ADR time relationship: Quickly tired after exertion the following days for long term side effects, that''s the big question. ADR description: Vaccine received at 11:15am, high fever flare up overnight with "delirium", not the presence of mind to call for help, pain in injection arm. The next day and the 2 following days, fever flare-ups, nausea, loss of appetite, malaise, drop in blood pressure, chills, loss of energy.; Reporter''s Comments: Summary of Reporter Comment: Treatment received. Evolution not reported. ADR time relationship: Quickly tired after exertion the following days for long term side effects, that''s the big question. ADR description: Vaccine received at 11:15 am, high fever flare up overnight with "delirium", not the presence of mind to call for help, pain in injection arm. The next day and the 2 following days, fever flare-ups, nausea, loss of appetite, malaise, drop in blood pressure, chills, loss of energy.


VAERS ID: 1982262 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Electric shock sensation, Erythema, Flushing, Headache, Oedema, Pain in extremity, Pyrexia, Swelling face, Vaccination site erythema, Vaccination site pain, Vaccination site reaction, Vaccination site swelling, Vaccination site warmth
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LETROX
Current Illness: Allergy to insect sting (bee sting); Asthma; Drug allergy (some antibiotics, biosil, paralen); Food allergy (temporary, reoccuring); Numbness in hand (temporary, reoccurring occasional loss of sensation in the hands); Pollen allergy; RA; Spinal disorder (neurological problems with the cervical spine)
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylactic shock (once, to a bee sting); Thyroidectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC202101774061

Write-up: redness in arms and legs; redness in arms and legs; electric shock sensation in arms and legs; headache; low grade fever; pain of the upper extremity; injection site reactions: pain, swelling, redness, heat; injection site reactions: pain, swelling, redness, heat; injection site reactions: pain, swelling, redness, heat; injection site reactions: pain, swelling, redness, heat; redness of the face; facial swelling; dizziness; injection site reactions: pain, swelling, redness, heat; redness of arms and chest; swelling of arms and chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory authority-WEB. Regulatory number: CZ-CZSUKL-21012663 . A 55 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroidectomy" (not ongoing); "Numbness in hand" (ongoing), notes: temporary, reoccurring, occasional loss of sensation in the hands; "Anaphylactic shock" (not ongoing), notes: once, to a bee sting; "Food allergy" (ongoing), notes: temporary, reoccuring; "RA" (ongoing); "Pollen allergy" (ongoing); "Drug allergy" (ongoing), notes: some antibiotics, biosil, paralen; "Spinal disorder" (ongoing), notes: neurological problems with the cervical spine; "Allergy to insect sting" (ongoing), notes: bee sting; "Asthma" (ongoing). Concomitant medication(s) included: LETROX taken for thyroidectomy, start date: 2010. The following information was reported: ERYTHEMA (medically significant) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "redness of the face"; FLUSHING (medically significant), ERYTHEMA (medically significant) all with onset 22Nov2021, outcome "recovering" and all described as "redness in arms and legs"; ERYTHEMA (medically significant) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "redness of arms and chest"; OEDEMA (medically significant) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "swelling of arms and chest"; ELECTRIC SHOCK SENSATION (medically significant) with onset 22Nov2021, outcome "recovering", described as "electric shock sensation in arms and legs"; SWELLING FACE (medically significant) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "facial swelling"; DIZZINESS (non-serious) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "dizziness"; VACCINATION SITE REACTION (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 20Nov2021, outcome "recovering" and all described as "injection site reactions: pain, swelling, redness, heat"; HEADACHE (non-serious) with onset 21Nov2021, outcome "recovered" (25Nov2021), described as "headache"; PYREXIA (non-serious) with onset 21Nov2021, outcome "recovered" (21Nov2021), described as "low grade fever" (mild); PAIN IN EXTREMITY (non-serious) with onset 20Nov2021, outcome "recovered", described as "pain of the upper extremity". The events "redness of the face", "redness in arms and legs", "redness of arms and chest", "swelling of arms and chest", "electric shock sensation in arms and legs", "facial swelling", "redness in arms and legs", "dizziness", "injection site reactions: pain, swelling, redness, heat", "headache", "low grade fever", "pain of the upper extremity", "injection site reactions: pain, swelling, redness, heat", "injection site reactions: pain, swelling, redness, heat", "injection site reactions: pain, swelling, redness, heat" and "injection site reactions: pain, swelling, redness, heat" were evaluated at the physician office visit. Therapeutic measures were taken as a result of erythema, flushing, erythema, oedema, electric shock sensation, swelling face, erythema, vaccination site reaction, headache, pyrexia, pain in extremity, vaccination site erythema, vaccination site pain, vaccination site swelling, vaccination site warmth. The patient treated these adverse reactions with Xyzal and ice. Clinical course: During the night, there was great pain in the hand and the injection site, followed by redness and swelling of the face, chest, and both hands. After about an hour, the patient began to have very unpleasant electric shocks with redness in the hands and feet, which disappeared after a while. On day 4, the adverse reactions escalated and the patient visited a general practitioner, where she was given calcium into her veins. The patient was taking Zyrtec and Paralen for adverse reactions. On the 5th day, the adverse reactions did not subside, the headache still persisted, the swollen and red hand, the patient got calcium into her veins again. The patient was taking Zyrtec and Paralen for adverse reactions.On the 6th day, hand and head pain persisted, electrical attacks are only in the hands and not in the legs. The patient regained calcium in her veins. The patient regained calcium in her veins. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1982264 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN ACA6111 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Paraesthesia, Tinnitus
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hearing impairment (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: CZJNJFOC20211255827

Write-up: This spontaneous report received from a consumer by a Regulatory Authority (EVHUMAN Vaccines, CZ-CZSUKL-21013271) on 24-DEC-2021 and concerned a 61-year-old female, unknown race, and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: ACA6111 expiry: UNKNOWN) 1 dosage forms, 1 total, administered on 19-NOV-2021 for covid-19 immunization. (Dose number in series 1). No concomitant medications were reported. On 20-NOV-2021, the patient experienced tinnitus, and tingling feet/hands. The action taken with covid-19 vaccine was not applicable. The patient recovered from tinnitus, and tingling feet/hands on 20-NOV-2021. This report was serious (Other Medically Important Condition).


VAERS ID: 1982556 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7369 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Immunisation, Interchange of vaccine products, Malaise, Migraine, Off label use, Pyrexia, Vaccination site reaction
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Medication errors (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 INC202101779407

