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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 585 out of 10,317

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VAERS ID: 1960750 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Nasal discomfort
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ISPFIZER INC202101730703

Write-up: irritation in the nasal mucosa; Angioedema in tongue and uvula; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority-WEB. Regulatory number: IS-IMA-7292 . A 83 year-old male patient received bnt162b2 (COMIRNATY), administration date 15Nov2021 (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: ANGIOEDEMA (medically significant) with onset 16Nov2021, outcome "recovering", described as "Angioedema in tongue and uvula"; NASAL DISCOMFORT (medically significant), outcome "recovering", described as "irritation in the nasal mucosa". Therapeutic measures were taken as a result of angioedema. Clinical course: On 16Nov2021 the patient developed angioedema (in tongue and uvula). No other triggers have been identified when taking the medical history of the patient, the patient has no known allergies. It was reported that the patient has experienced irritation in the nasal mucosa with no explained cause. The angioedema was treated with Telfast and steroids with good effect. However, there is still slight edema present. The event was assessed as serious as considered medically important. The reporter considered the event possibly related to the drug. It is not known whether the patient is fully vaccinated. Sender comments: Follow-up attempt made, no further information available at the time of reporting. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1960822 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-12
Onset:2021-11-16
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase MB, Body temperature, Chest pain, Echocardiogram, Headache, Magnetic resonance imaging, Myocarditis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: CK-MB; Result Unstructured Data: Test Result:increased; Test Date: 20211123; Test Name: CK-MB; Result Unstructured Data: Test Result:started to decrease; Test Date: 20211116; Test Name: Body temperature; Result Unstructured Data: Test Result:<=38.4 Centigrade; Test Date: 20211123; Test Name: Echocardiogram; Result Unstructured Data: Test Result:Left ventricle systolic dysfunction; Test Date: 20211123; Test Name: MRI; Result Unstructured Data: Test Result:showed findings suggestive of myocarditis; Comments: Heart MRI showed findings suggestive of myocarditis
CDC Split Type: LVPFIZER INC202101728631

Write-up: Myocarditis; Chest pain; Pyrexia; Headache; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: LV-SAM-2021117193 (RA). A 18 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 12Nov2021 (Batch/Lot number: unknown) as dose 1, 0.3ml single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: MYOCARDITIS (hospitalization, medically significant) with onset 23Nov2021, outcome "recovering", described as "Myocarditis"; CHEST PAIN (hospitalization) with onset 16Nov2021, outcome "recovering", described as "Chest pain"; PYREXIA (non-serious) with onset 16Nov2021, outcome "recovering", described as "Pyrexia"; HEADACHE (non-serious) with onset 16Nov2021, outcome "recovering", described as "Headache". The patient was hospitalized for chest pain (start date: 20Nov2021). The patient underwent the following laboratory tests and procedures: blood creatine phosphokinase mb: (20Nov2021) increased; (23Nov2021) started to decrease; body temperature: (16Nov2021) <=38.4 Centigrade; echocardiogram: (23Nov2021) left ventricle systolic dysfunction; magnetic resonance imaging: (23Nov2021) showed findings suggestive of myocarditis, notes: Heart MRI showed findings suggestive of myocarditis. Clinical course: The patient was hospitalized on 20Nov2021. A physician (cardiologist) reports regarding a patient - male, 18 years old. The patient received the 1st vaccination dose with Comirnaty (BioNTech, batch No. not known) 0,3 ml intramuscularly on 12Nov2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1960837 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood test, Dyspnoea, Lip swelling, Malaise, Sneezing, Stridor
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic urticaria (chronic spontaneous urticaria)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood tests; Result Unstructured Data: Test Result:Unknown results.
CDC Split Type: NLPFIZER INC202101719505

Write-up: This is a spontaneous report received from a contactable reporter (physician) from the Regulatory Authority. Regulatory number: NL-LRB-00716489 (RA). A 17-year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FG6273) at the age of 17 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic urticaria" (ongoing), notes: chronic spontaneous urticaria. The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (dose 1, single), administration date: 09Sep2021, for covid-19 immunisation, reaction(s): "Edema", "Urticaria", "Dyspnoea". The following information was reported: ANAPHYLACTIC REACTION (hospitalization, life threatening) with onset 16Nov2021, outcome "recovering", described as "after 20 min: sneezing fit, thick lips, not getting well, stuffy, wheezing. adrenaline given."; DYSPNOEA (hospitalization, life threatening) with onset 16Nov2021, outcome "recovering", described as "Muggy"; STRIDOR (hospitalization, life threatening) with onset 16Nov2021, outcome "recovering", described as "Beep"; MALAISE (hospitalization, life threatening) with onset 16Nov2021, outcome "recovering", described as "Feeling unwell"; SNEEZING (hospitalization, life threatening) with onset 16Nov2021, outcome "recovering", described as "Sneeze"; LIP SWELLING (hospitalization, life threatening) with onset 16Nov2021, outcome "recovering", described as "Thick lips". The patient was hospitalized for anaphylactic reaction, dyspnoea, stridor, malaise, sneezing, lip swelling (hospitalization duration: 3 day(s)). The patient underwent the following laboratory tests and procedures: blood test: unknown results. Therapeutic measures were taken as a result of anaphylactic reaction, dyspnoea, stridor, malaise, sneezing, lip swelling. Additional information ADR: anaphylaxis with protraction course. Confounding factors, allergy: presumably PEG. Treatment: anaphylactic reaction and its symptoms were treated with adrenaline 1.5 mg IM and later continuous adrenaline IV, prednisone 25 mg, and Tavegyl. The patient was recovering from anaphylactic reaction, dyspnoea, feeling unwell, lip swelling, sneezing and stridor 3 days after onset. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s): NL-PFIZER INC-202101724858 same patient, different dose, and ADR.


VAERS ID: 1960984 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-11-16
   Days after vaccination:104
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4442 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20211116; Test Name: COVID-19; Test Result: Positive ; Comments: positive Iu international unit(s)
CDC Split Type: PTPFIZER INC202101736201

Write-up: Covid + 16Nov2021; Covid +; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Agency Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202111-1661 (INFARMED). A 62 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 04Aug2021 (Lot number: FG4442) as dose 2, 0.3ml, single and intramuscular, administration date 07Jul2021 (Lot number: FA4632) as dose 1, 0.3ml, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Covid + 16Nov2021"; COVID-19 (medically significant) with onset 16Nov2021, outcome "unknown", described as "Covid +". The patient underwent the following laboratory tests and procedures: covid-19: (16Nov2021) positive, notes: positive Iu international unit(s). Clinical Course includes: The reporter''s assessment of the causal relationship of the [All events] with the suspect product was: Source of assessment: Notifier, Method of assessment: Unknown, Result of Assessment: Probable Reporter Comment: Other information-First dose: 07Jul2021~Pfizer~FA4632 No follow-up attempts are possible. No further information is expected.


VAERS ID: 1961002 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SDFE2 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Chills, Cough, Pruritus, Swelling of eyelid, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC202101730801

Write-up: This is a spontaneous report received from a contactable reporter(s) (physician) from the regulatory authority. Regulatory number: RO-NMA-2021-SPCOV15071 (RA). A 47-year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: SDFE2) at the age of 47 years 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), for COVID-19 immunization. The following information was reported: CHILLS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Chills"; ANAPHYLACTIC REACTION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Anaphylactic reaction"; PRURITUS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Pruritus"; COUGH (medically significant) with onset 16Nov2021, outcome "unknown", described as "Dry cough"; SWELLING OF EYELID (medically significant) with onset 16Nov2021, outcome "unknown", described as "Palpebral angioedema"; THROAT TIGHTNESS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Foreign body sensation in the pharynx". The events "chills", "anaphylactic reaction", "pruritus", "dry cough", "palpebral angioedema" and "foreign body sensation in the pharynx" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of chills, anaphylactic reaction, pruritus, cough, swelling of eyelid, throat tightness. Clinical course: On 16Nov2021 the patient received the second dose of Comirnaty. On the same day, at the vaccination centre, 4 minutes after vaccination the patient experienced anaphylactic reaction, palpebral angioedema, pruritus, as a corrective therapy the patient received hydrocortisone hemi succinate. Chills appear after 20 minutes, dry cough, foreign pharyngeal sensation, cutaneous pruritus, adrenaline was administered. After one hour from the administration, the condition was improved, the patient remains in the emergency room for observation. In the reporter''s opinion the events were related to Comirnaty, lot SDFE2. The patient was not diagnosed with SARS-CoV-2 infection before or after vaccination. Information received on 18-Nov-2021 from the Regulatory Authority (RA), Bucharest: following investigation of the case the conclusions were that the case is: vaccine-induced AEFI. Sender''s comment: This case was reported by a physician in the Regulatory Authority (RA) and received by the Regulatory Authority (RA). The seriousness of the case was not provided by the Reporter. The case was considered serious (other medically important) by the Sender (RA) based on IME List. No follow-up attempts were possible. No further information was expected.


VAERS ID: 1963643 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-02
Onset:2021-11-16
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5782 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hot flush, Lip disorder, Myalgia, Paraesthesia oral, Tinnitus, Vaccination site reaction, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hearing impairment (narrow), Vestibular disorders (narrow), 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: Medical History/Concurrent Conditions: Abstains from alcohol; Contraception; Non-smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101728386

Write-up: Headache; Lips that fall asleep; Hot flush; Joint pain; Chills; Fatigue; Vertigo; Buzzing in the ears; Muscle pain; Injection site reaction; Pounding in head; lips fall asleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the RA. The reporter is the patient. Regulatory number: BE-FAMHP-DHH-N2021-109419 (ra). A 23 year-old female patient received bnt162b2 (COMIRNATY), administration date 02Nov2021 (Lot number: Fj5782) as dose 1, single for covid-19 immunisation. Relevant medical history included: "I don''t smoke" (unspecified if ongoing); "I don''t drink" (unspecified if ongoing); "Contraceptive pill" (unspecified if ongoing). The patient took concomitant medication: Contraceptive pill. The following information was reported: HEADACHE (disability) with onset 16Nov2021, outcome "not recovered", described as "Headache"; PARAESTHESIA ORAL (disability) with onset 16Nov2021, outcome "not recovered", described as "Lips that fall asleep"; HOT FLUSH (disability) with onset 16Nov2021, outcome "not recovered", described as "Hot flush"; ARTHRALGIA (disability) with onset 16Nov2021, outcome "not recovered", described as "Joint pain"; CHILLS (disability) with onset 16Nov2021, outcome "not recovered", described as "Chills"; FATIGUE (disability) with onset 16Nov2021, outcome "not recovered", described as "Fatigue"; VERTIGO (disability) with onset 16Nov2021, outcome "not recovered", described as "Vertigo"; TINNITUS (disability) with onset 16Nov2021, outcome "not recovered", described as "Buzzing in the ears"; MYALGIA (disability) with onset 16Nov2021, outcome "not recovered", described as "Muscle pain"; VACCINATION SITE REACTION (disability) with onset 16Nov2021, outcome "not recovered", described as "Injection site reaction"; HEADACHE (disability) with onset 16Nov2021, outcome "not recovered", described as "Pounding in head"; LIP DISORDER (disability) with onset 16Nov2021, outcome "not recovered", described as "lips fall asleep". Therapeutic measures were not taken as a result of headache, paraesthesia oral, hot flush, arthralgia, chills, fatigue, vertigo, tinnitus, myalgia, vaccination site reaction, headache, lip disorder. Clinical course: The vaccine itself was bad for me. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1963705 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Extensive swelling of vaccinated limb, Fatigue, Headache, Joint stiffness, Musculoskeletal chest pain, Myalgia, Pain in jaw, Uterine pain, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth, Vulvovaginal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (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: SIPRALEXA; L-THYROXINE [LEVOTHYROXINE]; ALPRAZOLAM; PANTOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Delivery (6 weeks ago); Gastric bypass
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101728488

Write-up: Vaginal pain; Pain in the ribs; Headache; clenching of the jaw; Clenching of the jaw on the side of the injection with pain; Pain at the injection site; Fatigue; Injection site redness; Joint pain; Muscle pain; Swelling at the injection site; warmth at the injection site; Extended arm swelling; Uterine pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency WEB. Regulatory number: BE-FAMHP-DHH-N2021-109421 (RA). A 30 year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: Unknown) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gastric bypass" (unspecified if ongoing); "delivery" (unspecified if ongoing), notes: 6 weeks ago. Concomitant medication(s) included: escitalopram oxalate (SIPRALEXA); L-THYROXINE [LEVOTHYROXINE]; ALPRAZOLAM; PANTOPRAZOLE. Vaccination history included: Comirnaty (first dose; batch number: FG9019), administration date: 26Oct2021, for COVID-19 immunisation, reaction(s): "Vaginal pain"; Comirnaty (first dose; batch number: FG9019), administration date: 26Oct2021, for covid-19 immunisation, reaction(s): "uterine pain". The following information was reported: VULVOVAGINAL PAIN (disability) with onset 16Nov2021, outcome "unknown", described as "Vaginal pain"; MUSCULOSKELETAL CHEST PAIN (disability) with onset 16Nov2021, outcome "unknown", described as "Pain in the ribs"; HEADACHE (disability) with onset 16Nov2021, outcome "unknown", described as "Headache"; JOINT STIFFNESS (disability) with onset 16Nov2021, outcome "unknown", described as "clenching of the jaw"; PAIN IN JAW (disability) with onset 16Nov2021, outcome "unknown", described as "Clenching of the jaw on the side of the injection with pain"; VACCINATION SITE PAIN (disability) with onset 16Nov2021, outcome "unknown", described as "Pain at the injection site"; FATIGUE (disability) with onset 16Nov2021, outcome "unknown", described as "Fatigue"; VACCINATION SITE ERYTHEMA (disability) with onset 16Nov2021, outcome "unknown", described as "Injection site redness"; ARTHRALGIA (disability) with onset 16Nov2021, outcome "unknown", described as "Joint pain"; MYALGIA (disability) with onset 16Nov2021, outcome "unknown", described as "Muscle pain"; VACCINATION SITE SWELLING (disability) with onset 16Nov2021, outcome "unknown", described as "Swelling at the injection site"; VACCINATION SITE WARMTH (disability) with onset 16Nov2021, outcome "unknown", described as "warmth at the injection site "; EXTENSIVE SWELLING OF VACCINATED LIMB (disability) with onset 16Nov2021, outcome "unknown", described as "Extended arm swelling"; UTERINE PAIN (disability) with onset 16Nov2021, outcome "unknown", described as "Uterine pain". Therapeutic measures were not taken as a result of vulvovaginal pain, musculoskeletal chest pain, headache, joint stiffness, pain in jaw, vaccination site pain, fatigue, vaccination site erythema, arthralgia, myalgia, vaccination site swelling, vaccination site warmth, extensive swelling of vaccinated limb, uterine pain. Reporter Comment: Vaginal pain, uterine pain (delivery 6 weeks ago) already present at the first dose but stronger this time. Clenching of the jaw on the side of the injection with pain. Intense headache Swelling, pain and warmth at the injection site extended over a diameter of 11 cm Pain in the ribs on the side of the injection. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Vaginal pain, uterine pain (delivery 6 weeks ago) already present at the first dose but stronger this time. Clenching of the jaw on the side of the injection with pain. Intense headache Swelling, pain and warmth at the injection site extended over a diameter of 11 cm Pain in the ribs on the side of the injection.; Sender''s Comments: Linked Report(s) : BE-PFIZER INC-202101775402 same patient/product, different events


VAERS ID: 1964043 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 F48469 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Immunisation, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), 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: RIVOTRIL; PRAMIPEXOL MABO; PREGABALIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101733844

Write-up: Booster; Shivering; Fatigue; Severe muscle and joint pain all over the body; Severe muscle and joint pain all over the body; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP) from the Regulatory Authority-WEB. The reporter is the patient. Regulatory number: BE-FAMHP-DHH-N2021-109480 (RA). A 69-year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: F48469) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: RIVOTRIL; PRAMIPEXOL MABO; PREGABALIN. Vaccination history included: Comirnaty (1st dose), for Covid-19 immunisation; Comirnaty (2nd dose), for Covid-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 16Nov2021, outcome "unknown", described as "Booster"; CHILLS (disability) with onset 16Nov2021, outcome "recovering", described as "Shivering"; FATIGUE (disability) with onset 16Nov2021, outcome "recovering", described as "Fatigue"; MYALGIA (disability), ARTHRALGIA (disability) all with onset 16Nov2021, outcome "recovering" and all described as "Severe muscle and joint pain all over the body". Therapeutic measures were not taken as a result of chills, fatigue, myalgia, arthralgia. Additional information: Date of end of reaction/event (Shivering, Fatigue, Arthralgia, Myalgia) 18Nov2021. Reporter Comment: Treatment - No. Evolution of the ADR - Recovering. ADR description - Severe muscle and joint pain all over the body. Also a fatigue, I was too tired to move a foot (also considering the pain). No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Treatment - No. Evolution of the ADR - Recovering. ADR description - Severe muscle and joint pain all over the body. Also a fatigue, I was too tired to move a foot (also considering the pain).


VAERS ID: 1964213 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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: COVID-19, Chest X-ray, Immunisation, SARS-CoV-2 test positive, Ultrasound Doppler, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: APROVEL; GLUCOPHAGE; CRESTOR; AMARYL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Hypertriglyceridaemia; Multiple myeloma (multiple IgG myeloma (undergoing chemo, last course in september)); Type II diabetes mellitus (non insulin requiring type II diabetes)
Allergies:
Diagnostic Lab Data: Test Name: chest x-ray; Result Unstructured Data: Test Result:shows its bilateral diffuse infiltrates; Comments: predominantly in the bases.; Test Date: 20211124; Test Name: COVID-19 PCR test positive; Test Result: Positive ; Test Name: veinous Doppler ultrasound; Result Unstructured Data: Test Result:negative for a venous thrombosis
CDC Split Type: CHPFIZER INC202101766538

Write-up: COVID-19; Vaccination failure; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: CH-SM-2021-29293. A 78 year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 78 years as dose 3 (booster), single, administration date 10Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date 13Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Plasma cell myeloma" (unspecified if ongoing), notes: multiple IgG myeloma (undergoing chemo, last course in september); "Hypertension" (unspecified if ongoing); "Hypertriglyceridaemia" (unspecified if ongoing); "Type 2 diabetes mellitus" (unspecified if ongoing), notes: non insulin requiring type II diabetes. Concomitant medication(s) included: APROVEL; GLUCOPHAGE; CRESTOR; AMARYL. The following information was reported: VACCINATION FAILURE (hospitalization) with onset 19Nov2021, outcome "recovered" (27Nov2021), described as "Vaccination failure"; SARS-COV-2 TEST POSITIVE (hospitalization) with onset 24Nov2021, outcome "unknown", described as "COVID-19 PCR test positive"; COVID-19 (hospitalization), outcome "recovered", described as "COVID-19"; IMMUNISATION (non-serious) with onset 16Nov2021, outcome "unknown", described as "Booster". The patient underwent the following laboratory tests and procedures: chest x-ray: (unspecified date) shows its bilateral diffuse infiltrates, notes: predominantly in the bases; sars-cov-2 test positive: (24Nov2021) positive; ultrasound doppler: (unspecified date) negative for a venous thrombosis. Clinical information: Regulatory authority assessed this case as serious with seriousness criteria serious (hospitalization) Causality assessment: A causal relationship between Comirnaty and Vaccination failure, COVID-19 PCR test positive, COVID-19 was assessed as being Possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1964294 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-19
Onset:2021-11-16
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH S0CN1 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chest X-ray, Chest pain, Cough, Dyspnoea, Echocardiogram, Feeling cold, Headache, Heart rate, Oropharyngeal pain, Palpitations, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life 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: 20211116; Test Name: body temperature; Result Unstructured Data: Test Result:fever; Test Name: Chest x-ray; Result Unstructured Data: Test Result:unknown results; Test Name: Echo; Result Unstructured Data: Test Result:unknown results; Test Date: 20211116; Test Name: heart rate; Result Unstructured Data: Test Result:racing
CDC Split Type: DEPFIZER INC202101728955

Write-up: Throat pain; Short of breath; Headache; stabbing chest pain; Chilliness; Dry cough; Fever; Heart racing; This is a spontaneous report received from a non-contactable Physician. Other Case identifier(s): DE-PEI-202100260137 (PEI), DE-DCGMA-21194868 (DCGMA). A 24 year-old female patient received bnt162b2 (COMIRNATY, Strength 0.3ml), intramuscular, administration date 19Oct2021 (Lot number: S0CN1) at the age of 24 years as single dose for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Throat pain"; DYSPNOEA (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Short of breath"; HEADACHE (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Headache"; CHEST PAIN (medically significant) with onset 16Nov2021, outcome "not recovered", described as "stabbing chest pain"; FEELING COLD (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Chilliness"; COUGH (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Dry cough"; PYREXIA (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Fever"; PALPITATIONS (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Heart racing". The patient underwent the following laboratory tests and procedures: chest x-ray: (unspecified date) unknown results; echocardiogram: (unspecified date) unknown results; body temperature: (16Nov2021) fever; heart rate: (16Nov2021) racing. Measures: Cefurox 500 -1-0-1, salbutamol. Relatedness of drug to all events/Source of assessment: PEI/D. Unclassifiable. Reporter Comment: Measures: Cefurox 500 -1-0-1, salbutamol, echo, chest x-ray. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Measures: Cefurox 500 -1-0-1, salbutamol, echo, chest x-ray.


VAERS ID: 1964299 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-16
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, C-reactive protein increased, Cytomegalovirus test, Epstein-Barr virus test, Hepatitis viral test, Investigation, Laboratory test, Lipase, Lipase increased, Pyrexia, Transaminases, Transaminases increased, Troponin I, Ultrasound scan
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: RAMIPRIL; EUTHYROX; ALLOPURINOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; COVID-19; Gout attack; Hypothyreosis; Pollen allergy
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: body temperature; Result Unstructured Data: Test Result:fever; Test Date: 20211116; Test Name: C-reactive protein; Result Unstructured Data: Test Result:increased; Test Name: Cytomegalovirus; Result Unstructured Data: Test Result:no evidence of acute infection; Test Name: EBV; Result Unstructured Data: Test Result:no evidence of acute infection; Test Name: Serology for hepatitis; Result Unstructured Data: Test Result:no evidence of acute infection; Test Name: Investigation NOS; Result Unstructured Data: Test Result:no matching clinical picture of pancreatitis; Test Name: Laboratory test; Result Unstructured Data: Test Result:Elevated infection values without tangible finding; Test Date: 20211116; Test Name: Lipase; Result Unstructured Data: Test Result:Elevated; Test Date: 20211116; Test Name: Transaminase; Result Unstructured Data: Test Result:Elevated; Test Name: Troponin I; Result Unstructured Data: Test Result:44; Test Name: Sonography; Result Unstructured Data: Test Result:id not reveal any pathology of the upper abdomen
CDC Split Type: DEPFIZER INC202101728919

Write-up: Intermittent fever; Lipase increased; Transaminases increased; C-reactive protein increased; This is a spontaneous report received from a non-contactable Physician from the regulatory authority-WEB. Other Case identifier(s): DE-PEI-202100261222 (PEI), DE-DCGMA-21194911 (DCGMA). A 52 year-old female patient received bnt162b2 (COMIRNATY, Strength 0.3ml), intramuscular, administration date 2021 (Lot number: Unknown) at the age of 52 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Hypothyreosis" (unknown if ongoing); "Arterial hypertension" (unknown if ongoing); "Gout attack" (not ongoing); "Pollen allergy" (unknown if ongoing); "COVID-19" (not ongoing). Concomitant medications included: RAMIPRIL taken for arterial hypertension; EUTHYROX taken for hypothyroidism; ALLOPURINOL taken for gout. The following information was reported: PYREXIA (medically significant, Hospitalization) with onset 16Nov2021, outcome "not recovered", described as "Intermittent fever"; LIPASE INCREASED (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Lipase increased"; TRANSAMINASES INCREASED (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Transaminases increased"; C-REACTIVE PROTEIN INCREASED (medically significant) with onset 16Nov2021, outcome "not recovered", described as "C-reactive protein increased". The patient underwent the following laboratory tests and procedures: body temperature: (16Nov2021) fever; c-reactive protein: (16Nov2021) increased; cytomegalovirus test: (unspecified date) no evidence of acute infection; epstein-barr virus test: (unspecified date) no evidence of acute infection; hepatitis viral test: (unspecified date) no evidence of acute infection; investigation: (unspecified date) no matching clinical picture of pancreatitis; laboratory test: (unspecified date) elevated infection values without tangible finding; lipase: (16Nov2021) elevated; transaminases: (16Nov2021) elevated; troponin i: (unspecified date) 44; ultrasound scan: (unspecified date) id not reveal any pathology of the upper abdomen. Relatedness assessment: Intermittent fever, Lipase increased, Transaminases increased, C-reactive protein increased: D. Unclassifiable; Source of assessment: PEI. Reporter Comment: Inpatient admission was due to intermittent fever. Elevated infection values without tangible findings. Elevated transaminases and lipase. There was no matching clinical picture of pancreatitis. Anti-infective therapy was omitted in the absence of a clinical focus. Sonography did not reveal any pathology of the upper abdomen. Serology for hepatitis, Cytomegalovirus and Epstein-Barr virus showed no evidence of acute infection. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Inpatient admission was due to intermittent fever, Elevated infection values without tangible findings. Elevated transaminases and lipase. There was no matching clinical picture of pancreatitis. Anti-infective therapy was omitted in the absence of a clinical focus. Sonography did not reveal any pathology of the upper abdomen. Serology for hepatitis, Cytomegalovirus and Epstein-Barr virus showed no evidence of acute infection.


