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

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



Case Details (Reverse Sorted by Onset Date)

This is page 375 out of 8,010

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VAERS ID: 1729417 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-08-27
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2625 / 2 - / -

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: IEPFIZER INC202101193796

Write-up: BELL''S PALSY; This is a spontaneous from a contactable consumer downloaded from the Regulatory Authority-WEB. This is a report received Regulatory authority report number IE-HPRA-2021-083565 with Safety Report Unique Identifier IE-HPRA-2021-083565. Initial report received by the Regulatory Authority on 29Aug2021 from a member of the public reporting on behalf of herself. Regulatory Authority A 43-year-old female patient received second dose of Comirnaty (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot Number: FE2625), via an unspecified route of administration on 08Jul2021 as dose 2, single for covid-19 immunization. Patient took her 1st dose of comirnaty (Pfizer BioNTech covid-19 vaccine, lot number: FC8889) on 08Jun2021. The patient medical history and concomitant medications were not reported. On 27Aug2021, 49 days following the administration of the second dose of Comirnaty, patient experienced bell''s palsy. At the time of reporting, the outcome of the patient''s reaction was reported as unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : IE-HPRA-2021-083826


VAERS ID: 1729584 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-27
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Anaphylactic shock, Blood test, Body temperature, CSF test, Chills, Gait disturbance, Hyperventilation, Hypoaesthesia, Hypokalaemia, Intervertebral disc protrusion, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Muscle twitching, Muscular weakness, Nerve conduction studies, Neuropathy peripheral, Oxygen saturation, Pyrexia, Respiratory alkalosis, Sensory disturbance, Somatic symptom disorder, Swelling of eyelid, Urticaria
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Hypokalaemia (narrow), Immune-mediated/autoimmune disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma bronchial; Rhinitis allergic; Vitamin B12 deficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: blood test; Result Unstructured Data: Test Result:Hypokalaemia; Test Date: 20210902; Test Name: blood test; Result Unstructured Data: Test Result:no abnormality; Test Date: 20210827; Test Name: body temperature; Result Unstructured Data: Test Result:37.8 Centigrade; Test Date: 20210902; Test Name: CSF test; Result Unstructured Data: Test Result:no abnormality; Test Date: 20210903; Test Name: head MRI; Result Unstructured Data: Test Result:no abnormality; Test Date: 20210903; Test Name: MRA; Result Unstructured Data: Test Result:unknown result; Test Date: 20210903; Test Name: whole spine MRI/ spine MRI; Result Unstructured Data: Test Result:intervertebral disc herniation; Comments: only intervertebral disc herniation was found, and Demyelinating disease was not found; Test Date: 20210907; Test Name: Peripheral nerve conduction velocity test; Result Unstructured Data: Test Result:no abnormality; Test Date: 20210827; Test Name: SpO2; Test Result: 98 %
CDC Split Type: JPPFIZER INC202101177909

Write-up: Anaphylactic shock; Hyperventilation; urticaria on front chest and forearm; peripheral nerve disorder; swelling in binocular eyelids; twitching of the face/ twitching of the limbs; anaphylaxis; Hypokalaemia; pyrexia of 37.8 degrees centigrade; chills; numbness of fingers/ numbness of hand/ numbness in lower limbs; respiratory alkalosis; muscular weakness; gait disturbance; symptoms were psychogenic; strange feeling on limbs; intervertebral disc herniation; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21127357. A 17-year-and 3-month-old female patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown) via an unspecified route of administration as a single dose on 27Aug2021 at 19:30 (at the age of 17-years-old) for COVID-19 immunization. The patient''s medical history included using fluticasone propionate (FLUTIDE), Montelukast sodium (KIPRES) and mometasone fumarate (NASONEX, Nasal) for asthma bronchial, rhinitis allergic and the patient orally took Methycobal for vitamin B12 deficiency. Concomitant medications were not reported. On 27Aug2021 at 19:30 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY). On 27Aug2021 at 19:37 (7 minutes after the vaccination), the patient experienced peripheral nerve disorder. On 27Aug2021 (the day of vaccination), the patient was admitted to the hospital. The course of the event was as follows: 7 minutes after the vaccination, swelling in binocular eyelids and twitching of the face appeared. Ten minutes after the vaccination, hyperventilation, urticaria on front chest and forearm appeared. Although SpO2 was 98%, oxygen was administered. It seemed that twitching of the limbs also appeared. Twenty minutes after the vaccination, it was diagnosed as anaphylactic shock, through intravenous drip, Solu-Medrol administration, 25 minutes after the vaccination, adrenaline were administered. After that, the patient experienced pyrexia of 37.8 degrees centigrade and chills also admitted. Hyperventilation persisted therefore the patient was introduced to reporters clinic. At the time of consultation, urticaria and hyperventilation disappeared. However the symptoms were treated as anaphylaxis, and numbness of fingers was confirmed, and with blood test, hypokalaemia was admitted, so the patient was hospitalized. With the follow-up blood test after hospitalization, hypokalaemia was recovering. It was thought to be due to respiratory alkalosis caused by hyperventilation. Since allergic symptoms did not reoccur after hospitalization, the patient was discharged from the hospital on 28Aug2021. However, after discharge, numbness of hand, weakness, twitching of the face, numbness in lower limbs and gait disturbance due to weakness continued. On 02Sep2021, the patient revisited. Blood test, CSF test were performed. On 03Sep2021, head MRI, MRA, and whole spine MRI were performed. Blood test, CSF test, and head MRI showed no abnormality. Through spine MRI, only intervertebral disc herniation was found, and demyelinating disease was not found. On 07Sep2021, peripheral nerve conduction velocity test was performed, however no abnormality was found. At reconsultation on 08Sep2021, the strange feeling on limbs remained, however muscular strength was in a tendency of recover. Through the above clinical course that the patient went through, it was low possibility that the symptom could be diagnosed as Guillain-Barre syndrome, ADEM and MS. It was considered as vaccination triggered hyperventilation, and later these symptoms were psychogenic and persistent, but it could not be determined. On 08Sep2021 (12 days after the vaccination), outcome of strange feeling on limbs was not recovered, of psychogenic symptoms was unknown, while of the other events was recovering. The reporting physician classified the events as serious (caused hospitalized from 27Aug2021 to 28Aug2021) and assessed that the causality between the events and BNT162b2 as unassessable. Other possible causes of the events such as any other diseases were vaccination triggered hyperventilation, and it was possible that psychogenic symptoms appeared after that. The reporting physician commented as follows: The urticaria developed could be thought as an allergic reaction of vaccination, however as for hyperventilation syndrome, numbness of limbs, muscular weakness and gait disturbance, considering by physical and examination findings, and clinical course, they differed from the clinical course usually taken for Guillain-Barre syndrome and ADEM. However, it was true that these symptoms appeared due to hyperventilation caused by the vaccination, and although the patient was currently in a tendency of recover, it could not be completely denied as an adverse reaction to the vaccine, therefore reported. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1729591 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-27
   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 FE8206 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Fibrin D dimer, Inflammation, Rash, Thrombosis
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: 20210823; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210827; Test Name: D-dimer; Result Unstructured Data: Test Result:36.28 ng/ml; Comments: increased
CDC Split Type: JPPFIZER INC202101179566

Write-up: Thrombosis; rash in both hands; Inflammatory response increased was noted; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21126199. The patient was a 71-year-old female. Body temperature before vaccination was 36.5 degrees Centigrade. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 23Aug2021 in the afternoon (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FE8206 , Expiration date 31Oct2021) via an unspecified route of administration as dose 1, single for COVID-19 immunization. On 27Aug2021 (4 days after the vaccination), the patient experienced the following events. On 01Sep2021 (9 days after the vaccination), the outcome of the event thrombosis was recovering. Outcome of the remaining events was unknown. The course of the events was reported as follows: On 23Aug2021, the patient received the vaccine. Nothing special happened and the patient went home. On 27Aug2021, the patient experienced rash in both hands and visited the hospital. Blood sampling showed D-dimer increased (36.28 ng/ml). Inflammatory response increased was noted. A diagnosis of thrombosis was made. Treatment was started. There were no diseases or medications for internal use having a risk of thrombosis. So, the reporter judged that the reaction was caused by the vaccine. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. Other possible cause of the event such as any other diseases was not provided.


VAERS ID: 1729746 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-27
   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 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Inflammation, Lymphadenopathy, Pyrexia, Vaccination site discomfort
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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC202101183029

Write-up: ganglion inflammation on the side he was applied the vaccine/swollen lymph nodes; ganglion inflammation on the side he was applied the vaccine/clavicle inflammation; febricula; discomfort in vaccination site; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 1 unknown on 27Aug2021 (Batch/Lot Number: FF8838) at the age of 29-years-old as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 27Aug2021, the patient experienced discomfort in vaccination site; a week from the report started with ganglion inflammation on the side he was applied the vaccine, clavicle inflammation and febricula on 09Sep2021. The patient reported that a week from this report, he began to have swollen lymph nodes on the side that was administered the vaccine, at the level of the clavicle (inflammation in the clavicular are and added he had a low-grade fever (37.3 C). The patient was prescribed ciprofloxacin 500mg for 7 days and analgesic (paracetamol / naproxen). The events were assessed serious, medically significant. The outcome of the events was unknown.


VAERS ID: 1729769 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-27
   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 FF2595 / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Erythema, Pain, Pruritus, Sensitive skin, Vaccination site pain
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC202101190312

Write-up: This is a spontaneous report from a noncontactable other healthcare professional, received via the regulatory authority (report number: 17547-9). A 26-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# FF2595; expiration date: Dec 31, 2021), at the age of 26, intramuscularly, in left arm, on Aug 27, 2021, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications not reported. The patient was not pregnant at the time of the vaccination. The patient had no infectious disease in the last 15 days prior to vaccination. No known allergies. The patient was healthy before vaccination. On Aug 27, 2021, patient experienced pain, sensitivity, erythema/redness and pruritus (medically significant). The patient indicated it started 20 minutes after vaccination with pruritus, cutaneous erythema and pain in the area of application (medically significant). The patient received dexamethasone 8mg, intramuscularly, single dose, as the treatment for the events. No treatment prior to receiving medical attention. No hospitalization required. The outcome of the events: unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1729770 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-27
   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 FF2595 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, Dizziness, Erythema
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy NOS
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: Body temperature; Result Unstructured Data: Test Result:Increased
CDC Split Type: MXPFIZER INC202101190318

Write-up: Skin erythema; Body temperature increased; Dizziness; This is a spontaneous report from a non-contactable Health Care Professional. This is a report receive from Regulatory authority report number is 17548-9. A 26-years-old non-pregnant female patient received the second dose of BNT162B2 (BNT162B2, Lot Number: FF2595; Expiration Date: 31Dec2021) intramuscularly, in the left arm, on 27Aug2021, at single dose, for COVID-19 immunisation. Relevant medical history included Allergy NOS (not specified) from an unknown date. Healthy before vaccination. No previously disease was reported. No infectious disease in the last 15 days prior to vaccination was reported. Concomitant medications were unknown. On 27Aug2021, 10 minutes after the vaccination, the patient experienced skin erythema, body temperature increased and dizziness. Treatment was received (Dexametasone 8 mg, intramuscular, single dose). Clinical outcome of the adverse events was unknown at time of his report. Events Supposedly Attributable to Vaccination or Immunization (ESAVI) type: not serious.


VAERS ID: 1729775 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-27
   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 FT8838 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Maternal exposure during pregnancy, Respiratory distress, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypersensitivity (broad), Respiratory failure (narrow), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC202101190356

Write-up: dyspnea / respiratory distress; dyspnea / respiratory distress; dizziness; tachycardia; Pregnant: Yes; This is a Spontaneous report from a non-contactable other healthcare professional. This is a report receive from regulatory authority via email. Regulatory authority report number is 17597-9. A 28-years-old pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in the left arm on 27Aug2021 at the age of 28 years old (Batch/Lot Number: FT8838; Expiration Date: 31Dec2021) as single dose for COVID-19 immunisation. Medical history included allergies from an unknown date. The patient''s concomitant medications were not reported. There was no infectious disease in the last days. Patient was healthy before vaccination. On 27Aug2021, 8 minutes after vaccination, patient experienced dizziness, tachycardia, dyspnea / respiratory distress. The patient was treated with oxygen at 4 liters per minute. The mother reported she became pregnant while taking BNT162B2. The mother was 9 weeks pregnant at the onset of the event. Patient was kept under observation and was discharged due to improvement. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1729923 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-27
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: Cold sweat, Myalgia, Pyrexia, Sciatica
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pollen allergy; Comments: Allergy to pollen, hay and latex dust.
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210943255

Write-up: Sciatica; Fever; Cold sweat; Muscle pain; This spontaneous report received from a consumer via a Regulatory Authority (EVHUMAN Vaccines, PT-INFARMED-T202109-373) was received on 22-SEP-2021 and concerned a 35 year old male. The patient''s weight was 74 kilograms, and height was 167 centimeters. The patient''s concurrent conditions included: pollen allergy, and other pre-existing medical conditions included: Allergy to pollen, hay and latex dust. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C11-05 expiry: UNKNOWN) .5 ml, 1 total administered on 26-AUG-2021 for covid-19 vaccination. No concomitant medications were reported. On 27-AUG-2021, the patient experienced fever, cold sweat. and muscle pain. On 28-AUG-2021, the patient experienced sciatica. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, cold sweat, and muscle pain on 30-AUG-2021, and the outcome of sciatica was not reported. This report was serious (Disability Or Permanent Damage).; Reporter''s Comments: Medicamento Concomitante-Nenhum Ocorreu Erro de Medica??o?-N?o sei Outras informa??es-Alergia ao p?len, fenos e p? do latex


VAERS ID: 1729947 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-27
   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 FE4721 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Chest discomfort, Chills, Electrocardiogram, Investigation, Myocarditis, Pyrexia, Troponin
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Lichen sclerosus; Vitiligo
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210829; Test Name: CRP; Result Unstructured Data: Test Result:110; Test Date: 20210829; Test Name: ECG; Result Unstructured Data: Test Result:general ST elevations; Comments: in chest leads; Test Name: ECO; Result Unstructured Data: Test Result:normal function; Comments: ECO showed normal left and right chamber function, no PEX and no regionality; Test Name: Troponin; Result Unstructured Data: Test Result:declining; Test Date: 20210829; Test Name: Troponin; Result Unstructured Data: Test Result:288
CDC Split Type: SEPFIZER INC202101180525

Write-up: Myocarditis; pressure in the chest; fever; chills; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number SE-MPA-2021-081243. A 30-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 27Aug2021 (Batch/Lot Number: FE4721) (at age 30-years-old) as dose 2, single for covid-19 immunisation. Medical history included vitiligo and lichen sclerosus; both ongoing. The patient''s concomitant medications were not reported. Reported suspect adverse event was myocarditis on 29Aug2021. Patient develop fever and chills on 27Aug2021. The next day debut of pressure in the chest on 28Aug2021. Persistent during the evening/night and the man then sought emergency care. At the emergency room on 29Aug2021: troponin 288, and CRP: 110 was found. ECG with general ST elevations in chest leads. No signs of failure in status, pulm with pure breathing sounds, cor without beeping / whistling sound. Three days of care with telemetry, no arrhythmias registered. Troponin declining. ECO showed normal left and right chamber function, no PEX and no regionality. The man was discharged from hospital prosperous. Planned to be followed up by the heart clinic and an examination with MRI heart would be performed. Outcome of the event of myocarditis was not recovered while for the other events was unknown. Case was reported assessed as serious, hospitalisation. No follow-up attempts possible. No further information expected.


VAERS ID: 1729993 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-27
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Blood pressure measurement, Body temperature, C-reactive protein, Chest X-ray, Chest discomfort, Cold sweat, Cough, Dyspnoea, Electrocardiogram, Haemoglobin, Headache, Heart rate, Oxygen saturation, Pyrexia, Respiratory distress, Respiratory rate, Urine analysis, White blood cell count
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Arthritis (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: Blood pressure; Result Unstructured Data: 115/74; Test Date: 20210804; Test Name: Body temperature; Result Unstructured Data: 38.4?; Test Date: 20210807; Test Name: Body temperature; Result Unstructured Data: Patient''s temperature dropped to 36?; Test Date: 20210803; Test Name: Chest X-ray; Result Unstructured Data: mild bilateral infiltration; Test Date: 20210803; Test Name: CRP; Result Unstructured Data: 0.44; Test Date: 20210803; Test Name: electrocardiogram; Result Unstructured Data: normal; Test Date: 20210803; Test Name: Hemoglobin; Result Unstructured Data: 12.8; Test Date: 20210803; Test Name: PR; Result Unstructured Data: 102; Test Date: 20210803; Test Name: SPO2; Result Unstructured Data: 100 %; Test Date: 20210803; Test Name: respiratory rate; Result Unstructured Data: abnormal; Test Date: 20210803; Test Name: RR; Result Unstructured Data: 20; Test Date: 20210804; Test Name: U/A; Test Result: Positive ; Result Unstructured Data: bacteria3+; Test Date: 20210803; Test Name: WBC; Result Unstructured Data: 15400; Test Date: 20210806; Test Name: WBC; Result Unstructured Data: 7980
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Mild cough; Shoulder aches; Headache; Fever; Cold sweat; Chest tightness; Shortness of breath when speaking; Mild respiratory distress (92-94%); This regulatory authority case was reported by a pharmacist and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever), COLD SWEAT (Cold sweat), CHEST DISCOMFORT (Chest tightness), DYSPNOEA (Shortness of breath when speaking), RESPIRATORY DISTRESS (Mild respiratory distress (92-94%)), COUGH (Mild cough) and ARTHRALGIA (Shoulder aches) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Aug-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 27-Aug-2021, the patient experienced HEADACHE (Headache) (seriousness criterion hospitalization), PYREXIA (Fever) (seriousness criterion hospitalization), COLD SWEAT (Cold sweat) (seriousness criterion hospitalization), CHEST DISCOMFORT (Chest tightness) (seriousness criterion hospitalization), DYSPNOEA (Shortness of breath when speaking) (seriousness criterion hospitalization) and RESPIRATORY DISTRESS (Mild respiratory distress (92-94%)) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced COUGH (Mild cough) (seriousness criterion hospitalization) and ARTHRALGIA (Shoulder aches) (seriousness criterion hospitalization). The patient was treated with KETOROLAC at a dose of 30 milligram; DIPHENHYDRAMINE at a dose of 30 milligram and CEPHALEXIN [CEFALEXIN] at a dose of 1 gram every eight hours. At the time of the report, HEADACHE (Headache), PYREXIA (Fever), COLD SWEAT (Cold sweat), CHEST DISCOMFORT (Chest tightness), DYSPNOEA (Shortness of breath when speaking), RESPIRATORY DISTRESS (Mild respiratory distress (92-94%)), COUGH (Mild cough) and ARTHRALGIA (Shoulder aches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Blood pressure measurement: 115/74 115/74. On 03-Aug-2021, C-reactive protein: 0.44 0.44. On 03-Aug-2021, Chest X-ray: mild bilateral infiltration (abnormal) mild bilateral infiltration. On 03-Aug-2021, Electrocardiogram: normal (normal) normal. On 03-Aug-2021, Haemoglobin: 12.8 12.8. On 03-Aug-2021, Heart rate: 102 102. On 03-Aug-2021, Oxygen saturation: 100 % 100 %. On 03-Aug-2021, Respiratory rate: 20 (abnormal) abnormal and 20 20. On 03-Aug-2021, White blood cell count: 15400 15400. On 04-Aug-2021, Body temperature: 38.4? 38.4?. On 04-Aug-2021, Urine analysis: bacteria3+ (Positive) bacteria3+. On 06-Aug-2021, White blood cell count: 7980 7980. On 07-Aug-2021, Body temperature: 36? (Low) Patient''s temperature dropped to 36?. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. On 03 Aug 2021, the patient started experienced cold sweat, chest tightness, shortness of breath, headache, shortness of breath when speaking and mild respiratory distress (92 - 94%) starting from about 3:00 p.m. The patient mentioned that he recently had mild cough. The electrocardiogram was normal and this was suspected to be a vaccine-related adverse reaction. )n 06 Aug 2021, the patient had a headache and shoulder aches and the pain was relieved after administering ketorolac 30mg/amp. On 07 Aug 2021, the patient''s temperature dropped to 36? and the Attending Physician said that the patient was in a stable condition after the ward round, and the patient was allowed to return home to rest. Company comment: This case concerns a 51 year-old, female without important medical history, who experienced the unexpected serious events (Hospitalization) of HEADACHE, PYREXIA, COLD SWEAT, CHEST DISCOMFORT, DYSPNOEA, RESPIRATORY DISTRESS, ARTHRALGIA and COUGH. The event occurred approximately x24 days after the second 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 51 year-old, female without important medical history, who experienced the unexpected serious events (Hospitalization) of HEADACHE, PYREXIA, COLD SWEAT, CHEST DISCOMFORT, DYSPNOEA, RESPIRATORY DISTRESS, ARTHRALGIA and COUGH. The event occurred approximately x24 days after the second 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: 1730630 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-08-27
   Days after vaccination:36
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: C-reactive protein, Fibrin D dimer, Inappropriate schedule of product administration, Pulmonary microemboli
SMQs:, Embolic and thrombotic events, venous (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: C-reactive protein; Result Unstructured Data: increased; Test Name: Fibrin D dimer; Result Unstructured Data: increased
CDC Split Type: DEMODERNATX, INC.MOD20213