Write-up: Off label use; Interchange of vaccine products; Immunisation; Fatigue; Arthralgia; Headache; Malaise; Shivering; Fever; Migraine; Injection site reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer) from the regulatory agency-WEB. The reporter is the patient. Regulatory number: BE-FAMHP-DHH-N2021-110058. A 33 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FG7369) at the age of 33 years as dose 3(booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Vaxzevria (lot# ABW4805), administration date: 25May2021, for COVID-19 immunisation; Vaxzevria (lot# ABV5441), administration date: 01Mar2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Immunisation"; FATIGUE (disability) with onset 20Nov2021, outcome "recovering", described as "Fatigue"; ARTHRALGIA (disability) with onset 20Nov2021, outcome "recovering", described as "Arthralgia"; HEADACHE (disability) with onset 20Nov2021, outcome "recovering", described as "Headache"; MALAISE (disability) with onset 20Nov2021, outcome "recovering", described as "Malaise"; CHILLS (disability) with onset 20Nov2021, outcome "recovering", described as "Shivering"; PYREXIA (disability) with onset 20Nov2021, outcome "recovering", described as "Fever"; MIGRAINE (disability) with onset 20Nov2021, outcome "recovering", described as "Migraine"; VACCINATION SITE REACTION (disability) with onset 20Nov2021, outcome "recovering", described as "Injection site reaction". Therapeutic measures were taken as a result of fatigue, arthralgia, headache, malaise, chills, pyrexia, migraine, vaccination site reaction included Ibuprofen and Paracetamol. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1983204 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-01
Onset:2021-11-20
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blister, Crying, Pain, SARS-CoV-2 test, Skin necrosis, Skin ulcer
SMQs:, Severe cutaneous adverse reactions (narrow), Extravasation events (injections, infusions and implants) (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; COVID-19 MRNA VACCINE BNT162B2; PERINDOPRIL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Skin necrosis; Weepy; Pain; Leg ulcer; Blistering; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26338344) on 16-Dec-2021 and was forwarded to Moderna on 16-Dec-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of SKIN ULCER (Leg ulcer), BLISTER (Blistering), SKIN NECROSIS (Skin necrosis), CRYING (Weepy) and PAIN (Pain) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included AMLODIPINE from 21-Dec-2020 to an unknown date and PERINDOPRIL for Hypertension, TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) for an unknown indication. In November 2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced SKIN ULCER (Leg ulcer) (seriousness criteria disability and medically significant) and BLISTER (Blistering) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced SKIN NECROSIS (Skin necrosis) (seriousness criteria disability and medically significant), CRYING (Weepy) (seriousness criteria disability and medically significant) and PAIN (Pain) (seriousness criteria disability and medically significant). At the time of the report, SKIN ULCER (Leg ulcer) and BLISTER (Blistering) had not resolved and SKIN NECROSIS (Skin necrosis), CRYING (Weepy) and PAIN (Pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information was provided Flucloxacillin and heparinoid cream. No medical history was reported. Patient came in November (two days after having her vaccine) with a black rash on legs that looked like under skin bruising and bleeding. Reporter referred her to the GP as it looked like it could be a clot. Patient was checked by a GP and referred to a dermatologist for a biopsy. Flucloxacillin and heparinoid cream was given, but did not help. Since patient returned to the pharmacy, with big black ulcers on the legs that are weepy and burning to the touch. Reporter referred her urgently back to the GP or an A&E as it almosts looks like skin necrosis. Patient struggled to walk due to the pain and to sleep at night. Awaiting for results from further tests. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment: This case concerns a female patient of an unknown age with no previous relevant medical history reported, who experienced the serious unexpected events of Skin ulcer, Blister, Skin necrosis, Crying and Pain. The events of skin ulcer and blistering began two days after the third dose of COVID-19 Vaccine Moderna (mRNA-1273) and on an unknown date the patient developed skin necrosis, weepy and pain. It was reported that the patient was checked by a general practitioner and referred to a dermatologist for a biopsy and that Flucloxacillin and heparinoid cream was given, but the lesions didn''t resolved. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.; Sender''s Comments: This case concerns a female patient of an unknown age with no previous relevant medical history reported, who experienced the serious unexpected events of Skin ulcer, Blister, Skin necrosis, Crying and Pain. The events of skin ulcer and blistering began two days after the third dose of COVID-19 Vaccine Moderna (mRNA-1273) and on an unknown date the patient developed skin necrosis, weepy and pain. It was reported that the patient was checked by a general practitioner and referred to a dermatologist for a biopsy and that Flucloxacillin and heparinoid cream was given, but the lesions didn''t resolved. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.


VAERS ID: 1983516 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0114 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Hypomenorrhoea
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101773722

Write-up: HEADACHE; PERIOD STOPPED/HAD JUST STARTED PERIOD THE DAY BEFORE VACCINE AND IT STOPPED THE DAY AFTER I GOT IT; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority-WEB. Regulatory number: IE-HPRA-2021-087351 (HPRA). Other Case identifier(s): IE-HPRA-CVARR2021112622863 (HPRA). A 44 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FH0114) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), administration date: 22Oct2021, for COVID-19 immunization. The following information was reported: HEADACHE (medically significant) with onset 20Nov2021, outcome "unknown", described as "HEADACHE"; HYPOMENORRHOEA (medically significant) with onset 20Nov2021, outcome "unknown", described as "PERIOD STOPPED/HAD JUST STARTED PERIOD THE DAY BEFORE VACCINE AND IT STOPPED THE DAY AFTER I GOT IT". Clinical course: Patient reported that their period was always quite heavy for the first 3 days so it was highly unusual for it to stop suddenly like this. They were now afraid that this has affected their menstrual cycle. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1985426 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-20
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101789506

Write-up: Deep vein thrombosis; Pulmonary embolism; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 677791 (RA ADR#). A 45 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DEEP VEIN THROMBOSIS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Deep vein thrombosis"; PULMONARY EMBOLISM (medically significant) with onset 20Nov2021, outcome "unknown", described as "Pulmonary embolism". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1985972 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-13
Onset:2021-11-20
   Days after vaccination:280
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SULPIRIDE; GLICLAZIDE; DIGOXIN; METFORMIN; OLANZAPINE; AMLODIPINE; PANTOPRAZOLE; LEVEMIR; NEBIVOLOL
Current Illness: Diabetes mellitus; Hypertension; Paranoid schizophrenia; Psoriasis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: EEPFIZER INC202101782675

Write-up: Vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Agency WEB and product quality group. Regulatory number: EE-SAM-63162111293 (RA). A 71-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 13Feb2021 (Lot number: EJ6789, Expiration Date: 31May2021) as dose 2, 0.3 ml single and administration date 21Jan2021 (Lot number: EJ6134) as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Psoriasis" (ongoing); "Hypertension" (ongoing); "Paranoid schizophrenia" (ongoing); "Diabetes mellitus" (ongoing). Concomitant medication(s) included: SULPIRIDE; GLICLAZIDE; DIGOXIN; METFORMIN; OLANZAPINE; AMLODIPINE; PANTOPRAZOLE; LEVEMIR; NEBIVOLOL. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant) with onset 20Nov2021, outcome "recovering", described as "Vaccination failure"; COVID-19 (hospitalization, medically significant) with onset 20Nov2021, outcome "recovering", described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Nov2021) positive. Clinical course: It was reported that the patient was vaccinated with the first and second dose of Comirnaty vaccine on 21Jan2021 and 13Feb2021, respectively. Nursing home patient. Developed febrile fevers, increased urination, weakness, and the patient could no longer go to the toilet. Low fluid intake. The patient did not complain about anything, after the interview he said that there was a cough for more than one day. SARS-CoV-2 test was positive on 20th November 2021, the patient was hospitalized on the same day. The patient did not need a supplemental oxygen, on the first day of subfebrile, further fever-free. Correction of treatment of comorbid conditions was required. As of 29Nov2021, the patient''s condition was improving. For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced ID resulted in the following conclusion: Reference ID # (see # File attachment in this investigation record) The complaint for LOE/adverse event of 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 EJ6789. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product. Health Authority Comments: Serious vaccine ineffectiveness report. The causal relationship is considered possible. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1986368 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Postmenopausal haemorrhage, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211128; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101788252

