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From the 9/10/2021 release of VAERS data:

Found 686,636 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 344 out of 6,867

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VAERS ID: 1688647 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-07-14
Onset:2021-07-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: 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: Desvenlafaxine Succinate ER 50mg
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Arm pain that is not the same as the injection site soreness. Arm pain starts in upper arm and runs down to the hand.


VAERS ID: 1481677 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: School       Purchased by: ?
Symptoms: Eye pruritus, Night blindness, Ocular hyperaemia, Vision blurred
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

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

Write-up: Left eye: blurry vision. Noticeably impaired night vision. Less ability to focus on objects with left eye. Both eyes: redness, itchiness


VAERS ID: 1483752 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Erythema, Fatigue, Headache, Muscular weakness, Peripheral swelling, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Escitalopram 10 Eutirox 10
Current Illness:
Preexisting Conditions: Hypotyreose
Allergies: Lactose, fructose
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever (all day and night long, 39?C), headache, upper back pain, a big red and swelled spot at my left arm, weakness in legs and arms, fatigue.


VAERS ID: 1485430 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA9099 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain, Disturbance in attention, Dyspnoea, Headache, Nausea, Pyrexia, Sleep disorder
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: 11am: Felt myself waking up with a fever and had Dyspnea (unexpected). Could not formulate coherent thoughts (unexpected) but no headache (expected). By 9pm I developed nausea (expected). Then the Dyspnea succumbed to a level that I could sleep. This whole time, even the slightest movement caused me to need to hyperventilate to sate this Dyspnea. I woke up the next day with the same level of nausea but no Dyspnea. Every time I moved around the slightest I had abdominal pain. (expected from fever). Then made a full recovery by 2pm that day.


VAERS ID: 1486519 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       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: GBMODERNATX, INC.MOD20212

Write-up: Fainting; This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Fainting) in a 22-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. No Medical History information was reported. On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant). On 17-Jul-2021, SYNCOPE (Fainting) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. 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: 1486520 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anxiety, 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: Medical History/Concurrent Conditions: Anxiety; Syncope
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Anxiety; Syncope; This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Syncope) in a 22-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Anxiety and Syncope. On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant). On an unknown date, the patient experienced ANXIETY (Anxiety). On 17-Jul-2021, SYNCOPE (Syncope) had resolved. At the time of the report, ANXIETY (Anxiety) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. 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: 1488434 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse drug reaction
SMQs:

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

Write-up: Red mark on arm but not around injection site. It is like a bruise/ Jolting pain in forearm below injection site; This regulatory authority case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Red mark on arm but not around injection site. It is like a bruise/ Jolting pain in forearm below injection site) in a 21-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for Ill-defined disorder. No medical history was provided. On 15-Jul-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced ADVERSE DRUG REACTION (Red mark on arm but not around injection site. It is like a bruise/ Jolting pain in forearm below injection site) (seriousness criterion medically significant). At the time of the report, ADVERSE DRUG REACTION (Red mark on arm but not around injection site. It is like a bruise/ Jolting pain in forearm below injection site) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The concomitant medications were not reported. The 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 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: 1488598 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Sore throat; Fever chills; Headache; This regulatory authority case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Fever chills) and HEADACHE (Headache) in a 32-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 on 17-Jul-2021. On 16-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Fever chills) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. This case concerns a 32-year-old male with a serious unexpected event of oropharyngeal pain, pyrexia and headache. Event latency 1 day after second 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.; Sender''s Comments: This case concerns a 32-year-old male with a serious unexpected event of oropharyngeal pain, pyrexia and headache. Event latency 1 day after second 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: 1488602 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       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: GBMODERNATX, INC.MOD20212

Write-up: Syncope; This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Syncope) in a 42-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. No Medical History information was reported. On 17-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant). On 17-Jul-2021, SYNCOPE (Syncope) had resolved. There was no concomitant medication reported. There was no treatment medication reported. Reported information included, patient had not tested positive for COVID-19. 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: 1488605 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Coagulation test, Fibrin D dimer, Malaise, Platelet count, Syncope, Thrombocytopenia, Wound haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (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: Medical History/Concurrent Conditions: Head injury; Non-smoker; Trauma (Patient has had a recent trauma/head injury); Comments: Patient is usually fit and well No regular medication Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: Coagulation test; Result Unstructured Data: normal; Test Name: Fibrin D dimer; Test Result: Inconclusive ; Result Unstructured Data: D-dimer of 668; Test Name: platelet count; Test Result: Inconclusive ; Result Unstructured Data: Bloods identified thrombocytopenia platelet count 128
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: platelet count <150 x 109/L; collapse episode; head wound; generally unwell; Thrombocytopenia; This regulatory authority case was reported by an other health care professional and describes the occurrence of THROMBOCYTOPENIA (platelet count <150 x 109/L), THROMBOCYTOPENIA (Thrombocytopenia) and SYNCOPE (collapse episode) in a 38-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Patient is usually fit and well No regular medication Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. The patient''s past medical history included Head injury, Non-smoker and Trauma (Patient has had a recent trauma/head injury). Previously administered products included for an unreported indication: HEPARIN. On 16-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced THROMBOCYTOPENIA (Thrombocytopenia) (seriousness criterion medically significant). On an unknown date, the patient experienced THROMBOCYTOPENIA (platelet count <150 x 109/L) (seriousness criterion medically significant), SYNCOPE (collapse episode) (seriousness criterion medically significant), WOUND HAEMORRHAGE (head wound) and MALAISE (generally unwell). At the time of the report, THROMBOCYTOPENIA (platelet count <150 x 109/L), SYNCOPE (collapse episode), WOUND HAEMORRHAGE (head wound) and MALAISE (generally unwell) outcome was unknown and THROMBOCYTOPENIA (Thrombocytopenia) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jul-2021, Coagulation test: normal (normal) normal. On an unknown date, Fibrin D dimer: d-dimer was not $g4000 (Inconclusive) D-dimer of 668. On an unknown date, Platelet count: 128 (Inconclusive) Bloods identified thrombocytopenia platelet count 128. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was mentioned. No treatment medication information was mentioned. 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: 1488606 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Postmenopausal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: post menaupausal bleeding; Felt faint; This regulatory authority case was reported by an other health care professional and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (post menaupausal bleeding) in a 19-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced DIZZINESS (Felt faint). On an unknown date, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (post menaupausal bleeding) (seriousness criterion medically significant). On 17-Jul-2021, DIZZINESS (Felt faint) had resolved. At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (post menaupausal bleeding) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment information were not provided by reporter. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. The events were captured as reported by the Authority despite this appearing to be incorrect as the patient was a young male supposedly suffering from postmenopausal bleeding. Based on this information, a causal relationship cannot be established.; Sender''s Comments: The events were captured as reported by the Authority despite this appearing to be incorrect as the patient was a young male supposedly suffering from postmenopausal bleeding. Based on this information, a causal relationship cannot be established.


