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From the 7/23/2021 release of VAERS data:

Found 506,830 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 250 out of 5,069

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VAERS ID: 1486823 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-05-18
Onset:2021-06-03
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0182 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine.


VAERS ID: 1487261 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-02-01
Onset:2021-06-03
   Days after vaccination:122
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 001A21A / 1 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 038A21A / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Angiogram, Bell's palsy, Blindness unilateral, Cardiac monitoring, Chest X-ray, Computerised tomogram head, Dysarthria, Eye movement disorder, Facial paralysis, Full blood count, Hypoaesthesia, Magnetic resonance imaging, Malaise, Metabolic function test, Musculoskeletal pain, Neurological symptom, Prothrombin time, Venous angioma of brain, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Congenital, familial and genetic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (broad), Ocular motility disorders (narrow), Tendinopathies and ligament disorders (broad), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Premarin 0.45 mg , Multivitamin
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: 6/3/21: chest xray, cbc,sma12, cardiac profile, pro time, MRI, MRA brain and carotids, ct brain
CDC Split Type:

Write-up: I had a severe outbreak of Bells Palsy. Went to Hospital on 6/3/21 at 11 pm. Stroke symptoms diagnosed severe Bells Palsy. I was there for 8 hours in the emergency room. Very ill, severe left facial droop, blind in the left eye, unable to close left eye. Extreme pain in the left gluteal area, slurred speech. I have seen 7 MD,s since then. Have had a complete neuroscience exam, cardiology exam, MRI and MRA of brain and carotid arteries. Extensive blood work. The aortic exam was thoracic and abdominal. I still have a left eye unable to close or focus clearly. Saw eye Dr, specialist X2 yesterday also. Facial numbness.


VAERS ID: 1490458 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 003C21A / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Lymphoedema
SMQs:, Retroperitoneal fibrosis (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lortadine, Microgestin
Current Illness: None
Preexisting Conditions: None
Allergies: Penacillin
Diagnostic Lab Data: Blood work, exam
CDC Split Type:

Write-up: Lymphodema super clavicular lasting longer than six weeks


VAERS ID: 1492069 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 036C21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Back pain, Chest pain, Epistaxis, Pain in extremity
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament 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: I caught shingles after a shingles vaccine that I did not want or request.
Other Medications: Benazepril/Hcz20-25 Mg tablets and Amlodipine 5 MG tablets
Current Illness: None
Preexisting Conditions: High blood pressure and pure hypercholesterolemia
Allergies: All groups of Statins Strawberries and everything else.
Diagnostic Lab Data: None. I prepared to die at home.
CDC Split Type:

Write-up: Severe pain in Left arm, left chest, left back. Had a nose bleed and Prepared to die at home. I felt better after the nose bleed.


VAERS ID: 1497715 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: New York  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0177 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Systemic: Tingling (specify: facial area, extemities)-Medium


VAERS ID: 1497716 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: New York  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0177 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Systemic: Numbness (specify: facial area, extremities)-Medium


VAERS ID: 1375835 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0216 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Marvalon (birth control)
Current Illness: None
Preexisting Conditions: Ankylosing spondylitis
Allergies: Cosentyx
Diagnostic Lab Data: None, talked to my doctor
CDC Split Type:

Write-up: Hives that started on my feet, and very quickly worked their way up my legs and down my arms. Took an allergy pill and it seemed to help. Woke up this morning with hives all over my body (with exception to my face). Allergy pills are not helping at this point


VAERS ID: 1382023 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-03
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Dysmenorrhoea, Heavy menstrual bleeding, Injection site reaction, Pruritus, Rash, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: Sulfa
Diagnostic Lab Data:
CDC Split Type:

Write-up: Delayed onset of immune response at injection site. Itchy. Swollen. Red patch. Sore. Warm to the touch. Full on anxiety attack (before noticing the arm) early onset period. Earlier, heavier and more painful then ever before.


VAERS ID: 1393569 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Abdominal pain; This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal pain) in a 35-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. No Medical History information was reported. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant). At the time of the report, ABDOMINAL PAIN (Abdominal pain) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medicines were reported. No treatment information were reported. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Abdominal pain located around the belly button area; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1394858 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0221 / 1 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Thrombosis, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), 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? 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:

Write-up: Received Menstrual Cycle 11 Days Earlier than regular schedule. Cycle was very heavy and lasted 8 day with clotting. By day three, broke out in hives all across arm.


VAERS ID: 1397774 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Conversion disorder
SMQs:

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: Lactation decreased; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Hysteria; This regulatory authority case was reported by a consumer and describes the occurrence of CONVERSION DISORDER (Hysteria) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased and Suspected COVID-19 (Unsure when symptoms stopped) on 01-Mar-2020. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced CONVERSION DISORDER (Hysteria) (seriousness criterion disability). At the time of the report, CONVERSION DISORDER (Hysteria) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Treatment medication was not provided. Very limited information regarding this event has been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further information is expected.


VAERS ID: 1397779 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 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: GBPFIZER INC2021655535

Write-up: Facial droop; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202106030954140220-7DMZZ, Safety Report Unique Identifier GB-MHRA-ADR 25411042. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 01Jun2021 as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. The patient experienced facial droop on 03Jun2021. The outcome of the event was not resolved. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1397788 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Febrile convulsion, Heart rate, Hyperhidrosis, Hypotension, Oxygen saturation, Pyrexia, Respiratory rate, Seizure, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Convulsion
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: Blood pressure; Result Unstructured Data: unable to be obtained; Comments: @ 1420; Test Date: 20210603; Test Name: Blood pressure; Result Unstructured Data: 101/69; Comments: @ 1435; Test Date: 20210603; Test Name: Blood pressure; Result Unstructured Data: 97/71; Comments: @ 1450; Test Date: 20210603; Test Name: Blood pressure; Result Unstructured Data: 106/73; Comments: @ 1515; Test Date: 20210603; Test Name: Heart rate; Result Unstructured Data: 46; Comments: @ 1420; Test Date: 20210603; Test Name: Heart rate; Result Unstructured Data: 62; Comments: @ 1435; Test Date: 20210603; Test Name: Heart rate; Result Unstructured Data: 68; Comments: @ 1450; Test Date: 20210603; Test Name: Heart rate; Result Unstructured Data: 56; Comments: @ 1515; Test Date: 20210603; Test Name: Oxygen Saturation; Result Unstructured Data: 96%; Comments: @ 1420; Test Date: 20210603; Test Name: Oxygen Saturation; Result Unstructured Data: 99%; Comments: @ 1515; Test Date: 20210603; Test Name: Respiratory rate; Result Unstructured Data: 18; Comments: @ 1420; Test Date: 20210603; Test Name: Respiratory rate; Result Unstructured Data: 16; Comments: @ 1435; Test Date: 20210603; Test Name: Respiratory rate; Result Unstructured Data: 16; Comments: @ 1450
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: febrile convulsion; Sweating; 101/69 temperature; Hypotension; Fainting; convulsion; This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Fainting) and SEIZURE (convulsion) in a 32-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Convulsion. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant), SEIZURE (convulsion) (seriousness criterion medically significant) and HYPOTENSION (Hypotension). On an unknown date, the patient experienced FEBRILE CONVULSION (febrile convulsion), HYPERHIDROSIS (Sweating) and PYREXIA (101/69 temperature). On 03-Jun-2021, SYNCOPE (Fainting) had resolved. At the time of the report, SEIZURE (convulsion), FEBRILE CONVULSION (febrile convulsion), HYPERHIDROSIS (Sweating) and PYREXIA (101/69 temperature) had resolved and HYPOTENSION (Hypotension) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2021, Blood pressure measurement: unable to be obtained (abnormal) unable to be obtained, 101/69 (normal) 101/69, 97/71 (normal) 97/71 and 106/73 (normal) 106/73. On 03-Jun-2021, Heart rate: 46 (Low) 46, 62 (normal) 62, 68 (normal) 68 and 56 (Low) 56. On 03-Jun-2021, Oxygen saturation: 96% (normal) 96% and 99% (normal) 99%. On 03-Jun-2021, Respiratory rate: 18 (High) 18, 16 (normal) 16 and 16 (normal) 16. 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. Treatment information and concomitant medicatuibs were not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, there appears to be an error in one of the reported patient temperature(101/69). Also, patient''s historical condition of convulsion is a confounder. No further follow up information is expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, there appears to be an error in one of the reported patient temperature(101/69). Also, patient''s historical condition of convulsion is a confounder. No further follow up information is expected.


VAERS ID: 1397792 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Chills, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: stomach pain; Stomach ache; Nausea; Chills; This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach ache), NAUSEA (Nausea), CHILLS (Chills) and ABDOMINAL PAIN UPPER (stomach pain) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach pain) (seriousness criterion medically significant). At the time of the report, ABDOMINAL PAIN UPPER (Stomach ache), NAUSEA (Nausea) and CHILLS (Chills) had not resolved and ABDOMINAL PAIN UPPER (stomach pain) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No treatment medication were provided. No concomitant medication were provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1397793 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE; PANADOL EXTRA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Vomiting; This regulatory authority case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concomitant products included LEVOTHYROXINE for Hypothyroidism, CAFFEINE, PARACETAMOL (PANADOL EXTRA) from 03-Jun-2021 to 03-Jun-2021 for Pain. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). At the time of the report, VOMITING (Vomiting) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication sere provided. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1397800 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-06-03
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Rash, Rash pruritic
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: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial No medical history was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: itchy rash; Rash; This regulatory authority case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash) and RASH (Rash) in a 32-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial No medical history was reported. On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant). On an unknown date, the patient experienced RASH PRURITIC (itchy rash) (seriousness criterion medically significant). At the time of the report, RASH PRURITIC (itchy rash) and RASH (Rash) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. The patient reported no immediate side effects. Eight days later, a large itchy rash appeared where injection was and also he had a slightly tender armpit in injection arm. No treatment medication was reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1397806 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dysmenorrhoea, Fatigue, Pain, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Endometriosis
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: pain; Fatigue; Period pains; This regulatory authority case was reported by a consumer and describes the occurrence of DYSMENORRHOEA (Period pains), PAIN (pain) and FATIGUE (Fatigue) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Endometriosis. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced DYSMENORRHOEA (Period pains) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (pain) (seriousness criterion medically significant). At the time of the report, DYSMENORRHOEA (Period pains) had not resolved, PAIN (pain) outcome was unknown and FATIGUE (Fatigue) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication were provided. No treatment medication were provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of these event, a causal relationship cannot be excluded. However, the previous history of Endometriosis is a confounder.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of these event, a causal relationship cannot be excluded. However, the previous history of Endometriosis is a confounder.