VAERS ID: 1964714 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 UNKNOWN / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Diarrhoea, Fatigue, Headache, Immunisation, Influenza like illness, Lymphadenopathy, Mobility decreased, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: body temperature; Result Unstructured Data: Test Result:fever
CDC Split Type: FRPFIZER INC202101728301

Write-up: flu syndrome; Diarrhoea; Lymphadenopathy; fever; headache; severe state of fatigue; inability to lift the arm that has undergone the injection; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: FR-AFSSAPS-LL20217765 (RA). A 50 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 16Nov2021 (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: 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: IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "booster"; INFLUENZA LIKE ILLNESS (medically significant) with onset 17Nov2021, outcome "recovering", described as "flu syndrome"; DIARRHOEA (medically significant) with onset 17Nov2021, outcome "recovering", described as "Diarrhoea"; LYMPHADENOPATHY (medically significant) with onset 17Nov2021, outcome "recovering", described as "Lymphadenopathy"; PYREXIA (medically significant) with onset 17Nov2021, outcome "recovering", described as "fever"; HEADACHE (medically significant) with onset 17Nov2021, outcome "recovering", described as "headache"; FATIGUE (medically significant) with onset 17Nov2021, outcome "recovering", described as "severe state of fatigue"; MOBILITY DECREASED (medically significant) with onset 17Nov2021, outcome "recovering", described as "inability to lift the arm that has undergone the injection". The patient underwent the following laboratory tests and procedures: body temperature: fever.Person had not developed a COVID-19 disease. Patient did not tested covid-19. Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1964758 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   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 FG3739 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Auscultation, Blood creatinine, Blood test, C-reactive protein, Chest discomfort, Costochondritis, Electrocardiogram, Fibrin D dimer, Immunisation reaction, Oropharyngeal pain, Positron emission tomogram, Renal function test, Troponin, White blood cell count
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data: Test Name: computed tomography angiography; Result Unstructured Data: Test Result:no pulmonary embolism; Test Name: cardiac auscultation; Result Unstructured Data: Test Result:regular; Test Name: creatinine; Result Unstructured Data: Test Result:53; Test Name: blood work; Result Unstructured Data: Test Result:normal; Comments: no biological inflammatory syndrome; Test Name: C-reactive protein; Result Unstructured Data: Test Result:4.2; Test Name: electrocardiography; Result Unstructured Data: Test Result:non-pathological; Test Name: D-dimers; Result Unstructured Data: Test Result:0.72; Test Name: fluorodeoxyglucose; Result Unstructured Data: Test Result:$g90; Test Name: renal function; Result Unstructured Data: Test Result:okay; Test Name: troponins; Result Unstructured Data: Test Result:<3; Test Name: white blood cells; Result Unstructured Data: Test Result:10.3
CDC Split Type: FRPFIZER INC202101728248

Write-up: Tietze syndrome; Reactogenicity event; Sore throat; Chest pressure sensation/a lump in the lungs, a feeling of tightness and belch-like reflux; .This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: FR-AFSSAPS-MA20215299 (RA). A 28 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 15Nov2021 (Lot number: FG3739) as dose 1, single and intramuscular, administration date 06Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: IMMUNISATION REACTION (medically significant) with onset 16Nov2021, outcome "recovered" (18Nov2021), described as "Reactogenicity event"; OROPHARYNGEAL PAIN (medically significant) with onset 16Nov2021, outcome "recovered" (18Nov2021), described as "Sore throat"; CHEST DISCOMFORT (medically significant) with onset 16Nov2021, outcome "recovered" (18Nov2021), described as "Chest pressure sensation/a lump in the lungs, a feeling of tightness and belch-like reflux"; COSTOCHONDRITIS (non-serious), outcome "recovered", described as "Tietze syndrome". The patient underwent the following laboratory tests and procedures: angiogram: no pulmonary embolism; auscultation: regular; blood creatinine: 53; blood test: normal, notes: no biological inflammatory syndrome; c-reactive protein: 4.2; electrocardiogram: non-pathological; fibrin d dimer: 0.72; positron emission tomogram: $g90; renal function test: okay; troponin: <3; white blood cell count: 10.3. Therapeutic measures were taken as a result of immunisation reaction, oropharyngeal pain, chest discomfort, costochondritis. Patient felt "a lump in the lungs, a feeling of tightness and belch-like reflux". She went to the emergency room where she stayed for 7 hours because of these chest pains. Prescription of a simple analgesic and healing without sequelae in 2 days. The patient took her 2nd dose (D2) on 06Dec2021 with the COMIRNATY vaccine. She presented the same symptoms as the first time, but they were less strong this time. She took PARACETAMOL for symptoms and did not go to her doctor. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1964766 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-11-16
   Days after vaccination:93
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: Decreased appetite, Eye pain, Eye swelling, Fatigue, Ophthalmic herpes zoster, Pain, Swelling face, Visual brightness
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Glaucoma (broad), Ocular infections (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101728188

Write-up: Swelling of the entire left side of the face as well as the eye; Swelling of the entire left side of the face as well as the eye; I felt like stings in the eye and it hurt a lot; A lot of pain on all the left side of the face (throbbing pain); I could not open my eyes, I was too dazzled; A lot of fatigue; loss of appetite; Herpes zoster ophthalmic; 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: FR-AFSSAPS-MA20215427 (RA). A 41 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 15Aug2021 (Lot number: Unknown) at the age of 41 years as dose 2,single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1. Manufacturer unknown.), for Covid-19 immunisation. The following information was reported: OPHTHALMIC HERPES ZOSTER (medically significant) with onset 16Nov2021, outcome "recovering", described as "Herpes zoster ophthalmic"; SWELLING FACE (non-serious), EYE SWELLING (non-serious), outcome "recovering" and all described as "Swelling of the entire left side of the face as well as the eye"; EYE PAIN (non-serious), outcome "recovering", described as "I felt like stings in the eye and it hurt a lot"; PAIN (non-serious), outcome "recovering", described as "A lot of pain on all the left side of the face (throbbing pain)"; VISUAL BRIGHTNESS (non-serious), outcome "recovering", described as "I could not open my eyes, I was too dazzled"; FATIGUE (non-serious), outcome "recovering", described as "A lot of fatigue"; DECREASED APPETITE (non-serious), outcome "recovering", described as "loss of appetite". On 16Nov2021, the shingles requiring medical consultation. On 25Nov2021, the patient was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1964897 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Immunisation
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN; LERCANIDIPINE; PRAZOLE D; ROSUVASTATIN; COVERSYL AM; MACROGOL; UVEDOSE; PARACETAMOL
Current Illness: Dyslipidaemia; Hypertension arterial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101728656

Write-up: Booster; Lip angioedema; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from the Regulatory Authority-WEB. Regulatory number: FR-AFSSAPS-RN20213485 (RA). A 89 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 89 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension arterial" (ongoing); "Dyslipidaemia" (ongoing). Concomitant medication(s) included: ASPIRIN; LERCANIDIPINE; PRAZOLE D; ROSUVASTATIN; COVERSYL AM; MACROGOL; UVEDOSE; PARACETAMOL. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Primary Immunisation series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; ANGIOEDEMA (medically significant) with onset 16Nov2021, outcome "recovered" (16Nov2021), described as "Lip angioedema". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1964925 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-10
Onset:2021-11-16
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH9951 / 1 LA / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blindness unilateral, Visual impairment, Vitreous haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METHOTREXATE; NOVATREX [AZITHROMYCIN]; DEXAFREE; INDOCOLLYRE; SIMBRINZA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Sarcoidosis; Uveitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101730364

Write-up: degraded vision in the left eye; Vitreous hemorrhage; Unqualified visual loss, one eye; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority. -WEB. Regulatory number: FR-AFSSAPS-TO20219121. A 67-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 10Nov2021 (Lot number: FH9951) as dose 1, single for covid-19 immunisation; fluindione (PREVISCAN [FLUINDIONE]), oral (Lot number: Unknown) for product used for unknown indication. Relevant medical history included: "COVID-19" (unspecified if ongoing); "Uveitis" (unspecified if ongoing); "Sarcoidosis" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE; NOVATREX [AZITHROMYCIN]; DEXAFREE; INDOCOLLYRE; SIMBRINZA. On 21Nov2021, the patient experienced Vitreous hemorrhage. On 16Nov201, the patient experienced Unqualified visual loss, one eye. On an unspecified date, the patient experienced degraded vision in the left eye. The action taken for fluindione was unknown. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1964938 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-31
Onset:2021-11-16
   Days after vaccination:77
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Vaccination failure
SMQs:, Lack of efficacy/effect (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: Meningioma; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20214

Write-up: Vaccination failure; This case was received via Regulatory Authority (Reference number: FR-AFSSAPS-TS20215914) on 10-Dec-2021 and was forwarded to Moderna on 10-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of VACCINATION FAILURE (Vaccination failure) in a 68-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient''s past medical history included Dyslipidemia. Concurrent medical conditions included Type 2 diabetes mellitus and Meningioma. On 31-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 16-Nov-2021, the patient experienced VACCINATION FAILURE (Vaccination failure) (seriousness criterion hospitalization). At the time of the report, VACCINATION FAILURE (Vaccination failure) had not resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided by reporter. No treatment drug was provided by reporter. This case concerns a 68-year-old female patient with no relevant medical history, who experienced the unexpected event of Vaccination Failure. The event, which caused hospitalization for the patient, occurred approximately 3 months after receiving an unspecified dose of mRNA-1273 Vaccine. The rechallenge reported as not applicable by the regulatory authority. No hospitalization details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 68-year-old female patient with no relevant medical history, who experienced the unexpected event of Vaccination Failure. The event, which caused hospitalization for the patient, occurred approximately 3 months after receiving an unspecified dose of mRNA-1273 Vaccine. The rechallenge reported as not applicable by the regulatory authority. No hospitalization details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1964949 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-12
Onset:2021-11-16
   Days after vaccination:4
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: Appendicitis
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101738673

Write-up: appendicitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. A 13 year-old female patient received bnt162b2 (COMIRNATY), administration date 12Nov2021 (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: APPENDICITIS (hospitalization) with onset 16Nov2021, outcome "unknown", described as "appendicitis". Therapeutic measures were taken as a result of appendicitis. The reporter''s daughter (a 13 year-old female patient) received her first dose of COMIRNATY vaccine on 12Nov2021. Then, 4 days later, they rushed her to the hospital with vomiting; she had emergency surgery and her appendicitis was removed and was about to burst. The lot number for bnt162b2 was not provided and will be requested during follow-up.


VAERS ID: 1964981 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 FK0112 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Facial pain, Immunisation, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test, Sinus congestion, Tenderness
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Glaucoma (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: Medical History/Concurrent Conditions: Suspected COVID-19 (Tested positive on 27Sep2020)
Allergies:
Diagnostic Lab Data: Test Date: 20200927; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101751746

Write-up: Pain in face; Sore throat; Patient received third dose of Comirnaty on 16Nov2021; Sinus congestion; Fever; Coughing; Tenderness around the jaw and eye sockets; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-APPCOVID-202112071919583130-SPXJV (RA). Other Case identifier(s): GB-MHRA-ADR 26300164 (RA). A 46 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: FK0112) at the age of 46 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 26Sep2020, stop date: 17Oct2020, notes: Tested positive on 27Sep2020. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. Past drug history included: Sertraline, notes: Prescribed Sertraline 100mg. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot number: Unknown), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE, Batch/Lot number: Unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Patient received third dose of Comirnaty on 16Nov2021"; SINUS CONGESTION (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Sinus congestion"; PYREXIA (medically significant) with onset 16Nov2021, outcome "recovering", described as "Fever"; COUGH (medically significant) with onset 16Nov2021, outcome "recovering", described as "Coughing"; FACIAL PAIN (medically significant) with onset 21Nov2021, outcome "recovering", described as "Pain in face"; OROPHARYNGEAL PAIN (medically significant) with onset 21Nov2021, outcome "recovered" (24Nov2021), described as "Sore throat"; TENDERNESS (medically significant) with onset 2021, outcome "unknown", described as "Tenderness around the jaw and eye sockets". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Sep2020) positive. Clinical course: Pain in face relates to tenderness around the jaw and eye sockets. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1965037 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
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: Chills, Confusional state, Diarrhoea, Headache, Injection site mass, Muscular weakness, Pyrexia, SARS-CoV-2 test, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: headache; large; day; Confusion; Chills; Diarrhea; Muscle weakness; Swelling; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26306778) 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 HEADACHE (headache), INJECTION SITE MASS (large), PYREXIA (day), SWELLING (Swelling), MUSCULAR WEAKNESS (Muscle weakness), CONFUSIONAL STATE (Confusion), CHILLS (Chills) and DIARRHOEA (Diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) 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 Vaccination, INFLUENZA VACCINE (INFLUENZA VIRUS) from 18-Sep-2021 to an unknown date for an unknown indication. On 16-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced SWELLING (Swelling) (seriousness criterion disability). On 20-Nov-2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakness) (seriousness criterion disability). On 21-Nov-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion disability). On 22-Nov-2021, the patient experienced CONFUSIONAL STATE (Confusion) (seriousness criterion disability) and CHILLS (Chills) (seriousness criterion disability). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criterion disability), INJECTION SITE MASS (large) (seriousness criterion disability) and PYREXIA (day) (seriousness criterion disability). On 20-Nov-2021, SWELLING (Swelling) had resolved. On 26-Nov-2021, MUSCULAR WEAKNESS (Muscle weakness), CONFUSIONAL STATE (Confusion), CHILLS (Chills) and DIARRHOEA (Diarrhea) had resolved. At the time of the report, HEADACHE (headache), INJECTION SITE MASS (large) and PYREXIA (day) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Nov-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment information was not provided. Large, egg shaped swelling at injection site. Felt ''off colour'' for the next few days. Headache on day 5, day 6 extreme muscle weakness, lack of focus and confusion, chills and diarrhea. Confusion had passed by day 9, felt a lot better by day 11. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial Company comment: This is a regulatory case concerning a patient of unknown age and gender with no reported medical history and administration of influenza vaccine 2 months prior, who experienced the serious (due to disability) unexpected, according CCDS, events of headache, Injection site mass, pyrexia, swelling, Muscular weakness, Confusional state, chills and Diarrhoea. The event Swelling, occurred the same day after the booster dose of mRNA-1273 vaccine; the event Muscular weakness 4 days after; the event Diarrhoea 5 days after; the events Confusional state and chills 6 days after; the events headache, pyrexia and Injection site mass on an unknown date. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The administration of influenza vaccine 2 months prior remains a confounder. The patient received two doses of COVID-19 vaccine AstraZeneca approximately 7 months prior, interchange of vaccine products is considered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a patient of unknown age and gender with no reported medical history and administration of influenza vaccine 2 months prior, who experienced the serious (due to disability) unexpected, according CCDS, events of headache, Injection site mass, pyrexia, swelling, Muscular weakness, Confusional state, chills and Diarrhoea. The event Swelling, occurred the same day after the booster dose of mRNA-1273 vaccine; the event Muscular weakness 4 days after; the event Diarrhoea 5 days after; the events Confusional state and chills 6 days after; the events headache, pyrexia and Injection site mass on an unknown date. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The administration of influenza vaccine 2 months prior remains a confounder. The patient received two doses of COVID-19 vaccine AstraZeneca approximately 7 months prior, interchange of vaccine products is considered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1965044 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 FG6431 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Back pain, Confusional state, Immunisation, Influenza, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (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), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101734363

Write-up: Acute back pain; Stomach ache; Flu symptoms; booster; Mental confusion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: GB-MHRA-WEBCOVID-202111301325533520-2S1HB (RA). Other Case identifier(s): GB-MHRA-ADR 26271401 (RA). A 47 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FG6431) at the age of 47 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), for COVID-19 immunisation; Bnt162b2 (Dose 2), for covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "booster"; CONFUSIONAL STATE (medically significant) with onset 16Nov2021, outcome "recovered" (18Nov2021), described as "Mental confusion"; BACK PAIN (medically significant) with onset 18Nov2021, outcome "recovering", described as "Acute back pain"; ABDOMINAL PAIN UPPER (medically significant) with onset 18Nov2021, outcome "recovering", described as "Stomach ache"; INFLUENZA (medically significant) with onset 17Nov2021, outcome "recovered" (18Nov2021), described as "Flu symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) negative, notes: No - Negative COVID-19 test. Clinical course: Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1965055 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-23
Onset:2021-11-16
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest X-ray, Cough, Diarrhoea, Dyspnoea, Fatigue, Headache, Memory impairment, Myalgia, Oropharyngeal pain, Pain, Pharyngeal swelling, Pyrexia, Respiratory distress, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: chest x-ray; Result Unstructured Data: Test Result:Unknown; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101743398

Write-up: cough; high temperature; sore throat; shortness of breath; extreme aches and pains all over body; Generalised muscle aches; Fever; Throat swelling; Breathlessness; Fatigue; Respiratory distress; Forgetfulness; Diarrhea; Headache fullness; This is a spontaneous report received from contactable reporter(s) (Other HCP) from the regulatory authority-WEB. Regulatory number: GB-MHRA-WEBCOVID-202112021807305830-3CIC3 (regulatory authority). Other Case identifier(s): GB-MHRA-ADR 26282774 (regulatory authority). A 33 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 23Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Date of last menstrual period: 14Nov2021. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose-1), for COVID-19 immunisation, reaction(s): "diarrhoea". The following information was reported: DYSPNOEA (medically significant) with onset 17Nov2021, outcome "recovered" (19Nov2021), described as "Breathlessness"; FATIGUE (medically significant) with onset 17Nov2021, outcome "recovering", described as "Fatigue"; RESPIRATORY DISTRESS (medically significant) with onset 17Nov2021, outcome "recovered" (19Nov2021), described as "Respiratory distress"; MEMORY IMPAIRMENT (medically significant) with onset 17Nov2021, outcome "recovering", described as "Forgetfulness"; COUGH (medically significant), outcome "not recovered", described as "cough"; PHARYNGEAL SWELLING (medically significant) with onset 17Nov2021, outcome "recovered" (19Nov2021), described as "Throat swelling"; PYREXIA (medically significant), outcome "not recovered", described as "high temperature"; PYREXIA (medically significant) with onset 17Nov2021, outcome "recovered with sequelae" (25Nov2021), described as "Fever"; DIARRHOEA (medically significant) with onset 16Nov2021, outcome "recovered" (18Nov2021), described as "Diarrhea"; OROPHARYNGEAL PAIN (medically significant), outcome "not recovered", described as "sore throat"; DYSPNOEA (medically significant), outcome "not recovered", described as "shortness of breath"; HEADACHE (medically significant) with onset 16Nov2021, outcome "recovered" (26Nov2021), described as "Headache fullness"; MYALGIA (medically significant) with onset 17Nov2021, outcome "recovering", described as "Generalised muscle aches"; PAIN (medically significant), outcome "unknown", described as "extreme aches and pains all over body". The patient underwent the following laboratory tests and procedures: chest x-ray: unknown; sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of dyspnoea, fatigue, respiratory distress, memory impairment, cough, pharyngeal swelling, pyrexia, pyrexia, diarrhoea, oropharyngeal pain, dyspnoea, headache, myalgia, pain. Clinical course: Last menstrual period date was 14Nov2021. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Became very unwell after receiving 2nd vaccine, started with diarrhoea within the first of getting vaccine that continued for 48 hours followed by extreme headaches, throat closing over making it hard to breath, shortness of breath, fever/high temperature/extreme fatigue/extreme aches and pains all over body, cough and sore throat. Seen by GP which then organised an ambulance to transfer the patient to hospital. Penicillin and fluids were given. Co-codamol. The patient was sent home on a week supply of antibiotics. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. This report did not relate to possible blood clots or low platelet counts, myocarditis or pericarditis. Chest x-ray was done. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1965262 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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: Asthma, Cough, Dyspnoea, Immunisation, Lethargy, Productive cough, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Hypoglycaemia (broad), Infective pneumonia (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: AMLODIPINE BESILATE; BECLOMETASONE DIPROPIONATE; LOSARTAN POTASSIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Clinical trial participant (Study); Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20211127; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101739533

Write-up: Cough; Breathlessness; Asthma/Asthma exacerbated; Lethargy; Phlegm; The patient received third (booster) dose; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112060705439820-Z93UZ (regulatory authority). Other Case identifier(s): GB-MHRA-ADR 26294181 (regulatory authority). A 55 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FH8469) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Hypertension arterial" (unspecified if ongoing); "Clinical trial participant" (unspecified if ongoing), notes: Study. Unsure if patient has had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding. Concomitant medication(s) included: AMLODIPINE BESILATE taken for hypertension, start date: 14Jan2021; BECLOMETASONE DIPROPIONATE taken for asthma, start date: 01May1998; LOSARTAN POTASSIUM taken for hypertension, start date: 01Mar2021. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE;Lot number: Unknown; Route of administration: Unknown.), for COVID-19 immunisation; Bnt162b2 (DOSE 1, SINGLE;Lot number: Unknown; Route of administration: Unknown.), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "The patient received third (booster) dose"; COUGH (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Cough"; DYSPNOEA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Breathlessness"; ASTHMA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Asthma/Asthma exacerbated"; LETHARGY (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Lethargy"; PRODUCTIVE COUGH (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Phlegm". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Nov2021) no - negative covid-19 test. Therapeutic measures were taken as a result of cough, dyspnoea, asthma, productive cough. Detail course was reported as Exacerbated asthma symptoms within 12 hours if booster. GP has stepped up asthma treatment and prescribed Fostair inhaler on 2021/12/03. 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: 1965374 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Hypoaesthesia, Immunisation, Interchange of vaccine products, Neck pain, Off label use, Pain, SARS-CoV-2 test, Sensitive skin, Vaccination site erythema
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Arthritis (broad), Medication errors (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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101739151

Write-up: aching; painful for a week; neck skin feels sensitive and slightly numb; Sensitive skin; Off label use; Interchange of vaccine products; Booster; Shoulder soreness; Neck pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112061725272570-LRMCK. Other Case identifier(s): GB-MHRA-ADR 26296804. A 63 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 63 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 (1ST DOSE, MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (2ND DOSE, MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; ARTHRALGIA (medically significant) with onset 16Nov2021, outcome "recovering", described as "Shoulder soreness"; NECK PAIN (medically significant) with onset 16Nov2021, outcome "recovered with sequelae" (2021), described as "Neck pain"; PAIN (medically significant), outcome "recovering", described as "aching"; SENSITIVE SKIN (medically significant) with onset 23Nov2021, outcome "recovered with sequelae" (2021), described as "Sensitive skin"; VACCINATION SITE ERYTHEMA (medically significant), outcome "recovering", described as "painful for a week"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "neck skin feels sensitive and slightly numb". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: Unsure if patient has had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. It was reported that, patient had aching, pain of left shoulder and neck started straight away following injection in left arm. Painful for a week, had phone conversation with doctor following 111. Pain has subsided but neck skin feels sensitive and slightly numb. 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: 1965946 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN ACA5778 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Recovered from COVID-19 six months before vaccination); Comments: Currently healthy
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: Body temperature; Result Unstructured Data: 39.6 C.
CDC Split Type: HRJNJFOC20211235712

Write-up: This spontaneous report received from a consumer by a Regulatory Authority (EVHUMAN Vaccines, HR-HALMED-300052663) on 15-DEC-2021 and concerned a 39-year-old male patient of unspecified race and ethnicity. The patient''s height, and weight were not reported. The patient''s past medical history included: covid-19 on MAY/2021 (recovered from COVID-19 six months before vaccination), and other pre-existing medical conditions included: Patient was healthy at the time of reporting. The patient received covid-19 vaccine (Dose number in series 1) (suspension for injection, intramuscular, batch number: ACA5778 and expiry: unknown) dose was not reported, 1 total, administered on 15-NOV-2021 for covid-19 immunization. No concomitant medications were reported. On 16-NOV-2021, the patient experienced high temperature. Laboratory data included: Body temperature (NR: 36 - 37) 39.6 Celsius. The action taken with covid-19 vaccine was not applicable. The patient recovered from high temperature on 17-NOV-2021. This report was serious (Other Medically Important Condition).


