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

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



Case Details (Reverse Sorted by Onset Date)

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VAERS ID: 1717036 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Body temperature, Dyspnoea, Insomnia, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210901; Test Name: Fever; Result Unstructured Data: Test Result:Unknown; Test Date: 20210901; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101176273

Write-up: Anxiety state; Couldnt breathe; Insomnia; Fever; This is a spontaneous report from a contactable consumer. This report is received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109071043465710-6CEP2. Safety Report Unique Identifier GB-MHRA-ADR 25905601. A 32-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 24Aug2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 via an unspecified route of administration, on unspecified date (Batch/Lot Number: not reported) as dose 1, single for covid-19 immunization. No other medications or vaccinations within last 12 months. Patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 25Aug2021, the patient experienced anxiety state, insomnia, fever. All the events were considered as serious (medically significant). Patient woke with fever after a couple of hours sleep. Patient could not get back to sleep. Fever stopped after around 6-8 hours. Patient could not breathe and felt overwhelmed with anxiety which she did not suffer from and she have never had an anxiety attack. Patient continued with anxiety the following day and could not concentrate or think properly. Further reported returned back to normal on the third day. The patient underwent lab tests and procedures which included body temperature: unknown on 01Sep2021, sars-cov-2 test: no - negative covid-19 test on 01Sep2021 No - Negative COVID-19 test. The outcome of Anxiety state was recovered on 27Aug2021. The outcome of Insomnia was recovered on 26Aug2021. The outcome of fever was recovered on 25Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. .


VAERS ID: 1717238 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis lupus erythematosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101155571

Write-up: Fatigue; Tingling sensation; Dizziness; Numbness of head; This is a spontaneous report from a contactable other HCP downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-777706. A 32-year-old female patient received first dose of bnt162b2 (COMIRNATY- formulation: solution for injection, Batch/Lot Number: FG4686), via an unspecified route of administration, administered in Deltoid Left on 25Aug2021 at 13:00 (at the age of 32-year-old) as single dose for covid-19 immunisation. Medical history included Arthritis lupus erythematosus from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced fatigue, tingling sensation, dizziness and numbness of head on 25Aug2021 at 13:00. The patient reports that to date the symptomatology persists, especially the tingling in the face (as if I had been to the dentist). The outcome of the events was reported as not recovered. No follow-up attempts are possible. No further information expected.; Reporter''s Comments: Reaction time: 13:00 h - Submitted by VigiCovid19-card


VAERS ID: 1717243 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Cold sweat, Computerised tomogram head, Dyspnoea, Neurological examination, Paraesthesia, Vision blurred
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood test; Result Unstructured Data: Test Result:all normal; Test Date: 20210827; Test Name: Head CT; Result Unstructured Data: Test Result:no results; Test Date: 20210827; Test Name: Neurological examination; Result Unstructured Data: Test Result:no results
CDC Split Type: ITPFIZER INC202101155457

Write-up: Air hunger; Cold sweat; Blurring of vision; Paraesthesia of limbs; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-777833. A 36-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FG4493; Expiration Date: 30Nov2021) via intramuscular, administered in Arm Left on 25Aug2021 at 17:12 (at the age of 36-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 25Aug2021 the patient experienced air hunger, cold sweat, blurring of vision, paraesthesia of limbs. It was reported that neurologic examination within the norm Conclusions: Intermittent subjective sensory disorders, not worsening, occurred after a post-vaccination pre-sincope episode. No current neurologic anomalies detected. No ischemia or haemorragy lesions at the moment. On-axis midline structures. Liquor and ventricular spaces consistent with the age of the patient. The patient underwent lab tests and procedures which included blood test: all normal on unknown date in 2021, computerised tomogram head: no results on 27Aug2021, neurological examination: no results on 27Aug2021. Outcome of the events was recovering.


VAERS ID: 1717313 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Drug ineffective, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: SARS-CoV-2 RNA; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC202101159136

Write-up: Sars-cov-2 infection with symptoms (fever, cough); Sars-cov-2 infection with symptoms (fever, cough); fever; cough; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-779029. A 50-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced SARS-CoV-2 infection with symptoms (fever, cough) on 25Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown results on 25Aug2021. The outcome of the events was unknown. Case considered as serious (medically significant). Senders comment: Request the following data from the reporting clinician and we await a reply: - batch number of the vaccine; - specify whether it is a first or second dose; - administration area; - date of administration; No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1717413 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, Neuropathy peripheral, Sensory disturbance, Swelling, Ultrasound scan
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210902; Test Name: Ultrasonography; Result Unstructured Data: Test Result:Lymph nodes cervical swollen
CDC Split Type: JPPFIZER INC202101162272

Write-up: Ulnar nerve disorder; Lymph nodes cervical swollen; Abnormal sensation; Swelling of the left axilla; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21126509. The patient was a 48-year and 0-month-old female (age at vaccination, second dose). Body temperature before vaccination was not provided. On 25Aug2021 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration in the left shoulder, at 48-year-old, as a single dose for COVID-19 immunization. Medical history was none. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration in the left shoulder on an unknown date, as single dose(Batch/Lot number was unknown) for COVID-19 immunization. On 25Aug2021(the day of vaccination), the patient received second dose of BNT162b2 and experienced swelling of the left axilla. On 01Sep2021 (7 days after vaccination), the patient experienced abnormal sensation, ulnar nerve disorder and Lymph nodes cervical swollen. The course of the event was as follows: Symptoms included feeling cold and numbness on the left forearm ulnar side. Signs included hypoesthesia of the ulnar nerve territory, finger escape sign. Slight, no obvious muscle weakness, no obvious subjective or objective impairment of finger movements. Course included numbness and pain in the upper right limb was being treated. No history of left upper limb symptoms. After the first vaccination (left shoulder), there was no awareness of coldness or numbness in the upper limbs on the vaccination side (left). On25Aug2021: Swelling of the left axilla was noticed on the same day of the second vaccination (left shoulder). From 01Sep2021, the patient realized that left forearm scale side felt cold like a furnace. On 02Sep2021, the patient visited the clinic. The patient was diagnosed with ulnar nerve disorder. Ultrasonography showed Lymph nodes cervical swollen. Therapeutic measures were taken as a result of all events. On 02Sep2021 (8 days after vaccination), the outcome of the events Ulnar nerve disorder, Lymphadenopathy and Abnormal sensation were not recovered. The outcome of Swelling of the left axilla was unknown. The reporting physician classified the events as non-serious and assessed that the event was related to bnt162b2. Other possible cause of the event such as any other diseases was Thoracic outlet syndrome. The reporting physician commented as follows: There was a history of numbness and pain in the upper right limb, but no history of the upper left limb. Axillary swelling that occurred on the day of vaccination was likely to be swelling of the axillary nodes. At the first visit, cervical limba node swelling was observed, so C7 ultrasound-guided hydro release (saline 5 cc) was performed, but there was no improvement in coldness and numbness on the forearm ulnar side. If the subjective symptoms are alleviated as the lymph nodes shrink when the patient was placed under monitoring, the effect of vaccination will be high. In addition, if the symptoms persist, ulnar nerve hydro release in the axilla will be performed. At the moment, the situation was suspected to be related to the vaccine. The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Reporter''s Comments: Patient had history of numbness and pain in the upper right limb. Axillary swelling that occurred on the day of vaccination is likely to be swelling of the axillary nodes. At the first visit, C7 ultrasound-guided hydro release (saline 5 cc) was performed but no improvement. the situation is suspected to be related to the vaccine.


VAERS ID: 1717436 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8206 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Diarrhoea, Hypoaesthesia oral, Malaise, Pruritus
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Drug-induced lymphocyte stimulation test positive
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101169595

Write-up: mild numbness lips; diarrhoea; general malaise; pruritus facial; Anaphylaxis; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21126108. A 52-year-old female patient received BNT162b2 (COMIRNATY, Solution for injection) via an unspecified route of administration, on 25Aug2021 at 13:15 (Lot number FE8206, Expiration date 31Oct2021) , at the age of 52 years old, as a first single dose, for COVID-19 immunization. The patient had medical history of numbness in hand caused by oral Amolin, Drug-induced lymphocyte stimulation test positive (DLST+), and anaphylaxis shock caused by Naron Ace. The patient''s concomitant drugs were not provided. The patient''s body temperature on 25Aug2021, before vaccination, was 36.7 degrees Centigrade. About 15 minutes after the 1st dose of BNT162b2, the patient experienced mild numbness of lips. Since the event was improving, the patient went home. After getting home, the patient had diarrhoea, general malaise, and facial pruritus. The reported events were anaphylactic reaction, numbness of lips, diarrhoea, general malaise, and facial pruritus. On 27Aug2021 (2 days after the vaccination), the patient was recovering from the events. The reporting physician classified the event as non-serious and assessed that the events were related to BNT162b2. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1717482 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005239 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (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:
Current Illness: Contrast media allergy (Allergy to contrast medium: iomeprol); Fabry''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Anaphylaxis; This case was received via Takeda Pharmaceuticals (Reference number: 2021TJP087380) on 07-Sep-2021 and was forwarded to Moderna on 18-Sep-2021. This case was reported by a physician via Drug Information Center and was reported by a physician via a medical representative. Also, this case, reported by a physician, was received by Takeda Pharmaceutical Company Limited via Moderna''s adverse reaction reporting site (TASK0021572), and reported to the regulatory authority by a physician, was received via the RA (Ref, v21126182). The patient had concurrent condition of Fabry''s disease and was under treatment with drip injection of agalsidase beta. The patient had a history of drug allergy (contrast medium: iomeprol). On an unknown date, body temperature before the vaccination: 36.4 degrees Celsius. On 25-Aug-2021, at 14:18, the patient received the 1st dose of the vaccine. At 14:45, anaphylaxis suddenly developed. The patient complained of sick feeling. Subsequently, the patient experienced pharynx strange sensation and rash in the body trunk, which were rapidly progressive. After administration of adrenaline and drip infusion, the patient was emergently transported. Thereafter, the patient recovered and returned home on the same day without hospitalization. The outcome of anaphylaxis was reported as recovered. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Not reported.; Sender''s Comments: This case concerns 58- year-old, male with a history of allergy to contrast medium and Fabry?s disease, who experienced the expected event of Anaphylactic Reaction. The event occurred approximately 27 minutes after the first dose of mRNA-1273 Moderna vaccine. The rechallenge was not aplicable since this is and adverse event from the first dose. The events were considered related to the study drug per the reporter''s assessment. The event is consistent with the current understanding of the mechanism of action of the study medication . The medical history of contras media allergy could be a potentially confounder. The Benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report


VAERS ID: 1717622 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Postmenopausal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UTROGEST; ESTRADOT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Postmenopause (Last menstrual bleed was /Des/2016.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101155462

Write-up: postmenopausal hemorrhage with black-colored blood and slime; This is a spontaneous report from a non-contactable consumer (patient) downloaded from the regulatory authority , regulatory authority number NO-NOMAADVRE-PASRAPP-2021-U71x9n. A 44-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: Unknown), via an intramuscular route, administered in arm left on 23Aug2021 at 12:15 (reported as monday) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included postmenopause from an unknown date and unknown if ongoing (Last menstrual bleed was /Des/2016). The reporter reports not to have any other diseases concomitant with this adverse reaction. She reports that she is POSTMENOPAUSE and has not had a menstrual bleed since Dec2016. Concomitant medications included progesterone (UTROGEST) taken for premature menopause from Feb2021 to an unspecified stop date; estradiol (ESTRADOT) taken for premature menopause from Mar2021 to an unspecified stop date. On 25Aug2021, reported as wednesday, the patient developed postmenopausal hemorrhage with black-colored blood and slime. The reporter reported not to have any other diseases concomitant with this adverse reaction. The patient reported that she was postmenopause and did not have a menstrual bleed since Dec2016. The reactions/case was considered to be serious due to other serious (Important Medical Events). The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1717713 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-08-25
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6840 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head, Dizziness, Gait disturbance, Headache, Magnetic resonance imaging, Nausea
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ESCITALOPRAM ACCORD; OMEPRAZOL APOFRI; OXYTARM
Current Illness: Depression (I have been taking very low dose antidepressants for 9 years now to prevent recurrent depression.)
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: computed tomography imaging of the head; Result Unstructured Data: Test Result:Not reported; Test Date: 20210825; Test Name: magnetic resonance imaging; Result Unstructured Data: Test Result:without remark; Comments: no diagnosis could be established.
CDC Split Type: SEPFIZER INC202101155656

Write-up: Dizziness; unsteady gait; mild headache; nausea; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number is SE-MPA-2021-078451. A 47-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), dose 2 via an unspecified route of administration on 20Jul2021 (Batch/Lot Number: FA6840) as dose 2, single for COVID-19 immunisation. Medical history included depression from 2010 and ongoing (I have been taking very low dose antidepressants for 9 years now to prevent recurrent depression) and diabetes. Concomitant medications included escitalopram oxalate (ESCITALOPRAM ACCORD) taken for an unspecified indication from 01Oct2013; omeprazole (OMEPRAZOL APOFRI) taken for an unspecified indication from 01Apr2020; ascorbic acid, bioflavonoids nos, magnesium hydroxide (OXYTARM) taken for an unspecified indication from 18Aug2021 to 25Aug2021. The patient previously took BNT162B2 (COMIRNATY, solution for injection), dose 1 on 2021 for COVID-19 immunisation. The patient woke up with serious dizziness (led to hospitalization), unsteady gait, mild headache and nausea. The woman visited the emergency ward room, and various examinations were performed by ear specialists and a neurologist. The computed tomography imaging of the head was done because the symptoms indicated neurologically rather than ears/the vestibular sensory system. The next day, a magnetic resonance imaging was performed without remark and no diagnosis could be established. The woman has no history of migraine or dizziness. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1717739 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, C-reactive protein increased, Echocardiogram, Electrocardiogram, Investigation, Myalgia, Troponin
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DAIVOBET [BETAMETHASONE DIPROPIONATE;CALCIPOTRIOL]; ELVANSE; PRONAXEN
Current Illness: ADHD; Psoriasis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: C-reactive protein; Result Unstructured Data: Test Result:30; Comments: Slightly elevated; Test Name: bedside echo; Result Unstructured Data: Test Result:normal conditions; Comments: no signs of pericardial fluid; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:slight ST-T wave changes but nothing significant; Test Name: baseline investigation; Result Unstructured Data: Test Result:normal; Test Name: Troponin; Result Unstructured Data: Test Result:<5 2x series
CDC Split Type: SEPFIZER INC202101155938

Write-up: Slightly elevated C-reactive protein of 30; Myalgia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number SE-MPA-2021-080040. A 28-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 23Aug2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. Medical history included ongoing attention deficit hyperactivity disorder (ADHD), ongoing psoriasis. Concomitant medication(s) included betamethasone dipropionate, calcipotriol (DAIVOBET); lisdexamfetamine mesilate (ELVANSE); naproxen (PRONAXEN); all taken for unspecified indications, start and stop dates were not reported. On 25Aug2021, the patient experienced myalgia (between shoulder blade and thoracic spine). According to medical records: Slightly elevated C-reactive protein of 30. In addition to it, normal baseline investigation. Electrocardiogram shows slight ST-T wave changes but nothing significant. Troponin <5 2x series. Discussion is conducted with an infection specialist who requires observation due to documented cases of perimyocarditis after Pfizer vaccine. The morning after admission in good health and asymptomatic. No persistent pain. A bedside echo is performed showing normal conditions, no signs of pericardial fluid. Inflammatory activity decreases. Course was recovering/resolving. Outcome of events was recovering. The case assessed as serious, hospital care. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1720544 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-25
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE9174 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Joint swelling, Pruritus, Rash, Throat irritation, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Blood test; Result Unstructured Data: Test Result:Unknown results; Comments: Renal parameters; Test Date: 202108; Test Name: Blood test; Result Unstructured Data: Test Result:Unknown results; Comments: Fluid balance parameters; Test Date: 202108; Test Name: Blood test; Result Unstructured Data: Test Result:Unknown results; Comments: Infections parameters; Test Date: 202108; Test Name: Blood test; Result Unstructured Data: Test Result:Unknown results; Comments: Liver parameters
CDC Split Type: DKPFIZER INC202101166114

Write-up: Generalized urticaria; Itchy throat; Joint swelling; Generalized pruritus; Skin rash; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number is DK-DKMA-WBS-0086655. A 15-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 15Aug2021 (Batch/Lot Number: FE9174; Expiration Date: 31Oct2021) as DOSE 2, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine includedbnt162b2 (COMIRNATY), intramuscular on 08Jul2021 (Batch/Lot Number: FC1433; expiration date: 31Oct2021) for COVID-19 immunization. The patient experienced generalized urticaria on 25Aug2021 with outcome of not recovered, itchy throat on 25Aug2021 with outcome of unknown, joint swelling on 25Aug2021 with outcome of not recovered, generalized pruritus on 25Aug2021 with outcome of not recovered, skin rash on 25Aug2021 with outcome of not recovered. The ADRs were by the reporter reported as resulting in hospitalization (In Aug2021). No treatment or medical procedure due to the ADRs was reported. The patient underwent lab tests and procedures which included: Blood test, Aug2021, Infections parameters (Unknown results). Blood test, Aug2021, Liver parameters (Unknown results). Blood test, Aug2021, Fluid balance parameters (Unknown results). Blood test, Aug2021, Renal parameters (Unknown results). The events were reported as serious, hospitalization. No follow-up attempts possible. No further information is expected.


VAERS ID: 1720561 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-25
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy
SMQs:, 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: ESPFIZER INC202101166172

Write-up: Supraclavicular lymph nodes enlarged; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-986679. A 20-year-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in Arm Left on 19Aug2021 (Batch/Lot Number: FG4686) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced supraclavicular lymph nodes enlarged on 25Aug2021 with outcome of recovering. She was not pregnant in the administration of the vaccine. It is unknown if she has COVID 19 passed. Pathology still in recovery and very painful. Seriousness criteria of the event was medically significant. No follow up attempts possible, no further information expected.


VAERS ID: 1720650 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-25
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, C-reactive protein, Chest pain, Computerised tomogram, Dyspnoea, Electrocardiogram, Feeling abnormal, Lymphadenopathy, Pericarditis, SARS-CoV-2 test, Scan
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diethylstilboestrol syndrome; Myocardial infarction (installation of a defibrillator, brother had myocardial infarction, died at age of 48); Myocardial infarction; Smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210814; Test Name: computed tomography with injection; Result Unstructured Data: Test Result:shows a left pleural effusion; Comments: No pulmonary embolism. Troponin and brain natriuretic peptide negative.; Test Date: 20210819; Test Name: C-reactive protein; Result Unstructured Data: Test Result:17.6 mg/l; Test Date: 20210814; Test Name: Electrocardiography; Result Unstructured Data: Test Result:no particular feature; Test Date: 20210816; Test Name: Electrocardiography; Result Unstructured Data: Test Result:normal; Test Date: 20210825; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Negative; Test Date: 20210825; Test Name: thoracic scanner; Result Unstructured Data: Test Result:multiple inflammatory lymph nodes; Comments: multiple inflammatory lymph nodes in the right and left axillary areas
CDC Split Type: FRPFIZER INC202101219019

Write-up: pericarditis; multiple inflammatory lymph nodes in the right and left axillary areas; Chest pain; asthenia; dyspnoea; still being felt; This is a spontaneous report from a contactable consumer or other non-Healthcare Professional. This is the second of two reports. The first report is a report downloaded from the Agency Regulatory Authority, regulatory authority number FR-AFSSAPS-BS20211680. A 52-years-old female patient received second dose of BNT162B2 (COMIRNATY, Formulation: Solution for Injection, Lot number: FG4493, Expiration date was not reported) via intramuscular, administered in Arm Left on 21Aug2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included myocardial infarction, tobacco user, diethylstilboestrol syndrome. The patient''s family medical history included myocardial infarction (father had three myocardial infarctions with installation of a defibrillator, brother had myocardial infarction and died at the age of 48). The patient''s concomitant medications were not reported. patient previously received first dose of (COMIRNATY, solution for injection, Lot number- FF4213), via intramuscular route in the left arm on 31Jul2021 as dose 1, single for covid-19 immunisation and experienced Chest pain, dyspnea, pleural effusion, back pain, c-reactive protein increased, blood pressure ambulatory increased, inflammatory reaction, precordial pain, headache, stiffness, shortness of breath. On 25Aug2021, the patient experienced multiple inflammatory lymph nodes in the right and left axillary area, pericarditis, Chest pain, asthenia, dyspnoea, still being felt. went to see her general practitioner for chest pain, asthenia, dyspnoea, still being felt, who directed her to the Emergency Room. In the emergency room, a thoracic scanner shows multiple inflammatory lymph nodes in the right and left axillary areas. A diagnosis of other chest pain or pericarditis was made. Treatment with Tramadol was established. The patient stated that she has not recovered as of 26Aug2021. In conclusion, chest pain, asthenia and dyspnoea on Day 14 from the first COMIRNATY vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 25Aug2021, scan: multiple inflammatory lymph nodes on 25Aug2021 multiple inflammatory lymph nodes in the right and left axillary areas, Computerised tomogram (No pulmonary embolism. Troponin and brain natriuretic peptide negative) on 14Aug2021, C-reactive protein 17.6 mg/l on 19Aug2021, Electrocardiography no particular feature on 14Aug2021, Electrocardiography normal on 16Aug2021. Therapeutic measures were taken as a result of events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1720801 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspepsia, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific dysfunction (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101182442

Write-up: Heartburn; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109081951089650-REQ14, Safety Report Unique Identifier GB-MHRA-ADR 25914316. A 27-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FE3380), via an unspecified route of administration on 24Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On 25Aug2021, the patient experienced heartburn. The event was reported as serious (disability). It was reported that patient have really painful heartburn in late evening and continuing through the night. Patient has never suffered from heartburn before. The patient underwent lab tests which included SARS-CoV-2 test: Negative (No - Negative COVID-19 test) on an unspecified date. The outcome of event was recovered on 26Aug2021. No follow up attempts are possible. No further information is expected.