VAERS ID: 1397807 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-06-03
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Peripheral swelling, Rash, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CODEINE; NUROFEN; PANADOL; SERTRALINE
Current Illness: Drug allergy (to penicillin.); Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Redness; Rash; Swollen arm; This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Redness) and RASH (Rash) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 since 30-May-2021 and Drug allergy (to penicillin.) since an unknown date. Concomitant products included SERTRALINE for Anxiety, CODEINE, IBUPROFEN, IBUPROFEN LYSINE (NUROFEN) and PARACETAMOL (PANADOL) for an unknown indication. On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant) and RASH (Rash) (seriousness criterion medically significant). On an unknown date, the patient experienced ERYTHEMA (Redness) (seriousness criterion medically significant). At the time of the report, PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Redness) and RASH (Rash) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jun-2021, SARS-CoV-2 test: negative negative (Negative) negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1397808 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pain in extremity, SARS-CoV-2 test
SMQs:, Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL; FORMOTEROL FUMARATE DIHYDRATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Pain in arm; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concomitant products included FORMOTEROL FUMARATE DIHYDRATE from 01-Jan-2016 to an unknown date for Asthma, PARACETAMOL from 03-Jun-2021 to 03-Jun-2021 for Vaccination. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Pain in arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1397811 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Depression, Depression suicidal, Eye pain, Fatigue, Limb discomfort, Muscular weakness, Oropharyngeal pain, Taste disorder, Tension headache
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Suicide/self-injury (narrow), Taste and smell disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (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: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Depression suicidal; depression; Chest pain; Pain behind eyes; Sore throat; Weakness of limbs; Arm discomfort; Tiredness; Bad taste in mouth; Band-like headache; This regulatory authority case was reported by a consumer and describes the occurrence of DEPRESSION SUICIDAL (Depression suicidal), DEPRESSION (depression), CHEST PAIN (Chest pain), EYE PAIN (Pain behind eyes), OROPHARYNGEAL PAIN (Sore throat), MUSCULAR WEAKNESS (Weakness of limbs), TENSION HEADACHE (Band-like headache), LIMB DISCOMFORT (Arm discomfort) and FATIGUE (Tiredness) in a 52-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced TENSION HEADACHE (Band-like headache) (seriousness criterion medically significant). On an unknown date, the patient experienced DEPRESSION SUICIDAL (Depression suicidal) (seriousness criterion medically significant), DEPRESSION (depression) (seriousness criterion medically significant), CHEST PAIN (Chest pain) (seriousness criterion medically significant), EYE PAIN (Pain behind eyes) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant), MUSCULAR WEAKNESS (Weakness of limbs) (seriousness criterion medically significant), LIMB DISCOMFORT (Arm discomfort) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and TASTE DISORDER (Bad taste in mouth). At the time of the report, DEPRESSION SUICIDAL (Depression suicidal) and LIMB DISCOMFORT (Arm discomfort) was resolving, DEPRESSION (depression) and TASTE DISORDER (Bad taste in mouth) outcome was unknown, CHEST PAIN (Chest pain) had resolved and EYE PAIN (Pain behind eyes), OROPHARYNGEAL PAIN (Sore throat), MUSCULAR WEAKNESS (Weakness of limbs), TENSION HEADACHE (Band-like headache) and FATIGUE (Tiredness) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Patient has not tested positive for COVID-19 since having the vaccine.The patient experienced Dull headache around front of face and over top of head around eyes and temples, Throat feels swollen, Tired and heavy, Sore arms, Bad taste in mouth, Pain in chest, Depression and suicidal feelings. Treatment information was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine, the reporter did not provide any causality assessments. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1397813 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Diaphragmalgia, Fatigue, Pain, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (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: RENNIE PEPPERMINT; BUSCOPAN; IBUPROFEN; PARACETAMOL
Current Illness: Heartburn; Pain; Stress
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Pain; tiredness; Chest tightness; Chest discomfort; Pain in diaphragm; This regulatory authority case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest tightness), CHEST DISCOMFORT (Chest discomfort), DIAPHRAGMALGIA (Pain in diaphragm), PAIN (Pain) and FATIGUE (tiredness) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Heartburn, Stress and Pain. Concomitant products included CALCIUM CARBONATE, MAGNESIUM CARBONATE (RENNIE PEPPERMINT) from 28-May-2021 to an unknown date for Heartburn, IBUPROFEN and PARACETAMOL for Period pains, HYOSCINE BUTYLBROMIDE (BUSCOPAN) for an unknown indication. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced CHEST DISCOMFORT (Chest tightness) (seriousness criterion medically significant), CHEST DISCOMFORT (Chest discomfort) (seriousness criterion medically significant) and DIAPHRAGMALGIA (Pain in diaphragm) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (Pain) (seriousness criterion medically significant) and FATIGUE (tiredness) (seriousness criterion medically significant). At the time of the report, CHEST DISCOMFORT (Chest tightness), CHEST DISCOMFORT (Chest discomfort) and DIAPHRAGMALGIA (Pain in diaphragm) had not resolved and PAIN (Pain) and FATIGUE (tiredness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. As reported, the patient experienced ab accelerated pounding heartbeat for a few seconds. The patient did breathing exercises. In the following hours, tiredness came accompanied with this feeling of tightness on the chest and discomfort. The patient could breathe normally at the moment but diaphragm felt weird as if it is constrained and randomly felt soreness towards the back of rib cage. The patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment medications were not reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1397816 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Hyperhidrosis, Nausea, Pain, Pain in extremity, SARS-CoV-2 test, Sensitive skin, Thirst
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLENIL MODULITE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant; Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210422; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Pain; Thirsty; Sweaty; Tiredness; Nausea; Headache; Increased thirst; Ache; Sensitive skin; Painful arm; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Pain) and PAIN IN EXTREMITY (Painful arm) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased, Suspected COVID-19 from 21-Apr-2021 to 06-May-2021 and Clinical trial participant. Concomitant products included BECLOMETASONE DIPROPIONATE (CLENIL MODULITE) from 08-Jun-2015 to an unknown date for Asthma. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), SENSITIVE SKIN (Sensitive skin), THIRST (Increased thirst) and PAIN (Ache). On 04-Jun-2021, the patient experienced HYPERHIDROSIS (Sweaty), FATIGUE (Tiredness), NAUSEA (Nausea) and HEADACHE (Headache). On an unknown date, the patient experienced PAIN (Pain) (seriousness criterion medically significant) and THIRST (Thirsty). At the time of the report, PAIN (Pain), THIRST (Thirsty), NAUSEA (Nausea) and HEADACHE (Headache) was resolving, PAIN IN EXTREMITY (Painful arm), SENSITIVE SKIN (Sensitive skin), THIRST (Increased thirst), PAIN (Ache) and FATIGUE (Tiredness) had not resolved and HYPERHIDROSIS (Sweaty) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Patient has not tested for positive for COVID-19 since having the vaccine. No treatment information provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1397819 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Axillary pain, Body temperature, Diarrhoea, Dizziness, Fatigue, Limb discomfort, Pyrexia, SARS-CoV-2 test, Swelling, Tremor, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Iron low
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data: Test Date: 20201230; Test Name: Fever; Result Unstructured Data: 38.5; Test Date: 20201230; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: positive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: bad cramps; Exhaustion; swelling; Diarrhea; Fever; Shaking; Vomiting; Dizziness; Armpit pain; Arm discomfort; This regulatory authority case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Armpit pain), LIMB DISCOMFORT (Arm discomfort), ABDOMINAL PAIN (bad cramps), FATIGUE (Exhaustion), DIZZINESS (Dizziness), SWELLING (swelling), VOMITING (Vomiting), DIARRHOEA (Diarrhea), PYREXIA (Fever) and TREMOR (Shaking) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Pregnancy. Concurrent medical conditions included Iron low. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced AXILLARY PAIN (Armpit pain) (seriousness criterion disability), LIMB DISCOMFORT (Arm discomfort) (seriousness criterion disability), DIZZINESS (Dizziness) (seriousness criterion disability), VOMITING (Vomiting) (seriousness criterion disability), PYREXIA (Fever) (seriousness criterion disability) and TREMOR (Shaking) (seriousness criterion disability). On 04-Jun-2021, the patient experienced ABDOMINAL PAIN (bad cramps) (seriousness criterion disability) and SWELLING (swelling) (seriousness criterion disability). 04-Jun-2021, the patient experienced FATIGUE (Exhaustion) (seriousness criterion disability) and DIARRHOEA (Diarrhea) (seriousness criterion disability). On 04-Jun-2021, TREMOR (Shaking) had resolved. At the time of the report, AXILLARY PAIN (Armpit pain), LIMB DISCOMFORT (Arm discomfort), ABDOMINAL PAIN (bad cramps), FATIGUE (Exhaustion), DIZZINESS (Dizziness) and SWELLING (swelling) had not resolved and VOMITING (Vomiting), DIARRHOEA (Diarrhea) and PYREXIA (Fever) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2020, Body temperature: 38.5 (High) 38.5. On 30-Dec-2020, SARS-CoV-2 test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1397825 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Nausea, Pain in extremity, Poor quality sleep, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (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:
Allergies:
Diagnostic Lab Data: Test Date: 20210420; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Headache; Nausea; High temperature; Exhaustion; Poor sleep; Pain in arm; This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NAUSEA (Nausea), PAIN IN EXTREMITY (Pain in arm), PYREXIA (High temperature), FATIGUE (Exhaustion) and POOR QUALITY SLEEP (Poor sleep) in a 24-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. No Medical History information was reported. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant). On 04-Jun-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant), FATIGUE (Exhaustion) (seriousness criterion medically significant) and POOR QUALITY SLEEP (Poor sleep) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), NAUSEA (Nausea), PAIN IN EXTREMITY (Pain in arm), PYREXIA (High temperature), FATIGUE (Exhaustion) and POOR QUALITY SLEEP (Poor sleep) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not reported. No treatment information provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1397827 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-06-03
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dysmenorrhoea, Muscle spasms, SARS-CoV-2 test
SMQs:, Dystonia (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: 2021; Test Name: SARS-COV-2 TEST; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: severe menstrual cramps; Cramps menstrual; This regulatory authority case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (severe menstrual cramps) and DYSMENORRHOEA (Cramps menstrual) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced DYSMENORRHOEA (Cramps menstrual) (seriousness criterion medically significant). On an unknown date, the patient experienced MUSCLE SPASMS (severe menstrual cramps) (seriousness criterion medically significant). At the time of the report, MUSCLE SPASMS (severe menstrual cramps) outcome was unknown and DYSMENORRHOEA (Cramps menstrual) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. Treatment for the events were not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1397833 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Nasopharyngitis, SARS-CoV-2 test, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Cold symptoms; Fatigue; Visual phenomena; This regulatory authority case was reported by an other and describes the occurrence of NASOPHARYNGITIS (Cold symptoms), FATIGUE (Fatigue) and VISUAL IMPAIRMENT (Visual phenomena) in a 30-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 from 01-Sep-2020 to 08-Sep-2020. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant) and VISUAL IMPAIRMENT (Visual phenomena) (seriousness criterion medically significant). On 04-Jun-2021, the patient experienced NASOPHARYNGITIS (Cold symptoms) (seriousness criterion medically significant). On 03-Jun-2021, VISUAL IMPAIRMENT (Visual phenomena) had resolved. At the time of the report, NASOPHARYNGITIS (Cold symptoms) had not resolved and FATIGUE (Fatigue) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. There was no concomitant medication reported. Visual phenomena were flashing/sparkling lights and rings: started 7 hours after vaccine and lasted about 2 hours. There was no relevant treatment medication reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1397835 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Muscle tightness, Muscle twitching, Pain, SARS-CoV-2 test
SMQs:, Dyskinesia (broad), Dystonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: twitching; pain; Muscle tension; This regulatory authority case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (twitching), PAIN (pain) and MUSCLE TIGHTNESS (Muscle tension) in a 37-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. No Medical History information was reported. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced MUSCLE TIGHTNESS (Muscle tension) (seriousness criterion medically significant). On an unknown date, the patient experienced MUSCLE TWITCHING (twitching) (seriousness criterion medically significant) and PAIN (pain) (seriousness criterion medically significant). At the time of the report, MUSCLE TWITCHING (twitching), PAIN (pain) and MUSCLE TIGHTNESS (Muscle tension) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. After 5 hour''s of getting vaccination, his upper arm started twitching a little, then found it near impossible to raise arm above shoulder level. Laying down made the pain worse. After about 30-40hrs the pain quite literally vanished and movement returned with only a slight aching feel to the same arm. No treatment information was provided. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1397869 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Chills, Cough, Headache, Hyperhidrosis, Migraine, Pain in extremity, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IMPLANON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210214; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Cough; Excruciating migraines that lasted for 20 hours at a time; Sweating; Migraine; Back pain; Leg pain; Shivering; This regulatory authority case was reported by a consumer and describes the occurrence of COUGH (Cough), MIGRAINE (Migraine), BACK PAIN (Back pain), PAIN IN EXTREMITY (Leg pain), HYPERHIDROSIS (Sweating), HEADACHE (Excruciating migraines that lasted for 20 hours at a time) and CHILLS (Shivering) in a 35-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased and Suspected COVID-19 from 14-Feb-2021 to 28-Feb-2021. Concomitant products included ETONOGESTREL (IMPLANON) for an unknown indication. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced BACK PAIN (Back pain), PAIN IN EXTREMITY (Leg pain) and CHILLS (Shivering). On 04-Jun-2021, the patient experienced MIGRAINE (Migraine) and HYPERHIDROSIS (Sweating). On an unknown date, the patient experienced COUGH (Cough) and HEADACHE (Excruciating migraines that lasted for 20 hours at a time). On 04-Jun-2021, CHILLS (Shivering) had resolved. On 05-Jun-2021, PAIN IN EXTREMITY (Leg pain) had resolved. On 06-Jun-2021, HYPERHIDROSIS (Sweating) had resolved. At the time of the report, COUGH (Cough) and HEADACHE (Excruciating migraines that lasted for 20 hours at a time) had resolved, MIGRAINE (Migraine) had not resolved and BACK PAIN (Back pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had Covid minus cough. Excruciating migraines that lasted for 20 hours at a time and back felt sore with pressure. Treatment information was not provided.; Sender''s Comments: This case concerns a 35-year-old female with serious unexpected events of cough, migraine, back pain, pain in extremity, hyperhidrosis, headache, and chills. Event latency within 24 hours after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1398075 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-03
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Pulmonary embolism, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AVODART; PLAUNAC; OMNIC; LASIX [FUROSEMIDE]
Current Illness: Arterial hypertension; Benign prostatic hyperplasia
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210623249

Write-up: THROMBOPENIA; PULMONARY EMBOLISM; INTERMUSCULAR VENOUS THROMBOSIS; This spontaneous report was received from a physician via the Regulatory Authority, case reference number IT-MINISAL02-739365, and concerned a 68 year-old male patient. The patient''s height and weight were not reported. The patient''s concurrent conditions included benign prostatic hyperplasia and arterial hypertension. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, intramuscular, batch number not reported), 0.5 mL, administered once in total on 20-MAY-2021 for COVID-19 vaccination. The company is unable to perform follow-up to request the batch number. Concomitant medications included dutasteride and tamsulosin hydrochloride, both for benign prostatic hyperplasia, and furosemide and olmesartan medoxomil, both for arterial hypertension. On 03-JUN-2021, 14 days post-vaccination, the patient experienced thrombopenia, pulmonary embolism and intermuscular venous thrombosis. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The patient was recovering from thrombopenia, pulmonary embolism, and intermuscular venous thrombosis. This report was serious (life-threatening).; Sender''s Comments: V0: This spontaneous report received from a physician via Regulatory Authority IT-MINISAL02-739365] concerning a 68 year old male, unknown ethnicity, noted to have thrombocytopenia, pulmonary embolism, and intramuscular venous thrombosis 14 days after receiving the Janssen Covid-19 vaccine. The patient''s height and weight were not reported. The patient''s concurrent conditions included benign prostatic hyperplasia and arterial hypertension. Concomitant medications included dutasteride, tamsulosin hydrochloride, furosemide and olmesartan. Information is limited in this case. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate. Additional information has been requested.


VAERS ID: 1398619 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002180 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Dizziness, Heart rate, Hyperventilation, Nausea, Oxygen saturation
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma (Asthma at influenza vaccination, on the pre-examination form was reported)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: Blood pressure; Test Result: Inconclusive ; Result Unstructured Data: At 14:34 blood pressure was reported as 157/118 mm[Hg]; Test Date: 20210603; Test Name: Blood pressure; Test Result: Inconclusive ; Result Unstructured Data: At 14:40 blood pressure was reported as 170/98 mm[Hg]; Test Name: Body temperature; Test Result: Inconclusive ; Result Unstructured Data: 36.0 degree Celsius was reported; Test Date: 20210603; Test Name: Pulse rate; Test Result: Inconclusive ; Result Unstructured Data: At 14:34 pulse rate was reported as 83 per minute.; Test Date: 20210603; Test Name: Pulse rate; Test Result: Inconclusive ; Result Unstructured Data: At 14:40 pulse rate was as 81 per minute.; Test Date: 20210603; Test Name: SpO2; Test Result: Inconclusive 99 %; Result Unstructured Data: At 14:34 reported as 99 percent; Test Date: 20210603; Test Name: SpO2; Test Result: Inconclusive 99 %; Result Unstructured Data: At 14:40 reported as 99 percent
CDC Split Type: JPTAKEDA2021TJP035750

Write-up: Hyperpnoea; Queasy; Dizziness; This regulatory authority case was reported by a physician and describes the occurrence of HYPERVENTILATION (Hyperpnoea), NAUSEA (Queasy) and DIZZINESS (Dizziness) in a 48-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002180) for COVID-19 vaccination. Concurrent medical conditions included Asthma (Asthma at influenza vaccination, on the pre-examination form was reported). On 03-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced HYPERVENTILATION (Hyperpnoea) (seriousness criterion hospitalization) and NAUSEA (Queasy) (seriousness criterion hospitalization). 03-Jun-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion hospitalization). The patient was hospitalized from 03-Jun-2021 to 03-Jun-2021 due to DIZZINESS, HYPERVENTILATION and NAUSEA. On 03-Jun-2021, HYPERVENTILATION (Hyperpnoea), NAUSEA (Queasy) and DIZZINESS (Dizziness) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2021, Blood pressure measurement: 157 / 118 (Inconclusive) At 14:34 blood pressure was reported as 157/118 mm[Hg] and 170 / 98 (Inconclusive) At 14:40 blood pressure was reported as 170/98 mm[Hg]. On 03-Jun-2021, Heart rate: 83 per minute (Inconclusive) At 14:34 pulse rate was reported as 83 per minute. and 81 per minute (Inconclusive) At 14:40 pulse rate was as 81 per minute.. On 03-Jun-2021, Oxygen saturation: 99 percent (Inconclusive) At 14:34 reported as 99 percent and 99 percent (Inconclusive) At 14:40 reported as 99 percent. On an unknown date, Body temperature: 36.0 (Inconclusive) 36.0 degree Celsius was reported. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered HYPERVENTILATION (Hyperpnoea) and NAUSEA (Queasy) to be possibly related. No further causality assessment was provided for DIZZINESS (Dizziness). No concomitant medications were reported. Treatment information was not provided. The patient received vaccination on 2.21pm and experienced the events by 2.31 pm. Later she was allowed to lay down and was examined. As the symptoms persisted, the patient was transported by ambulance to the emergency outpatient department of a hospital to undergo examinations and other medical care. After discharge from hospital no further follow-up investigation was made. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1401352 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Heart rate, Oxygen saturation
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? Yes
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: THYRADIN S
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Thyroiditis chronic
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: BP; Result Unstructured Data: Test Result:121/70; Comments: at 14:55; Test Date: 20210603; Test Name: BP; Result Unstructured Data: Test Result:107/66; Comments: at 16:00; Test Date: 20210603; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210603; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: at 14:55; Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Test Result:37.8 Centigrade; Comments: in the morning; Test Date: 20210603; Test Name: P; Result Unstructured Data: Test Result:95; Comments: at 14:55; Test Date: 20210603; Test Name: P; Result Unstructured Data: Test Result:71; Comments: at 16:00; Test Date: 20210603; Test Name: SAT; Test Result: 96 %; Comments: at 14:55; Test Date: 20210603; Test Name: SAT; Test Result: 98 %; Comments: at 16:00
CDC Split Type: JPPFIZER INC2021665651