VAERS ID: 1965952 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
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: Chills, Influenza like illness, Musculoskeletal stiffness, Nasopharyngitis, Pain in extremity, Pain of skin, Palpitations, Poor quality sleep, Temperature regulation disorder
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (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: OLMESARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101728913

Write-up: UNABLE TO MAINTAIN BODY HEAT; PAINS IN LIMBS; AWAKE ALL NIGHT; COLD FLU LIKE SYMPTOMS; SORE SKIN; STIFFNESS OF LIMBS; HEART PALPITATIONS, AS THOUGH MY HEART WAS GOING TO COME OUT OF MY CHEST / SEVERE HEART PALPITATIONS; COLD FLU LIKE SYMPTOMS; SHIVERING ALL NIGHT LONG; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: IE-HPRA-2021-087061. Other Case identifier(s): IE-HPRA-CVARR2021111922740. A 70 year-old male patient received bnt162b2 (COMIRNATY), administration date 15Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN. Vaccination history included: Vaxzevria (Chimpanzee Adenovirus encoding the SARS CoV 2 Spike glycoprotein (ChAdOx1-S), Dose 2), for COVID-19 immunization, reaction(s): "no adverse effect"; Vaxzevria (Chimpanzee Adenovirus encoding the SARS CoV 2 Spike glycoprotein (ChAdOx1-S), Dose 1), for COVID-19 immunization, reaction(s): "no adverse effect". Patient had no history of Covid-19 infection. The following information was reported: TEMPERATURE REGULATION DISORDER (disability, medically significant) with onset 16Nov2021, outcome "recovered", described as "UNABLE TO MAINTAIN BODY HEAT"; PAIN IN EXTREMITY (disability) with onset 16Nov2021, outcome "recovered", described as "PAINS IN LIMBS"; POOR QUALITY SLEEP (disability) with onset 16Nov2021, outcome "recovered", described as "AWAKE ALL NIGHT"; NASOPHARYNGITIS (disability), INFLUENZA LIKE ILLNESS (disability) all with onset 16Nov2021, outcome "recovered" and all described as "COLD FLU LIKE SYMPTOMS"; PAIN OF SKIN (disability) with onset 16Nov2021, outcome "recovered", described as "SORE SKIN"; MUSCULOSKELETAL STIFFNESS (disability) with onset 16Nov2021, outcome "recovered", described as "STIFFNESS OF LIMBS"; PALPITATIONS (disability) with onset 16Nov2021, outcome "recovered" after four hours, described as "HEART PALPITATIONS, AS THOUGH MY HEART WAS GOING TO COME OUT OF MY CHEST / SEVERE HEART PALPITATIONS"; CHILLS (disability) with onset 16Nov2021, outcome "recovered", after four hours described as "SHIVERING ALL NIGHT LONG". Time onset of the reactions were 10 hours. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1965955 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 JH8469 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Burning sensation, Dyspnoea, Fatigue, Headache, Immunisation, Interchange of vaccine products, Myalgia, Off label use, Palpitations, Rash erythematous, Rash macular
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101733965

Write-up: Legs Burning Feeling; Heart racing; Large red patches of rash on body / 48 Hrs after booster top torso in red rash / Large red blotches / Rach; Anaphylactic shock; Shortness of breath; Large red blotches / Rash; Fatigue; Headache; Aching Muscles; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional) from the Agency WEB. Regulatory number: IE-HPRA-2021-087083 (RA). A female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: JH8469) as dose 3 (booster), single for covid-19 immunization. The patient''s relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Vaxzevria (DOSE NUMBER: 1, batch details: ABV3025), administration date: 16Feb2021, for COVID-19 immunization; Vaxzevria (DOSE NUMBER: 2, batch details: ABX3507), administration date: 25May2021, for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; BURNING SENSATION (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Legs Burning Feeling"; PALPITATIONS (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Heart racing"; HEADACHE (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Headache"; MYALGIA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Aching Muscles"; RASH ERYTHEMATOUS (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Large red patches of rash on body / 48 Hrs after booster top torso in red rash / Large red blotches / Rach"; ANAPHYLACTIC SHOCK (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Anaphylactic shock"; DYSPNOEA (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Shortness of breath"; RASH MACULAR (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Large red blotches / Rash"; FATIGUE (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Fatigue". Therapeutic measures were taken as a result of burning sensation, palpitations, headache, myalgia, rash erythematous, anaphylactic shock, dyspnoea, rash macular, fatigue. Clinical Course: Less than 24 hours later, on 17Nov2021, the patient experienced aching muscles, fatigue and a headache. 48 hours later, on 18Nov2021, the patient experienced red rash, described as "top torso in red rash". The patient then experienced a burning feeling on their legs, with large, red blotches/rash, described as "large red patches of rash on body," shortness of breath and heart racing. This had persisted for over forty-eight hours and remained the same, at the time of reporting. The patient reported also anaphylactic shock. The patient was treated with epinephrine and hydrocortisone. At the time of reporting, the patient had not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1966020 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006275 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Hypertension, Insomnia, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Progressive increase in blood pressure in the day. Difficulty expanding chest crate. Insomnia. In the days to follow pain in the lower limbs, feet, inability to hold myself, anti-inflammatory drugs.; Progressive increase in blood pressure in the day. Difficulty expanding chest crate. Insomnia. In the days to follow pain in the lower limbs, feet, inability to hold myself, anti-inflammatory drugs.; Progressive increase in blood pressure in the day. Difficulty expanding chest crate. Insomnia. In the days to follow pain in the lower limbs, feet, inability to hold myself, anti-inflammatory drugs.; Progressive increase in blood pressure in the day. Difficulty expanding chest crate. Insomnia. In the days to follow pain in the lower limbs, feet, inability to hold myself, anti-inflammatory drugs.; This case was received via regulatory authority (Reference number: IT-MINISAL02-815799) on 10-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 DYSPNOEA (Progressive increase in blood pressure in the day. Difficulty expanding chest crate. Insomnia. In the days to follow pain in the lower limbs, feet, inability to hold myself, anti-inflammatory drugs.), PAIN IN EXTREMITY (Progressive increase in blood pressure in the day. Difficulty expanding chest crate. Insomnia. In the days to follow pain in the lower limbs, feet, inability to hold myself, anti-inflammatory drugs.), INSOMNIA (Progressive increase in blood pressure in the day. Difficulty expanding chest crate. Insomnia. In the days to follow pain in the lower limbs, feet, inability to hold myself, anti-inflammatory drugs.) and HYPERTENSION (Progressive increase in blood pressure in the day. Difficulty expanding chest crate. Insomnia. In the days to follow pain in the lower limbs, feet, inability to hold myself, anti-inflammatory drugs.) in a 68-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3006275) for COVID-19 immunisation. No Medical History information was reported. On 16-Nov-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 16-Nov-2021, the patient experienced DYSPNOEA (Progressive increase in blood pressure in the day. Difficulty expanding chest crate. Insomnia. In the days to follow pain in the lower limbs, feet, inability to hold myself, anti-inflammatory drugs.) (seriousness criterion life threatening), PAIN IN EXTREMITY (Progressive increase in blood pressure in the day. Difficulty expanding chest crate. Insomnia. In the days to follow pain in the lower limbs, feet, inability to hold myself, anti-inflammatory drugs.) (seriousness criterion life threatening), INSOMNIA (Progressive increase in blood pressure in the day. Difficulty expanding chest crate. Insomnia. In the days to follow pain in the lower limbs, feet, inability to hold myself, anti-inflammatory drugs.) (seriousness criterion life threatening) and HYPERTENSION (Progressive increase in blood pressure in the day. Difficulty expanding chest crate. Insomnia. In the days to follow pain in the lower limbs, feet, inability to hold myself, anti-inflammatory drugs.) (seriousness criterion life threatening). At the time of the report, DYSPNOEA (Progressive increase in blood pressure in the day. Difficulty expanding chest crate. Insomnia. In the days to follow pain in the lower limbs, feet, inability to hold myself, anti-inflammatory drugs.), PAIN IN EXTREMITY (Progressive increase in blood pressure in the day. Difficulty expanding chest crate. Insomnia. In the days to follow pain in the lower limbs, feet, inability to hold myself, anti-inflammatory drugs.), INSOMNIA (Progressive increase in blood pressure in the day. Difficulty expanding chest crate. Insomnia. In the days to follow pain in the lower limbs, feet, inability to hold myself, anti-inflammatory drugs.) and HYPERTENSION (Progressive increase in blood pressure in the day. Difficulty expanding chest crate. Insomnia. In the days to follow pain in the lower limbs, feet, inability to hold myself, anti-inflammatory drugs.) was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant medication were reported. No treatment medication were reported. The patient had a history of Benign prostatic hypertrophy, Basal cell carcinomas, Allergy to caffeine, Allergy to erythromycin and hepatitis C infection in 2015, which got cured with the use of Sofosbuvir. Company comment: This is a regulatory authority case concerning a 68-year-old male patient with no relevant medical history, who experienced dyspnoea, pain in extremity, insomnia and hypertension. The events occurred the same day after the administration of a dose of mRNA-1273 vaccine (unspecified dose number). It was reported that patient developed progressive increase in blood pressure in the day, difficulty in expanding ribcage, insomnia, pain in the lower limbs and feet. Treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reporter''s Comments: Former hepatitis C cured with Sofosbuvir year 2015. Currently, kidney stones. Benign prostatic hypertrophy. Basal cell carcinomas. Allergy to caffeine and erythromycin.; Sender''s Comments: This is a regulatory authority case concerning a 68-year-old male patient with no relevant medical history, who experienced dyspnoea, pain in extremity, insomnia and hypertension. The events occurred the same day after the administration of a dose of mRNA-1273 vaccine (unspecified dose number). It was reported that patient developed progressive increase in blood pressure in the day, difficulty in expanding ribcage, insomnia, pain in the lower limbs and feet. Treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1966122 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-16
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: Superficial vein thrombosis
SMQs:, Embolic and thrombotic events, 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:
CDC Split Type: ITPFIZER INC202101785489

Write-up: After intervention in the hospital with general anesthesia, complete thrombosis in the left leg safenic vein. FU admission and therapy with heparin and antibiotic. Suspected pfizer vaccine reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory authority. A 49 year-old male patient received bnt162b2 (COMIRNATY) (Lot number: Unknown) as dose 2, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (dose 1, MANUFACTURER UNKNOWN), for covid-19 immunisation. It was reported that after Pfizer vaccination: after surgery in day hospital with general anesthesia, complete thrombosis in the left leg saphenous vein on 16Nov2021. Followed hospitalization and therapy with heparin and antibiotic. suspected Pfizer vaccine reaction. Continuous therapy with heparin indefinitely, angiologist and hematologist visits without finding possible triggering causes. ADR in place. - Actions taken (CONTINUOUS HEPARIN THERAPY FOR INDETERMINATE TIME, ANGIOLOGIST AND HEMATOLOGIST VISITS WITHOUT FINDING POSSIBLE TRIGGERING CAUSES. THE ONLY POSSIBLE CAUSE IS VACCINATION) - Impact on quality of life (10/10). Outcome of the event was not recovered. Senders comment: 09.12.2021 - Suspect drug batch is requested. Hospitalization medical record. Date and time of vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1966157 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Depressed level of consciousness, Dizziness, Dyspnoea, Electroencephalogram, Epilepsy, Loss of consciousness, Oxygen saturation, Oxygen saturation decreased, Therapeutic response unexpected
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy; Mental disorder (serious mental disease); Overactive bladder (whitening overactive bladder); Renal disorder NOS (kidney value was worse)
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: blood test; Result Unstructured Data: Test Result:unknown result; Test Name: brain wave test; Result Unstructured Data: Test Result:no abnormality in alpha waves, but had abnormality; Comments: in the spiny waves or spiny slow waves, which are a little more dangerous.; Test Date: 20211130; Test Name: brain wave test; Result Unstructured Data: Test Result:the symptom of epilepsy was almost back to normal; Comments: and disappearing. The brain wave, the signal itself seemed to be coming out, but it seemed like the epilepsy was hiding in the clouds.; Test Date: 20211116; Test Name: oxygen; Result Unstructured Data: Test Result:getting thinner, down to the 10% range %
CDC Split Type: JPPFIZER INC202101752786

Write-up: the symptom of epilepsy was almost back to normal and disappearing; consciousness was twilight; the patient lost all consciousness/unconsciousness; Epilepsy; the patient''s oxygen was getting thinner, down to the 10% range; Dyspnoea; Light-headed feeling/Giddiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (the day of vaccination), (Batch/Lot number: unknown) via an unspecified route of administration as dose 2, single for covid-19 immunisation at a privacy medical center. Relevant medical history included: "Mental disorder" (unspecified if ongoing), notes: serious mental disease; "Overactive bladder" (unspecified if ongoing), notes: whitening overactive bladder; "Renal disorder NOS" (unspecified if ongoing), notes: kidney value was worse; "Epilepsy" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Comirnaty (Lot number unknown, Expiration date unknown) via an unspecified route of administration. (For dose 1, three weeks before dose 2, serious reaction), for COVID-19 immunisation, reaction(s): "Adverse reaction". The following information was reported: DEPRESSED LEVEL OF CONSCIOUSNESS (medically significant) with onset 16Nov2021, outcome "unknown", described as "consciousness was twilight"; LOSS OF CONSCIOUSNESS (medically significant) with onset 16Nov2021, outcome "unknown", described as "the patient lost all consciousness/unconsciousness"; EPILEPSY (medically significant) with onset 16Nov2021, outcome "unknown", described as "Epilepsy"; OXYGEN SATURATION DECREASED (non-serious) with onset 16Nov2021, outcome "unknown", described as "the patient''s oxygen was getting thinner, down to the 10% range"; DYSPNOEA (non-serious) with onset 16Nov2021, outcome "unknown", described as "Dyspnoea"; DIZZINESS (non-serious) with onset 16Nov2021, outcome "unknown", described as "Light-headed feeling/Giddiness"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 30Nov2021, outcome "unknown", described as "the symptom of epilepsy was almost back to normal and disappearing". The events "consciousness was twilight", "the patient lost all consciousness/unconsciousness", "epilepsy", "the patient''s oxygen was getting thinner, down to the 10% range", "dyspnoea" and "light-headed feeling/giddiness" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (16Nov2021) unknown result; electroencephalogram: (unspecified date) no abnormality in alpha waves, but had abnormality, notes: in the spiny waves or spiny slow waves, which are a little more dangerous; (30Nov2021) the symptom of epilepsy was almost back to normal, notes: and disappearing. The brain wave, the signal itself seemed to be coming out, but it seemed like the epilepsy was hiding in the clouds; oxygen saturation: (16Nov2021) getting thinner, down to the 10% range. Therapeutic measures were taken as a result of depressed level of consciousness, loss of consciousness, epilepsy, oxygen saturation decreased, dyspnoea, dizziness. Additional Information: The patient was an unknown age male. The patient had serious mental disease, whitening overactive bladder, the patient had illness since kidney value was worse, and the patient received vaccine in this condition. There was serious reaction after both Dose 1 and Dose 2. After the first dose, the patient was transferred to emergency, since the patient had Epilepsy originally, while (inaudible) Epilepsy, and watched its progress, it took the patient about an hour and the patient went home that day. There was some problem on 16Nov2021, when the patient received the second dose, the TV said there would be reaction after the second dose. The patient thought he was the one that experienced immediately. About 10 minutes after the second dose, consciousness was twilight. Once consciousness was regained, the patient lost all consciousness. The patient was transferred straight to emergency building. The patient was given anti-epileptic drug, drip infusion administration, physiological saline, drip infusion administration, and drip infusion administration for E Keppra. And since the patient''s oxygen was getting thinner, down to the 10% range, the patient was in condition of Dyspnoea, the patient received something like 5ml of oxygen aspiration and blood test. After 2 or 3 hours of unconsciousness, the patient gradually regained consciousness. The patient gradually regained consciousness with the doctors'' best efforts. After that, when the patient was about to leave, since the patient admitted Light-headed feeling and was going to fall, the patient was told that he should be hospitalized. But the patient refused to be hospitalized, the patient was given drug to help with Giddiness and went home on that day. After that, on 30Nov2021, the patient received regular brain wave test at an university hospital since the patient had Epilepsy originally. It was about once every 2 months. The patient had always had abnormalities, and the patient was told that it was difficult to make a proper decision between generalized and partial epilepsy, but the patient had been receiving drug and treat since the patient probably had epilepsy. About the brain wave, the patient thought that there was spiny waves or spiny slow waves until now. The patient had always had no abnormality in alpha waves, but had abnormality in the spiny waves or spiny slow waves, which were a little more dangerous. The result the patient asked yesterday was that, the symptom of epilepsy was almost back to normal and disappearing. The brain wave, the signal itself seemed to be coming out, but it seemed like the epilepsy was hiding in the clouds. 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) : JP-PFIZER INC-202101771239 same reporter/patient/product, different dose/AE


VAERS ID: 1966193 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 FK0115 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Deep vein thrombosis, Inappropriate schedule of product administration, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ligament rupture; Thrombosis (Thrombosis in the left calf following several weeks of immobilisation (cause: rupture of ligaments))
Allergies:
Diagnostic Lab Data: Test Date: 20211124; Test Name: Angiogram; Result Unstructured Data: Test Result:Pulmonary embolism of 8mm; Comments: 5 days old (19Nov2021)
CDC Split Type: LUPFIZER INC202101728800

Write-up: venous thrombosis deep in the right calf (3 cm); pulmonary embolism (8 mm); Comirnaty dose1: 15Sep2021 dose2:16Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from the regulatory authority-WEB. Regulatory number: LU-ALMPS-202103185. A 46-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: FK0115) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thrombosis" (unspecified if ongoing), notes: Thrombosis in the left calf following several weeks of immobilisation (cause: rupture of ligaments); "rupture of ligaments" (unspecified if ongoing). She didn''t smoke, she did sport, she didn''t take any contraceptive pill. No allergy. The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (dose 1, lot: FG3716, intramuscular), administration date: 15Sep2021, for Covid-19 immunisation. The following information was reported: DEEP VEIN THROMBOSIS (medically significant) with onset 21Nov2021, outcome "recovering", described as "venous thrombosis deep in the right calf (3 cm)"; PULMONARY EMBOLISM (medically significant) with onset 19Nov2021, outcome "not recovered", described as "pulmonary embolism (8 mm)"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 16Nov2021, outcome "unknown", described as "Comirnaty dose1: 15Sep2021 dose2:16Nov2021". The patient underwent the following laboratory tests and procedures: angiogram: (24Nov2021) pulmonary embolism of 8mm, notes: 5 days old (19Nov2021). Therapeutic measures were taken as a result of deep vein thrombosis. On 21Nov2021, 5 days after the D2, she experienced a venous thrombosis deep in the right calf (3 cm). Treatment with ELIQUIS and immobilization. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1966258 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-11-16
   Days after vaccination:168
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive, Urticaria, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Lack of efficacy/effect (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Elderly
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: SARS-CoV-2 test positive; Test Result: Positive
CDC Split Type: NLPFIZER INC202101763311

Write-up: Urticaria; Vaccination Failure; COVID-19; 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-00724284. Other Case identifier(s): NL-LRB-00725737. A 69 year-old female patient received bnt162b2 (COMIRNATY), administration date 01Jun2021 (Batch/Lot number: unknown) as dose 2, 0.3 ml single and administration date 27Apr2021 (Batch/Lot number: unknown) as dose 1, 0.3 ml single for covid-19 immunisation; pneumococcal vaccine polysacch 23v (PNEUMOVAX 23), administration date 25Oct2021 (Batch/Lot number: unknown) as dose number unknown, single, vaccine for pneumococcal immunisation; influenza vaccine (INFLUENZA VACCINE), administration date 25Oct2021 (Batch/Lot number: unknown) as dose number unknown, single, vaccine for influenza immunisation. Relevant medical history included: "elderly" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Vaccination Failure"; COVID-19 (medically significant) with onset 16Nov2021, outcome "unknown", described as "COVID-19"; URTICARIA (non-serious) with onset 02Dec2021, outcome "recovered", described as "Urticaria". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: (16Nov2021) positive. It was reported that there was a kind of hives on her arms, legs, stomach and breasts. In the morning she thought she had been stung by a mosquito, during the day she got itchy all over. third day - her skin looked great again. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1966336 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-11-16
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Deep vein thrombosis, Oedema peripheral, Ultrasound scan
SMQs:, Cardiac failure (broad), Angioedema (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Forearm fracture (Bilateral forearm fracture (Bilateral distal antebrachial fracture ))
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: CT scan; Result Unstructured Data: Test Result:No findings; Comments: No findings of venous anomalies on CT.; Test Date: 20211116; Test Name: Ultrasound examination; Result Unstructured Data: Test Result:Large deep vein thrombosis; Comments: Large deep vein thrombosis iliofemoral. No signs of pulmonary embolism or other thrombus.
CDC Split Type: NOPFIZER INC202101733881

Write-up: Deep vein thrombosis right lower extremity (iliofemoral); EDEMA LOWER LIMB (RIGHT LEG); This is a spontaneous report received from contactable reporters (physician and consumer) from the WEB. Regulatory number: NO-NOMAADVRE-FHI-2021-Ux422x. Other Case identifier(s): NO-NOMAADVRE-E2B_00063880. A 15 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 25Sep2021 (Lot number: Unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Forearm fracture", start date: Jan2021 (unspecified if ongoing), notes: Bilateral forearm fracture (Bilateral distal antebrachial fracture). Concomitant medication(s) included: BOOSTRIX POLIO taken for immunisation, administration date 25Oct2021. The following information was reported: OEDEMA PERIPHERAL (hospitalization) with onset 16Nov2021, outcome "recovering", described as "EDEMA LOWER LIMB (RIGHT LEG)"; DEEP VEIN THROMBOSIS (hospitalization) with onset 18Nov2021, outcome "recovering", described as "Deep vein thrombosis right lower extremity (iliofemoral)". The patient was hospitalized for oedema peripheral, deep vein thrombosis (start date: 18Nov2021, discharge date: 25Nov2021, hospitalization duration: 7 day(s)). The patient underwent the following laboratory tests and procedures: computerised tomogram: (16Nov2021) no findings, notes: No findings of venous anomalies on CT; ultrasound scan: (16Nov2021) large deep vein thrombosis, notes: Large deep vein thrombosis iliofemoral. No signs of pulmonary embolism or other thrombus. Therapeutic measures were taken as a result of oedema peripheral, deep vein thrombosis. Clinical course: Time to onset for event deep vein thrombosis was 55 days latency and for event edema lower limb (right leg) was 53 days latency for suspect drug Comirnaty. Time to onset for event deep vein thrombosis was 25 days latency and for event edema lower limb (right leg) was 23 days latency for Boostrix Polio. The patient is healthy from before, no family history of thrombosis at a young age in close family. Received Covid-19 vaccine (allegedly Comirnaty, BioNTech, Pfizer) 25Sep2021 and DTP vaccine 25Oct2021. Pursues active sports in the form of rowing. After intense training sessions with rowing 13Nov2021 -15Nov2021, he noticed 16Nov2021 swelling in his right leg. Admitted to hospital 18Nov2021 with pronounced swelling in the entire right lower extremetie. Subcutaneous anticoagulation (Klexane, enoxaparin) was initiated with transition to oral treatment in the form of Xarelto (rivaroxaban) after 5 days. Good clinical improvement. Discharged from hospital after 1 week, followed up outpatient. The patient did not have thrombocytopenia. So far, no underlying risk factors for thrombosis have been found, but not all results are available as of today. Reporter find the large thrombus in a healthy boy without a family history of the thrombus striking. They assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible. Reporter''s Comment: 03Dec2021 FHI: requested additional information. If new medical information is received, report will be updated. Health Authority''s Comment: Since the report describes a suspected adverse reaction that is serious and in order to better assess the incident that was reported, we have requested additional information from PRIVACY Hospital. We will send an updated feedback if the additional information changes our assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: 03Dec2021 FHI: requested additional information. If new medical information is received, report will be updated.