VAERS ID: 1721047 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-25
Onset:2021-08-25
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Diarrhoea, Hallucination, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101163426

Write-up: After 30 days from II administration of Comirnaty hallucinations; After 30 days from II administration of Comirnaty very severe belly pain.; After 30 days from II administration of Comirnaty diarrhea,; After 30 days from II administration of Comirnaty fever; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB IT-MINISAL02-779589. A 30-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 25Jul2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on 25Aug2021 (also reported as after 30 days) from second (ii) administration the patient experienced hallucinations, very severe belly pain, diarrhea and fever. The outcome of the events was recovered with sequelae. Impact on quality of life (10/10). Reporter''s comments: No pathology. Sender''s comments: 1/9: production lot and date of first administration required. No follow-up attempts are possible, information on batch number cannot be obtained.; Reporter''s Comments: No pathology.


VAERS ID: 1721052 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF7481 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypertensive crisis, Myocardial ischaemia
SMQs:, Hypertension (narrow), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular event; Hypertensive (being hypertensive and on therapy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101163428

Write-up: Severe hypertensive crisis in hypertensive patient on therapy; ischemic heart disease; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority. WEB; the Regulatory Authority report number is IT-MINISAL02-779684. A 76-year-old female patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 24Aug2021 (batch/lot number: FF7481) as DOSE 1, SINGLE for COVID-19 immunization. The patient''s medical history included being hypertensive and on therapy and previous cerebrovascular events; dates not specified for both. Concomitant medications were not reported. On 25Aug2021, the patient experienced severe hypertensive crisis in hypertensive patient on therapy (crisis hypertensive) and ischemic heart disease. Therapeutic measures were taken in response to the events. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments:


VAERS ID: 1721064 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-08-25
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Body temperature, Chest discomfort, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Cardiac physical examination; Result Unstructured Data: Test Result:valid rhythmic heart tones not murmurs; Test Date: 2021; Test Name: Pulmonary physical examination; Result Unstructured Data: Test Result:Ubiquitous breath sounds, not bronchospasm; Test Date: 2021; Test Name: body temperature; Result Unstructured Data: Test Result:37.2; Comments: No units provided
CDC Split Type: ITPFIZER INC202101166057

Write-up: Chest pressure sensation; fever 37.2; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-779890. A 28-year-old female patient received bnt162b2 (COMIRNATY), first dose intramuscularly, administered in arm left (left shoulder) on 18Aug2021 at 11:56 (Batch/Lot Number: FG4686) as dose 1, 0.3 mL, single total for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient chest tightness one week post vaccine on 25Aug2021 for SARS-COV2 fever 37.2 in 2021. Pulmonary physical examination in 2021: Ubiquitous breath sounds, not bronchospasm. Cardiac physical examination in 2021: valid rhythmic heart tones not murmurs. Discharge with improvement of symptoms. The outcome of events was recovering. The events considered as serious as medically significant.


VAERS ID: 1721138 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101163130

Write-up: Inflammatory reaction increased; suspected as some infection; Pyrexia/pyrexia continued and did not improve; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. The regulatory authority report number is v21125930. A 94-year-old (also reported as 94-year and 3-month-old) female patient received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN Solution for injection), via an unspecified route of administration, on 24Aug2021 (lot number and expiration date unknown), as dose 2, single, for COVID-19 immunisation. On 27Aug2021 at 18:30 (3 days after the vaccination), the patient experienced pyrexia. The course of the event was as follows: On 24Aug2021, the patient received the vaccination. From 25Aug2021, pyrexia continued and did not improve. On 27Aug2021 (3 days after the vaccination), the patient was admitted to the hospital by ambulance. Inflammatory reaction increased, which was suspected as some infection, but infection focus could not be found. So, it was suspected as pyrexia after vaccination. On 05Sep2021 (12 days after the vaccination), the patient was discharged from the hospital. On 05Sep2021 (12 days after the vaccination), the outcome of the events pyrexia and inflammation reaction was recovering. The outcome of infection was unknown. The reporting physician classified the event as serious (hospitalized) and assessed that the causality between the event and bnt162b2 as unassessable. The reporting physician commented as follows: No comment. The lot number for BNT162B2 was not provided and will be requested during follow up.


VAERS ID: 1721208 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-25
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Coronavirus infection; This case was received via the regulatory authority (Reference number: JP-TAKEDA-2021TJP085190) on 02-Sep-2021 and was forwarded to Moderna on 15-Sep-2021. This case was reported by a vaccine recipient via the regulatory authority Corona virus infection was assessed as serious by the RA. On 16-Aug-2021, at 17:00, the patient received the 1st dose of this vaccination. On 24-Aug-2021, pyrexia of 39.5 degrees Celsius was noted, and malaise and symptom like cold was observed. On 25-Aug-2021, the patient visited a medical institution. Coronavirus infection was noted. On an unknown date, the symptoms resolved. The outcome of coronavirus infection was reported as recovered. No follow-up investigation is possible due to the reporters non-cooperation. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 43-year-old, male patient with no relevant medical history reported, who experienced the unexpected event of COVID 19. The event occurred approximately 8 days after the first dose of Spikevax. The rechallenge was not applicable, as the events happened after the first dose. The reporter assessed the events as related to the product. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness was assessed as per reported information in source documents.


VAERS ID: 1722329 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Hyperhidrosis, Pericarditis, Pyrexia, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 INC202101169899

Write-up: Pericarditis; chest pain; Dyspnoea; Hyperhidrosis; pyrexia; tremor; This is a spontaneous report from a contactable health professional via the regulatory authority. Regulatory authority report number is 613534. A 32-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation, and levothyroxine, via an unspecified route of administration from an unspecified date to an unspecified date at an unspecified dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced pericarditis, chest pain, dyspnoea, hyperhidrosis, pyrexia, and tremor on 25Aug2021. The action taken in response to the events for levothyroxine was unknown. Outcome of the events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1722357 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Myocarditis, Troponin, Troponin abnormal
SMQs:, Pseudomembranous colitis (broad), 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: Test Date: 20210825; Test Name: Troponin; Result Unstructured Data: Test Result:abnormal
CDC Split Type: AUPFIZER INC202101170204

Write-up: Myocarditis; Diarrhoea; Troponin abnormal; This is a spontaneous report from a contactable other health care professional (HCP) via the Regulatory Authority. Regulatory authority report number is 615202. A 25-year-old male patient received BNT162B2(COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose (dose number unknown) for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced myocarditis, diarrhoea and troponin abnormal on 25Aug2021. The event myocarditis was serious for being medical significant. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1722376 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Electrocardiogram, Electrocardiogram abnormal, Myocarditis, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:abnormal
CDC Split Type: AUPFIZER INC202101170316

Write-up: Myocarditis; Chest pain; Electrocardiogram abnormal; Palpitations; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 615919. A 49-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced myocarditis on 25Aug2021, chest pain on 25Aug2021, electrocardiogram abnormal on 25Aug2021, palpitations on 25Aug2021. The patient underwent lab tests and procedures which included electrocardiogram: abnormal on 25Aug2021. 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: 1723459 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101169952

Write-up: Anaphylactic reaction; This is a spontaneous report from a contactable healthcare professional via the Regulatory Authority. The regulatory authority report number is 614145. A 51-year-old female patient received BNT162B2 (COMIRNATY, Lot unknown, unknown if first or second dose) solution for injection intramuscular on 25Aug2021 (at the age of 51-years-old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient experienced anaphylactic reaction on 25Aug2021. The outcome of the event anaphylactic reaction was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1723460 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-25
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101169971

Write-up: Pericarditis; This is a spontaneous report from a contactable healthcare professional via the Regulatory Authority. The regulatory authority report number is 614375. A 38-year-old female patient received BNT162B2 (COMIRNATY, Lot unknown, unknown if first or second dose) solution for injection intramuscular on 19Aug2021 (at the age of 38-years-old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient experienced pericarditis on 25Aug2021. The outcome of the event pericarditis was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724229 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-25
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4728 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Covid-19: 11Sep2020 PCR POSITIVE)
Allergies:
Diagnostic Lab Data: Test Date: 20200911; Test Name: PCR; Result Unstructured Data: Test Result:Positive
CDC Split Type: ESPFIZER INC202101194785

Write-up: Herpes zoster/ papulous lesions on an erythematous/ dermatome in belt-like upper abdominal area/ it squeezes from a day before the injuries appear; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. Regulatory authority number ES-AEMPS-987114. A 23-years-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FE4728, Expiration date was not reported), via intramuscular route on 16Aug2021 as dose 1, single for covid-19 immunization. Medical history included covid-19 PCR positive from 11Sep2020 to an unknown date. The patient''s concomitant medications were not reported. On 25Aug2021, the patient experienced herpes zoster. Presentation on 26Aug2021: papulous lesions on an erythematous basis following a dermatome in belt-like upper abdominal area under the right breast, it squeezes from a day before the injuries appear. Diagnostic Judgment: compatible with shingles. Patient received treatment with copper sulphate solution at 1/1000 qs (sufficient quantity) 100 ml from 26Aug2021 to 01Sep2021. Presentation on 02Sep2021: greater extension, but already quite dry lesions. Presentation 08Sep2021: dry lesions and many already disappeared, it itches a little and prolong the TD (Temporary Disability) one more week. On 08Sep2021, it was reported that, patient was young and healthy, and because of the temporal relationship with the vaccine, reporter guessed outcome will be recovery, but the injuries had just begun. Therapeutic measures were taken as a result of event. The outcome of event was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1724252 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-08-25
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Amenorrhoea, Menstruation delayed
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Psoriasis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101174689

Write-up: Delayed menstruation; My period is 7 days late after getting the pfizer vaccine; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority - [ES-AEMPS-991637]. A 35-year-old non-pregnant female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration, administered in Arm Left on 21Jul2021 (Batch/Lot Number and expiration date were unknown) as a single dose for covid-19 immunisation. The patient was not pregnancy at time of vaccination. Medical history included psoriasis. The patient''s concomitant medications were not reported. The patient experienced delayed menstruation, ''my period is 7 days late after getting the Pfizer vaccine'', both on 25Aug2021. Event of delayed menstruation was reported as medically significant. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724353 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angioedema
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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angioneurotic edema (due to kininogenase abnormality); Pollen allergy (with old desensitization)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101188213

Write-up: Angioneurotic edema; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-AN20213566. A 47-years-old male patient received second dose of bnt162b2 (COMIRNATY; Solution for injection; Lot Number: FG6273), via intramuscular route administered in the left arm on 25Aug2021 at 10:00 as dose 2, single for COVID-19 immunization. Medical history included edema due to kininogenase abnormalities from an unknown date and unknown if ongoing. Regarding the history of angioneurotic edema was reported as no background treatment, triggers usually dietary, frequency of relapses <1 / year. Patient had pollen allergy with old desensitization, no other history and no usual treatment. Patient had no history of COVID-19 and no risk of developing a severe form of COVID-19 disease. Covid-19 test (Polymerase Chain Reaction/serology) was not performed. There were no concomitant medications. The patient previously received first dose of bnt162b2 (COMIRNATY), via unspecified route of administration on an unspecified date for COVID-19 immunization. On 25Aug2021 at 14:00, 4 hours later of vaccination, the patient experienced angioneurotic edema. Clinical examinations include edema of the left upper lip and eyelid. No skin signs. Prescription of Exacycle rapidly favorable evolution. No need to go to the emergency room. Approximate period of onset of the adverse reaction was 4 hours. No triggering factor found for this return, no recent drug initiation. Patient did not received treatment. The outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts possible. No further information expected.


VAERS ID: 1724386 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 214018 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, C-reactive protein, Chest pain, Cough, Dyspnoea, Echocardiogram, Electrocardiogram, Heart rate, Heart rate increased, Interchange of vaccine products, Myocarditis, N-terminal prohormone brain natriuretic peptide, Off label use, Oxygen saturation, SARS-CoV-2 test, Troponin
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Smoker (active smoker at 27 pack years)
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: Blood pressure; Result Unstructured Data: Test Result:131/76 mmHg; Test Date: 20210826; Test Name: C-reactive protein; Result Unstructured Data: Test Result:36.1 mg/l; Test Date: 20210826; Test Name: Trans-thoracic echocardiography; Result Unstructured Data: Test Result:Abnormal; Comments: Non-dilated left ventricle, with no left ventricular hypertrophy, preserved left ventricular ejection fraction at 70% with homogeneous hyperkinesia, non-dilated left atrium, type 2 mitral profile with no elevation of the left filling pressures, minimal central aortic insufficiency, minimal to moderate mitral insufficiency centred on the small mitral valve, non-dilated right ventricle, segmental systolic function, overall normal, tricuspid insufficiency, non-dilated inferior vena cava, well modulated, free pericardium, normal-sized ascending aorta, cross and abdominal aorta.; Test Date: 20210826; Test Name: Electrocardiography on admission; Result Unstructured Data: Test Result:Abnormal; Comments: regular sinus rhythm, heart rate at 100 bpm, normal axis, diffuse elevation with no mirror image.; Test Date: 20210826; Test Name: Cardiac frecuency; Result Unstructured Data: Test Result:116; Comments: bpm; Test Date: 20210826; Test Name: N-terminal pro b-type natriuretic peptide; Result Unstructured Data: Test Result:200 pg/mL; Test Date: 20210826; Test Name: Saturation; Test Result: 97 %; Comments: In ambient air; Test Date: 20210826; Test Name: COVID-19 Polymerase Chain Reaction test; Test Result: Negative ; Test Date: 20210826; Test Name: Troponin; Result Unstructured Data: Test Result:248 ug/L
CDC Split Type: FRPFIZER INC202101166818

Write-up: blood pressure at 131/76 mmHg; cardiac frequency at 116 bpm; coughing; medio-thoracic pains/increased thoracic pain; dyspnoea; Myopericarditis; 1st intramuscular injection of the MODERNA COVID vaccine on 26Jul2021.; 1st intramuscular injection of the MODERNA COVID vaccine on 26Jul2021.; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB, regulatory authority number is FR-AFSSAPS-PO20214690. A 42-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), intramuscular on 23Aug2021 (Batch/Lot Number: 214018) as dose 2 (initial Pfizer dose), 0.3 mL single for COVID-19 immunisation. Medical history included depression and an active smoker at 27 pack years. The patient''s concomitant medications were not reported. The patient was previously administered with MRNA 1273 (MODERNA), intramuscular on 26Jul2021 as dose 1, single for COVID-19 immunisation. On 25Aug2021 around 23:00, medio-thoracic pains associated with a feeling of dyspnoea. It was also reported that patient experienced myopercarditis on 25Aug2021. Hospitalisation on 26Aug2021.On 26Aug2021, upon admission, afebrile, blood pressure at 131/76 mmHg, cardiac frequency at 116 bpm, saturation at 97% in ambient air, increased thoracic pain on coughing and on deep inhalation. Electrocardiography on admission: abnormal, regular sinus rhythm, heart rate at 100 bpm, normal axis, diffuse elevation with no mirror image. Blood panel on 26Aug2021: C-reactive protein at 36.1 mg/l, troponin at 248 ug/l, N-terminal pro b-type natriuretic peptide at 200 pg/ml. Trans-thoracic echocardiography on 26Aug2021: Abnormal. Non-dilated left ventricle, with no left ventricular hypertrophy, preserved left ventricular ejection fraction at 70% with homogeneous hyperkinesia, non-dilated left atrium, type 2 mitral profile with no elevation of the left filling pressures, minimal central aortic insufficiency, minimal to moderate mitral insufficiency centered on the small mitral valve, non-dilated right ventricle, segmental systolic function, overall normal, tricuspid insufficiency, non-dilated inferior vena cava, well-modulated, free pericardium, normal-sized ascending aorta, cross and abdominal aorta. Differential diagnoses: Viral serologies not done besides a negative COVID-19 Polymerase Chain Reaction test. Start on 26Aug2021: treatment with intravenous aspirin 1g 3x/day and a trinitrine patch 14 mg/24 hours, then on 27Aug2021 of treatment with ramipril 2.5 mg/day, bisoprolol 2.5 mg/day, colchicine 0.5 mg/day. Outpatient Magnetic Resonance Imaging scheduled. Patient returned home on 27Aug2021. Outcome of events was recovering.


VAERS ID: 1724395 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH J07BX03 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Burning sensation, Chills, Cognitive test, Disturbance in attention, Dyspnoea, Facial paralysis, Headache, Heart rate, Heart rate increased, Hypertension, Influenza like illness, Migraine, Nausea, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: blood pressure; Result Unstructured Data: Test Result:high; Test Date: 20210901; Test Name: cognitive test; Result Unstructured Data: Test Result:normal; Test Date: 20210826; Test Name: heart rate; Result Unstructured Data: Test Result:160; Test Date: 20210827; Test Name: heart rate; Result Unstructured Data: Test Result:normal; Test Date: 20210827; Test Name: Sars-Cov-2 test; Result Unstructured Data: Test Result:Negative
CDC Split Type: FRPFIZER INC202101186627

Write-up: asthenia; difficulty in concentrating with some headache; Facial palsy; Shortness of breath; burning sensation in the lungs; high blood pressure; acceleration of the heart rate; Tachycardia; Nausea; Influenza like illness/flu state; Headache; migraines; chills; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority number FR-AFSSAPS-SE20212345. This is one of the two cases. A 38-years-old female patient received BNT162B2 (COMIRNATY; Solution for Injection; Lot Number: J07BX03), via intramuscular, administered in Arm Left on 25Aug2021 (at the age of 38-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (COMIRNATY, Solution for Injection, lot number: unknown) on unspecified date as dose 1 single for covid-19 immunisation and experienced flu state, nausea, migraines, chills and difficulty concentrating. It was reported that declaration made via the Reporting Portal on 01Sep2021, not medically confirmed. Patient Background was reported as none and had no covid-19 history. The patient experienced facial palsy on 01Sep2021, nausea, influenza like illness/flu state, migraines, chills on 25Aug2021, headache on 25Aug2021, tachycardia, acceleration of the heart rate on 26Aug2021(one day after vaccination), shortness of breath, burning sensation in the lungs, high blood pressure on 27Aug2021, asthenia, difficulty in concentrating with some headache on 06Sep2021. The patient underwent lab tests and procedures which included blood pressure measurement: high on 27Aug2021, cognitive test: normal on 01Sep2021, heart rate: 160 on 26Aug2021, heart rate: normal on 27Aug2021, sars-cov-2 test: negative on 27Aug2021. On Day0 (25Aug2021), patient had flu state with nausea, migraines, chills "as after D1". On Day1 (26Aug2021), acceleration of the heart rate (connected watch which rose to 160). On Day2 (27Aug2021), medical consultation for slightly high blood pressure (figure not reported) normal heart rate. Positive burning sensation in the lungs. Breathing difficulty during an effort (stairs, discussion). On Day7 (01Sep): feeling of paralysis on the left side of the face and jaw. Medical consultation showed normal "cognitive" tests. Restored (unclear statement). On Day12 (06Sep): she still presented asthenia and some difficulty in concentrating with some headache. She was no longer out of breath. Conclusion stated as flu syndrome, tachycardia, breathing difficulties and feeling of paralysis following the D2 of COMIRNATY. Clinical outcome of headache was recovering; outcome of asthenia, difficulty in concentrating with some headache was unknown and the other events recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1724441 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Pain, Pyrexia, SARS-CoV-2 test, Tension headache
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: Ache; Chills; Fever; Headache tension; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25858325) on 29-Aug-2021 and was forwarded to Moderna on 29-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of TENSION HEADACHE (Headache tension), PAIN (Ache), CHILLS (Chills) and PYREXIA (Fever) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced TENSION HEADACHE (Headache tension) (seriousness criterion medically significant). On 26-Aug-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, TENSION HEADACHE (Headache tension), PAIN (Ache), CHILLS (Chills) and PYREXIA (Fever) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. The patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment information was provided. Company comment: This case concerns a 28-year-old female with no relevant medical history, who experienced the unexpected events of tension headache, pain, chills and pyrexia 1 day after second dose of mRNA-1273 (Moderna CoviD-19 Vaccine). The rechallenge was unknown as there''s no information available about the first dose. The benefit-risk relationship of mRNA-1273 (Moderna CoviD-19 Vaccine) is not affected by this report.; Sender''s Comments: This case concerns a 28-year-old female with no relevant medical history, who experienced the unexpected events of tension headache, pain, chills and pyrexia 1 day after second dose of mRNA-1273 (Moderna CoviD-19 Vaccine). The rechallenge was unknown as there''s no information available about the first dose. The benefit-risk relationship of mRNA-1273 (Moderna CoviD-19 Vaccine) is not affected by this report.