Write-up: Anaphylaxis; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is v21112072. A 40-year and 2-month-old female patient received the second dose of BNT162B2 (COMIRNATY; Lot Number: EY4834; Expiration Date: 31Aug2021), via an unspecified route of administration, on 03Jun2021 at 14:40 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroiditis chronic. Concomitant medications included levothyroxine sodium (THYRADIN S) taken for thyroiditis chronic. The patient previously received the first dose of BNT162B2 (COMIRNATY) on 12May2021 for COVID-19 immunisation and experienced pyrexia of 39.2 degrees centigrade. The patient experienced anaphylaxis on 03Jun2021 at 14:50 (10 minutes after the vaccination), which was reported as life-threatening. The clinical course was reported as follows: The body temperature before vaccination was 36.6 degrees centigrade on 03Jun2021. At 14:40, the patient was vaccinated. At 14:55, pharynx strange sensation of, pharynx strangled sensation of, and chest tightness appeared. The blood pressure (BP) was 121/70, pulse (P) was 95, oxygen saturation (SAT) was 96%, and body temperature was 36.8 degrees centigrade on 03Jun2021 at 14:55. Unspecified infusion was initiated. At 15:30, the patient developed aggravation of pharynx strangled sensation of, phonation difficulty, hoarseness, feeling cold, and suspected oedema around mandibula. There was no skin symptom or consciousness disturbed. At 15:50, hydrocortisone sodium succinate 500 mg was intravenously injected and promethazine hydrochloride was intramuscularly injected. The patient was placed on monitor. At 16:00 on 03Jun2021, blood pressure was 107/66, pulse was 71, and SAT was 98%. At 16:30, subjective symptoms improved. Hoarseness disappeared and oedema around mandibula improved. At 17:00, the patient refused to be hospitalized; thus, epinephrine (EPIPEN) was prescribed and the patient returned home. After returning home, the patient had no physical deconditioning. On the following day in the morning, the patient had pyrexia of 37.8 degrees centigrade on 04Jun2021. The reporting physician commented as follows: In the beginning of the onset, infusion was initiated for suspected vagal reflex. However, the condition aggravated gradually, which was not usual; thus, it was diagnosed as anaphylaxis. There was no skin symptom. Hoarseness reported was closer to wheezing. Progression of the condition seemed slow. Adrenaline administration was considered in case the condition further aggravated; however, it should have been administered at an early stage. Therapeutic measures were taken as a result of anaphylaxis as aforementioned. The clinical outcome of anaphylaxis was recovered on 03Jun2021 (on the same day of the vaccination). The reporting physician assessed that the event was related to BNT162B2. There was no other possible cause of the event, such as any other diseases. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1401535 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1921 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia
SMQs:, Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypersensitivity
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021669970

Write-up: hip pain (pain specifically between the trunk and buttocks area); This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: FD1921) 0.3ml, via intramuscular route administered in the right arm on 01Jun2021 (55-year-old at the time of vaccination) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient mentioned that she has allergies (not specified). The patient experienced hip pain (pain specifically between the trunk and buttocks area) on 03Jun2021. The patient mentioned that the pain causes her trouble when walking and sitting. Therapeutic measures were taken as a result of hip pain included applying a regular gel on the affected area by the suggestion of a physiotherapist. The outcome of the event was not recovered. No follow-up attempts needed. No further information is expected.


VAERS ID: 1401990 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-03
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Hyperpyrexia, Malaise, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Test Date: 20210604; Test Name: Hyperpyrexia; Result Unstructured Data: Fever 40.5 to 42 degrees Celsius
CDC Split Type: NLJNJFOC20210623253

Write-up: FEVER 40.5 TO 42 DEGREES CELSIUS; COLD CHILLS; FEELING UNWELL; HEADACHE; NAUSEA; This spontaneous report received from a consumer via a Regulatory Authority concerned a 44 year old male of unknown ethnic origin.The patient''s weight was 85 kilograms, and height was 194 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD985 expiry: unknown) frequency 1 total, dose 0.5ml, administered on 03-JUN-2021 for covid-19 immunisation. No concomitant medications were reported. On 03-JUN-2021, the patient experienced fever 40.5 to 42 degrees Celsius, cold chills, feeling unwell, headache, nausea. On 04-JUN-2021, Laboratory data included Hyperpyrexia (NR not provided) Fever 40.5 to 42 degrees Celsius. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold chills on 04-JUN-2021, and was recovering from fever 40.5 to 42 degrees celsius, feeling unwell, headache, and nausea. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210623253-covid-19 vaccine ad26.cov2.s -Fever 40.5 to 42 degrees Celsius. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1404115 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / 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? No
Previous Vaccinations:
Other Medications: XAGGITIN XL
Current Illness: ADHD (predominantly inattentive type)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Muscle ache; Headache; Joint pain; This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Muscle ache), HEADACHE (Headache) and ARTHRALGIA (Joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included ADHD (predominantly inattentive type). Concomitant products included METHYLPHENIDATE HYDROCHLORIDE (XAGGITIN XL) from 14-Mar-2021 to an unknown date for ADHD, predominantly inattentive type. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and ARTHRALGIA (Joint pain) (seriousness criterion medically significant). At the time of the report, MYALGIA (Muscle ache) and HEADACHE (Headache) had not resolved and ARTHRALGIA (Joint pain) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. Patient has not had symptoms associated with COVID-19 nor has had a COVID-19 test. Patient is not enrolled in clinical trial. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1404119 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Pyrexia, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210111; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Rash; Fever; Tiredness; This regulatory authority case was reported by a consumer and describes the occurrence of RASH (Rash), PYREXIA (Fever) and FATIGUE (Tiredness) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concomitant products included PARACETAMOL for Headache. On 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant). On 04-Jun-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 05-Jun-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant). The patient was treated with PARACETAMOL ongoing since an unknown date for Fever, at a dose of 1 dosage form. On 05-Jun-2021, PYREXIA (Fever) and FATIGUE (Tiredness) had resolved. At the time of the report, RASH (Rash) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. Patient experienced usual tiredness and then it developed into fever of 38.1 degree Celsius. On the second day patient developed rash on the vaccinated arm.Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial Patient is not pregnant,Patient is not currently breastfeeding. Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per SD Authority reporting. Events seriousness per overall case assessment by Authority; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per SD Authority reporting. Events seriousness per overall case assessment by Authority


VAERS ID: 1404121 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-03
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Malaise, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210607; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: armpit swelling; Feeling sick; Feeling faint; This regulatory authority case was reported by a non-health professional and describes the occurrence of SWELLING (armpit swelling), MALAISE (Feeling sick) and DIZZINESS (Feeling faint) in a 31-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 31-May-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced MALAISE (Feeling sick) (seriousness criterion medically significant) and DIZZINESS (Feeling faint) (seriousness criterion medically significant). On 04-Jun-2021, the patient experienced SWELLING (armpit swelling) (seriousness criterion medically significant). At the time of the report, SWELLING (armpit swelling) had not resolved and MALAISE (Feeling sick) and DIZZINESS (Feeling faint) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jun-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19 Patient was not enrolled in clinical trial Patient was not pregnant, Patient was not currently breastfeeding No concomitant medication was not reported. No treatment medication was not reported Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1404361 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Headache, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201226; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Backache; Fever; Headache; This regulatory authority case was reported by a consumer and describes the occurrence of BACK PAIN (Backache), PYREXIA (Fever) and HEADACHE (Headache) in a 31-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced BACK PAIN (Backache) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, BACK PAIN (Backache), PYREXIA (Fever) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Dec-2020, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Concomitant and treatment medications were not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1404365 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Migraine
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Migraine
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: headache; Migraine; This regulatory authority case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine) and HEADACHE (headache) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Migraine. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced MIGRAINE (Migraine) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criterion medically significant). The patient was treated with PARACETAMOL for Migraine, at an unspecified dose and frequency and IBUPROFEN LYSINE for Migraine and Headache, at an unspecified dose and frequency. At the time of the report, MIGRAINE (Migraine) was resolving and HEADACHE (headache) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were provided. Patient was not enrolled in clinical trial, had not had symptoms associated with COVID-19 and was not breast feeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient had migraine with light sensitivity, which was not responsive to paracetamol so took ibuprofen lysine and had a nap which helped to resolve it. Patient had slight headache on day 2 but not as bad as the previous day and took ibuprofen lysine again. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1404377 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Nausea; Fatigue; This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and NAUSEA (Nausea) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, FATIGUE (Fatigue) had not resolved and NAUSEA (Nausea) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by investigator. No treatment medications provided by the reporter. Patient has not tested positive for COVID-19 since having the vaccine. Clinical trial participant Study details: Office for national statistics. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1404387 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Lethargy, Oropharyngeal pain, Pharyngeal swelling, SARS-CoV-2 test, Tension headache
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Covid-19 test; Test Result: Negative ; Result Unstructured Data: Patient has not tested positive for COVID-19 since having the vaccine
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Tension headache; Sore throat; Throat swelling; Light-headed; Lethargy; This regulatory authority case was reported by a consumer and describes the occurrence of TENSION HEADACHE (Tension headache), OROPHARYNGEAL PAIN (Sore throat), PHARYNGEAL SWELLING (Throat swelling), DIZZINESS (Light-headed) and LETHARGY (Lethargy) in a 31-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. No Medical History information was reported. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced TENSION HEADACHE (Tension headache) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant), PHARYNGEAL SWELLING (Throat swelling) (seriousness criterion medically significant), DIZZINESS (Light-headed) (seriousness criterion medically significant) and LETHARGY (Lethargy) (seriousness criterion medically significant). On 05-Jun-2021, DIZZINESS (Light-headed) was resolving. At the time of the report, TENSION HEADACHE (Tension headache) and LETHARGY (Lethargy) was resolving and OROPHARYNGEAL PAIN (Sore throat) and PHARYNGEAL SWELLING (Throat swelling) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Patient has not tested positive for COVID-19 since having the vaccine. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. The patient has not had symptoms associated with COVID-19. The patient has not had a positive COVID-19 test and is not enrolled in clinical trial. Treatment information was not provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1404391 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657865

Write-up: Palsy Bells; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106052026522830-NWNXS, Safety Report Unique Identifier GB-MHRA-ADR 25426431. A 31-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number unknown) 1st dose via an unspecified route of administration, on 03Jun2021 at a single dose for COVID-19 immunization. The patient''s medical history included lactation decreased. The patient''s concomitant medications were not reported. Patient did not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. On 03Jun2021 patient experienced palsy bells. Patient has not been tested positive for COVID-19 since having the vaccine. 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: 1404398 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dehydration, Dizziness, Headache, Muscle fatigue, Pain in extremity, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Psoriasis
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Muscle fatigue; Painful arm; Light-headed; Dehydration; High temperature, Fever; Headache; This regulatory authority case was reported by an other and describes the occurrence of MUSCLE FATIGUE (Muscle fatigue), PAIN IN EXTREMITY (Painful arm), DIZZINESS (Light-headed), DEHYDRATION (Dehydration), PYREXIA (High temperature, Fever) and HEADACHE (Headache) in a 32-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Psoriasis and Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...). On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced MUSCLE FATIGUE (Muscle fatigue) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), DIZZINESS (Light-headed) (seriousness criterion medically significant), DEHYDRATION (Dehydration) (seriousness criterion medically significant), PYREXIA (High temperature, Fever) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). The patient was treated with PARACETAMOL ongoing since an unknown date at an unspecified dose and frequency. On 05-Jun-2021, DIZZINESS (Light-headed) and DEHYDRATION (Dehydration) had resolved. At the time of the report, MUSCLE FATIGUE (Muscle fatigue), PAIN IN EXTREMITY (Painful arm), PYREXIA (High temperature, Fever) and HEADACHE (Headache) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported by investigator. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1404402 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-03
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BECLOMETHASONE
Current Illness: Allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of URTICARIA (hives) and HYPERSENSITIVITY (Allergy) in a 35-year-old female patient who received mRNA-1273 (CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Allergic reaction in 2015 and Allergy. Concomitant products included BECLOMETHASONE for an unknown indication. On 31-May-2021, the patient received first dose of (CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced HYPERSENSITIVITY (Allergy) (seriousness criterion medically significant). On an unknown date, the patient experienced URTICARIA (hives) (seriousness criterion medically significant). At the time of the report, URTICARIA (hives) was resolving and HYPERSENSITIVITY (Allergy) had not resolved. The action taken with (CoviD-19 Vaccine) (Unknown) was unknown. Treatment information included unspecified antihistamines. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per reporting. Events seriousness per overall case assessment by Authority; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per reporting. Events seriousness per overall case assessment by Authority


VAERS ID: 1404427 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blepharospasm, Dizziness, Fatigue, Restless legs syndrome, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Vestibular disorders (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Eyelid twitching; Restless legs; Dizzy spells; Fatigue; This regulatory authority case was reported by a consumer and describes the occurrence of BLEPHAROSPASM (Eyelid twitching), RESTLESS LEGS SYNDROME (Restless legs), DIZZINESS (Dizzy spells) and FATIGUE (Fatigue) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced RESTLESS LEGS SYNDROME (Restless legs) (seriousness criterion medically significant), DIZZINESS (Dizzy spells) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 07-Jun-2021, the patient experienced BLEPHAROSPASM (Eyelid twitching) (seriousness criterion medically significant). At the time of the report, BLEPHAROSPASM (Eyelid twitching), RESTLESS LEGS SYNDROME (Restless legs) and FATIGUE (Fatigue) had not resolved and DIZZINESS (Dizzy spells) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant and treatment medications were unknown. Patient has not had symptoms associated with COVID-19 Patient was not enrolled in clinical trial Patient was not currently breastfeeding. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.