VAERS ID: 1488607 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Loss of consciousness, Presyncope
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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: passed out; feeling faint; Near fainting; This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) and PRESYNCOPE (Near fainting) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. On 16-Jul-2021 at 7:00 PM, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced PRESYNCOPE (Near fainting) (seriousness criterion medically significant). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant) and DIZZINESS (feeling faint). At the time of the report, LOSS OF CONSCIOUSNESS (passed out) and DIZZINESS (feeling faint) outcome was unknown and PRESYNCOPE (Near fainting) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant products were not provided. Treatment medication were not reported. Patient has not tested positive for COVID-19 since having the vaccine 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: 1488611 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Hemiplegia, Lip swelling, Malaise, Paralysis, Pyrexia, SARS-CoV-2 test, Syncope, Temperature intolerance
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (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 Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Anaphylaxis; Paralysis; Heat radiating; Felt sick; Spiking temperature; Swollen lips; Right sided paralysis; Faint; This regulatory authority case was reported by an other health care professional and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis), PARALYSIS (Paralysis), HEMIPLEGIA (Right sided paralysis), SYNCOPE (Faint), TEMPERATURE INTOLERANCE (Heat radiating), LIP SWELLING (Swollen lips), MALAISE (Felt sick) and PYREXIA (Spiking temperature) in a 29-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced HEMIPLEGIA (Right sided paralysis) (seriousness criterion medically significant), SYNCOPE (Faint) (seriousness criterion medically significant), LIP SWELLING (Swollen lips) (seriousness criterion medically significant) and PYREXIA (Spiking temperature) (seriousness criterion medically significant). On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant), PARALYSIS (Paralysis) (seriousness criterion medically significant), TEMPERATURE INTOLERANCE (Heat radiating) (seriousness criterion medically significant) and MALAISE (Felt sick) (seriousness criterion medically significant). The patient was treated with ADRENALINE [EPINEPHRINE] (intramuscular) at a dose of 0.5ml 1 in 1000 and OXYGEN at an unspecified dose and frequency. On 17-Jul-2021, HEMIPLEGIA (Right sided paralysis) was resolving, SYNCOPE (Faint) and LIP SWELLING (Swollen lips) had resolved. At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis), PARALYSIS (Paralysis), TEMPERATURE INTOLERANCE (Heat radiating), MALAISE (Felt sick) and PYREXIA (Spiking temperature) 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. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. The patient received his 1st Moderna vaccine, and suffered anaphylaxis within 2 minutes. The patient fainted. His lips started to swell, he said he felt heat radiating down his body, felt right side paralysis, and he had felt sick.. Adrenaline 0.5ml 1 in 1000 given Intramuscular (IM) and oxygen given and ambulance was called. Patient had not tested positive for COVID-19 since having the vaccine. Patient was 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: 1488614 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hallucination, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (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: 20210717; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Hallucinating; This regulatory authority case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinating) in a 20-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 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced HALLUCINATION (Hallucinating) (seriousness criterion medically significant). At the time of the report, HALLUCINATION (Hallucinating) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided by the reporter. Treatment information was not provided. Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.; Sender''s Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.