VAERS ID: 1724520 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Eye swelling, Headache, Hyperhidrosis, Muscle spasms, Muscle twitching, Nausea, Palpitations, Vertigo
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dyskinesia (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BOOTS ALLERGY RELIEF ANTIHISTAMINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Genital herpes; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101168306

Write-up: muscle twitches; vertigo; nausea; headache; Sweats; Muscle spasms; Eye swelling; Tummy problems; Palpitations aggravated/Palpitations/heart palpitations; This is a spontaneous report from a contactable consumer received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109070718325140-7RPDK, Safety Report Unique Identifier: GB-MHRA-ADR 25904877. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 22Aug2021 (Lot Number: FE3380) as dose 2, single for COVID-19 immunisation. Medical history included genital herpes, suspected COVID-19 from 10Mar2019 to 15Mar2019 (dates as reported), and immunodeficiency (had an illness or condition, not listed above, which reduces the immune response (e.g. immunodef). Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medication included chlorphenamine maleate (BOOTS ALLERGY RELIEF ANTIHISTAMINE) taken for an unspecified indication, start and stop date were not reported. The patient experienced muscle twitches, palpitations, vertigo, nausea, and headache on an unspecified date; and palpitations aggravated on 25Aug2021. Clinical course reported: vertigo, headache, nausea, sweats, muscle twitches/spasms, eye swelling, heart palpitations (for over two weeks), and tummy problems. Relevant investigations or tests conducted: none. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the event palpitations aggravated was recovered on 07Sep2021; and for the rest of events was unknown. Regulatory authority assessed the events as serious: medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1724570 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Off label use, Product use issue, SARS-CoV-2 test
SMQs:, Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
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 INC202101182447

Write-up: Chills; Fatigue; Off label use; Drug use in unapproved population; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109081324474160-T2O7E, Safety Report Unique Identifier is GB-MHRA-ADR 25912090. This consumer reported information for both mother and baby. This is the maternal report. Only this case is serious. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 25Aug2021 (at the age of 42 years old) as dose 2, single for COVID-19 immunization. Medical history included ongoing breast feeding. Unsure if patient has had symptoms associated with COVID-19. Patient was not pregnant. The patient''s concomitant medications were not reported. The patient experienced chills on 27Aug2021 and fatigue on 26Aug2021, both reported as serious per other medically important condition. The patient experienced off label use and drug use in unapproved population on 25Aug2021, as patient was breast feeding when she received the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. The clinical course was reported as follows: The patient will be contacting her GP as the fatigue seemed to be ongoing. It was adversely affecting her ability to work or get things done at home. She was usually very physically active but not able to be. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event chills was recovered on 28Aug2021, while outcome of the event fatigue was not recovered. The outcome of the remaining events was unknown. No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101190267 Baby case


VAERS ID: 1724755 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FFE3380 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191466

Write-up: Heavy periods; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109120856028750-4GGHU, Safety Report Unique Identifier GB-MHRA-ADR 25928869. A 21-year-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number FFE3380), via an unspecified route of administration on 25Aug2021 (at the age of 21-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not enrolled in clinical trial. Patient was not pregnant. Patient was not currently breastfeeding. Patient has not had symptoms associated with COVID-19. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 27Jun2021 (Lot number: FC9001) for COVID-19 immunisation. On 25Aug2021 inappropriate schedule of vaccine administered, on 26Aug2021 patient experienced heavy periods. It was reported that the extreme heavy bleeding for nearly three weeks. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests which included sars-cov-2 test: negative on an unspecified date No - Negative COVID-19 test. The outcome for heavy periods was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724801 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal hypokinesia, Foetal monitoring, Lethargy, Maternal exposure during pregnancy
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (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: 20210826; Test Name: fetal monitoring; Result Unstructured Data: Test Result:the heartbeat was fine; Comments: and there were sufficient movements according to their monitoring system
CDC Split Type: GBPFIZER INC202101243897

Write-up: had the vaccine at 32 weeks; Fetal movements decreased; baby was very lethargic; This is a spontaneous report from a contactable consumer (patient''s mother). This consumer reported information for both mother and fetus. This is the fetus report. The maternal report is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109020752513510-5XNNU. A fetus patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FE3380), via transplacental route on 25Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The mother was pregnant and had the vaccine at 32 weeks. The fetal movements decreased for a period of 36 hours after the vaccine, on 25Aug2021, and it was very different: the baby was very lethargic and did not move around much or vigorously at all. The mother went to the hospital for fetal monitoring on the evening of 26Aug2021 and the heartbeat was fine and there were sufficient movements according to their monitoring system. On 27Aug2021, the movements started picking up again and went back to the normal pattern. The patient had recovered from the events on 27Aug2021. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101145525 Mother case


VAERS ID: 1724828 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Body temperature, Dysuria, Hyperpyrexia, SARS-CoV-2 antibody test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Arthritis (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: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: body temperature; Result Unstructured Data: 39.5 Celsius; Test Date: 20210818; Test Name: COVID-19 serology test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was initially received via regulatory authority (Reference number: IT-MINISAL02-775953) on 01-Sep-2021. The most recent information was received on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of HYPERPYREXIA, ARTHRALGIA, DYSURIA and ASTHENIA in a 71-year-old female patient who received mRNA-1273 for COVID-19 immunisation. The patient''s past medical history included COVID-19. On 24-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced HYPERPYREXIA (seriousness criterion medically significant), ARTHRALGIA (seriousness criterion medically significant), DYSURIA (seriousness criterion medically significant) and ASTHENIA (seriousness criterion medically significant). At the time of the report, HYPERPYREXIA, ARTHRALGIA, DYSURIA and ASTHENIA was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2021, SARS-CoV-2 antibody test: negative (Negative) Negative. On 25-Aug-2021, Body temperature: 39.5 (High) 39.5 Celsius. For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medication information provided. No relevant treatment medication information provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Translation received on 03-SEP-2021 and does not contain any new information. On 09-Sep-2021: FU received: updated with lab investigation, dose and date of start of vaccine.; Reporter''s Comments: Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1724972 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Biopsy skin, Erythema, Erythema multiforme, Mycoplasma test, Oedema peripheral, Pemphigus, Skin exfoliation, Streptococcus test, Target skin lesion
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210830; Test Name: Skin biopsy; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210830; Test Name: Mycoplasma; Test Result: Negative ; Test Date: 20210830; Test Name: pemphigus; Test Result: Negative ; Test Date: 20210830; Test Name: ASO; Test Result: Negative
CDC Split Type: JPPFIZER INC202101183243

Write-up: scattering of target lesions was seen on the upper tight(s); walnut-sized round desquamations; Erythema multiforme; oedema extremities/erythema diffuse and oedema; Erythema oedematous was confirmed on the trunk and extremities/erythema diffuse and oedema; This is a spontaneous report from a contactable pharmacist received from the regulatory authority. Regulatory authority report number is v21127154. A 51-year and 10-month-old male patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF3620, Expiration date 30Nov2021) via intramuscular route of administration on 22Aug2021 at 16:30 (the day of vaccination, at the age of 51-years-old), as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 25Aug2021 at 17:00 (3 days after the vaccination), the patient experienced erythema multiforme, erythema oedematous was confirmed on the trunk and extremities/erythema diffuse and oedema, oedema extremities/erythema diffuse and oedema. On 30Aug2021, the patient experienced scattering of target lesions was seen on the upper tight(s), walnut-sized round desquamations. The course of the event was as follows: from 25Aug2021, three days after the vaccination on 22Aug2021, oedema extremities appeared, and the patient visited a nearby physician. The patient received treatment with MINOMYCIN and a combination drug of MYSER plus OXAROL. On 30Aug2021, the patient was referred to by the nearby physician and visited dermatology of the hospital. Erythema oedematous was confirmed on the trunk and extremities, and scattering of target lesions was seen on the upper tights on 30Aug2021. On the peripheral side of the extremities, erythema diffuse and oedema were confirmed, and scattering of walnut-sized round desquamations was confirmed. At the hospital, skin biopsy was performed, and administration of PREDONINE 20 mg was started. Mycoplasma was negative, antistreptolysin O (ASO) was negative, and pemphigus, etc. were negative. In addition, based upon the onset timing, the symptoms were considered as side reactions caused by the intramuscular injection of COMIRNATY. On 06Sep2021, when the patient re-visited the hospital, the erythema disappeared. On 06Sep2021 (15 days after the vaccination), the outcome of the event was recovered. The reporting pharmacist classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting pharmacist commented as follows: as there were no other identification findings, and also based upon the onset timing, the symptoms were considered as side reactions caused by injection of COMIRNATY.


VAERS ID: 1725099 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-25
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SEFE8163 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210831; Test Name: RTPCR; Test Result: Positive ; Comments: THE RESULT IS POSITIVE FOR COVID-19
CDC Split Type: PHPFIZER INC202101183223

Write-up: COVID-19; COVID-19; cough; cold; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the regulatory authority. Regulatory authority report number PH-PHFDA-300104441 A 24 year old female patient received bnt162b2 (COMIRNATY, Solution for Injection, Batch/Lot Number: SEFE8163), via intramuscular on 20Aug2021, as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced covid-19 on 31Aug2021 08:00, cough and cold on 25Aug2021 08:00. On 31Aug2021, the patient under went lab test with RTPCR and the result is positive for Covid-19. She was under home quarantine. The outcome of cough and cold were recovered and other events were unknown No follow-up attempts are possible. No further information is expected.


VAERS ID: 1725100 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210831; Test Name: SARS-CoV-2 RT-PCR test; Result Unstructured Data: Positive
CDC Split Type: PHJNJFOC20210929840

Write-up: CONFIRMED CLINICAL VACCINE FAILURE; CONFIRMED COVID-19 INFECTION; COUGH; FEVER; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300104652] concerned a 37 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 212C21A expiry: UNKNOWN) dose was not reported,1 total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-AUG-2021, at 08:00 the patient experienced cough and fever. On 31-AUG-2021, the patient experienced confirmed clinical vaccine failure and confirmed covid-19 infection. Laboratory data included: SARS-CoV-2 RT-PCR test (NR: not provided) Positive. product quality complaint for the reason of confirmed clinical vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cough, and fever, and the outcome of confirmed clinical vaccine failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). Additional information was received from health care professional on 17-Sep-2021. The following information was updated and incorporated into the case narrative: additional events of confirmed covid-19 infection and confirmed clinical vaccine failure event was added.; Sender''s Comments: V1: This follow up adds- additional events of confirmed covid-19 infection and confirmed clinical vaccine failure event. 20210929840-covid-19 vaccine ad26.cov2.s- confirmed clinical vaccination failure. Follow-up received regarding Clinical Details. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1725103 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-08-25
   Days after vaccination:69
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4342 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, COVID-19, Cough, Decreased appetite, Dry mouth, Dysgeusia, Headache, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Arthritis (broad), Infective pneumonia (broad), Dehydration (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: FINLEPSIN 200 RETARD; ALPROX; HYDROXYZINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Sarcoidosis
Allergies:
Diagnostic Lab Data: Test Date: 20210903; Test Name: COVID-19 test (antigen and PCR); Test Result: Negative ; Comments: COVID-19 test (antigen and PCR); Test Date: 20210831; Test Name: COVID-19 test (saliva RT-PCR); Test Result: Positive ; Comments: COVID-19 test (saliva RT-PCR)
CDC Split Type: PLPFIZER INC202101181359

Write-up: She received a positive COVID-19 (saliva RT-PCR) test on 31Aug2021.; vaccination failure; headache; tart/metallic taste in the mouth; cough; lack of appetite; dry mouth; weakness; severe pain in the joints; This is a spontaneous report from a contactable consumer (patient) forwarded by Pfizer colleague. A 21-year-old female patient received second dose of bnt162b2 (COMIRNATY; Solution for injection; Lot Number: FD4342), via intramuscular route administered in the left arm on 17Jun2021 as dose 2, single, and received first dose of bnt162b2 (COMIRNATY; Lot Number: FA5715), via intramuscular route administered in the left arm on 13May2021 as dose 1, single; both for COVID-19 immunization. Medical history included asthma diagnosed on an unspecified date in 2015 and sarcoidosis diagnosed on an unspecified date in Mar2020. Concomitant medications included carbamazepine (FINLEPSIN 200 RETARD) taken for an unspecified indication from unspecified date in Jun2021 and ongoing; alprazolam (ALPROX) 1mg and Hydroxyzine 25 mg; both taken for an unspecified indication, start and stop dates were not reported. On 25Aug2021, the patient experienced headache, tart or harsh or metallic taste in the mouth, cough, loss of appetite, dry mouth, weakness and severe pain in the joints. On 31Aug2021, patient tested positive for COVID-19 (saliva RT-PCT) with vaccination failure. It was reported that joint pain persists. The patient underwent lab tests and procedures which included sars-cov-2 tests, COVID-19 (saliva RT-PCT) test on 31Aug2021 resulted as positive and COVID (antigen and PCR) tests on 03Sep2021 resulted as negative. The outcome of the event severe pain in the joints was not recovered and the outcome of other events was unknown.


VAERS ID: 1725111 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-16
Onset:2021-08-25
   Days after vaccination:101
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: SARS-CoV-2 RT-PCR test; Test Result: Positive
CDC Split Type: PTPFIZER INC202101193958

Write-up: Possible vaccination failure; COVID-19; This is a spontaneous report from a contactable nurse downloaded from the Regulatory Authority WEB. This is a report received from INFARMED Regulatory authority report number [PT-INFARMED-B202108-3756] with Safety Report Unique Identifier [PT-INFARMED-B202108-3756]. Spontaneous notification refers to a case sent by a nurse. A 49-years-old an adult male patient received first dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: EW9127) via intramuscularly, administered on 17Apr2021 as dose 1, 0.3 ML single and second dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: EX8680) via intramuscularly, administered on 16May2021 as dose 2, 0.3 ML single for COVID-19 immunisation, with an interval of 29 days. Approximately 3 months after completing the Comirnaty vaccine schedule, the patient presented with COVID-19 on 25Aug2021, confirmed by a positive PCR test for SARS-CoV-2 infection. The patient manifested symptoms associated with COVID-19, namely odynophagia and nasal congestion. The lab test included RT-PCR test for SARS-CoV-2 was positive on 25Aug2021. At the time of reporting, the outcome of the events were unknown. The reporter''s assessment of the causal relationship of the (covid-19, vaccination failure) with the suspect product was not provided at the time of this report. Since no determination had been received, the case was managed based on the company causality assessment. No follow-up attempts were possible. No further information was expected.; Reporter''s Comments: Other information- RT PCR test positive on 25Aug2021 Odynophagia, nasal congestion


VAERS ID: 1725112 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-08-25
   Days after vaccination:102
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive, 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: 20210825; Test Name: SARS-CoV-2 RT-PCR test; Test Result: Positive
CDC Split Type: PTPFIZER INC202101193584

Write-up: Possible vaccination failure; COVID-19; This is a spontaneous report from a contactable nurse downloaded from the Regulatory authority-WEB. This is a report received from Regulatory authority report number [PT-INFARMED-B202108-3758] with Safety Report Unique Identifier [PT-INFARMED-B202108-3758]. A 48-years-old male patient received second dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: EX8680), dose 2 intramuscular on 15May2021 as dose 2, 0.3 ml single and received first dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: EW9127), dose 1 via intramuscular route of administration, administered in Arm Left on 17Apr2021 as dose 1, 0.3 ml single for covid-19 immunisation. The patient medical his-tory concomitant medications were not reported. Approximately 3 months after completing the Comirnaty vaccine schedule, on 25Aug2021, the patient diagnosed with COVID-19, confirmed by a positive PCR test for SARS-CoV-2 infection. The patient manifested symptoms associated with COVID-19, namely headache, fever and nasal congestion. No additional data known. The outcome of event was unknown. The reporter''s assessment of the causal relationship of the [covid-19, vaccination failure] with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Other information- RT PCR test positive on 25Aug2021 Headache, fever, nasal congestion


VAERS ID: 1725151 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Investigation, Ultrasound scan
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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: DIENORETTE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: survey; Result Unstructured Data: Test Result:widespread left-sided DVT; Comments: widespread left-sided DVT with thrombus peak in prox v iliaca communis sin, just before confluence to v. cava inferior.; Test Name: ultrasound; Result Unstructured Data: Test Result:no thrombosis
CDC Split Type: SEPFIZER INC202101166757

Write-up: DVT; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The Regulatory Authority report number is SE-MPA-2021-080793. A 17-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 22Aug2021 (Batch/Lot Number: FE8235) as dose 1, single for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant medication included dienogest, ethinylestradiol (DIENORETTE) from 22Feb2021 to 27Aug2021. The patient experienced DVT (deep vein thrombosis) on 25Aug2021. On 22Aug2021, the patient received the first dose of COVID vaccine. The next day, the patient woke up with swelling and sore thigh. The symptoms worsened and she sought medical help a few days later (unspecified date) where ultrasound showed no thrombosis. New survey a day later showed widespread left-sided DVT with thrombus peak in prox v iliaca communis sin, just before confluence to v. cava inferior. Stopped on birth control pills, otherwise none risk factors for clogging disease. The patient was administered with Fragmin and given thrombolysis, continued DOAC treatment. The patient was hospitalized on an unspecified date due to the events. The outcome of the event was recovering. The event was assessed as serious (hospitalization). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1725928 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004729-CDC / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Blood fibrinogen, Computerised tomogram, Diarrhoea, Ecchymosis, Fibrin D dimer, Platelet count
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: fibrinogen; Result Unstructured Data: decreased; Test Name: abdominal CT; Result Unstructured Data: TTS; Test Name: D-dimer; Result Unstructured Data: 1.16; Test Name: Platelet; Result Unstructured Data: 292 x 1000/uL
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Diarrhoea; Blood stasis; Abdominal pain; This regulatory authority case was reported by a pharmacist and describes the occurrence of ABDOMINAL PAIN (Abdominal pain) and ECCHYMOSIS (Blood stasis) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3004729-CDC) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant). On 26-Aug-2021, the patient experienced ECCHYMOSIS (Blood stasis) (seriousness criterion medically significant). On 27-Aug-2021, the patient experienced DIARRHOEA (Diarrhoea). At the time of the report, ABDOMINAL PAIN (Abdominal pain), ECCHYMOSIS (Blood stasis) and DIARRHOEA (Diarrhoea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood fibrinogen: decreased (Low) decreased. On an unknown date, Computerised tomogram: abnormal (abnormal) TTS. On an unknown date, Fibrin D dimer: 1.16 (High) 1.16. On an unknown date, Platelet count: 292 x 1000/ul (High) 292 x 1000/uL. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The concomitant medications were not reported. The treatment information was not provided. On 25AUG2021 it was expected to have abdominal CT, and it was suspected that it may be TTS, and ADR was notified. Company Comment : This case concerns a 58-year-old, female patient with no relevant medical history, who experienced the unexpected events of abdominal pain and ecchymosis. The events occurred two days after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 58-year-old, female patient with no relevant medical history, who experienced the unexpected events of abdominal pain and ecchymosis. The events occurred two days after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1725979 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-08-25
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthma, Chest discomfort, Chest pain, Fatigue, Muscular weakness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (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: TWMODERNATX, INC.MOD20213

Write-up: asthma; chest pain; tightness; limb weakness; fatigue; syncope; This regulatory authority case was reported by a pharmacist and describes the occurrence of SYNCOPE (syncope), ASTHMA (asthma), CHEST PAIN (chest pain) and CHEST DISCOMFORT (tightness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced SYNCOPE (syncope) (seriousness criterion medically significant), ASTHMA (asthma) (seriousness criterion hospitalization), CHEST PAIN (chest pain) (seriousness criterion hospitalization), CHEST DISCOMFORT (tightness) (seriousness criterion hospitalization), MUSCULAR WEAKNESS (limb weakness) and FATIGUE (fatigue). At the time of the report, SYNCOPE (syncope), MUSCULAR WEAKNESS (limb weakness) and FATIGUE (fatigue) was resolving and ASTHMA (asthma), CHEST PAIN (chest pain) and CHEST DISCOMFORT (tightness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant products were not provided. received Moderna vaccination on July 3, syncope and exhaust and fatigue continued for 4 days. This admission was due to asthma, chest pain, tightness for 2-3 days when stayed home. Report from Hospital emergency room included Weak breath sounds in both lower lung lobes, check Tro-I 1360.4 PR NSTEI S/P PCI CAD3 with LAD lesion due to SOB, on BiPAP support since Aug-20 Treatment product was not provided by the reporter. Company Comment: This case concerns a 83-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of syncope, asthma, chest pain, chest discomfort, muscular weakness and fatigue. The events occurred approximately 53 days after the first dose of Moderna COVID-19 Vaccine. Syncope and exhaust and fatigue continued for 4 days. The admission was due to asthma, chest pain, tightness. The rechallenge was not applicable, as the events happened after the first dose. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 83-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of syncope, asthma, chest pain, chest discomfort, muscular weakness and fatigue. The events occurred approximately 53 days after the first dose of Moderna COVID-19 Vaccine. Syncope and exhaust and fatigue continued for 4 days. The admission was due to asthma, chest pain, tightness. The rechallenge was not applicable, as the events happened after the first dose. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1726078 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101170551