Write-up: Off label use; Interchange of vaccine products; Booster; Heavy periods; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112131106105040-RSMBU (RA). Other Case identifier(s): GB-MHRA-ADR 26327079 (RA). A 54 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: not known) as dose 3 (booster), single for covid-19 immunisation. Patient has not had symptoms associated with COVID-19. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), for Vaccination; Covid-19 vaccine astrazeneca (Dose 2), for Vaccination. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; HEAVY MENSTRUAL BLEEDING (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Heavy periods". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Nov2021) no - negative covid-19 test. Period despite despite being post menopause Patient has not tested positive for COVID-19 since having the vaccine Unsure if patient is enrolled in clinical trial Study details: Office of National Statistics. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1986612 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypersensitivity, Immunisation, Interchange of vaccine products, Lip swelling, Off label use, Rash, Swelling of eyelid, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Medication errors (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: Depression (On anti depressants)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101796516

Write-up: Allergy; Dose 1 and Dose 2: AstraZeneca Covid vaccine and Dose 3: Pfizer Covid vaccine; Dose 1 and Dose 2: AstraZeneca Covid vaccine and Dose 3: Pfizer Covid vaccine; Dose number 3; Swollen lips (very) and eye lids; Swollen lips (very) and eye lids; rash/hives all over body; rash/hives all over body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The Regulatory Authority number GB-MHRA-WEBCOVID-202112141213454980-VVIL0, other case identifiers GB-MHRA-ADR 26331774. A 56 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH4751) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included Depression (unspecified if ongoing), On antidepressants. The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient did not have a COVID-19 test. Concomitant medication(s) included INFLUENZA VIRUS taken for immunisation, administration date 09Oct2021. Vaccination history included Covid-19 vaccine astrazeneca (DOSE 2), administration date: 13May2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (DOSE 1), administration date: 21Feb2021, for COVID-19 immunisation. The following information was reported OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 20Nov2021, outcome unknown; IMMUNISATION (medically significant) with onset 20Nov2021, outcome unknown; HYPERSENSITIVITY (medically significant) with onset 22Nov2021, outcome recovered with sequelae (2021); LIP SWELLING (medically significant), SWELLING OF EYELID (medically significant) all with onset 2021, outcome unknown; RASH (medically significant), URTICARIA (medically significant) all with onset 2021, outcome unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1986698 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Immunisation, Insomnia, Interchange of vaccine products, Neck pain, Off label use, Pain in extremity, Periarthritis, SARS-CoV-2 test
SMQs:, Arthritis (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101796699

Write-up: Pain in my right arm; difficult to sleep; shoulder and neck pain; shoulder and neck pain; Off label use; Interchange of vaccine products; Booster; Frozen shoulder; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112141954110530-UPWNP (MHRA). Other Case identifier(s): GB-MHRA-ADR 26335104 (MHRA). A 64-year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK9413) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), administration date: 08Mar2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (Dose 2), administration date: 19May2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; PERIARTHRITIS (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Frozen shoulder"; PAIN IN EXTREMITY (medically significant), outcome "unknown", described as "Pain in my right arm"; INSOMNIA (medically significant), outcome "unknown", described as "difficult to sleep"; ARTHRALGIA (medically significant), NECK PAIN (medically significant), outcome "unknown" and all described as "shoulder and neck pain". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: negative, notes: No - Negative COVID-19 test. Clinical course: 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. Pain in her right arm had not subsided after vaccine, now painful and difficult to sleep, causing shoulder and neck pain. Relevant investigations or tests conducted: "none". Reaction report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1986703 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, SARS-CoV-2 test, Sinus headache
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: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101797057

Write-up: patient received third (booster) dose of BNT162b2; Headache sinus; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112142009285340-HOCOU. Other Case identifier(s): GB-MHRA-ADR 26335472. A 63 year-old patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "patient received third (booster) dose of BNT162b2"; SINUS HEADACHE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Headache sinus". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient had not tested positive for COVID-19 since having the vaccine. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1986733 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Immunisation, Menstrual disorder, Pain, 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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101796616

Write-up: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112142240356950-59PT0 (RA). Other Case identifier(s): GB-MHRA-ADR 26336541 (RA). A 31 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE-1, Similar experience following first two doses), for COVID-19 immunisation, reaction(s): "Extremely heavy and painful period"; Bnt162b2 (DOSE-2, Similar experience following first two doses), for COVID-19 immunisation, reaction(s): "Extremely heavy and painful period". The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; PAIN (medically significant) with onset 2021, outcome "not recovered", described as "pain"; MENSTRUAL DISORDER (medically significant) with onset 12Dec2021, outcome "not recovered", described as "Extremely heavy and painful period/Menstrual cycle abnormal"; DYSMENORRHOEA (medically significant) with onset 12Dec2021, outcome "recovering", described as "Pain menstrual/painful period". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: Extremely heavy and painful period. Similar experience following first two doses. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). Patient is not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. The patient LMP date reported as 12Dec2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1987306 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-20
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1016A / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Cardiovascular examination, Computerised tomogram thorax, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Emergency care examination, Fatigue, Fibrin D dimer, Heart rate, Hypokalaemia, Immunisation, Magnetic resonance imaging heart, Oxygen saturation, Palpitations
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypokalaemia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NACREZ
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac ablation (patient with remote ablation surgery for ventricular arrhythmia)
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: blood pressure; Result Unstructured Data: Test Result:rise (190/95); Test Date: 20211125; Test Name: cardiological examination; Result Unstructured Data: Test Result:a dubious outcome of myocardial pericarditis; Comments: in a patient with a previous ablation of VT and a finding of hypokalaemia; Test Date: 20211123; Test Name: Thorax CAT; Result Unstructured Data: Test Result:result unknown; Test Date: 20211126; Test Name: Doppler echocardiography; Result Unstructured Data: Test Result:result unknown; Test Name: ECG; Result Unstructured Data: Test Result:documented RS with normal repolarization; Test Date: 20211123; Test Name: ECG; Result Unstructured Data: Test Result:sinus tachycardia at 140 / min; Comments: ECG sinus tachycardia with incomplete right delay; Test Name: holter; Result Unstructured Data: Test Result:result unknown; Test Date: 20211123; Test Name: Emergency care examination; Result Unstructured Data: Test Result:result unknown; Test Name: D-Dimer; Result Unstructured Data: Test Result:716 ng/ml; Comments: D-Dimer value 716 ng / ml-FEU.; Test Date: 20211123; Test Name: heart rate; Result Unstructured Data: Test Result:tachycardia at 140/min; Test Name: Cardiac MRI; Result Unstructured Data: Test Result:unknown; Test Date: 20211123; Test Name: Spo2; Result Unstructured Data: Test Result:normal
CDC Split Type: ITPFIZER INC202101783746