VAERS ID: 1966339 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5782 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Cerebral disorder, Fall, Immunisation, Lethargy, Vomiting
SMQs:, Acute pancreatitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101729196

Write-up: booster; cerebral event; Shoulder pain; Lethargy; Vomiting; Fall; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the regulatory authority. Regulatory number: NO-NOMAADVRE-FHI-2021-Uy5q5q. Other Case identifier(s): NO-NOMAADVRE-E2B_00062164. A 90 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 15Nov2021 16:00 (Lot number: FJ5782) 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 (1st dose, lot number: unknown), administration date: 05Feb2021, for covid-19 immunisation; Comirnaty (2nd dose, lot number: EP9598), administration date: 26Feb2021, for covid-19 Immunisation. The following information was reported: IMMUNISATION (hospitalization), outcome "unknown", described as "booster"; ARTHRALGIA (hospitalization) with onset 16Nov2021, outcome "recovered" (17Nov2021), described as "Shoulder pain"; LETHARGY (hospitalization) with onset 16Nov2021, outcome "recovered" (17Nov2021), described as "Lethargy"; VOMITING (hospitalization) with onset 16Nov2021, outcome "recovered" (17Nov2021), described as "Vomiting"; FALL (hospitalization) with onset 16Nov2021, outcome "recovered" (17Nov2021), described as "Fall"; CEREBRAL DISORDER (hospitalization), outcome "unknown", described as "cerebral event". The patient vomited, got severe bilateral proximal pain shoulders and lethargy - fall the day after vaccination with Comirnaty, third dose. She had felt and was hanging in a chair. She was hospitalized with question about cerebral event. The regulatory authority assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as possible. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1968304 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-14
Onset:2021-11-16
   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 - / 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 INC202101740682

Write-up: Deep vein thrombosis; Pulmonary embolism; This is a spontaneous report received from a contactable other healthcare professional from Regulatory Authority. Regulatory number: 675606 Regulatory Authority. A 30-year-old male patient received bnt162b2 (COMIRNATY), administration date 14Nov2021 (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: On 16Nov2021, the patient experienced deep vein thrombosis and pulmonary embolism. The events were considered medically significant. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1968330 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-16
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: Bell's palsy
SMQs:, Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101740862

Write-up: Bell''s palsy; This is a spontaneous report received from a contactable other healthcare professional from Regulatory Authority. Regulatory number: 676370. A 40-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: Bell''s palsy (medically significant) with onset 16Nov2021. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1968391 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 FG7900 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Headache, Heart rate, Malaise, Myalgia, Nausea, Pyrexia, Tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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), 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:
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: heart rate; Result Unstructured Data: Test Result:110/120
CDC Split Type: BEPFIZER INC202101733997

Write-up: Heart rate 110/120 at rest; Shivering; Malaise; Fever; Arthralgia; Myalgia; Nausea; Headache; This is a spontaneous report received from a contactable reporter (consumer) from a Regulatory Authority. Regulatory number: BE-FAMHP-DHH-N2021-109628. A 46 year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FG7900) at the age of 46 years as dose 2, single and administration date 28Oct2021 (Lot number: FH0160) 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: TACHYCARDIA (disability) with onset 16Nov2021, outcome "not recovered", described as "Heart rate 110/120 at rest"; CHILLS (disability) with onset 16Nov2021, outcome "not recovered", described as "Shivering"; MALAISE (disability) with onset 16Nov2021, outcome "not recovered", described as "Malaise"; PYREXIA (disability) with onset 16Nov2021, outcome "not recovered", described as "Fever"; ARTHRALGIA (disability) with onset 16Nov2021, outcome "not recovered", described as "Arthralgia"; MYALGIA (disability) with onset 16Nov2021, outcome "not recovered", described as "Myalgia"; NAUSEA (disability) with onset 16Nov2021, outcome "not recovered", described as "Nausea"; HEADACHE (disability) with onset 16Nov2021, outcome "not recovered", described as "Headache". The patient underwent the following laboratory tests and procedures: heart rate: (16Nov2021) 110/120. Therapeutic measures were not taken as a result of tachycardia, chills, malaise, pyrexia, arthralgia, myalgia, nausea, headache. Additional information: "Second dose administered; already effective at first dose and starts again and still in progress after one week." Reporter Comment: Treatment - No. Evolution of the ADR - No improvement. Situations - Other: Examinations - Physician recommended Dafalgan for the heart. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Treatment - No. Evolution of the ADR - No improvement. Situations - Other: Examinations - Physician recommended Dafalgan for the heart.


VAERS ID: 1969080 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 SCVT5 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Condition aggravated, Immunisation, Interchange of vaccine products, Off label use
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), 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: Medical History/Concurrent Conditions: Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101743280

Write-up: worsening stroke symptoms; worsening stroke symptoms; Off label use; Interchange of vaccine products; DOSE 3 (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-CADR2021203601. Other Case identifier(s): DE-CADRPEI-2021203601, DE-PEI-202100229200. A 57 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: SCVT5) as dose 3 (booster), 0.3 ml single for covid-19 immunisation. Relevant medical history included: "stroke", start date: Sep2016 (unspecified if ongoing). No known allergies. The patient''s concomitant medications were not reported. Vaccination history included: Vaxzevria (1st dose. Vaccine AstraZeneca suspension for injection. Batch/lot number: ABV3374. Date of start of reaction: 06Mar2021. Date of end of reaction: 22Nov2021. Caused hospitalization. Recovered with sequel.), administration date: 05Mar2021, for COVID-19 immunisation, reaction(s): "Increased spasticity of the hand / increasingly worsening", "Hand hardly movable without pain"; Spykevax (2nd dose. Vaccine Moderna. Batch/lot number: 3001651), administration date: 04Apr2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (hospitalization) with onset 16Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (hospitalization) with onset 16Nov2021, outcome "unknown", described as "DOSE 3 (BOOSTER)"; CEREBROVASCULAR ACCIDENT (hospitalization), CONDITION AGGRAVATED (hospitalization), outcome "unknown" and all described as "worsening stroke symptoms". Clinical course: Immediately after vaccination (the specified vaccine was pending clarification) worsening stroke symptoms of 2016 with direct emergency hospital stay.


VAERS ID: 1969424 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101765338

Write-up: Slight swelling of upper torso on side that vaccine was given, over chest and shoulder and underarm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from the WEB. Regulatory number: GB-MHRA-WEBCOVID-202112051344562530-RVLVE. Other Case identifier(s): GB-MHRA-ADR 26291212. A 15 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 15 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19, had not tested positive for COVID-19 since having the vaccine and not enrolled in clinical trial. The following information was reported: SWELLING (medically significant) with onset 16Nov2021, outcome "recovering", described as "Slight swelling of upper torso on side that vaccine was given, over chest and shoulder and underarm" and reported as gradually lessening over last few weeks. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1969457 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blister, Chapped lips, Cheilitis, Gingival blister, Gingival swelling, Immunisation, Interchange of vaccine products, Lip blister, Lip haemorrhage, Lip swelling, Mouth swelling, Noninfective gingivitis, Off label use, Oral mucosal blistering, Oral pain, Swelling
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Oropharyngeal allergic conditions (narrow), Gingival disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
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
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101739199

Write-up: Sore mouth; sores on lips; sore gums; swelling on lips; swelling inside mouth; swelling gums; blisters on lips; blisters inside mouth; blisters gums; cracked edge of lips; lips bleeding; Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY; Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY; The patient received third (booster) dose.; swelling; blisters; This is a spontaneous report received from a contactable Consumer or other non HCP from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112061956482850-GR5KJ (MHRA). Other Case identifier(s): GB-MHRA-ADR 26297281 (MHRA). A 54 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Clinical trial participant" (unspecified if ongoing), notes: The Virus watch team. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 2, SINGLE. MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, SINGLE. MANUFACTUERER UNKNOWN), for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. On an unknown date in 2021, the patient experienced swelling and blisters with outcome of recovering. On 28Nov2021, the patient experienced sore mouth with outcome of not recovered. The events swelling, blisters and sore mouth were reported as serious for being medically significant. The patient had awful sores, swelling, blisters, on her lips, inside mouth and gums, cracked edge of lips bleeding on 28Nov2021 and up to this date still suffering from it with outcome of not recovered. The report was not relate to possible inflammation of the heart (myocarditis or pericarditis). The events "swelling", "blisters", "sore mouth", "sores on lips", "sore gums", "swelling on lips", "swelling inside mouth", "swelling gums", "blisters on lips", "blisters inside mouth", "blisters gums", "cracked edge of lips" and "lips bleeding" were evaluated at the physician office visit. Patient has not tested positive for COVID-19 since having the vaccine. It was reported that the patient''s had no investigation by GP (general practitioner) and GP guessed it might be related to vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1969947 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-09
Onset:2021-11-16
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F039A / 1 - / OT

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

Life Threatening? 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: HKPFIZER INC202101802968

Write-up: This is a spontaneous report received from non-contactable reporter (Other health care professional) from Regulatory Authority. Regulatory number: DH/21/6592 (Regulatory Authority). Other Case identifier(s): HK-Fosun-2021FOS006613 (RA). This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority (RA). The regulatory authority report number is DH/21/6592. A 40-year-old female patient started to receive 1st doses of Tozinameran (COMIRNATY) (batch number: 1F039A) on 09-Nov-2021 via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. The patient experienced immune thrombocytopenia 7 days after vaccination with the 1st dose of Comirnaty (16-Nov-2021). Immune thrombocytopenia 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 unknown. Initial report was received on 10-Dec-2021. Follow-up closed; no further information is possible. Causality Assessment for the event Immune thrombocytopenia per reporter and per company was possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1969983 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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: Arthralgia, Body temperature, Fatigue, Headache, Immunisation, Nausea, Palpitations, Periorbital swelling, Pyrexia, Vision blurred
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: Body temperature; Result Unstructured Data: Test Result:very high temp
CDC Split Type: IEPFIZER INC202101753678

Write-up: Very fatigued; Nausea; Puffy eyes; Intermittent palpitations; Headache / Occasional headaches; Joint pains; Blurred vision; High temp / Very high temp; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority-WEB. The reporter is the patient. Regulatory number: IE-HPRA-2021-087162 (RA). A 58 year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FH0114) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Comirnaty (DOSE NUMBER: 1, batch number: unknown), administration date: 07Jan2021, for COVID-19 immunisation; Comirnaty (DOSE NUMBER: 2, batch number: unknown), administration date: 28Jan2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (disability) with onset 16Nov2021, outcome "unknown", described as "Booster"; FATIGUE (disability) with onset 17Nov2021, outcome "not recovered", described as "Very fatigued"; NAUSEA (disability) with onset 17Nov2021, outcome "unknown", described as "Nausea"; PERIORBITAL SWELLING (disability) with onset 17Nov2021, outcome "unknown", described as "Puffy eyes"; PALPITATIONS (disability) with onset 17Nov2021, outcome "unknown", described as "Intermittent palpitations"; HEADACHE (disability) with onset 17Nov2021, outcome "not recovered", described as "Headache / Occasional headaches"; ARTHRALGIA (disability) with onset 17Nov2021, outcome "unknown", described as "Joint pains"; VISION BLURRED (disability) with onset 17Nov2021, outcome "unknown", described as "Blurred vision"; PYREXIA (disability) with onset 17Nov2021, outcome "unknown", described as "High temp / Very high temp". The patient underwent the following laboratory tests and procedures: body temperature: (17Nov2021) very high temp. Therapeutic measures were taken as a result of fatigue, nausea, periorbital swelling, palpitations, headache, arthralgia, vision blurred, pyrexia and treatment included paracetamol (brand unspecified). Clinical course: On 17Nov2021, 15 hours later, the patient experienced a very high temperature, nausea, headache, joint pains, blurred vision, puffy eyes and had intermittent palpitations. The duration of the reaction was reported as 3 days. At the time of reporting, the patient continued to feel very fatigued and had occasional headaches. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1970039 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 - / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Impaired quality of life, Investigation
SMQs:, Supraventricular tachyarrhythmias (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Drug allergy (vivinc); Penicillin allergy
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Impact on quality of life; Result Unstructured Data: Test Result:5; Test Date: 2021; Test Name: Investigations; Result Unstructured Data: Test Result:in progress
CDC Split Type: ITPFIZER INC202101742764

Write-up: Atrial fibrillation; Impact on quality of life (5/10); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: IT-MINISAL02-816728. A 61 year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), administered in arm right, administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 61 years as dose 1, 0.3 ml, single for covid-19 immunisation. Relevant medical history included: "drug allergy" (unspecified if ongoing), notes: vivinc; "penicillin allergy" (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "Drug allergies"; Plasil, reaction(s): "Drug allergies"; Uniplus, reaction(s): "Drug allergies". The following information was reported: ATRIAL FIBRILLATION (hospitalization, medically significant) with onset 16Nov2021, outcome "recovered with sequelae" (2021), described as "Atrial fibrillation"; IMPAIRED QUALITY OF LIFE (non-serious) with onset 2021, outcome "unknown", described as "Impact on quality of life (5/10)". The event "atrial fibrillation" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: investigation (normal high range 10): (2021) 5; investigation: (2021) in progress. Therapeutic measures were taken as a result of atrial fibrillation. Investigations to be carried out 3 weeks after the event as prescribed by the emergency room doctors. Clinical course: Atrial fibrillation resolved spontaneously after urination. stay in the emergency room for stabilization and monitoring. Investigations in progress. Thyroid and holter still to be performed. Reporter Comment: Drug allergies: aspirin, penicillin, plasil, vivinc, uniplus. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Drug allergies: aspirin, penicillin, plasil, vivinc, uniplus.


VAERS ID: 1970048 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-21
Onset:2021-11-16
   Days after vaccination:268
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: SARS-CoV-2 PCR test; Test Result: Positive; Test Date: 20211125; Test Name: SARS-CoV-2 PCR test; Test Result: Negative.
CDC Split Type: ITPFIZER INC202101736391

Write-up: Drug ineffective; positive molecular swab; Asymptomatic COVID-19; This is a non-interventional study report from the Regulatory Authority. The Regulatory Authority number IT-MINISAL02-816815. A 30-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 21Feb2021 (Lot number: EJ6790, Expiration Date: 31May2021) as dose 1, single for covid-19 immunisation. Relevant medical history included COVID-19, start date: 08Dec2020, stop date: 30Dec2020. The patient''s concomitant medications were not reported. The following information was reported DRUG INEFFECTIVE (medically significant) with onset 16Nov2021, outcome unknown; SARS-COV-2 TEST POSITIVE (medically significant) with onset 16Nov2021, outcome recovered (25Nov2021); ASYMPTOMATIC COVID-19 (medically significant) with onset 16Nov2021, outcome recovered (25Nov2021). The patient underwent the following laboratory tests and procedures SARS-CoV-2 PCR test: (16Nov2021) positive; (25Nov2021) negative. 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 EJ6790. 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. The reporter''s assessment of the causal relationship of the drug ineffective, positive molecular swab, and asymptomatic covid-19 with the suspect product(s) bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected. Based on the information in the case report, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.


VAERS ID: 1970138 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   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 FJ1763 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood creatine phosphokinase increased, Blood test, Body temperature, C-reactive protein, C-reactive protein increased, Chest pain, Echocardiogram, Electrocardiogram, Initial insomnia, Myocarditis, Palpitations, Troponin T, Troponin T increased, Viral infection
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: CK; Result Unstructured Data: Test Result:583 IU/l; Test Date: 20211118; Test Name: CK-MB; Result Unstructured Data: Test Result:37 ng/ml; Test Date: 20211118; Test Name: blood test; Result Unstructured Data: Test Result:indicating increase in CK and troponin; Test Date: 20211115; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before the vaccination; Test Date: 20211118; Test Name: CRP; Test Result: 1.50 mg/dl; Test Date: 20211118; Test Name: Echocardiography; Result Unstructured Data: Test Result:showed no abnormality; Test Date: 20211118; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:showed no abnormality; Test Date: 20211119; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:showed changes including fluctuations in ST in; Comments: leads V4-6 and negative T wave, and currently, the symptoms and test findings have been followed up.; Test Date: 20211118; Test Name: troponin T; Result Unstructured Data: Test Result:10463 pg/mL
CDC Split Type: JPPFIZER INC202101781293

Write-up: Viral infection; CRP of 1.50 mg/dL; CK of 583 IUL/increase in CK; troponin T of 10,463 pg/mL/ increase in troponin; difficulty in falling asleep; Myocarditis/ Acute myocarditis; chest pain; palpitations; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: V21132121. A 14 year-old (14-year and 11-month-old as reported) male patient received bnt162b2 (COMIRNATY), administration date 15Nov2021 17:15 (the day of vaccination) (Lot number: FJ1763, Expiration Date: 30Apr2022) at the age of 14 years as dose 2, single for covid-19 immunisation. Body temperature before vaccination was 36.5 degrees Centigrade. Birth weight was 2550g. There were points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) was not provided. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (hospitalization, medically significant) with onset 16Nov2021 07:00, outcome "recovering", described as "Myocarditis/ Acute myocarditis"; CHEST PAIN (hospitalization) with onset 16Nov2021 07:00, outcome "recovering", described as "chest pain"; PALPITATIONS (hospitalization) with onset 16Nov2021 07:00, outcome "recovering", described as "palpitations"; INITIAL INSOMNIA (hospitalization) with onset 17Nov2021, outcome "recovering", described as "difficulty in falling asleep"; C-REACTIVE PROTEIN INCREASED (hospitalization) with onset 18Nov2021, outcome "recovering", described as "CRP of 1.50 mg/dL"; BLOOD CREATINE PHOSPHOKINASE INCREASED (hospitalization) with onset 18Nov2021, outcome "recovering", described as "CK of 583 IUL/increase in CK"; TROPONIN T INCREASED (hospitalization) with onset 18Nov2021, outcome "recovering", described as "troponin T of 10,463 pg/mL/ increase in troponin"; VIRAL INFECTION (hospitalization), outcome "unknown", described as "Viral infection". The patient was hospitalized for myocarditis, chest pain, palpitations, initial insomnia, c-reactive protein increased, blood creatine phosphokinase increased, troponin t increased, viral infection (start date: 18Nov2021). The events "myocarditis/ acute myocarditis", "chest pain", "palpitations", "difficulty in falling asleep", "crp of 1.50 mg/dl", "ck of 583 iul/increase in ck" and "troponin t of 10,463 pg/ml/ increase in troponin" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood creatine phosphokinase: (18Nov2021) 583 IU/l; blood creatine phosphokinase mb: (18Nov2021) 37 ng/ml; blood test: (18Nov2021) indicating increase in ck and troponin; body temperature: (15Nov2021) 36.5 Centigrade, notes: before the vaccination; c-reactive protein: (18Nov2021) 1.50 mg/dl; echocardiogram: (18Nov2021) showed no abnormality; electrocardiogram: (18Nov2021) showed no abnormality; (19Nov2021) showed changes including fluctuations in st in, notes: leads V4-6 and negative T wave, and currently, the symptoms and test findings have been followed up; troponin t: (18Nov2021) 10463 pg/mL. Therapeutic measures were taken as a result of myocarditis, chest pain, palpitations, initial insomnia, c-reactive protein increased, blood creatine phosphokinase increased, troponin t increased. Clinical course: On 16Nov2021 at about 07:00 (1 day after the vaccination), the patient experienced Myocarditis [chest pain, palpitations]. In the morning of 16Nov2021, chest pain developed. In the daytime on the same day, chest pain and palpitations were aggravated, and the symptoms persisted even during the night. Even on 17Nov2021, the same symptoms persisted and the patient experienced a difficulty in falling asleep, too. The patient was referred to our department on an outpatient basis for close examination and treatment on 18Nov2021. Blood test showed CRP of 1.50 mg/dL, CK of 583 IUL, CK-MB of 37 ng/mL, troponin T of 10,463 pg/mL, indicating increase in CK and troponin. Acute myocarditis was diagnosed based on the test findings and progression of the symptoms, and the patient was hospitalized for treatment and monitoring. Echocardiography, Electrocardiogram on admission showed no abnormality, but electrocardiography performed on the following day of the hospitalization (19Nov2021) showed changes including fluctuations in ST in leads V4-6 and negative T wave, and currently, the symptoms and test findings have been followed up. Chest pain and palpitations showed a tendency to reduce and disappear after the hospitalization. On 22Nov2021 (7 days after the vaccination), the outcome of the event was recovering. The reporter classified the event as serious hospitalized from 18Nov2021 (3 days after the vaccination), and assessed that the event was related to bnt162b2. Other possible cause(s) of the event such as any other diseases was Viral infection (currently [illegible writing] has been submitted.