VAERS ID: 1404450 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Pain in extremity
SMQs:, 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: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped); Comments: No, my health and immune system are strong and I am pretty fit. Not had a COVID-19 test Patient is not enrolled in clinical trial Patient is not pregnant,Patient is not currently breastfeeding.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Fatigue; Painful arm; This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and PAIN IN EXTREMITY (Painful arm) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. No, my health and immune system are strong and I am pretty fit. Not had a COVID-19 test Patient is not enrolled in clinical trial Patient is not pregnant,Patient is not currently breastfeeding. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 24-Mar-2020. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). At the time of the report, FATIGUE (Fatigue) and PAIN IN EXTREMITY (Painful arm) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient was under stress as a result of high workload and financial pressure . Concomitant and treatment drugs were not reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1404725 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-03
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Hallucination, Pyrexia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210625746

Write-up: I TAKE DEPAKIN CHRONO 500MG AND AFTER THE ADMINISTRATION OF THE JOHNSON VACCINE I HAD, FOR 3 HOURS, VERY STRONG HALLUCINATIONS; I TAKE DEPAKIN CHRONO 500MG AND AFTER THE ADMINISTRATION OF THE JOHNSON VACCINE I HAD, FOR 3 HOURS, VERY STRONG TREMORS; I TAKE DEPAKIN CHRONO 500MG AND AFTER THE ADMINISTRATION OF THE JOHNSON VACCINE I HAD, FOR 3 HOURS, FEVER AT 39; This spontaneous report received from a concerned a 29-year-old female. The patient''s weight was 73 kilograms, and height was 170 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) frequency 1 total, 0.5 ml, start therapy date was not reported for covid-19 vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: valproate sodium (extended release tablet, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. The patient mentioned that after the administration of the Johnson vaccine, the patient took Depakin Chrono 500 milligrams and for 3 hours, on 03-Jun-2021, the patient experienced very strong hallucinations and tremors and fever at 39. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from I take Depakin chrono 500mg and after the administration of the Johnson vaccine I had, for 3 hours, fever at 39, I take Depakin chrono 500mg and after the administration of the Johnson vaccine I had, for 3 hours, very strong hallucinations, and I take Depakin chrono 500mg and after the administration of the Johnson vaccine I had, for 3 hours, very strong tremors. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210625746-covid-19 vaccine ad26.cov2.s-I take Depakin Chrono 500mg and after the administration of the Johnson vaccine I had, for 3 hours, very strong hallucinations. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1404834 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-03
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Paraesthesia
SMQs:, Peripheral neuropathy (broad), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Tingling pins and needles in both feets


VAERS ID: 1406232 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Chills, Dizziness, Headache, Musculoskeletal stiffness, Pain, Pain in extremity, Somnolence
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM
Current Illness: Anxiety
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: dizzy turn; pain; stiffness; Stomach pain; Leg pain; Shivering; Drowsiness; Headache; Dizziness; This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy turn), PAIN (pain), MUSCULOSKELETAL STIFFNESS (stiffness), ABDOMINAL PAIN UPPER (Stomach pain), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Leg pain), SOMNOLENCE (Drowsiness), CHILLS (Shivering) and HEADACHE (Headache) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Anxiety. Concomitant products included CITALOPRAM from 12-Nov-2020 to an unknown date for Anxiety. On 03-Jun-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 03-Jun-2021 at 7:00 PM, the patient experienced SOMNOLENCE (Drowsiness) (seriousness criterion medically significant). On 04-Jun-2021, the patient experienced DIZZINESS (dizzy turn) (seriousness criterion medically significant), PAIN (pain) (seriousness criterion medically significant) and MUSCULOSKELETAL STIFFNESS (stiffness) (seriousness criterion medically significant). 04-Jun-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) (seriousness criterion medically significant), PAIN IN EXTREMITY (Leg pain) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). At the time of the report, DIZZINESS (dizzy turn), PAIN (pain), MUSCULOSKELETAL STIFFNESS (stiffness), ABDOMINAL PAIN UPPER (Stomach pain), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Leg pain), SOMNOLENCE (Drowsiness), CHILLS (Shivering) and HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. The day after receiving the vaccine, the patient awoke at 4am then kept drifting in and out of sleep. Her arm was heavy and sore and her head was sore too. She went to her job as a post man and while driving to work found it difficult to change gears due to the pain and stiffness in her arm. During her shift the patient became extremely lightheaded and dizzy and had to sit down a few times. Her arm continued to be in excruciating pain throughout the day. On returning home she took a dizzy turn and found herself on the floor unsure if it was seconds or minutes that had passed. Afterward, she laid on the couch with a sore and heavy head. Additionally, she felt pain from her stomach down her legs which she found was stopping her from being as mobile as was usual. The patient considered herself to be somewhat fit (but not extremely) so this was a strange sensation none of which occurred prior to having the vaccine. Treatment information included painkillers. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded


VAERS ID: 1408050 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2021655018

Write-up: found passed out the bathroom floor and was unresponsive; unresponsive; This is a spontaneous report from a contactable consumer or other non hcp. This report was received via a sales representative. An 18-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot Number: Unknown), via intramuscularly on 02Jun2021, as 1st dose single for covid-19 immunisation. The patient medical history and concomitant was not reported. The patient did not receive any other vaccine in four weeks and did not receive any other medications within 2 weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. On 03Jun2021, it was reported that, the patient was found passed out the bathroom floor and was unresponsive. the patient, mother, called 911 and ambulance transported her to Hospital. Hospitalization not prolonged. The outcome of the event was resolved unknown date in the year 2021 .


VAERS ID: 1408301 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-06-03
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 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: FRPFIZER INC2021681569

Write-up: left facial palsy; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 27-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number: Unknown) via an unspecified route of administration on 22May2021 (Age at vaccination 27-year-old), first dose, single dose for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 03Jun2021, the patient experienced left facial palsy. The outcome of event was not recovered at the time of reporting.


VAERS ID: 1408770 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dry eye, Facial paralysis, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Corneal disorders (broad), Hearing impairment (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), 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: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657351

Write-up: Dry eye; Facial droop; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106041026461900-RVN7R, Safety Report Unique Identifier GB-MHRA-ADR 25419147. A 33-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ET8885), via an unspecified route of administration on 03jun2021 as 1st dose, single dose for covid-19 immunization. Patient medical history included suppressed lactation and depression. Concomitant medication included sertraline taken for depression from 03Apr2020 to an unspecified stop date. On 03Jun2021 patient experienced facial droop and dry eye. The eye of the side of the vaccine was bit droopy. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test resulted as No - Negative COVID-19 test on an unspecified date. Patient has not had symptoms associated with COVID-19 and patient was not enrolled in clinical trial. Patient was not currently breastfeeding. Outcome of events were reported as not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1408773 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-03
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021657636

Write-up: SARS-CoV-2 infection/ COVID-19 PCR test positive; SARS-CoV-2 infection/ COVID-19 PCR test positive; This is a spontaneous report from a contactable healthcare professional received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106041236156700-WJGX3. Safety Report Unique Identifier is GB-MHRA-ADR 25420328. A 54-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), dose 1 on an unspecified date and dose 2 on an unspecified date in 2021, via an unspecified route of administration as single dose for COVID-19 immunisation. Medical history included suppressed lactation. Nil- normally fit and well. She has not had symptoms associated with COVID-19, not enrolled in clinical trial, not pregnant, and not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced SARS-CoV-2 infection/ COVID-19 PCR test positive on 03Jun2021 with outcome of not recovered. She underwent lab tests and procedures which included COVID-19 virus test: yes - positive COVID-19 test on 03Jun2021. Case narrative: She has developed signs of COVID infection and had a positive PCR test over a month after receiving second dose of Pfizer vaccine. This report is not related to possible blood clots or low platelet counts. Case was reported as non-serious by health authority. Follow-up attempts are completed. Information about lot/batch number cannot be obtained. No further information is expected


VAERS ID: 1408788 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-03
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood test, Dizziness, Infection, Nausea, Nervousness, Pain in extremity, Peripheral swelling, Pruritus, Rash, Rash erythematous, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), 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? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN; PIRITON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased (Patient is not currently breastfeeding.)
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Test Result: Negative ; Result Unstructured Data: No sign of infection
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: dizziness; itchy; infection; red rash; swelling; Swelling arm; Skin rash; Feeling shaky; Aching in limb; Nausea; Dizzy spells; This regulatory authority case was reported by a consumer and describes the occurrence of RASH (Skin rash), NERVOUSNESS (Feeling shaky), PAIN IN EXTREMITY (Aching in limb), DIZZINESS (dizziness), PERIPHERAL SWELLING (Swelling arm), PRURITUS (itchy), INFECTION (infection), RASH ERYTHEMATOUS (red rash), NAUSEA (Nausea), SWELLING (swelling) and DIZZINESS (Dizzy spells) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased (Patient is not currently breastfeeding.). Concomitant products included IBUPROFEN and CHLORPHENAMINE MALEATE (PIRITON) for an unknown indication. On 27-May-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced PAIN IN EXTREMITY (Aching in limb) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and DIZZINESS (Dizzy spells) (seriousness criterion medically significant). On 04-Jun-2021, the patient experienced RASH (Skin rash) (seriousness criterion medically significant), NERVOUSNESS (Feeling shaky) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (dizziness) (seriousness criterion medically significant), PRURITUS (itchy) (seriousness criterion medically significant), INFECTION (infection) (seriousness criterion medically significant), RASH ERYTHEMATOUS (red rash) (seriousness criterion medically significant) and SWELLING (swelling) (seriousness criterion medically significant). On 05-Jun-2021, NAUSEA (Nausea) and DIZZINESS (Dizzy spells) had resolved. At the time of the report, RASH (Skin rash) had not resolved, NERVOUSNESS (Feeling shaky) outcome was unknown and PAIN IN EXTREMITY (Aching in limb), DIZZINESS (dizziness), PERIPHERAL SWELLING (Swelling arm), PRURITUS (itchy), INFECTION (infection), RASH ERYTHEMATOUS (red rash) and SWELLING (swelling) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: no sign of infection (Negative) No sign of infection. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1408791 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Arthralgia, Blood test, Cardiac function test, Chest X-ray, Chest pain, Heart rate, Heart rate increased, Hypoaesthesia, Myocardial infarction, Pain in extremity, Palpitations, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cluster headache
Allergies:
Diagnostic Lab Data: Test Name: bloods; Result Unstructured Data: Test Result:showed wasn''t having a heart attack; Test Name: heart tracing; Result Unstructured Data: Test Result:looked fine; Test Name: chest x-ray; Result Unstructured Data: Test Result:looked fine; Test Name: heart rate; Result Unstructured Data: Test Result:above 130bpm; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021671371

Write-up: heart attack; sharp shooting pain in chest/heart going down left arm; sharp shooting pain in chest/heart going down left arm; Heart rate increased; Chronic chest pain; Numbness of upper arm; Heart racing; Joint pain; This is a spontaneous report from a contactable consumer received from the Regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106071949581930-LVRTV, and Safety Report Unique Identifier: GB-MHRA-ADR 25433377. A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jun2021 (lot number: EW3143) as 1st dose, single dose for COVID-19 immunisation. Medical history included cluster headache. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medication included paracetamol taken for cluster headache. The patient experienced heart attack on an unspecified date with outcome of unknown, heart racing on 04Jun2021 with outcome of not recovered, chronic chest pain on 05Jun2021 with outcome of not recovered, numbness of upper arm on 05Jun2021 with outcome of not recovered, joint pain on 03Jun2021 with outcome of not recovered, heart rate increased on 05Jun2021 with outcome of not recovered, and sharp shooting pain in chest/heart going down left arm on an unspecified date with outcome of unknown. The patient underwent lab test which included COVID-19 virus test: no - negative COVID-19 test on an unknown date. Case narrative: Patient was taken to hospital, heart rate above 130bpm, sharp shooting pain in chest/heart going down left arm. Bloods showed wasn''t having a heart attack, chest x-ray looked fine and so did the heart tracing. Prior to the vaccine no issues whatsoever. Patient has not tested positive for COVID-19 since having the vaccine. The events were assessed by health authority as serious with seriousness criteria of life threatening, hospitalization and medically significant. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1408906 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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:
CDC Split Type: IEPFIZER INC2021648195

Write-up: fainted; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 19-years-old female patient (no pregnant) received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in Arm Left on 03Jun2021 11:00 (Lot Number: EW6126) at 19-years-old as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history reported as none. The patient''s concomitant medications were not reported. The patient experienced fainted on 03Jun2021 11:15 with outcome of unknown. the event caused physician office visit. No other vaccine in four weeks; No covid diagnosed prior vaccination; No covid tested post vaccination.


VAERS ID: 1409102 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Body temperature, Cold sweat, Coma scale, Feeling abnormal, Heart rate, Heart rate decreased, Oxygen saturation, Presyncope, Pulse pressure decreased, Shock, Visual field defect, Volume blood decreased
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Noninfectious encephalitis (broad), Optic nerve disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:99/64 mmHg; Test Date: 20210603; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:106/66 mmHg; Test Date: 20210603; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:127/73 mmHg; Test Date: 20210603; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:149/80 mmHg; Test Date: 20210603; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:returned to usual values of 147/92 mmHg; Test Date: 20210603; Test Name: Body temperature; Result Unstructured Data: Test Result:35.7 Centigrade; Comments: before vaccination; Test Date: 20210603; Test Name: JCS; Result Unstructured Data: Test Result:0; Test Date: 20210603; Test Name: Pulse rate; Result Unstructured Data: Test Result:42/minute; Test Date: 20210603; Test Name: Pulse rate; Result Unstructured Data: Test Result:56/minute; Test Date: 20210603; Test Name: Pulse rate; Result Unstructured Data: Test Result:63/minute; Test Date: 20210603; Test Name: Pulse rate; Result Unstructured Data: Test Result:58/minute; Test Date: 20210603; Test Name: SpO2; Test Result: 100 %; Test Date: 20210603; Test Name: SpO2; Test Result: 100 %; Test Date: 20210603; Test Name: SpO2; Test Result: 98 %
CDC Split Type: JPPFIZER INC2021646229