Write-up: booster; Hypokalaemia; blood pressure rise (190/95); Palpitations and premature fatigue (at minimum efforts); Palpitations and premature fatigue (at minimum efforts); This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority-WEB. Regulatory number: -MINISAL02-819487 (MINISAL02). A 43-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), intramuscular, administered in arm left, administration date 16Nov2021 09:12 (Lot number: 1F1016A, Expiration Date: 30Apr2022) as dose 3 (booster), 0.3 ml single for covid-19 immunisation. Relevant medical history included: ablation surgery (unspecified if ongoing), notes: patient with remote ablation surgery for ventricular arrhythmia. Concomitant medication(s) included: NACREZ. Vaccination history included: Comirnaty (dose 1, single, batch EJ6797, time 10:16, left shoulder), administration date: 12Jan2021, for covid-19 immunisation; Comirnaty (dose 2, single, batch EK9788, time10:10, left shoulder), administration date: 02Feb2021, for covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome recovered with sequelae, described as booster; HYPOKALAEMIA (medically significant) with onset 20Nov2021, outcome recovered with sequelae, described as Hypokalaemia; BLOOD PRESSURE INCREASED (medically significant) with onset 20Nov2021, outcome "recovered with sequelae, described as blood pressure rise (190/95); FATIGUE (medically significant) with onset 20Nov2021, outcome recovered with sequelae (23Nov2021), PALPITATIONS (medically significant) with onset 20Nov2021, outcome recovered with sequelae and all described as Palpitations and premature fatigue (at minimum efforts). The events booster, hypokalaemia, blood pressure rise (190/95), palpitations and premature fatigue (at minimum efforts) and palpitations and premature fatigue (at minimum efforts) were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (23Nov2021) rise (190/95); cardiovascular examination: (25Nov2021) a dubious outcome of myocardial pericarditis, notes: in a patient with a previous ablation of VT and a finding of hypokalaemia; computerised tomogram thorax: (23Nov2021) result unknown; echocardiogram: (26Nov2021) result unknown; electrocardiogram: (unspecified date) documented rs with normal repolarization; (23Nov2021) sinus tachycardia at 140 / min, notes: ECG sinus tachycardia with incomplete right delay; electrocardiogram ambulatory: (unspecified date) result unknown; emergency care examination: (23Nov2021) result unknown; fibrin d dimer: (unspecified date) 716 ng/ml, notes: D-Dimer value 716 ng / ml-FEU; heart rate: (23Nov2021) tachycardia at 140/min; magnetic resonance imaging heart: (unspecified date) unknown; oxygen saturation: (23Nov2021) normal. Therapeutic measures were taken as a result of immunisation, hypokalaemia, blood pressure increased, fatigue, palpitations. Clinical course: Actions taken (Integration of K and beta blocker therapy.) The patient comes to the emergency room on 23Nov2021 for intermittent episodes of heartbeat and premature fatigue that lasted for 3 days. More marked symptoms on 23Nov than in the previous days. At triage tachycardia, Blood pressure rise, spO2 normal. At the triage ECG sinus tachycardia at 140 / min. Administered metoprolol 1fl in 250 of physiological, the patient reports well-being to the reassessment. ECG performed again documenting RS with normal repolarization. Diagnosis in emergency room: Heartache and malaise. We recommend bisoprolol 1.25mg in the morning 1 capsule and re-evaluation by the doctor. On 11/25/2021 the patient underwent a cardiological examination with a dubious outcome of myocardial pericarditis in a patient with a previous ablation of Ventricular Tachycardia and a finding of hypokalaemia. In addition to bisoprolol we also recommend KCL retard 1 cl in the morning and evening for 5 days and performing tests: kalaemia, renal function, blood count, PCR, ESR, trop I CK-MB. Report dated 11/30/2021 with D-Dimer value 716 ng / ml-FEU. In emergency room, ECG examination is performed. Upon arrival to an emergency room on 23Nov ECG with sinus tachycardia at 140 / min. ECG is then repeated which documents RS with repolarization in the norm; Pulmonary embolism excluded; No evidence of myocarditis. Previously unknown septal-wall dyskinesia in patient with remote ablation surgery for ventricular arrhythmia; ECG sinus tachycardia with incomplete right delay. Conclusions: doubtful pericarditis or myocarditis; upon completion of the diagnosis, cardiac MRI and holter ECG are performed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1987717 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-11-20
   Days after vaccination:129
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20211252456

Write-up: VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority (EVHUMAN Vaccines, PT-INFARMED-T202112-2146) on 23-DEC-2021 and concerned a 41 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 (dose number in series was 1) (suspension for injection, intramuscular, batch number: 203A21A and expiry: unknown) 0.5 ml, 1 total (first dose), administered on 14-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 20-NOV-2021, the patient had vaccination failure (Ineffective vaccination). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccination failure on 13-DEC-2021. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Reporter''s Comments: Other information: P15 CHRONIC ALCOHOL ABUSE 11-Jun-2015 P19 DRUG ABUSE Hashish, cocaine 11-Jun-2015 P17 ABUSE OF TOBACCO 24-May-2011 T82 OBESITY 24-May-2011


VAERS ID: 1987813 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: Erythema multiforme; Result Unstructured Data: Test Result:15x5 cm on the right thigh
CDC Split Type: SIPFIZER INC202101785808

Write-up: ring erythema of various sizes on broad of the back, the largest in diameter of 15x5 cm on the right thigh - erythema multiforme; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority. Regulatory number: SI-JAZMP-NCPHV-2021SI1430_1430. Other Case identifier(s): JAZMP-300019134. A 72 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 19Nov2021 (Lot number: FG6273, Expiration Date: 28Feb2022) as dose 2, 30 ug single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose), for COVID-19 immunization. The following information was reported: ERYTHEMA MULTIFORME (medically significant) with onset 20Nov2021, outcome "unknown", described as "ring erythema of various sizes on broad of the back, the largest in diameter of 15x5 cm on the right thigh - erythema multiforme". The patient underwent the following laboratory tests and procedures: erythema multiforme: (20Nov2021) 15x5 cm on the right thigh. Clinical Course: On 20Nov2021, the patient experienced above adverse event. (Lasting for 7 days). No additional data arrived in the initial case report. Side effect (20Nov2021): annular erythema of various sizes on the shoulders, the largest diameter of 15x5 cm on the right thigh - erythema multiforme (lasts 7 days). Other important history: not reported. Measures: observation. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1987848 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-08
Onset:2021-11-20
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiocardiogram, Blood creatinine, C-reactive protein, Cardiac failure acute, Cardiac function test, Chest X-ray, Computerised tomogram thorax, Echocardiogram, Ejection fraction, Electrocardiogram, Fibrin D dimer, Haemoglobin, Investigation, N-terminal prohormone brain natriuretic peptide, Oxygen saturation, Pulmonary arterial wedge pressure, Pulmonary oedema, Troponin I
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BISOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to NSAIDs (allergy of NSAIDs); Arrhythmia; Periodontal disease; Smoker (Smoking for 30 years)
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: Angiogram coronary; Result Unstructured Data: Test Result:showed insignificant Arteriosclerotic heart; Comments: disease (CAD); Test Date: 20211120; Test Name: Creatinine; Result Unstructured Data: Test Result:0.6; Test Date: 20211121; Test Name: Cardiac function test; Result Unstructured Data: Test Result:RV 35/10mmHg; RA 8mmHg; Test Date: 20211120; Test Name: Chest X-ray; Result Unstructured Data: Test Result:severe cardiomegaly with pulmonary edema; Test Date: 20211121; Test Name: Chest X-ray; Result Unstructured Data: Test Result:no pulmonary edema; Test Date: 20211120; Test Name: Chest CT; Result Unstructured Data: Test Result:showed Cardiomegaly, mild dilatation of main and; Comments: bilateral pulmonary artery, Back flow of contrast medium to IVC and hepatic vein can be noted, heart failure was suspected. In addition, there was no obvious pulmonary embolism can be noted in the Chest CT test.; Test Date: 20211120; Test Name: High-sensitivity C-reactive protein; Test Result: 0.56 mg/dl; Test Date: 20211120; Test Name: Echocardiogram; Result Unstructured Data: Test Result:showed impaired LV contractility with LV distend; Test Date: 20211121; Test Name: Ejection fraction; Result Unstructured Data: Test Result:<30 %; Test Date: 20211120; Test Name: Left ventricular ejection fraction; Result Unstructured Data: Test Result:<30 %; Test Date: 20211120; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:showed sinus rhythm with frequent VPCs; Test Date: 20211120; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:5450; Test Date: 20211120; Test Name: Haemoglobin; Result Unstructured Data: Test Result:14.2; Test Date: 20211121; Test Name: Investigation; Result Unstructured Data: Test Result:34/15; Test Date: 20211120; Test Name: NT-proBNP; Result Unstructured Data: Test Result:2950; Test Date: 20211121; Test Name: O2 saturation; Test Result: 70.8 %; Test Date: 20211121; Test Name: Pulmonary capillary wedge pressure; Result Unstructured Data: Test Result:14 mmHg; Test Date: 20211120; Test Name: Troponin I; Result Unstructured Data: Test Result:<0.010 ng/ml
CDC Split Type: TWPFIZER INC202101854859