VAERS ID: 1970146 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase, Blood creatine phosphokinase increased, Body temperature, Brain natriuretic peptide, Brain natriuretic peptide increased, Chest pain, Electrocardiogram, Electrocardiogram ST segment, Electrocardiogram ST segment depression, Myocarditis, Nausea, Poor quality sleep, Pyrexia, Troponin T, Troponin T increased, Viral myocarditis, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Other ischaemic heart disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ABILIFY
Current Illness: Autism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: CK; Test Result: 567 uL; Comments: increased; Test Date: 20211116; Test Name: pyrexia of 38 degrees centigrade; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20211117; Test Name: BNP; Result Unstructured Data: Test Result:59.7 pg/mL; Comments: increased; Test Date: 20211116; Test Name: electrocardiogram; Result Unstructured Data: Test Result:no abnormality; Test Date: 20211117; Test Name: electrocardiogram; Result Unstructured Data: Test Result:right axis deviation and ST depressed in V1-2; Test Date: 20211117; Test Name: ST; Result Unstructured Data: Test Result:depressed in V1-2; Test Date: 20211117; Test Name: high sensitivity troponin T; Result Unstructured Data: Test Result:0.534 ng/ml; Comments: elevation
CDC Split Type: JPPFIZER INC202101789331

Write-up: possibility of viral myocarditis; ST depressed in V1-2; vomited; CK increased (567 U/L); high sensitivity troponin T elevation (0.534 ng/mL); BNP increased (59.7 pg/mL); pyrexia of 38 degrees centigrade; chest pain; could not sleep well; feeling queasy; Acute myocarditis/ myocarditis; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: v21132541 (RA). A 13-year-and-0-month-old male patient received bnt162b2 (COMIRNATY), administration date 15Nov2021 (the day of the vaccination), (Batch/Lot number: unknown) via an unspecified route of administration as dose 2, single for covid-19 immunisation. Patient history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included: Ongoing oral treatment with Abilify for autism. Relevant medical history included: "Ongoing oral treatment with Abilify for autism" (ongoing). Concomitant medication(s) included: ABILIFY taken for autism spectrum disorder (ongoing). Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation, reaction(s): "cold symptoms". The following information was reported: MYOCARDITIS (hospitalization, medically significant) with onset 16Nov2021, outcome "recovering", described as "Acute myocarditis/ myocarditis"; VIRAL MYOCARDITIS (hospitalization, medically significant), outcome "unknown", described as "possibility of viral myocarditis"; ELECTROCARDIOGRAM ST SEGMENT DEPRESSION (hospitalization, medically significant) with onset 17Nov2021, outcome "recovering", described as "ST depressed in V1-2"; PYREXIA (hospitalization) with onset 16Nov2021, outcome "recovering", described as "pyrexia of 38 degrees centigrade"; CHEST PAIN (hospitalization) with onset 16Nov2021, outcome "recovering", described as "chest pain"; POOR QUALITY SLEEP (hospitalization) with onset 16Nov2021, outcome "recovering", described as "could not sleep well"; NAUSEA (hospitalization) with onset 16Nov2021, outcome "recovering", described as "feeling queasy"; VOMITING (hospitalization) with onset 17Nov2021, outcome "recovering", described as "vomited"; BLOOD CREATINE PHOSPHOKINASE INCREASED (hospitalization) with onset 17Nov2021, outcome "recovering", described as "CK increased (567 U/L)"; TROPONIN T INCREASED (hospitalization) with onset 17Nov2021, outcome "recovering", described as "high sensitivity troponin T elevation (0.534 ng/mL)"; BRAIN NATRIURETIC PEPTIDE INCREASED (hospitalization) with onset 17Nov2021, outcome "recovering", described as "BNP increased (59.7 pg/mL)". The patient was hospitalized for myocarditis, viral myocarditis, electrocardiogram st segment depression, pyrexia, chest pain, poor quality sleep, nausea, vomiting, blood creatine phosphokinase increased, troponin t increased, brain natriuretic peptide increased (start date: 17Nov2021, discharge date: 21Nov2021, hospitalization duration: 4 day(s)). The events "acute myocarditis/ myocarditis", "st depressed in v1-2", "pyrexia of 38 degrees centigrade", "chest pain", "could not sleep well", "feeling queasy", "vomited", "ck increased (567 u/l)", "high sensitivity troponin t elevation (0.534 ng/ml)" and "bnp increased (59.7 pg/ml)" were evaluated at the physician office visit. On 16Nov2021 (1 day after the vaccination), the patient experienced myocarditis. on 17Nov2021 (2 days after the vaccination), the patient was hospitalized. On 25Nov2021 (10 days after the vaccination), the outcome of the events was recovering. The course of the event was as follows: On 15Nov2021, the patient received the second dose of COVID-19 vaccine. On 16Nov2021, the patient had pyrexia of 38 degrees centigrade, and chest pain in the morning. The patient was examined by a local pediatrist and the electrocardiogram showed no abnormality, and an analgesic drug was prescribed. He could not sleep well due to feeling queasy and chest pain in the night. On 17Nov2021, the patient vomited once in the morning and the chest pain persisted. The patient went to the reporting hospital for examination. The electrocardiogram showed right axis deviation and ST depressed in V1-2. From the blood test, CK increased (567 U/L), high sensitivity troponin T elevation (0.534 ng/mL) and BNP increased (59.7 pg/mL). Acute myocarditis was diagnosed, and he was admitted. During the admission, he rested, and the course was observed. The symptoms were recovering. On 21Nov2021, the patient discharged with no symptoms. The course after the discharge was favorable with no recurrence of the symptoms. The patient underwent the following laboratory tests and procedures: blood creatine phosphokinase: (17Nov2021) 567 uL, notes: increased; body temperature: (16Nov2021) 38 Centigrade; brain natriuretic peptide: (17Nov2021) 59.7 pg/mL, notes: increased; electrocardiogram: (16Nov2021) no abnormality; (17Nov2021) right axis deviation and st depressed in v1-2; electrocardiogram st segment: (17Nov2021) depressed in v1-2; troponin t: (17Nov2021) 0.534 ng/ml, notes: elevation. Therapeutic measures were taken as a result of pyrexia, chest pain, poor quality sleep, nausea. The reporting physician classified the event as non-serious and the causality between the event and bnt162b2 as related. The other possible cause of the event included: The patient had cold symptoms on 07Nov2021. Therefore, a possibility of viral myocarditis cannot be ruled out. The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender''s Comments: Linked Report(s) : JP-PFIZER INC-202101816036 same patient/ product; different dose/AE


VAERS ID: 1970266 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-11-16
   Days after vaccination:166
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 21C11-05 / 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: PTJNJFOC20211242751

Write-up: VACCINATION FAILURE; This spontaneous report received from a physician by a Regulatory Authority (EVHUMAN Vaccines, PT-INFARMED-T202111-2501) on 20-DEC-2021 concerned a 57 year old of an unspecified sex, race and ethnic origin. The patient''s height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number: 21C11-05, expiry: unknown) 0.5 ml, frequency time 1 total, first dose administered on 03-JUN-2021 for covid-19 immunisation. No concomitant medications were reported. On 16-NOV-2021, the patient had vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccination failure. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1972144 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-27
Onset:2021-11-16
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac dysfunction, Chest pain, Diarrhoea, Myocarditis, Oropharyngeal pain
SMQs:, Cardiac failure (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101740945

Write-up: Cardiac dysfunction; Myocarditis; Chest pain; Diarrhoea; Oropharyngeal pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 676646 Regulatory Authority. A 26 year-old male patient received bnt162b2 (COMIRNATY), administration date 27Oct2021 (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: CARDIAC DYSFUNCTION (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Cardiac dysfunction"; MYOCARDITIS (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Myocarditis"; CHEST PAIN (non-serious) with onset 16Nov2021, outcome "not recovered", described as "Chest pain"; DIARRHOEA (non-serious) with onset 16Nov2021, outcome "not recovered", described as "Diarrhoea"; OROPHARYNGEAL PAIN (non-serious) with onset 16Nov2021, outcome "not recovered", described as "Oropharyngeal pain". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1972186 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 FG7369 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Dizziness, Dyspepsia, Fatigue, Feeling cold, Headache, Malaise, Myalgia, Nausea, Pain in extremity, Vaccination site reaction, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (narrow), 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:
CDC Split Type: BEPFIZER INC202101753961

Write-up: Weakness; Vertigo; Difficult digestion; dizziness; Injection site reaction; Headache; Myalgia; Malaise; Nausea; Shivering; Pain in arm; Coldness; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer) from the European Medicines Agency (EMA) EudraVigilance-WEB. Regulatory number: BE-FAMHP-DHH-N2021-109900 (FAMHP). A 33-year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FG7369) at the age of 33 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: NAUSEA (disability) with onset 16Nov2021, outcome "recovered" (21Nov2021), described as "Nausea"; CHILLS (disability) with onset 16Nov2021, outcome "recovered" (21Nov2021), described as "Shivering"; PAIN IN EXTREMITY (disability) with onset 16Nov2021, outcome "recovered" (19Nov2021), described as "Pain in arm"; FEELING COLD (disability) with onset 16Nov2021, outcome "recovered" (21Nov2021), described as "Coldness"; FATIGUE (disability) with onset 16Nov2021, outcome "recovered" (21Nov2021), described as "Fatigue"; ASTHENIA (disability) with onset 17Nov2021, outcome "recovered" (20Nov2021), described as "Weakness"; VERTIGO (disability) with onset 17Nov2021, outcome "recovered" (20Nov2021), described as "Vertigo"; HEADACHE (disability) with onset 16Nov2021, outcome "recovered" (21Nov2021), described as "Headache"; MYALGIA (disability) with onset 16Nov2021, outcome "recovered" (21Nov2021), described as "Myalgia"; MALAISE (disability) with onset 16Nov2021, outcome "recovered" (21Nov2021), described as "Malaise"; DYSPEPSIA (disability) with onset 17Nov2021, outcome "recovered" (20Nov2021), described as "Difficult digestion"; VACCINATION SITE REACTION (disability) with onset 16Nov2021, outcome "recovered" (21Nov2021), described as "Injection site reaction"; DIZZINESS (disability) with onset 17Nov2021, outcome "recovered" (20Nov2021), described as "dizziness". Therapeutic measures were taken as a result of nausea, chills, pain in extremity, feeling cold, fatigue, asthenia, vertigo, headache, myalgia, malaise, dyspepsia, vaccination site reaction, dizziness, treatment included Paracetamol. Clinical course: It started with the cold and the shivers about 1 hour after the vaccine. The arm pain appeared gradually and became almost unbearable after 4-5 hours and for 3 days. The next day started the dizziness, weakness and digestive problems. These symptoms diminished over the next 3 days. Fatigue persisted until day 5. ADR description: Persistent cold, shivering, weakness, great fatigue, dizziness, digestive disorders and extreme pain in the stung arm. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1972623 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 FH3226 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Hypertensive crisis, Immunisation
SMQs:, 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: PERINDOPRIL TERT-BUTYLAMINE; PANTOPRAZOLE BIOGARAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hiatus hernia; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: blood pressure; Result Unstructured Data: Test Result:"20/10"; Comments: crisis hypertensive
CDC Split Type: FRPFIZER INC202101754276

Write-up: booster; Crisis hypertensive/ BP "20/10"; This is a spontaneous report from a contactable reporter (consumer or other non-healthcare professional) from the regulatory authority-WEB; the Regulatory report number is FR-AFSSAPS-TO20219297 (regulatory authority). A 67-year-old male patient received the third dose of bnt162b2 (COMIRNATY), intramuscularly, administered in the left arm on 16Nov2021 (batch/lot number: FH3226) at the age of 67 years old, as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Relevant medical history included: "Hiatus hernia" (unspecified if ongoing) and "Hypertension arterial" (unspecified if ongoing). Concomitant medications included: PERINDOPRIL TERT-BUTYLAMINE and PANTOPRAZOLE BIOGARAN. Vaccination history included: Comirnaty [first dose, via an unspecified route of administration on an unspecified date (batch/lot number: unknown) as DOSE 1, SINGLE)] for COVID-19 immunization; Comirnaty (second dose, via an unspecified route of administration on an unspecified date (batch/lot number: unknown) as DOSE 2, SINGLE] for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown" described as "booster"; HYPERTENSIVE CRISIS (medically significant) with onset 16Nov2021, outcome "recovered" (16Nov2021), described as "Crisis hypertensive/ BP "20/10"." The patient underwent the following laboratory tests and procedures: blood pressure measurement: (16Nov2021) "20/10", notes: crisis hypertensive. Additional information: COVID test: no; According to the patient: This effect occurred during all 3 doses. No further information. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1973194 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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: Burning sensation, Gastrooesophageal reflux disease, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Throat irritation
SMQs:, Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific dysfunction (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ischaemic heart disease (Heart disease)
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101770305

Write-up: Acid reflux (esophageal); Dose 1 and Dose 2: Non- Pfizer COVID vaccine and Dose 3: Pfizer COVID vaccine; Dose 1 and Dose 2: Non- Pfizer COVID vaccine and Dose 3: Pfizer COVID vaccine; Third dose of COMIRNATY; burning sensation; Burning sensation in throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112111109156620-UPFE3 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26323311 (MHRA). A 49 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FH4751) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Ischaemic heart disease" (unspecified if ongoing), notes: Heart disease. The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient''s concomitant medications were not reported. 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 (disability), INTERCHANGE OF VACCINE PRODUCTS (disability) all with onset 16Nov2021, outcome "unknown" and all described as "Dose 1 and Dose 2: Non- Pfizer COVID vaccine and Dose 3: Pfizer COVID vaccine"; IMMUNISATION (disability) with onset 16Nov2021, outcome "unknown", described as "Third dose of COMIRNATY"; BURNING SENSATION (disability) with onset 2021, outcome "not recovered", described as "burning sensation"; 6 days after booster developed dreadful GASTROOESOPHAGEAL REFLUX DISEASE (disability) with onset 22Nov2021, outcome "not recovered", described as "Acid reflux (esophageal)"; THROAT IRRITATION (disability) with onset 2021, outcome "unknown", described as "Burning sensation in throat" that was waking the patient up each morning. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Aug2021) no - negative covid-19 test. The patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1973632 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Myocardial infarction
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (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:
CDC Split Type: NZPFIZER INC202101760260

Write-up: Myocardial infarction; Chest discomfort; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from Regulatory Authority. Regulatory number: AEFI-A-049888. A 37 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 37 years 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, reaction(s): "Chest pain". The following information was reported: MYOCARDIAL INFARCTION (hospitalization, medically significant) with onset 16Nov2021 12:00, outcome "recovering", described as "Myocardial infarction"; CHEST DISCOMFORT (hospitalization) with onset 16Nov2021 12:00, outcome "recovering", described as "Chest discomfort". Reporter''s description of AEFI: Chest pain - similar reaction to his first dose (which was reported to his GP). 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) : NZ-PFIZER INC-202101797913 same patient and product, different doses/events


VAERS ID: 1973651 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Hypertension, Transient ischaemic attack, Troponin
SMQs:, Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: BP; Result Unstructured Data: Test Result:160/88; Comments: next few days; Test Date: 20211116; Test Name: BP; Result Unstructured Data: Test Result:195/109; Comments: next day / night( after vaccination); Test Name: Mild troponin; Result Unstructured Data: Test Result:15; Comments: Mild troponin rise to 15
CDC Split Type: NZPFIZER INC202101760435

Write-up: Transient ischaemic attack; Hypertension; This is a spontaneous report received from a contactable reporter, Physician, from Regulatory Authority. Regulatory number: AEFI-A-051535 (MedSafe AEFI Case Number). A 78-year-old male patient received bnt162b2 (COMIRNATY), administration date 15Nov2021 (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: transient ischaemic attack (hospitalization, medically significant) with onset 16Nov2021 18:30, outcome recovering; hypertension (hospitalization) with onset 16Nov2021 18:30, outcome recovering. Awaiting further echo and cardiology review now. No previous history of hypertension. The patient underwent the following laboratory tests: blood pressure measurement: (unspecified date) 160/88, notes: next few days; (16Nov2021) 195/109, (normal is 110/65) notes: next day / night(after vaccination); troponin: (unspecified date) 15, notes: Mild troponin rise to 15. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1973673 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-12
Onset:2021-11-16
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 320780 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Dizziness
SMQs:, Anticholinergic syndrome (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular 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: PHPFIZER INC202101758981

Write-up: Cardiac dysrhythmias; Dizziness; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300122598 Regulatory Authority. A 67-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 12Nov2021 (Lot number: 320780) at the age of 67 years 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: ARRHYTHMIA (hospitalization, medically significant) with onset 16Nov2021 06:00, outcome "recovered" (2021), described as "Cardiac dysrhythmias"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Dizziness". The patient was hospitalized for arrhythmia (start date: 2021). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1973822 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-11-16
   Days after vaccination:139
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8274 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101784019

Write-up: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202111-2254. A 53-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 30Jun2021 (Lot number: FD8274) as dose 2, 0.3 ml single and intramuscular, administration date 02Jun2021 (Lot number: FA8142) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 16Nov2021, outcome "recovered" (25Nov2021), described as "Drug ineffective"; COVID-19 (medically significant) with onset 16Nov2021, outcome "recovered" (25Nov2021), described as "COVID-19". Clinical course: The reporter assessed the causal relationship of the event vaccination failure as probable to the bnt162b2 (COMIRNATY); Method of assessment was unknown. There is no information on performing a specific test with a positive result for the SARS-2 virus. No information was reported on symptomatology. Health authority comment: Other information-1st dose-02Jun2021-Covid19Pfizer FA8142 without records. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Other information-1st dose-02Jun2021-Covid19Pfizer FA8142 without records


VAERS ID: 1974712 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 FE7053 / 2 - / -
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Malaise, Nausea, Vaccination site pain, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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 INC202101762747

Write-up: This is a spontaneous report received from a contactable reporter from the Regulatory Authority. Regulatory number: BE-FAMHP-DHH-N2021-109805. A 12 year-old female patient received bnt162b2, administered in arm, administration date 16Nov2021 (Lot number: FE7053) at the age of 12 years as dose 2, single for covid-19 immunisation; hpv vaccine (Batch/Lot number: unknown) as dose 1, single for immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, manufacturer unknown), for COVID-19 immunisation. The following information was reported: vomiting with onset 16Nov2021, outcome recovered (18Nov2021); chills with onset 16Nov2021, outcome recovered (16Nov2021); vaccination site pain with onset 16Nov2021, outcome recovered (16Nov2021); headache with onset 16Nov2021, outcome recovered (16Nov2021); malaise with onset 16Nov2021, outcome recovered (16Nov2021); nausea with onset 16Nov2021, outcome recovered (16Nov2021). Therapeutic measures were taken as a result of vomiting, chills, vaccination site pain, headache, malaise, nausea. Clinical course: The night after the administration of the 2nd dose in the afternoon she vomited, she had chills, an increase (no fever), muscle pain in injected arm, headache, and she did not feel well. Patient was treated with paracetamol for 2 days and rest. Combination with first dose of HPV vaccine may have an influence. Evolution of the ADR: Restored. 2.5 days.


VAERS ID: 1974870 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-06
Onset:2021-11-16
   Days after vaccination:10
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: Balance disorder, Diarrhoea, Fatigue, Head discomfort, Hypersomnia, Immunisation, Interchange of vaccine products, Malaise, Meniere's disease, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (narrow), Noninfectious diarrhoea (narrow), Medication errors (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: ANTISTAX [VITIS VINIFERA LEAF]; SELENIUM; L-THYROXINE [LEVOTHYROXINE]; VITAMIN D NOS; VITAMIN C [ASCORBIC ACID]; VITAMIN E NOS; ARTERIN PLUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dust allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101761964

Write-up: interchange of vaccine products; booster; Irrepressible sleep, I slept a day and a half of heavy sleep; Fatigue; Vomiting; Getting up difficult with imbalance (Meniere type): my husband had to support me; Malaise; Getting up difficult with imbalance; Heavy head with a feeling of circulatory blockage; Diarrhea; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: BE-FAMHP-DHH-N2021-109862 (RA). A 67 year-old female patient received bnt162b2 (COMIRNATY), administration date 06Nov2021 (Lot number: FG7369) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "dust allergy" (unspecified if ongoing). Concomitant medication(s) included: ANTISTAX [VITIS VINIFERA LEAF]; SELENIUM; L-THYROXINE [LEVOTHYROXINE]; VITAMIN D NOS; VITAMIN C [ASCORBIC ACID]; VITAMIN E NOS; ARTERIN PLUS. Vaccination history included: Vaxzevria (DOSE 1, single, LOT: ABV8877), administration date: 13Apr2021, for COVID-19 immunisation; Vaxzevria (DOSE 2 single, LOT: ABX8332), administration date: 02Jul2021, for COVID-19 immunisation. 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"; HYPERSOMNIA (disability) with onset 16Nov2021 09:00, outcome "recovered" (17Nov2021 09:00), described as "Irrepressible sleep, I slept a day and a half of heavy sleep"; FATIGUE (disability) with onset 16Nov2021 09:00, outcome "recovered" (17Nov2021 09:00), described as "Fatigue"; VOMITING (disability) with onset 16Nov2021 09:00, outcome "recovered" (17Nov2021 09:00), described as "Vomiting"; MENIERE''S DISEASE (disability) with onset 16Nov2021 09:00, outcome "recovered" (17Nov2021 09:00), described as "Getting up difficult with imbalance (Meniere type): my husband had to support me"; MALAISE (disability) with onset 16Nov2021 09:00, outcome "recovered" (17Nov2021 09:00), described as "Malaise"; BALANCE DISORDER (disability) with onset 16Nov2021 09:00, outcome "recovered" (17Nov2021 09:00), described as "Getting up difficult with imbalance"; HEAD DISCOMFORT (disability) with onset 16Nov2021 09:00, outcome "recovered" (17Nov2021 09:00), described as "Heavy head with a feeling of circulatory blockage"; DIARRHOEA (disability) with onset 16Nov2021 09:00, outcome "recovered" (17Nov2021 09:00), described as "Diarrhea"; NAUSEA (disability) with onset 16Nov2021 09:00, outcome "recovered" (17Nov2021 09:00), described as "Nausea". Therapeutic measures were not taken as a result of hypersomnia, fatigue, vomiting, meniere''s disease, malaise, balance disorder, head discomfort, diarrhoea, nausea. Patient waited without going to the doctor and took Arterine and vitamins and slept a day and a half of heavy sleep. The next day, symptoms gone. So they made the link with the vaccine. Patient vaccinated the same day, had to rest as well, same heavy headache, but lesser side effects. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : BE-PFIZER INC-202101811193 same drug, same date of vaccination, different patient


VAERS ID: 1976684 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Dizziness, Dyspnoea, Influenza, Pyrexia, Tachycardia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101753760

Write-up: This is a spontaneous report received from a non-contactable reporter(s) (consumer or other non-HCP) from Regulatory Authority. Regulatory number: DE-PEI-CADR2021201293 (RA). Other Case identifier(s): DE-CADRPEI-2021201293 (RA), DE-PEI-202100225828 (RA). A 56-year-old patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: Unknown) at the age of 56 years 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: INFLUENZA (hospitalization) with onset 16Nov2021, outcome "unknown", described as "Flu symptoms"; DYSPNOEA (hospitalization) with onset 16Nov2021, outcome "unknown", described as "Dyspnoea"; ARRHYTHMIA (hospitalization, medically significant) with onset 16Nov2021, outcome "unknown", described as "Arrhythmia"; PYREXIA (hospitalization) with onset 16Nov2021, outcome "unknown", described as "Pyrexia"; VOMITING (hospitalization) with onset 16Nov2021, outcome "unknown", described as "Vomiting"; TACHYCARDIA (hospitalization) with onset 16Nov2021, outcome "unknown", described as "Tachycardia"; DIZZINESS (hospitalization) with onset 16Nov2021, outcome "unknown", described as "Dizziness". Sender''s comment: Have you or the person concerned any known allergies? If yes, which? No. Information on risk factors or previous illnesses none. Acute and shock-like. Relatedness: Comirnaty / Flu symptoms, Dyspnoea, Arrhythmia, Pyrexia, Vomiting, Tachycardia, Dizziness / PEI: A. Consistent causal association to immunization No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1976964 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 FG7911 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Asthenia, Back pain, Confusional state, Constipation, Headache, Hemiparaesthesia, Hemiparesis, Immunisation reaction, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Ankylosing spondylitis; Hypothyroidism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101762426