VAERS ID: 1488615 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abnormal dreams, Chills, Fatigue, Hallucination, Lethargy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: Food intolerance NOS; Irritable bowel syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Hallucinations; Lethargic; Distressing dreams; Chills; Fever chills; Fatigue; This regulatory authority case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinations) in a 36-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Irritable bowel syndrome and Food intolerance NOS. On 17-Jul-2021 at 9:00 AM, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced PYREXIA (Fever chills). 17-Jul-2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced HALLUCINATION (Hallucinations) (seriousness criterion medically significant), LETHARGY (Lethargic), ABNORMAL DREAMS (Distressing dreams) and CHILLS (Chills). At the time of the report, HALLUCINATION (Hallucinations), LETHARGY (Lethargic), ABNORMAL DREAMS (Distressing dreams) and CHILLS (Chills) outcome was unknown and PYREXIA (Fever chills) and FATIGUE (Fatigue) was resolving. Concomitant product use was not provided by the reporter. Patient had extremely strange dreams and difficulty standing up. At 3 am patient started to normalize. 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: 1488620 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Myalgia, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No medical history was reported.
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: muscle aches; Headache; Fever; Painful arm; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm), MYALGIA (muscle aches), HEADACHE (Headache) and PYREXIA (Fever) in a 39-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced PAIN IN EXTREMITY (Painful arm). On 18-Jul-2021, the patient experienced HEADACHE (Headache) and PYREXIA (Fever). On an unknown date, the patient experienced MYALGIA (muscle aches). On 19-Jul-2021, HEADACHE (Headache) and PYREXIA (Fever) had resolved. At the time of the report, PAIN IN EXTREMITY (Painful arm) was resolving and MYALGIA (muscle aches) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. No concomitant medication reported. No Treatment medication reported; 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: 1489296 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-17
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Headache, Nausea, Pericarditis
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: Severe Headache and nausea from day 2 to 7 and then on sat 18-7-21 Pericarditis


VAERS ID: 1489928 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Gastrooesophageal reflux disease, Headache, Lethargy, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: 20210718; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Esophageal reflux; Lethargy; Headache; Vomiting; This regulatory authority case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (Esophageal reflux), LETHARGY (Lethargy), HEADACHE (Headache) and VOMITING (Vomiting) in a 40-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Jul-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Esophageal reflux) (seriousness criterion medically significant), LETHARGY (Lethargy) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and VOMITING (Vomiting) (seriousness criterion medically significant). At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (Esophageal reflux), LETHARGY (Lethargy) and HEADACHE (Headache) had not resolved and VOMITING (Vomiting) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Relevant concomitant medications were not provided. Treatment information 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 events, a causal relationship cannot be excluded. Events seriousness was captured as per Regulatory Authority assessment in Source Document.; 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. Events seriousness was captured as per Regulatory Authority assessment in Source Document.


VAERS ID: 1489979 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002621 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Myalgia, Nausea, SARS-CoV-2 test, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (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: CO-CODAMOL
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: This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Exhaustion), MYALGIA (muscle soreness), NAUSEA (Nausea), HEADACHE (Headache) and MYALGIA (Muscle ache) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002621) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. Concomitant products included CODEINE PHOSPHATE, PARACETAMOL (CO-CODAMOL) from 30-Jun-2021 to an unknown date for Back pain. On 16-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced FATIGUE (Exhaustion) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and VACCINATION SITE PAIN (soreness at the vaccination site). On an unknown date, the patient experienced MYALGIA (muscle soreness) (seriousness criterion medically significant). At the time of the report, FATIGUE (Exhaustion), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (Muscle ache) and VACCINATION SITE PAIN (soreness at the vaccination site) had not resolved and MYALGIA (muscle soreness) 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 Route) was unknown. Treatment medication information was not provided. Around 18 hours after vaccine soreness at vaccination site started, followed muscle soreness over the whole body and around 3 hours later nausea and loss of appetite began and 24 hours after vaccine exhaustion set in and was unable to stay awake. Patient was resting and drinking plenty of fluids. Symptoms likened with past post op experience after waking up from anesthesia. 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: 1489986 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Headache, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Headache; Aching joints; Rash; This regulatory authority case was reported by a consumer and describes the occurrence of RASH (Rash), HEADACHE (Headache) and ARTHRALGIA (Aching joints) in a 24-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. On 17-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and ARTHRALGIA (Aching joints) (seriousness criterion medically significant). At the time of the report, RASH (Rash), HEADACHE (Headache) and ARTHRALGIA (Aching joints) had not resolved. The concomitant medication was not reported. The treatment information was not reported. Patient has not tested positive for COVID-19 hence having the vaccine. Patient was not enrolled in clinical trial. 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: 1489990 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache, Hypoaesthesia, Nausea, Pain in extremity, Pyrexia, Rash, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