Write-up: Anaphylaxis; Warm shock or vasovagal reflex; Warm shock or vasovagal reflex; temporary visual field constriction; feels poorly; cold sweat; pulse pressure decreased; blood pressure of 99/64 mmHg,; pulse rate of 42/minute,; circulating plasma volume was insufficient; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. A 57-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 03Jun2021 10:59 (Batch/Lot Number: EY2173; Expiration Date: 31Aug2021) as 2ND DOSE, SINGLE, dose 1 intramuscular for covid-19 immunisation. Medical history included hypertension. The patient''s concomitant medications were not reported. The patient received first dose of COMIRNATY on 13May2021 for COVID-19 immunisation (Received at 10:30, intramuscular in the arm left. Lot# ER9480 (expiration date 31Jul2021); 1st dose). Event onset time was 11:12 (13 minutes after the vaccination). Events of anaphylaxis and warm shock or vasovagal reflex were reported. On 03Jun2021 at 11:15 (15 minutes after the vaccination), the patient experienced blood pressure decreased, temporary visual field constriction, pure white in front of the eyes, and feels poorly (mucocutaneous and respiratory symptoms were absent). The outcome of the event was recovered with treatment including intramuscular injection of adrenaline and No. 1 infusion 500 mL. AE resulted in visiting a clinic, emergency room or emergency treatment. Since the vaccination, it was unknown if the patient has been tested for COVID-19. Thirteen minutes after the vaccination, while the patient sat down and waited in the hospital, the patient complained of sudden onset of pure white in front of the eyes and visual field constriction. The patient was guided by a nurse and lay down on bed. Vital signs were measured, which showed blood pressure of 99/64 mmHg, pulse rate of 42/minute, and SpO2 of 100%. JCS was 0 and consciousness was clear; however, cold sweat and pulse pressure decreased were noted. The patient had no mucocutaneous or gastrointestinal symptoms. Since it was confirmed that the patient''s normal diastolic blood pressure was 80-90mmHg, it was assessed that the patient had warm shock or vagal reflex. The patient was immediately placed in Trendelenburg position and BOSMIN 0.3 mg was intramuscularly injected into the right deltoid muscle. Two minutes later, blood pressure was 106/66 mmHg, pulse rate was 56/minute, and SpO2 was 100%. The patient said feels poorly improved to some extent. Ten minutes later, blood pressure was 127/73 mmHg and pulse rate was 63/minute, showing normalization of blood pressure. The patient was released from the position, raised upper body, and complained of feels poorly again. Physician considered that circulating plasma volume was insufficient and No. 1 infusion solution 500 mL was administered. The patient was placed in Trendelenburg position again. During the infusion, consciousness of the patient remained clear. One hour later, when the infusion solution was almost completed, vitals signs were measured again, which showed blood pressure of 149/80 mmHg, pulse rate of 58/minute, and SpO2 of 98%. Pulse pressure recovered and periphery was cold. The patient said blood pressure was normally around these values and the patient was told to have athletic heart and pulse was slow. Thus, the condition of warm shock was considered improved and the patient was tried to be placed in sitting position again. Subsequently, the patient did not complain of feels poorly either in sitting position or in standing position. Blood pressure returned to usual values of 147/92 mmHg; thus, infusion was ended and withdrawn. It was confirmed for another 10 minutes that the patient had no abnormality and then the patient returned home. The reporting physician classified the event as serious (medically significant) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was fatigue after an overnight shift, followed by 4-km walking. The reporting physician commented as follows: The patient visited the reporting hospital by walking 4 kilometers after an overnight shift. The patient had a history of hypertension, which was not listed on the vaccine screening questionnaire. Warm shock or vagal reflex occurred due to overlap of COMIRNATY vaccination and fatigue but their correlation was not clear. However, it was not inconsistent with COMIRNATY''s adverse reaction of anaphylactic shock, which occurs with a certain probability; thus, it was considered as adverse reaction of COMIRNATY. The patient underwent lab tests and procedures which included blood pressure measurement: 99/64 mmhg on 03Jun2021, blood pressure measurement: 106/66 mmhg on 03Jun2021, blood pressure measurement: 127/73 mmhg on 03Jun2021, blood pressure measurement: 149/80 mmhg on 03Jun2021, blood pressure measurement: returned to usual values of 147/92 mmhg on 03Jun2021, body temperature: 35.7 centigrade on 03Jun2021 before vaccination , coma scale: 0 on 03Jun2021, heart rate: 42/minute on 03Jun2021, heart rate: 56/minute on 03Jun2021, heart rate: 63/minute on 03Jun2021, heart rate: 58/minute on 03Jun2021, oxygen saturation: 100 % on 03Jun2021, oxygen saturation: 100 % on 03Jun2021, oxygen saturation: 98 % on 03Jun2021. Therapeutic measures were taken as a result of the events. The outcome of the events was recovered on 03Jun2021.; Sender''s Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported serious Events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1409167 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MOHRUS L
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Osteoarthritis of cervical spine
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021650728

Write-up: Urticaria; This is a spontaneous report from a contactable physician received via COVID-19 Vaccine Adverse Event Self-Reporting Regulatory Authority. The patient was a 72-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received ketoprofen (MOHRUS tape L) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has other medical history included osteoarthritis of cervical spine. The patient had no allergies to medications, food, or other products. On 03Jun2021 at 11:00 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31Aug2021) intramuscular at left arm (at the age of 72-years-old) for COVID-19 immunization. On 03Jun2021 at 16:00 (5 hours after the vaccination), the patient experienced that urticaria appeared both on both legs and arms. The reporter stated the event result in doctor or other healthcare professional office/clinic visit. The outcome of the event was not recovered with treatment included: infusion, POLARAMINE, CELESTAMINE. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information expected.


VAERS ID: 1409175 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Blood pressure systolic increased, Body temperature, Erythema, Flushing, Heart rate, Hypoaesthesia oral, Oxygen saturation, Palpitations
SMQs:, Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dehydration; Dry mouth; Hypertension (taking oral medications)
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: blood pressure; Result Unstructured Data: Test Result:165-60; Comments: 10:00; Test Date: 20210603; Test Name: blood pressure; Result Unstructured Data: Test Result:162-66; Comments: 10:30; Test Date: 20210603; Test Name: blood pressure; Result Unstructured Data: Test Result:150-73; Comments: 11:20; Test Date: 20210603; Test Name: Body temperature; Result Unstructured Data: Test Result:35.4 Centigrade; Comments: Before vaccination; Test Date: 20210603; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: 10:30; Test Date: 20210603; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: 11:20; Test Date: 20210603; Test Name: pulse; Result Unstructured Data: Test Result:74; Comments: 10:00; Test Date: 20210603; Test Name: pulse; Result Unstructured Data: Test Result:78; Comments: 10:30; Test Date: 20210603; Test Name: pulse; Result Unstructured Data: Test Result:84; Comments: 11:20; Test Date: 20210603; Test Name: Sop2; Result Unstructured Data: Test Result:98; Comments: 10:00; Test Date: 20210603; Test Name: Sop2; Result Unstructured Data: Test Result:98; Comments: 10:30; Test Date: 20210603; Test Name: Sop2; Result Unstructured Data: Test Result:97; Comments: 11:20
CDC Split Type: JPPFIZER INC2021650957

Write-up: Anaphylaxis; All face reddish; Numbness lips; Palpitations; Flushed face; blood pressure was 165-60/blood pressure is 162-66/blood pressure is 150-73; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21111486. The patient was an 85-year and 1-month-old (as reported) female. Body temperature before vaccination was 35.4 degrees Centigrade. The points to be considered on the vaccine screening questionnaire including without allergy, the patient has Hypertension and is taking oral medications, the patient had mild Dehydration symptoms and dry mouth in mid-May. After that, the examination results showed that there was no problem, and then the patient was vaccinated. On 03Jun2021 at 09:50 (the day of vaccination, at the age of 85-year-old), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31-AUG-2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 03Jun2021 at 10:00 (10 minutes after the vaccination), the patient experienced Anaphylaxis, All face reddish, Numbness lips, Palpitations, Flushed face. On 03Jun2021 (the same day of vaccination), the patient was admitted to the hospital. The outcome of the events was unknown. The course of the event was as follows: Without allergy, the patient had symptoms of Dehydration and Dry mouth in mid-May. After that, the patient went to the hospital to see a doctor. The examination results showed that there was no problem, and then the patient went home. On 03Jun2021, the patient was vaccinated and went to measure the body temperature, which was 35.4 degrees Centigrade, and other symptoms were ok. The comirnaty vaccine was vaccinated at 9:50, Anaphylaxis, All face reddish, Numbness lips, Palpitations, blood pressure was 165-60, pulse was 74, Sop2 was 98, and flushed face appeared soon. At 10:15, Adrenaline 0.3mg. At 10:20, 100 mg of normal saline, and 100 mg of Solu-Cortef. At 10:25, POLARAMINE 5mg, 10:30 Body temperature is 36.4 (degrees Centigrade), pulse is 78, blood pressure is 162-66, Sop2 is 98. 10:40 normal saline 100, Solu-Cortef 100 mg. At 11:05, the situation is the same as at 10:40. At 11:20, Body temperature is 36.3 (degrees Centigrade), pulse is 84, blood pressure is 150-73, Sop2 is 97. Patient took an ambulance. The reporting physician classified the event as serious (Be hospitalized) and assessed that the events was related to BNT162B2.


VAERS ID: 1409179 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Blood pressure systolic increased, Body temperature, Dysgeusia, Heart rate, Oxygen saturation
SMQs:, Anaphylactic reaction (narrow), Taste and smell disorders (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Food allergy; Hypertension; Reflux oesophagitis; Throat irritation; Thyroid function decreased (she was receiving oral medicines for thyroid gland related disease)
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: BP; Result Unstructured Data: Test Result:183/75; Comments: at around 11:23; Test Date: 20210603; Test Name: BP; Result Unstructured Data: Test Result:152/78; Comments: 12:11; Test Date: 20210603; Test Name: BP; Result Unstructured Data: Test Result:169/68; Comments: 12:34; Test Date: 20210603; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: at around 11:23; Test Date: 20210603; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: 12:11; Test Date: 20210603; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: 12:34; Test Date: 20210603; Test Name: HR; Result Unstructured Data: Test Result:78; Comments: at around 11:23; Test Date: 20210603; Test Name: HR; Result Unstructured Data: Test Result:78; Comments: 12:11; Test Date: 20210603; Test Name: HR; Result Unstructured Data: Test Result:84; Comments: 12:34; Test Date: 20210603; Test Name: SpO2; Test Result: 97 %; Comments: at around 11:23 on air; Test Date: 20210603; Test Name: SpO2; Test Result: 96 %; Comments: 12:11 on air; Test Date: 20210603; Test Name: SpO2; Test Result: 96 %; Comments: 12:34
CDC Split Type: JPPFIZER INC2021650990

Write-up: Anaphylaxis; Blood pressure (BP) was 183/75; strange feeling inside the mouth appeared; This is a spontaneous report from a contactable physician received from the regulatory authority. The Regulatory authority report number is v21111485. A 79-year-old female patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration on 03Jun2021 11:08 at 79-year-old as a single dose for COVID-19 immunisation. Medical history included hypertension, reflux oesophagitis and symptoms relating to Thyroid gland disorders and she was receiving oral medicines for thyroid gland related disease, allergy to peach and cherry, irritated feeling in the throat (not severe) due to peach and cherry. About cosmetic allergy, it was ok (illegible). She did not have drug allergy. No information on family history was provided. Body temperature before vaccination was not reported. The patient had hypertension, reflux oesophagitis, and receiving medicine for conditions relating to thyroid gland. For the treatment, the patient was visiting a hospital regularly. As above mentioned, the patient had only food allergy, therefore, the physician thought it was ok to give the vaccination to the patient (on 03Jun2021 at 11:08). On 03Jun2021 at around 11:23, the patient experienced anaphylaxis ,hot flushes facial, irritated feeling of the lips and strange feeling inside the mouth appeared, Blood pressure (BP) was 183/75, oxygen saturation percutaneous (SpO2) was 97% (on air) and heart rate (HR) was 78 and body temperature (BT) was 36.5 degrees Centigrade. At 11:25, BOSMIN 0.3 mg was intramuscularly administered. However, as strange feeling inside the mouth did not disappear. At 11:40, BOSMIN 0.3 mg was intramuscularly administered, and subsequently the symptoms obviously improved. Finally, hot flushes facial improved. She was put on bed rest and received IV drip of normal saline solution 500 mL at 12:09. At 12:11, BT was 36.3 degrees Centigrade, HR was 78, BP was 152/78 and SpO2 was 96% on air. At 12:18, POLARAMINE 1 ampule was administered. At 12:22, SOLU-CORTEF 300 mg plus normal saline solution was administered. At 12:34, BP was 169/68, HR was 84, SpO2 was 96% and BT was 36.6 degrees Centigrade. Strange feeling inside the mouth improved but slightly remained. Hot flushes facial recovered completely. Irritated feeling of the lips showed improvement as well. The patient was transferred to a different hospital. On 03Jun2021 (the day of vaccination), the outcome of the events was recovering. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases (he stated so but the reporter was not sure). The reporting physician commented as follows: Since the symptoms slightly remained, the patient was transferred to the hospital of her family doctor.


VAERS ID: 1409245 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0195 / 2 - / -

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? 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 INC2021649814

Write-up: ''myocarditis'' where chest pain is one of the symptoms; Yesterday was applied the second dose of the vaccine and today woke up with a constant chest pain; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A 51-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EW0195) via unspecified route of administration on 02Jun2021 as single dose of COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EW-2245) via unspecified route of administration on 05May2021 as single dose of COVID-19 immunization. The patient indicated that that on 02Jun2021 (yesterday) he received the second dose of BNT162B2 against COVID-19 and on 03Jun2021 (today) he woke up with continuous chest pain. The patient commented comments that he read an article about a possible adverse event associated with BNT162B2 called "myocarditis" where chest pain was one of the symptoms, for which he wished to report the information and asked the medical information team recommendation what to do. The event myocarditis was considered serious medically significant. Outcome of the events was unknown.


VAERS ID: 1409330 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-06-03
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET9096 / 2 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Facial paralysis, Pain in extremity, Pyrexia, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hearing impairment (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? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: Test Result:38-38.5 Centigrade; Comments: fever (38-38.5 degrees Celsius)
CDC Split Type: PEPFIZER INC2021702314

Write-up: facial paralysis; pain in the arm where he received the vaccine; fever (38-38.5 degrees Celsius); very sleepy; This is a spontaneous report from Regulatory Authority. This report came from a contactable consumer. A 34-years-old male patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number: ET9096) via an unspecified route of administration, administered in right arm on 07Apr2021 as single dose (at the age of 34-years-old) for COVID-19 immunisation. The patient medical history was reported as none. The patient previously received first dose of COMIRNATY (Lot Number: EP9605) via an unspecified route of administration, administered in right arm on 17Mar2021 as single dose (at the age of 34-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient''s concomitant medications were reported as none. The patient also said that he had had a healthy life and he had never experienced this kind of problems, it only occurred after receiving the vaccine. On an unspecified date in 2021, after receiving the second dose of the vaccine, the patient experienced pain in the arm where he received the vaccine, fever (38-38.5 degrees Celsius) and very sleepy. Reporter did not remember the exact start or end dates of the events, but they lasted a few days. Treatment for the events only included paracetamol. Sometime later, approximately on 03Jun2021, the patient began to experience discomfort in his right eye. Then, progressively, he felt the same discomfort on his cheek and mouth (right side). The patient went to a physician, who said it could have been because of the cold weather and that it would soon pass. The physician did not indicate treatment and the patient continued working. On Saturday 12Jun2021, the patient began to feel more that discomfort; and today (14Jun2021), he could no longer move the right side of his face, make gestures or smile. The patient went to another physician, who indicated rest and medical treatment. Treatment included: orphenadrine, diclofenac, dexamethasone, and NEURO-VIT. The physician did not take further action until medical re-evaluation on following Thursday. The outcome of events pain in the arm where he received the vaccine, fever (38-38.5 degrees Celsius) and very sleepy was resolved on an unspecified date in 2021. The outcome of event facial paralysis was not recovered. Information on the lot/batch number has been requested. Follow-up (14Jun2021): New information received from same contactable consumer (patient''s wife) included: Description of patient details (age), suspect product (dosage regimen and vaccine information) and events (pain in the arm where he received the vaccine, fever (38-38.5 degrees Celsius) and very sleepy), treatment and outcome of event were updated.