Write-up: Pericarditis; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 616430. A 24-year-old male patient received BNT162B2 (COMIRNATY) via unspecified route on an unspecified date single dose for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced pericarditis (medically significant) on 25Aug2021 with outcome of recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1728642 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-08-25
   Days after vaccination:126
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001650 / 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: Arterial hypertension; Chronic lymphoid leukemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Vaccination failure; This case was received via regulatory authority (Reference number: FR-AFSSAPS-GR20213938) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of VACCINATION FAILURE (Vaccination failure) in a 77-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3001650) for COVID-19 vaccination. Concurrent medical conditions included Arterial hypertension and Chronic lymphoid leukemia. On 21-Apr-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 ml. On 25-Aug-2021, the patient experienced VACCINATION FAILURE (Vaccination failure) (seriousness criterion hospitalization). At the time of the report, VACCINATION FAILURE (Vaccination failure) was resolving. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 21-Apr-2021. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No rechallenge was done. Treatment medication was not provided by the reporter. Company comment- This case concerns a 77-year-old, male patient with relevant medical history of chronic lymphoid leukemia, who experienced the unexpected event of vaccination failure. The event vaccination failure occurred 127 days after the unknown dose of mRNA-1273 vaccine administration. No product report assessment was given from the reporter. The medical history of chronic lymphoid leukemia remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 77-year-old, male patient with relevant medical history of chronic lymphoid leukemia, who experienced the unexpected event of vaccination failure. The event vaccination failure occurred 127 days after the unknown dose of mRNA-1273 vaccine administration. No product report assessment was given from the reporter. The medical history of chronic lymphoid leukemia remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1728936 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7051 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Erythema, Facial discomfort, Headache, Lacrimation increased, Localised oedema, Lymphadenopathy, Neck pain, Ocular discomfort, Paranasal sinus discomfort, Pruritus, Somnolence, Swelling, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Lacrimal 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? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC202101195056

Write-up: Swollen lymph nodes; Sensation of pressure in eye; Eyes tearing; Skin red; Local swelling (on the forehead); Sinus pressure; Headache; Neck pain; Iin the morning after waking up a large amount of drowsiness; Overall slight itching of the left half of the face, including the top of the head; Neck oedema; Swelling of face; Facial discomfort; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority, regulatory authority number CZ-CZSUKL-21010393. A 48-year-old male patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: FE7051, Expiry date: unknown), via intramuscularly on 24Aug2021 as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On the same day, patient had especially severe dizziness in the area of the jaw joint near the ear, increased tearing of eyes, especially in the left eye and mild pressure in the left eye. In the morning after waking up a large amount of drowsiness, very glued eyes, which was not before vaccination. In the left frontal and nasal cavity, a feeling of pressure like in a cold, but without mucus and without the need to blow your nose. On the left back of the neck, flat swelling and reddened skin and in the same place enlarged palpable slightly painful pea-sized lymph node. When rotating the head to the right, mild muscle soreness on this left side. Overall slight itching of the left half of the face, including the top of the head. So far without increased temperature. Unimpaired vision, compared to the standard. No fatigue or other symptoms. On 29Aug2021, Adverse reactions still persist, mild general deterioration, mild relief, swelling persists - they move from place to place. On 30Aug2021, Stagnation state in some locations a slight improvement. Therapeutic measures were taken as a result of swollen lymph nodes, swelling of face, sensation of pressure in eye, facial discomfort, eyes tearing, skin red, local swelling (on the forehead), sinus pressure, headache, neck pain, neck oedema, in the morning after waking up a large amount of drowsiness, overall slight itching of the left half of the face, including the top of the head and Treatment of ADR: Ibalgin 400 mg. The reporter does not wish to contact the physician. As of the reporting date adverse reactions persist for 6 days. The clinical outcome of event in the morning after waking up a large amount of drowsiness, overall slight itching of the left half of the face, including the top of the head was unknown and other events was not recovered. No follow-up attempts possible. No further information expected.


VAERS ID: 1729412 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3716 / 2 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Chest pain, Fatigue, Heart rate increased, Pain in extremity, Parosmia, Taste disorder
SMQs:, Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Tendinopathies and ligament disorders (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101195069

Write-up: Fatigue; Sense of smell and taste disoriented; Sense of smell and taste disoriented; Fast heartbeat; Left arm pain eventhough i was administered in the right arm; Heart pain; Chest pain; This is a spontaneous report from a contactable consumer. This is a report downloaded from the Regulatory Authority-WEB, regulatory authority number IE-HPRA-2021-083366, Safety Report Unique Identifier IE-HPRA-2021-083366. Initial report received by the HPRA on 25Aug2021 from a member of the public, reporting on behalf of herself. A 25-year-old female patient received second dose of BNT162B2 (Comirnaty solution for injection, Lot Number: FG3716), via an unspecified route of administration, administered in Arm Right on 25Aug2021 as a Dose 2, single for COVID-19 immunization (at the age of 25-year-old). The patient medical history and patient''s concomitant medications were not reported. The patient''s historical vaccine included BNT162B2 (Comirnaty solution for injection, Lot Number: FC1433), dose 1 via an unspecified route of administration on 27Jul2021 as a single dose for COVID-19 immunization (at the age of 25-year-old). The patient experienced fatigue, sense of smell and taste disoriented, sense of smell and taste disoriented, fast heartbeat, left arm pain eventhough i was administered in the right arm, heart pain, chest pain on 25Aug2021. Clinical course of events includes; Eight hours post second dose administration on 25Aug2021, the patient experienced heart pain, left arm pain, sense of smell and taste disoriented, fatigue, chest pain, and a fast heartbeat. The patient described that it felt like she was going to have a heart attack. The outcome of all the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1729542 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-08-25
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003605 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Hypersensitivity, Inappropriate schedule of product administration, Pruritus, Throat irritation
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Medication errors (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: Penicillin allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: inappropriate schedule of vaccine administrated;This regulatory authority case was reported by a physician and describes the occurrence of HYPERSENSITIVITY, ERYTHEMA, PRURITUS and THROAT IRRITATION in a 46-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3003605) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy. On 14-Jul-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter in total. On 25-Aug-2021, the patient experienced HYPERSENSITIVITY (seriousness criterion medically significant), ERYTHEMA (seriousness criterion medically significant), PRURITUS (seriousness criterion medically significant) and THROAT IRRITATION (seriousness criterion medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administrated). On 25-Aug-2021, HYPERSENSITIVITY, ERYTHEMA, PRURITUS and THROAT IRRITATION had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administrated) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medications was not reported. Treatment medication was not reported. This case concerns a 46 year-old, female subject, with medical history of allergy to penicillin, who experienced the unexpected events of Hypersensitivity, Erythema, Pruritus, and Throat irritation. The events occurred approximately 1 month and 10 days after the first dose of Spikevax, and on the same day of vaccination with the second dose. The medical history of allergy to penicillin remains a confounder. The benefit-risk relationship of Spikevax is not affected by this report. Event?s seriousness was assessed as per regulatory authority report. Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Received on 21sep21 includes previous dose information; Sender''s Comments: This case concerns a 46 year-old, female subject, with medical history of allergy to penicillin, who experienced the unexpected events of Hypersensitivity, Erythema, Pruritus, and Throat irritation. The events occurred approximately 1 month and 10 days after the first dose of Spikevax, and on the same day of vaccination with the second dose. The medical history of allergy to penicillin remains a confounder. The benefit-risk relationship of Spikevax is not affected by this report. Event?s seriousness was assessed as per regulatory authority report.


VAERS ID: 1729651 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9880 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Heart rate, Oxygen saturation, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pollinosis
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: BP; Result Unstructured Data: Test Result:126/80; Test Date: 20210825; Test Name: BP; Result Unstructured Data: Test Result:131/90; Comments: At 16:10; Test Date: 20210825; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210825; Test Name: pulse; Result Unstructured Data: Test Result:60; Comments: /min; Test Date: 20210825; Test Name: pulse; Result Unstructured Data: Test Result:58; Comments: /min, At 16:10; Test Date: 20210825; Test Name: spo2; Test Result: 99 %; Comments: At 15:21; Test Date: 20210825; Test Name: spo2; Test Result: 98 %; Comments: At 16:10
CDC Split Type: JPPFIZER INC202101191949

Write-up: Urticaria/Wheals was mild; generalised itching/itching in the right forearm; This is a spontaneous report from a contactable physician received from the regulatory authority report number is v21126452. A 42-year-old female received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FC9880, Expiration date 30Sep2021) via an unspecified route of administration on 25Aug2021 at 15:05 at patient age of 42-year and 8-month-old as a single dose for COVID-19 immunization. Body temperature before vaccination was 36.5 degrees Centigrade. Medical history included pollinosis. The patient concomitant medications were not reported. Past drug history included oral bepotastine Besilate OD tablets 10 mg x 2 (morning and evening) prescribed at a clinic (at the season of pollen in the air). On unspecified date, the patient previously received the first dose of BNT162B2 (COMIRNATY, Lot# FC9880, Expiration date 30Sep2021) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. On 25Aug2021 at 15:05, the patient received the second vaccination. About 5 minutes after the vaccination (on 25Aug2021 at 15:10), itching in the right forearm developed. BP 126/80, pulse 60/minute. On 25Aug2021 at 15:15 (the day of vaccination), generalized itching and urticaria on the limbs developed. Wheals were mild. On 25Aug2021 at 15:21, subcutaneous injection with hydroxyzine hydrochloride (ATARAX-P) 25mg, betamethasone sodium phosphate (LINOLOSAL) 2mg was performed. SpO2 99%. On 25Aug2021 at 16:10, BP 131/90, pulse 58/minute, SpO2 98%. Generalised itching and urticaria on the limbs abated. Oral administration of antiallergics prescribed at an otolaryngology clinic, and the patient returned home. On 25Aug2021 (the day of vaccination), the outcome of the event was recovering. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162B2.There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: No reports about changes such as aggravation of the symptoms after the patient returned home.


VAERS ID: 1729688 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9942 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, CSF test, Electroencephalogram, Electroencephalogram abnormal, Encephalitis, Encephalopathy, Headache, Magnetic resonance imaging head, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test, Seizure
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210829; Test Name: body temperature; Result Unstructured Data: Test Result:40 Centigrade; Test Date: 20210906; Test Name: cerebrospinal fluid test; Result Unstructured Data: Test Result:cause of the Convulsion was not clarified; Test Date: 20210906; Test Name: Electroencephalogram; Result Unstructured Data: Test Result:slow wave was confirmed in a wide range; Test Date: 20210906; Test Name: Head MRI; Result Unstructured Data: Test Result:cause of the Convulsion was not clarified; Test Date: 20210829; Test Name: PCR test of COVID-19; Test Result: Negative
CDC Split Type: JPPFIZER INC202101194115

Write-up: Encephalitis; Encephalopathy; Convulsion; headache; slow wave was confirmed in a wide range; Pharyngodynia; Low grade fever/Pyrexia of 40 degrees centigrade; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21127794. A 13-year and 2-month-old female patient received the first dose of bnt162b2 (COMIRNATY) via an unspecified route of administration at age of 13-years, on 25Aug2021 (Lot Number: FF9942; Expiration Date: 30Nov2021) as DOSE 1, SINGLE for covid-19 immunisation. Medical history was none and concomitant medications were not reported. The patient experienced encephalitis, encephalopathy and convulsion on 06Sep2021 10:00, headache on 06Sep2021, slow wave was confirmed in a wide range on 06Sep2021, low grade fever/pyrexia of 40 degrees centigrade on 25Aug2021, pharyngodynia on 29Aug2021. The patient was hospitalized from 06Sep2021 to an unknown date. Therapeutic measures were taken for events encephalitis, encephalopathy, convulsion, headache and slow wave was confirmed in a wide range. The outcome of the event pyrexia was recovered on 01Sep2021, while for remains events was not recovered. The reporting physician classified the event as serious (Hospitalized from 06Sep2021, may cause disability) and assessed that the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was: four days after vaccination, Pyrexia of 40 degrees centigrade and Pharyngodynia occurred, so probably infected by some kind of virus. The clinical course of the events was reported as follows: On 25Aug2021, the patient experienced Low grade fever after vaccination, but it soon alleviated. From 29Aug2021, Pyrexia of 40 degrees centigrade and Pharyngodynia began to occur. PCR test of COVID-19 was negative. On 01Sep2021, the pyrexia was subsided and patient was able to go to school on 03Sep2021. Until the 05Sep2021, the patient felt good. In the morning of 06Sep2021, headache occurred, at 10:00, the patient was emergently transferred to the hospital because of Convulsion. After transferred to the hospital, Convulsion was confirmed, although Head MRI and cerebrospinal fluid test were performed, the cause of the Convulsion was not clarified. Convulsion occurred repeatedly after hospitalization, slow wave was confirmed in a wide range by Electroencephalogram. Pulse steroid therapy and administration of Aciclovir were started for Encephalitis/Encephalopathy. After that, the symptoms began to alleviate gradually, until now. The reporting physician commented as follows: Encephalitis and encephalopathy may due to infection of some kind of virus. However, as the events occurred 12 days after vaccination, the impact of the vaccine cannot be denied. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1729771 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-25
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3593 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Asthenia, Body temperature, Chills, Diarrhoea, Fatigue, Generalised tonic-clonic seizure, Headache, Irritability, Nausea, Pruritus, Pyrexia, Rhinorrhoea, Seizure, Syncope, Vital signs measurement, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Body temperature; Result Unstructured Data: Test Result:upper than or equal to 38 celcius degrees; Comments: Fever; Test Date: 20210825; Test Name: Vital Signs; Result Unstructured Data: Test Result:normal
CDC Split Type: MXPFIZER INC202101190339

Write-up: Presented tonic-clonic seizure; Afebrile convulsion crisis; Syncope; Fever upper than or equal to 38 Celsius degrees; Headache; Asthenia/Adynamia; Fatigue; Irritability; Chills; Pruritus; Nausea; Vomit; Abdominal pain; Diarrhea; Rhinorrhea; This is a Spontaneous report from a non-contactable Other Health Professional (patient). This is a report received via email. Regulatory authority report number is 17563-9. A 37-year-old female patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) intramuscular, administered in Arm Left on 16Aug2021 (at the age of 37 years old) (Batch/Lot Number: FE3593; Expiration Date: 30Nov2021) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. No previous disease. No infectious Disease in the last 15 Days prior to vaccination. Patient was healthy before vaccination. The patient has no allergies. On 25Aug2021, patient experienced afebrile convulsion crisis, syncope, fever upper than or equal to 38 degrees celsius, headache, asthenia/adynamia, fatigue, irritability, chills, pruritus, nausea, vomiting, abdominal pain, diarrhea and rhinorrhea. Clinical course: Patient reported that 1 day after the application she presented a tonic-clonic seizure and general symptoms, normal vital signs, currently stable. Treatment received was diclofenac, metoclopramide 1 tablet every 12 hours. The outcome of the events was unknown. No?follow-up?attempts?possible. No?further?information?is expected.


VAERS ID: 1729777 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8838 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dizziness, Facial paralysis, Fatigue, Headache, Hyperaesthesia, Loss of consciousness, Nausea, Pain, Syncope, Vaccination site pain, Vaginal haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hearing impairment (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Menstruation normal
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC202101190369

Write-up: Loss of consciousness; Facial paralysis; Transvaginal bleeding after menstruation; Pain at the application site; Syncope; Headache; Asthenia/ Adynamia; Fatigue; Pain; Sensitivity; Dizziness; Nausea; This is a spontaneous report from a non-contactable Other Health Professional. This is a report received from Regulatory Authority via email. Regulatory authority report number is 17568-9. A 31-year-old female patient received first dose of bnt162b2 (BNT162B2; Batch/Lot Number: FF8838; Expiration Date: 01Dec2021), intramuscular, administered in Arm Right on 25Aug2021 (at the age of 31-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient''s medical history included allergy (not specific) from an unknown date and unknown if ongoing and ''menstruating'' since 24Aug2021 and ongoing. Patient was not pregnant at the time of vaccination. It was reported that patient was healthy before vaccination. Patient has no infectious disease in the last 15 days prior to vaccination. The patient''s concomitant medications were not reported. The patient experienced syncope, headache, ''asthenia/adynamia'', fatigue, pain, sensitivity, dizziness, nausea, and pain at the application site on 25Aug2021; loss of consciousness, facial paralysis, and transvaginal bleeding after menstruation on 28Agu2021. Patient''s clinical course is as follows: It was reported that symptoms began one hour after the application of the vaccine with headache, asthenia and adynamia, pain at the application site. It was reported that patient''s transvaginal bleeding (VTS) increased, later referring to bleeding on 28Aug2021. On the same date of 28Aug2021, patient loses consciousness with facial paralysis and was consulted by a private gynecologist for VTS giving medication with specifically referring. Patient currently attends for VTS and facial paralysis. It was reported that patient has received no treatment before receiving medical attention. Treatment received for events was paracetamol and others indication by the gynecologist without specifying. The events loss of consciousness, facial paralysis, and syncope were assessed as serious (medically significant); the remaining events were assessed as non-serious. Outcome of the events was unknown. No follow-up attempts possible. No further information is expected. Information about the batch number has been obtained.


VAERS ID: 1729922 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: SARS-CoV-2 test; Result Unstructured Data: Positive Iu international unit(s)
CDC Split Type: PTJNJFOC20210943178

Write-up: Vaccination failure; This spontaneous report received from a physician Via a Regulatory authority (EVHUMAN Vaccines, PT-INFARMED-T202109-119) on 22-SEP-2021 concerned a 52 year old female of an unspecified race and ethnic origin. The patient''s height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD986, expiry: unknown) 0.5 ml, frequency time 1 total administered on 07-JUN-2021 for covid-19 immunisation. No concomitant medications were reported. On 25-AUG-2021, the patient experienced vaccination failure. Laboratory data included: Severe acute respiratory syndrome coronavirus (SARS-CoV) 2 test (NR: not provided) Positive international unit (s) (Iu). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1730005 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-08-25
   Days after vaccination:43
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute myocardial infarction, Chest discomfort, Cold sweat, Coronary artery occlusion, Decreased appetite, Diarrhoea, Dyspnoea, Echocardiogram, Ejection fraction, Palpitations, Pulmonary embolism, Stenosis
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMLODIPINE
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: LAD-DB; Result Unstructured Data: M/3: 50% stenosis with TIMI 2-3 distal runoff; Test Name: LMCA; Result Unstructured Data: normal; Test Date: 20210829; Test Name: D-Dimer; Result Unstructured Data: 4,525 ng/mL FEU; Test Date: 20210830; Test Name: Echocardiography; Result Unstructured Data: showed fair LV contractility (LVEF: 59% by M-mode), LV diastolic dysfunction with E/A reverse.; Test Name: LVEF; Result Unstructured Data: 41%; Test Date: 20210830; Test Name: LVEF; Result Unstructured Data: LVEF: 59% by M-mode; Test Name: M/3 Stenosis; Result Unstructured Data: M/3: 50% stenosis
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: pulmonary embolism; palpitations; Cold sweat; AMI; shortness of breath; chest tightness; diarrhea; loss of appetite; This regulatory authority case was reported by a pharmacist and describes the occurrence of DIARRHOEA (diarrhea), DECREASED APPETITE (loss of appetite), ACUTE MYOCARDIAL INFARCTION (AMI), DYSPNOEA (shortness of breath), CHEST DISCOMFORT (chest tightness), PULMONARY EMBOLISM (pulmonary embolism), PALPITATIONS (palpitations) and COLD SWEAT (Cold sweat) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE for Hypertension. On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 25-Aug-2021, the patient experienced DYSPNOEA (shortness of breath) (seriousness criterion hospitalization prolonged) and CHEST DISCOMFORT (chest tightness) (seriousness criterion hospitalization prolonged). On 27-Aug-2021, the patient experienced ACUTE MYOCARDIAL INFARCTION (AMI) (seriousness criteria hospitalization prolonged and medically significant). On 27-Aug-2021 at 4:00 PM, the patient experienced PALPITATIONS (palpitations) (seriousness criterion hospitalization) and COLD SWEAT (Cold sweat) (seriousness criterion hospitalization). On an unknown date, the patient experienced DIARRHOEA (diarrhea) (seriousness criterion hospitalization prolonged), DECREASED APPETITE (loss of appetite) (seriousness criterion hospitalization prolonged) and PULMONARY EMBOLISM (pulmonary embolism) (seriousness criteria hospitalization and medically significant). The patient was hospitalized until 03-Sep-2021 due to ACUTE MYOCARDIAL INFARCTION, CHEST DISCOMFORT, COLD SWEAT, DECREASED APPETITE, DIARRHOEA, DYSPNOEA, PALPITATIONS and PULMONARY EMBOLISM. The patient was treated with HEPARIN at a dose of 3 L/min; ENOXAPARIN for Pulmonary embolism, at an unspecified dose and frequency; APIXABAN for Pulmonary embolism, at an unspecified dose and frequency; ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency and Surgery (cardiac catheterization) for Acute myocardial infarction. At the time of the report, DIARRHOEA (diarrhea), DECREASED APPETITE (loss of appetite), ACUTE MYOCARDIAL INFARCTION (AMI), PULMONARY EMBOLISM (pulmonary embolism), PALPITATIONS (palpitations) and COLD SWEAT (Cold sweat) outcome was unknown and DYSPNOEA (shortness of breath) and CHEST DISCOMFORT (chest tightness) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Aug-2021, D-Dimer: 4,525 ng/ml (Low) 4,525 ng/mL FEU. On 30-Aug-2021, Echocardiogram: normal (normal) showed fair LV contractility (LVEF: 59% by M-mode), LV diastolic dysfunction with E/A reverse.. On 30-Aug-2021, Ejection fraction: normal (normal) LVEF: 59% by M-mode. On an unknown date, Coronary artery occlusion: 50% (Low) M/3: 50% stenosis with TIMI 2-3 distal runoff and normal (normal) normal. On an unknown date, Ejection fraction: 41% (Low) 41%. On an unknown date, Stenosis: 50% (normal) M/3: 50% stenosis. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Company Comment: This case concerns a 51-years-old male patient with relevant medical Hypertension, who experienced the unexpected events Diarrhoea, Decreased appetite and pulmonary embolism after unspecified days, Dyspnoea, chest tightness 1 month 13 days, Acute myocardial infarction 1 month 15 days after the first dose of Spikevax. The reporter did not provide causality assessment. The rechallenge was not applicable. The benefit-risk relationship of Spikevax in not affected by this report.; Sender''s Comments: This case concerns a 51-years-old male patient with relevant medical Hypertension, who experienced the unexpected events Diarrhoea, Decreased appetite and pulmonary embolism after unspecified days, Dyspnoea, chest tightness 1 month 13 days, Acute myocardial infarction 1 month 15 days after the first dose of Spikevax. The reporter did not provide causality assessment. The rechallenge was not applicable. The benefit-risk relationship of Spikevax in not affected by this report.