Write-up: Pulmonary microemboli; Inappropriate schedule of vaccine administered; This case was received (Reference number: DE-PEI-202100187377) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PULMONARY MICROEMBOLI (Pulmonary microemboli) in a 66-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004671) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Aug-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 30-Aug-2021, the patient experienced PULMONARY MICROEMBOLI (Pulmonary microemboli) (seriousness criterion medically significant). On 27-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, PULMONARY MICROEMBOLI (Pulmonary microemboli) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: increased (High) increased. On an unknown date, Fibrin D dimer: increased (High) increased. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. Company comment: This is a case of Inappropriate schedule of product administration for this 66-year-old male patient with no relevant medical history reported, who experienced unexpected event of Pulmonary microemboli. The event occurred 4 days after the second dose of mRNA-1273. No adverse events reported after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translated document was received on 21-Sep-2021 included patient initials, lab data and first vaccination details.; Sender''s Comments: This is a case of Inappropriate schedule of product administration for this 66-year-old male patient with no relevant medical history reported, who experienced unexpected event of Pulmonary microemboli. The event occurred 4 days after the second dose of mRNA-1273. No adverse events reported after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1730824 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214018 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arrhythmia, Hypotension, Influenza like illness, Nausea, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210820; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Arrhythmia NOS; Arterial hypotension; Influenza like illness; Nausea; Skin breakout; This case was received (Reference number: FR-AFSSAPS-GR20213928) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Arrhythmia NOS) in a 40-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214018) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced ARRHYTHMIA (Arrhythmia NOS) (seriousness criterion medically significant), HYPOTENSION (Arterial hypotension), INFLUENZA LIKE ILLNESS (Influenza like illness), NAUSEA (Nausea) and RASH (Skin breakout). On 28-Aug-2021, HYPOTENSION (Arterial hypotension) and INFLUENZA LIKE ILLNESS (Influenza like illness) had resolved. On 29-Aug-2021, ARRHYTHMIA (Arrhythmia NOS) had resolved. On 30-Aug-2021, RASH (Skin breakout) had resolved. At the time of the report, NAUSEA (Nausea) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 26-Aug-2021. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. Company Comment: This case concerns a 40-year-old, male patient with no relevant medical history, who experienced the unexpected event of arrhythmia Nos. The event occurred approximately 2 days after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Spikevax is not affected by this report. Further information expected (English translation).; Reporter''s Comments: Sender''s Comments: This case concerns a 40-year-old, male patient with no relevant medical history, who experienced the unexpected event of arrhythmia Nos. The event occurred approximately 2 days after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Spikevax is not affected by this report. Further information expected (English translation).


VAERS ID: 1730837 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214021 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Decreased appetite, Influenza like illness, Localised oedema, Lymphadenopathy, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (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? 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: 20210804; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Chest pain; Neck oedema; Influenza like illness; Anorexia; Nausea; Lymphadenopathy cervical; This case was received via European Medicines Agency (Reference number: FR-AFSSAPS-RE20212463) 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 CHEST PAIN (Chest pain) and LOCALISED OEDEMA (Neck oedema) in a 49-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214021) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion medically significant), LOCALISED OEDEMA (Neck oedema) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Influenza like illness), DECREASED APPETITE (Anorexia), NAUSEA (Nausea) and LYMPHADENOPATHY (Lymphadenopathy cervical). At the time of the report, CHEST PAIN (Chest pain), LOCALISED OEDEMA (Neck oedema), INFLUENZA LIKE ILLNESS (Influenza like illness), DECREASED APPETITE (Anorexia), NAUSEA (Nausea) and LYMPHADENOPATHY (Lymphadenopathy cervical) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Aug-2021, SARS-CoV-2 test: negative (Negative) negative. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 26-Aug-2021. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information provided. No treatment medication information provided. Company Comment: This case concerns a 49 year-old female with no medical history provided, who experienced the unexpected events of Chest pain, Localised oedema, Influenza, and Decreased Appetite. With the expected events of Nausea and Lymphadenopathy. All events occurred approximately one day after the first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed.The event was considered related to the study drug per the reporter''s assessment.The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation document received on 21 SEP 2021 contains no new information; Sender''s Comments: This case concerns a 49 year-old female with no medical history provided, who experienced the unexpected events of Chest pain, Localised oedema, Influenza, and Decreased Appetite. With the expected events of Nausea and Lymphadenopathy. All events occurred approximately one day after the first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed.The event was considered related to the study drug per the reporter''s assessment.The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1730839 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004233 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Dizziness, Hypertension
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Vestibular disorders (broad)

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

Write-up: Hypertension; Asthenia; Giddiness; This case was received via regulatory authority (Reference number: FR-AFSSAPS-RN20212721) 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 HYPERTENSION (Hypertension) in a 49-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004233) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension arterial. On 27-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced HYPERTENSION (Hypertension) (seriousness criterion medically significant), ASTHENIA (Asthenia) and DIZZINESS (Giddiness). At the time of the report, HYPERTENSION (Hypertension), ASTHENIA (Asthenia) and DIZZINESS (Giddiness) had not resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications provided. No treatment medications provided. Company comment: This case concerns a 49-year-old, male patient with no relevant medical history, who experienced the unexpected serious event of hypertension and unexpected non-serious event of asthenia and dizziness on the same day after receiving Spikevax. The rechallenge is not applicable. The reporter assessed the events as possible. The benefit-risk relationship of Spikevax in not affected by this report.; Sender''s Comments: This case concerns a 49-year-old, male patient with no relevant medical history, who experienced the unexpected serious event of hypertension and unexpected non-serious event of asthenia and dizziness on the same day after receiving Spikevax. The rechallenge is not applicable. The reporter assessed the events as possible. The benefit-risk relationship of Spikevax in not affected by this report.


VAERS ID: 1730874 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-08-27
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002616 / UNK LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Headache, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: ; This case was received via regulatory authority (Reference number: NO-NOMAADVRE-E2B_00047707) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYALGIA , ARTHRALGIA and HEADACHE in a 53-year-old female patient who received mRNA-1273 (batch no. 3002616) for Vaccination. No Medical History information was reported. On 18-Aug-2021, the patient received dose of mRNA-1273 (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received dose of mRNA-1273 (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced MYALGIA (seriousness criterion hospitalization), ARTHRALGIA (seriousness criterion hospitalization) and HEADACHE (seriousness criterion hospitalization). At the time of the report, MYALGIA , ARTHRALGIA and HEADACHE had not resolved. For mRNA-1273 (Unknown), the reporter did not provide any causality assessments. Concomitant medications was not provided by the reporter. Treatment information was not provided This case concerns a 53-year-old, female patient with no previous relevant medical history, who experienced the expected events of Myalgia, Arthralgia and Headache. The event occurred approximately 10 days after the second dose of vaccine. The rechallenge was not applicable since only information about the second dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation received on 20-sep-2021 include no new information.; Reporter''s Comments: 09-sep-2021 : requested additional information. If new medical information is received, report will be updated.; Sender''s Comments: This case concerns a 53-year-old, female patient with no previous relevant medical history, who experienced the expected events of Myalgia, Arthralgia and Headache. The event occurred approximately 10 days after the second dose of vaccine. The rechallenge was not applicable since only information about the second dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity


VAERS ID: 1730888 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-27
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: 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: 20210828; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Positive Iu international unit(s)
CDC Split Type: PTJNJFOC20210937827

Write-up: COVID-19; VACCINE FAILURE; This spontaneous report received from a physician via a Regulatory Authority (PT-INFARMED-B202108-4058) on 20-SEP-2021 and concerned a 54 year old female of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C13-01 expiry: UNKNOWN) 0.5 ml, 1 total administered on 28-JUL-2021 for covid-19 immunisation. The duration of administration was 0 days. No concomitant medications were reported. On 27-AUG-2021, the patient experienced covid-19 and vaccine failure. On 28-AUG-2021, Laboratory data included: SARS-CoV-2 PCR test (NR: not provided) Positive Iu international unit (s). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 and vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint:90000194150.; Reporter''s Comments: Other information-Single dose on 28-Jul. Onset of symptoms on 25-Aug: dry cough, odynophagia and otalgia. Positive self-test on 27-Aug, Positive PCR on 28-Aug.


VAERS ID: 1732758 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-27
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: Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (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: Chronic renal failure; Ischaemic heart disease
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210945501

Write-up: Thrombopenia; This spontaneous report received from a pharmacist by a Regulatory Authority (EVHUMAN Vaccines, FR-AFSSAPS-GR20214167) was received on 23-SEP-2021 and concerned a 97 year old male. The patient''s weight was 68 kilograms, and height was not reported. The patient''s concurrent conditions included: ischaemic heart disease, and chronic renal failure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported and expiry: unknown) .5 ml, administered on 13-AUG-2021 for covid-19 vaccination. The batch number was not reported. As per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 27-AUG-2021, the patient experienced thrombopenia, and was hospitalized (date unspecified). Treatment with covid-19 vaccine ad26.cov2.s was withdrawn on 13-AUG-2021. The patient recovered from thrombopenia on 07-SEP-2021. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1732876 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-27
   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 - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Rash, Rash maculo-papular
SMQs:, Anaphylactic reaction (broad), 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:
Preexisting Conditions: Medical History/Concurrent Conditions: Pollen allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101251710

Write-up: Inappropriate schedule of vaccine administered/received bnt162b2 dose 1 on 08May2021/ received dose 2 on 27Aug2021; Generalised eruption; maculo-papular rash; This is a spontaneous report from a contactable consumer. This is the second of two reports. The first report was downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-AM20212437. A 48-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 27Aug2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included allergy to ash pollen. The patient''s concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY), dose 1 on 08May2021 (Batch/Lot number EX6537) as DOSE 1, SINGLE for covid-19 immunisation, and experienced Generalised eruption and Pruritus. Consultation with the allergist who proposed a protocol for the administration of the 2nd dose. Second dose in hospital on 27Aug2021 in 5 injections under anti-allergic protocol. Reappearance during monitoring of the rash on the folds of the elbows and neck, recovery in 3 days without further treatment. Onset of maculo-papular rash following vaccination with Comirnaty. The patient experienced generalised eruption, maculo-papular rash on 27Aug2021 with outcome of recovered in 2021, and assessed serious as Medically Significant, inappropriate schedule of vaccine administered on an unspecified date with outcome of unknown.


VAERS ID: 1733300 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7053 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Eye irritation, Facial pain, Facial paralysis, Swelling face, Throat irritation, Vision blurred
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Glaucoma (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Hearing impairment (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Drug allergy (Facial and mucosal swelling and rash. Not anaphylactic.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101194890

Write-up: Slight blurring of vision; Pain to touch below the orbital bone; Query bell''s palsy; Left sided facial swelling and drooping; Minor irritation of throat; Irritation of the left eye; Left sided facial swelling and dropping; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority. Regulatory authority number IE-HPRA-2021-083462, Safety Report Unique Identifier IE-HPRA-2021-083462. Initial report received by the HPRA on 27Aug2021 from a healthcare professional. A 23-years-old female patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number: FE7053), via an unspecified route of administration on 26Aug2021 as dose 1, 0.3 ml single for COVID-19 immunization. Medical history included drug allergy (facial and mucosal swelling and rash, not anaphylactic) from an unknown date and unknown if ongoing. The patient was not taking any concomitant medication. On 27Aug2021, 20 hours later the patient experienced left sided facial swelling and dropping, pain to touch below the orbital bone, irritation of the left eye, slight blurring of vision and minor irritation of throat. It was reported that the patient was referred to primary care GP for follow up regarding possible diagnosis/query Bell''s Palsy. The patient was treated with hypromellose eye drops (brand unspecified) and ibuprofen (brand unspecified). At the time of reporting, the patient''s symptoms were continuing. The reporter considered the events as serious (medically significant). The outcome of events was not resolved. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1733448 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Epilepsy, Heart rate, Heart rate increased, Hypertonia, Oral discharge, Oxygen saturation, Oxygen saturation decreased, Seizure
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Parkinson-like events (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (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: Cerebral palsy; Constipation; Epilepsy; Gastric fistula repair; Haemangioma cavernous; Hypertension; Intellectual disability; Intra-cerebral haemorrhage; Seizure
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:146/107 mmHg; Comments: 03:00; Test Date: 20210827; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:159/112 mmHg; Comments: 03:10; Test Date: 20210827; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:209/112 mmHg; Comments: 03:30; Test Date: 20210827; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:129/51 mmHg; Comments: 04:00; Test Date: 20210825; Test Name: body temperature; Result Unstructured Data: Test Result:35.6 Centigrade; Comments: before the vaccination; Test Date: 20210827; Test Name: Heart rate; Result Unstructured Data: Test Result:120-130; Comments: /min(03:00); Test Date: 20210827; Test Name: Heart rate; Result Unstructured Data: Test Result:120-130; Comments: /min(03:10); Test Date: 20210827; Test Name: Heart rate; Result Unstructured Data: Test Result:119; Comments: /min(03:30); Test Date: 20210827; Test Name: SpO2; Result Unstructured Data: Test Result:88-90 %; Comments: 03:00; Test Date: 20210827; Test Name: SpO2; Test Result: 95 %; Comments: 03:10; Test Date: 20210827; Test Name: SpO2; Test Result: 94 %; Comments: 03:30
CDC Split Type: JPPFIZER INC202101192899

Write-up: Epilepsy; Convulsion; Hypertonia; Oral discharge blowout from the oral cavity; Oxygen saturation decreased (88-90%); blood pressure 146/107 mmHg; HR 120-130/min; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21126541. A 52-year-old (also reported as 52-year and 7-month-old) male patient received bnt162b2 (COMIRNATY, solution for injection; Batch/Lot Number: EY0573; Expiration Date: 30Sep2021) via an unspecified route of administration on 25Aug2021 09:40 (the day of vaccination)(at the age of 52-year-old) as dose 2, single for COVID-19 immunisation. Body temperature before vaccination was 35.6 centigrade on 25Aug2021. There were points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) as follows: cerebral palsy, intellectual disability, epilepsy, sequelae of Intra-cerebral haemorrhage, hypertension, constipation, intracranial multiple cavernous hemangioma, after gastric fistula construction, seizure when having intracerebral hemorrhage; Patient previously took Phenobarbital by oral, Norvasc by oral, GOOFICE and PICOPREP by oral. On 27Aug2021 at 03:00 (two days after the vaccination; as reported), the patient experienced convulsion. The course of the event was as follows: On 27Aug2021 at 03:00, the patient experienced hypertonia, oral discharge blowout from the oral cavity, oxygen saturation decreased (88-90%), Blood pressure 146/107 mmHg, HR 120-130/min and Oxygen 3L/min was used. At 03:10, SpO2: 95%, HR 120-130/min, Blood pressure 159/112 mmHg. At 03:20 DIAPP was used. At 03:30, Blood pressure 209/112 mmHg, HR 119/min, SpO2: 94%. Oral medicine in the morning was administered as soon as possible. At 04:00, Blood pressure 129/51 mmHg decreased, SpO2 also improved. At 05:30, stopped the Oxygen and then vital signs were not considered abnormal. From the progress, judged this episode to be Convulsion. On 27Aug2021 (two days after the vaccination), the outcome of the events was recovered. The reporter classified the events as non-serious and the causality between the events and bnt162b2 as unassessable (as reported). Other possible cause(s) of the event such as any other diseases was Epilepsy. Reporter Comment: The patient took Phenobarbital orally and Epilepsy was controlled well. The patient didn''t have seizures except when having intracerebral hemorrhage. Clinically, as a causality, it was probably related to bnt162b2 (as reported). No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: The patient took Phenobarbital orally and Epilepsy was controlled well. The patient didn''t have seizures except when having intracerebral hemorrhage. Clinically, as a causality, it was probably related to bnt162b2 (as reported).


VAERS ID: 1733602 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-27
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Heart rate, PO2, Respiratory rate
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylaxis
Allergies:
Diagnostic Lab Data: Test Name: BP; Result Unstructured Data: Test Result:180/80; Test Name: P; Result Unstructured Data: Test Result:106; Test Name: P02; Result Unstructured Data: Test Result:$g100%; Test Name: RR; Result Unstructured Data: Test Result:20
CDC Split Type: NZPFIZER INC202101204995

Write-up: Anaphylactic reaction; This is a spontaneous report from a contactable RA vaccinator (other HCP) via Regulatory Authority. Regulatory authority report number is AEFI-A-013030. A 32-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 27Aug2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included multiple anaphylaxis to multiple allergens. Concomitant medications were not reported. The patient experienced anaphylactic reaction on 27Aug2021 15:30 with outcome of recovering. The event required a visit to the emergency room. The patient underwent lab tests and procedures which included on 27Aug2021: blood pressure measurement: 180/80; heart rate: 106; po2: $g100%; respiratory rate: 20. Therapeutic measures were taken as a result of anaphylactic reaction. Seriousness criteria of the event was reported as medically significant. The clinical course was reported as follows: KNown Multiple anaphylaxis to multiple allergens $g pt recognized what was happening , laid on floor , legs elevated, Given 0.5 ml Adrenalin IMI at 1533 with good response after 5mins Given high flow Oz as well for 3 mins Ambulance called & transferred to ED for observation P02 $g 100 % , BP 180/80, P =106, RR 20. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1733727 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-08-27
   Days after vaccination:44
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Limb discomfort, Rash, Vaccination site erythema, Vaccination site swelling
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Skin rash (non-injection site); Redness at the vaccination site; Swelling at the vaccination site; Left upper pain; This regulatory authority case was reported by a pharmacist and describes the occurrence of RASH (Skin rash (non-injection site)), VACCINATION SITE ERYTHEMA (Redness at the vaccination site), VACCINATION SITE SWELLING (Swelling at the vaccination site) and LIMB DISCOMFORT (Left upper pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 27-Aug-2021, the patient experienced RASH (Skin rash (non-injection site)) (seriousness criterion medically significant), VACCINATION SITE ERYTHEMA (Redness at the vaccination site) (seriousness criterion medically significant), VACCINATION SITE SWELLING (Swelling at the vaccination site) (seriousness criterion medically significant) and LIMB DISCOMFORT (Left upper pain) (seriousness criterion medically significant). The patient was treated with CLARITHROMYCIN (oral) at a dose of 500 mg twice a day; SULTAMICILLIN (UNASYNE [SULTAMICILLIN]) (oral) at a dose of UNK, bid; LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) (oral) at a dose of UNK, bid and FLUOCINONIDE (TOPSYM) at a dose of .005 percent once a day. At the time of the report, RASH (Skin rash (non-injection site)), VACCINATION SITE ERYTHEMA (Redness at the vaccination site), VACCINATION SITE SWELLING (Swelling at the vaccination site) and LIMB DISCOMFORT (Left upper pain) 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 medication information was mentioned by reporter The patient orally took clarithromycin 500 mg 1# BID+ NSAID+ antihistamine and orally took Unasyn 1#BID, Xyzal 1#BID, Deplyretin 1#BID and Topsym cream 0.05% qs QD for 7-day treatment. Company Comment: This case concerns a 76-year-old female with serious unexpected events of rash, vaccination site erythema, vaccination site swelling and limb discomfort. Latency 44 days after mRNA-1273. Event outcomes unknown. Rechallenge not reported. Reporter causality not provided. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 76-year-old female with serious unexpected events of rash, vaccination site erythema, vaccination site swelling and limb discomfort. Latency 44 days after mRNA-1273. Event outcomes unknown. Rechallenge not reported. Reporter causality not provided. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1736117 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-27
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: Deep vein thrombosis, SARS-CoV-2 test positive
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210820; Test Name: SARS-CoV-2 test positive; Result Unstructured Data: Positive
CDC Split Type: NLJNJFOC20210942496

Write-up: Deep vein thrombosis leg; This spontaneous report received from a consumer via regulatory authority (EVHUMAN Vaccines, NL-LRB-00677500) on 22-SEP-2021 concerned a 21 year old male of an unspecified race and ethnic origin. The patient''s weight was 82 kilograms, and height was 183 centimeters. The patient''s past medical history included: Covid-19. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD974, and expiry: unknown) 1 dosage forms, 1 total was administered on 06-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 20-AUG-2021, he underwent, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test which was positive. On 27-AUG-2021, the patient had deep vein thrombosis leg. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from deep vein thrombosis leg. This report was serious (Life Threatening).