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

Write-up: Numbness; Rash; Vomiting; Fever; Nausea; Headache; Tiredness; Aching joints; Aching in limb; Diarrhea; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Aching in limb), DIARRHOEA (Diarrhea), HYPOAESTHESIA (Numbness), RASH (Rash), ARTHRALGIA (Aching joints), VOMITING (Vomiting), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 from 22-Mar-2020 to 20-Dec-2020. On 17-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced PAIN IN EXTREMITY (Aching in limb) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) (seriousness criterion medically significant), ARTHRALGIA (Aching joints) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 18-Jul-2021, the patient experienced HYPOAESTHESIA (Numbness) (seriousness criterion medically significant), RASH (Rash) (seriousness criterion medically significant) and VOMITING (Vomiting) (seriousness criterion medically significant). On 18-Jul-2021, DIARRHOEA (Diarrhea) and HYPOAESTHESIA (Numbness) had resolved, VOMITING (Vomiting) was resolving. At the time of the report, PAIN IN EXTREMITY (Aching in limb), RASH (Rash), ARTHRALGIA (Aching joints), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Tiredness) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. The numbness was pins and needs in patient arm that was jabbed. No treatment information was provided. Not had a COVID-19 test . 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: 1491469 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-07-17
   Days after vaccination:60
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Injection site pain, Insomnia, Nasal congestion, Pain, SARS-CoV-2 test
SMQs:, Extravasation events (injections, infusions and implants) (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19. No Medical History information was reported.
Allergies:
Diagnostic Lab Data: Test Date: 20210711; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: pain; difficulty sleeping; headache; Fatigue; Headache dull; Nasal stuffiness; Injection site pain; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (pain), INSOMNIA (difficulty sleeping), NASAL CONGESTION (Nasal stuffiness), INJECTION SITE PAIN (Injection site pain), HEADACHE (headache), FATIGUE (Fatigue) and HEADACHE (Headache dull) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19. No Medical History information was reported. . On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jul-2021, the patient experienced INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant). On 18-Jul-2021, the patient experienced NASAL CONGESTION (Nasal stuffiness) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and HEADACHE (Headache dull) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (pain) (seriousness criterion medically significant), INSOMNIA (difficulty sleeping) (seriousness criterion medically significant) and HEADACHE (headache) (seriousness criterion medically significant). The patient was treated with PARACETAMOL on 18-Jul-2021 for Injection site pain, at a dose of 1 dosage form. On 18-Jul-2021, NASAL CONGESTION (Nasal stuffiness) had resolved. At the time of the report, PAIN (pain), INSOMNIA (difficulty sleeping), INJECTION SITE PAIN (Injection site pain) and HEADACHE (headache) had not resolved and FATIGUE (Fatigue) and HEADACHE (Headache dull) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jul-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 reported. No information regarding corrective treatment was reported by the patient. 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: 1491657 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-07-17
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER ABX3120 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Erythema, Face oedema, Rash erythematous, Rash pruritic
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: Coversyl 4mg daily
Current Illness: none
Preexisting Conditions: hypertension, type 2 diabetes diet controlled
Allergies: none
Diagnostic Lab Data: CBC pending
CDC Split Type:

Write-up: Received the 2nd dose of Astrazeneca Covishield on June 22. On Day 25 post vaccine (July 17), he awoke with a palpable, itchy, erythematous rash on the anterior part of his neck. Later on that day the rash progressed to his chest, bilateral arms and legs but spared his back and trunk. He shortly developed facial edema especially around his eyes. He did not feel short of breath or have any throat symptoms. He presented to my clinic on July 20 with patchy, faint erythema of the volar aspect of his arms and chest. His edema and itch had resolved by that time and he felt and appeared well.


VAERS ID: 1492187 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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; Comments: No concomitant medication was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Flu-like aching; Tiredness; Drowsy; This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like aching) and FATIGUE (Tiredness) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No concomitant medication was reported. The patient''s past medical history included Lactation decreased. On 16-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like aching) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and SOMNOLENCE (Drowsy). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like aching), FATIGUE (Tiredness) and SOMNOLENCE (Drowsy) had not resolved. It was reported that patient slept for most of the afternoon due to being excessively tired/drowsy Patient was not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. Treatment information was not provided. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Not applicable) was Not applicable. 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. 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. No further information is expected at this time.


VAERS ID: 1492198 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NK / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Pancreatitis
SMQs:, Acute pancreatitis (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: Acute mid abdominal pain; Pancreatitis; This regulatory authority case was reported by a consumer and describes the occurrence of PANCREATITIS (Pancreatitis) in a 46-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. NK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced PANCREATITIS (Pancreatitis) (seriousness criterion medically significant). On an unknown date, the patient experienced ABDOMINAL PAIN (Acute mid abdominal pain). At the time of the report, PANCREATITIS (Pancreatitis) had resolved with sequelae and ABDOMINAL PAIN (Acute mid abdominal pain) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product was not provided by the reporter. Patient reported that she experienced stitch like sensation within 30 hours, a few hours later had acute mild abdominal pain, and this lasted for 6-8 hours. Treatment information was not provided For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), 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: 1492204 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diabetes mellitus inadequate control, Foetal heart rate, Heart rate, Maternal exposure during pregnancy
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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: FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Miscarriage
Allergies:
Diagnostic Lab Data: Test Name: Fetal heart rate; Result Unstructured Data: high; Test Date: 20210717; Test Name: Heart rate; Result Unstructured Data: high
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: needed 2l of fluids to stabilise heart rates; Maternal exposure during pregnancy; This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of DIABETES MELLITUS INADEQUATE CONTROL (needed 2l of fluids to stabilise heart rates) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 34-year-old female patient (gravida 2) who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Miscarriage. Concurrent medical conditions included Pregnancy. Concomitant products included FOLIC ACID for Folic acid supplementation. On 17-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 17-Jul-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced DIABETES MELLITUS INADEQUATE CONTROL (needed 2l of fluids to stabilise heart rates) (seriousness criteria hospitalization and medically significant). On 17-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, DIABETES MELLITUS INADEQUATE CONTROL (needed 2l of fluids to stabilise heart rates) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jul-2021, Heart rate: high (High) high. On an unknown date, Foetal heart rate: high (High) high. Patient was exposed to vaccine in the third-trimester (29-40 weeks). She was admitted to the hospital with high heart rate and high fetal heart rate. She did not have symptoms associated with COVID-19 and had not tested positive for COVID-19 since having the vaccine. Treatment information was not provided. Very limited information regarding this event has been provided at this time. No further information is expected. It was reported that the patient was admitted to the hospital with high heart rate and high fetal heart rate and needed 2l of fluids to stabilise heart rates. Company causality for Diabetes mellitus inadequate control is assessed as possible, while company causality for Maternal exposure during pregnancy is not applicable.; Sender''s Comments: This is a case of product exposure during pregnancy with associated event Diabetes mellitus inadequate control. Very limited information regarding this event has been provided at this time. No further information is expected. It was reported that the patient was admitted to the hospital with high heart rate and high fetal heart rate and needed 2l of fluids to stabilise heart rates. Company causality for Diabetes mellitus inadequate control is assessed as possible, while company causality for Maternal exposure during pregnancy is not applicable.