VAERS ID: 1409834 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-03
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210621875

Write-up: ABDOMINAL CRAMP; VOMITING; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, AT-BASGAGES-2021-30712] concerned a 49 year old female of unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included none. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, one total administered on 02-JUN-2021 for an unspecified indication. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 03-JUN-2021, the patient experienced abdominal cramp, vomiting and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abdominal cramp, and vomiting. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210621875-COVID-19 VACCINE AD26.COV2.S- abdominal cramp, vomiting. This events is considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.


VAERS ID: 1410582 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-06-03
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0199 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Chest discomfort, Heart rate, Insomnia, Palpitations
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dry eyes
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:120/76 mmHg; Test Name: Pulse; Result Unstructured Data: Test Result:84
CDC Split Type: CAPFIZER INC2021656404

Write-up: I started getting heart palpitations; left side of chest feels so tight; i cud not slept; This is a spontaneous report received via COVAES from a contactable consumer (patient). This consumer reported 2 reports for different patient, this is the first of 2 reports. A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 15May2021 (Batch/Lot Number: EW0199) as 1ST DOSE, SINGLE for covid-19 immunisation at Workplace clinic. Medical history included only dry eyes problem. The patient''s concomitant medications were not reported. Relevant past drug history: Nope. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced started getting heart palpitations on 03Jun2021 19:00 (as reported). The patient started getting heart palpitations, only when he lie down at bed, it came on 3rd day he thought its nothing and gone when woke up for water and then again 5 or 6th day, but it came on 12th day so hard then realized its due to vaccine, the patient could not slept on 03Jun2021, his friend who took with the patient he also got this he said start running and do yoga in morning, the patient started doing but after 5 days patient was getting again, even day before yesterday and yesterday, heart beats so fast and his left side of chest feels so tight on 03Jun2021, but the patient could breathe normally. The patient checked his blood pressure going rexall it was 120/76 and pulse 84. The patient did not know what to do, he was so fit he had no issues, the patient was thinking to visit hospital. The outcome of events was reported as not recovered.; Sender''s Comments: Linked Report(s) : CA-PFIZER INC-2021671186 Same reporter and product, different patient.


VAERS ID: 1410591 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-06-03
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8721 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2021665409

Write-up: large blood clots.; Very heavy period bleeding; This is a spontaneous report from a contactable consumer (patient) received via regulatory authority. This 32-year-old non-pregnant female consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot FA8721) on an unspecified date in May2021 (at 32 years old), at single dose, for COVID-19 immunisatio. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history and concomitant medications were not reported. The patient had a very heavy period bleeding and large blood clots on 03Jun2021. The events had not yet resolved at the time of the report.


VAERS ID: 1411409 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haematochezia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (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 INC2021655321

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority report (number: GB-MHRA-WEBCOVID-202106030846065480-ZDTPY; safety report unique identifier: GB-MHRA-ADR 25410364). A 35-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, on Jun 2, 2021, single dose, for COVID-19 immunisation. The patient''s medical history was not reported. Patient has not had symptoms associated with COVID-19, nor had a COVID-19 test. Patient has not tested positive for COVID-19 since the vaccination. Patient is not enrolled in a clinical trial. The patient''s concomitant medications were not reported. The patient never had blood in stool before and had this for the first time the morning of Jun 3, 2021 (after the Pfizer vaccination). The outcome of the event was not recovered. No follow-up attempts are possible. Information about lot number cannot be obtained.


VAERS ID: 1411436 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Gait inability, Headache, Limb discomfort, Muscle spasms, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021655407

Write-up: Cramps in legs; headache; dizziness; heavy legs so much that I didn''t think I could walk; heavy legs so much that I didn''t think I could walk; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106031102340470-0KA7X, Safety Report Unique Identifier is GB-MHRA-ADR 25411594. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 03Jun2021 (at the age of 31 years old) as first dose, single for COVID-19 immunization. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19 and she was not enrolled in clinical trial. She was not pregnant and not currently breastfeeding. The patient''s concomitant medications were not reported. On 03Jun2021, the patient experienced cramps in legs, headache, dizziness, and "heavy legs so much that I didn''t think I could walk". The events were reported as serious, with seriousness criteria of other medically important condition. The clinical course was reported as follows: 5 minutes after getting the vaccine patient had headache, dizziness and heavy legs so much that she didn''t think she could walk. This has continued since. The patient underwent COVID-19 virus test on an unspecified date with the following result: No - Negative COVID-19 test. The outcome of the events was not recovered. No follow-up attempts are possible, information about batch number cannot be obtained.


VAERS ID: 1411444 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Dehydration, Fatigue, Heart rate increased, Malaise, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Dehydration (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021655514

Write-up: vomiting; Sickness; Aching joints; Tiredness; dehydrated; my heart was a bit fast; This is a spontaneous report from a contactable consumer (patient). This is a report received from the regulatory authority, report number is GB-MHRA-WEBCOVID-202106031130368580-RBRTB,Safety Report Unique Identifier(GB-MHRA-ADR 25416273). A 22-year-old female patient (not pregnant, not currently breastfeeding) received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot EW3143), via an unspecified route of administration on 02Jun2021 as first dose, single for COVID-19 immunisation. Medical history included suppressed lactation. The patient''s concomitant medications were not reported. On 03Jun2021, the patient experienced sickness, aching joints and tiredness. Also on 03Jun2021, she started vomiting at 5am and the following 4.5 hours, she continued and had vomited 6 times. After calling 111 they sent her to hospital for an urgent care appointment. They proceeded to fully check her and she was dehydrated and her heart was a bit fast. They sent her home to rest with ant sickness medication and to sip liquid. The events were reported as serious medically significant. The patient underwent laboratory test which included Sars-cov-2 test: no - negative covid-19 test on unknown date. The outcome of events dehydrated and heart was a bit fast was unknown; for other events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411450 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Joint range of motion decreased, Pain, Pain in extremity
SMQs:, 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021655371

Write-up: Unable to lift above 45 degrees. Restrictions to ROM; very sore arm; Pain; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority, report number is GB-MHRA-WEBCOVID-202106031235151340-SUCPU, Safety Report Unique Identifier GB-MHRA-ADR 25412265. A 28-year-old female patient (not pregnant, not currently breastfeeding) received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot unknown), via an unspecified route of administration on 02Jun2021 as first dose, single for COVID-19 immunization. Medical history included suppressed lactation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced very sore arm and she was unable to lift above 45 degrees with restrictions to ROM (range of motion); pain on 03Jun2021. The events were reported as serious medically significant. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1411465 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia oral, Lip swelling, Oral discomfort, Paraesthesia oral, Photopsia, SARS-CoV-2 test, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Retinal disorders (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LORATADIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hay fever; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021655473

Write-up: hives; Numb mouth; Edges of lips were tingling/burning; Edges of lips were tingling/burning; Edges of lips were tingling/burning like hives were appearing but appearance looked fine, just slightly swollen; flashing patch in my vision; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority report number is GB-MHRA-WEBCOVID-202106031431037190-VERWM, Safety Report Unique Identifier GB-MHRA-ADR 25413423. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 03Jun2021 (Lot Number ew3143) (at the age of 35-years-old) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included lactation decreased and hay fever. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient is not pregnant and not currently breastfeeding. Concomitant medication included loratadine (LORATADIN) taken for hay fever from 01Jan1998 to an unspecified stop date. On 03Jun2021, the patient experienced hives and numb mouth. The clinical course was also reported as follows: Edges of lips were tingling/burning like hives were appearing but appearance looked fine, just slightly swollen. Roof of mouth went numb after this. When lips and mouth returned to normal, the patient got a flashing patch in her vision at the top edge. This lasted about 10 seconds then stopped. The events were considered serious, medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: no- negative COVID-19 test on unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of all the events was recovered on 03Jun2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411480 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Palpitations, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021655395

Write-up: tachycardia; Palpitations; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority, report number is GB-MHRA-WEBCOVID-202106031535023090-SMIDF. Safety Report Unique Identifier is GB-MHRA-ADR 25414026. A 37-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 03Jun2021 (at the age of 37-year-old) as first dose, single for covid-19 immunisation. Medical history included lactation decreased. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. Patient was not pregnant. Patient was not currently breastfeeding. Concomitant medications were not reported. The patient experienced tachycardia and palpitations on 03Jun2021. The events were reported as serious (Other medically important condition). It was reported that patient experienced sudden onset of tachycardia and intermittent palpitations around 90 minutes post vaccination that had lasted over 5hrs. Patient had not tested positive for COVID-19 since having the vaccine. The patient recovered from the events on an unspecified date in Jun2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1411483 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021655641

Write-up: bleeding; menstruation; Excessive menstruation; This is a spontaneous report from a contactable consumer or other non hcp received from the Medicines and Healthcare products Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106031600379310-OBLSV, Safety Report Unique Identifier GB-MHRA-ADR 25414218. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 01Jun2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included Lactation decreased. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient was not pregnant or currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced bleeding on unknown date, menstruation (Absence of menstruation) on unknown date and excessive menstruation on 03Jun2021. Menstruation began when not normally due (due to contraceptive implant). Bleeding heavily through pads/pants/trousers. 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 01Jun2021. The outcome of event Excessive menstruation was not recovered, others was unknown. This case was reported as medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1411498 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Hyperhidrosis, Nausea, SARS-CoV-2 test, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GAVISCON DOUBLE ACTION; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Heartburn
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021655691

Write-up: Shivers; Shaking of hands; Sweating; Tiredness; Nausea; This is a spontaneous report from a contactable consumer received from the Regulatory Authority report. A 34-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW3143), via an unspecified route of administration at the age of 34-year-old on 03Jun2021 at single dose for COVID-19 immunisation. Medical history included depression and heartburn. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medications included calcium carbonate, sodium alginate, sodium bicarbonate (GAVISCON DOUBLE ACTION) taken for heartburn; sertraline taken for depression. The patient experienced tiredness on 03Jun2021, shivers on an unspecified date, shaking of hands on an unspecified date, nausea on 03Jun2021, sweating on an unspecified date. The events were reported as serious, medically significant and disability. The patient underwent lab tests included COVID-19 virus test: negative on an unspecified date (reported as No - Negative COVID-19 test). The outcome of event shivers was recovering, of event nausea was recovered, of event sweating was recovered with sequel and other events was not recovered. No follow up attempts are possible. No further information is expected.


VAERS ID: 1411500 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Confusional state, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021655495

Write-up: confusion; nausea; Headache; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106031749428820-QBVIR, Safety Report Unique Identifier GB-MHRA-ADR 25415132. A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ET8885, expiry date not reported), via an unspecified route of administration on 02Jun2021 as first dose, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient experienced confusion and nausea on an unspecified date, severe headache on 03Jun2021. The events were reported as serious (Other medically important condition). Patient has not tested positive for COVID-19 since having the vaccine. The patient had not recovered from headache while outcome of the remaining events was unknown. No follow up attempts are possible. No further information is expected.


VAERS ID: 1411554 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre 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: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20201117; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021655603

Write-up: tingling sensation/pins and needles/tingling; headache; This is a spontaneous report. A 31-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration on 03Jun2021 (batch/lot number ET8885 and expiry date unknown) at 31 years of age as 1st dose, single for covid-19 immunization. Medical history included lactation decreased. The patient has not had symptoms associated with COVID-19, was not enrolled in clinical trial, not currently breastfeeding. The patient''s concomitant medications were not reported. On 03Jun2021, the patient experienced tingling sensation, pins and needles, headache, tingling. The reporter informed that the patient experienced slight headache in hours following vaccine (although perhaps due to other factors), tingling sensation/pins and needles all over the body approximately 4-5 hours after vaccine administered. The events were reported serious as other medically important condition. The patient underwent lab tests and procedures which included COVID-19 virus test: yes - positive covid-19 test on 17Nov2020. The outcome of the event pins and needles was unknown, while not recovered for the rest of the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411563 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-03
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885/V1193 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased, Hypopnoea, Respiratory rate increased, Seizure, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy
Allergies:
Diagnostic Lab Data: Test Name: BP; Result Unstructured Data: Test Result:high; Test Name: heart rate; Result Unstructured Data: Test Result:140; Comments: 140 bpm
CDC Split Type: GBPFIZER INC2021655474

Write-up: very unresponsive, breathing rapid and shallow; very unresponsive, breathing rapid and shallow; very unresponsive, breathing rapid and shallow; heart rate at 140 bpm; Fit (non-epileptic); This is a spontaneous report from a contactable pharmacist received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106031841517160-ZHFBU; Safety Report Unique Identifier: GB-MHRA-ADR 25415501. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on an unspecified date (lot number: ET8885/v1193) as 1st dose, single, for COVID-19 immunisation. Medical history included epilepsy. The patient''s concomitant medications were not reported. On 03Jun2021, the patient experienced fit (non-epileptic). On unspecified date, the patient was very unresponsive, breathing rapid and shallow, heart rate at 140 bpm, and blood pressure (BP) high. Additional information: Patient had a fit. No history of epilepsy. The events were considered serious due to other medically important condition. The patient recovered from the event fit (non-epileptic) on unspecified date in Jun2021, while for the other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411565 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3743 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysgeusia, Dysmenorrhoea, Poisoning, Vaccination complication, Vertigo
SMQs:, Taste and smell disorders (narrow), Vestibular 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:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021655701

Write-up: Intoxication; Vaccination related malaise; Taste metallic; Menstrual cramps; Vertigo; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106031845409640-PQ2ZZ,Safety Report Unique Identifier GB-MHRA-ADR 25415844. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Jun2021 (Batch/Lot Number: EW3743) as single dose for COVID-19 immunisation. Medical history included suspected COVID-19 from 09Mar2020 to an unknown date (Unsure when symptoms stopped). Not had a COVID-19 test. Unsure if patient is enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced intoxication, vaccination related malaise, taste metallic, menstrual cramps, and vertigo on 03Jun2021. The outcome of the events Vaccination related malaise and Taste metallic was not recovered, and the outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411566 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Fatigue, Myalgia, Retching, SARS-CoV-2 test, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210601; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021655336

Write-up: gagging; muscle aches; Vomiting; Fatigue/very tired; Coughing/coughing fits; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106031846029410-ISZEP, Safety Report Unique Identifier: GB-MHRA-ADR 25415535. A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02Jun2021 (lot number: not known) at 1st dose, single for COVID-19 immunisation. The patient medical''s history was not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced vomiting, fatigue, and coughing on 03Jun2021. Clinical course reported: when he woke in the morning (unspecified date), he started gagging and vomiting, since then have had coughing fits that resulted in vomiting, he was very tired despite sleeping and napping, also experiencing muscle aches. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on 01Jun2021. The outcome of the events vomiting and coughing was recovering; fatigue was not recovered; and gagging and muscle aches was unknown. Regulatory authority assessed the events as serious for being medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1411570 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Diarrhoea
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021655627

Write-up: stomach pain; Diarrhea; This is a spontaneous report from a contactable consumer. This is a report received from a regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202106031911096380-99OLN, Safety Report Unique Identifier GB-MHRA-ADR 25415767. A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EW3143) at the age of 33-years, via an unspecified route of administration on 03Jun2021 at single dose for COVID-19 immunization. Medical history included lactation decreased. Patient had not had symptoms associated with COVID-19, not had a COVID-19 test, was not enrolled in clinical trial. Patient was not pregnant at time of vaccination, was not currently breastfeeding. Concomitant medications were not reported. The patient experienced stomach pain with outcome of unknown; diarrhea on 03Jun2021 with outcome of not recovered. It was reported that severe stomach pain and diarrhoea. The events were reported as serious and seriousness criteria was provided as other medically important condition. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411580 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: 20210603; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021655399

Write-up: Chest pain/ Sharp pains all over the inside of my chest; This is a spontaneous report from a contactable consumer received from the regulatory authority, report number is GB-MHRA-WEBCOVID-202106032059486480-SXPBF. Safety Report Unique Identifier GB-MHRA-ADR 25416628. A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jun2021 (at the age of 34 years) (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient experienced sharp pains all over the inside of the chest that are worse when breathing on 03Jun2021. The event was assessed as serious (medically significant). Lab data includes COVID-19 virus test: No - Negative COVID-19 test on 03Jun2021. The outcome of the event was not recovered. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible, information about the batch number cannot be obtained.