VAERS ID: 1730013 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-08-25
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Facial paralysis, Facial paresis, Skin wrinkling, Vertigo
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Vestibular disorders (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN [ACETYLSALICYLIC ACID]
Current Illness: Asthma; Diabetes mellitus; GERD; Hypertension (long-term aspirin use)
Preexisting Conditions: Medical History/Concurrent Conditions: Alcoholism; Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: vertigo; dispersing of right forehead wrinkle; facial muscle weakness; Facial palsy; dizziness; This regulatory authority case was reported by a pharmacist and describes the occurrence of FACIAL PARESIS (facial muscle weakness), VERTIGO (vertigo), DIZZINESS (dizziness), SKIN WRINKLING (dispersing of right forehead wrinkle) and FACIAL PARALYSIS (Facial palsy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939599-CDC) for COVID-19 vaccination. The patient''s past medical history included GERD since an unknown date, Smoker and Alcoholism. Concurrent medical conditions included Diabetes mellitus, Hypertension (long-term aspirin use) and Asthma. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Hypertension. On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 25-Aug-2021, the patient experienced DIZZINESS (dizziness) (seriousness criterion medically significant) and FACIAL PARALYSIS (Facial palsy) (seriousness criterion medically significant). On 28-Aug-2021, the patient experienced FACIAL PARESIS (facial muscle weakness) (seriousness criterion medically significant). On an unknown date, the patient experienced VERTIGO (vertigo) (seriousness criterion medically significant) and SKIN WRINKLING (dispersing of right forehead wrinkle) (seriousness criterion medically significant). At the time of the report, FACIAL PARESIS (facial muscle weakness), VERTIGO (vertigo), DIZZINESS (dizziness), SKIN WRINKLING (dispersing of right forehead wrinkle) and FACIAL PARALYSIS (Facial palsy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment information were reported. Patient''s age reported as 73.3. Reported that MP: grossly symmetric, gait: ok. the patient arranged for MRI of the brain on September 13 Company comment :This case concerns a 73 year-old, female with a history of DM, HTN (long-term aspirin use), asthma, GERD, smoker, Alcohol drinking; Allergy, who experienced the unexpected events (ALL seriousness criterion medically significant as RA) of FACIAL PARALYSIS (AESI), DIZZINESS,, FACIAL PARESIS, VERTIGO, SKIN WRINKLING. The event occurred approximately 40 days after the first dose of mRNA-1273 Moderna vaccine. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report; Sender''s Comments: This case concerns a 73 year-old, female with a history of DM, HTN (long-term aspirin use), asthma, GERD, smoker, Alcohol drinking; Allergy, who experienced the unexpected events (ALL seriousness criterion medically significant as RA) of FACIAL PARALYSIS (AESI), DIZZINESS,, FACIAL PARESIS, VERTIGO, SKIN WRINKLING. The event occurred approximately 40 days after the first dose of mRNA-1273 Moderna vaccine. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report


VAERS ID: 1730049 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-08-25
   Days after vaccination:47
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939600 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Gait disturbance, Haemoglobin, Haemoglobin decreased, Muscular weakness, Pallor
SMQs:, Rhabdomyolysis/myopathy (broad), Haematopoietic erythropenia (broad), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: hemoglobin; Result Unstructured Data: 6.2
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Hemoglobin decreased; dizziness; Weakness of limbs; walking without strength; pale face; This regulatory authority case was reported by an other and describes the occurrence of HAEMOGLOBIN DECREASED (Hemoglobin decreased), DIZZINESS (dizziness), MUSCULAR WEAKNESS (Weakness of limbs), GAIT DISTURBANCE (walking without strength) and PALLOR (pale face) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939600) for COVID-19 vaccination. No Medical History information was reported. On 09-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced HAEMOGLOBIN DECREASED (Hemoglobin decreased) (seriousness criterion medically significant), DIZZINESS (dizziness) (seriousness criterion medically significant), MUSCULAR WEAKNESS (Weakness of limbs) (seriousness criterion medically significant), GAIT DISTURBANCE (walking without strength) (seriousness criterion medically significant) and PALLOR (pale face) (seriousness criterion medically significant). The patient was treated with CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HAEMOGLOBIN DECREASED (Hemoglobin decreased), DIZZINESS (dizziness), MUSCULAR WEAKNESS (Weakness of limbs), GAIT DISTURBANCE (walking without strength) and PALLOR (pale face) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Aug-2021, Haemoglobin: 6.2 (Low) 6.2. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. concomitant medication information was not provided. Treatment medication information included blood products. Company Comment: This case concerns a 57-year-old, female subject, with no relevant medical history, who experienced the unexpected serious events of Haemoglobin decreased, Dizziness, Muscular weakness, Gait disturbance and Pallor approximately 47 days after the first dose of mRNA-1273 (COVID-19 Vaccine Moderna). The rechallenge was not applicable as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 (COVID-19 Vaccine Moderna) is not affected by this report.; Sender''s Comments: This case concerns a 57-year-old, female subject, with no relevant medical history, who experienced the unexpected serious events of Haemoglobin decreased, Dizziness, Muscular weakness, Gait disturbance and Pallor approximately 47 days after the first dose of mRNA-1273 (COVID-19 Vaccine Moderna). The rechallenge was not applicable as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 (COVID-19 Vaccine Moderna) is not affected by this report.


VAERS ID: 1730078 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-25
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Limb discomfort, Nausea, Peripheral swelling, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: dizziness; Syncope; Pain of limbs; Nausea; Vomiting; swollen and painful; This regulatory authority case was reported by a pharmacist and describes the occurrence of SYNCOPE (Syncope) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included No adverse event. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant), LIMB DISCOMFORT (Pain of limbs), NAUSEA (Nausea), VOMITING (Vomiting) and PERIPHERAL SWELLING (swollen and painful). On an unknown date, the patient experienced DIZZINESS (dizziness). At the time of the report, SYNCOPE (Syncope), LIMB DISCOMFORT (Pain of limbs), NAUSEA (Nausea), VOMITING (Vomiting), PERIPHERAL SWELLING (swollen and painful) and DIZZINESS (dizziness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Painkillers and antiemetic were prescribed to the patient. Company Comment: This case concerns a 55-year-old, female patient with no relevant medical history, who experienced the unexpected events of Syncope. The events occurred approximately 1 day after the first dose of moderna covid -19 vaccine. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 55-year-old, female patient with no relevant medical history, who experienced the unexpected events of Syncope. The events occurred approximately 1 day after the first dose of moderna covid -19 vaccine. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1732445 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2832 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Headache, Insomnia, Pyrexia, Syncope, Vertigo
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Insect sting allergy (bee sting)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Body temperature; Result Unstructured Data: Test Result:37.3 Centigrade
CDC Split Type: CZPFIZER INC202101228453

Write-up: Fainting (2x); Difficulty sleeping (impossibility to fall asleep); Headache; Strong spinning of the head; Subfebrilie 37,3?C; This is a spontaneous report from a contactable consumer or other non hcp (patient) downloaded from the regulatory authority-WEB, regulatory authority number CZ-CZSUKL-21010502. A 22-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 24Aug2021 (Batch/Lot Number: FF2832) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing allergy to arthropod sting bee sting. The patient received the 1st dose of Comirnaty for COVID-19 immunisation on Jul2021 (Batch/Lot Number: Unknown). The patient''s concomitant medications were not reported. The patient experienced fainting, difficulty sleeping, headache, strong spinning of the head, subfebrilie 37,3?c on 25Aug2021. Therapeutic measures were taken as a result of fainting, difficulty sleeping, headache, strong spinning of the head and subfebrilie 37,3?c. The next morning after vaccination (on 25Aug) the patient complained about headache and sleeping difficulty (he could not fall asleep). Subsequently, the patient fell from a chair to the floor, where he lay helpless. After a short period of fainting - open eyes without reaction, consciousness was acquired (with the assistance of parents). The patient complained of a strong "spinning" of the head, which receded slightly while lying down. Subsequently, about 1 and a half hours after the first fainting, the collapse occurred again during a toilet. The temperature was 37.3 ?C. Ibalgin was administered after consultation with a general practitioner. The collapse did not happen again. The headache subsided the second day. The event fainting was reported as life-threatening. Outcome of events fainting, Difficulty sleeping, Head spinning and Subfebrile was recovered on unknown date, of headache was recovered on 27Aug2021. Event faint was reported as life-threatening. No follow-up attempts possible. No further information expected.


VAERS ID: 1732682 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-08-25
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214010 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood alkaline phosphatase, Blood bilirubin, Blood calcium, Blood chloride, Blood cholesterol, Blood creatinine, Blood glucose, Blood lactate dehydrogenase, Blood phosphorus, Blood potassium, Blood sodium, Blood thyroid stimulating hormone, Blood urea, Blood uric acid, C-reactive protein, Chest X-ray, Chest pain, Echocardiogram, Electrocardiogram, Gamma-glutamyltransferase, Glomerular filtration rate, Haemoglobin, High density lipoprotein, Low density lipoprotein, Malaise, Myocarditis, Odynophagia, Platelet count, Protein total, Pyrexia, Rhinorrhoea, White blood cell count
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210828; Test Name: CXR; Result Unstructured Data: Chest X-ray: Normal CTI, no infiltrates, no pleural effusion.; Test Date: 20210828; Test Name: Echocardiogram; Result Unstructured Data: Echocardiogram: LV not dilated (EDD 51 mm, ESD 35 mm) or hypertrophic (IVS 9 mm, PW 9 mm) with preserved global EF (Teicholz estimate 58%); no segmental contractility disorders. Normal transmitral filling pattern. Normal LA (35 mm). Normal RV. Normal pulmonary valve. Normal tricuspid valve. Normal aortic valve. Normal mitral valve. Normal-size aorta. No pericardial effusion.; Test Date: 20210828; Test Name: ECG; Result Unstructured Data: Echocardiogram: LV not dilated (EDD 51 mm, ESD 35 mm) or hypertrophic (IVS 9 mm, PW 9 mm) with preserved global EF (Teicholz estimate 58%); no segmental contractility disorders. Normal transmitral filling pattern. Normal LA (35 mm). Normal RV. Normal pulmonary valve. Normal tricuspid valve. Normal aortic valve. Normal mitral valve. Normal-size aorta. No pericardial effusion.; Test Date: 20210828; Test Name: Hb; Result Unstructured Data: 14.7; Test Date: 20210828; Test Name: Leukocytes; Result Unstructured Data: 7400; Test Date: 20210828; Test Name: Platelets; Result Unstructured Data: 218000; Test Date: 20210828; Test Name: Creatinine; Result Unstructured Data: 0.8; Test Date: 20210828; Test Name: GF; Result Unstructured Data: 90; Test Date: 20210828; Test Name: Glucose; Result Unstructured Data: 92; Test Date: 20210828; Test Name: Urea; Result Unstructured Data: 41; Test Date: 20210828; Test Name: Sodium; Result Unstructured Data: 141; Test Date: 20210828; Test Name: Potassium; Result Unstructured Data: 4.8; Test Date: 20210828; Test Name: Chloride; Result Unstructured Data: 103; Test Date: 20210828; Test Name: CRP; Result Unstructured Data: 4.6; Test Date: 20210828; Test Name: Bilirubin; Result Unstructured Data: 0.2; Test Date: 20210828; Test Name: GGT; Result Unstructured Data: 26; Test Date: 20210828; Test Name: ALP; Result Unstructured Data: 122; Test Date: 20210828; Test Name: LDH; Result Unstructured Data: 266; Test Date: 20210828; Test Name: Uric acid; Result Unstructured Data: 5.4; Test Date: 20210828; Test Name: Calcium; Result Unstructured Data: 9.7; Test Date: 20210828; Test Name: Phosphate; Result Unstructured Data: 5.3; Test Date: 20210828; Test Name: Protein; Result Unstructured Data: 7.0; Test Date: 20210828; Test Name: Total cholesterol; Result Unstructured Data: 137; Test Date: 20210828; Test Name: HDL; Result Unstructured Data: 32; Test Date: 20210828; Test Name: LDL; Result Unstructured Data: 87; Test Date: 20210828; Test Name: TSH; Result Unstructured Data: 1.28
CDC Split Type: ESMODERNATX, INC.MOD20213

Write-up: Thoracic pain; Myopericarditis; Rhinorrhea; General malaise; Fever; Odynophagia; This case was received via a regulatory authority (Reference number: ES-AEMPS-994726) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of CHEST PAIN (Thoracic pain) and MYOCARDITIS (Myopericarditis) in an 18-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 214010 and 3005695) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 24-Aug-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced ODYNOPHAGIA (Odynophagia), MALAISE (General malaise) and PYREXIA (Fever). On 27-Aug-2021, the patient experienced CHEST PAIN (Thoracic pain) (seriousness criterion hospitalization), MYOCARDITIS (Myopericarditis) (seriousness criteria hospitalization and medically significant) and RHINORRHOEA (Rhinorrhea). In August 2021, ODYNOPHAGIA (Odynophagia), RHINORRHOEA (Rhinorrhea) and PYREXIA (Fever) had resolved. On 31-Aug-2021, CHEST PAIN (Thoracic pain), MYOCARDITIS (Myopericarditis) and MALAISE (General malaise) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2021, Blood alkaline phosphatase: 122 122. On 28-Aug-2021, Blood bilirubin: 0.2 0.2. On 28-Aug-2021, Blood calcium: 9.7 9.7. On 28-Aug-2021, Blood chloride: 103 103. On 28-Aug-2021, Blood cholesterol: 137 137. On 28-Aug-2021, Blood creatinine: 0.8 0.8. On 28-Aug-2021, Blood glucose: 92 92. On 28-Aug-2021, Blood lactate dehydrogenase: 266 266. On 28-Aug-2021, Blood phosphorus: 5.3 5.3. On 28-Aug-2021, Blood potassium: 4.8 4.8. On 28-Aug-2021, Blood sodium: 141 141. On 28-Aug-2021, Blood thyroid stimulating hormone: 1.28 1.28. On 28-Aug-2021, Blood urea: 41 41. On 28-Aug-2021, Blood uric acid: 5.4 5.4. On 28-Aug-2021, C-reactive protein: 4.6 4.6. On 28-Aug-2021, Chest X-ray: normal (normal) Chest X-ray: Normal CTI, no infiltrates, no pleural effusion.. On 28-Aug-2021, Echocardiogram: normal (normal) Echocardiogram: LV not dilated (EDD 51 mm, ESD 35 mm) or hypertrophic (IVS 9 mm, PW 9 mm) with preserved global EF (Teicholz estimate 58%); no segmental contractility disorders. Normal transmitral filling pattern. Normal LA (35 mm). Normal RV. Normal pulmonary valve. Normal tricuspid valve. Normal aortic valve. Normal mitral valve. Normal-size aorta. No pericardial effusion.. On 28-Aug-2021, Electrocardiogram: normal (normal) Echocardiogram: LV not dilated (EDD 51 mm, ESD 35 mm) or hypertrophic (IVS 9 mm, PW 9 mm) with preserved global EF (Teicholz estimate 58%); no segmental contractility disorders. Normal transmitral filling pattern. Normal LA (35 mm). Normal RV. Normal pulmonary valve. Normal tricuspid valve. Normal aortic valve. Normal mitral valve. Normal-size aorta. No pericardial effusion.. On 28-Aug-2021, Gamma-glutamyltransferase: 26 26. On 28-Aug-2021, Glomerular filtration rate: 90 90. On 28-Aug-2021, Haemoglobin: 14.7 14.7. On 28-Aug-2021, High density lipoprotein: 32 32. On 28-Aug-2021, Low density lipoprotein: 87 87. On 28-Aug-2021, Platelet count: 218000 218000. On 28-Aug-2021, Protein total: 7.0 7.0. On 28-Aug-2021, White blood cell count: 7400 7400. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 24-Aug-2021. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was Drug withdrawn. No concomitant medication details were reported. No treatment medication details was reported. This case concerns an 18-year-old, male patient with no relevant medical history, who experienced the unexpected event of chest pain and expected event of myocarditis. The events occurred approximately 3 days after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as events occurred after second dose and no further dosing was reported or planned, based on information provided. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. Chest pain could be symptom of myocarditis. Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Translation received on 20-SEP-2021 and lab test result were updated.; Sender''s Comments: This case concerns an 18-year-old, male patient with no relevant medical history, who experienced the unexpected event of chest pain and expected event of myocarditis. The events occurred approximately 3 days after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as events occurred after second dose and no further dosing was reported or planned, based on information provided. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. Chest pain could be symptom of myocarditis.


VAERS ID: 1732729 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-25
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101193486

Write-up: Pericarditis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB with regulatory authority report number FR-AFSSAPS-BX20217968. A 26-year-old male patient received the second dose of BNT162b2 (COMIRNATY, solution for injection, lot number FF2834), intramuscular on 21Aug2021 as dose 2, single for covid-19 immunisation. Medical history included obesity. The patient has no covid-19 history. Reaction to dose 1 of product with unknown manufacturer/trade name was not specified. The patient''s concomitant medications were not reported. On day 4, 25Aug2021, the patient experienced pericarditis with consultation (physician office visit), without further information. Evolution/Outcome of the event: Under recovery (recovering). RA: Imputation made without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1733418 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8206 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Rhinitis allergic (details unknown); Urticaria (had a history of urticaria)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101113217

Write-up: Wheals/Urticaria/Generalised urticaria on Face, upper limbs, lower limbs, trunk, buttocks; Generalised itching; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21124949. A 35-year and 2-month-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: FE8206, Expiration date: 31Oct2021), via an unspecified route of administration on 25Aug2021 09:00 (the day of vaccination), (at the age of 35-year and 2-month-old), as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history includes: history of previous allergies to specific products or conditions indicative of an allergy included Urticaria. The patient also had a history of Rhinitis allergic (details unknown) and had a history of urticaria. The patient did not take (or had readily available) specific medication related to the previous history of allergies. There were no prior vaccinations within four weeks prior to the first administration date of the suspect vaccine. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient''s concomitant medications were not reported. On 25Aug2021 at 20:00 (11 hours after the vaccination), the patient experienced wheals and generalised itching. The course of the event was as follows: After received the vaccine, around 20:00, the patient experienced Generalised itching with Wheals/ Generalised on face, upper limbs, trunk, low limbs, abscess, back, buttocks etc. It was added that After the vaccination, about 11 hours later, symptoms appeared and gradually spread to the whole body. Even 24 hours after the vaccination, symptoms remained. In the outpatient department, the patient was treated with Corticosteroids DIV and oral Antihistamine administration (as reported). After then, on the next day, Urticaria almost disappeared. There was no relevant test taken. There was no multiorgan involvement. There was no Respiratory, Cardiovascular, Gastrointestinal or any other symptoms/signs. The event required initiation of new medication/other treatment/procedure, which included that the patient was administered of Corticosteroids DIV and oral Antihistamine (also reported as Corticosteroids, Antihistamine and IV fluids). Outcome of the event urticaria was recovered for the other event was recovering. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporter classified the event as non-serious. Event required visit to Physician office. Follow up attempts are completed. Further information is not expected. Follow-up (10Sep2021): New information received the same contactable physician includes: additional relevant medical history, treatment details and clinical course details. Case upgraded to serious. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1733525 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8838 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anxiety disorder, Asthenia, Body temperature, Chills, Dizziness, Eye pain, Fatigue, Headache, Movement disorder, Pain, Pyrexia, Sensitive skin, Speech disorder, Vaccination site movement impairment, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: body temperature; Result Unstructured Data: Test Result:greater than or equal to 38 centigrade Centigrade; Comments: 1hr. after vaccination
CDC Split Type: MXPFIZER INC202101190304