Write-up: CUTE DECOMPENSATED HEART FAILURE; PULMONARY EDEMA; This is a spontaneous report received from non-contactable healthcare professional from License Party and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014439. Other Case identifier(s): TW-Fosun-2021FOS006865. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100014439. A 50-year-old female patient (height: 156 cm; weight: 96 kg) started to receive 2nd dose of Tozinameran (COMIRNATY) (batch number was not reported) on 08-Nov-2021 via unknown routed at unknown dose with unspecified dosing frequency for COVID-19 immunization. The 1st dose of vaccination was received on an unknown date. Medical history included taking bisoprolol (2.5mg QD) used for the past disease history of arrhythmia not regularly. The past disease also included allergy of NSAIDs and periodontal disease(in 2021/02). Smoking for 30 years. Concomitant medication and past product were not reported. The patient experienced acute decompensated heart failure and pulmonary edema on 20-Nov-2021. It was reported that the patient had normal result of Angiogram coronary (CAG) 3 years ago, and no other evidence of heart failure was noted before. The patient denied previous medical history of diabetes, hypertension or Cough variant asthma (CVA). On 08-Nov-2021, the patient received the second dose of the BNT vaccine. On 20-Nov-2021, she visited emergency department (ED) due to progressive dyspnea in recent days, worsening in these 2 days. There was also orthopnea breathing, cough, paroxysmal nocturnal dyspnea, legs edema 1+. Serum lab data sgiwed Haemoglobin (Hb):14.2; Creatinine(Cre): 0.6; High-sensitivity C-reactive protein (hsCRP): 0.56 mg/Dl; NT-proBNP:2950; D-dimer:5450; Troponin I(AQT90): <0.010 ng/mL; Chest X-ray showed severe cardiomegaly with pulmonary edema; Electrocardiogram(ECG) showed sinus rhythm with frequent VPCs. Bedside Echocardiogram (echo) showed impaired LV contractility with LV distend, LVEF<30%. Chest CT also showed Cardiomegaly, mild dilatation of main and bilateral pulmonary artery, Back flow of contrast medium to IVC and hepatic vein can be noted, heart failure was suspected. In addition, there was no obvious pulmonary embolism can be noted in the Chest CT test. The situation was diagnosed as acute decompensated heart failure with pulmonary edema, nature to be determied. On 21-Nov-2021, the patient was admitted to coronary care unit (CCU) for further care. After admitted to CCU, the patient was given the treatment of Lasix iv form and NTG infusion therapy. Then, the Dapagliflozin po for heart failure treatment, arranged coronary angiography survey showed insignificant Arteriosclerotic heart disease (CAD), Pulmonary capillary wedge pressure (PCW) 14mmHg, PA 34/15 and O2 saturation (SpO2)70.8%; RV 35/10mmHg; RA 8mmHg; Ejection fraction (EF)<30%; it was suspected that dilated cardiomyopathy (DCM) related. Also occasionally frequent Premature ventricular contractions (VPCs) in CCU, Mexiletine po was given. On 24-Nov-2021, she was transferred to general ward. No dysnpea, no chest pain. Tolerate ambulation well and chest X-Ray (CXR) showed no pulmonary edema. Check Virus profile which still pending. On 26-Nov-2021, the patient discharged due to relative stable condition. On 02-Dec-2021, the patient returned to the clinic, the asthma and foot edema were much better than before. Acute decompensated heart failure and pulmonary edema met the seriousness criterion of Hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. On 24-Nov-2021, the outcome of pulmonary edema was recovered. At the time of the report, the outcome of the Acute decompensated heart failure was recovering. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. Bnt162b2 (COMIRNATY) is under agreement with company.


VAERS ID: 1987907 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-23
Onset:2021-11-20
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1H055A / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anti-platelet factor 4 antibody test, Blood test, Chest X-ray, Chest pain, Computerised tomogram, Electrocardiogram, Fibrin D dimer, Leukocytosis, Neutrophil percentage, Pain in extremity, Platelet count, Pulmonary embolism, Pyuria, White blood cell count
SMQs:, Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), 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? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy (laparoscopic appendectomy); Appendicitis
Allergies:
Diagnostic Lab Data: Test Date: 20211126; Test Name: Anti-Platelet Factor 4 Antibody; Result Unstructured Data: Test Result:Unknown results; Test Date: 20211124; Test Name: Blood test; Result Unstructured Data: Test Result:showed: leukocytosis; Test Date: 20211124; Test Name: Chest X-ray; Result Unstructured Data: Test Result:no active lung lesion; Test Date: 20211124; Test Name: Computerised tomography; Result Unstructured Data: Test Result:bilateral pulmonary embolism; Test Date: 20211124; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Sr, Tramadol.; Test Date: 20211124; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:1195 ng/ml; Test Date: 20211125; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:880 ng/ml; Test Date: 20211124; Test Name: Segmented neutrophil percentage; Result Unstructured Data: Test Result:82.6; Test Date: 20211124; Test Name: Platelet count; Result Unstructured Data: Test Result:133000/uL; Test Date: 20211126; Test Name: Platelet count; Result Unstructured Data: Test Result:165000/uL; Test Date: 20211124; Test Name: White blood cells; Result Unstructured Data: Test Result:13.94
CDC Split Type: TWPFIZER INC202101855421