VAERS ID: 1492206 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Pain in extremity, Palpitations, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (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: DIAZEPAM; IBUPROFEN; NITROFURAZON; PIRITON; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20201204; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Stomachache; Aches & pains in legs; Heart racing; Palpitations; This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomachache), PALPITATIONS (Palpitations), PAIN IN EXTREMITY (Aches & pains in legs) and PALPITATIONS (Heart racing) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 01-Dec-2020. Concomitant products included IBUPROFEN from 10-Jul-2021 to 16-Jul-2021 and NITROFURAL (NITROFURAZON) from 10-Jul-2021 to 16-Jul-2021 for Kidney pain, DIAZEPAM from 10-Jul-2021 to an unknown date, CHLORPHENAMINE MALEATE (PIRITON) from 01-Jan-2018 to an unknown date and PARACETAMOL from 01-Jan-2018 to an unknown date for an unknown indication. On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced PALPITATIONS (Palpitations) (seriousness criteria disability and medically significant) and PALPITATIONS (Heart racing) (seriousness criteria disability and medically significant). On 18-Jul-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomachache) (seriousness criteria disability and medically significant) and PAIN IN EXTREMITY (Aches & pains in legs) (seriousness criteria disability and medically significant). At the time of the report, ABDOMINAL PAIN UPPER (Stomachache), PALPITATIONS (Palpitations), PAIN IN EXTREMITY (Aches & pains in legs) and PALPITATIONS (Heart racing) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No treatment drug 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: 1492209 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Myalgia, Nausea, Pain, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (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? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: 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: Fatigue; Muscle ache; ached all over; nauseous; This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and MYALGIA (Muscle ache) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. Previously administered products included for an unreported indication: CO-CODAMOL. On 16-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion disability) and MYALGIA (Muscle ache) (seriousness criterion disability). 17-Jul-2021, the patient experienced PAIN (ached all over) and NAUSEA (nauseous). The patient was treated with CODEINE PHOSPHATE HEMIHYDRATE, PARACETAMOL (COCODAMOL) for Adverse event, at an unspecified dose and frequency. On 18-Jul-2021, FATIGUE (Fatigue), MYALGIA (Muscle ache), PAIN (ached all over) and NAUSEA (nauseous) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. Concomitant products 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.; 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: 1492211 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-07-17
   Days after vaccination:63
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Dizziness, Fatigue, Pain in extremity, Productive cough, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (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), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? 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: Cough; Phlegm; Light-headed; Pain in arm; Fatigue; Fever; This regulatory authority case was reported by a consumer and describes the occurrence of COUGH (Cough), PRODUCTIVE COUGH (Phlegm), DIZZINESS (Light-headed), PAIN IN EXTREMITY (Pain in arm), FATIGUE (Fatigue) and PYREXIA (Fever) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3002332 and 3003607) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jul-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 18-Jul-2021, the patient experienced COUGH (Cough) (seriousness criterion medically significant), PRODUCTIVE COUGH (Phlegm) (seriousness criterion medically significant) and DIZZINESS (Light-headed) (seriousness criterion medically significant). On 19-Jul-2021, PYREXIA (Fever) had resolved. At the time of the report, COUGH (Cough) and PRODUCTIVE COUGH (Phlegm) had not resolved and DIZZINESS (Light-headed), PAIN IN EXTREMITY (Pain in arm) 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) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was 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: 1493317 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Maternal exposure during breast feeding, Myalgia, Paraesthesia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Neonatal exposures via breast milk (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Maternal exposure during breast feeding; Tingling sensation; Muscle ache; Chills; Fatigue; This regulatory authority case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation), MYALGIA (Muscle ache), CHILLS (Chills), FATIGUE (Fatigue) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. Concurrent medical conditions included Breast feeding. On 16-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced PARAESTHESIA (Tingling sensation) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant). At the time of the report, PARAESTHESIA (Tingling sensation), MYALGIA (Muscle ache), CHILLS (Chills) and FATIGUE (Fatigue) had not resolved and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Company Comment: This is a case of Maternal exposure during breastfeeding with associated AE of chills, myalgia, paraesthesia and fatigue. 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. Events seriousness was captured as per RA assessment provided on Source Document. This case was linked to MOD-2021-261532. See case MOD-2021-261532 for details regarding the child case.; Sender''s Comments: This is a case of Maternal exposure during breastfeeding with associated AE of chills, myalgia, paraesthesia and fatigue.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. Events seriousness was captured as per RA assessment provided on Source Document.