VAERS ID: 1736128 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-27
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: 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? 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: Sudoresis; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: SARS-CoV-2 test; Result Unstructured Data: Positive Iu international unit(s)
CDC Split Type: PTJNJFOC20210945486

Write-up: VACCINATION FAILURE; This spontaneous report received from a health care professional via Regulatory Authority (EVHUMAN Vaccines, PT-INFARMED-T202109-535) on 23-SEP-2021 and concerned a 29 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: sudoresis, and suspected covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 expiry: UNKNOWN) 0.5 ml, 1 total, administered on 17-JUL-2021 for covid-19 immunisation. The drug start period was 41 days. No concomitant medications were reported. On 27-AUG-2021, the patient experienced vaccination failure. Laboratory data included: SARS-CoV-2 test (NR: not provided) Positive Iu international unit (s). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccination failure on 04-SEP-2021. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint; Reporter''s Comments: Other information: INFECTION BY COVID-19 on 28-Aug-2021; R29.01 SUSPECTED INFECTION BY COVID-19 on 09-Nov-2020; A09 SUDORESIS PROBLEM


VAERS ID: 1736333 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-27
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Muscle ache; Light headedness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25946104) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness) and MYALGIA (Muscle ache) in a 38-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No Medical History information was reported. On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced DIZZINESS (Light headedness) (seriousness criterion medically significant). On 29-Aug-2021, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant). At the time of the report, DIZZINESS (Light headedness) and MYALGIA (Muscle ache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient advised ache all over and lymph node above the collar bone get swollen. Concomitant medications were not reported. No treatment details were provided. Company comment: This case concerns a 38-year-old male subject, who experienced the unexpected events of Dizziness and Myalgia. The events occurred approximately 7 days after the first dose of Moderna COVID-19 Vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 38-year-old male subject, who experienced the unexpected events of Dizziness and Myalgia. The events occurred approximately 7 days after the first dose of Moderna COVID-19 Vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1736409 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004224 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Face oedema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Edema upper extremities; Edema of lower extremities; Edema lips & face; This case was received via Regulatory Authority (Reference number: NO-NOMAADVRE-E2B_00046686) 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 EDEMA PERIPHERAL (Oedema upper extremities), EDEMA PERIPHERAL (Edema of lower extremities) and FACE OEDEMA (Oedema lips & face) in a 20-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004224) for Vaccination. No Medical History information was reported. On 25-Aug-2021 at 2:45 PM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced EDEMA PERIPHERAL (Edema upper extremities) (seriousness criterion hospitalization), EDEMA PERIPHERAL (Oedema of lower extremities) (seriousness criterion hospitalization) and FACE EDEMA (Edema lips & face) (seriousness criterion hospitalization). On 28-Aug-2021, OEDEMA PERIPHERAL (Edema upper extremities), OEDEMA PERIPHERAL (Edema of lower extremities) and FACE EDEMA (Edema lips & face) was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered EDEMA PERIPHERAL (Oedema upper extremities), EDEMA PERIPHERAL (Oedema of lower extremities) and FACE EDEMA (Oedema lips & face) to be possibly related. Concomitant medication use information was not provided by reporter. Treatment information included hydrocortisone (injection or infusion) and dexchlorpheniramine with effect. The patients condition improved. Company Comment: This case concerns a 20-year-old, female patient with no previous relevant medical history, who experienced the unexpected events of edema peripheral of upper and loer extremities and face edema. The events occurred 2 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation received on 22-sep-2021, updated narrative.; Sender''s Comments: This case concerns a 20-year-old, female patient with no previous relevant medical history, who experienced the unexpected events of edema peripheral of upper and loer extremities and face edema. The events occurred 2 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.


VAERS ID: 1736554 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3716 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Investigation, Malaise, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cow''s milk allergy; Gluten intolerance; Pollen allergy
Allergies:
Diagnostic Lab Data: Test Name: examination; Result Unstructured Data: Test Result:unknown result
CDC Split Type: BEPFIZER INC202101194411

Write-up: Headache; Myalgia; Fever; Feeling unwell; Shivering; Nausea; This is a spontaneous report from a contactable Consumer downloaded from the Regulatory Authority-WEB BE-FAMHP-DHH-N2021-106364. A 14-year-old male patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 26Aug2021 (Lot Number: FG3716) as single dose for covid-19 immunisation. Medical history included cow''s milk allergy, gluten allergy, pollen allergy. The patient''s concomitant medications were not reported. The patient experienced headache, myalgia, fever, feeling unwell, shivering, nausea (all disability) on 27Aug2021. Antipyretic agent pain reliever after examination by primary care provider. The outcome of the events was recovered on 29Aug2021. Reporter comment: Treatment - Yes antipyretic agent pain reliever after examination by primary care provider. Evolution of the adverse drug reaction - Recovered. Situations - Other: new vaccine - there hasn''t been enough time for extensive testing on young people. Adverse drug reaction description - fever blazing headache inability to function. Batch/lot no: FG3716 No follow-up attempts are needed. No further information is expected.; Reporter''s Comments: Treatment - Yes antipyretic agent pain reliever after examination by primary care provider. Evolution of the adverse drug reaction - Recovered. Situations - Other: new vaccine - there hasn''t been enough time for extensive testing on young people. Adverse drug reaction description - fever blazing headache inability to function.


VAERS ID: 1737680 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-27
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101213278

Write-up: Myocarditis; Chest pain; This is a spontaneous report from a contactable healthcare professional via the Regulatory Authority. The regulatory authority report number is 620123. A 45-year-old female patient received the dose of BNT162B2 (COMIRNATY solution for injection; lot number and expiration date not reported), via an unspecified route of administration on 19Aug2021 (at an unspecified age) at dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 27Aug2021, 8 days after the vaccination, the patient experienced myocarditis and chest pain. Outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1737829 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-27
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E021A / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Sinus tachycardia raised by 0.2 mV (millivolt) in; Comments: Sinus tachycardia raised by 0.2 mV (millivolt) in precordial leads; Test Date: 20210827; Test Name: Heart enzymes; Result Unstructured Data: Test Result:normal
CDC Split Type: DEPFIZER INC202101194275

Write-up: Myocarditis; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Agency (RA)-WEB [DE-PEI-202100185667]. A 17-year-old male patient received the second dose of BNT162B2 (COMIRNATY solution for injection; lot number: 1E021A), via an unspecified route of administration on 16Aug2021 (at the age of 17-years-old) at dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (COMIRNATY; lot number: FC1436) received on 12Jul2021 (at the age of 17-years-old) for COVID-19 immunisation. On 27Aug2021, the patient experienced myocarditis. The patient was hospitalized on an unspecified date in 2021 due to myocarditis. On 27Aug2021, the patient underwent electrocardiogram with result "Sinus tachycardia raised by 0.2 mV (millivolt) in precordial leads" and heart enzymes with result "normal". Outcome of the events was recovered on 04Sep2021. Relatedness of the events to BNT162B2 (COMIRNATY) was B. indeterminate (source of assessment: agency). Sender''s comment: Electrocardiogram on 27Aug2021: Sinus tachycardia raised by 0.2 mV (millivolt) in precordial leads, and heart enzymes on 27Aug2021: normal. First vaccination with BNT162B2 (COMIRNATY; lot number: FC1436) was in 12Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1737970 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-27
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8405 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chronic obstructive pulmonary disease
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to metals
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101194629

Write-up: COPD exacerbation; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-CADR2021176729. Sender''s Safety Report Unique Identifier: DE-PEI-202100186093. A 66-years-old female patient received the second dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 20Aug2021 (Lot Number: FE8405) as dose 2, single for covid-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease (COPD), Chrome/nickel allergy. The patient''s concomitant medications were not reported. Historical Vaccine included the first dose of bnt162b2 (COMIRNATY) on an unspecified date for covid-19 immunisation. On 27Aug2021, the patient experienced COPD exacerbation, treatment with prednisolone 50mg for 5 days. Outcome of the event was not recovered. This report is serious with seriousness criteria of medically significant. Result of assessment (source: regulatory authority) unclassifiable No follow-up activities possible. No further information expected.


VAERS ID: 1738134 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-27
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214013 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood glucose, Blood urea, Chest X-ray, Chest pain, Coagulation test, Echocardiogram, Electrocardiogram, Full blood count, Laboratory test, Pericarditis, Pharyngeal exudate, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: Chemistry NOS ( glucose); Result Unstructured Data: 102 mg/dL; Test Date: 20210827; Test Name: Urea; Result Unstructured Data: 36.7 mg/dL; Test Date: 20210827; Test Name: CXR; Result Unstructured Data: No nodules or opacities are observed in the lung parenchyma. No signs of pleural disease are identified. Cardiothoracic ratio and mediastinum within the normal limit. No bone or soft tissue lesions are identified. No findings of pathological significance..; Test Date: 20210827; Test Name: Abnormal coagulation profile; Result Unstructured Data: Coagulation study: Patient (PT) 15.4 sec, Ratio (PT) 1.4 R, Activity (Quick Index) 61(70-130)%, INR 1.4 INR, Patient (aPTT) 29.3 sec, Ratio (aPTT) 0.95, Derived fibrinogen 5.65(2-4)g/L, D-dimer 561(0-500)ngr/mL; Test Date: 20210827; Test Name: Echocardiography; Result Unstructured Data: Echocardiogram: Fine line of pericardial effusion visible in the long axis and subcostal planes.; Test Date: 20210827; Test Name: ECG; Result Unstructured Data: Sinus rhythm. HR: 78 bpm. Generalized concave ST elevation. Slight decrease of PR segment in derivation [cohort.] No signs of repolarization [disturbances].; Test Date: 20210827; Test Name: Hemogram; Result Unstructured Data: Hemoglobina 14.1 g/dL; Hematies 5.01 10^6/microL; Hematocrito 40.8 %. Leucocitos 9.60 10^3/microL (Neutr?filos 64.0 % (40-62); Linfocitos 19.5 % (19-48); Monocitos 15.3 % (3-10)). Plaquetas 161.0 10^3/microL. VSG 13 mm (3-12).; Test Date: 20210827; Test Name: Chemistry NOS; Result Unstructured Data: Bioqu?mica: Glucosa 102 mg/dL, Urea 36.7 mg/dL, Creatinina (enzim?tica) 0.82 mg/dL, Sodio 136 mmol/L, Potasio 3.7 mmol/L, Cloro 103 mmol/L, Bilirrubina total 0.45 mg/dL, GPT (ALT) 24.8 U/L, GOT (AST) 27.0 U/L, Gamma GT 13.0 U/L, Fosfatasa alcalina 71.0(74-390)U/L, CPK - Creat?n kinasa 193 U/L, PCR 5.75(0.5) mg/dL, Procalcitonina 0.27 ng/mL. Troponina I de alta sensibilidad 16.6(34)pg/mL, CK - MB Masa 0.60(<5.20)ng/mL; Test Date: 20210827; Test Name: Pharyngeal exudate; Result Unstructured Data: Bordetella pertussis y parapertussis, Chlamydia pneumoniae, Mycoplasma pneumoniae: Negativos. T?cnica: RT-PCR en tiempo real de VRS, Virus Influenza A, Influenza B, Virus Respiratorio Sincitial, Coronavirus: negativos. Mediante PCR se analiza presencia de ADN de Adenovirus y ARN de Coronavirus (NL63, OC43, 229E, HKU1 y MERS-CoV), Enterovirus/Rinovirus, Metapneumovirus y Virus Parainfluenza (1, 2, 3 y 4): Negativo
CDC Split Type: ESMODERNATX, INC.MOD20213

Write-up: Pericarditis; Thoracic pain; Fever; This case was initially received via Regulatory Agency (Reference number: ES-AEMPS-995618) on 17-Sep-2021. The most recent information was received on 17-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 PERICARDITIS (Pericarditis), CHEST PAIN (Thoracic pain) and PYREXIA (Fever) in a 14-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 3005695 and 214013) for COVID-19 vaccination. No Medical History information was reported. On 29-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 26-Aug-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced PERICARDITIS (Pericarditis) (seriousness criteria hospitalization prolonged and medically significant), CHEST PAIN (Thoracic pain) (seriousness criterion hospitalization prolonged) and PYREXIA (Fever) (seriousness criterion hospitalization prolonged). On 28-Aug-2021, PYREXIA (Fever) had resolved. At the time of the report, PERICARDITIS (Pericarditis) and CHEST PAIN (Thoracic pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, Blood glucose: 102 mg/dl (normal) 102 mg/dL. On 27-Aug-2021, Blood urea: 36.7 mg/dl (High) 36.7 mg/dL. On 27-Aug-2021, Chest X-ray: No nodules or opacities are observed in the lung parenchyma. No signs of pleural disease are identified. Cardiothoracic ratio and mediastinum within the normal limit. No bone or soft tissue lesions are identified. No findings of pathological significance... On 27-Aug-2021, Coagulation test: abnormal (abnormal) Coagulation study: Patient (PT) 15.4 sec, Ratio (PT) 1.4 R, Activity (Quick Index) 61(70-130)%, INR 1.4 INR, Patient (aPTT) 29.3 sec, Ratio (aPTT) 0.95, Derived fibrinogen 5.65(2-4)g/L, D-dimer 561(0-500)ngr/mL. On 27-Aug-2021, Echocardiogram: normal (normal) Echocardiogram: Fine line of pericardial effusion visible in the long axis and subcostal planes.. On 27-Aug-2021, Electrocardiogram: normal (normal) Sinus rhythm. HR: 78 bpm. Generalized concave ST elevation. Slight decrease of PR segment in derivation [cohort.] No signs of repolarization [disturbances].. On 27-Aug-2021, Full blood count: Hemoglobina 14.1 g/dL; Hematies 5.01 10^6/microL; Hematocrito 40.8 %. Leucocitos 9.60 10^3/microL (Neutr?filos 64.0 % (40-62); Linfocitos 19.5 % (19-48); Monocitos 15.3 % (3-10)). Plaquetas 161.0 10^3/microL. VSG 13 mm (3-12).. On 27-Aug-2021, Laboratory test: Bioqu?mica: Glucosa 102 mg/dL, Urea 36.7 mg/dL, Creatinina (enzim?tica) 0.82 mg/dL, Sodio 136 mmol/L, Potasio 3.7 mmol/L, Cloro 103 mmol/L, Bilirrubina total 0.45 mg/dL, GPT (ALT) 24.8 U/L, GOT (AST) 27.0 U/L, Gamma GT 13.0 U/L, Fosfatasa alcalina 71.0(74-390)U/L, CPK - Creat?n kinasa 193 U/L, PCR 5.75(0.5) mg/dL, Procalcitonina 0.27 ng/mL. Troponina I de alta sensibilidad 16.6(34)pg/mL, CK - MB Masa 0.60(<5.20)ng/mL. On 27-Aug-2021, Pharyngeal exudate: Bordetella pertussis y parapertussis, Chlamydia pneumoniae, Mycoplasma pneumoniae: Negativos. T?cnica: RT-PCR en tiempo real de VRS (Exudado nasofaringeo), Virus Influenza A, Influenza B, Virus Respiratorio Sincitial, Coronavirus: negativos. Mediante PCR se analiza presencia de ADN de Adenovirus y ARN de Coronavirus (NL63, OC43, 229E, HKU1 y MERS-CoV), Enterovirus/Rinovirus, Metapneumovirus y Virus Parainfluenza (1, 2, 3 y 4): Negativo. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 29-Jul-2021. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment information was provided. This case concerns a 14-year-old, male patient with no relevant medical history, who experienced the unexpected event of Chest pain and the expected events of Pericarditis, Pyrexia. The events occurred around 2 days after the second dose of Spikevax. The rechallenge was not applicable since no events were reported after the first dose. The events Pericarditis and Pyrexia 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 17-Sep-2021: Follow-Up received translation document, updating lab data result; Sender''s Comments: This case concerns a 14-year-old, male patient with no relevant medical history, who experienced the unexpected event of Chest pain and the expected events of Pericarditis, Pyrexia. The events occurred around 2 days after the second dose of Spikevax. The rechallenge was not applicable since no events were reported after the first dose. The events Pericarditis and Pyrexia 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: 1738357 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-08-27
   Days after vaccination:199
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: Delta variant
CDC Split Type: FRPFIZER INC202101194693

Write-up: Vaccination failure; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-GR20213909. A 89-year-old female patient received bnt162b2 (COMIRNATY, formulation: Solution for injection, EJ6788; Expiration Date: 30Apr2021), via an intramuscular on 19Jan2021 as dose 1, single and 2nd dose via an intramuscular on 09Feb2021 as dose 2, 0.3 ml single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 27Aug2021, the patient experienced vaccination failure and COVID-19 confirmed by positive COVID-19 test. On the same day, the patient was hospitalized for vaccination failure and COVID-19. On 27Aug2021, the patient underwent lab tests and procedures which included SARS-CoV-2 PCR test: positive (Delta variant). The outcome of the events was recovering. New information provided from division Regulatory Authority includes results: 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 lots of the reported lot EJ6788. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The Regulatory Authority process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible, no further information is expected.; Reporter''s Comments: Hospitalization of an Accommodation facility for dependent elderly people resident with a complete vaccination schedule due to desaturation. COVID + variant delta.


VAERS ID: 1738381 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7051 / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Immunisation reaction, Pyrexia, Tremor, Vaccination site hypoaesthesia, Vaccination site paraesthesia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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:
CDC Split Type: FRPFIZER INC202101195021

Write-up: This is a spontaneous report from a contactable consumer, downloaded via the regulatory authority (FR-AFSSAPS-LL20216189). A 23-year-old male patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# FE7051), at the age of 23, intramuscularly, in right arm, on Aug 27, 2021, at 15:05, single dose, for COVID-19 immunisation. The patient''s medical history and the concomitant medications not reported. The patient experienced trembling, reactogenicity and injected arm numbness with tingling, fever, vomiting on Aug 27, 2021 (the same evening). The reactions required a sick leave on Saturday. Some resolution of the reactions on Aug 29, 2021. The outcome of tremble, reactogenicity: not recovered. Trembling and reactogenicity assessed serious (medically significant). No follow-up attempts needed. No further information expected.