VAERS ID: 1411588 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-06-03
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5456 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dysmenorrhoea, Mobility decreased, Pain, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Parkinson-like events (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210515; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021655560

Write-up: pain; lightheaded; Menstrual cramps/Pain menstrual; unable to move for at least an hour; This is a spontaneous report from a contactable consumer (patient). This is a report received from the RA. Regulatory authority report number is GB-MHRA-WEBCOVID-202106032202308070-IZLUE. Safety Report Unique Identifier is GB-MHRA-ADR 25417141. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EY5456), via an unspecified route of administration on 21May2021 as first dose, single for COVID-19 immunization. Medical history included lactation decreased. Patient had not had symptoms associated with COVID-19 and she was not enrolled in clinical trial. She was not pregnant and was not currently breastfeeding. Concomitant medications were not reported. The patient experienced pain, lightheaded, menstrual cramps/pain menstrual and unable to move for at least an hour, all on 03Jun2021. All events were reported as medically significant. The clinical course was reported as follows: Her period was due today or tomorrow and this evening she got the worst cramps she had had in recent memory, possibly ever. She was unable to move for at least an hour. She took one paracetamol tablet about three hours ago and the pain subsided enough for her to stand up and make dinner, but it still felt tender. She also felt lightheaded for the first two hours. She hadn''t bled yet though, which was unusual because when she did get menstrual cramps, they usually happened on the first day of her flow. Her cycle had always been fairly regular, and her cramps were never severe enough to require more than one paracetamol three or four times a year. Patient had not tested positive for COVID-19 since having the vaccine. The patient underwent COVID-19 virus test on 15May2021 with the following results: No - Negative COVID-19 test. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411592 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5456 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, Oesophageal pain
SMQs:, Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021655503

Write-up: Oesophageal pain; Supraclavicular lymph nodes enlarged; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106032232200460-JBTR6. Safety Report Unique Identifier GB-MHRA-ADR 25417296. A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jun2021 (Lot Number: EY5456) as first dose, single for COVID-19 immunization. Medical history included suppressed lactation. Patient has not had symptoms associated with COVID-19; Not had a COVID-19 test; Patient is not enrolled in clinical trial; Patient is not pregnant; Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient previously took cortisol. The patient experienced oesophageal pain on an unspecified date with outcome of unknown, and supraclavicular lymph nodes enlarged on 03Jun2021 with outcome of not recovered. The events were reported as serious, medically significant. The patient spoke to emergency services who advised me that a GP will phone. Injection was given very high up (more or less in shoulder) which seems to fit with research linking technique to supraclavicular reaction. Patient has not tested positive for COVID-19 since having the vaccine. No follow up attempts are possible. No further information is expected.


VAERS ID: 1411600 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-03
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstruation delayed
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021655293

Write-up: Period pains; Period was due day after vaccine/Arrived 5 days late and much heavier and more painful; Period was due day after vaccine/Arrived 5 days late and much heavier and more painful; This is a spontaneous report. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported) via an unspecified route of administration on 31May2021 as first dose, single for covid-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. It was reported that patient experienced period pains on 03Jun2021. It was reported that period was due day after vaccine. Always regular. Arrived 5 days late and much heavier and more painful than usual. The events were reported as serious (Other medically important condition). Patient has not tested positive for COVID-19 since having the vaccine. Outcome of period pains was not recovered, while outcome of the remaining events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained


VAERS ID: 1411648 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021710019

Write-up: This is a spontaneous report from a contactable consumer received from the Regulatory Agency. A 33-years-old non pregnant female patient received bnt162b2, dose 1 via an unspecified route of administration on 02Jun2021 (at the age of 33 years old) as 1st dose, single for covid-19 immunisation. Patient was not currently breastfeeding. Medical history included lactation decreased. Concomitant medications were not reported. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with covid-19. Not had a covid-19 test. On 03Jun2021, the patient experienced painful arm. On 11Jun2021, the patient experienced shingles. The events painful arm and shingles were serious (medically significant). Treatment was received included antivirals. Outcome of the event shingles was resolving. Outcome of the event painful arm was resolved on 05Jun2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected


VAERS ID: 1411730 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PAA165994/EX653 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021654443

Write-up: Syncope post vaccine; This is a spontaneous report from a contactable other HCP (patient). This 48-year-old male patient received BNT162B2 (COMIRNATY), at the age of 48-year-old ,dose 1 via an unspecified route of administration, administered in Arm Left on 03Jun2021 04:00 PM (Batch/Lot Number: PAA165994/EX6537) at 1st dose, single for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced syncope post vaccine on 03Jun2021 16:30 with outcome of recovered. Therapeutic measures were taken as a result of syncope post vaccine. Seriousness criteria of the events was medically significant. Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination. Reported Event: Syncope post vaccine. Treatment received for the adverse event included Oxygen applied, vital signs monitered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on close temporal association, a causal relationship between the event syncope and BNT162B2 (COMIRNATY) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1411820 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-03
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210628025

Write-up: PAIN IN LEGS; HEADACHE; FEVER (37,7); This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, IT-MINISAL02-740527] concerned a 36 year old male with unknown ethnicity and race. The patient''s weight was 72 kilograms, and height was 170 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD985 expiry: unknown) 1 dosage forms, 1 total administered on 02-JUN-2021 for covid-19 immunisation. No concomitant medications were reported. After the vaccination, on 03-JUN-2021, the patient had headache and fever (37,7), which were disappeared the next day. Unfortunately, the pain in legs was getting worse and worse and patient could not stay in any position. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache and fever (37,7) and pain in legs. This report was serious (Disability Or Permanent Damage).; Reporter''s Comments: Nessuna; Sender''s Comments: V0: 20210628025-COVID-19 VACCINE AD26.COV2.S-PAIN IN LEGS, HEADACHE, FEVER (37,7). This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1411845 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-06-03
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Pneumonia bacterial
SMQs:, Infective pneumonia (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: 20210603; Test Name: body temperature; Result Unstructured Data: Test Result:38.1 Centigrade; Test Date: 20210603; Test Name: body temperature; Result Unstructured Data: Test Result:37 Centigrade
CDC Split Type: JPPFIZER INC2021651519

Write-up: bacterial pneumonia; This is a spontaneous report from a contactable pharmacist via a sales representative who contacted medical information team. An 87-year-old female patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on 24May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced bacterial pneumonia on 03Jun2021 with outcome of recovering. The patient was hospitalized for bacterial pneumonia from 03Jun2021 to an unknown date. The patient underwent lab tests and procedures which included body temperature: 38.1 centigrade on 03Jun2021, and body temperature: 37 centigrade on 03Jun2021. Therapeutic measures were taken as a result of bacterial pneumonia and includes cephems. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of bacterial pneumonia. The reported event likely represent intercurrent medical condition in this elderly 87-year-old patient. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1411848 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Abdominal pain, Blood pressure increased, Blood pressure measurement, Body temperature, Breath sounds, Heart rate, Oxygen saturation, Vital signs measurement, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Oesophageal carcinoma (Post operation); Osteoporosis; Pancreatitis chronic
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: Blood pressure; Result Unstructured Data: Test Result:142/54; Comments: Before vaccination; Test Date: 20210603; Test Name: Blood pressure; Result Unstructured Data: Test Result:165/83; Comments: After vaccination; Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination; Test Date: 20210601; Test Name: pulse; Result Unstructured Data: Test Result:87; Comments: Before vaccination; Test Date: 20210603; Test Name: SpO2; Test Result: 96 %; Comments: After vaccination; Test Date: 20210603; Test Name: breath sounds; Result Unstructured Data: Test Result:normal; Test Date: 20210603; Test Name: Vital check; Result Unstructured Data: Test Result:clear consciousness
CDC Split Type: JPPFIZER INC2021651778

Write-up: Bloating; Abdominal pain; vomiting; BP165/83; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is v21111472. A 85-year-old female patient received BNT162B2 (COMIRNATY), via intramuscular route in upper left arm on 01Jun2021 16:25 (Batch/Lot Number: EY5420; Expiration Date: 31Aug2021) as 1st dose, single for COVID-19 immunization. Medical history included atrial fibrillation, pancreatitis chronic, esophageal carcinoma (post operation), and osteoporosis. The patient''s concomitant medications were not reported. Body temperature was 36.4 degrees Centigrade, BP was 142/54, and Pulse was 87 before vaccination. The patient had no family history. Observation after vaccination was over 30 minutes. On 03Jun2021 at 17:05 (2 days 40mins after the vaccination (as reported)), the patient experienced bloating, abdominal pain and vomiting. No skin eruption. Vital check showed SPO2 96%, BP 165/83, clear consciousness, normal breath sounds. BOSMIN for Intramuscular and SOLITA-T No.3 500ml (17:10) Injection lasted till 18:20. Abdominal pain was recovering, and after Vital signs measurement (all clear and normal). The reporting physician commented as follows: BOSMIN was used as the patient was in pre-anaphylaxis status, Hemodynamics and breath were stable. On 04Jun2021, the outcome of the events was recovered. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162B2.


VAERS ID: 1411855 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Body temperature, Discomfort, Feeling abnormal, Heart rate, Hypoaesthesia, Musculoskeletal discomfort, Oxygen saturation, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dementia (broad), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: blood pressure; Result Unstructured Data: Test Result:normal; Test Date: 20210603; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before Vaccination; normal; Test Date: 20210603; Test Name: pulse; Result Unstructured Data: Test Result:normal; Test Date: 20210603; Test Name: blood oxygen saturation; Result Unstructured Data: Test Result:normal
CDC Split Type: JPPFIZER INC2021652078

Write-up: Numbness in the left half of the body; Paraesthesia in left face(Numbness); Floating feeling; Feelings of weakness; discomfort and floating feeling on the left face centered on the neck had continued; discomfort and floating feeling on the left face centered on the neck had continued; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21111529. The patient was a 43-year and 7-month-old female. Body temperature before vaccination was 36.7 Centigrade. The patient previously received the first single dose of BNT162B2(COMIRNATY, Solution for injection, Lot number Unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. After the first vaccination, the patient had a slight temperature last for a week and vaccination site pain. On 03JUN2021 13:17 (the day of the vaccination), the patient received the second single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date~31AUG2021) via an unspecified route of administration as a single dose for COVID-19 immunization. The course of the event was as follows: On 03JUN2021, about a few minutes after the second vaccination (13:38), the patient was numbness in the left half of the body. But the patient''s blood pressure, pulse, body temperature, and blood oxygen saturation were all normal. About 20 minutes after the vaccination, the numbness in the left half of the body had disappeared. The discomfort and floating feeling on the left face centered on the neck had continued. After the drip, the symptoms were relieved and the floating sensation was also improved. But the numbness on the face was still existing . About two hours after the vaccination, the patient had gone home. The reporting physician classified the event as non-serious and assessed the causality between the event and the BNT162B2 as unassessable. The events were also reported as paraesthesia in left face(Numbness) and feelings of weakness. The outcome of the event numbness in the left half of the body recovered after about 20 minutes. The patient has not recovered from Paraesthesia in left face(Numbness). The patient was recovering from the remaining events. The patient received treatment for all events.


VAERS ID: 1411858 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-03
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Lacunar infarction, Magnetic resonance imaging
SMQs:, Peripheral neuropathy (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Guillain-Barre 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: MRI; Result Unstructured Data: Test Result:lacunar infarction
CDC Split Type: JPPFIZER INC2021652221

Write-up: Lacunar infarction; numbness of left upper extremities and it was difficult to exert force; This is a spontaneous report from a non-contactable pharmacist received via regulatory authority. The patient was an 84-year-old male. It was unknown if the patient received other vaccination within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. On 27May2021 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) intramuscular route of administration for COVID-19 immunization. On 03Jun2021 at 08:30 (8 days after the vaccination), the patient experienced numbness of left upper extremities and it was difficult to exert force from the morning. The patient watched the situation at home, but did not see any improvement in the symptoms and went to see a doctor. MRI was performed and lacunar infarction was diagnosed. The reporter classified the events as serious (hospitalized) and stated the event(s) result in doctor or other healthcare professional office/clinic visit. The outcome of the event was not recovered with drug therapy. Since the vaccination, it was unknown whether the patient has been tested for COVID-19. No follow up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information currently available, a possible contribution of the suspect drug administration to the reported event cannot be excluded, due to a plausible temporal relationship. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1411861 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Auscultation, Body temperature, Bronchospasm, Cough, Rales
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Emphysema; Smoker
Allergies:
Diagnostic Lab Data: Test Name: Auscultation; Result Unstructured Data: Test Result:continuous lung rales; Test Date: 20210603; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021652984

Write-up: Cough; Continuous lung rales; bronchospasm; asthmatic attack; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21111510. The patient was a 75-year and 5-month-old female. Body temperature before vaccination was 36.3 degrees Centigrade. It was unknown whether the patient had 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).Medical history included emphysema,Smoker. On 03Jun2021 at 13:30 (at 75 years old) (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 03Jun2021 at 13:35 (5 minutes after the vaccination), the patient experienced cough, continuous lung rales, bronchospasm and asthmatic attack. The course of the event was as follows: The patient visited the reporting hospital regularly. The patient had emphysema. From 5 minutes after vaccination of COMIRNATY, the patient experienced cough. Because auscultation showed continuous lung rales, inhalation of Intal and intravenous drip of Neophyllin and Solu-Cortef were performed. After 20 minutes, the symptoms improved and the patient returned home. On 03Jun2021 at 14:00 (30 minutes after the vaccination), the outcome of the events were recovered. 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 emphysema due to smoking. The reporting physician commented as follows: Cough occurred frequently from 5 minutes after vaccination of COMIRNATY. Following inhalation and intravenous drip, the patient returned home because the symptoms improved.