VAERS ID: 1493321 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant; Lactation decreased; Suspected COVID-19 (Unsure when symptoms stopped.)
Allergies:
Diagnostic Lab Data: Test Date: 20201211; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Painful arm; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm) in a 27-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, Suspected COVID-19 (Unsure when symptoms stopped.) on 08-Dec-2020 and Clinical trial participant. On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Painful arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. 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 event, a causal relationship cannot be excluded. Event seriousness was captured as per Regulatory Authority assessment; 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. Event seriousness was captured as per Regulatory Authority assessment.


VAERS ID: 1493516 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER 1821287 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRJNJFOC20210740912

Write-up: ANAPHYLAXIS; This spontaneous report received from a patient concerned a male of unspecified age of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821287, expiry: UNKNOWN) dose was not reported, 1 total administered on 16-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. The patient reported he had an allergic reaction on 17-JUL-2021 early morning, anaphylaxis, with very swollen face and lips, and strong itchiness in the back, which turned very red and with bruises. He reported going to the hospital The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anaphylaxis was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210740912-COVID-19 VACCINE AD26.COV2.S-ANAPHYLAXIS. This event is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1496359 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: 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: Fever; Nausea; Fainting; This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting), PYREXIA (Fever) and NAUSEA (Nausea) in a 41-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 MENOTROPHIN (MENOPUR) from 14-Jul-2021 to an unknown date for Pregnancy. On 17-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 17-Jul-2021, SYNCOPE (Fainting) was resolving. At the time of the report, PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown. 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. Patient reported Fever, slight nausea, and extreme fainting spell with shakes. She also could not stand up. 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: 1496368 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-07-17
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Dysmenorrhoea, Muscle spasms
SMQs:, Retroperitoneal fibrosis (broad), Dystonia (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; Comments: Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant,Patient is not currently breastfeeding.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: cramping; Low back pain; Pain menstrual; This regulatory authority case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (cramping), BACK PAIN (Low back pain) and DYSMENORRHOEA (Pain menstrual) in a 31-year-old female 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 pregnant,Patient is not currently breastfeeding. The patient''s past medical history included Lactation decreased. On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced DYSMENORRHOEA (Pain menstrual) (seriousness criterion medically significant). On an unknown date, the patient experienced MUSCLE SPASMS (cramping) (seriousness criterion medically significant) and BACK PAIN (Low back pain) (seriousness criterion medically significant). At the time of the report, MUSCLE SPASMS (cramping) and BACK PAIN (Low back pain) outcome was unknown and DYSMENORRHOEA (Pain menstrual) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication were provided. Patient was took pain relief and using heat pack to reduce. Patient has not tested positive for COVID-19 test. No treatment information was 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: 1496371 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood test, Chest pain, Electrocardiogram, Hyperhidrosis, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypoglycaemia (broad), COVID-19 (broad)

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

Write-up: sweating; Chest pain; This regulatory authority case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating) and CHEST PAIN (Chest pain) in a 36-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERHIDROSIS (sweating) (seriousness criterion medically significant). On 17-Jul-2021, CHEST PAIN (Chest pain) had resolved. At the time of the report, HYPERHIDROSIS (sweating) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: unknown Unknown. On an unknown date, Electrocardiogram: unknown Unknown. 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 concomitant medication reported. No 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: 1496372 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002621 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Cold sweat, Dehydration, Dizziness, Eye pain, Fatigue, Feeling of body temperature change, Headache, Hyperhidrosis, Influenza, Injection site pain, Musculoskeletal stiffness, Myalgia, Nausea, Pain, Pyrexia, SARS-CoV-2 test, Sensitive skin, Syncope, Tenderness
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ARIPIPRAZOLE; DIAZEPAM; MIRTAZAPINE
Current Illness: Anxiety; Depression
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210214; 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: Sweaty; Swaying; Clammy; Head hurt; Flu; Going to pass out; Dehydrated; Too hot, too cold; Injection site pain; Injection site pain; Stiffness; Sensitive skin; Tenderness; Sweating; Pain; Headache; Fever; Chills; Muscle ache; Tiredness; Joint ache; Nausea; This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Going to pass out) in a 28-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002621) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ARIPIPRAZOLE from 07-Mar-2021 to an unknown date for Anxiety, DIAZEPAM from 05-Mar-2021 to an unknown date for Anxious mood, MIRTAZAPINE from 05-May-2020 to an unknown date for Depression. On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness), SENSITIVE SKIN (Sensitive skin), TENDERNESS (Tenderness), HYPERHIDROSIS (Sweating), PAIN (Pain), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle ache), FATIGUE (Tiredness), ARTHRALGIA (Joint ache) and NAUSEA (Nausea). On an unknown date, the patient experienced COLD SWEAT (Clammy), EYE PAIN (Head hurt), INFLUENZA (Flu), HYPERHIDROSIS (Sweaty), DIZZINESS (Swaying), DEHYDRATION (Dehydrated), SYNCOPE (Going to pass out) (seriousness criterion medically significant), FEELING OF BODY TEMPERATURE CHANGE (Too hot, too cold) and INJECTION SITE PAIN (Injection site pain). At the time of the report, COLD SWEAT (Clammy), EYE PAIN (Head hurt), INFLUENZA (Flu), HYPERHIDROSIS (Sweaty), and DIZZINESS (Swaying) was resolving, MUSCULOSKELETAL STIFFNESS (Stiffness), SENSITIVE SKIN (Sensitive skin), TENDERNESS (Tenderness), HYPERHIDROSIS (Sweating), PAIN (Pain), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle ache), FATIGUE (Tiredness), ARTHRALGIA (Joint ache) and NAUSEA (Nausea) had not resolved and DEHYDRATION (Dehydrated), SYNCOPE (Going to pass out), FEELING OF BODY TEMPERATURE CHANGE (Too hot, too cold) and INJECTION SITE PAIN (Injection site pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-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. Patient not had symptoms associated with COVID-19. Patient not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment medication was provided by the reporter.; 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. Events seriousness were captured as per Regulatory Authority assessment in Source Document.