VAERS ID: 1738448 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-08-27
   Days after vaccination:119
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood electrolytes, Coma scale, Computerised tomogram aorta, Computerised tomogram head, Full blood count, Headache, Magnetic resonance imaging head, Paraesthesia, Paraesthesia oral, Physical examination, Renal function test, SARS-CoV-2 test, Transient ischaemic attack
SMQs:, Peripheral neuropathy (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; COVID-19 (COVID-19 infection in Jun2021)
Allergies:
Diagnostic Lab Data: Test Name: blood count; Result Unstructured Data: Test Result:No abnormalities; Test Name: blood electrolytes; Result Unstructured Data: Test Result:No abnormalities; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:15; Test Name: Cerebral angiography computed tomography + supra-aortic trunks; Result Unstructured Data: Test Result:no ischemic or haemorrhagic lesion; Comments: No carotid lesion, good permeability of the four arterial axes leading to the brain with a threadlike left vertebral artery ending in posterior inferior cerebellar artery.; Test Name: Cerebral angiography computed tomography + supra-aortic trunks; Result Unstructured Data: Test Result:no ischemic or haemorrhagic lesion; Comments: No carotid lesion, good permeability of the four arterial axes leading to the brain with a threadlike left vertebral artery ending in posterior inferior cerebellar artery.; Test Name: cerebral magnetic resonance imaging; Result Unstructured Data: Test Result:no ischaemic or haemorrhagic lesion; Test Name: Physical examination; Result Unstructured Data: Test Result:no focal neurological deficit; Comments: no spatio-temporal disorientation, no sensory-motor deficit, no ataxia, no aphasia. No cardiopulmonary or abdominal examination abnormality.; Test Name: renal function; Result Unstructured Data: Test Result:No abnormalities; Test Date: 20210828; Test Name: COVID 19 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101194500

Write-up: paraesthesia of the face and left limb; paraesthesia of the face and left limb; Headache; serious asthenia; Transient ischaemic attack; paraesthesia of the left lip; This is a spontaneous report from a contactable physician downloaded from a Regulatory Authority, regulatory authority number FR-AFSSAPS-NC20214068. A 49-year-old female patient received the second dose of BNT162B2 (COMIRNATY) via intramuscular on the left arm on 30Apr2021 (Batch/Lot Number: ET6956) as single dose for COVID-19 immunization. Medical history included asthma and unknown if ongoing and COVID-19 infection from Jun2021. Concomitant medication was not reported. On 27Aug2021, the patient experienced transient ischaemic attack and paraesthesia of the left lip lasting less than an hour. On 28Aug2021, the patient experienced paraesthesia of the face and left limb that regressed in less than an hour, headache and serious asthenia. The events resulted in hospitalization from an unknown date to 30Aug2021. Hospitalisation in vascular medicine. Patient Glasgow 15. Bolus of Kardegic in the emergency room then hospitalisation in vascular medicine. Then long-term initiation of treatment with Kardegic and Tahor. Good clinical course recurrence of an episode of paraesthesia of the left foot spontaneously regressive. Returned home on 30Aug2021. Other treatments included antipyretic. The patient underwent lab tests and procedures which included blood count: no abnormalities, blood electrolytes: no abnormalities, cerebral angiography computed tomography + supra-aortic trunks: no ischemic or haemorrhagic lesion. No carotid lesion, good permeability of the four arterial axes leading to the brain with a threadlike left vertebral artery ending in posterior inferior cerebellar artery, computerised tomogram head: no ischemic or haemorrhagic lesion. No carotid lesion, good permeability of the four arterial axes leading to the brain with a threadlike left vertebral artery ending in posterior inferior cerebellar artery, magnetic resonance imaging head: no ischaemic or haemorrhagic lesion, renal function test: no abnormalities, sars-cov-2 test: negative on 28Aug2021, Glasgow coma scale: 15, physical examination: no focal neurological deficit no spatio-temporal disorientation, no sensory-motor deficit, no ataxia, no aphasia. No cardiopulmonary or abdominal examination abnormality. Therapeutic measures were taken for events. The outcome of events was unknown. No follow-up attempts are possible. No further information expected.


VAERS ID: 1738539 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-27
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Phlebitis deep
SMQs:, Thrombophlebitis (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101228450

Write-up: Phlebitis deep; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB FR-AFSSAPS-PC20213601. A 58-year-old male patient received first dose of bnt162b2 (COMIRNATY) intramuscular in left arm 0.3 ml single for covid-19 immunisation on 17Aug2021 at 58-year-old. The patient medical history was not reported. No COVID-19 history, COVID-19 test not performed. The patient''s concomitant medications were not reported. The patient experienced phlebitis deep, had diagnosis of phlebitis of the left lower limb (life threatening) on 27Aug2021 with outcome of not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1738669 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Echocardiogram, Hypertension, Hypotension, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypertension (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: Cardiac assessment (ultrasound); Result Unstructured Data: Test Result:pending; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101194552

Write-up: Hypertension; Hypotension; Arrhythmia NOS; fever; This is a spontaneous report from a contactable pharmacist downloaded from the WEB, regulatory authority number FR-AFSSAPS-TS20214054. A 39-year-old male patient received bnt162b2 (COMIRNATY) Intramuscularly on 25Aug2021 at the age of 39-year-old (Lot: FG6273) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On Day 2 after Comirnaty, heart rhythm disorder/arrhythmia/Arrhythmia NOS, rise and fall of blood pressure/hypotension and hypertension. Fever. The patient underwent lab test and procedure which included, SARS COV-2 test with result of negative. Cardiac assessment (ultrasound) pending. Event fever was reported as non-serious and other events was reported as serious due to Medically significant. The outcome of the event Fever was unknown, of others was Recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1738838 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-27
   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 - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Heart rate increased, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (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: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101211393

Write-up: Pulse rapid; Fatigue; Headache; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109141949342810-2VRB4, Safety Report Unique Identifier (GB-MHRA-ADR 25940962). A 43-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number and Expiration date was not reported) via an unspecified route of administration on 27Aug2021 (at the age of 43-years-old) as dose 2, single for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number and Expiration date was not reported), via an unspecified route of administration, on an unknown date, as dose 1, single for COVID-19 immunization. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 27Aug2021, the patient experienced fatigue and headache. On 31Aug2021, the patient had experienced pulse rapid. On 27Aug2021, the patient underwent SARS-COV-2 test which resulted negative. Outcome of the events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1739522 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-08-27
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101195530

Write-up: Miscarriage at about 7 weeks; This is a spontaneous report from a contactable consumer or other non hcp (patient) downloaded from the Regulatory Authority-WEB NL-LRB-00681317. A 26-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 01Jul2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. No previous COVID-19 infection. The patient experienced miscarriage at about 7 weeks on 27Aug2021. This was the first Covid vaccination, which took place before pregnancy. The outcome was unknown. Sender Comment: Since the nature of the reported reaction does imply seriousness according to one of the CIOMS critera, the reaction was considered as serious by the Regulatory Authority. Reporter''s comment: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. Miscarriage Additional information ADR: On 03Sep, it was announced that I had a miscarriage at about 7 weeks of pregnancy confounding factors COVID-19 vaccine exposure during pregnancy week: 0-1 COVID-19 Previous COVID-19 infection: No Other diagnostic procedures: No No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no Miscarriage Additional information ADR: On 03Sep, it was announced that I had a miscarriage at about 7 weeks of pregnancy confounding factors COVID-19 vaccine exposure during pregnancy week: 0-1 COVID-19 Previous COVID-19 infection: No Other diagnostic procedures: No


VAERS ID: 1739556 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004224 / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Echocardiogram, Interchange of vaccine products, Pericarditis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Echocardiography; Result Unstructured Data: No findings
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This case was received via Regulatory Authority (Reference number: NO-NOMAADVRE-E2B_00046964) 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 PERICARDITIS (I30.9, CHEST PAIN, PYREXIA and INTERCHANGE OF VACCINE PRODUCTS (REVACCINATION WITH DIFFERENT COVID-19 VACCINE) in a 25-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004224) for Vaccination. Previously administered products included for Product used for unknown indication: Comirnaty. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced PERICARDITIS (I30.9) (seriousness criterion medically significant), CHEST PAIN (seriousness criterion medically significant) and PYREXIA (seriousness criterion medically significant). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (REVACCINATION WITH DIFFERENT COVID-19 VACCINE) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (I30.9), CHEST PAIN and PYREXIA was resolving and INTERCHANGE OF VACCINE PRODUCTS (REVACCINATION WITH DIFFERENT COVID-19 VACCINE) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Echocardiogram: normal (normal) No findings. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. The patient had symptoms in the form of chest pain and fever after the second dose. Company Comment: This case concerns a 25-year-old female patient with no details on previous relevant medical history, who experienced the expected events of Pericarditis associated with Chest pain and Pyrexia after Spikevax (mRNA- 1273 vaccine), second vaccination dose. Additionally, Revaccination with different COVID-19 vaccine was also reported as the patient recived first dose of Comirnaty (Pfizer mRNA vaccine). The onset of the events occurred approximately 2 days after Spikevax. The rechallenge was not applicable, as the events were reported exclusively after the second dose. Pericarditis 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: Translation document received on 22-Sep-2021 contain no new information.; Reporter''s Comments: Sender''s Comments: This case concerns a 25-year-old female patient with no details on previous relevant medical history, who experienced the expected events of Pericarditis associated with Chest pain and Pyrexia after Spikevax (mRNA- 1273 vaccine), second vaccination dose. Additionally, Revaccination with different COVID-19 vaccine was also reported as the patient recived first dose of Comirnaty (Pfizer mRNA vaccine). The onset of the events occurred approximately 2 days after Spikevax. The rechallenge was not applicable, as the events were reported exclusively after the second dose. Pericarditis 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: 1739674 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-27
   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 FG4442 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Headache, Nausea, Tremor, Vision blurred
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (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 (narrow), 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101195211

Write-up: Tremor; Nausea; Vision blurred; Headache; Dyspnoea; This is a Spontaneous report from a contactable Physician downloaded from the regulatory authority-WEB. This is a report received from Regulatory authority report number PT-INFARMED-B202108-3778 with Safety Report Unique Identifier PT-INFARMED-B202108-3778. An 18-years-old male patient received bnt162b2 (COMIRNATY), the first dose via intramuscular on 27Aug2021 (Batch/Lot Number: FG4442, CAUL: 43221-A) as 0.3ml single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced tremor on 27Aug2021, nausea on 27Aug2021, vision blurred on 27Aug2021, headache on 27Aug2021, dyspnoea on 27Aug2021. Adverse drug reactions (ADR) started 2 hours after administration of the dose 1 of the suspected vaccine. The patient was transported by emergency and resuscitation vehicle to the hospital. Fluid therapy was administered and oxygen therapy was performed. The evolution of ADR is unknown. The events were reported as serious due to hospitalization. Therapeutic measures were taken as a result of the events. The outcome of the events was unknown. Reporter comment: Concomitant medication: No. Did Medication Error Occur: No. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Concomitant medication: No. Did Medication Error Occur: No.


VAERS ID: 1739710 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-08-27
   Days after vaccination:115
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2172 / 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: 20210827; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Positive Iu international unit(s)
CDC Split Type: PTPFIZER INC202101229427

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 regulatory authority report number PT-INFARMED-T202108-4064 with Safety Report Unique Identifier PT-INFARMED-T202108-4064. A 91-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: EY2172) via intramuscular on 04May2021 as dose 2, 0.3 ML single and received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: EW2239) via intramuscular on 06Apr2021 as dose 1, 0.3 ML single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Aug2021 the patient experienced vaccination failure, covid-19. It was reported that the adverse reaction was found, using a test for COVID-19, 143 and 115 days after, respectively, the administration of the 1st and 2nd dose of the suspect drug, with total duration unknown. ADR motivated severe (unspecified) symptoms and hospitalization. The suspect drug was not suspended since the vaccination schedule was complete. There is no suspected interaction between medications. There are no data on history of previous reactions to other drugs/vaccines or allergies, on specific treatment of the reaction, or on the usual medication use. The patient was hospitalized for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 27Aug2021 Positive Iu international units. Outcome of the event was unknown. The reporter''s assessment of the causal relationship of the (event) with the suspect product was: This part was not received in the source document. 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.


VAERS ID: 1739713 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-27
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: 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: 20210827; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Positive Iu international unit(s)
CDC Split Type: PTJNJFOC20210945233

Write-up: Vaccination failure; This spontaneous report received from a health care professional via a Regulatory Authority (EVHUMAN Vaccines, PT-INFARMED-T202109-471) was received on 23-SEP-2021 and concerned a 22 year old male of unknown 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: 21C11-05 expiry: UNKNOWN) .5 ml, frequency 1 total, administered on 13-AUG-2021 for covid-19 immunisation. No concomitant medications were reported. On 27-AUG-2021, the patient experienced vaccination failure. Laboratory data included: SARS-CoV-2 PCR test (NR: not provided) Positive Iu international unit (s). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vaccination failure. This report was serious (Other Medically Important Condition). Case is associated with Product Quality Complaint.; Reporter''s Comments: Other info - girlfriend also + and with who is doing isolation; user reported: odynophagia, myalgias, headaches, nasal congestion;


VAERS ID: 1739780 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-27
   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 FE8235 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Headache, Nausea, Photophobia, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Hashimoto''s thyroiditis
Preexisting Conditions: Asthma; Hashimoto''s thyroiditis
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101194150

Write-up: This is a spontaneous report from a contactable consumer, downloaded via the regulatory authority (SE-MPA-2021-081247). A 45-year-old female patient received the second dose of BNT162B2 (Comirnaty, batch/lot# FE8235), via an unspecified route of administration, on Aug 26, 2021, single dose, for COVID-19 immunization. Medical history included Hashimoto''s thyroiditis from 2019; and asthma from 2010 (both ongoing). Concomitant medications not reported. On Aug 27, 2021, patient was tired. On Aug 28, 2021, patient experienced nausea, headache, photosensitivity and dizziness. On Aug 29, 2021, patient vomited. She sought emergency care on Sep 2, 2021, and went to the hospital. The outcome of nausea, headache and vomiting: not recovered. The outcome of other events: unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1739786 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-08-27
   Days after vaccination:68
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101195696

Write-up: blood clot in the right calf; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority SE-MPA-2021-081258. A 49-year-old male patient received the first dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 20Jun2021 (Lot Number: UNKNOWN) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced blood clot in the right calf (hospitalization) on 27Aug2021. Clinical course: About 2 months after vaccination begand suspect adverse event thrombosis right calf (leg). Report assessed as serious, hospitalisation. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1739843 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-27
   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 FH0161 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Ophthalmological examination, Vision blurred, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Fibromyalgia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: examining the eye; Result Unstructured Data: Test Result:there was nothing wrong with the eye itself; Comments: there was nothing wrong with the eye itself but could with correction of -0.25 in glass, have normal vision and the eye felt restored
CDC Split Type: SEPFIZER INC202101195717

Write-up: Visual impairment; blurred vision; received first dose of bnt162b2 (COMIRNATY) on 09Jul2021, second dose of bnt162b2 (COMIRNATY) on 27Aug2021; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB SE-MPA-2021-082443. A 20-years-old female patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration at the age of 20-years-old on 27Aug2021 (Lot Number: FH0161) as single dose for covid-19 immunisation. Medical history included fibromyalgia from 2020 and ongoing. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY) on 09Jul2021 (batch Number: FF0680) as single dose for covid-19 immunisation. The patient experienced visual impairment on 27Aug2021. The woman described that after the vaccination with the second dose of Comirnaty she felt like something happened in her eye and after about one hour she developed blurred vision as in a half-moon in her right eye. The woman contacted health care counseling who referred her to the emergency room. At the emergency room they examined the woman and she got to see a physician who asked her to see an ophthalmologist after the weekend if no improvement with the eye. The vision was just as blurred after the weekend so the woman contacted the eye clinic who asked her to use lubricate eye drops in a few days, made no difference. The woman then had to see an ophthalmologist and when examining the eye, there was nothing wrong with the eye itself but could with correction of -0.25 in glass, have normal vision and the eye felt restored. Was then referred to optician. The woman had not previously experienced blurred or need of glasses. The woman was unsure about if this was permanent or would disappear but it had been exactly as blurred since she took the second dose of the vaccine. Report assessed as serious, disability. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1740667 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-27
   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 - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood glucose increased, Deep vein thrombosis, Fibrin D dimer, Fibrin D dimer increased, Pulmonary embolism
SMQs:, Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: Blood glucose; Result Unstructured Data: Test Result:increased; Test Date: 20210827; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:increased
CDC Split Type: AUPFIZER INC202101212440

Write-up: Pulmonary embolism; Deep vein thrombosis; Blood glucose increased; Fibrin D dimer increased; This is a spontaneous report from a contactable other health professional via the Regulatory Agency (RA). Regulatory authority report number is 618169. A 52-year-old male patient received BNT162B2(COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on 16Aug2021 at single dose (dose number unknown) for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced pulmonary embolism, deep vein thrombosis, blood glucose increased, fibrin d dimer increased on 27Aug2021. The events pulmonary embolism and deep vein thrombosis were serious for being medical significant. The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1742115 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-08-27
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D020A / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101214652

Write-up: Right facial paresis/facial palsy; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100188808. A 46-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 11Aug2021 (Batch/Lot Number: 1D020A) (at the age of 46 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced Right facial paresis/facial palsy on 27Aug2021 with outcome of not recovered. Result of Assessment: Comirnaty/ event(s): Facial palsy/ RA: D. Unclassifiable No follow-up attempts are possible. No further information is expected.


VAERS ID: 1742551 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-27
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: COVID-19, COVID-19 pneumonia, Computerised tomogram, Drug ineffective, SARS-CoV-2 test, X-ray
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ct; Result Unstructured Data: Test Result:severe COVID pneumonitis; Test Date: 20210827; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test; Test Name: xray; Result Unstructured Data: Test Result:severe COVID pneumonitis
CDC Split Type: GBPFIZER INC202101217750

Write-up: Pneumonitis/severe COVID pneumonitis; SARS-CoV-2 infection; Drug Ineffective; This is a spontaneous report from a contactable physician. This is a report via the regulatory authority, report number is GB--WEBCOVID-202109151452219700-K5DSZ, Safety Report Unique Identifier GB--ADR 25945784. A 87-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration on unspecified date as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Patient was not enrolled in clinical trial. The patient did not relate to possible blood clots or low platelet counts. The patient''s concomitant medications were not reported. On 27Aug2021 patient experienced sars-cov-2 infection and drug ineffective. On unspecified date had pneumonitis/severe COVID pneumonitis. Case summary: severe COVID pneumonitis on CT / x-ray. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 27Aug2021 Yes - Positive COVID-19 test, computerised tomogram: severe COVID pneumonitis on an unspecified date, x-ray: severe COVID pneumonitis on an unspecified date. The clinical outcome of the event sars-cov-2 infection and pneumonitis/severe COVID pneumonitis was recovering and drug ineffective was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1742885 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Diarrhoea, Dizziness, Irregular breathing, Muscle spasms, Myalgia, Nausea, Paraesthesia, Psoriasis, Quality of life decreased, Vision blurred, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve insufficiency; Asthma; Celiac disease; Drug allergy (Allergic to various drugs and pollen); Fibromyalgia; Food allergy (63 food allergies,); Guttate psoriasis; Mitral insufficiency; Pollen allergy (Allergic to various drugs and pollen)
Allergies:
Diagnostic Lab Data: Test Name: impact on quality of life; Result Unstructured Data: Test Result:9/10
CDC Split Type: ITPFIZER INC202101209398

Write-up: dizziness; severe muscle aches; Diarrhea; Muscle spasms; Asthenia; Vomiting; breathing difficulties; Nausea; blurred vision; Paraesthesia; Worsening Psoriasis; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority number IT-MINISAL02-782950. A 37-years-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: ff2834, Expiration date: unknown), via intramuscular route, administered in Arm Right on 26Aug2021, at 17:17 as dose 1, 0.3 ml, single for COVID-19 immunization. The patient''s medical included fibromyalgia, asthma, guttate psoriasis, food allergy (63 food allergies,), coeliac disease, drug hypersensitivity Allergic to various drugs and pollen, aortic valve incompetence and seasonal allergy (Allergic to various drugs and pollen), mild mitral and aortic insufficiency, pollen allergy. The patient''s concomitant medications were not reported. On 27Aug2021 the patient experienced dizziness, severe muscle aches, diarrhea, muscle spasms, asthenia, vomiting, breathing difficulties, nausea, blurred vision, paraesthesia and worsening psoriasis. The patient underwent lab tests and procedures which included quality of life decreased which should 9/10 result on an unspecified date. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1742924 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-08-27
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 2 LA / -

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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101207838

Write-up: Bell''s palsy; This is a spontaneous report from a contactable consumer downloaded from a regulatory authority-WEB, regulatory authority number IT-MINISAL02-784020. A 33-year-old female patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: FF0688) via an unspecified route of administration, administered in deltoid left (shoulder) on 22Jul2021 as single dose for COVID-19 immunization. The patient''s medical history was not reported. The patient''s concomitant medication(s) included levothyroxine sodium (EUTIROX) taken for thyroid therapy from 2002 to an unspecified stop date; minerals NOS, vitamins NOS taken for postpartum state, lactation normal. The patient previously took amoxicillin and experienced drug intolerance, clavulanic acid, and experienced allergies. On 27Aug2021 at 16:00, the patient experienced bell''s palsy (subsumed with on 28Aug2021 appearance of asymmetry of the oral rhyme on the left and difficulty in closing the left eyelid). Patient went to the emergency room. Therapeutic measures were taken as a result of bell''s palsy and included treatment with steroid therapy was undertaken, with benefit. The clinical outcome of the event was reported as recovering. Health Authority Comments: - Allergies: Amoxicillin and clavulanic acid intolerance - Reaction time: 16:00 - Posted by VigiCovid19-tab. Sender''s comments: 10Sep2021 a regulatory authority: requested to the reporter lot number and clinical documentation. Feedback received; the report will be attached in where gravity upgrade will be carried out, event in IME list. No follow-up attempts are possible. No further information expected.