Write-up: paresthesia and muscle weakness of the right half of the body; paresthesia and muscle weakness of the right half of the body; Acute onset of confusion; Reactogenicity event; Abdominal pain; severe back pain; Constipation; Severe Asthenia; myalgia predominant on the right half of the body; Headache; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: FR-AFSSAPS-BR20214091 (RA). A 56-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), intramuscular, administration date 16Nov2021 (Lot number: FG7911) at the age of 56 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Hypothyroidism" (ongoing); "Ankylosing spondylitis" (ongoing). The patient''s concomitant medications were not reported. The following information was reported: HEMIPARAESTHESIA (medically significant), HEMIPARESIS (medically significant) all with onset 16Nov2021, outcome "recovering" and all described as "paresthesia and muscle weakness of the right half of the body", table of reactogenicity and symptoms suggestive according to the doctor declaring polyneuritis affecting the right hemibody and the right half of the face, the onset of which started 30 minutes after the first injection; CONFUSIONAL STATE (medically significant) with onset 16Nov2021, outcome "recovered" (2021), described as "Acute onset of confusion"; IMMUNISATION REACTION (non-serious) with onset 16Nov2021, outcome "recovering", described as "Reactogenicity event"; ABDOMINAL PAIN (non-serious) with onset 16Nov2021, outcome "recovering", described as "Abdominal pain"; BACK PAIN (non-serious) with onset 16Nov2021, outcome "recovering", described as "severe back pain"; CONSTIPATION (non-serious) with onset 16Nov2021, outcome "recovering", described as "Constipation"; ASTHENIA (non-serious) with onset 16Nov2021, outcome "recovering", described as "Severe Asthenia"; MYALGIA (non-serious) with onset 16Nov2021, outcome "recovering", described as "myalgia predominant on the right half of the body"; HEADACHE (non-serious) with onset 16Nov2021, outcome "recovering", described as "Headache". The symptoms lasted for 2 weeks and have been improving since "28Dec2021" - as reported, not confirmed. There was no electrophysiological exploration carried out. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1977237 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 FK5475 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Chest pain, Dyspnoea, Fatigue, Heart rate, Heart rate increased, Hypertension, Immunisation, Interchange of vaccine products, Off label use, Palpitations, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Medication errors (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:141/109; Test Name: Blood pressure; Result Unstructured Data: Test Result:131/111; Test Name: Blood pressure; Result Unstructured Data: Test Result:164/97; Test Name: Pulse rate; Result Unstructured Data: Test Result:109; Test Name: Pulse rate; Result Unstructured Data: Test Result:145; Test Name: Pulse rate; Result Unstructured Data: Test Result:96
CDC Split Type: GBPFIZER INC202101770114

Write-up: Pulse rapid; Fatigue/unusual tiredness; Chest pain; Shortness of breath; Heart palpitations; Racing heart (tachycardia); Blood pressure: 141/109; 131/111; 164/97; Heart racing; 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 Agency Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112091222466130-2OFCI. Other Case identifier(s): GB-MHRA-ADR 26312004. A male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FK5475) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "angina" (unknown if ongoing). Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. Past drug history included: Monopost, notes: 50 ml eye drops.; Candesartan, notes: 16mg; Atorvastatin, notes: 40mg; Glyceryl trinitrate, notes: spray - occasional use only; Aspirin, notes: 75mg. 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: OFF LABEL USE (medically significant) with onset 16Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; HEART RATE INCREASED (medically significant), outcome "unknown", described as "Pulse rapid"; PALPITATIONS (medically significant) with onset 21Nov2021, outcome "recovered" (22Nov2021), described as "Heart racing"; FATIGUE (medically significant), outcome "unknown", described as "Fatigue/unusual tiredness"; CHEST PAIN (medically significant), outcome "unknown", described as "Chest pain"; DYSPNOEA (medically significant), outcome "unknown", described as "Shortness of breath"; PALPITATIONS (medically significant), outcome "unknown", described as "Heart palpitations"; TACHYCARDIA (medically significant), outcome "unknown", described as "Racing heart (tachycardia)"; HYPERTENSION (medically significant), outcome "unknown", described as "Blood pressure: 141/109; 131/111; 164/97". The patient underwent the following laboratory tests and procedures: blood pressure measurement: 141/109; 131/111; 164/97; heart rate: 109; 145; 96. Clinical course: Severe heart palpitations overnight. The report not related to possible inflammation of the heart (myocarditis or pericarditis). The symptoms didn''t lead to a hospital stay. Diagnosis wasn''t made by a medical professional. There were not any blood tests, such as for certain proteins (called troponin) that signal heart muscle damage taken. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1977632 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Arthralgia, Cardiac murmur, Hypoaesthesia, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Medication errors (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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101779999

Write-up: Upset stomach; Patient received first and second dose of Non-Pfizer vaccine and booster dose of COMIRNATY; Patient received first and second dose of Non-Pfizer vaccine and booster dose of COMIRNATY; Patient received booster dose of COMIRNATY; Heart murmur; Joint ache; Numbness; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112121710548200-WDVBG (RA). Other Case identifier(s): GB-MHRA-ADR 26324960 (RA). A 58 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 58 years 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, manufacture unknown), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, manufacture unknown), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 16Nov2021, outcome "unknown" and all described as "Patient received first and second dose of Non-Pfizer vaccine and booster dose of COMIRNATY"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Patient received booster dose of COMIRNATY"; CARDIAC MURMUR (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Heart murmur"; ARTHRALGIA (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Joint ache"; HYPOAESTHESIA (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Numbness"; ABDOMINAL DISCOMFORT (medically significant) with onset 17Nov2021, outcome "recovering", described as "Upset stomach". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Patient did not test positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1977981 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 FH0114 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Cough, Headache, Immunisation, Impaired work ability, Malaise, Myalgia, Nausea, Pyrexia, Tachycardia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TAMSULOSIN; OZEMPIC; VIT C; VIT D [COLECALCIFEROL]; OMEGA-3 FATTY ACIDS; TURMERIC CURCUMIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: BPH; COVID-19 virus test positive; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101773691

Write-up: Booster; MALAISE; DRY COUGH; VOMITING; FEVER; NO ENERGY / GENERAL WEAKNESS / GENERALISED WEAKNESS; INCAPACITATING, OUT OF WORK; NAUSEA; MYALGIA; HEADACHE; TACHYCARDIA; ROGORS / RIGORS; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: IE-HPRA-2021-087134 (HPRA). A 68 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FH0114) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19 virus test positive", start date: Mar2020 (unspecified if ongoing); "BPH" (unspecified if ongoing); "Type 2 diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN taken for benign prostatic hyperplasia, start date: 01Feb2019, stop date: 22Nov2021; OZEMPIC taken for type 2 diabetes mellitus, start date: 15Feb2020, stop date: 22Nov2021; VIT C; VIT D [COLECALCIFEROL]; OMEGA-3 FATTY ACIDS; TURMERIC CURCUMIN. Vaccination history included: Comirnaty (Dose 1, single, Lot number: not reported., Approximately 12 hours after each dose, the patient experienced suspected adverse reactions to Comirnaty.), administration date: 09Jan2021, for COVID-19 immunisation, reaction(s): "suspected adverse reactions"; Comirnaty (Dose 2, single, Lot number: not reported., Approximately 12 hours after each dose, the patient experienced suspected adverse reactions to Comirnaty.), administration date: 30Jan2021, for COVID-19 immunisation, reaction(s): "suspected adverse reactions". The following information was reported: IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; MALAISE (medically significant) with onset 16Nov2021, outcome "recovered" (18Nov2021), described as "MALAISE"; COUGH (medically significant) with onset 16Nov2021, outcome "recovered" (18Nov2021), described as "DRY COUGH"; VOMITING (medically significant) with onset 16Nov2021, outcome "recovered" (18Nov2021), described as "VOMITING"; PYREXIA (medically significant) with onset 16Nov2021, outcome "recovered" (18Nov2021), described as "FEVER"; ASTHENIA (medically significant) with onset 16Nov2021, outcome "recovered" (18Nov2021), described as "NO ENERGY / GENERAL WEAKNESS / GENERALISED WEAKNESS"; IMPAIRED WORK ABILITY (medically significant) with onset 16Nov2021, outcome "recovered" (18Nov2021), described as "INCAPACITATING, OUT OF WORK"; NAUSEA (medically significant) with onset 16Nov2021, outcome "recovered" (18Nov2021), described as "NAUSEA"; MYALGIA (medically significant) with onset 16Nov2021, outcome "recovered" (18Nov2021), described as "MYALGIA"; HEADACHE (medically significant) with onset 16Nov2021, outcome "recovered" (18Nov2021), described as "HEADACHE"; TACHYCARDIA (medically significant) with onset 16Nov2021, outcome "recovered" (18Nov2021), described as "TACHYCARDIA"; CHILLS (medically significant) with onset 16Nov2021, outcome "recovered" (18Nov2021), described as "ROGORS / RIGORS". Therapeutic measures were taken as a result of malaise, cough, vomiting, pyrexia, asthenia, impaired work ability, nausea, myalgia, headache, tachycardia, chills. Clinical course: Approximately 12 hours later (also reported as 23Nov2021), the patient experienced fever, rigors, dry cough, tachycardia, nausea, vomiting, myalgia, malaise, general/generalised weakness, no energy and headache. The patient''s symptoms persisted for 48 hours. The patient was treated with supportive, fluids (not further specified) and paracetamol (brand unspecified). It was reported that this was incapacitating and that the patient was out of work for 2 days. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1978124 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-03
Onset:2021-11-16
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Heart rate, Heart rate increased, Immunisation
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Non-smoker
Allergies:
Diagnostic Lab Data: Test Date: 202111; Test Name: Pulse rate; Result Unstructured Data: Test Result:150 - 160; Comments: 150-160.
CDC Split Type: NOPFIZER INC202101765153

Write-up: booster; HIGH PULSE RATE 150 - 160; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory authority. A 82 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 03Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Non-smoker" (unspecified if ongoing). The patient''s concomitant medications were not reported. 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 (hospitalization), outcome "unknown", described as "booster"; HEART RATE INCREASED (hospitalization) with onset 16Nov2021, outcome "recovered" (19Nov2021), described as "HIGH PULSE RATE 150 - 160". The event "high pulse rate 150 - 160" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: heart rate: (Nov2021) 150 - 160, notes: 150-160. Clinical course: The patient reported contact with physician. The patient has never been hospitalized due to disease before. The patient has no allergies and does not use any dietary supplement. The Agency did not provide a causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: The patient reported contact with physician. The patient has never been hospitalized due to disease before. The patient has no allergies and does not use any dietary supplement.


VAERS ID: 1978238 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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: Anaphylactic reaction, Anaphylactoid reaction, Blood pressure measurement, Dyspnoea, Feeling of body temperature change, Flushing, Heart rate, Oxygen saturation, Presyncope, Respiratory rate
SMQs:, Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: BP; Result Unstructured Data: Test Result:96/59; Comments: after the vaccination; Test Date: 20211116; Test Name: BP; Result Unstructured Data: Test Result:136/88; Comments: after used 0.5mg IM adrenaline administered, maintained BP 136/88; Test Date: 20211116; Test Name: HR; Result Unstructured Data: Test Result:51; Comments: after the vaccination; Test Date: 20211116; Test Name: HR; Result Unstructured Data: Test Result:63; Comments: after used 0.5mg IM adrenaline administered, maintained HR 63; Test Date: 20211116; Test Name: SpO2; Test Result: 100 %; Comments: after the vaccination; Test Date: 20211116; Test Name: SpO2; Result Unstructured Data: Test Result: greater than98 %; Comments: after used 0.5mg IM adrenaline administered, maintained SpO2 greater than98%; Test Date: 20211116; Test Name: RR; Result Unstructured Data: Test Result:16; Comments: after used 0.5mg IM adrenaline administered, maintained RR 16
CDC Split Type: NZPFIZER INC202101760248

Write-up: Anaphylactic reaction; Anaphylactoid reaction; Dyspnoea; Feeling of body temperature change; Flushing; Presyncope; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Regulatory number: AEFI-A-049637. A 37 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 37 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: ANAPHYLACTIC REACTION (medically significant) with onset 16Nov2021 09:45, outcome "recovered" (2021), described as "Anaphylactic reaction"; ANAPHYLACTOID REACTION (medically significant) with onset 16Nov2021 09:45, outcome "recovered" (2021), described as "Anaphylactoid reaction"; DYSPNOEA (medically significant) with onset 16Nov2021 09:45, outcome "recovered" (2021), described as "Dyspnoea"; FEELING OF BODY TEMPERATURE CHANGE (medically significant) with onset 16Nov2021 09:45, outcome "recovered" (2021), described as "Feeling of body temperature change"; FLUSHING (medically significant) with onset 16Nov2021 09:45, outcome "recovered" (2021), described as "Flushing"; PRESYNCOPE (medically significant) with onset 16Nov2021 09:45, outcome "recovered" (2021), described as "Presyncope". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (16Nov2021) 96/59, notes: after the vaccination; (16Nov2021) 136/88, notes: after used 0.5mg IM adrenaline administered, maintained BP 136/88; heart rate: (16Nov2021) 51, notes: after the vaccination; (16Nov2021) 63, notes: after used 0.5mg IM adrenaline administered, maintained HR 63; oxygen saturation: (16Nov2021) 100 %, notes: after the vaccination; (16Nov2021) greater than98, notes: after used 0.5mg IM adrenaline administered, maintained SpO2 greater than98%; respiratory rate: (16Nov2021) 16, notes: after used 0.5mg IM adrenaline administered, maintained RR 16. Therapeutic measures were taken as a result of anaphylactic reaction, anaphylactoid reaction, dyspnoea, feeling of body temperature change, flushing, presyncope. Clinical course: Date first reported: 16Nov2021. Reporter''s description of AEFI: Patient reports within 10minutes of vaccine administration patient began to feel hot/flushed and faint. Felt was about to lose consciousness so lowered self to ground to prevent syncope. Simultaneously developed acute throat tightening, chest tightness and difficulty breathing. Witnessed by vaccination nurses and report stridor, looked flat, pale, recorded hypotension BP 96/59 HR 51 SpO2 100% - 0.5mg IM adrenaline administered Placed on 10L O2 with quick resolution of stridor - second adrenaline therefore not administered Some faint end-expiratory wheeze noted Weaned off O2 - maintained SpO2 $g98%, BP 136/88, HR 63, RR 16. Whole episode occurred over approx. 30minutes. Seriousness: Medically Significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1978286 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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: Anaphylactic reaction, Anaphylactoid reaction, Angioedema, Bronchospasm
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202101760428

Write-up: Anaphylactic reaction; Anaphylactoid reaction; Angioedema; Bronchospasm; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: AEFI-A-052485 (regulatory authority Case Number). A 43 year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (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: ANAPHYLACTIC REACTION (medically significant) with onset 16Nov2021 20:30, outcome "recovered" (2021), described as "Anaphylactic reaction"; ANAPHYLACTOID REACTION (medically significant) with onset 16Nov2021 20:30, outcome "recovered" (2021), described as "Anaphylactoid reaction"; ANGIOEDEMA (medically significant) with onset 16Nov2021 20:30, outcome "recovered" (2021), described as "Angioedema"; BRONCHOSPASM (medically significant) with onset 16Nov2021 20:30, outcome "recovered" (2021), described as "Bronchospasm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1978311 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-12
Onset:2021-11-16
   Days after vaccination:4
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: Dizziness, Muscle spasms, Presyncope
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202101760464

Write-up: Presyncope/Faint in response to attempt at movement; Dizziness/saw stars moving from bed to en-suite; Muscle spasms/Muscle spasm on every movement to the degree screamed /paused involuntarily in reaction; 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-051561. A 41 year-old female patient received bnt162b2 (COMIRNATY), administration date 12Nov2021 (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: PRESYNCOPE (hospitalization) with onset 16Nov2021 13:41, outcome "recovering", described as "Presyncope/Faint in response to attempt at movement"; DIZZINESS (hospitalization) with onset 16Nov2021 13:41, outcome "recovering", described as "Dizziness/saw stars moving from bed to en-suite"; MUSCLE SPASMS (hospitalization) with onset 16Nov2021 13:41, outcome "recovering", described as "Muscle spasms/Muscle spasm on every movement to the degree screamed /paused involuntarily in reaction". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1978314 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-14
Onset:2021-11-16
   Days after vaccination:2
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: Chest discomfort, Dyspnoea, Fatigue, Headache, Myocarditis, Pericarditis
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (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:
CDC Split Type: NZPFIZER INC202101760467

Write-up: fatigue; Myocarditis; Pericarditis; Chest discomfort; Dyspnoea; Headache; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. A 34 year-old female patient received bnt162b2 (COMIRNATY), administration date 14Nov2021 (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: MYOCARDITIS (hospitalization) with onset 16Nov2021 16:22, outcome "recovering", described as "Myocarditis"; PERICARDITIS (hospitalization) with onset 16Nov2021 16:22, outcome "recovering", described as "Pericarditis"; CHEST DISCOMFORT (hospitalization) with onset 16Nov2021 16:22, outcome "recovering", described as "Chest discomfort"; DYSPNOEA (hospitalization) with onset 16Nov2021 16:22, outcome "recovering", described as "Dyspnoea"; HEADACHE (hospitalization) with onset 16Nov2021 16:22, outcome "recovering", described as "Headache"; FATIGUE (hospitalization) with onset 26Nov2021, outcome "unknown", described as "fatigue". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1978337 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-16
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101764441

Write-up: vaccine impaired response; vaccine impaired response; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority-WEB. Regulatory number: PT-INFARMED-T202111-1735. A 58 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 25Jun2021 (Lot number: unknown) as dose 02, 0.3 ml, single and intramuscular (Batch/Lot number: unknown) as dose 01, 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 16Nov2021, outcome "unknown" and all described as "VACCINE IMPAIRED RESPONSE". Clinical course: case not serious, there was no information about carrying out a specific test with a positive result for the SARS-2 virus. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1978364 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-08
Onset:2021-11-16
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1013A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Amnesia, Blindness, Chills, Cold sweat, Feeling hot, Headache, Hyperventilation, Investigation, Malaise, Muscular weakness, Palpitations, Paraesthesia, Speech disorder, Visual impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Lactose intolerant
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: tests; Result Unstructured Data: Test Result:without remarks
CDC Split Type: SEPFIZER INC202101765372

Write-up: Cold sweating; heart palpitations; memory loss; Tingling in the whole body as if it sleeped/"it felt like when the whole body was asleep" it stung "everywhere"; Headache; Vision loss; Chills; Muscle weakness; became hot; began to see pixels at the edges of the field of view/pixels taken over the entire field of view; hyperventilating; did not feel well; felt that she could not talk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: SE-MPA-2021-095273. Other Case identifier(s): SE-VISMA-1638177435892. A 12 year-old female patient received bnt162b2 (COMIRNATY), administration date 08Nov2021 (Lot number: 1F1013A) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lactose intolerant" (ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (dose 1), for COVID-19 immunisation. The following information was reported: COLD SWEAT (medically significant) with onset 16Nov2021, outcome "recovered" (16Nov2021), described as "Cold sweating"; PALPITATIONS (medically significant) with onset 16Nov2021, outcome "recovered" (16Nov2021), described as "heart palpitations"; AMNESIA (medically significant) with onset 16Nov2021, outcome "recovered" (16Nov2021), described as "memory loss"; PARAESTHESIA (medically significant) with onset 16Nov2021, outcome "recovered" (16Nov2021), described as "Tingling in the whole body as if it sleeped/"it felt like when the whole body was asleep" it stung "everywhere""; HEADACHE (medically significant) with onset 16Nov2021, outcome "recovered" (16Nov2021), described as "Headache"; BLINDNESS (medically significant) with onset 16Nov2021, outcome "recovered" (16Nov2021), described as "Vision loss"; CHILLS (medically significant) with onset 16Nov2021, outcome "recovered" (16Nov2021), described as "Chills"; MUSCULAR WEAKNESS (medically significant) with onset 16Nov2021, outcome "recovered" (16Nov2021), described as "Muscle weakness"; FEELING HOT (medically significant) with onset 16Nov2021, outcome "recovered" (16Nov2021), described as "became hot"; VISUAL IMPAIRMENT (medically significant) with onset 16Nov2021, outcome "recovered" (16Nov2021), described as "began to see pixels at the edges of the field of view/pixels taken over the entire field of view"; HYPERVENTILATION (medically significant) with onset 16Nov2021, outcome "recovered" (16Nov2021), described as "hyperventilating"; MALAISE (medically significant) with onset 16Nov2021, outcome "recovered" (16Nov2021), described as "did not feel well"; SPEECH DISORDER (medically significant) with onset 16Nov2021, outcome "recovered" (16Nov2021), described as "felt that she could not talk". The patient underwent the following laboratory tests and procedures: investigation: (16Nov2021) without remarks. Clinical course: The reporter states that the girl had memory loss when she was going to tell a thing to 2 classmates and the teacher "does not remember". In this situation, the girl became hot, sweaty and began to see pixels at the edges of the field of view. The girl did not feel well. The girl became even more sweaty, walked about 2 m and had to sit down due to the pixels taken over the entire field of view. In connection with this, the girl shouted that she did not see anything. The girl froze and her heart raced. Furthermore, the reporter states that the girl was hyperventilating, "it felt like when the whole body was asleep" it stung "everywhere". The girl was asked to breathe calmly, the sight came back a little closer. Muscle weakness made the girl unable to hold and drink a glass of water. Furthermore, she felt that she could not talk or do anything. The ambulance was called, tests were done on site without remarks. The girl has never seen anything like it. The Medical Products Agency assesses suspected incidents of memory loss and loss of vision as a serious, important medical event, while the reporter states as non-serious. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1978380 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-03
Onset:2021-11-16
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deafness unilateral, Immunisation
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BACTRIM; IMDUR; METOPROLOL; IMBRUVICA; ACETYLSALICYLSYRA ACTAVIS; AMLODIPINE; ATORBIR; CANDESARSTAD
Current Illness: Cardiac failure (congestive cardiac failure); Hypertension; Retinal detachment; Von Waldenstrom macroglobulinemia
Preexisting Conditions: Medical History/Concurrent Conditions: Lymphoma; Malignant neoplasm of nasopharynx
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101764928

Write-up: Booster; Loss of hearing in the left ear; This is a spontaneous report received from a contactable reporter (Consumer) from the WEB. Regulatory number: SE-MPA-2021-095904 (MPA). A 69-year-old male patient received bnt162b2 (COMIRNATY), administration date 03Nov2021 (Lot number: Unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (ongoing); "Cardiac failure" (ongoing), notes: congestive cardiac failure; "Retinal detachment" (ongoing); "Lymphoma" (not ongoing); "Von Waldenstrom macroglobulinemia" (ongoing); "Malignant neoplasm of nasopharynx" (not ongoing). Concomitant medication(s) included: BACTRIM; IMDUR; METOPROLOL; IMBRUVICA, start date: 20Aug2020; ACETYLSALICYLSYRA ACTAVIS, start date: 20Aug2020; AMLODIPINE; ATORBIR; CANDESARSTAD. Vaccination history included: Covid-19 vaccine (1st dose; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (2nd dose; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The patient experienced loss of hearing in the left ear on 16Nov2021. Therapeutic measures were taken as a result of deafness unilateral. "According to the physician, it is inflammation of the auditory nerve." The patient was now taking cortisone, but it has not helped. The outcome of event was not recovered. Case assessed as serious, permanent disability. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1979548 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-11-16
   Days after vaccination:174
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1B014A / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101799096