Write-up: diagnosed as remitted anxiety disorder.; Fever greater than or equal to 38 centigrade; Headache; Asthenia; Fatigue; Chills; Pain; Sensitive skin; Dizziness; retroocular pain on the left side; pain in the left arm; difficulty in movement of the left arm and leg on the same side; difficulty in movement of the left arm and leg on the same side; difficulty speaking; This is a Spontaneous report from a non-contactable other health professional. This is a report received from the regulatory authority via email. Regulatory authority report number is 17545-9. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: FF8838) intramuscularly, administered into left arm on 25Aug2021 (at the age of 52-year-old) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient was not pregnant. On 25Aug2021 1hr. after vaccination patient experienced fever greater than or equal to 38 centigrade, headache, asthenia, fatigue, chills, pain, sensitive skin, dizziness, retroocular pain on the left side, pain in the left arm, difficulty in movement of the left arm and leg on the same side and difficulty speaking. On an unspecified date patient was diagnosed as remitted anxiety disorder. The events required emergency room visit and were reported as serious since it caused hospitalization on an unspecified date. Patient was treated with Paracetamol tablet 650 mg every 12 hours and sodium chloride for the events fever greater than or equal to 38 centigrade, headache, asthenia, fatigue, chills, pain, sensitive skin, dizziness, retroocular pain on the left side, pain in the left arm, difficulty in movement of the left arm and leg on the same side and difficulty speaking. Outcome of event remitted anxiety disorder was unknown while the outcome of all other events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1733604 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chest discomfort, Dyspnoea, Hypertension, Lymphadenopathy, Tachycardia, Urticaria, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202101204997

Write-up: swollen lymph node (neck); joint pain; chest discomfort; Dyspnoea; hypertension; Tachycardia; Urticaria; wheezing; This is a spontaneous report from a contactable consumer from the regulatory authority report number AEFI-A-012651. A 37-year-old male patient reported that received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 25Aug2021 (Batch/Lot number was not reported) (at the age of 37-years-old ) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 25Aug2021 at 11:30 the patient experienced Chest discomfort,Dyspnoea, Hypertension, Tachycardia, Urticaria and Wheezing. In addition the patient reported swollen lymph node (neck), left side of the body and joint pain on an unknown date. The events required hospitalisation. The outcome was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1733605 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-25
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident
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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202101204998

Write-up: Cerebrovascular accident / stroke; This is a spontaneous report from a contactable consumer . Regulatory authority report number is AEFI-A-013127. A 64-years-old male patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration, on 21Aug2021, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On 25Aug2021 at 13:30, the patient experienced cerebrovascular accident. Hospitalization required. Clinical outcome of the adverse event was recovering at time of this report. Reporter''s description of AEFI: had stroke 4 days later, on 25Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1736380 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-25
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Laboratory test, Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: Lab test; Result Unstructured Data: abnormal.
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was initially received via Regulatory Authority (Reference number: IT-MINISAL02-780825) on 16-Sep-2021. The most recent information was received on 16-Sep-2021 and was forwarded to Moderna on 20-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Moderna il 1/8/2021) in a 23-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 01-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 25-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced MYOCARDITIS Moderna il 1/8/2021) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS ( Moderna il 1/8/2021) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Aug-2021, Laboratory test: abnormal (abnormal) abnormal. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment was reported. Company comment- This case concerns a 23-year-old, male patient with no relevant medical history, who experienced the expected event of Myocarditis. The event occurred approximately 25 days after the first dose of Spikevax which led to hospitalization of patient, but is now recovering. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Translation received on 20-sep-2021 dose information updated from unknown to dose 1; Reporter''s Comments: 02/09/2021 RLFV: Sender''s Comments: This case concerns a 23-year-old, male patient with no relevant medical history, who experienced the expected event of Myocarditis. The event occurred approximately 25 days after the first dose of Spikevax which led to hospitalization of patient, but is now recovering. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1736410 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004498 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angiogram, C-reactive protein, COVID-19 immunisation, Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram, Influenza like illness, Magnetic resonance imaging heart, Myocarditis, Nausea, Troponin I
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NASONEX
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210829; Test Name: Angiography; Result Unstructured Data: Open coronary arteries; Test Date: 20210827; Test Name: C-reactive protein; Result Unstructured Data: Slightly elevated.; Test Date: 20210827; Test Name: Echocardiography; Result Unstructured Data: Possible hypokinesia.; Test Date: 20210827; Test Name: ECG; Result Unstructured Data: Some changes in the ST-segment observed.; Test Date: 20210830; Test Name: Magnetic resonance imaging heart; Result Unstructured Data: Findings compatible with myocarditis.; Test Date: 20210827; Test Name: Troponin I; Result Unstructured Data: Elevated.
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: Dyspnea; Chest Pain; Nausea; Myocarditis; Revaccination with different COVID-19 vaccine; Flu-like symptoms; This case was received via regulatory authority on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of DYSPNOEA (Dyspnea), CHEST PAIN (Chest Pain), NAUSEA (Nausea) and MYOCARDITIS (Myocarditis) in a 42-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004498) for Vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Vaccination: Comirnaty. Concomitant products included MOMETASONE FUROATE (NASONEX) for Allergy. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). On 27-Aug-2021, the patient experienced DYSPNOEA (Dyspnea) (seriousness criterion hospitalization), CHEST PAIN (Chest Pain) (seriousness criterion hospitalization), NAUSEA (Nausea) (seriousness criterion hospitalization) and MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). At the time of the report, DYSPNOEA (Dyspnea), CHEST PAIN (Chest Pain), NAUSEA (Nausea), MYOCARDITIS (Myocarditis) and INFLUENZA LIKE ILLNESS (Flu-like symptoms) was resolving and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, C-reactive protein: slightly elevated. (High) Slightly elevated.. On 27-Aug-2021, Echocardiogram: possible hypokinesia. (abnormal) Possible hypokinesia.. On 27-Aug-2021, Electrocardiogram: changes in the st-segment (abnormal) Some changes in the ST-segment observed.. On 27-Aug-2021, Troponin I: elevated (High) Elevated.. On 29-Aug-2021, Angiogram: open coronary arteries (abnormal) Open coronary arteries. On 30-Aug-2021, Magnetic resonance imaging heart: abnormal (abnormal) Findings compatible with myocarditis.. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered DYSPNOEA (Dyspnea), CHEST PAIN (Chest Pain), MYOCARDITIS (Myocarditis) and INFLUENZA LIKE ILLNESS (Flu-like symptoms) to be possibly related. No further causality assessments were provided for NAUSEA (Nausea) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). No treatment medication information provided by the reporter. Company comment: This case concerns a 42-year-old male patient with no previous relevant medical history, who experienced the expected event of Myocarditis and the unexpected events of Dyspnoea, Chest pain and Nausea after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The onset of the events occurred approximately 4 days after the Spikevax, second dose number. Additionally, Revaccination with different COVID-19 vaccine was reported. The rechallenge was not applicable since only one dose of Spikevax was given. The event was considered related to the product per the reporter''s assessment. The event Myocarditis is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Spikevax vaccine is not affected by this report Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translated document received on 23-SEP-2021 included no new information.; Sender''s Comments: This case concerns a 42-year-old male patient with no previous relevant medical history, who experienced the expected event of Myocarditis and the unexpected events of Dyspnoea, Chest pain and Nausea after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The onset of the events occurred approximately 4 days after the Spikevax, second dose number. Additionally, Revaccination with different COVID-19 vaccine was reported. The rechallenge was not applicable since only one dose of Spikevax was given. The event was considered related to the product per the reporter''s assessment. The event Myocarditis is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Spikevax vaccine is not affected by this report


VAERS ID: 1737854 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute polyneuropathy, Facial paralysis, Quadriparesis
SMQs:, Peripheral neuropathy (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210944535

Write-up: Acute polyradiculoneuritis; Tetraparesis; Facial palsy; This spontaneous report received from a consumer via a Regulatory Authority (DE-PEI-202100194209) on 23-SEP-2021 and concerned a 57 year old male of unknown race and ethnicity. The patient''s weight was 90 kilograms, and height was 186 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) 1 dosage forms,1 total administered on 18-AUG-2021 for an unspecified indication. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 25-AUG-2021, the patient experienced acute polyradiculoneuritis, tetraparesis, facial palsy and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from acute polyradiculoneuritis, tetraparesis, and facial palsy. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1737951 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCTN4 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Cerebrovascular accident, Chest pain, Electrocardiogram, Full blood count, Hypoaesthesia, Paraesthesia, Renal function test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Peripheral neuropathy (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to chemicals; Asthma; COVID-19; Dermatitis contact; Pneumonia; Pollen allergy
Allergies:
Diagnostic Lab Data: Test Name: blood count; Result Unstructured Data: Test Result:not a heart muscle inflammation; Test Name: electrocardiogram; Result Unstructured Data: Test Result:not a heart muscle inflammation; Test Date: 20210913; Test Name: test of the kidney values; Result Unstructured Data: Test Result:unknown results
CDC Split Type: DEPFIZER INC202101193993

Write-up: Pressing pain on the chest, independent of movement, partly dependent on performance, better when lying down; Possible stroke according to emergency report; Acute renal failure.; Left side of the patient''s body (leg, arm, above all, left half of the face and left side of the head) suddenly started to feel tingly and a little numb; Left side of the patient''s body (leg, arm, above all, left half of the face and left side of the head) suddenly started to feel tingly and a little numb; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority report number: DE-PEI-CADR2021175314. A 27-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Lot Number: SCTN4; Expiration date was not reported) on 23Aug2021 as dose 2, 0.3 ml, single, with route of administration unspecified, for COVID-19 immunization. Medical history included pollen allergy; hair dye allergy; contact allergy; and COVID-19 from Apr2021 to Apr2021. There were no concomitant medications. The patient had previously received the first dose of BNT162B2 (COMIRNATY, Lot number and expiration date were not reported) on an unspecified date for COVID-19 immunization. On 25Aug2021, the patient had pressing pain on the chest, independent of movement, partly dependent on performance, better when lying down, and was a possible stroke according to emergency report. The events, pressing pain on the chest and possible stroke, had led to an emergency room visit, and were reported to be serious (medically significant). The pressure on the chest was, according to the blood count and electrocardiogram on an unspecified date in 2021, not a heart muscle inflammation, and could not be diagnosed. The pain did not depend on movements but it was performance-related and less when lying down than when sitting up or standing. On an unspecified date in 2021, while sitting in the car as a front passenger, the left side of the patient''s body (leg, arm, above all, left half of the face and left side of the head) suddenly started to feel tingly and a little numb; assessed as serious (medically significant). Also on 25Aug2021, the patient had acute renal failure; assessed as serious (medically significant). A new test of the kidney values was done on 13Sep2021. The outcome of the events was not recovered. The reporter''s assessment on the causal relationship between the suspect vaccine and the events was unclassifiable.


VAERS ID: 1738093 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-25
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4442 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Antidepressant drug level, Barbiturates, Benzodiazepine drug level, Blood cannabinoids, Blood creatine phosphokinase, Body temperature, Cytomegalovirus test, Epstein-Barr virus test, Hepatic cytolysis, Investigation, Laboratory test, Opiates, Rhabdomyolysis, Skeletal muscle enzymes, Ultrasound scan
SMQs:, Rhabdomyolysis/myopathy (narrow), Hepatitis, non-infectious (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Neuroleptic malignant 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Tricyclic antidepressants; Test Result: Negative ; Comments: Tricyclic antidepressants: Negative; Test Name: Barbiturics; Test Result: Negative ; Test Name: Benzodiazepines; Test Result: Negative ; Comments: Benzodiazepines: Negative; Test Name: Tetrahydrocannabinol-Marijuana; Test Result: Negative ; Comments: Tetrahydrocannabinol-Marijuana: Negative; Test Date: 20210826; Test Name: Creatine kinase; Result Unstructured Data: Test Result:36742 IU/l; Comments: (24 - 195); Test Date: 20210828; Test Name: Creatine kinase; Result Unstructured Data: Test Result:47182 IU/l; Comments: (24-195); Test Date: 20210825; Test Name: fever; Result Unstructured Data: Test Result:38.4; Test Date: 20210826; Test Name: fever; Result Unstructured Data: Test Result:38.4; Test Name: Cytomegalovirus; Test Result: Negative ; Test Name: Epstein barr; Test Result: Negative ; Test Name: Ecstasy; Test Result: Negative ; Comments: Ecstasy: Negative; Test Name: Methadone; Test Result: Negative ; Comments: Methadone: Negative; Test Name: Phencyclidine; Test Result: Negative ; Comments: Phencyclidine: Negative; Test Name: analytical analysis; Result Unstructured Data: Test Result:rhabdomyolysis has decreased; Comments: rhabdomyolysis has decreased, hepatic cytolysis without cholestasis is presented without objectifying alarm data in analytical analysis; Test Name: Opiates; Test Result: Negative ; Test Name: Muscle enzymes; Result Unstructured Data: Test Result:of 47000 and at high around 1000; Comments: It has had a peak of muscle enzymes of 47000 and at high around 1000; Test Date: 20210827; Test Name: Muscle ultrasound; Result Unstructured Data: Test Result:ultrasound changes; Comments: ultrasound changes are compatible with the clinical diagnosis of rhabdomyolysis
CDC Split Type: ESPFIZER INC202101193679

Write-up: Rhabdomyolysis; hepatic cytolysis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number ES-AEMPS-989173. A 26-year-old male patient received BNT162B2 (Batch/Lot Number: FG4442), via intramuscular route on 05Aug2021 as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 25Aug2021, the patient experienced rhabdomyolysis. Patient admitted on 26Aug2021, reported fever since last night of 38.4 without odynophagia or headache or voiding syndrome, no ageusia or dyspnea, no diarrhea, refered pain in upper limbs to palpation of muscle masses and mobilization, denied dark urine and intense exercise denied intake of toxics. Muscle ultrasound soft parts MSD was performed, ultrasound changes were compatible with the clinical diagnosis of rhabdomyolysis. During the stay on the floor in hospital, the patient evolved favorably from the clinical point of view, had remained hemodynamically stable, afebrile, and pain-free. It had a peak of muscle enzymes of 47000 and at high around 1000. In addition, in the analytical follow-up, as rhabdomyolysis had decreased, hepatic cytolysis without cholestasis was presented without objectifying alarm data in analytical analysis on an unknown date. The patient underwent lab tests and procedures which included tricyclic antidepressants: negative on an unknown date, barbiturates: negative on an unknown date, benzodiazepine: negative on an unknown date, Tetrahydrocannabinol-Marijuana: negative on an unknown date, creatine phosphokinase: 36742 iu/l on 26Aug2021 (24 - 195) , creatine phosphokinase: 47182 iu/l on 28Aug2021 (24-195) , body temperature: 38.4 on 25Aug2021, body temperature: 38.4 on 26Aug2021, cytomegalovirus test: negative on an unknown date, epstein-barr test: negative on an unknown date, Ecstasy: Negative on an unknown date, Methadone: Negative on an unknown date, Phencyclidine: Negative on an unknown date, analytical analysis: rhabdomyolysis had decreased, hepatic cytolysis without cholestasis is presented without objectifying alarm data in analytical analysis on an unknown date, opiates: negative on an unknown date and Muscle ultrasound: ultrasound changes are compatible with the clinical diagnosis of rhabdomyolysis on 28Aug2021. Main diagnosis was reported as idiopathic rhabdomyolysis vs secondary to post-vaccination adverse reaction. The outcome was recovered for rhabdomyolysis on 02Aep2021 and unknown for hepatic cytolysis. No follow-up attempts are possible. No further information is expected.?


VAERS ID: 1738548 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005285 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza like illness, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

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

Write-up: Embolism pulmonary; Influenza like illness; This case was received (Reference number: FR-AFSSAPS-PO20214752) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Embolism pulmonary) and INFLUENZA LIKE ILLNESS (Influenza like illness) in a 47-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005285) for COVID-19 vaccination. No Medical History information was reported. On 24-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) at an unspecified dose. On 25-Aug-2021, the patient experienced PULMONARY EMBOLISM (Embolism pulmonary) (seriousness criteria hospitalization and medically significant) and INFLUENZA LIKE ILLNESS (Influenza like illness) (seriousness criterion hospitalization). At the time of the report, PULMONARY EMBOLISM (Embolism pulmonary) and INFLUENZA LIKE ILLNESS (Influenza like illness) was resolving. The action taken with mRNA-1273 (Spikevax) (Unknown Route) and mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided. Company comment: This case concerns a 47-year-old female patient with no relevant medical history, who experienced the unexpected events of Pulmonary embolism and Influenza like illness .The events occurred two days after administration unknown dose of Spikevax. . The rechallenge was unknown as there''s no information available about the dose number. The benefit-risk relationship of Spikevax is not affected by this report.Very limited information regarding these events has been provided at this time.; Sender''s Comments: This case concerns a 47-year-old female patient with no relevant medical history, who experienced the unexpected events of Pulmonary embolism and Influenza like illness .The events occurred two days after administration unknown dose of Spikevax. The rechallenge was unknown as there''s no information available about the dose number. The benefit-risk relationship of Spikevax is not affected by this report. Very limited information regarding these events has been provided at this time.


VAERS ID: 1738681 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Foetal hypokinesia, Foetal monitoring, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal 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: Pregnancy (No medical problems - very low risk pregnancy.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: Fetal monitoring; Result Unstructured Data: Test Result:heartbeat was fine; Comments: the heartbeat was fine and there were sufficient movements according to their monitoring system.
CDC Split Type: GBPFIZER INC202101205490

Write-up: Fetal movements decreased; pregnant and had the vaccine at 32 weeks; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-ADR 25931297, Safety Report Unique Identifier GB-MHRA-ADR 25931297. A female patient of an unspecified age, pregnant at 32 weeks, received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, lot FE3380), via an unspecified route of administration on 25Aug2021 as dose 1, single for COVID-19 immunisation. Medical history included ongoing pregnancy no medical problems very low risk pregnancy. The patient''s concomitant medications were not reported. On 25Aug2021, the fetal movements decreased for a period of 36 hours after the vaccine and it was very different -the baby was very lethargic and didn''t move around much or vigorously at all. She went to the hospital for fetal monitoring on the evening of 26Aug2021 and the heartbeat was fine and there were sufficient movements according to their monitoring system. On 27Aug2021, the movements started picking up again and went back to the normal pattern. The event was reported as serious medically significant. The outcome of event was recovered on 27Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1738800 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-25
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Diarrhoea, Dizziness, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (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: GBPFIZER INC202101211432

Write-up: Diarrhea; Weakness; Dizziness; Nausea; Headache; This is a spontaneous report from a contactable Consumer or other non-health care professional received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109141252029330-EVGY5. Safety Report Unique Identifier GB-MHRA-ADR 25938622. A 24-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number unknown) via an unspecified route of administration on 21Aug2021 as dose 2, single for COVID-19 immunization. Previously patient received first dose of Historical Vaccine BNT162B2 as dose 1, single on an unspecified date for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No previous illness or medicine taken before incident Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test, Patient was not currently breastfeeding. The patient experienced dizziness, nausea, headache, weakness on 25Aug2021 and diarrhea on 26Aug2021. All the events were medically significant. It was reported that Symptoms started late in the evening four days after second jab was given. Most symptoms lasted one whole day and were treated with Aspirin. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Therapeutic measures were taken as a result of adverse events. The outcome of the events dizziness, nausea, headache recovered on 27Aug2021, diarrhea recovered on 03Sep2021 and the event weakness recovered on 29Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1739109 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Arthralgia, Asthenia, Dehydration, Diarrhoea, Headache, Myalgia, Pyrexia, Uterine haemorrhage, Vertigo, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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: HRPFIZER INC202101195489

Write-up: Uterine bleeding; Diarrhea; Vomiting; Weakness; Pyrexia; Vertigo; pain in the intestines and stomach; Muscle pain; Headache; Dehydration; Joint pain; This is a serious spontaneous report from a contactable consumer downloaded from the Regulatory Authority HR-HALMED-300050649. A 25-years-old female patient received BNT162B2, intramuscular in 2021 (Batch/Lot Number: unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 25Aug2021, the patient experienced uterine bleeding (medically significant), diarrhea, vomiting, weakness, pyrexia, vertigo, pain in the intestines and stomach, muscle pain, headache, dehydration, joint pain. 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: 1739111 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-08-25
   Days after vaccination:161
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Fatigue, Laboratory test, SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: Cycle Threshold for E gene; Result Unstructured Data: Test Result:17.8; Comments: 17.8; Test Date: 20210827; Test Name: Cycle Threshold for SarsCoV2 gen; Result Unstructured Data: Test Result:19.7; Comments: 19.7; Test Date: 20210827; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: HRPFIZER INC202101195551

Write-up: sars-cov-2 test positive; Vaccination failure; Dry cough; Difficulty breathing; Fatigue; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB HR-HALMED-300050678 A 63-years-old male patient received bnt162b2 (COMIRNATY), first dose on 23Feb2021 (Lot Number: EJ 6790), second dose on 17Mar2021 (Lot Number: ET3620), both intramuscularly as 0.3 mL single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced vaccination failure on 26Aug2021, sars-cov-2 test positive on 27Aug2021; dry cough, difficulty breathing and fatigue on 25Aug2021. The patient was hospitalized for the events from 27Aug2021. The patient underwent lab tests and procedures on 27Aug2021 which included positive PCR (polymerase chain reaction) test on the same day, cycle threshold value for E gene 17.8, cycle threshold value for SarsCoV2 gene 19.7. Therapeutic measures were taken as a result of the events including at the hospital on oxygen. The outcome of the events was recovering. As of 14Sep2021,investigation results from Complaint Team provided from division Regulatory Authority includes: A sample was not sent to the Lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID5757372 (see File attachment in this investigation record.The complaint for adverse event/LOE of "PFIZERBIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot 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. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. A sample was not sent to the Lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5824348 (see File attachment in this investigation record) The complaint for adverse event/LOE of "PFIZERBIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot ET3620. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1739273 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005294 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Q fever
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad)

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

Write-up: This case was received via regulatory authority (Reference number: IT-MINISAL02-781874) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of Q FEVER in a 50-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005294) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter in total. On 25-Aug-2021, the patient experienced Q FEVER (seriousness criterion medically significant) and CHEST PAIN. On 26-Aug-2021, Q FEVER and CHEST PAIN had resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Event as reported by the primary source was changed to following administration of the first vaccine dose, the male patient has oppressive chest pain and fever Treatment information was not provided. Company Comment: This case concerns a 50 year-old female patient with no reported medical history who experienced the unexpected event of Q fever. The event occurred approximately 1 day after the first dose of mRNA-1273 (Spikevax). The rechallenge was not applicable as the event occurred after the first dose. The benefit-risk relationship of mRNA-1273 (Spikevax) is not affected by this report. Narrative text in the source document describes the patient as male, whereas additional data indicates the patient is female. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Significant follow up appended - Event Q fever added. On 17-Sep-2021: Translation received on 23-Sep-2021 included: Added dose number, event as reported by the primary source has changed and narrative updated.; Sender''s Comments: This case concerns a 50 year-old female patient with no reported medical history who experienced the unexpected event of Q fever. The event occurred approximately 1 day after the first dose of mRNA-1273 (Spikevax). The rechallenge was not applicable as the event occurred after the first dose. The benefit-risk relationship of mRNA-1273 (Spikevax) is not affected by this report. Narrative text in the source document describes the patient as male, whereas additional data indicates the patient is female.