VAERS ID: 1743065 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Febrile convulsion; Pollinosis
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210827; Test Name: Head CT; Result Unstructured Data: Test Result:normal; Comments: after the vaccination
CDC Split Type: JPPFIZER INC202101206857

Write-up: The patient walked 30m and suddenly lost consciousness and fell backward and bruised the back of head.; Vasovagal reflex; The patient walked 30m and suddenly lost consciousness and fell backward and bruised the back of head.; The patient walked 30m and suddenly lost consciousness and fell backward and bruised the back of head.; This is a spontaneous report from a contactable physician received via regulatory authority and from the regulatory authority. Regulatory authority report number is v21127858. A 16-year and 4-month-old non-pregnant female patient received the first single dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF0843, Expiration date 31Oct2021), via intramuscular, in the left arm on 27Aug2021 at 14:15 (the day of vaccination, at the age of 16-year and 4-month-old), as dose 1, single for COVID-19 immunization. Medical history included febrile convulsion and had pollinosis from an unknown date and unknown if ongoing. The patient has no family medical history. Body temperature before vaccination was 36.2 degrees Centigrade on 27Aug2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient''s concomitant medications were not reported. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Aug2021 at 14:20 (5 minutes after the vaccination), the patient walked 30m and suddenly lost consciousness and fell backward and bruised the back of head and vasovagal reflex. The clinical course was reported as follows: the patient walked 30m and suddenly lost consciousness and fell backward and bruised the back of head. The patient went to the hospital emergency room unit for a head CT, and no problem was found. After the patient''s symptoms became recovering, the patient went home. The reporter stated the events results in emergency room/department or urgent care. On 27Aug2021, the outcome of events was recovering. The reporting same Physician 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 same physician commented as follows: The same reporter thought that it is possible that the patient fell backward due to Vasovagal reflex immediately after vaccination. This report meet the criteria of Vasovagal reflex. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1743073 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2782 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Dyspnoea, Erythema, Feeling abnormal, Heart rate, Heart rate increased, Multiple allergies, Oxygen saturation, Rash, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fruit allergy; Wheezing.
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:138/79; Comments: 14:50; Test Date: 20210827; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:131/87; Comments: 15:00; Test Date: 20210827; Test Name: body temperature; Result Unstructured Data: Test Result:unknown results Centigrade; Comments: Before vaccination.; Test Date: 20210827; Test Name: PR; Result Unstructured Data: Test Result:179; Comments: 14:50; Test Date: 20210827; Test Name: PR; Result Unstructured Data: Test Result:100; Comments: 15:00; Test Date: 20210827; Test Name: PR; Result Unstructured Data: Test Result:around 90; Comments: HR; Test Date: 20210827; Test Name: SpO2; Test Result: 99 %; Comments: 15:00
CDC Split Type: JPPFIZER INC202101207237

Write-up: Skin redness (urticaria) appeared from the face to the precordium; Skin redness (urticaria) appeared from the face to the precordium; Dyspnoea/Mild dyspnoea; PR 179; Skin eruption; delayed allergies; Anaphylaxis; feels poorly; This is a spontaneous report from a contactable other Health Professional received from the Regulatory Authority. Regulatory authority report number is v21126786. A 56-year-old male the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF2782, Expiration date 30Nov2021) via an unspecified route of administration on 27Aug2021 at around 14:45 (the day of vaccination) (at age of 56-year-old) as dose 1, single for COVID-19 immunization. Body temperature before vaccination was unknown. It was unknown that the patient had family history. There were points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations, and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status): Kiwi allergy and Wheezing. Patient concomitant medications were not reported. On 27Aug2021 at 14:50 (the day of vaccination), the patient experienced Anaphylaxis. On 27Aug2021 (the day of vaccination), the patient was admitted to the hospital. The course of the event was as follows: On 27Aug2021 at 14:45, the patient received the COVID-19 vaccination (first time) (as reported), At 14:48 (after 3 minutes) complained of feels poorly. At 14:50 (5mins after vaccination) BP 138/79, PR 179, Skin redness (urticaria) appeared from the face to the precordium. Dyspnoea developed. At 15:00, the patient was transported to the treatment room. BP 131/87, PR 100, SpO2 99%, Mild dyspnoea. At 15:25, Rinderon 4mg was Intravenous injection. (Rinderon was administered because allergy to succinate was unknown). After that, the skin eruption disappeared. Disappearance of respiratory symptoms. HR around 90. Blood pressure has not dropped, but delayed allergies are possible. The patient was admitted to the hospital. Discharged the next day. The patient underwent lab tests and procedures on 27Aug2021 which included blood pressure measurement: 138/79 at 14:50, blood pressure measurement: 131/87 at 15:00, body temperature: unknown results centigrade (Before vaccination), heart rate: 179 at 14:50, heart rate: 100 at 15:00, heart rate: around 90, oxygen saturation: 99 % at 15:00. Therapeutic measures were taken as a result of the events. On 27Aug2021 on unspecified time (the day of vaccination), the outcome of the events was recovered. The reporting Other Health Professional classified the events as serious (caused hospitalization from 27Aug2021 to 28Aug2021) 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: Since the symptoms appear immediately after vaccination, it is considered to be a side reaction due to the vaccine. No follow up attempts are possible. No further information is expected.


VAERS ID: 1743197 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-27
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Pyrexia
SMQs:, 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:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Low grade fever; Coronavirus infection; This case was received via regulatory authority (Reference number: JP-TAKEDA-2021TJP090299) on 15-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case was reported by a family member of a vaccine recipient via the regulatory authority. Coronavirus infection was assessed as serious by the regulatory authority. On 17-Aug?2021, around 14:00, the patient received the 1st dose of this vaccine. On 27-Aug-2021, coronavirus infection was noted, and the patient recuperated at home. On 14-Sep-2021, around 14:00, the patient received the 2nd dose of this vaccine. the patient had low grade fever. The outcome of coronavirus infection was unknown. The outcome of low grade fever was reported as ongoing and unchanged. Follow-up investigation will be impossible due to the reporter''s non-cooperation. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Company Comment: This case concerns a 16-year-old male patient with no relevant medical history, who experienced the unexpected serious regulatory authority event of COVID-19. The event occurred approximately 11 days after the first dose of Moderna COVID-19 Vaccine administration. The rechallenge was positive since the patient experienced pyrexia after the second dose. The benefit-risk relationship is not affected by this report.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. JP-TAKEDA-2021TJP090298:Original case: 2021TJP090298 JP-TAKEDA-2021TJP090300:Original case: 2021TJP090298 JP-TAKEDA-2021TJP090295:Original case: 2021TJP090298; Sender''s Comments: This case concerns a 16-year-old male patient with no relevant medical history, who experienced the unexpected serious regulatory authority event of COVID-19. The event occurred approximately 11 days after the first dose of Moderna COVID-19 Vaccine administration. The rechallenge was positive since the patient experienced pyrexia after the second dose. The benefit-risk relationship is not affected by this report. JP-TAKEDA-2021TJP090298: JP-TAKEDA-2021TJP090300: JP-TAKEDA-2021TJP090295:


VAERS ID: 1743229 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005239 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Petit mal epilepsy, Presyncope
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Vasovagal reaction (vasovagal reflex with influenza vaccination)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Absence; Vasovagal reflex; This case was received via a regulatory authority (Reference number: 2021TJP095933) on 17-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of PETIT MAL EPILEPSY (Absence) in a 23-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3005239) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Vasovagal reaction (vasovagal reflex with influenza vaccination). On 27-Aug-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced PETIT MAL EPILEPSY (Absence) (seriousness criterion medically significant) and PRESYNCOPE (Vasovagal reflex). On 27-Aug-2021, PETIT MAL EPILEPSY (Absence) and PRESYNCOPE (Vasovagal reflex) had resolved. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered PETIT MAL EPILEPSY (Absence) and PRESYNCOPE (Vasovagal reflex) to be possibly related. This case concerns a 23-year-old, female patient with a medical history of Presyncope (with influenza vaccination), who experienced the unexpected serious event of Petit mal epilepsy. The event occurred approximately 9 minutes after the first dose of Spikevax. The rechallenge was unknown as the events happened after the first dose and there is no information on second dose. The event was considered related to the vaccine per the reporter''s assessment. The medical history of presyncope (with influenza vaccination) and concurrent event presyncope remain a confounder. The benefit-risk relationship of Spikevax is not affected by this report.; Reporter''s Comments: The event is considered as vasovagal reflex.; Sender''s Comments: This case concerns a 23-year-old, female patient with a medical history of Presyncope (with influenza vaccination), who experienced the unexpected serious event of Petit mal epilepsy. The event occurred approximately 9 minutes after the first dose of Spikevax. The rechallenge was unknown as the events happened after the first dose and there is no information on second dose. The event was considered related to the vaccine per the reporter''s assessment. The medical history of presyncope (with influenza vaccination) and concurrent event presyncope remain a confounder. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1745900 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-08-27
   Days after vaccination:101
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hypersensitivity vasculitis
SMQs:, Vasculitis (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20213

Write-up: Allergic vasculitis; This case was received via regulatory authority (Reference number: DE-PEI-202100189598) 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 HYPERSENSITIVITY VASCULITIS (Allergic vasculitis) in a 17-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3002620) for Prophylactic vaccination. No Medical History information was reported. On 18-May-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Jun-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced HYPERSENSITIVITY VASCULITIS (Allergic vasculitis) (seriousness criteria hospitalization and medically significant). At the time of the report, HYPERSENSITIVITY VASCULITIS (Allergic vasculitis) had not resolved. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication details were reported. No treatment medication details was reported. Company comment: This case concerns a 17-year-old, male patient with no relevant medical history, who experienced the unexpected events of Hypersensitivity vasculitis. The events occurred approximately 3 months and 10 days after the second dose of Spikevax. The rechallenge is not applicable since no event about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity; Sender''s Comments: This case concerns a 17-year-old, male patient with no relevant medical history, who experienced the unexpected events of Hypersensitivity vasculitis. The events occurred approximately 3 months and 10 days after the second dose of Spikevax. The rechallenge is not applicable since no event about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity


VAERS ID: 1746066 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-27
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4592 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Amenorrhoea
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101222707

Write-up: Amenorrhea; This is a spontaneous report received from a contactable consumer or other non HCP downloaded from the Regulatory Authority-WEB, Regulatory Authority number ES-AEMPS-993934. A twenty-eight-year-old non-pregenant female patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Lot number: FG4592) via intramuscular route of administration in left arm on 19Aug2021 as dose 2, single for COVID-19 immunisation. The patient medical and concomitant medications were not reported. Patient was not pregnant at the time of vaccination and she don''t know previously she had COVID-19. Patient previously received her first dose of bnt162b2 (COMIRNATY, solution for injection, Lot number: FC1435) via intramuscular route of administration at left arm on 23Jul2021 as dose 1, single for COVID-19 immunisation. The patient experienced amenorrhea on 27Aug2021. Seriousness criteria was medically significant. Outcome of event was not recovered at the time of reporting. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1746089 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Fall, Fatigue, Headache, Limb injury, Loss of consciousness, Nausea
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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

Write-up: Hand injury; Fall; Loss of consciousness; Headache; Fatigue; Nausea; Asthenia; This case was received via the Regulatory Agency (Reference number: FI-FIMEA-20214543) 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 LIMB INJURY (Hand injury), FALL (Fall), LOSS OF CONSCIOUSNESS (Loss of consciousness), HEADACHE (Headache), FATIGUE (Fatigue), NAUSEA (Nausea) and ASTHENIA (Asthenia) in a 47-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 26-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced LIMB INJURY (Hand injury) (seriousness criterion medically significant), FALL (Fall) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and ASTHENIA (Asthenia) (seriousness criterion medically significant). At the time of the report, LIMB INJURY (Hand injury), FALL (Fall), LOSS OF CONSCIOUSNESS (Loss of consciousness), HEADACHE (Headache), FATIGUE (Fatigue), NAUSEA (Nausea) and ASTHENIA (Asthenia) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication reported No treatment medication reported Company Comment : This case concerns a patient with no previous relevant medical history, who experienced the unexpected events of limb injury, loos of consciousness, headache, fatigue, nausea, and asthenia. The events occurred 1 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender''s Comments: This case concerns a patient with no previous relevant medical history, who experienced the unexpected events of limb injury, loos of consciousness, headache, fatigue, nausea, and asthenia. The events occurred 1 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.


VAERS ID: 1746096 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-27
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003185 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Subarachnoid haemorrhage, Superior sagittal sinus thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLEONITA
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIMODERNATX, INC.MOD20213

Write-up: Superior sagittal sinus thrombosis; Subarachnoid haemorrhage; This case was received via Regulatory Authority (Reference number: FI-FIMEA-20214610) 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 SUPERIOR SAGITTAL SINUS THROMBOSIS (Superior sagittal sinus thrombosis) and SUBARACHNOID HAEMORRHAGE (Subarachnoid haemorrhage) in a 26-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3003185) for COVID-19 vaccination. no medical history was provided by reporter. Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL (CLEONITA) for an unknown indication. On 02-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced SUPERIOR SAGITTAL SINUS THROMBOSIS (Superior sagittal sinus thrombosis) (seriousness criteria medically significant and life threatening) and SUBARACHNOID HAEMORRHAGE (Subarachnoid haemorrhage) (seriousness criteria medically significant and life threatening). At the time of the report, SUPERIOR SAGITTAL SINUS THROMBOSIS (Superior sagittal sinus thrombosis) and SUBARACHNOID HAEMORRHAGE (Subarachnoid haemorrhage) 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. Treatment medication was not provided; Sender''s Comments: This case concerns a 26-year-old, female patient, with no relevant medical history, who experienced the unexpected events of Superior Sagittal sinus thrombosis and Subarachnoid haemorrhage. The events occurred approximately 26 days after the first dose of Spikevax. The rechallenge was unknown since no information about the second dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1746286 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-08-27
   Days after vaccination:31
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 pneumonia, Drug ineffective
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101215921

Write-up: Severe COVID pneumonia; Severe COVID pneumonia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-LY202110550. A 23-year-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, lot/batch number was not reported), intramuscular on 27Jul2021 as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. There was not reported covid history. The patient experienced severe COVID-19 pneumonia on 27Aug2021. The adverse event resulted into hospitalisation in intensive care unit. The outcome of event was unknown. No follow-up attempts were possible. No further information was expected. Batch/LOT number could not be obtained.


VAERS ID: 1746409 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7204 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Heart rate increased, Influenza like illness
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: CAPFIZER INC202101212244

Write-up: stabbing chest pain; Flu like symptoms are pounding; had a high resting heart rate; This is a spontaneous report received via regulatory authority from a contactable male consumer (patient) regarding product BNT162B2 the following information was reported. A 15-year-old male patient received second dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 25Aug2021 16:00 (Batch/Lot Number: FD7204) as DOSE 2, SINGLE for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced stabbing chest pain, flu like symptoms are pounding and had a high resting heart rate on 27Aug2021 05:00. The patient received first dose of Comirnaty on an unspecified date (DOSE 1, SINGLE, LOT NUMBER FE3591, ARM LEFT). Outcome of the events was recovered with sequel. The patient received initial dose of BNT162B2


VAERS ID: 1746410 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-08-27
   Days after vaccination:105
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0199 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Low birth weight baby, Maternal exposure during pregnancy, Premature baby, Weight
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: weight; Result Unstructured Data: Test Result:3.9 lbs
CDC Split Type: CAPFIZER INC202101281538

Write-up: BNT162B2 via transplacental route; premature live birth/Babies hospitalized in neonatology for underweight (premature); underweight; This is a spontaneous report from a contactable nurse. This nurse reported events for multiple patients (mother and two babies). This is the first of 2 baby cases (baby 1 of a twin pregnancy). A female neonate patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0199, Expiry: 30Sep2021) via transplacental route on 14May2021 as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The neonate experienced premature live birth with gestational age at birth: 33+2 weeks, Weight: 3.9 lbs, Height: 43 cm on 27Aug2021. The neonate was hospitalized in neonatology for underweight (premature) and learning to drink (drinking mother''s milk). Newborn status was normal (Apgar Index unknown). Newborn follow-up: No issues. The outcome of the events was unknown.; Sender''s Comments: Based on the information provided, the contributory role of the suspect product BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0199, Expiry: 30Sep2021) to reported events Maternal exposure during pregnancy, Premature birth, and Low birth weight, is possible. Case will be reassessed upon receipt of follow-up information.,Linked Report(s) : CA-PFIZER INC-2021640235 Maternal case;CA-PFIZER INC-202101281546 Baby #2 case


VAERS ID: 1746668 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CERAZETTE [DESOGESTREL]; NORTRIPTYLINE; TOPIRAMATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine; Migraine headache; Mood swings; Painful periods
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101225218

Write-up: Menorrhagia; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109161014384510-RMHHC, Safety Report Unique Identifier GB-MHRA-ADR 25951629. A 16-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Aug2021 (Lot Number: FE8087) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included migraine, mood swings, migraine headache, painful periods and "ME". Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medications included desogestrel (CERAZETTE) taken for mood swings, start and stop date were not reported; nortriptyline taken for migraine, start and stop date were not reported; topiramate taken for migraine headache, start and stop date were not reported. The patient experienced menorrhagia on 27Aug2021 with outcome of not recovered. The patient underwent lab test which included Covid-19 virus test: negative on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. The event was assessed as serious and medically significant. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1746759 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-27
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Epilepsy, Pruritus, Rash pruritic, SARS-CoV-2 test, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CETIRIZINE; FEXOFENADINE HYDROCHLORIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic urticaria; COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101224675

Write-up: hives; uncontrollable itching; Itchy rash; Epilepsy; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Regulatory Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202109161626057560-PYWJ4 with Safety Report Unique Identifier GB-MHRA-ADR 25954060. A 29-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 27Aug2021 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from 01Aug2021 to 12Aug2021 and chronic urticaria. On 03Aug2021, the patient underwent a COVID-19 virus test and the result was positive. The patient was not pregnant and was not breastfeeding at the time of this report. It was unsure whether the patient was enrolled in the clinical trial. Concomitant medications included cetirizine (MANUFACTURER UNKNOWN) and fexofenadine hydrochloride (MANUFACTURER UNKNOWN); both were taken for chronic urticaria from an unknown date and unknown if ongoing. On 27Aug2021, the patient experienced hives, uncontrollable itching and itchy rash. On an unknown date in 2021, the patient experienced epilepsy. The clinical course was reported as follows: The patient''s symptoms were manageable and were under routine but on the evening of her second dose of vaccination, the patient had uncontrollable itching and hives in normal cold showers. It was reported that medication or creams were not taking any effect to calm it down. Since the day of vaccination, the patient was reacting more and was taking more medication than usual to try and overcome the symptoms. At the time of this report, the patient was working with her doctor to try and calm that down or to make it a little more manageable than it was. The patient was referred by her doctor to a dermatologist. The patient had not been tested positive for COVID-19 since having the vaccine. The clinical outcome of the event epilepsy was recovered on an unknown date in 2021, while that of the events hives, uncontrollable itching and itchy rash was not recovered at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1746762 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Amenorrhoea, Chills, Menstruation delayed, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Fertility disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101224815

Write-up: Late period; Absence of menstruation; Fever; Chills; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109161636548250-7NJ8R, Safety Report Unique Identifier number is (GB-MHRA-ADR 25954044). A 26-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date was not reported), via an unspecified route of administration on 26Aug2021 (at the age at of 26-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. On an unspecified date, patient experienced late period, absence of menstruation. On 27Aug2021 fever, chills. The events caused medically significant. The outcome of the events was late period and absence of menstruation was not resolved. The outcome for the events fever and chills was resolved on 28Aug2021. No follow-up attempts were possible; information about lot/batch number cannot be obtained.