Write-up: LEUKOCYTOSIS; PYURIA; BILATERAL PULMONARY EMBOLISM; CHEST PAIN; RIGHT LEG PAIN; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014588 (TW-TFDA-TVS-1100014588). Other Case identifier(s): TW-Fosun-2021FOS006893. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100014596. A 38-year-old female patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: 1H055A) on 23-Oct-2021 via intramuscular at 0.3 ml with unspecified dosing frequency for COVID-19 immunization. Medical history included appendicitis, Surgical History was laparoscopic appendectomy on 27-Apr-2012. Concomitant medications and past product were not reported. The patient experienced chest pain on 20-Nov-2021, experienced leukocytosis, pyuria and pulmonary embolism on 24-Nov-2021, experienced right leg pain on an unknown date. On 23-Oct-2021, the patient received the 1st BNT vaccine. On 20-Nov-2021, the patient experienced chest pain. On 24-Nov-2021, the patient went to the emergency room (ER) complaining that she was painless when standing (no external impact), denied using birth control pills, and had right leg pain recently. Chest X-ray (CXR): no active lung lesion; Electrocardiogram (EKG): Sr, Tramadol. Blood test showed: leukocytosis (white blood cells (WBC): 13.94, segmented neutrophil percentage (SEG): 82.6); pyuria; d-dimer: 1195 ng/mL, platelet: 133000/uL. Computerised tomography (CT): bilateral pulmonary embolism. The patient was treated with EnoxaParin 6000 Unit Q12H and transferred to the adjustment ward. On 25-Nov-2021, the patient was hospitalized. Blood test: d-dimer: 880 ng / ml. On 26-Nov-2021, blood test: Platelet: 165000 / uL. The patient was treated with Dabigatran 150 mg BID and transferred to general ward care. The anti-Platelet Factor 4 Antibody was examined but the result was unknown. On 29-Nov-2021, the patient was discharged. Chest pain, leukocytosis, pyuria, right leg pain and pulmonary embolism met the seriousness criterion of Life Threatening and Hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were recovering. The patient was discharged on 29-Nov-2021. Initial report was received on 15-Dec-2021.Follow-up closed, no further information is possible. Causality assessment provided by company (RA) and reporter for reported event was Possible. BNT162B2 is under agreement with Regulatory Authority. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1987922 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-09
Onset:2021-11-20
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Blood creatinine, Blood glucose, Blood potassium, Blood pressure increased, Blood pressure measurement, Blood sodium, Body temperature, Chest discomfort, Chest pain, Coma scale, Dyspnoea exertional, Fibrin D dimer, Haemoglobin, Heart rate, Malaise, Oxygen saturation, Platelet count, Prothrombin time, Red blood cell count, Respiratory rate, Troponin I, White blood cell count
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: GPT; Result Unstructured Data: Test Result:17 IU/l; Comments: enzyme unit per litre; Test Date: 20211120; Test Name: Creatinine; Test Result: 0.91 mg/dl; Test Date: 20211120; Test Name: Blood glucose; Test Result: 101 mg/dl; Test Date: 20211120; Test Name: K; Result Unstructured Data: Test Result:3.6 mmol/L; Test Date: 20211120; Test Name: Blood pressure; Result Unstructured Data: Test Result:132/182 mmHg; Test Date: 20211120; Test Name: Sodium; Result Unstructured Data: Test Result:135.7 mmol/L; Test Date: 20211120; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Test Date: 20211120; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:E4, V5, M6; Test Date: 20211120; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:0.16 ug/ml; Test Date: 20211120; Test Name: Hemoglobin; Result Unstructured Data: Test Result:14.5 g/dl; Test Date: 20211120; Test Name: Heart rate; Result Unstructured Data: Test Result:74 {beats}/min; Test Date: 20211120; Test Name: Oxygen saturation; Test Result: 97 %; Test Date: 20211120; Test Name: Platelet count; Result Unstructured Data: Test Result:309 x10 3/mm3; Test Date: 20211120; Test Name: Prothrombin time; Test Result: 1.05 s; Test Date: 20211120; Test Name: Red blood cell count; Result Unstructured Data: Test Result:4.80 10*6/uL; Test Date: 20211120; Test Name: Respiratory rate; Result Unstructured Data: Test Result:20 {breaths}/min; Test Date: 20211120; Test Name: Troponin I; Result Unstructured Data: Test Result:0.003 ng/ml; Test Date: 20211120; Test Name: White blood cell count; Result Unstructured Data: Test Result:8.26 x10 3/mm3
CDC Split Type: TWPFIZER INC202101854424

Write-up: CHEST PAIN; EXERTIONAL DYSPNEA; GENERAL MALAISE; CHEST TIGHTNESS; Blood pressure (BP): 132/182 mmHg; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party (BioNTech)and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100013907. Other Case identifier(s): TW-Fosun-2021FOS006925. This is a spontaneous report received from a non-contactable HCP received via regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100013907. A 21-year-old male patient started to receive a dose of Tozinameran (COMIRNATY) (batch number was not reported) on 09-Nov-2021 via unknown route at unknown dose with unspecified dosing frequency for COVID-19 immunization. Non-known allergies. Medical history, concomitant medication and past product were not reported. The patient experienced chest pain, exertional dyspnea and general malaise on 20-Nov-2021, experienced chest tightness on 23-Nov-2021. On 20-Nov-2021, the patient experienced chest pain, exertional dyspnea and general malaise, no upper respiratory infection (Uri) symptoms and went to emergency. Life signs results showed: Blood pressure (BP): 132/182 mmHg, Heart rate (HR): 74 times / min; Respiratory rate (RR): 20 times / min; Body temperature(BT): 36.5 centigrade, Oxygen saturation (SPO2): 97%; Glasgow coma scale (GCS): E4, V5, M6; White blood cell count (WBC): 8.26 x1000/UL; Red blood cell count (RBC): 4.80 x10^6/UL; Hemoglobin (HGB): 14.5 g/dl; Platelet count (PLT): 309 x1000/UL; prothrombin time (Pt (INR)): 1.05s; Fibrin D dimer (D-DIMER): 0.16 ug/ml; Sugar :101 mg/dl; glutamic-pyruvic transaminase (GPT) 17 U/L; Creatinine: 0.91 mg/dl; Na: 135.7 mmol/L; K: 3.6 mmol/L; Tropo-I: 0.003 ng/ml. Treatment was given as follows : SODIUM CHLORIDE (Sodium Chloride 0.9% 250ml / Bag) 250 ml St IVD 1 day, Acetaminophen (DepyRetin 500mg / Tab) 1 Tab PO TID PC 3 days. On an unknown date, the patient was stabilized and discharged. On 23-Nov-2021, the patient had chest tightness and chest pain. Exertional dyspnea, chest pain, general malaise and chest tightness met the seriousness criterion of Hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were not recovered. The patient was discharged on an unknown date. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. The reporter and BioNTech SE both considered Relatedness of drug to the events Chest pain, Exertional dyspnea, General malaise, Chest tightness was Possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE.