VAERS ID: 1739299 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Epilepsy
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (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: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hydrocephalus; Intractable epilepsy; Quadriparesis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101195363

Write-up: worsening of the epileptic crisis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-782323. A 14-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 23Aug2021 16:16 (Batch/Lot Number: FG4686) as dose 1, single for covid-19 immunisation. Medical history included intractable epilepsy, hydrocephalus and quadriparesis. Concomitant medication included topiramate (TOPAMAX) taken for intractable epilepsy from 01Jan2014. On 25Aug2021, the patient experienced worsening of the epileptic crisis. Patient had one generalised crisis. On 26Aug2021, patient had five crises. On 27Aug2021, patient had four crises. On 28Aug2021, patient had three crises. On 29Aug2021, patient had four crises in a series. On 30Aug2021, patient had no crises. On 01Sep2021, patient had three crises. Therapy for the event included antiepileptic drugs administered with partial symptom control. Outcome of event was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1739333 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-14
Onset:2021-08-25
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (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: Pfizer, Inc. 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (asthmatic bronchitis)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101195225

Write-up: Breathing difficult; asthmatic bronchitis, strongly worsened after the 2nd dose of vaccine; This is a non-interventional study report from a contactable physician downloaded from the Regulatory Authority-WEB - IT-MINISAL02-783003. A 33-year-old female subject received bnt162b2 (COMIRNATY), dose 2 intramuscular on 14Aug2021 (Lot Number: FG4686) as single dose for covid-19 immunisation. Medical history included asthma (asthmatic bronchitis) from 22Jul2021 and unknown if ongoing. Concomitant medication included salbutamol sulfate (BRONCOVALEAS). The subject previously took the 1st dose of bnt162b2 (COMIRNATY) administered on 03Jul2021 for covid-19 immunisation. The subject was in ER (emergency room) on 22Jul2021 with a diagnosis of asthmatic bronchitis. The subject experienced breathing difficult on 25Aug2021. The subject was in ER on 22Jul with a diagnosis of asthmatic bronchitis, strongly worsened after the 2nd dose of vaccine in 2021. Event breathing difficult was reported as serious (medically significant). Outcome of breathing difficult was recovering, of asthmatic bronchitis worsened was unknown. The reporter''s assessment of the causal relationship of the events with the bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Sender comment: The report originated from the ACTIVE study. All the data in our possession have already been entered.; Sender''s Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events Dyspnoea and Asthma cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1739490 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2083 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Face oedema, Fatigue, Myalgia, Skin burning sensation, Urticaria, Vaccination site rash
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Urticaria (Urticaria after receiving influenza vaccination)
Allergies:
Diagnostic Lab Data:
CDC Split Type: LVPFIZER INC202101216142

Write-up: Face oedema; Fatigue; Myalgia; Injection site rash; Burning skin; Generalized urticaria; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number LV-SAM-2021096590. A 55-years-old female patient received first dose BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: FE2083), via an intramuscular on 24Aug2021 16:00 as dose 1, 0.3 ml single for COVID-19 immunization (Prophylactic vaccination). The patient previously received the Influenza vaccine on unknown date for Immunization. The patient medical history included urticaria from 2000 to 2000 (Urticaria after receiving influenza vaccination). There were no concomitant medications. On 25Aug2021, the patient experienced generalized urticaria and on 26Aug2021, the patient experienced face oedema, fatigue, myalgia, burning skin, injection site rash. The events generalized urticaria and face oedema were reported as eventually medically significant. The outcome of the events generalized urticaria, face oedema, myalgia, burning skin, injection site rash was recovered on 09Sep2021 and outcome of the event fatigue was recovering.


VAERS ID: 1739546 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-08-25
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3064 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Electrocardiogram, Interchange of vaccine products, Investigation, Off label use, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: 20210831; Test Name: ECG; Result Unstructured Data: Test Result:Global ST-elvations; Comments: Global ST-elvations; Test Date: 20210831; Test Name: Investigation; Result Unstructured Data: Test Result:Clinical findings consistent with pericarditis; Comments: Clinical findings consistent with pericarditis
CDC Split Type: NOPFIZER INC202101195571

Write-up: PERICARDITIS; CHEST PAIN; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Uj28p1. A 42-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 30Jun2021 (Batch/Lot Number: FE3064) as DOSE 1, SINGLE for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA, SPIKEVAX), intramuscular on 25Aug2021 (Batch/Lot Number: 3004952), at unspecified dose for immunisation. No information about medical history or concomitant medication was included in the report. On 31Aug2021, the patient was admitted to hospital due to acute respiration and position dependent chest pain. Pericarditis was diagnosed. Relevant laboratory findings and investigations included in the report (ECG on 31Aug2021, Global ST-elvations)(Investigation on 31Aug2021, Clinical findings consistent with pericarditis). The patient received treatment with colchicine and ibuprofen (Ibux), with effect. The patient''s outcome was recovering/resolving from chest pain and pericarditis at the time of the report. The case was considered to be serious. The Regulatory Health Authority assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible. No follow-up attempts possible. No further information expected.


VAERS ID: 1739559 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3716 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Computerised tomogram thorax, Echocardiogram, Fibrin D dimer, Pulmonary embolism, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Thromboembolism (her father may have had thromboembolism at the same age)
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Computerised tomogram thorax; Result Unstructured Data: Test Result:Pulmonary embolisms in the central arteries; Comments: Pulmonary embolisms in the central arteries of the left lower lobe and in the subsegmental arteries of the right upper lobe. No suspicion of malignancy.; Test Date: 20210825; Test Name: Echocardiography; Result Unstructured Data: Test Result:No pathological findings; Test Date: 20210825; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:Elavated
CDC Split Type: NOPFIZER INC202101195588

Write-up: Chest pain; Syncope; Pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the Agency-WEB NO-NOMAADVRE-FHI-2021-Uxa14x. A 50-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 23Aug2021 16:15 (Lot Number: FG3716) as Dose 2, single for covid-19 immunisation. The patient medical history was not reported. Family history included her father may have had thromboembolism at the same age. The concomitant medication included Hormonal contraceptives for systemic use since the age of 15. The patient experienced chest pain (hospitalization) on 25Aug2021 with outcome of recovering, syncope (hospitalization) on 25Aug2021 with outcome of recovering, pulmonary embolism (hospitalization) on 25Aug2021 with outcome of recovering. On 25Aug2021, the patient developed left-sided chest pain. The patient developed syncope in the emergency room and code blue was alerted, but the patient returns to consciousness. The patient underwent lab tests and procedures which included computerised tomogram thorax: pulmonary embolisms in the central arteries of the left lower lobe and in the subsegmental arteries of the right upper lobe. No suspicion of malignancy on 25Aug2021, echocardiogram: no pathological findings on 25Aug2021, fibrin d dimer: elavated on 25Aug2021. The primary reporter suggest Hormonal contraceptives for systemic use as a predisposing factor for the events. The Center 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: 1739810 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-25
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005242 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PRIONELLE 28
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20213

Write-up: RINGFORMAT ERYTEM; This case was received (Reference number: SE-MPA-2021-081564) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of ERYTHEMA (RINGFORMAT ERYTEM) in a 36-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005242) for COVID-19 vaccination. Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (PRIONELLE 28) for an unknown indication. In August 2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced ERYTHEMA (RINGFORMAT ERYTEM) (seriousness criterion medically significant). At the time of the report, ERYTHEMA (RINGFORMAT ERYTEM) had not resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No treatment medication were provided Company Comment: This case concerns a 36-year-old female patient with no relevant medical history, who experienced the unexpected event of Erythema .The event occurred on 25-Aug-2021 after unknown dose of Spikevax, the onset latency is unknown since date of administration of the vaccine was reported as unknown date in Aug 2021 .The rechallenge was unknown as there''s no information available about the dose number.The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. Very limited information regarding this event has been provided at this time; Sender''s Comments: This case concerns a 36-year-old female patient with no relevant medical history, who experienced the unexpected event of Erythema .The event occurred on 25-Aug-2021 after unknown dose of Spikevax, the onset latency is unknown since date of administration of the vaccine was reported as unknown date in Aug 2021 .The rechallenge was unknown as there''s no information available about the dose number.The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. Very limited information regarding this event has been provided at this time


VAERS ID: 1739835 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4728 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Electrocardiogram, Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Name: ECG-examination; Result Unstructured Data: Test Result:severely elevated heart damage markers in decreasi; Comments: severely elevated heart damage markers in decreasing during the care period 3-6 days after vaccination
CDC Split Type: SEPFIZER INC202101195614

Write-up: myocarditis (perimyocarditis); This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number SE-MPA-2021-082193. A 24-years-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 23Aug2021 (Lot Number: FE4728) as dose 1, single for covid-19 immunization. Medical history included covid-19 from Apr2021 to an unknown date. The patient''s concomitant medications were not reported. The patient experienced myocarditis (perimyocarditis) on 25Aug2021 with outcome of recovering. Report assessed as serious, hospitalisation. The day after vaccination, the man had physical training (conscription). The man hade chest pain. ECG-examination was done, severely elevated heart damage markers in decreasing during the care period 3-6 days after vaccination. The physican confirm the diagnosis of perimyocarditis. No follow-up attempts possible. No further information expected.


VAERS ID: 1740705 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-25
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: 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 INC202101213277

Write-up: Bell''s palsy; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 620092. A 21-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 19Aug2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced Bell''s palsy on 25Aug2021 (6 days after the vaccination). The patient has not yet recovered from the event. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1742078 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCRM8 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (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: Psychomotor retardation
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101202198

Write-up: Grade I anaphylaxis; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Agency (RA)-WEB, authority number is DE-PEI-202100184943. A 15-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), dose 1 via an unspecified route of administration on 25Aug2021 (Batch/Lot Number: SCRM8) as dose 1, single (at the age of 15 years old) for COVID-19 immunisation. Medical history included psychomotor retardation. The patient''s concomitant medications were not reported. The patient experienced about 2 minutes after the Covid-19 vaccination, bright red polygonal spots appear on the left upper arm, urticarial skin changes on the thorax, partly also on the face (grade i anaphylaxis) on 25Aug2021. Therapy: administration of cetirizine and prednisolone, monitoring for 60 minutes. The outcome of the events was recovered on an unspecified date. Comirnaty/ event /Agency/Result of Assessment : D. Unclassifiable Sender''s comments: Course: About 2 minutes after the Covid-19 vaccination, bright red polygonal spots appear on the left upper arm, urticarial skin changes on the thorax, partly also on the face. Therapy: administration of cetirizine and prednisolone, monitoring for 60 minutes. Basic disease: psychomotor retardation No follow-up attempts are possible. No further information is expected.


VAERS ID: 1742257 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-08-25
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004672 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: Myopericarditis; This case was received via Agency Regulatory Authority (Reference number: ES-AEMPS-1004287) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myopericarditis) in a 19-year-old male patient who received mRNA-1273 (COVID19 Moderna) (batch nos. 300005695 and 3004672) for COVID-19 vaccination. No Medical History information was reported. On 26-Jul-2021, the patient received first dose of mRNA-1273 (COVID19 Moderna) (unknown route) 1 dosage form. On 22-Aug-2021, received second dose of mRNA-1273 (COVID19 Moderna) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced MYOCARDITIS (Myopericarditis) (seriousness criteria hospitalization prolonged and medically significant). At the time of the report, MYOCARDITIS (Myopericarditis) was resolving. mRNA-1273 (COVID19 Moderna) (Unknown) was withdrawn on 26-Jul-2021. For mRNA-1273 (COVID19 Moderna) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter. Treatment information was not provided. Company Comment: This case concerns a 19- year-old, male patient with no relevant medical history, who experienced the expected serious AESI event of myocarditis. The event occurred approximately 4 days after the second dose of COVID19 Moderna. The rechallenge was not applicable as the event happened after the second dose and the vaccine was withdrawn. The benefit-risk relationship of COVID19 Moderna is not affected by this report.; Sender''s Comments: This case concerns a 19- year-old, male patient with no relevant medical history, who experienced the expected serious AESI event of myocarditis. The event occurred approximately 4 days after the second dose of COVID19 Moderna. The rechallenge was not applicable as the event happened after the second dose and the vaccine was withdrawn. The benefit-risk relationship of COVID19 Moderna is not affected by this report.


VAERS ID: 1742575 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Affective disorder, Body temperature fluctuation, Chills, Confusional state, Decreased appetite, Depressed mood, Dizziness, Educational problem, Emotional distress, Fatigue, Headache, Malaise, Psychiatric symptom, Pyrexia, Stress, Tension headache
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (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:
CDC Split Type: GBPFIZER INC202101217862

Write-up: shivers; fever; constant mild headaches; Been under the weather; don''t feel I can focus properly; Dizzy spells; Appetite lost; Feeling sad; Headache tension; Mental confusion; Underachievement; Loss of confidence; Fatigue; Mental distress; Stress; Body temperature fluctuation; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109152208172860-OJ3OB. Safety Report Unique Identifier: GB-MHRA-ADR 25948573. A 30-years-old non-pregnant female patient received bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, solution for injection, Batch/Lot Number: FE8087), via an unspecified route of administration on 25Aug2021 (at the age of 30-years-old) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. Patient had no symptoms associated with COVID-19 and not had a COVID-19 test. On an unspecified date, the patient experienced shivers, fever, constant mild headaches, been under the weather, don''t feel patient can focus properly. On 25Aug2021, the patient experienced body temperature fluctuation. On 26Aug2021, the patient experienced dizzy spells, appetite lost, feeling sad, headache tension, mental confusion, underachievement, loss of confidence, fatigue, mental distress, stress. It was reported that patient had shivers, body temperature drops and highs within 12 hours, fever, lost appetite the next day after 2nd dose for 2 and a half weeks, been under the weather, feeling said, confused, constant mild headaches, dizziness. Not been herself, lost herself, don''t feel patient can focus properly, fatigued. The outcome of the events body temperature fluctuation was recovered on 26Aug2021, and outcome of the event underachievement recovered on an unspecified date and the outcome of the event mental confusion was recovered with sequelae and the outcome of the event dizzy spells, feeling sad, loss of confidence, fatigue, mental distress, stress was not recovered and the outcome of the events appetite lost and headache tension was recovering and the outcome of the events shivers, pyrexia, constant mild headaches, been under the weather, don''t feel patient can focus properly was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1742834 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Burning sensation, Chest discomfort, Pain in extremity, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None. Full medical completed less than 6 months ago and doctor stated patient was in ?excellent health''.
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEJNJFOC20210951636

Write-up: Tightness in chest; Burning sensation; Sore feet; Pains in legs; Hives; This spontaneous report received from a pharmacist via Regulatory Authority (EVHUMAN Vaccines, IE-HPRA-2021-083571) on 27-SEP-2021 and concerned a 60 year old female. The patient''s weight was 57 kilograms, and height was not reported. The patient''s pre-existing medical conditions included: None. Full medical completed less than 6 months ago and doctor stated patient was in ?excellent health''. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE393 expiry: UNKNOWN) dose was not reported, administered on 19-AUG-2021 for covid-19 immunisation. No concomitant medications were reported. On 25-AUG-2021, the patient experienced tightness in chest, burning sensation, sore feet, pains in legs, and hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tightness in chest, sore feet, pains in legs, burning sensation, and hives. This report was serious (Other Medically Important Condition).


VAERS ID: 1742920 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-25
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Extrasystoles, Keratoconus, Pain in extremity, Tachycardia, Vision blurred
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Glaucoma (broad), Lens disorders (broad), Corneal disorders (narrow), Retinal disorders (broad), Tachyarrhythmia terms, nonspecific (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (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: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to animal; Contrast media allergy; Dust allergy; Nickel sensitivity
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101207504

Write-up: Blurred vision, difficulty wearing contact lenses left eye: worsening keratoconus in that eye, never happened before.; Frequent extrasystoles (even 60/70 per hour); Blurred vision; tachycardia; leg pain; This is a spontaneous report from contactable Consumer downloaded from the regulatory authority-WEB IT-MINISAL02-783950. A 39-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, lot number: FG4686, expiration date: not reported), intramuscular, administered in Arm Left on 12Aug2021 at 09:26 as dose 1, 0.3 mL, single for covid-19 immunization. Medical history included allergic to crustaceans, allergy to nickel, allergy from dust mites, allergy to contrast agent tac. Concomitant medication(s) included amitriptyline hydrochloride (LAROXYL) taken for migraine; cefaloridine (CERAZETTE [CEFALORIDINE]) taken for endometriosis from Mar2018 to an unspecified stop date. The patient is allergic to ketoprofen, contramal and rilamig. On 25Aug2021, the patient experienced blurred vision, difficulty wearing contact lenses left eye: worsening keratoconus in that eye, never happened before, frequent extrasystoles (even 60/70 per hour), blurred vision, tachycardia, leg pain. Actions taken (Eye specialist visit, pending cardiology visit.) - Impact on quality of life (7/10) - COVID 19 COMIRNATY VACCINE (PFIZER). Outcome of the events was reported as not recovered. Health Authority comments: As I indicated in the filled sheet at the vaccination hub, I have keratoconus, endometriosis (under Cerazette pill therapy since March 2018 so no cycle), migraine (under therapy with 8 drops Laroxyl in the evening), gastritis, gastro-oesophageal reflux, dilation infundibular, areas of gliosis on a post-ischemic vascular basis, allergic to ketoprofen, crustaceans, nickel, dust mites, reaction to contramal, contrast agent tac, rilamig.