VAERS ID: 1746775 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-27
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101225337

Write-up: Numbness in feet; Numbness in leg; Neck numbness; Numbness of limbs; Pins and needles; Numbness of upper arm; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202109161828061310-QTG9I, Safety Report Unique Identifier GB-MHRA-ADR 25954736. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),via an unspecified route of administration on 27Aug2021 (Batch/Lot number was not reported) (at the age of 32-years-old) as dose 2, single for COVID-19 immunisation .Medical history included endometriosis from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient was not pregnant, was not currently breastfeeding and was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced numbness of upper arm on 27Aug2021, pins and needles on 03Sep2021, numbness of limbs on 06Sep2021, neck numbness on 09Sep2021, numbness in leg on 10Sep2021, numbness in feet on 15Sep2021. The events were reported as serious (hospitalization and medically significant). Patient has not tested positive for COVID-19 since having 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 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: 1750689 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Basedow's disease, Disease recurrence
SMQs:, Optic nerve disorders (broad), Hyperthyroidism (narrow), Immune-mediated/autoimmune disorders (narrow)

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

Write-up: Basedow''s disease; Disease recurrence; This case was received via Agency (Reference number: FR-AFSSAPS-BR20213442) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of BASEDOW''S DISEASE (Basedow''s disease) in a 61-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Basedow''s disease. On 25-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced BASEDOW''S DISEASE (Basedow''s disease) (seriousness criterion medically significant) and DISEASE RECURRENCE (Disease recurrence). At the time of the report, BASEDOW''S DISEASE (Basedow''s disease) and DISEASE RECURRENCE (Disease recurrence) had not resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. The concomitant medications were not reported. The treatment information was not provided. Company Comment : This case concerns a 61-year-old female patient with a history of Basedow''s disease, who experienced the unexpected event of Basedow''s disease (considered an adverse event of special interest because of hyperthyroidism). The event occurred approximately 2 days after the most recent dose of mRNA-1273. The rechallenge was not applicable since there is no information on dose schedule. Medical history of Basedow''s disease is a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Translation received on 28-SEP-2021 contains no new information.; Sender''s Comments: This case concerns a 61-year-old female patient with a history of Basedow''s disease, who experienced the unexpected event of Basedow''s disease (considered an adverse event of special interest because of hyperthyroidism). The event occurred approximately 2 days after the most recent dose of mRNA-1273. The rechallenge was not applicable since there is no information on dose schedule. Medical history of Basedow''s disease is a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1750783 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-08-27
   Days after vaccination:119
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Biliary colic; Contact eczema; COVID-19; Degenerative joint disease; Facioplegia (after a seizure at the age of 2 years); Interstitial lung disease (treatments with corticosteroids, Azathioprine then mepolizumab (anti IL5)); Obesity; Pulmonary embolism
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101222620

Write-up: COVID infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-PC20213764. A 72-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: Unknown) intramuscularly on 30Apr2021 (at the age of 72-year-old) as dose 2, single and bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: Unknown) intramuscularly on 02Apr2021 (at the age of 72-year-old) as dose 1, single for covid-19 immunization. Medical history included covid-19, hepatic colic, obesity, arterial hypertension, facial paralysis after a seizure at the age of 2 years, osteoarthritis, irritative eczema from an unknown date and unknown if ongoing , diffuse interstitial lung disease, from Apr2020 to an unknown date, received treatments with corticosteroids, Azathioprine then mepolizumab (anti IL5) and pulmonary embolism from Jan2021 to an unknown. The patient''s concomitant medications were not reported. On 27Aug2021 the patient experienced covid infection and vaccination failure. The patient was hospitalized 3 months after the 2nd vaccination with comirnaty for events on an unspecified date in 2021, both of the events were medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test result was positive on 27Aug2021. Outcome of the events were not resolved. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.


VAERS ID: 1750862 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCEL5 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Disturbance in attention, Hypoaesthesia, Myalgia, Pain in extremity, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101222862

Write-up: Asthenia; Myalgia; Pain in arm; Concentration impairment; Hypoaesthesia facial; Paresthesia lower limb; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. WEB. The regulatory authority report number is FR-AFSSAPS-TO20217854. A 47-year-old female patient received BNT162B2 (COMIRNATY), via intramuscular route administered in left arm on 26Aug2021 (Batch/Lot Number: SCEL5) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 27Aug2021, the patient experienced disabling pain in the left arm (pain in arm), diffuse muscle pain in the lower and spinal limbs (myalgia), asthenia and disturbances in attention and concentration (concentration impairment), which persisted to this day, lower limb paresthesias (Paresthesia lower limb) and hemiface left hypoesthesia (hypoaesthesia facial). The events caused hospitalization. Outcome of the events was not recovered.


VAERS ID: 1750918 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Crying, Depression, Migraine, Pain, Palpitations, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac ablation (Had heart ablation to correct at 14 years old.); WPW syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101225141

Write-up: pain; crying; Migraine; Vomiting; Depression; Palpitations; This is a spontaneous report from a contactable consumer (patient). This is a report received from the regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109160939430350-VNF0Y, Safety Report Unique Identification Number: GB-MHRA-ADR 25951620. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection Batch/Lot Number were not reported) dose 2 via an unspecified route of administration on 27Aug2021 as dose 2, single for COVID-19 immunization. Medical history included wolff-parkinson-white syndrome and cardiac ablation from an unknown date and unknown if ongoing (the patient had heart ablation to correct at 14 years old). The patient''s concomitant medications were not reported. On 27Aug2021, the patient experienced migraine, vomiting, depression, palpitations, on an unspecified date, pain and crying. Had sensitivity to light (onset of the migraine) began at 4pm (my vaccine was 9:20am) then at 6pm she felt really down, depressed and a heavy heart feeling and palpitations. At 7pm the migraine got worse and kept me up through the night, she awoke at 1am and vomited. Migraine was severe by now. She was able to sleep on and off until 8am, where she was crying from the pain in my head. At 9am patient rung her mum to come over and help with household stuff, she told me to ring 111. She was then also sick again at around 9:30. 111 took all my symptoms down and said a clinician would call her back in a few hours. She was able to keep down some pain killers after eating. At 11am my migraine finally subsided. 12pm the clinician rung but as my symptoms had subsided no action was taken. If they hadn''t or they come back she was to go to A&E. The events were reported as medically significant. The patient underwent lab tests and procedures which included SARS-CoV-2 test was no - negative COVID-19 test on 15Sep2021. The patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The outcome of the events pain, crying was unknown, Outcome of vomiting, migraine was recovered on 28Aug2021, palpitations, depression was recovered on 27Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1751060 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Breast pain, Breast swelling, Breast tenderness, Menstruation irregular, Pain, Pain in extremity, Pelvic pain, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Lipodystrophy (broad), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Irregular periods (PCOS 8 years ago which caused irregular periods); Polycystic ovarian syndrome (I was diagnosed with PCOS).
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: Inconclusive test.
CDC Split Type: GBPFIZER INC202101226579

Write-up: pain in my right leg; pain; fainting; Irregular periods; tender breast; Painful breasts; swollen breast; slight pain in the pelvic; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109171909250620-EA0WP, Safety Report Unique Identifier GB-MHRA-ADR 25960989. A 28-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 27Aug2021(at the age of 28 years old) (Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included polycystic ovaries from an unknown date and unknown if ongoing. I was diagnosed with PCOS, menstruation irregular from an unknown date and unknown if ongoing, PCOS 8 years ago which caused irregular periods. Patient has not had symptoms associated with COVID-19. Inconclusive test. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced pain on an unspecified date, fainting on an unspecified date, irregular periods on 31Aug2021, pain in my right leg on an unspecified date, tender breast on 27Aug2021, painful breasts on 27Aug2021, swollen breast on 27Aug2021, slight pain in the pelvic on 27Aug2021. The first few days, she had pain in my right leg but these went away. Her period was supposed to be coming on 27th August, which was the same day, she took the first vaccination. However, she experienced a very painful swollen tender breast, and slight pain in the pelvic area for 3 weeks. These symptoms continued until 16th Sep when her period started which was yesterday. She was diagnosed with PCOS 8 years ago which caused irregular periods, however, since adopting healthy lifestyle, she was able to regulate her periods which always fall on 35 days She has never missed her period longer than 35 -38 days. After taking the vaccine, her period was delayed for 3 weeks (58 days since the last period). Also pain she experienced was very severe and it was not the normal pain she used to experience every period. The symptoms were pain which start from the lower abdomen and spreads to the right leg. She took painkillers (Panadols) but still she experienced the pain for 2 days especially on the right leg. She felt like fainting, but thankfully on the second day, the symptoms reduced. Her periods usually lasts 3 days, and the flow is moderate, at the moment, the flow is not heavy. She believes the vaccine had caused these severe pain, swollen breasts, and delayed irregular periods. Please would you kindly investigate if these symptoms are long term i.e. affect fertility or can the vaccine cause cancer? She was worried to take the second vaccine for fear of experiencing another pain. All events are medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: inconclusive test on an unspecified date. The outcome of the events pain, fainting, irregular periods was recovering and unknown for other events. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1751273 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-27
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Myalgia, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: Sore throat; Muscles; High temperature; Chest burning; This case was received via the RA (Reference number: XI-EMA-DD-20210913-banala_s-080716) 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 OROPHARYNGEAL PAIN (Sore throat), CHEST PAIN (Chest burning), MYALGIA (Muscles) and PYREXIA (High temperature) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 from 26-Feb-2021 to 20-Mar-2021. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced CHEST PAIN (Chest burning) (seriousness criterion medically significant). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant), MYALGIA (Muscles) (seriousness criterion medically significant) and PYREXIA (High temperature) (seriousness criterion medically significant). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), CHEST PAIN (Chest burning), MYALGIA (Muscles) and PYREXIA (High temperature) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. Treatment information was not provided. Company comment: This case concerns a female patient, of unknown age, with no relevant medical history, who experienced the unexpected events of oropharyngeal pain, chest pain, myalgia and pyrexia. The event chest pain occurred on 27Aug2021. The start dates of the events oropharyngeal pain, myalgia and pyrexia were not provided. The date of administration of the first dose of the Moderna COVID-19 Vaccine was likewise not provided. The rechallenge was not applicable as the events occurred after the first dose. The events myalgia and pyrexia are consistent with the current understanding of the mechanism of action of the Moderna COVID-19 Vaccine. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report. Event seriousness was assessed as per Regulatory Authority reporting; however, there was no information in the source document supporting that the events are medically significant.; Reporter''s Comments: This case is a master made from existing duplicates in the RA by the RA duplicate management team. The case numbers of the underlying duplicates are in the Other Case Identifiers section; Sender''s Comments: This case concerns a female patient, of unknown age, with no relevant medical history, who experienced the unexpected events of oropharyngeal pain, chest pain, myalgia and pyrexia. The event chest pain occurred on 27Aug2021. The start dates of the events oropharyngeal pain, myalgia and pyrexia were not provided. The date of administration of the first dose of the Moderna COVID-19 Vaccine was likewise not provided. The rechallenge was not applicable as the events occurred after the first dose. The events myalgia and pyrexia are consistent with the current understanding of the mechanism of action of the Moderna COVID-19 Vaccine. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report. Event seriousness was assessed as per Regulatory Authority reporting; however, there was no information in the source document supporting that the events are medically significant.


VAERS ID: 1751474 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-01
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? 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: JPMODERNATX, INC.MOD20213

Write-up: COVID-19 infection; This case was received via Regulatory Authority (Reference number: JP-TAKEDA-2021TJP094186) on 22-Sep-2021 and was forwarded to Moderna on 29-Sep-2021. This case was reported by a vaccine recipient. COVID-19 infection was assessed as serious. On 24-Aug-2021, the patient received the 1st dose of this vaccine. On 27-Aug-2021, the patient visited a medical institution, and a positive PCR test revealed COVID-19 infection. The patient was placed on home treatment. The outcome of COVID-19 infection was unknown. Follow-up investigation will be impossible due to non-cooperation of the reporter. 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 61 year-old male patient with no reported medical history, who experienced the unexpected serious event of COVID-19 infection. The event occurred 4 days after the first dose of mRNA-1273 vaccine. The event was considered related to the mRNA-1273 vaccine, however the vaccine does not contain virus capable of transmitting the infection. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant maintained for consistency with report, however there was no information in the source document supporting the seriousness criteria.


VAERS ID: 1751592 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-27
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4442 / 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: 20210827; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments:
CDC Split Type: PTPFIZER INC202101236675

Write-up: Vaccine against COVID-19 - Vaccine failure - User with a complete vaccine schedule for $g2 weeks had COVID-19; COVID-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. This is a report received from NFARMED regulatory authority report number PT-INFARMED-T202109-134.with Safety Report Unique Identifier PT-INFARMED-T202109-134. A 38-years-old male patient received first dose of bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number, FE6029, Expiry date: unknown) via intramuscular on 08Jul2021 as dose 1, 0.3ml single and received second dose of bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: FG4442, Expiry date: unknown) via intramuscular on 05Aug2021 as dose 2, 0.3ml single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 27Aug2021 the patient experienced vaccine against covid-19 - vaccine failure - user with a complete vaccine schedule for $g2 weeks had covid-19 vaccine and covid-19 (medically significant). The reporter (health authority) considered the events as serious. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 27Aug2021. The outcome of the events was unknown. The reporter''s 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 is expected.; Reporter''s Comments: Other information-Symptoms starting on 22Aug2021 Test carried out on 27Aug2021


VAERS ID: 1751597 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-08-27
   Days after vaccination:162
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210830; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: Iu international unit(s)
CDC Split Type: PTPFIZER INC202101250478

Write-up: SARS-CoV2 pneumonia; respiratory distress; PCR positive; COVID-19; This is a spontaneous report from a contactable nurse downloaded from the regulatory authority. This is a report received from RA regulatory authority report number PT-INFARMED-T202109-462 with Safety Report Unique Identifier PT-INFARMED-T202109-462. A 99-years-old female patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: EP2166), via intramuscular route on 25Feb2021 as dose 1, 0.3 ml single and received second dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: ET3620) via intramuscular route on 18Mar2021 as dose 2, 0.3 ml single for covid-19 immunization (for active immunization to prevent COVID-19 caused by the SARS-CoV-2 virus). The patient medical history and concomitant medications were not reported. On 27Aug2021, the patient experienced nasal congestion, cough, respiratory distress, which led to hospitalization. On 29Aug2021, the patient was admitted for SARS-CoV2 pneumonia. ADR is characterized by a lack of efficacy with the complete vaccination schedule, with the patient being hospitalized for SARS-CoV-2 pneumonia the day before the PCR test, with symptom onset about 2 days before (nasal congestion, cough and difficulty breathing). On 30Aug2021, the patient was tested as PCR positive and Covid-19 approximately 165 days after the administration of the second dose of the suspected drug. There was no suspicion of drug interactions. The adverse drug reaction (ADR) was detected through a positive PCR test approximately 165 days after the administration of the second dose of the suspected drug, with unknown duration. There is no suspicion of drug interactions. There is no information on previous reactions to the same or other drugs, on treatment of the reaction or on concomitant medication. The events resulted in (hospitalisation, prolonged hospitalisation). The patient underwent lab tests and procedures which included SARS-CoV-2 PCR test, positive on 30Aug2021 (Iu international units). The outcome of the events were unknown. The reporter''s assessment of the causal relationship of the [Vaccination failure, covid-19] with the suspect product was [Source of assessment: reporter, Method of assessment: unknown, Result of Assessment: probable]. Reporter''s comments: Other information symptoms since 27Aug2021: nasal congestion, cough, respiratory distress, which led to hospitalization Admitted to (private) on 29Aug2021 for SARS-CoV2 pneumonia. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1751641 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-08-27
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005238 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Costochondritis
SMQs:

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

Write-up: TIETZES SYNDROM; This case was received via regulatory authority (Reference number: SE-MPA-2021-083195) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of COSTOCHONDRITIS (TIETZES SYNDROM) in a 19-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005238) for COVID-19 vaccination. No Medical History information was reported. On 20-Jul-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced COSTOCHONDRITIS (TIETZES SYNDROM) (seriousness criterion medically significant). At the time of the report, COSTOCHONDRITIS (TIETZES SYNDROM) had not resolved. No concomitant medications reported by reporter. No treatment medications provided by the reporter. This case concerns a 19-year-old female patient with no reported medical history who experienced an unexpected event of Tietze''s syndrome. The event occurred 1 month 7 days after the second dose of Spikevax vaccination. The rechallenge was unknown as no details about the first dose was disclosed. Causality for the reported event was not provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority as medically significant. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Translated document was received on 27 September 2021 and contains no new information.; Sender''s Comments: This case concerns a 19-year-old female patient with no reported medical history who experienced an unexpected event of Tietze''s syndrome. The event occurred 1 month 7 days after the second dose of Spikevax vaccination. The rechallenge was unknown as no details about the first dose was disclosed. Causality for the reported event was not provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority as medically significant


VAERS ID: 1752973 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 pneumonia, Cough, Diarrhoea
SMQs:, Anaphylactic reaction (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: severe covid 19 pneumonia; cough; diarrhea; This regulatory authority case was reported by a pharmacist and describes the occurrence of COVID-19 PNEUMONIA (severe covid 19 pneumonia), COUGH (cough) and DIARRHOEA (diarrhea) in a 64-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 25-Aug-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced COVID-19 PNEUMONIA (severe covid 19 pneumonia) (seriousness criteria hospitalization and medically significant), COUGH (cough) (seriousness criterion hospitalization) and DIARRHOEA (diarrhea) (seriousness criterion hospitalization). At the time of the report, COVID-19 PNEUMONIA (severe covid 19 pneumonia), COUGH (cough) and DIARRHOEA (diarrhea) was resolving. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment medication reported. Company comment: This case concerns a 64-year-old, female patient with no relevant medical history, who experienced the unexpected events of Cough, Diarrhea and COVID-19 pneumonia. The events occurred approximately 3 days after the first dose of Spikevax. The rechallenge was unknown since no information about the second dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 64-year-old, female patient with no relevant medical history, who experienced the unexpected events of Cough, Diarrhea and COVID-19 pneumonia. The events occurred approximately 3 days after the first dose of Spikevax. The rechallenge was unknown since no information about the second dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity


VAERS ID: 1754581 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-27
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E021A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood cholesterol, Blood pressure measurement, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cholesterol high (cholesterol slightly elevated); Pressure blood increased (Blood pressure slightly increased (approx. 130/90))
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: cholesterol; Result Unstructured Data: Test Result:slightly elevated; Test Name: blood pressure; Result Unstructured Data: Test Result:130/90
CDC Split Type: DEPFIZER INC202101229018

Write-up: Infarct myocardial; This is a spontaneous report from a non-contactable consumer downloaded from the Agency -WEB, regulatory authority number DE-PEI-CADR2021177342. A 49-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 16Aug2021 (Batch/Lot Number: 1E021A) as dose number unknown, 0.3ml single for COVID-19 immunisation. Medical history included ongoing Pressure blood increased (blood pressure slightly increased, approx. 130/90) and ongoing cholesterol high (cholesterol slightly elevated). The patient''s concomitant medications were not reported. On 27Aug2021, the patient experienced infarct myocardial. On 01Sep2021, the outcome of the event was recovered with sequelae. This report is serious - hospitalization. Sender Comment: Information on risk factors or previous illnesses: Blood pressure slightly elevated (about 130/90), cholesterol slightly elevated, no stress. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1754600 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-08-27
   Days after vaccination:119
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101229028

Write-up: Infarct myocardial; This is a spontaneous report from a non-contactable consumer (patient himself) downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021178710. A 70-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 30Apr2021 (Batch/Lot Number: Unknown) as DOSE NUMBER UNKNOWN, 0.3 mL, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 27Aug2021, the patient experienced infarct myocardial. The patient was hospitalized on an unspecified date in 2021. The outcome of the event was recovered/resolved with sequel. This report is serious - hospitalization. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Reporter comment: Are you or the person concerned aware of any allergies? If so, which ones? None Information on risk factors or previous illnesses None No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Are you or the person concerned aware of any allergies? If so, which ones? None Information on risk factors or previous illnesses None


VAERS ID: 1754777 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-27
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Impaired work ability, Radiculopathy
SMQs:, Guillain-Barre syndrome (broad)

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

Write-up: Radiculitis; Impaired work ability; This case was received via Agency (Reference number: FI-FIMEA-20214763) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RADICULOPATHY (Radiculitis) and IMPAIRED WORK ABILITY (Impaired work ability) in a 43-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 13-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced RADICULOPATHY (Radiculitis) (seriousness criterion hospitalization) and IMPAIRED WORK ABILITY (Impaired work ability) (seriousness criterion hospitalization). At the time of the report, RADICULOPATHY (Radiculitis) and IMPAIRED WORK ABILITY (Impaired work ability) had not resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. There was no concomitant medication reported. There was no treatment medication reported. Company comment: This report concerns a 43 year old male patient with no relevant medical history who was hospitalized for unexpected events of radiculitis (coded to radiculopathy) and impaired work ability. The events occurred approximately 14 days after vaccination with mRNA-1273. The rechallenge is assessed as unknown as there is no information on whether the events happened after the first or the second dose of the vaccine. The outcome of the events is reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This report concerns a 43 year old male patient with no relevant medical history who was hospitalized for unexpected events of radiculitis (coded to radiculopathy) and impaired work ability. The events occurred approximately 14 days after vaccination with mRNA-1273. The rechallenge is assessed as unknown as there is no information on whether the events happened after the first or the second dose of the vaccine. The outcome of the events is reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1754889 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2707 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Heart rate, Influenza, Tachycardia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Infective pneumonia (broad), Dehydration (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: Test Date: 20210827; Test Name: tachycardia; Result Unstructured Data: Test Result:210; Comments: unit: bpm
CDC Split Type: FRPFIZER INC202101228907