VAERS ID: 1987924 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Pain, Pain assessment, Vaccination site erythema, Vaccination site induration, Vaccination site swelling
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: Pain scale; Result Unstructured Data: Test Result:4 points, acute peripheral moderate pain (range of; Comments: pain index: 4-7).
CDC Split Type: TWPFIZER INC202101854890

Write-up: HARD BLOCK; INOCULATION SITE RED; SWELLING AT THE INJECTION SITE; ACUTE PERIPHERAL MODERATE PAIN; This is a spontaneous report received from non-contactable healthcare professional from License Party(BioNTech) and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100013909 ( Center for Disease Control). Other Case identifier(s): TW-Fosun-2021FOS006930 (RA). This is a spontaneous report received from a non-contactable HCP received via Center for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100013909. A 22-year-old female patient started to receive a dose of Tozinameran (COMIRNATY) (batch number was not reported) on 18-Nov-2021 via unknown route of administration at unknown dose with unspecified dosing frequency for COVID-19 immunization. Medical history was not reported. Concomitant medications and past product were not reported. The patient experienced inoculation site red, swelling at the injection site, acute peripheral moderate pain on 20-Nov-2021, hard block on 24-Nov-2021. On 20-Nov-2021, the patient went to emergency due to local redness, acute peripheral moderate pain (range of pain index: 4-7), pain index 4 points, and the patient ignorant the red swelling of upper arm after vaccination until went to the emergency. The patient received following treatment: Acetaminophen (DepyRetin 500 mg/Tab) 1 Tab PO TID PC 3 days. Diphenhydramine (Vena 10 mg/Tab) 1 Tab PO TID PC 3 days. On an unknown date, the patient was stable and discharged. On 24-Nov-2021, the patient''s red swelling was no spread, but the part had a hard block, which had not yet retired. Inoculation site red, swelling at the injection site, acute peripheral moderate pain and hard block met the seriousness criterion of caused hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were recovering. Initial report was received on 15-Dec-2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1987945 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Hypoaesthesia, Myocarditis, Troponin I
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211127; Test Name: Troponin I; Result Unstructured Data: Test Result:50.7; Test Date: 20211128; Test Name: Troponin I; Result Unstructured Data: Test Result:120.1; Test Date: 20211128; Test Name: Troponin I; Result Unstructured Data: Test Result:362.0
CDC Split Type: TWPFIZER INC202101855495

Write-up: MYOCARDITIS (MYOCARDITIS); CHEST TIGHTNESS; INTERMITTENT NUMBNESS OVER LEFT FOREARM; This is a spontaneous report received from non-contactable reporter (Other HCP) from License Party and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014678. Other Case identifier(s): TW-Fosun-2021FOS007009. This is a spontaneous report received from a non-contactable HCP received via Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100014678. A 51-year-old male patient started to receive 2nd dose of Tozinameran (COMIRNATY) (batch number was not reported) on 20-Nov-2021 via unknown route at 0.3 ml with unspecified dosing frequency for COVID-19 immunization. The 1st dose was received on an unknown date. Medical history, concomitant medications and past product were not reported. The patient experienced chest tightness and intermittent numbness over left forearm on 20-Nov-2021, experienced Myocarditis (Myocarditis) on 28-Nov-2021. On 20-Nov-2021, the patient received 2nd dose of vaccination (injection site: left arm). The patient experienced chest tightness. In addition, intermittent numbness over left forearm was noted when heavy weight. At 21:50 of 27-Nov-2021, Troponin I =50.7. At night of 27-Nov-2021, progressive chest tightness was noted when the patient was watching. At 01:11 of 28-Nov-2021, Troponin I=120.1; at 09:02, Troponin I=362.0. On 01-Dec-2021, the patient rested at home. On 02-Dec-2021, There was no discomfort. Myocarditis (Myocarditis), chest tightness and intermittent numbness over left forearm met the seriousness criterion of Other Medically Important Condition. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. On 02-Dec-2021, the events were recovered. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE. The reporter and company considered the causal relationship between vaccine and events Myocarditis, Chest tightness, Numbness of upper extremities was possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1987967 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-09
Onset:2021-11-20
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Colitis ischaemic, Computerised tomogram, Computerised tomogram abdomen, Electrocardiogram, Enterocolitis infectious, Gastroenteritis, Heart rate, Iron deficiency anaemia, Laboratory test, Lower gastrointestinal haemorrhage, Physical examination, Respiratory rate, Sinus tachycardia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Supraventricular tachyarrhythmias (narrow), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (narrow), Hypertension (narrow), Noninfectious diarrhoea (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: Asthma
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: BP; Result Unstructured Data: Test Result:145/72 mmHg; Test Date: 20211125; Test Name: Body temperature; Result Unstructured Data: Test Result:37.8 Centigrade; Test Date: 20211201; Test Name: CT scan; Result Unstructured Data: Test Result:segmental poor enhancement of ascending and transv; Comments: segmental poor enhancement of ascending and transverse colon, ischemic change should be considered; diffuse wall thickening of colon, more prominent in ascending and transverse colon, consult CRS doctor.; Test Name: Abdomen CT; Result Unstructured Data: Test Result:colon wall thickening.; Test Date: 20211125; Test Name: Abdomen CT; Result Unstructured Data: Test Result:possibly (r/o) intra-abdominal infection (IAI), re; Comments: possibly (r/o) intra-abdominal infection (IAI), revealed wall thickening of transverse, descending and sigmoid colon; wall thickening of gastric antrum; several lymph nodes in the para-aortic region, aortocaval region and pelvis.; Test Date: 20211125; Test Name: EKG; Result Unstructured Data: Test Result:sinus tachycardia; Test Date: 20211125; Test Name: Heart rate; Result Unstructured Data: Test Result:125; Comments: Units:{beats}/min; Test Date: 20211125; Test Name: Laboratory test; Result Unstructured Data: Test Result:leukocytosis with elevated C-reactive protein (CRP; Comments: leukocytosis with elevated C-reactive protein (CRP), hypokalemia, stool routine white blood cell count (WBC)/ red blood cell (RBC) numerous.; Test Date: 20211125; Test Name: Physical examination; Result Unstructured Data: Test Result:gross abdominal tenderness without peritoneal sign; Comments: gross abdominal tenderness without peritoneal signs, clear breath sound, no flank pain.; Test Date: 20211125; Test Name: Respiratory rate; Result Unstructured Data: Test Result:18; Comments: Units:{breaths}/min
CDC Split Type: TWPFIZER INC202101855556