VAERS ID: 1496376 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Pain in extremity
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Pain in arm; Wooziness; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and DIZZINESS (Wooziness) in a 39-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 16-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant) and DIZZINESS (Wooziness) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Pain in arm) and DIZZINESS (Wooziness) had not resolved. No treatment drug information provided. No concomitant drug information provided.; 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: 1496380 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Contusion, Ear pain, Fatigue, Headache, Insomnia, Migraine, Nasopharyngitis, Pain, Pain in extremity, Puncture site bruise, Puncture site pain, Pyrexia, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CONCERTA; ESOMEPRAZOLE; FEXOFENADINE; METRONIDAZOLE; PREGABALIN; TETRACYCLINE; ZOMIG
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20200504; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Tested negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Bruise; Cold; Arm pain; Body aches; Also didn''t sleep very well; Fever; Ear pain; Puncture site bruise; Puncture site pain; Weakness; Fatigue; Migraine; Headache; This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), EAR PAIN (Ear pain), PUNCTURE SITE BRUISE (Puncture site bruise), PUNCTURE SITE PAIN (Puncture site pain), CONTUSION (Bruise), NASOPHARYNGITIS (Cold), PAIN IN EXTREMITY (Arm pain), PAIN (Body aches), ASTHENIA (Weakness), FATIGUE (Fatigue), MIGRAINE (Migraine) and HEADACHE (Headache) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. Concomitant products included METHYLPHENIDATE HYDROCHLORIDE (CONCERTA) from 04-Aug-2019 to an unknown date for ADHD, predominantly inattentive type, ESOMEPRAZOLE from 01-Jun-2021 to an unknown date for GERD, METRONIDAZOLE from 01-Jul-2021 to 07-Jul-2021 and TETRACYCLINE from 08-Jul-2021 to an unknown date for Gastritis, FEXOFENADINE from 01-Jan-2017 to an unknown date for Hay fever, ZOLMITRIPTAN (ZOMIG) for Migraine, PREGABALIN from 01-May-2017 to 05-Jul-2021 for Pain. On 17-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), EAR PAIN (Ear pain) (seriousness criterion medically significant), PUNCTURE SITE BRUISE (Puncture site bruise) (seriousness criterion medically significant), PUNCTURE SITE PAIN (Puncture site pain) (seriousness criterion medically significant), ASTHENIA (Weakness) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), MIGRAINE (Migraine) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced CONTUSION (Bruise) (seriousness criterion medically significant), NASOPHARYNGITIS (Cold) (seriousness criterion medically significant), PAIN IN EXTREMITY (Arm pain) (seriousness criterion medically significant), PAIN (Body aches) (seriousness criterion medically significant) and INSOMNIA (Also didn''t sleep very well). On 17-Jul-2021, HEADACHE (Headache) had resolved. On 18-Jul-2021, MIGRAINE (Migraine) had resolved. At the time of the report, PYREXIA (Fever), EAR PAIN (Ear pain), PUNCTURE SITE BRUISE (Puncture site bruise) and PUNCTURE SITE PAIN (Puncture site pain) had not resolved, CONTUSION (Bruise), NASOPHARYNGITIS (Cold), PAIN IN EXTREMITY (Arm pain), PAIN (Body aches), ASTHENIA (Weakness) and FATIGUE (Fatigue) was resolving and INSOMNIA (Also didn''t sleep very well) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2020, SARS-CoV-2 test: negative (Negative) Tested negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient was unsure if she had symptoms associated with COVID-19 and was not currently breastfeeding. 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. Events were classified as serious by regulatory authority (seriousness criteria: medically important condition). However, as per medical criteria none of the events was serious (not IME listed and resolved).; 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. Events were classified as serious by regulatory authority (seriousness criteria: medically important condition). However, as per medical criteria none of the events was serious (not IME listed and resolved).