Write-up: Tachycardia; Vomiting; flu syndrome; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority. -WEB, regulatory authority number FR-AFSSAPS-PC20213512. A 53-years-old male patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: FE2707), via intramuscular route of administration, administered in Arm Left on 27Aug2021(at the age of 53-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Aug2021 the same evening patient experienced tachycardia at "210 bpm", vomiting, flu syndrome. On 27Aug2021 patient underwent lab tests and procedures which included heart rate: 210, unit: bpm. The outcome of the event influenza recovered on 29Aug2021 and all other events on 27Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1754925 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-08-27
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF680 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, C-reactive protein, Computerised tomogram head, Echocardiogram, Ejection fraction, Electrocardiogram, Electrocardiogram ambulatory, Glycosylated haemoglobin, Ischaemic stroke, Liver function test, Low density lipoprotein, Platelet count, Thyroglobulin, Ultrasound Doppler
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial stenosis (On LIPTRUZET and DUOPLAVIN for intracranial arterial stenosis for 3 months.); Cystitis; Drug allergy; Drug-induced hepatitis; Lyme disease (only tick bite, no joint involvement); Polyp removal; Stroke (patient''s mother); Total hysterectomy
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: creatinine; Result Unstructured Data: Test Result:50 umol/l; Test Date: 20210830; Test Name: Computerized tomography brain angiogram; Result Unstructured Data: Test Result:right superficial sylvian ischaemic lesion; Comments: with tight stenosis of the right lower limb.; Test Date: 2021; Test Name: C-reactive protein; Result Unstructured Data: Test Result:unknown; Test Date: 2021; Test Name: Transthoracic ultrasound; Result Unstructured Data: Test Result:Non-dilated non-hypertrophied normokinetic LV; Comments: type I mitral profile, undilated left eye, undilated ascending aorta, no aortic stenosis, no aortic insufficiency, no mitral insufficiency, non-dilated right chamber, dry pericardium.; Test Date: 2021; Test Name: left ventricle ejection fraction; Test Result: 73 %; Test Date: 2021; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:in regular sinus rhythm; Comments: with presence of right bundle branch block.; Test Date: 2021; Test Name: Holter; Result Unstructured Data: Test Result:72 hour rhythmic Holter in progress; Test Date: 2021; Test Name: Glycated hemoglobin; Test Result: 6 %; Test Date: 2021; Test Name: liver function tests; Result Unstructured Data: Test Result:Normal; Test Date: 2021; Test Name: LDL; Result Unstructured Data: Test Result:0.64 g/l; Test Date: 2021; Test Name: platelets; Result Unstructured Data: Test Result:248; Test Date: 2021; Test Name: Thyroglobulin; Result Unstructured Data: Test Result:1.07 g/l; Test Date: 2021; Test Name: Echo Doppler of the supraoptic trunks; Result Unstructured Data: Test Result:regular moderate atheromatous overload; Comments: in the left primary carotid artery.
CDC Split Type: FRPFIZER INC202101228865

Write-up: Ischemic stroke; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority number FR-AFSSAPS-SE20212420. A 73-years-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot number: FF680) via intramuscular route of administration at left arm on 28Jul2021 as dose 1, single for COVID-19 immunisation. Medical history included lyme disease only tick bite, no joint involvement, Drug allergy, Polyp removal, Drug-induced hepatitis from 1971 Total hysterectomy, Cystitis, Patient put on LIPTRUZET and DUOPLAVIN due to intracranial arterial stenosis for an initial period of 3 months. The patient''s mother had a stroke. The patient''s concomitant medications were not reported. The patient previously took amoxicilline [amoxicillin] and experienced drug hypersensitivity. Patient did not have COVID-19 and patient was not tested for COVID-19. The patient experienced ischemic stroke on 27Aug2021. The patient was hospitalized for ischemic stroke from 30Aug2021 to 06Sep2021. The patient underwent lab tests and procedures which included blood creatinine: 50 umol/l on an unspecified date in 2021, computerised tomogram head: right superficial sylvian ischaemic lesion on 30Aug2021 with tight stenosis of the right lower limb , c-reactive protein: unknown on an unspecified date in 2021, echocardiogram: non-dilated non-hypertrophied normokinetic lv on an unspecified date in 2021 type I mitral profile, undilated left eye, undilated ascending aorta, no aortic stenosis, no aortic insufficiency, no mitral insufficiency, non-dilated right chamber, dry pericardium , ejection fraction: 73 % on an unspecified date in 2021, electrocardiogram: in regular sinus rhythm on an unspecified date in 2021 with presence of right bundle branch block , electrocardiogram ambulatory: 72 hour rhythmic holter in progress on an unspecified date in 2021, glycosylated haemoglobin: 6 % on an unspecified date in 2021, liver function test: normal on an unspecified date in 2021, low density lipoprotein: 0.64 g/l on an unspecified date in 2021, platelet count: 248 on an unspecified date in 2021, thyroglobulin: 1.07 g/l on an unspecified date in 2021, ultrasound doppler: regular moderate atheromatous overload on an unspecified date in 2021 in the left primary carotid artery. Therapeutic measures were taken as a result of ischemic stroke. Outcome of event was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information expected.


VAERS ID: 1755087 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Heavy menstrual bleeding, Inappropriate schedule of product administration, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101233792

Write-up: Heavy periods; patient took first dose of vaccine on 26Jun2021 and second dose on 27Aug2021; Abdominal cramping; This is a spontaneous report from a contactable consumer or other non HCP received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109192110188700-ZHLZT. Safety Report Unique Identifier GB-MHRA-ADR 25966386. A 20-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: FE3380, Expiration date was not reported) via an unspecified route of administration on 27Aug2021, as dose 2, single (at the age of 20-years-old) for COVID-19 immunisation. Medical history included suspected covid-19 from 25Mar2021 to 16Apr2021.The patient''s concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number and Expiration date was not reported), via an unspecified route of administration, on 26Jun2021, as dose 1, single for COVID-19 immunization. Patient was not pregnant. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unknown date in 2021, the patient experienced abdominal cramping. on 19Sept2021, patient experienced heavy periods. both events reported as medically significant. it was observed that patient took first dose of vaccine on 26Jun2021 and second dose on 27Aug2021. It was reported that her first period after her second dose was extremely heavy, much heavier than any she had previously. She bled through a ''super heavy'' tampon, pad, and pair of jeans within 90 mins, which felt noticeably excessive. She also experienced more abdominal cramping than normal. On an unknown date, the patient underwent lab test and procedure which include SARS-COV-2 test which resulted negative (No - Negative COVID-19 test). The outcome of event abdominal cramping was resolved unspecified date in 2021 and outcome of event heavy periods was resolving. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1755220 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-08-27
   Days after vaccination:90
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Laboratory test, Myalgia, Oropharyngeal pain, SARS-CoV-2 test, Vaccination failure
SMQs:, Rhabdomyolysis/myopathy (broad), Lack of efficacy/effect (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (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: 20210828; Test Name: Laboratory test; Result Unstructured Data: Test Result: 15.16; Comments: Cycle Threshold value for E gene 15.16; Test Date: 20210828; Test Name: Laboratory test; Result Unstructured Data: Test Result: 14.01; Comments: SARS-CoV-2 gene 14.01; Test Date: 20210828; Test Name: SARS-CoV-2 PCR test; Test Result: Positive.
CDC Split Type: HRPFIZER INC202101231104

Write-up: Vaccination failure; Positive Covid-19 test with symptoms; Sore throat; Myalgia; This is a spontaneous report from a contactable physician from the Regulatory authority number HR-HALMED-300050816. A 73-year-old male patient received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Lot number FC8736) via an intramuscular route of administration on 29May2021 as DOSE 2,0.3ML SINGLE for covid-19 immunization and also took bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, lot number EX3599 via an intramuscular route of administration on 28Apr2021 as DOSE 1,0.3ML SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 27Aug2021 the patient had experienced throat pain and muscle pain. On 28Aug2021 the patient had underwent lab test and procedures which included Cycle Threshold value for E gene 15.16, SARS-CoV-2 gene 14.01, and SARS-CoV-2 PCR test with positive result. The patient did not receive any treatment for AE. The outcome of the events were recovered on 31 Aug 2021. Follow-up report from Product Complaint Team provided includes For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced ID resulted in the following conclusion, Reference ID 5937614 (see File attachment in this investigation record). The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EX3599, FC8736. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, and stability. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root causes were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information expected.


VAERS ID: 1755263 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-08-27
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003604 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: C-reactive protein, Echocardiogram, Electrocardiogram, Impaired work ability, Loss of personal independence in daily activities, Myocarditis, Troponin
SMQs:, Dementia (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: C-reactive protein; Result Unstructured Data: Admission CRP 66; Test Date: 20210830; Test Name: C-reactive protein; Result Unstructured Data: normal; Test Date: 20210827; Test Name: Echocardiogram; Result Unstructured Data: No pericardial effusion. Normal LV function; Test Date: 20210827; Test Name: Troponin; Result Unstructured Data: Admission Troponin 893; Test Date: 202108; Test Name: ECG; Test Result: Inconclusive ; Result Unstructured Data: ECG wide spread concave upwards ST elevation
CDC Split Type: IEMODERNATX, INC.MOD20213

Write-up: COULD NOT TAKE PART IN CONTACT SPORTS. HE CAN RETURN TO HIS USUAL ACTIVITIES IN ABOUT 2 WEEKS / AVOIDING EXTREMES OF EXERTION; SHOULD STAY OFF WORK UNTIL MONDAY WEEK; MYO-PERICARDITIS - CHEST DISCOMFORT; This case was received via Regulatory Authority (Reference number: IE-HPRA-2021-083721) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (MYO-PERICARDITIS - CHEST DISCOMFORT), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (COULD NOT TAKE PART IN CONTACT SPORTS. HE CAN RETURN TO HIS USUAL ACTIVITIES IN ABOUT 2 WEEKS / AVOIDING EXTREMES OF EXERTION) and IMPAIRED WORK ABILITY (SHOULD STAY OFF WORK UNTIL MONDAY WEEK) in a 22-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 3004218 and 3003604) for COVID-19 vaccination. None. On 28-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Aug-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced MYOCARDITIS (MYO-PERICARDITIS - CHEST DISCOMFORT) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (COULD NOT TAKE PART IN CONTACT SPORTS. HE CAN RETURN TO HIS USUAL ACTIVITIES IN ABOUT 2 WEEKS / AVOIDING EXTREMES OF EXERTION) (seriousness criteria hospitalization and medically significant) and IMPAIRED WORK ABILITY (SHOULD STAY OFF WORK UNTIL MONDAY WEEK) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (MYO-PERICARDITIS - CHEST DISCOMFORT) was resolving and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (COULD NOT TAKE PART IN CONTACT SPORTS. HE CAN RETURN TO HIS USUAL ACTIVITIES IN ABOUT 2 WEEKS / AVOIDING EXTREMES OF EXERTION) and IMPAIRED WORK ABILITY (SHOULD STAY OFF WORK UNTIL MONDAY WEEK) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Electrocardiogram: inconclusive (Inconclusive) ECG wide spread concave upwards ST elevation. On 27-Aug-2021, C-reactive protein: 66 (abnormal) Admission CRP 66. On 27-Aug-2021, Echocardiogram: normal (normal) No pericardial effusion. Normal LV function. On 27-Aug-2021, Troponin: 893 (abnormal) Admission Troponin 893. On 30-Aug-2021, C-reactive protein: 10 (normal) normal. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided. No relevant concomitant medications were reported. Company comment: This case concerns a 22-year-old, male patient with no relevant medical history, who experienced the unexpected events of impaired work ability, loss of personal independence in daily activities, and the expected event of Myocarditis. The event Myocarditis occurred 1 day after the second dose of Spikevax. The rechallenge was not applicable, as no additional dosing will be given. The event myocarditis 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. Events term, onset date, outcome and seriousness captured per agency from Regulatory Authority reporting.; Sender''s Comments: This case concerns a 22-year-old, male patient with no relevant medical history, who experienced the unexpected events of impaired work ability, loss of personal independence in daily activities, and the expected event of Myocarditis. The event Myocarditis occurred 1 day after the second dose of Spikevax. The rechallenge was not applicable, as no additional dosing will be given. The event myocarditis 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. Events term, onset date, outcome and seriousness captured per agency from Regulatory Authority reporting.


VAERS ID: 1755514 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-08-27
   Days after vaccination:47
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3143 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body mass index, Echocardiogram, Electrocardiogram, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Overweight (BMI 28.1)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: non specified scan and blood tests; Result Unstructured Data: Test Result:results unknown; Test Name: BMI; Result Unstructured Data: Test Result:28.1; Test Date: 2021; Test Name: cardiac ultrasound; Result Unstructured Data: Test Result:results unknown; Test Date: 2021; Test Name: ECG; Result Unstructured Data: Test Result:results unknown
CDC Split Type: NLPFIZER INC202101229053

Write-up: Pulmonary embolism; This is a spontaneous report from a contactable consumer or other non hcp (patient) downloaded from the regulatory authority NL-LRB-00680752. A 55-years-old female patient received second dose of bnt162b2 (COMIRNATY) via unspecified route of administration on 11Jul2021 (lot number: FC3143) at single dose for COVID-19 immunization. Patient medical history included overweight (BMI 28.1). No concomitant medications received (none). Patient had no previous COVID-19 infection. The patient previously received first dose of bnt162b2 (COMIRNATY) via unspecified route of administration on 11Jun2021 at single dose for COVID-19 immunization and experienced no adverse reaction. On 27Aug2021, also reported as 7 weeks after vaccination, the patient experienced pulmonary embolism. Event was reported as serious, medically significant. An ECG, cardiac ultrasound, non-specified scan and blood tests were performed on unspecified date in 2021 (with results unknown). The patient was treated with unspecified anticoagulant. The patient was recovering from the event pulmonary embolism. Sender Comment: Since the nature of the reported reaction does imply seriousness according to one of the regulatory authority critera, the reaction pumonary embolism was considered as serious other medically important event by the regulatory authority. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: No Date: 11Jun2021 COVID19 Previous COVID-19 infection: No Other diagnostic procedures: Cardiogram, cardiac ultrasound, blood test. Scan


VAERS ID: 1755615 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-08-27
   Days after vaccination:184
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210902; Test Name: Oxygen saturation; Test Result: 85 %; Test Date: 20210827; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: Positive (IU) in international units
CDC Split Type: PTPFIZER INC202101256826

Write-up: PCR positive; COVID-19; This is a Spontaneous report from a contactable Nurse downloaded from the Regulatory authority-WEB. This is a report received Regulatory authority report number PT-INFARMED-T202109-476 with Safety Report Unique Identifier PT-INFARMED-T202109-476. A 80-years-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EP2166) via intramuscular on 24Feb2021as DOSE 2, 0.3 ML SINGLE, first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EJ6797) via intramuscular on 03Feb2021 as DOSE 1, 0.3 ML SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 27Aug2021 the patient experienced pcr positive and covid-19. The adverse reaction (ADR) was detected through a positive PCR test about 184 days after the administration of the second dose of the suspected drug, with duration unknown. ADR is characterized by lack of effectiveness with the complete vaccination schedule, having motivated hospital observation because oxygen saturation was 85%. There is no suspicion of drug interactions. There is no information on previous reactions to the same or other drugs, on treatment of the reaction or on concomitant medication. Patient still with fever, cold hands, tiredness and generalized weakness. The patient underwent lab tests and procedures which included oxygen saturation: 85 % on 02Sep2021, sars-cov-2 test: positive on 27Aug2021 Positive (IU) in international units. The outcome of the events was not recovered. The reporters assessment of the causal relationship of the event (COVID-19 and vaccination failure) with the suspect product was: Relatedness of drug to reaction(s)/event(s): Source of assessment: reporter, Method of assessment: unknown, Result of Assessment: probable. Reporter comment: Other information: patient mentioned fatigue and generalized weakness;on 02Sep2021 oxygen saturation on 85% cold hand, I still had fever yesterday. I was recommended going to the emergency below 90%, fever today. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1755652 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-08-27
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Musculoskeletal stiffness
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101234376

Write-up: stiff neck and stiff shoulders; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration in left arm on 09Jul2021 at 17:30 (Lot Number: Fd6840, unknown expiration) as dose 1, single at the age of 32 years old for COVID-19 immunisation. Medical history and concomitant medication reported as none. No known allergies. The patient has not received any other vaccine within 4 weeks. The patient experienced stiff neck and stiff shoulders on 27Aug2021 at 01:00. The patient received no treatment for the event. The patient has not been diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient recovered from the event with sequelae. The event is assessed as serious (disability). No follow-up attempts are possible; information about batch number was already obtained.


VAERS ID: 1757697 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA J07BX03 / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: C-reactive protein, COVID-19 immunisation, Cardiac telemetry, Echocardiogram, Electrocardiogram, Pericarditis, Red blood cell sedimentation rate, Troponin T, White blood cell count
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Cardiac telemetry; Result Unstructured Data: Normal; Test Date: 202108; Test Name: C-reactive protein; Test Result: Inconclusive ; Result Unstructured Data: 40; Test Date: 202108; Test Name: Echocardiography; Result Unstructured Data: Normal; Test Date: 202108; Test Name: ECG; Test Result: Inconclusive ; Result Unstructured Data: Slight ST-elevation scattered in all leads; Test Date: 202108; Test Name: Erythrocyte sedimentation rate; Test Result: Inconclusive ; Result Unstructured Data: 51; Test Date: 202108; Test Name: Troponin T; Test Result: Inconclusive ; Result Unstructured Data: <10; Test Date: 202108; Test Name: Leucocyte count; Test Result: Inconclusive ; Result Unstructured Data: 10
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: PERICARDITIS; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This case was received via regulatory authority (Reference number: NO-NOMAADVRE-E2B_00049034) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of COVID-19 IMMUNISATION (REVACCINATION WITH DIFFERENT COVID-19 VACCINE) and PERICARDITIS (PERICARDITIS) in a 47-year-old male patient who received mRNA-1273 (Spikevax) (batch no. J07BX03) for COVID-19 vaccination. Previously administered products included for Vaccination: Comirnaty (5''capped mRNA encoding full length SARS-CoV-2 spike protein). On 26-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In 2021, the patient experienced COVID-19 IMMUNISATION (REVACCINATION WITH DIFFERENT COVID-19 VACCINE) (seriousness criterion hospitalization prolonged). On 27-Aug-2021, the patient experienced PERICARDITIS (PERICARDITIS) (seriousness criteria hospitalization prolonged and medically significant). At the time of the report, COVID-19 IMMUNISATION (REVACCINATION WITH DIFFERENT COVID-19 VACCINE) and PERICARDITIS (PERICARDITIS) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, C-reactive protein: 40 (Inconclusive) 40. In August 2021, Cardiac telemetry: normal (normal) Normal. In August 2021, Echocardiogram: normal (normal) Normal. In August 2021, Electrocardiogram: slight st-elevation scattered in all leads (Inconclusive) Slight ST-elevation scattered in all leads. In August 2021, Red blood cell sedimentation rate: 51 (Inconclusive) 51. In August 2021, Troponin T: <10 (Inconclusive) <10. In August 2021, White blood cell count: 10 (Inconclusive) 10. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered PERICARDITIS (PERICARDITIS) to be possibly related. No further causality assessment was provided for COVID-19 IMMUNISATION (REVACCINATION WITH DIFFERENT COVID-19 VACCINE). No concomitant medications were provided by the reporter. Treatment for the events were not provided by the reporter. This is a case of revaccination with different Covid-19 vaccine (inter change of vaccine products) for this 47-year-old, male patient with no relevant medical history, who experienced the expected event of pericarditis. The event pericarditis occurred 2 days after the second dose of Spikevax vaccine administration. The rechallenge was not applicable because the patient previously received other brand (Comirnatry) of Covid-19 vaccine. The events were considered possibly related to the product per the reporter''s assessment. The benefit-risk relationship of Spikevax vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Translation received on 27-SEP-2021 and does not contain any new information.; Sender''s Comments: This is a case of revaccination with different Covid-19 vaccine (inter change of vaccine products) for this 47-year-old, male patient with no relevant medical history, who experienced the expected event of pericarditis. The event pericarditis occurred 2 days after the second dose of Spikevax vaccine administration. The rechallenge was not applicable because the patient previously received other brand (Comirnatry) of Covid-19 vaccine. The events were considered possibly related to the product per the reporter''s assessment. The benefit-risk relationship of Spikevax vaccine is not affected by this report.