Write-up: infectious enterocolitis; ischemic colitis; lower gastrointestinal (GI) bleeding; iron-deficiency anemia; INFECTIOUS GASTROENTERITIS; blood pressure (BP): 145/72mmHg; sinus tachycardia; This is a spontaneous report received from non-contactable healthcare professional from License Party (BioNTech SE) and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014744 (Regulatory Authority). Other Case identifier(s): TW-Fosun-2021FOS007054. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100014744. A 37-year-old female patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number was not reported) on 09-Oct-2021 via unknown route at unknown dose with unspecified dosing frequency for COVID-19 immunization. Medical history included a past medical history of asthma. Concomitant medication and past product were not reported. The patient experienced infectious gastroenteritis on 20-Nov-2021. On 09-Oct-2021, the patient received the BNT vaccine. On 20-Nov-2021, the patient ate sashimi and had diarrhea with acute abdominal gross colic pain since then, above 10 times per day. But her family did not have the same symptoms. From 20-Nov-2021 to 24-Nov-2021, the patient was admitted to hospital. Treatment of Levofloxacin was prescribed. Abdominal computed tomography (CT) was done and revealed colon wall thickening. After being discharged, her diarrhea and gross abdominal colic pain onset again insidiously, with bloody and mucoid stool passage. On 25-Nov-2021, the patient went to the emergency room of the hospital due to the above symptoms. Life vital signs showed: blood pressure (BP): 145/72mmHg, heart rate (HR): 125 beats/min, respiratory rate (RR): 18, body temperature (BT): 37.8 centigrade. Physical examination (PE) showed gross abdominal tenderness without peritoneal signs, clear breath sound, no flank pain. Lab data showed leukocytosis with elevated C-reactive protein (CRP), hypokalemia, stool routine white blood cell count (WBC)/ red blood cell (RBC) numerous. Electrocardiogram (EKG) sinus tachycardia. Abdominal computed tomography (CT) was done again and possibly (r/o) intra-abdominal infection (IAI), revealed wall thickening of transverse, descending and sigmoid colon; wall thickening of gastric antrum; several lymph nodes in the para-aortic region, aortocaval region and pelvis. Since 27-Nov-2021, under the impression of infectious enterocolitis, the patient was admitted to the ward for further treatment. The patient was given antibiotic treatment due to unspecified infectious gastroenteritis and colitis, including Brosym (From 27-Nov-2021 to 28-Nov-2021), Flomoxef (From 28-Nov-2021 to 30-Nov-2021), Meropenem (From 30-Nov-2021). From 28-Nov-2021 to 29-Nov-2021, the patient was given tranexamic acid for lower gastrointestinal (GI) bleeding. The patient was given Iron for iron-deficiency anemia. On 01-Dec-2021, the ischemic colitis suspected post-vaccination side effect. Computed tomography (CT): segmental poor enhancement of ascending and transverse colon, ischemic change should be considered; diffuse wall thickening of colon, more prominent in ascending and transverse colon, consult CRS doctor. Surgery/ procedure (s/p): laparoscopic right hemicolectomy with ileostomy were performed on the same day. The patient was diagnosed with infectious gastroenteritis, and antibiotic treatment was prescribed. Infectious gastroenteritis met the seriousness criterion of hospitalization. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was not recovered. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible.Causality Assessment: Infective gastroenteritis, Per Reporter = Possible, Per Company (BioNTech SE) = Possible. BNT162B2 (COMIRNATY) is under agreement with BioNTech SE. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1987968 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-12
Onset:2021-11-20
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Bacterial translocation, C-reactive protein, Epididymitis, Hernia, Incarcerated hernia, Orchitis, Physical examination, White blood cell count
SMQs:, Retroperitoneal fibrosis (broad), Sepsis (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: Medical History/Concurrent Conditions: Diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20211130; Test Name: C-reactive protein; Result Unstructured Data: Test Result:20.78; Comments: (elevated); Test Date: 20211120; Test Name: Physical examination; Result Unstructured Data: Test Result:left scrotum bulging; Comments: with incarcerated hernia, no swelling, no erythema, no high raising testes, no hamaturia, no dysuria, no flank pain, no upper respiratory infection (URI) symptoms, no constipation, no nausea or vomiting.; Test Date: 20211130; Test Name: Physical examination; Result Unstructured Data: Test Result:suspected of hernia; Test Date: 20211130; Test Name: WBC; Result Unstructured Data: Test Result:12.6; Comments: (elevated)
CDC Split Type: TWPFIZER INC202101842312

Write-up: BACTERIAL TRANSLOCATION; HERNIA; LEFT LOIN TENDERNESS; ACUTE EPIDIDYMO-ORCHITIS; INCARCERATED HERNIA; ACUTE EPIDIDYMITIS; This is a spontaneous report received from non-contactable healthcare professional from Regulatory Authority via License Party (BIONTECH SE). Regulatory number: TW-TFDA-TVS-1100014747 (Regulatory Authority). Other Case identifier: TW-Fosun-2021FOS007058. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100014747. A 49-year-old male patient started to receive 2nd dose of Tozinameran (COMIRNATY) (batch number was not reported) on 12-Nov-2021 via unknown route at unknown dose with unspecified dosing frequency for COVID-19 immunization. The 1st dose was received on an unknown date. Medical history included a past medical history of type 2 diabetes mellitus (DM). Concomitant medication and past product were not reported. The patient experienced left loin tenderness, acute epididymo-orchitis, incarcerated hernia and acute epididymitis on 20-Nov-2021, experienced bacterial translocation and hernia on 30-Nov-2021. On 12-Nov-2021, the patient received the 2nd dose of BNT vaccine. On 20-Nov-2021, the patient had the initial symptoms of intermittent fever with chillness and testicular swelling, the accompanied symptoms were left scrotum bulging and left loin tenderness. The patient went to local medical doctor (LMD) for help. Acute epididymitis was suspected and treatment with antibiotics was prescribed. However, the tenderness still persisted so the patient went to outpatient department (OPD) for help. Physical examination (PE) showed left scrotum bulging with incarcerated hernia, no swelling, no erythema, no high raising testes, no hamaturia, no dysuria, no flank pain, no upper respiratory infection (URI) symptoms, no constipation, no nausea or vomiting. On 30-Nov-2021, the above symptoms were not improved and the patient went to the outpatient clinic. Physical examination was suspected of hernia. Lab data showed elevated C-reactive protein (CRP) (20.78) and white blood cell count (WBC) (12.6). Under the impression of acute epididymo-orchitis or incarcerated hernia with bacterial translocation, the patient was admitted to hospital for further evaluation and treatment. Left loin tenderness, incarcerated hernia, acute epididymo-orchitis, bacterial translocation, acute epididymitis and hernia met the seriousness criterion of hospitalization. At the time of the report, the outcomes of the events were not recovered. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. Causality Assessments: Drug = COMIRNATY Event = Loin pain, Acute epididymo-orchitis, Incarcerated hernia, Epididymitis, Bacterial translocation, Hernia Per Reporter = Possible Per Company (BioNTech SE) = Possible. BNT162B2 (COMIRNATY) is under agreement with BioNTech SE. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected


VAERS ID: 1987991 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Discomfort, Headache, Interchange of vaccine products, Nausea, Off label use, Tenderness, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101855295

Write-up: CHEST DISCOMFORT; COMPRESSIVE PAIN; HEADACHE; NAUSEA; VOMITING; CHEST PAIN; OFF LABEL USE; INTERCHANGE OF VACCINE PRODUCTS; MILD DISCOMFORT; This is a spontaneous report received from a non-contactable reporter (Other HCP) from License Party and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014213. Other Case identifier(s): TW-Fosun-2021FOS007092. This is a spontaneous report received from a non-contactable HCP received via Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100014213. A 29-year-old male patient started to receive the 2nd dose of Tozinameran (COMIRNATY) (batch number was not reported) on 20-Nov-2021 via unknown route at unknown dose with unspecified dosing frequency for COVID-19 immunization. There was no family history. Past product included one dose of AstraZeneca COVID-19 vaccine received on 03-Sep-2021. The patient experienced mild discomfort on 20-Nov-2021, chest discomfort, compressive pain, headache, nausea, vomiting, chest pain on 22-Nov-2021. In the evening of 20-Nov-2021, the patient experienced mild discomfort after vaccination. Since 10:00 of 22-Nov-2021, the patient experienced chest discomfort. On the same day, the patient also experienced compressive pain, headache, nausea, vomiting once without blood or coffee grounds and went to hospital. There was no fever, no chills, no diarrhea with normal stool passage. The patient was administered piroxicam injection. After medical care, the patient was discharged. It was reported that the chest pain started on the same day. Mild discomfort, chest discomfort, compressive pain, headache, nausea, vomiting, chest pain met the seriousness criterion of Hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcome of chest pain was recovering. The outcomes of the other events were unknown. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. BNT162B2 (COMIRNATY) is under agreement with BioNTech SE Drug: Comirnaty Causality Assessments: Discomfort, Chest discomfort, Tenderness, Headache, Nausea, Vomiting, Chest pain, Interchange of vaccine products, Off label use Per Reporter= Possible Per Company (BioNTech SE) = Possible No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


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