VAERS ID: 1743108 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-25
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8162 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: White blood cell increased.
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: body temperature; Result Unstructured Data: Test Result:36.0; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101210354

Write-up: Fibromyalgia syndrome; left side facial palsy/peripheral facial nerve palsy; This is a spontaneous report from a contactable physician received via Regulatory Authority. A 26-year-old (also reported as 26-year and 10-month-old) female patient received BNT162B2 (COMRINATY Solution for injection), intramuscular in the right arm, on 04Aug2021 10:00 (Lot number: FE8162, Expiration date: 30Nov2021), at age 26 years old, as dose 1, single, for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Other medical history included white blood cell increased from an unknown date, not reported if ongoing or not. It was also reported that there were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient had a family history: HTLV-1 positive for mother. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Body temperature before vaccination on 04Aug2021 was 36.0 degrees Centigrade. On 25Aug2021 at 10:00 (21 days after the vaccination), the patient experienced left side facial palsy. The reporter stated the event resulted in doctor or other healthcare professional office/clinic visit. On 15Sep2021 (42 days after the vaccination), the outcome of the event was recovered with sequel (fibromyalgia syndrome). The course of the event was as follows: 3 weeks after vaccination, left side facial palsy appeared. The next day, 26Aug2021, the patient visited of a hospital. Diagnosed as peripheral facial nerve palsy. The outcome of "left side facial palsy/peripheral facial nerve palsy" was recovered/resolved with sequel on 15Sep2021, and the outcome of fibromyalgia syndrome was not recovered. The reporting physician classified the event as non-serious and assessed that the causality between the event and BNT162B2 as unassessable. There was no other possible cause of the event such as any other diseases. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1743230 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-08-25
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004220 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Acute myocarditis; This case was received via Regulatory Authority (Reference number: -2021TJP095943) on 17-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case, initially reported to the Regulatory Authority by a physician, was received via the Regulatory Authority (Ref, v21127034). On 18-Jul-2021, the patient received the 1st dose of this vaccine. On 22-Aug-2021, the patient received the 2nd dose of this vaccine. Pyrexia persisted from night (until the morning of 25-Aug-2021). On 25-Aug-2021, at 04:00, the patient visited the reporting hospital for subjective symptoms of chest pain and cold sweat. In the blood test, elevated cardiac enzymes and inflammatory reaction were found, and in the electrocardiogram, the ST elevation was noted. There was no coronary artery lesion in coronary ST, and the diagnosis of acute myocarditis was made. The patient was hospitalized. The patient was followed up, and the symtoms improved conservatively. On 31-Aug-2021, the remission of the symptom was confirmed. The patient was discharged from the hospital. The outcome of acute myocarditis was reported as resolving. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. As for other factors, investigation of viral infection is underway. Sender''s Comments: This case concerns a 45-year-old, male patient with no relevant medical history, who experienced the expected event of Myocarditis. The event occurred approximately 4 days after the second dose of Spikevax. The rechallenge was not applicable, as there is no additional dosing will be given. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1743349 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-08-25
   Days after vaccination:134
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / 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: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: (RT-PCR)-SARS-Covid 2; Test Result: Positive
CDC Split Type: PTPFIZER INC202101233410

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a contactable health care professional downloaded from the Regulatory Authority-WEB. This is a report received from Regulatory authority report number PT-INFARMED-M202109-1410 with Safety Report Unique Identifier PT-INFARMED-M202109-1410. A 32-years-old female patient received second dose of BNT162B2 (COMIRNATY, formulation: solution for injection, batch/lot no: EW8904) via intramuscular route on 13Apr2021 as DOSE 2, 0.3 ml, SINGLE and first dose via intramuscular route on 12Mar2021 (Batch/Lot Number: EP9605) as DOSE 1, 0.3 ml, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included seretide 50/250 mcg and avamys nasal spray. The patient experienced vaccination failure, covid-19, an interval of 30 days between each dose on 25Aug2021. It was reported that patient received first and second dose of Comirnaty vaccine. About 4 months after the patient was considered immunized, she tested positive for COVID 19 infection. There was no reduction in dosage, suspension or reintroduction of the suspected drug, since the vaccination schedule was complete. There were not any previous reactions to the same drug or to other drugs. The patient underwent lab test which included (RT-PCR)-SARS-Covid 2: positive (Nasopharyngeal + Oropharyngeal exudate) on unknown date. Treatment of the reaction consists of administering of Paracetamol 1g, 6/6h-3 days. The outcome of the events was recovered on 04Sep2021. The reporter assessment of the causal relationship of the Vaccination failure, covid-19 with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information expected.; Reporter''s Comments: Concomitant Medicine- Seretide 50 / 250mg; Avamys Nasal Spray Did Medication Error Occur? -No Other information-SARS-COV2 IgG ON 18/08/2021 POSITIVE - 2009.5 AU / ml


VAERS ID: 1743358 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-08-25
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: COVID-19; Test Result: Positive ; Comments: Positive
CDC Split Type: PTPFIZER INC202101229962

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number PT-INFARMED-T202108-3942. A 46-years-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: FF0688), via intramuscularly on 14Jul2021 as dose 2, 0.3 ml single and patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: FA4632), via intramuscularly on 16Jun2021 as dose 1, 0.3 ml single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 25Aug2021 the patient experienced vaccine failure, covid-19. Adverse reactions started after second dose. The patient underwent lab tests and procedures which included sars-cov-2 test resulted as positive on 25Aug2021 positive. Event vaccination failure was considered as medically significant, and covid-19 was considered as non-serious as per the reporter. It was reported that case non serious with PT-INFARMED-T202108-3942. The reporter assessment of the causal relationship of the Vaccination failure and COVID-19 with the suspect product was provided as relatedness of drug to reaction(s)/event(s) as per the source of assessme nt of reporter, method of assessment was unknown, result of Assessment was probable. The outcome of the events was recovering. No follow-up attempts are possible. No further information expected.


VAERS ID: 1744875 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-08-25
   Days after vaccination:116
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Base excess, Blood bicarbonate, Blood chloride, Blood gases, Blood glucose, Blood lactic acid, Blood potassium, Blood sodium, COVID-19, Calcium ionised, Carbon dioxide, Carboxyhaemoglobin, Computerised tomogram, Cough, Drug ineffective, Haemoglobin, Lung opacity, Lymphadenopathy, Oxygen saturation, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Interstitial lung disease (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Arthritis; Cerebrovascular accident; Dysarthria; Dyslipidemia; Gout; Left anterior descending coronary artery stenosis (90% stenosis LAD requiring dilation); Non-insulin-dependent diabetes mellitus; Non-sustained ventricular tachycardia (2 episodes); Obesity; Supraventricular arrhythmia NOS; Transient ischaemic attack (With VIIc)
Allergies:
Diagnostic Lab Data: Test Date: 20210902; Test Name: Base excess; Result Unstructured Data: Test Result:1.6 mmol/L; Comments: 1.6, -2.1, 1.7 (Normal range: -2.00000 - 3.00000.Standard Base excess: -2.5, -3.1, 1.0 mmol/L (Normal range: -2.00000 - 3.00000).; Test Date: 20210902; Test Name: Bicarbonate; Result Unstructured Data: Test Result:21.7 mmol/L; Comments: 21.7, 20.9, 24.2 mmol/L (Normal range: 21.0 - 28.0.Bicarbonate (pCO2 corrected): 23.6, 23.1, 26.2 mmol/L (Normal range: 21.0 - 28.0).; Test Date: 20210902; Test Name: Chloride; Result Unstructured Data: Test Result:99 mmol/L; Comments: 99, 100, 99 mmol/L (Normal range: 98 - 107; Test Date: 20210902; Test Name: Blood gases; Result Unstructured Data: Test Result:7.44; Comments: 7.44 (5-6 liters), 7.45 (2 liters), 7.50 (Normal range: 7.35 - 7.45).; Test Date: 20210902; Test Name: Glucose; Test Result: 459 mg/dl; Comments: 459, 383, 272 mg/dL (Normal range: 65 - 95).; Test Date: 20210902; Test Name: Lactic Acid:; Result Unstructured Data: Test Result:2.4 mmol/L; Comments: 2.4, 2.8, 1.0 mmol/L (Normal range: 0.5 - 2.2).; Test Date: 20210902; Test Name: Potassium; Result Unstructured Data: Test Result:3.9 mmol/L; Comments: 3.9, 3.7, 3.6 mmol/L (Normal range: 3.5 - 5.1; Test Date: 20210902; Test Name: Sodium; Result Unstructured Data: Test Result:132 mmol/L; Comments: 132, 133, 132 mmol/L (Normal range: 136 - 145).; Test Date: 20210902; Test Name: Calcium ionized; Result Unstructured Data: Test Result:1.15 mmol/L; Comments: 1.15, 1.09, 1.09 mmol/L (Normal range: 1.15 - 1.33).; Test Date: 20210902; Test Name: Partial pressure of CO2; Result Unstructured Data: Test Result:32.0 mmHg; Comments: 32.0, 30.0, 31.0 mmHg (Normal range: 35.0 - 48.0).; Test Date: 20210902; Test Name: Carboxyhemoglobin; Test Result: 1.7 %; Comments: 1.7 % (Normal range: 0.0 - 3.0).; Test Date: 2021; Test Name: Thorax CT scan; Result Unstructured Data: Test Result:Multiple scattered frosted glass densities; Comments: Multiple scattered frosted glass densities in all lung lobes both left and right, with peripheral predominance and with linear distribution in multiple sites: aspect distribution pattern highly suggestive of COVID pneumonitis. Visually affected 60-65% of the lungs. Multiple very large mediastinal lymph nodes.; Test Date: 20210902; Test Name: Hemoglobin; Result Unstructured Data: Test Result:14.9 g/dl; Comments: 14.9, 14.9, 14.1 g/dL (Normal range: 13.0 - 17.0).; Test Date: 20210902; Test Name: Oxygen saturation; Test Result: 96.5 %; Comments: 96.5, 94.9, 98.0 % (Normal range: 94.0 - 98.0).; Test Date: 20210902; Test Name: Partial pressure of O2; Result Unstructured Data: Test Result:71, 61.95 mmHg; Comments: 71, 61.95, mmHg (Normal range: 83 - 108).; Test Date: 20210825; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: BEPFIZER INC202101222317

Write-up: COVID-19; drug ineffective; Asthenia; Coughing; Multiple scattered ground glass compactions in all lung lobes both left and right, with a peripheral predominance and with linear distribution at multiple sites.; Several very large lymph nodes mediastinally (mainly paratracheal right and prevascular in the anterior mediastinum) and both hilar: most suitable for reactive lymph nodes.; This is a spontaneous report from a contactable other healthcare professional downloaded from the regulatory authority number BE-FAMHP-DHH-N2021-106393. A 71-years-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: Not reported), via an unspecified route of administration on an unspecified date in May2021 as dose 1, single for COVID-19 immunization. Medical history included 2 episodes of non sustained ventricular tachycardia, supraventricular arrhythmia, arterial hypertension, obesity, dyslipidaemia, arthritis, left anterior descending coronary artery stenosis (90% stenosis LAD requiring dilation and DES stent), type 2 diabetes mellitus, cerebrovascular accident (stroke), transient ischaemic attack (With VIIc), dysarthria, and gout; all from an unknown date and unknown if ongoing. Concomitant medication included nebivolol (NOBITEN, 5mg), hydrochlorothiazide, olmesartan medoxomil (BELSAR PLUS, 20mg/12.5mg), acetylsalicylic acid (ASAFLOW, 80mg), sitagliptin phosphate (JANUVIA, 100mg), tamsulosin hydrochloride (RANOMAX, 0.4mg), metformin hydrochloride (GLUCOPHAGE, 850mg), allopurinol (ALLOPURINOL, 100mg), atorvastatin calcium (TOTALIP, 80mg), and clopidogrel (CLOPIDOGREL, 75mg); all taken for unspecified indications, start and stop dates were not reported. It was reported that, patient later received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: Not reported), via an unspecified route of administration on 01Sep2021 as dose 2, single for COVID-19 immunization. On 25Aug2021 (vaccinated with Comirnaty in May2021) in the context of HRM, after first dose, patient had Positive COVID test. On an unspecified date in 2021, after first dose, the patient experienced, Asthenia, Coughing, Ground glass opacity in thoracic CT, Swollen lymph nodes. Reported that, Asthenia and coughing for 3 days. No subjective dyspnea. No fever, no malaise. No subjective dyspnea despite the gentleman admitting to feeling better with oxygen supplement. Dry cough and generally slightly less strength. No thoracic pain, no syncope, no abdominal pain, nor nausea or vomiting. The patient was hospitalized for events from 01Sep2021 and transferred to another hospital on 02Sep2021, to an unknown date. Therapeutic measures were taken as a result of events with paracetamol, augmentin, and dexamethasone. The patient underwent lab tests and procedures which included CT scan of thorax on an unspecified date in 2021, resulted as Multiple scattered frosted glass densities in all lung lobes both left and right, with peripheral predominance and with linear distribution in multiple sites: aspect distribution pattern highly suggestive of COVID pneumonitis. Visually affected 60-65% of the lungs. Multiple very large mediastinal lymph nodes (mainly right paratracheal and prevascular in the anterior mediastinum) and hilar on both sides: most appropriate for reactive lymph nodes. To be checked if necessary. Examinations - No pulmonary embolism detected. Furthermore: No pleural effusion. No increased pericardial fluid. Coronary calcifications. DISH dorsal. Sequence of rib fractures right. Sars-Cov-2 (COVID-19 virus) test resulted positive on 25Aug2021, Lab tests performed on 02Sep2021 included, Blood gases pH: 7.44 (5-6 liters), 7.45 (2 liters), 7.50 (Normal range: 7.35 - 7.45). Partial pressure of CO2: 32.0, 30.0, 31.0 mmHg (Normal range: 35.0 - 48.0). Partial pressure of O2: 71, 61.95, mmHg (Normal range: 83 - 108). Sodium: 132, 133, 132 mmol/L (Normal range: 136 - 145). Potassium: 3.9, 3.7, 3.6 mmol/L (Normal range: 3.5 - 5.1). Chloride: 99, 100, 99 mmol/L (Normal range: 98 - 107). Calcium ionized: 1.15, 1.09, 1.09 mmol/L (Normal range: 1.15 - 1.33). Hemoglobin: 14.9, 14.9, 14.1 g/dL (Normal range: 13.0 - 17.0). Oxygen saturation: 96.5, 94.9, 98.0 % (Normal range: 94.0 - 98.0). Carboxyhemoglobin: 1.7 % (Normal range: 0.0 - 3.0). Bicarbonate: 21.7, 20.9, 24.2 mmol/L (Normal range: 21.0 - 28.0). Bicarbonate (pCO2 corrected): 23.6, 23.1, 26.2 mmol/L (Normal range: 21.0 - 28.0). Base excess: -1.6, -2.1, 1.7 (Normal range: -2.00000 - 3.00000). Standard Base excess: -2.5, -3.1, 1.0 mmol/L (Normal range: -2.00000 - 3.00000). Glucose: 459, 383, 272 mg/dL (Normal range: 65 - 95). Lactic Acid: 2.4, 2.8, 1.0 mmol/L (Normal range: 0.5 - 2.2). The outcome of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.


VAERS ID: 1745834 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-08-25
   Days after vaccination:55
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Optic neuritis
SMQs:, Optic nerve disorders (narrow), Demyelination (narrow), Ocular infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension (under treatment (Beloc Zok, metoprolol 25 mg / day, suspended during the last and simultaneous hospitalization, Triatec, ramipril 10 mg / day))
Preexisting Conditions: Medical History/Concurrent Conditions: Melanoma (scalp melanoma in complete remission (treated with Keytruda, pembrolizumab, last administration, of 10 total cycles, dating back to Mar2019))
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC202101224056

Write-up: Bilateral optic neuritis; This is a spontaneous report received from a contactable physician via , the regulatory authority. Regulatory authority report number CH-SM-2021-22807. A 79-years-old male patient received BNT162B2 (COMIRNATY), dose 2 intramuscular in Jul2021 (Batch/Lot number was not reported) age at vaccination of 78-years-old, as single dose, for covid-19 immunisation. Medical history included ongoing hypertension (under treatment (Beloc Zok, metoprolol 25 mg / day, suspended during the last and simultaneous hospitalization, Triatec, ramipril 10 mg / day), malignant melanoma from 2019 to an unknown date (scalp melanoma in complete remission (treated with Keytruda, pembrolizumab, last administration, of 10 total cycles, dating back to Mar2019)). The patient received BNT162B2 (COMIRNATY), dose 1 intramuscular in Jun2021 (Batch/Lot number was not reported), as single dose, for covid-19 immunisation. Concomitant medications included metoprolol succinate (BELOC ZOK) taken for hypertension, start and stop date were not reported; ramipril (TRIATEC [RAMIPRIL]) taken for hypertension, start and stop date were not reported. The patient previously took keytruda for malignant melanoma (last administration, of 10 total cycles, dating back to Mar2019), pembrolizumab for malignant melanoma (last administration, of 10 total cycles, dating back to Mar2019). The patient experienced bilateral optic neuritis (hospitalization, medically significant) on 25Aug2021. The outcome of the event was unknown. Sender''s comments: Elderly patient experienced bilateral optic neuritis after about a month of latency from the conclusion of the vaccination cycle with Comirnaty. Severe adverse reaction (caused hospitalization, Other Medically Important Condition - Important medical event terms list version 23.1 (europa.eu): Optic perineuritis). Based on the scientific evidence currently available, the causal link between the adverse reaction coded as ''''optic neuritis'''' and Comirnaty is considered as possible, in consideration of the chronological plausibility, of the notoriety of the adverse reaction (10). A causal relationship between Comirnaty and Bilateral optic neuritis was assessed as being Possible This case was reported as serious (Other medically important condition, Caused/prolonged hospitalization). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1746026 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-08-25
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0932 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Immobile (Immobilised due to working at home); Overweight
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: Computerised tomogram thorax; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: DKPFIZER INC202101222399

Write-up: lung embolism; This is a spontaneous report from a contactable physician downloaded from the Agency WEB, regulatory authority number DK-DKMA-WBS-0087970. A 20-year-old male patient received bnt162b2 (COMIRNATY, solution for injection), intramuscular on 19Jul2021 (batch/lot number FD0932 and expiry date unknown) as dose 2, single for covid-19 immunisation. Medical history included ongoing immobile (immobilised due to working at home), ongoing overweight. The patient''s concomitant medications were not reported. The patient previously took dose 1 of Comirnaty on 14Jun2021 (batch/lot number FC2336, expiration date 30Sep2021) for covid-19 immunisation. On 25Aug2021, the patient experienced lung embolism. The physician informed that occurrence of lung embolism in a patient vaccinated with Comirnaty. On 25Aug2021, 37 days after the second vaccination, the patient developed lung embolism. The lung embolism was by the physician reported as causing hospitalization. The patient underwent lab test and procedures on 27Aug2021 which included computerised tomogram thorax: no result provided. The physician informed that the lung embolism was not recovered at the time of reporting. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1746224 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214005 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza like illness, Somnolence, Vaccination site reaction
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

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

Write-up: Influenza like illness; Somnolence; Vaccination site reaction; This case was received via a regulatory authority (Reference number: FR-AFSSAPS-AN20213612) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Influenza like illness) in a 34-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214005) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced SOMNOLENCE (Somnolence) and VACCINATION SITE REACTION (Vaccination site reaction). On 29-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (Influenza like illness) (seriousness criterion medically significant). On 26-Aug-2021, SOMNOLENCE (Somnolence) had resolved. On 29-Aug-2021, VACCINATION SITE REACTION (Vaccination site reaction) had resolved. On 05-Sep-2021, INFLUENZA LIKE ILLNESS (Influenza like illness) had resolved. No concomitant medication was provided by the reporter. No treatment information was provided by the reporter. This case concerns a 34-year-old, female subject with no relevant history reported, who experienced the unexpected event of INFLUENZA LIKE ILLNESS. The event occurred four days after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Translated received on 27-Sep-2021 contain no new information.; Sender''s Comments: This case concerns a 34-year-old, female subject with no relevant history reported, who experienced the unexpected event of INFLUENZA LIKE ILLNESS. The event occurred four days after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1746327 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214011 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza like illness, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Spondylitis ankylosing
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Vomiting; Influenza like illness; This case was received via a regulatory authority (Reference number: FR-AFSSAPS-NY20214045) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of VOMITING (Vomiting) and INFLUENZA LIKE ILLNESS (Influenza like illness) in a 21-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214011) for COVID-19 vaccination. Concurrent medical conditions included Spondylitis ankylosing. On 25-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion hospitalization) and INFLUENZA LIKE ILLNESS (Influenza like illness) (seriousness criterion hospitalization). At the time of the report, VOMITING (Vomiting) and INFLUENZA LIKE ILLNESS (Influenza like illness) had not resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant products were not provided. Treatment medication were not reported. Patient took second dose of vaccination on 25-AUG-2021. Company comment: This case concerns a 21-year-old female patient with no relevant medical history , who experienced the unexpected serious events of Vomiting, Influenza like illness.The events occurred approximately 1 day after the second dose of Spikevax. The rechallenge is not applicable since the event occurred after the second dose and no details were provided about the first dose. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Translation document received on 24-Sep-2021; reporters comment updated; Sender''s Comments: This case concerns a 21-year-old female patient with no relevant medical history , who experienced the unexpected serious events of Vomiting, Influenza like illness.The events occurred approximately 1 day after the second dose of Spikevax. The rechallenge is not applicable since the event occurred after the second dose and no details were provided about the first dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1746457 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-08-25
   Days after vaccination:55
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Computerised tomography chest; Result Unstructured Data: Test Result:No pulmonary embolism right in segmental branch.; Comments: There is a ground glass infiltrate, partially consolidating, predominantly basal and bilaterally sub pleural but mostly to the left with damage to the lung parenchyma estimated at about 25% to 50%.; Test Name: Polymerase Chain Reaction test; Test Result: Positive ; Comments: Identification of the variant: unknown Lymphopenia No known immunodepression.
CDC Split Type: FRPFIZER INC202101216081

Write-up: COVID-19; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-RS20212855, Safety Report Unique Identifier FR-AFSSAPS-2021126515. A 73-year-old male patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: Unknown), dose 2 intramuscular on an unspecified date in Jul2021 as dose 2, single and dose 1 intramuscular on an unspecified date in Jul2021 (Lot Number: Unknown) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Vaccination failure on 25Aug2021. About 1 month later i.e., 01Sep2021 on Day 7 of Covid: hospitalisation in intensive care unit for moderately serious covid infection upon return. The male patient was intubated and ventilated. Patient was suffered from serious Covid infection about 2 months after a complete vaccination schedule with the Comirnaty vaccine. The patient underwent lab tests and procedures which included computerised tomogram: no pulmonary embolism right in segmental branch (There is a ground glass infiltrate, partially consolidating, predominantly basal and bilaterally sub pleural but mostly to the left with damage to the lung parenchyma estimated at about 25% to 50%) on an unknown date, Polymerase Chain Reaction test: positive (Identification of the variant: unknown, Lymphopenia, No known immunodepression) on an unknown date. The outcome of all the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1746744 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cerebrovascular accident, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), 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), 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 Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101225415

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; stroke; Stroke syndrome; This is a spontaneous report from a contactable other healthcare professional received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109161449042340-BM0SD, Safety Report GB-MHRA-ADR 25953487. A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration on 25Aug2021 (at the age of 69-year-old) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient experienced stroke syndrome on 25Aug2021; stroke on 30Aug2021; SARS-CoV-2 infection on 16Sep2021. All the events were reported as serious for being medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: positive (Yes - Positive COVID-19 test) on an unspecified date. The report does not relate to possible blood clots or low platelet counts. Outcome of all the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


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