VAERS ID: 1758006 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-14
Onset:2021-08-27
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood test, Haemoglobin, Immune thrombocytopenia, Petechiae, Platelet count, Red blood cell count, Vaccination site pain, Vomiting, White blood cell count
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic tonsillitis; Lactose intolerance; Obesity; Otitis media chronic; Peanut allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Gastrointestinal disorder; Low grade fever (Antibiotic therapy and probiotics were prescribed); Menstrual disorder (took iron tablets); Pimples (Antibiotic therapy and probiotics were prescribed)
Allergies:
Diagnostic Lab Data: Test Date: 2016; Test Name: blood test; Result Unstructured Data: Test Result:without pathology; Test Date: 202002; Test Name: Hgb; Result Unstructured Data: Test Result:109 g/l; Test Date: 202002; Test Name: Platelet count; Result Unstructured Data: Test Result:410 x10 9/l; Test Date: 2021; Test Name: Platelet count; Result Unstructured Data: Test Result:177 x10 9/l; Test Date: 20210829; Test Name: Platelet count; Result Unstructured Data: Test Result:5 x10 9/l; Test Date: 202002; Test Name: RBC; Result Unstructured Data: Test Result:5.16 x10 12/l; Test Date: 202002; Test Name: WBC; Result Unstructured Data: Test Result:8.26 x10 9/l
CDC Split Type: EEPFIZER INC202101229470

Write-up: Petechial rash; Shoulder pain; Immune thrombocytopenia; Vaccination site pain; Vomiting reflexes; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. Regulatory authority number is EE-SAM-50102109067. A 15-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 14Aug2021 (Batch/Lot number was not reported) as DOSE 1, 0.3 mL, SINGLE for COVID-19 immunization. Medical history included ongoing chronic tonsillitis, ongoing lactose intolerance, ongoing obesity, ongoing food allergy (peanut allergy), ongoing otitis media chronic, pyrexia (small fever) from Feb2020 (antibiotic therapy and probiotics were prescribed), acne (pimples in mouth) from Feb2020 (Antibiotic therapy and probiotics were prescribed), bloody periods from Feb2020 (took iron tablets), and intestinal problems. Concomitant medications were not reported. The patient experienced immune thrombocytopenia on 28Aug2021 with outcome of recovering, vaccination site pain on 28Aug2021 with outcome of recovered on 15Sep2021, petechial rash on 29Aug2021 with outcome of recovering, shoulder pain on 28Aug2021 with outcome of recovered on 15Sep2021, and vomiting reflexes on 27Aug2021 with outcome of unknown. The patient was hospitalized due to the events from 02Sep2021 to an unknown date. The patient underwent lab tests and procedures which included platelet count: 5 x10 9/l on 29Aug2021, platelet count: 410 x10 9/l on Feb2020, platelet count: 177 x10 9/l on 2021, haemoglobin: 109 g/l on Feb2020, white blood cell count: 8.26 x10 9/l on Feb2020, red blood cell count: 5.16 x10 12/l on Feb2020, blood test: without pathology on 2016. Therapeutic measures were taken as a result of immune thrombocytopenia, vaccination site pain, shoulder pain and petechial rash with Solu-Medrol. The event immune thrombocytopenia was assessed as serious due to hospitalization, medically significant; events vaccination site pain, petechial rash, shoulder pain were assessed as serious, caused hospitalization; vomiting was assessed as non-serious. Case narrative: The patient was vaccinated with the first dose of Comirnaty vaccine on 14th August 2021. On August 28th, the patient developed shoulder pain, the next day a petechial rash developed over the body, more in the thighs and abdomen. PLT 5x10E9/l. Immune thrombocytopenia was diagnosed. On 2nd September 2021, the patient was hospitalized. Solu-Medrol was prescribed for treatment. The patient has not improved yet. She has allergy to peanut. On 6th September 2021, additional information from family nurse: in February 2020, a blood test was performed with PLT 410x10E9/l; Hgb 109 g/l; WBC 8,26x10E9/l; RBC 5,16x10E12/l. Then the patient had a small fever in the evening and pimples in mouth. Antibiotic therapy and probiotics were prescribed. Iron tablets due to bloody periods. In 2016, the blood test was without pathology. On August 30, the girl turned to a family doctor for a blistering rash that occurred after eating peanut butter. On August 27th, the complaints were vomiting reflexes, which were considered to be of a rather psychic nature. The patient wanted a reduced load in physical education class for running and jumping. Physiotherapy was also prescribed. The patient has a history of intestinal problems, lactose intolerance, chronic tonsillitis and chronic otitis media; obesity. Thus, thrombocytopenia has not been reported in the past, but other disorders have been reported. On 15th September 2021, follow-up information: The girl went for outpatient monitoring, treatment (high dose of the hormone). Platelets increased to 177x10E9/l, to be monitored. She also said that she had taken the SOS pill (Escapelle-Levonorgestrel) 3 days after vaccination. Sender''s comments: The serious (Immune thrombocytopenia requiring hospitalization) side effect. The causal relationship is considered possible. Stop date reported for events: immune thrombocytopenia, petechial rash: 15Sep2021 No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.


VAERS ID: 1758157 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-08-27
   Days after vaccination:211
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Dyspnoea, Polymerase chain reaction, Pyrexia, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), 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), 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: Diabetes; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Name: RT-PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101228637

Write-up: SARS-CoV-2 infection; Vaccination failure; Fever; Dyspnoea; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number IT-MINISAL02-786839. A 67-years-old male patient received bnt162b2(COMIRNATY, Solution for injection, Lot Number: EJ6797), via intramuscular route on 28Jan2021 as dose 2, 0.3 ug single, and second dose via an unspecified route of administration on 07Jan2021 (Lot Number: Unknown) as dose 1, single for COVID-19 immunisation. Medical history included hypertension arterial and diabetes mellitus- both unknown if ongoing. The patient experienced SARS-COV-2 infection, Vaccination failure, fever and dyspnoea on 27Aug2021. The RT-PCR test showed positive. Investigational report conclusion from division was: For this lot Adverse Event Safety Request for Investigation and/or lack of effect was previously investigated. A sample was not sent to the 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 5570166 (see File attachment in this investigation record): The complaint for Adverse Event Safety Request of PFIZER-BIONTECH COVID-19 was investigated. The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference samples, 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 EJ6797. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability.concludes that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification was required. The reported defect could not be confirmed on the reference samples. No root were identified as the complaint was not confirmed. The events were assessed as serious (medically significant). The events outcome was reported as unknown. No follow-up attempts are possible. No further information is expected


VAERS ID: 1758182 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005698 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Guillain-Barre syndrome, Polyneuropathy
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

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

Write-up: This case was received via the RA (Reference number: IT-MINISAL02-788085) 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 POLYNEUROPATHY (Guillain Barre) and GUILLAIN-BARRE SYNDROME (Guillain Barre) in an 87-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005698) for COVID-19 vaccination. The patient''s past medical history included Psoriasis on 08-Sep-2000. On 26-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 27-Aug-2021, the patient experienced POLYNEUROPATHY (Guillain Barre) (seriousness criteria hospitalization and medically significant) and GUILLAIN-BARRE SYNDROME (Guillain Barre) (seriousness criteria hospitalization and medically significant). At the time of the report, POLYNEUROPATHY (Guillain Barre) and GUILLAIN-BARRE SYNDROME (Guillain Barre) had not resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. After vaccination patient were experienced Pain in the lower limbs with functional deficit, and Exacerbation of psoriasis. The Neurological examination were done found suspected Guillain - Barr? syndrome. Patient was hospitalized in the neurology department due to GB syndrome. Company comment: This case concerns a 87-year-old, female patient with no previous relevant medical history, who experienced the unexpected events of polyneuropathy and gullain barre syndrome.. The events occurred 1 day after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up received on 28-SEP-2021 that contains Seriousness criteria of event updated as Hospitalization. On 28-Sep-2021: Additional information received on 30-SEP-2021 that contains updated Narrative.; Reporter''s Comments: (20/09/2021) GB; Sender''s Comments: This case concerns a 87-year-old, female patient with no previous relevant medical history, who experienced the unexpected events of polyneuropathy and gullain barre syndrome.. The events occurred 1 day after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.


VAERS ID: 1758439 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-27
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101238889

Write-up: Cardiac failure; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-202100191231. A 74-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced cardiac failure (hospitalization) on 27Aug2021. The outcome of the event was not recovered. Sender''s comment: JE; DE-AMK-253031_ COMIRNATY Batch/lot number Unknown Additional information about drug COMIRNATY Events : Cardiac failure Relatedness of drug to reaction(s)/event (s) Source of assessment Result of Assessment D. Unclassifiable No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1759845 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-27
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Petechiae, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101243040

Write-up: Thrombocytopenia; Petechiae; This is a spontaneous report from a contactable other health professional via a Regulatory Authority. Regulatory authority report number is 623984A. A 71-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced thrombocytopenia and petechiae on 27Aug2021. The outcome of the events was recovered on an unknown date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1760152 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-27
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Headache, Inflammatory marker test, Influenza like illness, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: inflammatory parameters; Result Unstructured Data: Test Result:High
CDC Split Type: CZPFIZER INC202101239056

Write-up: Fever, myalgia, arthralgia, severe headache; Fever; myalgia; arthralgia; severe headache; Weariness; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number CZ-CZSUKL-21010652. A 15-years-old female patient received bnt162b2 (COMIRNATY, Solution for Injection), intramuscularly on 23Aug2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously was vaccinated with first dose of comirnaty for covid-19 immunisation on unknown date. On 27Aug2021, the patient experienced fever, myalgia, arthralgia, severe headache (hospitalization, medically significant) and weariness (medically significant). The patient underwent lab tests and procedures which included inflammatory marker test results showed high on an unknown date. The outcome of all the events was not resolved and for the event weariness it was unknown. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.


VAERS ID: 1760500 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4592 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaesthesia oral, Hypoaesthesia oral
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101239559

Write-up: Anesthesia lip/ anesthesia of the hemilip-hemitongue; hypoesthesia of the hemilip-hemitongue; This is a spontaneous report from a contactable consumer or other non HCP downloaded from the regulatory authority-WEB, regulatory authority number ES-AEMPS-1003741. A 33-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 27Aug2021 at the age of 33-years-old (Lot Number: FG4592) as dose 1, 0.3 ml, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. According to his primary care doctor, he relates that 15'' (15 minutes) after administering the first one, he presented anesthesia-hypoesthesia of the hemilip-hemitongue which lasted about 15'' (15 minutes) and resolved spontaneously. The patient experienced anesthesia lip/ anesthesia of the hemilip-hemitongue (medically significant) on 27Aug2021 with outcome of recovered on 27Aug2021, hypoesthesia of the hemilip-hemitongue (non-serious) on 27Aug2021 with outcome of recovered on 27Aug2021. No follow-up attempts are possible. No further information expected.


VAERS ID: 1760546 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH JO7BX03 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Ecchymosis, Fatigue, Full blood count, Genital haemorrhage, Haemoglobin, Haemoglobin decreased, Haemorrhage, Headache, Heavy menstrual bleeding, Human chorionic gonadotropin, Hyperleukocytosis, Immune thrombocytopenia, Menometrorrhagia, Nasal oedema, Normocytic anaemia, Oedema, Oedema peripheral, Pain in extremity, Platelet count, Platelet count decreased, Thrombocytopenia, Thrombosis, Uterine haemorrhage
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related conditions (narrow), Thrombophlebitis (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 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 Name: thrombocytopenia; Result Unstructured Data: Test Result:3 g/l; Test Name: haemoglobin; Result Unstructured Data: Test Result:4.65 g/l; Test Date: 20210907; Test Name: haemoglobin; Result Unstructured Data: Test Result:7.5 g/l; Test Name: haemoglobin; Result Unstructured Data: Test Result:9.6 g/l; Test Name: betaHCG; Test Result: Negative ; Test Date: 20210904; Test Name: Platelet; Result Unstructured Data: Test Result:3000/mL; Comments: the norm is between 150,000 and 450,000 platelets/ml; Test Date: 20210907; Test Name: Platelet; Result Unstructured Data: Test Result:64; Comments: G/L
CDC Split Type: FRPFIZER INC202101239607

Write-up: Headaches; pain in the legs; vascular haemorrhages/ considerable blood loss; drop in the haemoglobin level; general fatigue; Thrombocytopenia; haemorrhages of the uterine endometrium (hypermenorrhoea); fall of the platelets; Fall in haemoglobin; heavy gynaecological bleeding; heavy clots in the vagina; Normocytic anaemia; Hyperleukocytosis; giant oedemas on the body (lower and upper limbs, and head (nose); giant oedemas on the body (lower and upper limbs, and head (nose); haemorrhages of the uterine endometrium (hypermenorrhoea); diffuse bruising; Menometrorrhagia; Ecchymosis; Immune thrombocytopenic purpura; Edema; This is a spontaneous report from a contactable consumer (parent) downloaded from the regulatory Authority report number is FR-AFSSAPS-CF20212682. A 20-year-old female patient received BNT162B2 (COMIRNATY), intramuscular, administered in left arm on 25Aug2021 (Batch/Lot Number: JO7BX03) as dose 2, single for COVID-19 immunisation. The patient has no medical history and there were no concomitant medications. The patient has not had COVID-19. The patient received the first dose of BNT162B2 (COMIRNATY) intramuscular on 04Aug2021 for COVID-19 immunization. On 27Aug2021. the patient experienced menometrorrhagia, ecchymosis, immune thrombocytopenic purpura, and edema. It as reported that the patient experienced immunological thrombocytopenia from 27Aug2021, 48 hours after the 2nd injection of the Pfizer anti-covid vaccine (administered on 25Aug2021). Impressive and unexplained menorrhagia given the reporter''s daughter''s excellent health. Considerable blood loss during 7 days and spontaneous onset of giant oedemas on the body (lower and upper limbs, and head (nose) on an unspecified date. The patient was Hospitalized on 04Sep2021 (in the morning) and was transferred to the internal medicine department. Diagnosis was Immunological thrombocytopenia, objectively linked to injection of pfizer anti-covid messenger ribonucleic acid vaccine (1st injection on 04Aug2021- 2nd injection on 25Aug2021). No other event or medical history can otherwise explain the cause of this Thrombocytopenia given the patient''s perfect health (no medication or infection or illness prior to the vaccination). Headaches, pain in the legs and right ankle in particular (giant oedema), subcutaneous oedemas that appeared and resulted from the "planetary fall" that caused vascular haemorrhages, a drop in the haemoglobin level and a general fatigue. All these effects associated with immunological Thrombocytopenia having generated vascular and important haemorrhages of the uterine endometrium (hypermenorrhea) + a fall of the platelets (rate reading of 3000/ml of blood on the first day of hospitalization, whereas the norm is between 150,000 and 450,000 platelets/ml), Fall in haemoglobin level still not back to normal by 15Sep2021. Treatment by corticosteroids and iron supplementation for 2 months. Medical follow-up with blood tests was done twice a week for 2 months on Mondays and Thursdays (Sep2021 and Oct2021) an the next medical assessment visit was scheduled on 06Oct2021 with the Professor of Internal Medicine. The patient was hospitalized on 04Sep2021 to 07Sep2021 due to the events. Hospitalization for heavy gynaecological bleeding. On an unspecified date, heavy clots in the vagina, thrombocytopenia at 3 g/L, Hb 9.6g/l, haemoglobin 4.65 g/L, betaHCG negative. Clinical examination with no abnormalities except for diffuse bruising of the left upper limbs and lower limbs, 16 in total, the largest of which was 15 cm on the right ankle, abundant menometrorrhagia with clots. Decreased platelet count, Normocytic anaemia, and Hyperleukocytosis on an unspecified date. Immune thrombocytopenia was treated by immunoglobulins and corticosteroids. No clinical evidence for connectivitis. Good response to corticosteroid therapy Solumedrol 1mg/kg plus 1 day of immunoglobulin. The blood test showed a re-association of platelets with 64 g/L and Haemoglobin 7.5 g/dl at discharge on 07Sep2021. Upon discharge: tardyferon, folates, and cortancyl with Close monitoring of blood counts. Reassessment at 1 month with autoimmune test, viral serologies. The outcome of the events Menometrorrhagia, Ecchymosis, Immune thrombocytopenia and Oedema were recovering while the outcome of the rest of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1760558 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: DOLIPRANE; CETIRIZINE ARROW
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101239734

Write-up: Chest pain; inflammation of the heart envelope; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority. WEB, regulatory authority number FR-AFSSAPS-LY202110535. A 34-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 26Aug2021 (Lot Number: FG7387) as DOSE 2,SINGLE for covid-19 immunisation . The patient medical history was not reported. Concomitant medications included paracetamol (DOLIPRANE); cetirizine hydrochloride (CETIRIZINE ARROW). The patient previously took the first dose bnt162b2 on in 2021 for covid-19 immunization and experienced urticaria, amenorrhea. The next day, 27Aug2021, the patient reports the onset of chest pain. Emergency room consultation. The doctor declares an "inflammation of the cardiac envelope". The outcome of events was not recovered. Seriousness criteria reported as medical significant No follow-up attempts are possible, no further information is expected.


VAERS ID: 1760813 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-27
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Menstrual disorder, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis)); Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101242773

Write-up: period pains; Menstruation abnormal; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109202040184070-XUFIB, Safety Report Unique Identifier GB-MHRA-ADR 25970723. A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Fe3380), via an unspecified route of administration on 23Aug2021 as dose 1, single for COVID-19 immunisation. Medical history included suspected covid-19 from 07Apr2020 (unsure when symptoms stopped) and inflammatory bowel disease (taking medicines for inflammatory bowel disease (crohn''s disease, ulcerative colitis). The patient''s concomitant medications were not reported. On 27Aug2021, the patient experienced menstruation abnormal and on an unknown date, patient experienced period pains. The patient underwent lab tests and procedures which included sars-cov-2 test resulted in positive on an unknown date. The patient had a 4-day bleed once a week. Constant pains that felt like period pains. Her periods were like click work until having the vaccine. Patient had not tested positive for COVID-19 since having the vaccine. Unsure if patient was enrolled in clinical trial. The outcome of the event menstruation abnormal was not recovered and for the event period pains was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1763880 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-27
Submitted: 0000-00-00
Entered: 2021-10-06
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: Medical History/Concurrent Conditions: Acute upper respiratory tract infection; Anxiety state; Back pain (with radiation); Bronchitis acute; Dyslipidaemia; Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: SARS-CoV-2 test; Result Unstructured Data: Positive Iu international unit(s)
CDC Split Type: PTJNJFOC20211005661

Write-up: Vaccination failure; This spontaneous report received from a health care professional via a Regulatory Authority (regulatory authority, PT-INFARMED-T202109-1447) was received on 04-OCT-2021 and concerned a 58 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: dyslipidaemia, anxiety state, acute upper respiratory tract infection, bronchitis acute, and back pain (with radiation). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C11-05 expiry: UNKNOWN) 0.5 ml, 1 total administered on 28-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 27-AUG-2021, the patient experienced vaccination failure. Laboratory data included: SARS-CoV-2 test (NR: not provided) Positive Iu international unit(s) (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccination failure was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1764166 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-27
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Epistaxis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

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

Write-up: This case was received via regulatory authority (Reference number: SE-MPA-2021-085079) on 28-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of EPISTAXIS in a 17-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Concurrent medical conditions included Acne. Concomitant products included ISOTRETINOIN for an unknown indication. On 10-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced EPISTAXIS (seriousness criterion hospitalization). At the time of the report, EPISTAXIS had resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No treatment information provided. Company comment: This case concerns a 17 year old female patient, with no relevant medical history reported, who experienced serious unexpected event of Epistaxis after dose of mRNA-1273. The event occurred 18 days after received dose of mRNA-1273. The rechalleange is unknown. Patient?s concomitant medication (isotretinoin) remain a confounder. The benefit-risk relationship of Spikevax in not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Translation document received on 30-Sep-2021 with no new information.; Sender''s Comments: This case concerns a 17 year old female patient, with no relevant medical history reported, who experienced serious unexpected event of Epistaxis after dose of mRNA-1273. The event occurred 18 days after received dose of mRNA-1273. The rechalleange is unknown. Patient?s concomitant medication (isotretinoin) remain a confounder. The benefit-risk relationship of Spikevax in not affected by this report.


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