VAERS ID: 1411863 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-06-03
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ascites, Computerised tomogram
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hepatic steatosis
Allergies:
Diagnostic Lab Data: Test Date: 20210521; Test Name: CT; Result Unstructured Data: Test Result:no Ascites; Test Date: 20210603; Test Name: CT; Result Unstructured Data: Test Result:Ascites
CDC Split Type: JPPFIZER INC2021653207

Write-up: Ascites; This is a spontaneous report received from a contactable physician via a Pfizer sales representative. An elderly male patient (age reported as above 65 years old) received BNT162B2 (COMIRNATY, Solution for injection), via an unspecified route of administration, on 20May2021 (lot number unknown), at 1st dose, single, for COVID-19 immunisation. Medical history included hepatic steatosis. On 20May2021, the patient received the first single dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number unknown) via an unspecified route of administration for COVID-19 immunisation. On 03Jun2021, the patient had Ascites. The details of the clinical course as following: On 21May2021, the patient went to the neighboring hospital for CT examination. There was no ascites. On 03Jun2021, the patient had ascites, saw a doctor in internal medicine of abdomen. The neighborhood hospital introduction that took CT. The vaccine is not caused, but the cause search is requested to a nearby hospital. The second dose of vaccination is stopped. The outcome of the event was unknown. Seriousness and causality of the events were not provided. The adverse event was occurred after the product was given. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. Based on currently known drug safety profile, the reported event ascites more likely represented intercurrent illness, but not related to BNT162B2.Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.


VAERS ID: 1411864 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Malaise, Pain in extremity, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210603; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021653384

Write-up: wheals on head and front chest; generalised pruritus; malaise; left upper arm pain; This is a spontaneous report from a contactable nurse received from the Agency. Regulatory authority report number is v21111513. The patient was 40-year and 7-month-old male. Body temperature before the vaccinations was 36.2 degrees Centigrade. On 03Jun2021 at 10:20 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 03Jun2021 at 10:29(the same day of the vaccination), the patient experienced wheals, generalized pruritus and malaise. The course of the event was as follows: At 10:20 on 03Jun2021, the patient received the vaccination. At 10:29 on 03Jun2021, the patient experienced wheals on head and front chest, generalized pruritus, malaise and left upper arm pain. At 10:30 on 03Jun2021, the patient received NS 100+Polaramine 1A+ Gaster 1A drip start. At 11:00 on 03Jun2021, pruritus appeared to be improved, although the patient still experienced generalized malaise; pruritus disappeared. NS 50+Solu-Medrol 125mg drip start. At 11:30 on 03Jun2021, div finished, wheals disappeared, no more other new indications appeared. At 11:55 on 03Jun2021, on the company of a colleague, the patient went home. The reporter did not provide seriousness assessment and assessed that the event was related to bnt162b2.


VAERS ID: 1411891 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Food allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021653969

Write-up: Anaphylaxis; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21111675. The patient was a 37-year and 10-month-old female. Body temperature before vaccination was not reported. The patient had allergy to buckwheat noodle. No information on concomitant medications or family history was provided. On 03Jun2021 at 15:18 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY2173, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 03Jun2021 at 15:42 (24 minutes after the vaccination), the patient experienced anaphylaxis. On 03Jun2021 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: On 03Jun2021, while the patient was being observed at the vaccination site (after receiving the vaccination), she complained of dyspnoea. Hot flushes facial and breathing difficulty were noted. Redness from the neck to the anterior chest was noted. At the time of the examination, her vital signs stabilized. The symptoms improved with administration of antihistamine medication. Afterwards, the patient returned home. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1411895 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Cold sweat, Coma scale, Dyspnoea, Heart rate, Hot flush, Hypertension, Oxygen saturation, Respiratory rate
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: BP; Result Unstructured Data: Test Result:178/116 mmHg; Test Date: 20210603; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210603; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Test Date: 20210603; Test Name: JCS; Result Unstructured Data: Test Result:L-1; Test Date: 20210603; Test Name: HR; Result Unstructured Data: Test Result:88; Comments: /min; Test Date: 20210603; Test Name: SPO2; Test Result: 97 %; Comments: (RA); Test Date: 20210603; Test Name: RR; Result Unstructured Data: Test Result:18; Comments: /min
CDC Split Type: JPPFIZER INC2021653990

Write-up: anaphylaxis; Dyspnoea; Cold sweat; hot flushes face neck; BP 178/116mmHg; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21111650. The patient was a 67-year and 3-month-old female. Body temperature before vaccination was 36.4 degrees Centigrade. The patient had no family history. On 03Jun2021 at 11:12 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FA5829, Expiration date 31Aug2021) via an unspecified route of administration at left upper arm at age of 67-year old as a single dose for COVID-19 immunization. On 03Jun2021 at 11:22 (10 minutes after the vaccination), the patient experienced anaphylaxis. On 03Jun2021 (the day of the vaccination), the outcome of the event was recovering. The course of the event was as follows: On 03Jun2021 11:12, the patient was vaccinated the new coronavirus vaccine on the L upper arm. 11:22, the symptoms of dyspnoea and cold sweat appeared, the patient was transported to emergency room of our hospital. Vital signs at the time of accepting patient was JCS L-1, BP 178/116mmHg, HR 88/min, RR 18/min, Body temperature 36.2 Centigrade, SPO2 97%(RA). There was hot flushes face neck. There were no gastrointestinal symptoms. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The outcome of the events was recovering.


VAERS ID: 1411896 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Oxygen saturation, Vital signs measurement
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: blood pressure; Result Unstructured Data: Test Result:93/60 mmHg; Test Date: 20210603; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210603; Test Name: oxygen saturation; Test Result: 93 %; Test Date: 20210603; Test Name: vital signs; Result Unstructured Data: Test Result:no abnormalities
CDC Split Type: JPPFIZER INC2021654021

Write-up: Anaphylaxis; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21111725. A 78-year-old female patient received BNT162B2 (COMIRNATY), 1st dose intramuscularly on 03Jun2021 14:30 (Lot Number: FA5829; Expiration Date: 31Aug2021) at age of 78 years old as a single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Body temperature before the vaccinations was 36.4 degrees Centigrade. 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, etc.). The patient experienced anaphylaxis on 03Jun2021 15:00. The patient was hospitalized for anaphylaxis from 03Jun2021 to 04Jun2021. The outcome of the event was recovered on 03Jun2021. Clinical course: On 03Jun2021 at 15:00 (the day of the vaccinations), the patient suddenly experienced generalized rash and dyspnoea after returning home and called emergency. After arriving at the hospital, the patient experienced progressively spreading generalized redness and wheals, and respiratory distress without wheezing. No gastrointestinal symptoms were observed. Blood pressure 93/60, SpO2 93% (room air) and no abnormalities with vital signs. Based on the above, the patient was diagnosed with anaphylaxis. The patient was treated with Adrenaline intramuscular injection, antihistamines and steroids and the symptoms rapidly improved. On 03Jun2021, the patient was admitted to the hospital. As of 03Jun2021, the outcome of the event was recovered. On 04Jun2021 (1 day after the vaccinations), the patient was discharged from the hospital. The reporter classified the event as serious (hospitalization) and assessed the causality between the event and the vaccines as related and there were no other causative factors. The reporter concluded as follows: not specified.


VAERS ID: 1411899 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Anaphylactic shock, Blood pressure measurement, Body temperature, Hypersensitivity
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: blood pressure; Result Unstructured Data: Test Result:100s; Test Date: 20210603; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021654064

Write-up: Anaphylaxis; Anaphylactic shock; allergic reaction; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21111674. The patient was 28-year-old female. Body temperature before the vaccinations was 36.6 degrees Centigrade. 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, etc.). On an unknown date, the patient received the first dose of bnt162b2 (COMIRNATY, Lot number: EX3617, expiration date: 31Aug2021) for COVID-19 immunisation and experienced extremely mild redness. On 03Jun2021 at 15:00 (the day of vaccinations), the patient received the second dose of BNT162B2 (COMIRNATY Intramuscular injection, Lot number: EY2173, expiration date: 31Aug2021), via an unspecified route of administration at single dose for COVID-19 immunisation. On 03Jun2021 at 15:15 (the day of the vaccinations), the patient experienced cough after vaccination during observation. Allergic reaction was suspected and after vascular route was secured the patient was treated with steroids intravenous injection (15 minutes after vaccination). Immediately after this, the patient experienced depressed level of consciousness. Anaphylactic shock was suspected and the patient was treated with adrenaline intramuscular injection. Consciousness was immediately regained and blood pressure was maintained at 100s. Cough disappeared, the symptoms recovered and the patient returned home. The patient experienced mild skin redness and did not experience gastrointestinal symptoms. Anaphylaxis was reported in source document. The outcome of the event was recovered on 03Jun2021 .The reporter classified the events as non-serious and assessed the causality between the event and the vaccines as related and there were no other causative factors.


VAERS ID: 1411901 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET9096 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Asthma, Body temperature, Cough, Palpitations
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (narrow), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), 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: Test Date: 20210603; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before the vaccinations
CDC Split Type: JPPFIZER INC2021654089

Write-up: Anaphylaxis; cough; palpitations; asthma bronchial; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21111676. The patient was 37-year and 11-month old female. Body temperature before the vaccinations was 36.7 degrees Centigrade. 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, etc.). On 03Jun2021 at 14:00 (the day of vaccinations), the patient received the second dose of BNT162B2(COMIRNATY Intramuscular injection, Lot number: ET9096, expiration date: 31Jul2021). Clinical course of the event was reported as follows: On 03Jun2021 at 14:30 (the day of the vaccinations), 30 minutes after vaccination, the patient experienced palpitations and frequent strong cough. The patient was treated with Adrenaline 0.3mg and solu-cortef 1000mg. Asthma bronchial was considered and Adrenaline 0.5mg. Anaphylaxis was reported. On 03Jun2021, the patient was admitted to the hospital. As of 03Jun2021, the outcome of the event was not recovered. The reporter classified the event as serious (hospitalization) and assessed the causality between the event and the vaccines as related and there were no other causative factors.


VAERS ID: 1411906 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure diastolic decreased, Blood pressure measurement, Body temperature, Chest discomfort, Dyspnoea, Feeling cold, Flushing, Headache, Heart rate, Hypoaesthesia, Hypoaesthesia oral, Nausea, Oropharyngeal discomfort, Oxygen saturation, Tachypnoea, Wheezing
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to legumes; Urticaria
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: Blood pressure; Result Unstructured Data: Test Result:130/87; Comments: 35 minutes after vaccination; Test Date: 20210603; Test Name: Blood pressure; Result Unstructured Data: Test Result:135/48; Comments: 30 minutes after vaccination; Test Date: 20210603; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210603; Test Name: pulse rate; Result Unstructured Data: Test Result:83; Comments: 35 minutes after vaccination,pulse rate 83/min.; Test Date: 20210603; Test Name: pulse rate; Result Unstructured Data: Test Result:84; Comments: 30 minutes after vaccination; Test Date: 20210603; Test Name: SPO2; Test Result: 99 %; Comments: 30 minutes after vaccination
CDC Split Type: JPPFIZER INC2021654186

Write-up: flushed face; wheezing inspiratory; tachypnoea; mild dyspnoea; Anaphylaxis; feeling queasy; pharyngeal~chest discomfort/ Pharynx strange sensation of; pharyngeal~chest discomfort; numbness of lips and limbs; numbness of lips and limbs; headache; feeling cold on fingertips; BP 135/48; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21111523. A 22-years-old female patient received the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 03Jun2021 10:40 (Lot Number: FA4597; Expiration Date: 31Aug2021) at the age of 22 years as 1st dose, single for covid-19 immunisation. Medical history included urticaria caused by pineapple and kiwi, allergy to peas, but not severe. The patient''s concomitant medications were not reported. The patient was a 22-year and 10-month-old female. Body temperature before vaccination was 36.2 degrees Centigrade. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included as follows: There had been a history of urticaria caused by pineapple and kiwi. Allergy to peas, but not severe. On 03Jun2021 at 10:40 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 03Jun2021 at 11:10 (30 minutes after the vaccination), the patient experienced anaphylaxis. On unknown day (the source not provided), the outcome of the event was recovered. The course of the event was as follows: Not long after vaccination, complained about "feeling queasy" (pharyngeal~chest discomfort). 30 minutes after vaccination, complained that numbness of lips and limbs, headache, feeling cold on fingertips.SPO2 99%,BP 135/48,PR 84. 35 minutes after vaccination, flushed face, wheezing inspiratory and tachypnoea appeared. Pharynx strange sensation of to mild dyspnoea appeared in sequence. Blood pressure 130/87, pulse rate 83/min. After 45 minutes, EPIPEN 0.3 mg was injected into the vastus lateralis of the right thigh. Because of emergency transported, although the details are not clear, the symptoms were slowly recovering. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2.There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Although it did not fully comply with the international standards of anaphylaxis, the initial symptoms of anaphylaxis appeared one after another. With the administration of EPIPEN, the progress was prevented and the symptoms were recovering, so it was reported as anaphylaxis. Outcome of events was recovered.


VAERS ID: 1411907 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Body temperature
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (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: Bronchial asthma; Diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021654197

Write-up: Asthmatic attack; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21111582. The patient was a 95-year and 7-month-old female. Body temperature before vaccination was 36.5 degrees Centigrade. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included diabetes mellitus, asthma bronchial. On 03Jun2021 at 14:25 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 03Jun2021 at unknown time (the source not provided), the patient experienced asthmatic attack. On 03Jun2021 (the same day of the vaccination), the outcome of the event was recovered. The course of the event was as follows: 15 minutes after vaccination, complained of head and neck discomfort, wheezing, and muscle injection with Adrenaline. Symptom improved by Aminophylline intravenous drip. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1411915 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-03
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Nausea, Oropharyngeal discomfort
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Urticaria chronic
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021654899

Write-up: Queasy; Pharynx strange sensation of; Cough; This is a spontaneous report from a non-contactable Other Health Professional received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). An adult female patient received the single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) at age of 27-year-old on an unspecified date for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Other medical history included urticaria chronic. The patient''s concomitant medications were not reported. On 03Jun2021, the patient the patient experienced queasy, pharynx strange sensation of, cough. The reporter classified the events as serious (Hospitalized) and stated the events result in hospitalization for 2 days in Jun2021. The outcome of the events was resolved in Jun2021 with treatment including adrenalin autoinjector (EPIPEN). Since the vaccination, the patient has not been tested for COVID-19. No follow up attempts are possible. No further information is expected.; Sender''s Comments: There is a reasonable possibility that the event queasy was related to BNT162b2 based on known drug safety profile. The association between the other events pharynx strange sensation of and cough with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


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