Write-up: suspected COVID-19; Drug ineffective; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the regulatory authority and product quality group. Regulatory number: DE-PEI-202100273806 (RA). A 33 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 26May2021 (Lot number: 1B014A) at the age of 32 years as dose 2,single and intramuscular, administration date 06May2021 (Lot number: EX85679) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 16Nov2021, outcome "unknown", described as "suspected COVID-19"; DRUG INEFFECTIVE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Drug ineffective". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1979634 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: C-reactive protein, Cardiac telemetry, Chest discomfort, Dyspnoea, Echocardiogram, Electrocardiogram, Investigation, Malaise, Myalgia, Myocarditis, Physical examination, Pyrexia, Troponin T
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cigarette smoker (Smokes 5 cigarettes per week)
Preexisting Conditions: Medical History/Concurrent Conditions: Substance user (Previous monthly user of cocaine but nothing since summer 2021)
Allergies:
Diagnostic Lab Data: Test Date: 202111; Test Name: Cardiac telemetry; Result Unstructured Data: No arrhythmias; Test Date: 20211120; Test Name: C-reactive protein; Result Unstructured Data: (At hospitalisation) 68 Unit not specified; Test Date: 20211121; Test Name: C-reactive protein; Result Unstructured Data: (At discharge) 31 Unit not specified; Test Date: 202111; Test Name: Transthoracic echocardiogram; Result Unstructured Data: Nothing abnormal, no pericardial accumulation; Test Date: 202111; Test Name: Electrocardiogram; Result Unstructured Data: Sinus rhythm, normal conduction; Test Date: 202111; Test Name: Electrocardiogram; Result Unstructured Data: Flattening of T-waves in V4 to V6; Test Date: 202111; Test Name: Electrocardiogram; Result Unstructured Data: (At cardiology unit) Normalised, nothing abnormal; Test Date: 202111; Test Name: Electrocardiogram; Result Unstructured Data: Borderline significant q-waves in V4 to V6; Test Date: 202111; Test Name: Electrocardiogram; Result Unstructured Data: Narrow complexes; Test Date: 20211121; Test Name: Investigation; Result Unstructured Data: Perimyocarditis without pericardial effusion; Test Date: 20211121; Test Name: Investigation; Result Unstructured Data: Slight enzyme emission; Test Date: 20211121; Test Name: Physical examination; Result Unstructured Data: Feeling well and without pain; Test Date: 20211120; Test Name: Troponin T; Result Unstructured Data: (At hospitalisation) 139 Unit not specified; Test Date: 20211121; Test Name: Troponin T; Result Unstructured Data: (At discharge) 83 Unit not specified
CDC Split Type: DKMODERNATX, INC.MOD20214

Write-up: Intermittent malaise; Intermittent chest pressure sometimes located centrally; Intermittent dyspnoea; Intermittent fever; Muscle pain; Myocarditis; This regulatory authority case was reported by a physician and describes the occurrence of DYSPNOEA (Intermittent dyspnoea), PYREXIA (Intermittent fever), MALAISE (Intermittent malaise), CHEST DISCOMFORT (Intermittent chest pressure sometimes located centrally), MYALGIA (Muscle pain) and MYOCARDITIS (Myocarditis) in a 28-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. The patient''s past medical history included Substance user (Previous monthly user of cocaine but nothing since summer 2021) in 2021. Previously administered products included for COVID-19 immunisation: SPIKEVAX in 2021. Past adverse reactions to the above products included No adverse event with SPIKEVAX. Concurrent medical conditions included Cigarette smoker (Smokes 5 cigarettes per week). On 15-Nov-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 16-Nov-2021, the patient experienced PYREXIA (Intermittent fever) (seriousness criterion hospitalization), MYALGIA (Muscle pain) (seriousness criterion hospitalization) and MYOCARDITIS (Myocarditis) (seriousness criterion hospitalization). On 17-Nov-2021, the patient experienced DYSPNOEA (Intermittent dyspnoea) (seriousness criterion hospitalization) and CHEST DISCOMFORT (Intermittent chest pressure sometimes located centrally) (seriousness criterion hospitalization). On 18-Nov-2021, the patient experienced MALAISE (Intermittent malaise) (seriousness criterion hospitalization). At the time of the report, DYSPNOEA (Intermittent dyspnoea), PYREXIA (Intermittent fever), MALAISE (Intermittent malaise), CHEST DISCOMFORT (Intermittent chest pressure sometimes located centrally), MYALGIA (Muscle pain) and MYOCARDITIS (Myocarditis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Cardiac telemetry: no arrhythmias No arrhythmias. In November 2021, Echocardiogram: nothing abnormal, no pericardial accumulation Nothing abnormal, no pericardial accumulation. In November 2021, Electrocardiogram: sinus rhythm, normal conduction Sinus rhythm, normal conduction, flattening of t-waves in v4 to v6 Flattening of T-waves in V4 to V6, normalised, nothing abnormal (At cardiology unit) Normalised, nothing abnormal, borderline significant q-waves in v4 to v6 Borderline significant q-waves in V4 to V6 and narrow complexes Narrow complexes. On 20-Nov-2021, C-reactive protein: 68 (At hospitalisation) 68 Unit not specified. On 20-Nov-2021, Troponin T: 139 (At hospitalisation) 139 Unit not specified. On 21-Nov-2021, C-reactive protein: 31 (At discharge) 31 Unit not specified. On 21-Nov-2021, Investigation: perimyocarditis without pericardial effusion (abnormal) Perimyocarditis without pericardial effusion and slight enzyme emission Slight enzyme emission. On 21-Nov-2021, Physical examination: feeling well and without pain Feeling well and without pain. On 21-Nov-2021, Troponin T: 83 (At discharge) 83 Unit not specified. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment medication were reported. This is a regulatory authority case concerning a 28-year-old, male patient with past medical history of substance Abuse (cocaine), who experienced the unexpected serious events of Dyspnoea, Pyrexia, Malaise, Chest discomfort, Myalgia and expected serious event of myocarditis. The events occurred approximately 1 day after the second dose of mRNA-1273 COVID 19 Vaccine. The events were reported as resolving. The rechallenge was unknown since no information about the first dose was disclosed. The medical history, of substance Abuse (cocaine) remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 28-year-old, male patient with past medical history of substance Abuse (cocaine), who experienced the unexpected serious events of Dyspnoea, Pyrexia, Malaise, Chest discomfort, Myalgia and expected serious event of myocarditis. The events occurred approximately 1 day after the second dose of mRNA-1273 COVID 19 Vaccine. The events were reported as resolving. The rechallenge was unknown since no information about the first dose was disclosed. The medical history, of substance Abuse (cocaine) remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.


VAERS ID: 1979799 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 1F1019A / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101779446

Write-up: This is a spontaneous report received from a contactable reporter (Pharmacist) Regulatory Authority. Regulatory number: FR-AFSSAPS-NY20215344 (RA). An 83-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: 1F1019A) at the age of 83 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 (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; COVID-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; OPHTHALMIC HERPES ZOSTER (medically significant), HERPES ZOSTER (medically significant) all with onset 04Dec2021, outcome "not recovered" and all described as "Shingles on the face and upper skull with suspicion of ophthalmic shingles". It was unknown if therapeutic measures were taken as a result of ophthalmic herpes zoster, herpes zoster. No lab test was provided. At the time of this initial report, no more information was provided. Clinical course: Shingles on the face and upper skull with suspicion of ophthalmic shingles to be confirmed by an ophthalmologist. Reporter Comment: 83-year-old male with shingles, possibly ophthalmic, 18 days after a COMIRNATY booster. Patient not recovered at time of reporting. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: 83-year-old male with shingles, possibly ophthalmic, 18 days after a COMIRNATY booster. Patient not recovered at time of reporting.


VAERS ID: 1980453 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Immunisation
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101779922

Write-up: Booster; chest pain left side; Shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority. Regulatory number: NO-NOMAADVRE-FHI-2021-Ux4j78. Other Case identifier(s): NO-NOMAADVRE-E2B_00064412. A 64 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Batch/Lot number: unknown) 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: Comirnaty (dose 1, batch no.unknown), for COVID-19 immunisation; Comirnaty (dose 2, batch no.unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; CHEST PAIN (medically significant) with onset 16Nov2021, outcome "recovering", described as "chest pain left side"; DYSPNOEA (medically significant) with onset 16Nov2021, outcome "recovering", described as "Shortness of breath". The regulatory authority assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1982540 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Migraine
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: Migraine
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101782347

Write-up: Migraine aggravated; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Agency Regulatory Authority-WEB. Regulatory number: AT-BASGAGES-2021-063200 (BASGAGES). A 36 year-old female patient received bnt162b2 (COMIRNATY), administration date 15Nov2021 (Lot number: Unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraine" (ongoing). The patient''s concomitant medications were not reported. The following information was reported: MIGRAINE (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Migraine aggravated". Additional information: Diagnosed migraines with very frequent occurrences since vaccination No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1982543 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cor pulmonale acute, Deep vein thrombosis, Dyspnoea, Immunisation, Pulmonary embolism
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary 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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Osteoporosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101782294

Write-up: Pulmonary embolism bilateral with acute cor pulmonale; Dyspnoea; Pulmonary embolism bilateral with acute cor pulmonale; Deep vein thrombosis on both sides (left 4 stage and right 3 stage); booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority. Regulatory number: AT-BASGAGES-2021-063282 (BASGAGES). Other Case identifier(s): AT-PFIZER INC-202101833797 (same patient, same drug, different doses). A 76 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 76 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Osteoporosis" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1, single), administration date: 11Apr2021, for Covid-19 immunisation; Comirnaty (Dose 2, single), administration date: 23May2021, for Covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "booster"; COR PULMONALE ACUTE (hospitalization), PULMONARY EMBOLISM (hospitalization) all with onset 24Nov2021, outcome "unknown" and all described as "Pulmonary embolism bilateral with acute cor pulmonale"; DYSPNOEA (hospitalization) with onset 24Nov2021, outcome "unknown", described as "Dyspnoea"; DEEP VEIN THROMBOSIS (hospitalization) with onset 24Nov2021, outcome "unknown", described as "Deep vein thrombosis on both sides (left 4 stage and right 3 stage)". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1982547 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 CNK 4293254 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Extensive swelling of vaccinated limb, Lymphadenopathy, Pain, Ultrasound scan
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: Test Name: ECHOGRAPHY; Result Unstructured Data: Test Result:results unknown
CDC Split Type: BEPFIZER INC202101779397

Write-up: Extensive swelling of vaccinated limb; Swollen glands; Pain; This is a spontaneous report received from a contactable reporter(s) (Consumer) from the WEB. Regulatory number: BE-FAMHP-DHH-N2021-109875 (FAMHP). A 43 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: CNK 4293254) at the age of 43 years 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, FJ3438), administration date: 14Oct2021, for covid-19 immunisation. The following information was reported: EXTENSIVE SWELLING OF VACCINATED LIMB (disability) with onset 16Nov2021, outcome "unknown", described as "Extensive swelling of vaccinated limb"; LYMPHADENOPATHY (disability) with onset 16Nov2021, outcome "unknown", described as "Swollen glands"; PAIN (disability) with onset 16Nov2021, outcome "unknown", described as "Pain". The patient underwent the following laboratory tests and procedures: ultrasound scan: results unknown. Therapeutic measures were not taken as a result of extensive swelling of vaccinated limb, lymphadenopathy, pain.


VAERS ID: 1982756 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG9428 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Fatigue, Ovarian bacterial infection, SARS-CoV-2 test
SMQs:, Guillain-Barre syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Migraine with aura
Allergies:
Diagnostic Lab Data: Test Date: 202111; Test Name: PCR test covid-19; Test Result: Negative
CDC Split Type: FRPFIZER INC202101779063

Write-up: Ovarian bacterial infection; Asthenia; fatigue; This is a spontaneous report from a contactable consumer from the regulatory authority-WEB. Regulatory number: FR-AFSSAPS-LY202112847. A 20-year-old female patient received BNT162b2 (COMIRNATY), intramuscular, administration date 15Nov2021 (Lot number: FG9428) as dose 2, single for covid-19 immunisation. Relevant medical history included: "asthma"; "migraine with aura". There were no concomitant medications. Vaccination history included: Covid-19 vaccine (1st dose, manufacturer unknown), for Covid-19 immunisation. The following information was reported: ovarian bacterial infection (medically significant) with onset 16Nov2021, outcome "recovering", described as "ovarian bacterial infection"; asthenia (non-serious) with onset 16Nov2021, outcome "recovered", described as "asthenia"; fatigue (non-serious) with onset 16Nov2021, outcome "recovered", described as "fatigue". The events "ovarian bacterial infection", "asthenia" and "fatigue" were evaluated at the physician office visit. 24 hours after vaccination, onset of fatigue and pain in the ovaries, abdomen and uterus accompanied by unusual white discharge, trembling hands and loss of blood outside the period. One week after onset of symptoms consultation with a gynaecologist and diagnosis of bacterial infection of the ovaries, patient started on doxycycline for 7 days. Resolution of fatigue after a few days. As of 08Dec2021, ovarian infection was improving. Control with gynaecologist was planned. The patient underwent the following laboratory tests and procedures: PCR test covid-19: (Nov2021) negative. Therapeutic measures were taken as a result of ovarian bacterial infection, asthenia, fatigue. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1983533 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0114 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blister, Immunisation
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (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 INC202101774297

Write-up: Booster; blisters to face and nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: IE-HPRA-2021-087587. Other Case identifier(s): IE-HPRA-CVARR2021120122968. A 36 year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FH0114) at the age of 36 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 (DOSE NUMBER UNKNOWN, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; BLISTER (medically significant) with onset 16Nov2021, outcome "not recovered", described as "blisters to face and nose". Therapeutic measures were taken as a result of blister. Clinical course: Time to onset of reaction: Straight away. Duration of reaction was 2 plus weeks. Patient used antibiotics and steroids to treat reaction but did not report names or dosages. Recovery from side effects: Symptoms persisting. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1983638 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0115 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Inappropriate schedule of product administration, Maternal exposure during pregnancy, Premature rupture of membranes
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immune system disorder (other immune system disorder)
Allergies:
Diagnostic Lab Data:
CDC Split Type: LUPFIZER INC202101779441

Write-up: Premature rupture of membranes; Abdominal pain; Comirnaty dose1: 15Jul2021 dose2: 16Nov2021; 19th week of amenorrhea - second injection of Comirnaty; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: LU-ALMPS-202103220 (RA). A 30 year-old female patient (pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: FK0115) at the age of 30 years as DOSE 2, SINGLE for covid-19 immunisation. Relevant medical history included: "Immune system disorder" (unspecified if ongoing), notes: Other immune system disorder. The patient was 19 weeks pregnant at the event onset. The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (dose 1, lot: FC5029), administration date: 15Jul2021, for Covid-19 immunisation, reaction(s): "Vaccine exposure before pregnancy". The following information was reported: PREMATURE RUPTURE OF MEMBRANES (hospitalization) with onset 17Nov2021, outcome "not recovered", described as "Premature rupture of membranes"; ABDOMINAL PAIN (non-serious) with onset 16Nov2021, outcome "recovered" (16Nov2021), described as "Abdominal pain"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 16Nov2021, outcome "unknown", described as "Comirnaty dose1: 15Jul2021 dose2: 16Nov2021"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 16Nov2021, outcome "unknown", described as "19th week of amenorrhea - second injection of Comirnaty". Clinical details reported as follows: This female vaccinated with a first dose of COMIRNATY (batch FC5029) on 15Jul2021, who started a pregnancy the following week. As the second vaccination could not be performed according to the current recommendations within 4 weeks, the patient waited until the 19th week of amenorrhea to receive her second injection (D2) of COMIRNATY: on 16Nov2021 (lot FK0115). Relatedness of Comirnaty to Abdominal pain was assessed as C2 S1 (I1 dubious) B3 Relatedness of Comirnaty to Premature rupture of membranes was assessed as C1 S1 (I1 dubious) B1 No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : LU-PFIZER INC-202101819792 the same patient, different events after 1st and 2nd dose


VAERS ID: 1983720 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypertension (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: BLOOD PRESSURE; Result Unstructured Data: Test Result:100/90
CDC Split Type: PHPFIZER INC202101662929

Write-up: HIGH BLOOD PRESSURE (100/90); Dizziness; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300119627. A 15 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: PCB0002) at the age of 15 years 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 16Nov2021 15:18, outcome "unknown", described as "HIGH BLOOD PRESSURE (100/90)"; DIZZINESS (non-serious) with onset 16Nov2021 15:18, outcome "unknown", described as "Dizziness". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (16Nov2021) 100/90. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1985540 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
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 INC202101790092

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: 679750 (RA ADR#). A 30 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (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 16Nov2021, outcome "unknown", described as "Deep vein thrombosis"; PULMONARY EMBOLISM (medically significant) with onset 16Nov2021, 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: 1986158 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 1F1003A / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Immunisation, Vertigo
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101783153

Write-up: Loss of balance; Vertigo; booster; This is a spontaneous report received from a contactable reporter (Pharmacist) from the Regulatory Authority. Regulatory number: FR-AFSSAPS-ST20214599 (RA). A 61 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: 1F1003A) as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (first dose, lot EM0477), administration date: 15May2021, for Covid-19 immunisation; Comirnaty (second dose, lot: ER0641), administration date: 12Jan2021, for Covid-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 16Nov2021, outcome "unknown", described as "booster"; BALANCE DISORDER (medically significant) with onset 19Nov2021, outcome "recovered" (19Nov2021), described as "Loss of balance"; VERTIGO (medically significant) with onset 19Nov2021, outcome "recovered" (19Nov2021), described as "Vertigo". Additional information: First dose was reported as 15May2021 and second dose was reported as 12Jan2021 (pending clarification).


VAERS ID: 1986294 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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: Axillary pain, Heart rate abnormal, Immunisation, Lymph node pain, SARS-CoV-2 test, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; Clinical trial participant (Zoe study); Obesity; Obstructive sleep apnea syndrome; Suspected COVID-19; Variegate porphyria
Allergies:
Diagnostic Lab Data: Test Date: 20201203; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101796611

Write-up: Racing heart (tachycardia); Axillary pain; Lymph node pain; Heart rate; 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-202112120935192810-EJK5G. Other Case identifier(s): GB-MHRA-ADR 26324489 A 53 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Variegate porphyria" (unknown if ongoing); "Suspected COVID-19", start date: 06Dec2020, stop date: 16Dec2020; "Clinical trial participant" (unknown if ongoing), notes: Zoe study; "Blood pressure high" (unknown if ongoing); "Obesity" (unknown if ongoing); "Obstructive sleep apnea syndrome" (unknown if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number 1), for COVID-19 immunization; Bnt162b2 (Dose number 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; HEART RATE ABNORMAL (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Heart rate"; TACHYCARDIA (medically significant), outcome "not recovered", described as "Racing heart (tachycardia)"; AXILLARY PAIN (medically significant), outcome "unknown", described as "Axillary pain"; LYMPH NODE PAIN (medically significant), outcome "unknown", described as "Lymph node pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Dec2020) positive. Therapeutic measures were not taken as a result of heart rate abnormal, tachycardia, axillary pain, lymph node pain. Clinical course: Patient was not currently breastfeeding. ''The night after my jab woke with intense gland pain under my arm and a racing heart which took 24 hours to settle. This racing heart keeps repeating itself every few days''. Relevant investigations or tests, imaging and blood test carried was not conducted. The symptoms did not lead to a hospital stay. The diagnosis was not made by a medical professional. No imaging was carried out such as, but not limited to, chest X-ray, echocardiogram, cardiac MRI, chest computerised tomography (CT). No blood tests taken, such as for certain proteins (called troponin) that signal heart muscle damage taken. The reaction is 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: 1986516 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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: Feeling abnormal, Headache, Herpes zoster, Immunisation, Interchange of vaccine products, Neuralgia, Off label use, Rash, Rash vesicular, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Dementia (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: INFLUENZA VACCINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chickenpox (I had chicken pox as a child).
Allergies:
Diagnostic Lab Data: Test Date: 20211124; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101788732

Write-up: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from Regulatory Authority (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112132138411810-PYFGD (RA). Other Case identifier(s): GB-MHRA-ADR 26329652 (RA). A 51-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chickenpox" (unspecified if ongoing), notes: I had chicken pox as a child. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, administration date 16Nov2021. Past drug history included: Influenza vaccine for Immunization, reaction(s): "Headache"; Influenza vaccine for Immunization, reaction(s): "Painful arm". Vaccination history included: Covid-19 vaccine (DOSE 2, SINGLE Lot number: UNKNOWN Route of administration: Unspecified Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, SINGLE Lot number: UNKNOWN Route of administration: Unspecified Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. On 24Nov2021, the patient underwent COVID-19 virus test, and the result was negative. The patient''s last menstrual date was 05Dec2021. The patient did not test positive for COVID-19 since having the vaccine. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 16Nov2021, outcome "unknown" and all described as "Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Dose number: 3"; NEURALGIA (medically significant) with onset 2021, outcome "not recovered", described as "Nerve pain"; RASH (medically significant) with onset 2021, outcome "not recovered", described as "Rash"; RASH VESICULAR (medically significant) with onset 2021, outcome "not recovered", described as "Varicella-like rash"; HERPES ZOSTER (medically significant) with onset 2021, outcome "not recovered", described as "Shingles"; HEADACHE (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Headache/ pain was always on the right sight of head"; FEELING ABNORMAL (medically significant) with onset 2021, outcome "unknown", described as "Strange sensation behind right ear, like something drilling through the skull, also felt it above the eye and around cheekbone". The events "nerve pain", "rash", "varicella-like rash", "shingles", "headache/ pain was always on the right sight of head" and "strange sensation behind right ear, like something drilling through the skull, also felt it above the eye and around cheekbone" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Nov2021) no - negative covid-19 test. Therapeutic measures were taken as a result of neuralgia, rash, rash vesicular, herpes zoster, headache, feeling abnormal. Clinical course: Within four hours of the vaccines, she also had a flu vaccine at the same time - incidentally she has had flu vaccines in the past with no adverse effects except for a sore arm for a day or two, she developed a headache. She took paracetamol and ibuprofen for a few days, but it didn''t help much. Then the pain was always on the right sight of her head, not like a normal headache, maybe nerve pain. Often, it''s a strange sensation behind her right ear, like something drilling through her skull. She has also felt it above her eye and around her cheekbone. After lots of checks, everything seemed to be fine. She asked if it could be shingles and they all said it could be. She does not have a rash. She had chicken pox as a child. She was taking amitriptyline which seemed to ease it. She does not have it all of the time, but she got it say, five days out of seven. Her jags were on 16Nov2021, and it still seemed to be lingering. The patient was checked by a nurse, general practitioner (GP) and an optician. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1986543 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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: Heavy menstrual bleeding, Immunisation, Menstrual disorder, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 INC202101788233

Write-up: Booster; After the booster I am on week 4 of continual bleeding and it is getting heavier; Menstruation has been unpredictable, Starting unexpectedly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112140225083980-LPR9A. Other Case identifier(s): GB-MHRA-ADR 26329855. A 36 year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 36 years as dose 3 (booster), single for COVID-19 immunisation. Date of last menstrual period: 2021. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 08Mar2021, for COVID-19 Immunisation, reaction(s): "Menstruation has been unpredictable", "Starting unexpectedly and lasting longer and much heavier"; Comirnaty (DOSE 2, SINGLE), administration date: 30Jul2021, for COVID-19 immunisation, reaction(s): "Inappropriate schedule of vaccine administered", "Menstruation has been unpredictable", "Starting unexpectedly and lasting longer and much heavier". The following information was reported: IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; HEAVY MENSTRUAL BLEEDING (medically significant) with onset 16Nov2021, outcome "not recovered", described as "After the booster I am on week 4 of continual bleeding and it is getting heavier"; MENSTRUAL DISORDER (medically significant), with onset 16Nov2021, outcome "not recovered", described as "Menstruation has been unpredictable, Starting unexpectedly". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative COVID-19 test. Clinical course was reported as: After each vaccine menstruation has been unpredictable. Starting unexpectedly and lasting longer and much heavier. After the booster patient was on week 4 of continual bleeding and it was getting heavier. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The reporter did not consider the report 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.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101807588 Same patient, different vaccine dose and events;GB-PFIZER INC-202101807589 Same patient, different vaccine dose and events


VAERS ID: 1986873 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Epilepsy
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (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: PFIZER BIONTECH COVID-19 VACCINE
Current Illness: Epilepsy; Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Epilepsy; This regulatory authority case was reported by a consumer and describes the occurrence of EPILEPSY (Epilepsy) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. Previously administered products included for Epilepsy: EPILIM CHRONOSPHERE (Epilim Chronosphere MR), CLOBAZAM (Perizam - Clobazam), ETHOSUXIMIDE (Ethosuximide Oral Solution) and LAMICTAL (Lamictal - Lamotrigine Dispersible). Past adverse reactions to the above products included No adverse event with CLOBAZAM, EPILIM CHRONOSPHERE, ETHOSUXIMIDE and LAMICTAL. Concurrent medical conditions included Epilepsy and Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...). Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 26-Feb-2021 to an unknown date for an unknown indication. On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EPILEPSY (Epilepsy) (seriousness criteria hospitalization, medically significant and life threatening). On 18-Nov-2021, EPILEPSY (Epilepsy) had resolved with sequelae. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. This is a regulatory authority case concerning a 33-year-old, female patient with concurrent medical conditions included Epilepsy and Immunodeficiency, who experienced the unexpected serious event of Epilepsy. The event occurred approximately 1 day after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter stated the event as related to the product. The events were reported as resolved with sequelae. The concurrent medical conditions included Epilepsy and Immunodeficiency remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 33-year-old, female patient with concurrent medical conditions included Epilepsy and Immunodeficiency, who experienced the unexpected serious event of Epilepsy. The event occurred approximately 1 day after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter stated the event as related to the product. The events were reported as resolved with sequelae. The concurrent medical conditions included Epilepsy and Immunodeficiency remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.


VAERS ID: 1987351 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 UNKNOWN / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Immunisation, Ophthalmological examination, Retinal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retinal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211204; Test Name: blood chemistry tests; Result Unstructured Data: Test Result:unknown results; Test Date: 20211204; Test Name: Specialist eye examinations; Result Unstructured Data: Test Result:macular haemorrhage right eye
CDC Split Type: ITPFIZER INC202101791407

Write-up: Macula lutea hemorrhage right eye; booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority. Regulatory number: IT-MINISAL02-820034 (RA). A 71 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 16Nov2021 (Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: RETINAL HAEMORRHAGE (medically significant) with onset 04Dec2021, outcome "not recovered", described as "Macula lutea hemorrhage right eye"; IMMUNISATION (non-serious) with onset 16Nov2021, outcome "unknown", described as "booster". The event "macula lutea hemorrhage right eye" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (04Dec2021) unknown results; ophthalmological examination: (04Dec2021) macular haemorrhage right eye. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: The patient was examined on 04Dec2021 at the ophthalmic department of the PRIVACY where she was diagnosed with macular haemorrhage right eye and suspected to be associated with the anti-Covid vaccine performed on 16Nov2021. The patient does not take other drugs.


VAERS ID: 1987614 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 PCB0002 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: PHPFIZER INC202101804632

Write-up: Chest pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300124935. A 17 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: PCB0002) at the age of 17 years 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), for covid-19 immunization. The following information was reported: CHEST PAIN (hospitalization) with onset 16Nov2021, outcome "recovered" (20Nov2021), described as "Chest pain".


VAERS ID: 1987711 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-11-16
   Days after vaccination:106
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: SARS-Covid2; Test Result: Positive
CDC Split Type: PTPFIZER INC202101826221

Write-up: Drug ineffective; Drug ineffective; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Agency Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-1896 (INFARMED). A 27 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 02Aug2021 (Lot number: FE8235) as dose 2 0.3 ml, single and intramuscular, administration date 04Jul2021 (Lot number: FE6029) 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 (medically significant), COVID-19 (medically significant) all with onset 16Nov2021, outcome "recovered" (2021) and all described as "Drug ineffective". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Nov2021) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Reporter Comment: Other information - Symptoms started on 16Nov2021 - Dry cough, nasal obstruction, anterior rhinorrhea, headache, weakness and myalgia covid+ test on 17Nov2021. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Other information - Symptoms started on 16Nov2021 - Dry cough, nasal obstruction, anterior rhinorrhea, headache, weakness and myalgia covid+ test on 17Nov2021


VAERS ID: 1987812 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   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 FJ8372 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Blood pressure measurement, Hypertension, Immunisation
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: Blood pressure; Result Unstructured Data: Test Result:199/112 mmHg
CDC Split Type: SIPFIZER INC202101785801

Write-up: Arrhythmia; increased blood pressure above 199/112 mmHg; booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority. WEB. Regulatory number: SI-JAZMP-NCPHV-2021SI1429_1429. Other Case identifier(s): JAZMP-300019130. A 77 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: FJ8372, Expiration Date: 31Mar2022) as dose 3 (booster), 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, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (2nd dose, manufacturer unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "booster"; ARRHYTHMIA (medically significant) with onset 17Nov2021, outcome "recovering", described as "Arrhythmia"; HYPERTENSION (medically significant) with onset 17Nov2021, outcome "recovering", described as "increased blood pressure above 199/112 mmHg". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (17Nov2021) 199/112 mmHg. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1987857 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-29
Onset:2021-11-16
   Days after vaccination:18
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: Asthenia, Blood creatinine, Blood pressure measurement, Body temperature, C-reactive protein, Coma scale, Heart rate, Oxygen saturation, Palpitations, Respiratory rate, Troponin I, White blood cell count
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidemia
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: Creatinine; Test Result: 0.73 mg/dl; Test Date: 20211116; Test Name: Blood pressure; Result Unstructured Data: Test Result:101/60 mmHg; Test Date: 20211116; Test Name: Body temperature; Result Unstructured Data: Test Result:36 Centigrade; Test Date: 20211116; Test Name: GCS; Result Unstructured Data: Test Result:E4V5M6; Test Date: 20211116; Test Name: C-reactive protein; Result Unstructured Data: Test Result:1.59 mg/l; Test Date: 20211116; Test Name: Heart rate; Result Unstructured Data: Test Result:75; Comments: Units:{beats}/min; Test Date: 20211116; Test Name: O2 saturation; Test Result: 97 %; Test Date: 20211116; Test Name: Respiratory rate; Result Unstructured Data: Test Result:20; Comments: Units:{breaths}/min; Test Date: 20211116; Test Name: Troponin I; Result Unstructured Data: Test Result:<0.0023 ng/ml; Test Date: 20211116; Test Name: White blood cells; Result Unstructured Data: Test Result:8.66 10*6/mL
CDC Split Type: TWPFIZER INC202101842006

Write-up: GENERAL WEAKNESS; PALPITATION; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014542 regulatory authority. Other Case identifier(s): TW-Fosun-2021FOS006885. This is a spontaneous report received from a non-contactable HCP received via regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100014542. A 44-year-old female patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number was not reported) on 29-Oct-2021 via intramuscular at 0.3 ml with unspecified dosing frequency for COVID-19 immunization. Medical history included dyslipidemia. The patient had no adverse reaction history. Concomitant medication and past product were not reported. The patient experienced palpitation on 16-Nov-2021, experienced general weakness on an unknown date. On 16-Nov-2021, she came to the hospital for a diagnosis, and the main complaint was uncomfortable for more than 7 days. Physician diagnosed as intermittent palpitation since few days ago and general weakness. No chest pain, no dyspnea, no chest tightness, no fever. Life signs: GCS: E4V5M6; Blood pressure (BP): 101/60 mmHg; Heart Rate (HR):75 times / min; Respiratory rate (RR): 20 times / min; Body temperature (BT): 36 Centigrade; O2 saturation (SPO2): 97%. White blood cells (WBC): 8.66x1000/UL. Tropo-i<0.0023ng/ml; C-reactive protein (CRP) (quantification):1.59mg/L; Creatinine: 0.73 mg /dl. After the diagnosis, the patient''s condition was stabilized and adjusted. The physician notified the vaccine adverse reactions. The patient said that the symptoms had been restored on 01-Dec-2021. Palpitation and general weakness met the seriousness criterion of Other Medically Important Condition. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. On 01-Dec-2021, the events were recovered. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. Causality assessment for Palpitation and general weakness, Per Reporter was Possible, Per Company was 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: 1987858 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-31
Onset:2021-11-16
   Days after vaccination:16
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: Chest discomfort, Dizziness, Mouth ulceration, Pruritus, Rash, Urticaria
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101842004

Write-up: SKIN ITCHY; SKIN RASH (NON-INJECTION SITE); ORAL ULCERS; URTICARIA IN THE MOUTH AND LEFT HAND; DIZZINESS; CHEST TIGHTNESS; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014545. Other Case identifier(s): TW-Fosun-2021FOS006886. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100014545. A 50-year-old female patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number was not reported) on 31-Oct-2021 via unknown routed at unknown dose with unspecified dosing frequency for COVID-19 immunization. Medical history was not reported. Concomitant medication and past product were not reported. The patient experienced skin itchy, skin rash (non-injection site), oral ulcers, urticaria in the mouth and left hand, dizziness and chest tightness on 16-Nov-2021. On 16-Nov-2021, after the BNT was inoculated, the skin itch was occurred, and the oral mucosa was broken. On 02-Dec-2021, learning from follow-up call, the patient currently had urticaria in the mouth and left hand, occasionally dizziness and chest tightness. On 10-Dec-2021, the patient would recover the blood test. Skin itchy, skin rash (non-injection site), oral ulcers, urticaria in the mouth and left hand, dizziness and chest tightness met the seriousness criterion of Other Medically Important Condition. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were recovering. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE. Drug: Comirnaty Causality Assessments: Itchy skin, Skin rash, Oral ulceration, Urticaria, Dizziness, Chest tightness Per Reporter= Possible Per Company (BioNTech) = Possible No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1987932 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-22
Onset:2021-11-16
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1H055A_1101118- / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Diarrhoea, Hypersensitivity
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101842000

Write-up: SEVERE ALLERGIC REACTION; DIARRHEA; CHEST TIGHTNESS; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100013578 (the regulatory authority). Other Case identifier(s): TW-Fosun-2021FOS006947. This is a spontaneous report received from a non-contactable HCP received via the regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100013578. A 42-year-old male patient started to receive a dose of Tozinameran (COMIRNATY) (batch number: 1H055A_1101118-CDC) on 22-Oct-2021 via intramuscular at an 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 severe allergic reaction, diarrhea, chest tightness on 16-Nov -2021. On 16-Nov-2021, the patient had votroration (unspecified), chest tightness, allergies, Ast asthid (unspecified) and diarrhea, then the patient hospitalized. On 22-Nov-2021, the symptoms, drug treatment were expected to return to forest long endocrinology. Severe allergic reaction, diarrhea, 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 recovering. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE. Drug: Comirnaty Causality Assessments: Anaphylactic reaction, Diarrhea, Chest tightness Per Reporter= Possible Per Company (BioNTech) = Possible


VAERS ID: 1987944 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-22
Onset:2021-11-16
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1H055A_1101117- / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Brain oedema, Cerebral haemorrhage, Coma scale, Computerised tomogram head, Heart rate, Hemiparesis, Hypertension, Ophthalmological examination, Respiratory rate
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: Blood pressure; Result Unstructured Data: Test Result:198 / 98 mmHg; Test Date: 20211116; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Test Date: 20211116; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:E42V4M6; Test Date: 20211116; Test Name: Brain CT; Result Unstructured Data: Test Result:there was acute intracerebral hemorrhage (ICH) at; Comments: left putamen with perifocal edema.; Test Date: 20211116; Test Name: Pulse rate; Result Unstructured Data: Test Result:89 beats/min; Test Date: 20211116; Test Name: Ophthalmological examination; Result Unstructured Data: Test Result:pupil size was L / R 3.5 / 3.5mm with light reflex; Test Date: 20211116; Test Name: Respiratory rate; Result Unstructured Data: Test Result:20 breaths/min
CDC Split Type: TWPFIZER INC202101842247

Write-up: RIGHT SIDE WEAKNESS; ACUTE INTRACEREBRAL HEMORRHAGE; PERIFOCAL EDEMA; hypertension poorly control under medicines/ blood pressure (BP) was 198/98 mmHg; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from Party and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100013706 (Regulatory authority). Other Case identifier(s): TW-Fosun-2021FOS007007. This is a spontaneous report received from a non-contactable HCP received via Regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100013706. A 35-year-old male patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: 1H055A_1101117-CDC) on 22-Oct-2021 via intramuscular at unknown dose with unspecified dosing frequency for COVID-19 immunization. Medical history included hypertension. Concomitant medications and past product were not reported. The patient experienced right side weakness, acute intracerebral hemorrhage, perifocal edema on 16-Nov-2021. On 16-Nov-2021, the patient had hypertension poorly control under medicines. The patient suffered from sudden onset of right side weakness and was noted. So the patient was sent to clinics, and the brain CT revealed there was acute intracerebral hemorrhage (ICH) at left putamen with perifocal edema. Then the patient was transferred to a hospital due to no nervous system (NS) available. At the clinics, the patient''s Glasgow Coma Scale (GCS) was E42V4M6; pupil size was L/R 3.5 / 3.5mm with light reflex; body temperature was 36.5 degree Centigrade; pulse rate was 89 times/min; respiratory rate was 20 times/min; blood pressure (BP) was 198/98 mmHg. Consulted nervous system (NS) doctor, full explain condition to the patient''s family, so the patient was admitted to the SICU for blood pressure control, to receive further management and evaluation. Right side weakness, acute intracerebral hemorrhage, perifocal edema 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. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. Causality Assessments per reporter and Company (BioNTech): Muscle weakness right-sided, Intracerebral hemorrhage, Brain edema were possibly related to bnt162b2. COMIRNATY is under agreement with BioNTech. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1987955 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   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 - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Blood pressure measurement, Body temperature, Coma scale, Heart rate, Respiratory rate
SMQs:, Anaphylactic reaction (broad), 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)

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: ESOMEPRAZOLE; MOSAPRIDE; SERETIDE; SPIRIVA; MONTELUKAST; OMALIZUMAB; FEXOFENADINE; DESLORATADINE; PREDNISOLONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: Blood pressure; Result Unstructured Data: Test Result:132/97; Test Date: 20211116; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Test Date: 20211116; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:E3V1M6 with unclear breathing sound; Test Date: 20211116; Test Name: Pulse rate; Result Unstructured Data: Test Result:113; Comments: Units:{beats}/min; Test Date: 20211116; Test Name: Respiratory rate; Result Unstructured Data: Test Result:28; Comments: Units:{breaths}/min
CDC Split Type: TWPFIZER INC202101841884

Write-up: ACUTE RESPIRATORY FAILURE; This is a spontaneous report received from non-contactable reporter (Other HCP) from License Party (BioNTech SE) and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100013736. Other Case identifier(s): TW-Fosun-2021FOS007031. This is a spontaneous report received from a non-contactable HCP received via Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100013736. A 39-year-old female patient started to receive the 2nd dose of Tozinameran (COMIRNATY) (batch number was not reported) on 15-Nov-2021 via intramuscular at unknown dose with unspecified dosing frequency for COVID-19 immunization. Detail of the first-dose vaccination was not reported. Medical history included asthma. Concomitant medications included esomeprazole, mosapride, seretide, spiriva, montelukast, omalizumab, fexofenadine, desloratadine, prednisolone. The patient experienced acute respiratory failure on 16-Nov-2021. On 16-Nov-2021, the patient went to the emergency room of a hospital due to shortness of breath and severe dyspnea. The patient received physical examination as follow: blood pressure was 132/97; pulse rate was 113 times/min; body temperature was 36.2 celsius; breathing rate was 28 times/minute; Glasgow coma scale ("Con''s" was reported) was E3V1M6 with unclear breathing sound. The patient was admitted into medical intensive care unit (MICU) and received treatment of intubation and mechanical ventilation (mv) support and medicines of IV steroid and inhalation drugs. On 17-Nov-2021, the patient was removed the breathing apparatus and in hospitalization for treatment. Acute respiratory failure 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 recovering. Initial report was received on 15-Dec-2021. 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: 1987961 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-09
Onset:2021-11-16
   Days after vaccination:7
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: Cerebrovascular accident, 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? 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: Intracranial hemorrhage
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: Nuclear magnetic resonance imaging; Result Unstructured Data: Test Result:cerebral infarction
CDC Split Type: TWPFIZER INC202101848544

Write-up: STROKE (THE GAIT WAS UNSTABLE, THE LEFT LOWER LIMB WAS WEAK, LIMB WEAKNESS); This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100013765 regulatory agency. Other Case identifier(s): TW-Fosun-2021FOS007044. This is a spontaneous report received from a non-contactable HCP received via regulatory agency. The regulatory authority report number is TW-TFDA-TVS-1100013765. A 46-year-old male patient started to receive the 2nd dose of BNT162B2 (COMIRNATY) (batch number was not reported) in 09Nov2021 via unknown route at unknown dose with unspecified dosing frequency for COVID-19 immunization. The 1st dose was received on 27Sep2021. Past medical history included left-side intracranial hemorrhage (ICH). Concomitant medication and past product were not reported. The patient experienced stroke (the gait was unstable, the left lower limb was weak, limb weakness) on 16Nov2021. On 11Nov2021, the patient went to dental clinics after BNT vaccination. On 16Nov2021, the patient complained that there was an unstable step. On 17Nov2021, the patient experienced weakness on the left lower limbs and couldn''t lift feet. On 18Nov2021, the patient went to the emergency department of a hospital for medical treatment. Detail of medical treatment was not reported. The patient received the examination of nuclear magnetic resonance which showed cerebral infarction. The patient was informed the situation of stroke and arranged into neurology department. On 19Nov2021, the patient was still in hospitalization. Stroke (the gait was unstable, the left lower limb was weak, limb weakness) met the seriousness criterion of Hospitalization. At the time of the report, the outcome of the event was not recovered. Causality Assessments: Drug: COMIRNATY with Stroke, Per Primary 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: 1988001 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-05
Onset:2021-11-16
   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 UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Hypoaesthesia, Muscular weakness, Respiration abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Respiratory failure (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: TWPFIZER INC202101849098

Write-up: BREATHING FEELING MORE BREATH; left hands numbness; HEADACHE; DIZZINESS; WEAKNESS OF THE LEFT LIMB/left hand was still weak; This is a spontaneous report received from non-contactable healthcare professional from License Party and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100013866 (the regulatory authority). Other Case identifier(s): TW-Fosun-2021FOS007106 (RA). This is a spontaneous report received from a non-contactable HCP received via the regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100013866. A 47-year-old female patient started to receive a dose of Tozinameran (COMIRNATY) (batch number was not reported) on 05-Nov-2021 via unknown route at an 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 dizziness, weakness of the left limb on 16-Nov-2021, experienced headache on 23-Nov-2021, experienced breathing feeling more breath on 24-Nov-2021. On 05-Nov-2021, the patient received BNT vaccine. On 16-Nov-2021, the patient had dizziness and left limb weakness, then went to outpatient department (OPD). On 20-Nov-2021, after the doctor''s advice, the patient was discharged. On 23-Nov-2021, the patient had numbness, dizziness, and headache, continued to be in hospital. On 24-Nov-2021, the patient''s symptoms included left hands numbness, headache, dizziness, breathing feeling more breath. It was reported that "speech will be discharged". On 02-Dec-2021, the left hand was still weak and numbness, now in the rehabilitation. Dizziness, weakness of the left limb, headache and breathing feeling more breath met the seriousness criterion of hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were recovering. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. BNT162B2 (COMIRNATY) is under agreement with BioNTech SE. Causality Assessment: Drug: COMIRNATY. Event: Abnormal breathing, Headache, Weakness of limbs, Dizziness. Per Reporter = Possible; Per Company = Possible.


VAERS ID: 1988020 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-03
Onset:2021-11-16
   Days after vaccination:13
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: Cutaneous vasculitis
SMQs:, Severe cutaneous adverse reactions (narrow), Vasculitis (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 INC202101854899

Write-up: VASCULITIS/skin vasculitis in the lower limbs; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party (BioNTech SE) and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014347. Other Case identifier(s): TW-Fosun-2021FOS007166. This is a spontaneous report received from a non-contactable HCP received via Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100014347. A 23-year-old male patient started to receive a dose of Tozinameran (COMIRNATY) (batch number: unknown) on 03-Nov-2021 via intramuscular at an unknown dose with unspecified dosing frequency for COVID-19 immunization. Inoculation units are unknown. Medical history, concomitant medications and past product were not reported. The patient experienced vasculitis on 16-Nov-2021. On 03-Nov-2021, the patient received 1st dose of BNT vaccine. On 16-Nov-2021, the patient experienced skin vasculitis in the lower limbs and went to the hospital. On 24-Nov-2021, the patient reciprocal continued lower limb skin vascular inflammation. It was reported that the symptom was recovering. Skin vasculitis 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 event was recovering. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE Causality assessment: Vasculitis, Per Reporter=Possible; Per Company=Possible.


VAERS ID: 1988063 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-12
Onset:2021-11-16
   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 1H059A / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Facial paralysis, Hepatitis B, Hepatitis B core antibody, Hepatitis B surface antibody, Hepatitis B surface antigen, Hepatitis C virus test
SMQs:, Liver infections (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Opportunistic infections (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: LUCKYHEPA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy NOS; Fatty liver; Hepatitis B; Renal cyst
Allergies:
Diagnostic Lab Data: Test Date: 20211005; Test Name: Glutamic-pyruvate transaminase; Result Unstructured Data: Test Result:70; Test Name: Hepatitis B; Test Result: Positive ; Test Name: Anti-HBc antibody; Test Result: Positive ; Test Name: Anti-HBs antibody; Test Result: Positive ; Test Name: Hepatitis B surface antigen; Test Result: Negative ; Test Name: Hepatitis C virus test; Test Result: Negative
CDC Split Type: TWPFIZER INC202101855520

Write-up: FACIAL NERVE PARALYSIS (FACIAL PALSY); This is a spontaneous report received from non-contactable healthcare professional from License Party (BioNTech SE) and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014112 (Regulatory Authority). Other Case identifier(s): TW-Fosun-2021FOS007246. This is a spontaneous report received from a non-contactable HCP received via Taiwan Center for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100014112. A 43-year-old male patient started to receive 2nd dose of Tozinameran (COMIRNATY) (batch number: 1H059A) on 12-Nov-2021 via intramuscular at 0.3 ml with unspecified dosing frequency for COVID-19 immunization. The 1st dose was received on an unknown date. Medical history included no known allergies(NKA), Hepatitis B. Abd echo mild fatty liver, right renal cyst on 25-Sep-2021. The patient had no operation history. Concomitant medications and past product included luckyhepa (1 cap qd po). The patient experienced facial nerve paralysis (facial palsy) on 16-Nov-2021. On 05-Oct-2021, glutamic-pyruvic transaminase (GPT) was 70.On unknown date, Hepatitis B Virus (HBV) was positive, Hepatitis B surface antigen (HBsAg) was negative, Antibody against hepatitis B core antibody (anti HBc) was positive, Antibody against hepatitis B surface antigen (antiHBs) was positive, HCV was negative. At 09:00 of 12-Nov-2021, the patient received 2nd dose of BNT vaccine. At 06:00 of 16-Nov-2021, the patient experienced face was tight. On 18-Nov-2021, the patient went to the liver clinic neurology consultation, physicians diagnosed as the color of nerve paralysis, recommended rehabilitation treatment. On 02-Dec-2021, the nerve paralysis of the face was slightly improved. Facial nerve paralysis (facial palsy) met the seriousness criterion of Other Medically Important Condition. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was not 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. Causality Assessment: Drug: bnt162b2 Facial nerve paralysis Per Reporter = Possible Per Company (BioNTech SE)= Possible


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