VAERS ID: 1496382 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Chills, Fatigue, Headache, Lethargy, Malaise, Pyrexia, SARS-CoV-2 test, Sensitive skin
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DEEP HEAT [MENTHOL;METHYL SALICYLATE]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210212; Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: low energy; chills; unwell; lethargic; headache; Sensitive skin; Tiredness; Fever; Fever chills; This regulatory authority case was reported by a consumer and describes the occurrence of MALAISE (unwell), LETHARGY (lethargic), SENSITIVE SKIN (Sensitive skin), ASTHENIA (low energy), CHILLS (chills), FATIGUE (Tiredness), PYREXIA (Fever), PYREXIA (Fever chills) and HEADACHE (headache) in a 39-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. Concomitant products included MENTHOL, METHYL SALICYLATE (DEEP HEAT [MENTHOL;METHYL SALICYLATE]) from 01-Jun-2021 to 08-Jun-2021 for Joint pain. On 17-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced SENSITIVE SKIN (Sensitive skin) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and PYREXIA (Fever chills) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (unwell) (seriousness criterion medically significant), LETHARGY (lethargic) (seriousness criterion medically significant), ASTHENIA (low energy) (seriousness criterion medically significant), CHILLS (chills) (seriousness criterion medically significant) and HEADACHE (headache) (seriousness criterion medically significant). The patient was treated with PARACETAMOL for Fever, at a dose of 1 dosage form. On 18-Jul-2021, SENSITIVE SKIN (Sensitive skin), FATIGUE (Tiredness), PYREXIA (Fever) and PYREXIA (Fever chills) had resolved. At the time of the report, MALAISE (unwell), LETHARGY (lethargic), ASTHENIA (low energy), CHILLS (chills) and HEADACHE (headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. The reported event started to appear 8 to 9 hours later after having vaccine. Overnight the fever and fever chills were at their highest and disrupted patient sleep. On 18th July patient was feeling tired and felt very low energy and fever chills and fever started to subside on 18th July. Patient felt lethargic by end of the day. Next morning patient felt ok but take some treatment medication to help reduce fever and handle the headache and unwell. 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: 1496394 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-07-17
   Days after vaccination:77
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001659 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Back pain, Headache, Inappropriate schedule of product administration, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Arthritis (broad), Medication errors (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; IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy; Suspected COVID-19
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: inappropriate schedule of product administration; Backache; Joint ache; Headache; High temperature; This regulatory authority case was reported by a consumer and describes the occurrence of BACK PAIN (Backache), ARTHRALGIA (Joint ache), HEADACHE (Headache) and PYREXIA (High temperature) in a 45-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3003608 and 3001659) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Pregnancy and Suspected COVID-19 from 20-Jan-2020 to 24-Jan-2020. Concomitant products included PARACETAMOL and IBUPROFEN for an unknown indication. On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jul-2021, the patient experienced BACK PAIN (Backache) (seriousness criterion medically significant), ARTHRALGIA (Joint ache) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and PYREXIA (High temperature) (seriousness criterion medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of product administration). At the time of the report, BACK PAIN (Backache), ARTHRALGIA (Joint ache), HEADACHE (Headache) and PYREXIA (High temperature) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of product administration) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was occurred sleep through the night and struggle carry out any activities through the day (over two day period) .Adverse reaction did not occur as a result of an exposure during pregnancy Treatment product 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. Seriousness of the events are based on the Regulatory Report received, as per medical judgement the events for this case are non serious. 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. Seriousness of the events are based on the Regulatory Report received, as per medical judgement the events for this case are non serious. No further information is expected at this time.


VAERS ID: 1496413 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-07-17
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

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

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

Write-up: bleeding; Vaginal bleeding; Frequent periods; This regulatory authority case was reported by a consumer and describes the occurrence of HAEMORRHAGE (bleeding), VAGINAL HAEMORRHAGE (Vaginal bleeding) and POLYMENORRHOEA (Frequent periods) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. No Medical History information was reported. On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding) (seriousness criterion medically significant) and POLYMENORRHOEA (Frequent periods) (seriousness criterion medically significant). On an unknown date, the patient experienced HAEMORRHAGE (bleeding) (seriousness criterion medically significant). At the time of the report, HAEMORRHAGE (bleeding), VAGINAL HAEMORRHAGE (Vaginal bleeding) and POLYMENORRHOEA (Frequent periods) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Consumer reported that she had a normal period on July 10th and then after a week she had another heavy one July 17th for 3 days and have been having light bleeding since and have not stopped. (not too heavy that a sanitary pad is needed) On unknown date consumer had COVID-19 virus test and it was negative. No relevant concomitant medications were provided. No treatment information was 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. Events seriousness were captured as per Regulatory Authority assessment in Source Document.; 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. Events seriousness were captured as per Regulatory Authority assessment in Source Document.


VAERS ID: 1496421 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-17
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Deafness, Ear pain, Excessive cerumen production
SMQs:, Hearing impairment (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; Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: wax buildup; Ear pain; Hearing loss; This regulatory authority case was reported by a consumer and describes the occurrence of DEAFNESS (Hearing loss) in a 20-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Not Known) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding. The patient''s past medical history included Lactation decreased. On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced DEAFNESS (Hearing loss) (seriousness criterion medically significant). On 19-Jul-2021, the patient experienced EAR PAIN (Ear pain). On an unknown date, the patient experienced EXCESSIVE CERUMEN PRODUCTION (wax buildup). At the time of the report, DEAFNESS (Hearing loss), EXCESSIVE CERUMEN PRODUCTION (wax buildup) and EAR PAIN (Ear pain) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No Concomitant medication information was provided. No treatment information was provided by the reporter. Patient reported her right ear started to feel blocked and stopped being able to hear, at first she thought it was regular wax buildup and tried to treat it, but not sure it is. It started to felt achey and possibly swollen. Very limited information regarding these events has been provided at this time and a causal relationship cannot be excluded.; Sender''s Comments: Very limited information regarding these events has been provided at this time and a causal relationship cannot be excluded


VAERS ID: 1496436 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Hyperhidrosis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: GBMODERNATX, INC.MOD20212

Write-up: Sweating; Fever; Headache; Based on the current case data, this case has been classified as invalid. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), PYREXIA (Fever) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced HYPERHIDROSIS (Sweating) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, HYPERHIDROSIS (Sweating), PYREXIA (Fever) and HEADACHE (Headache) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment information was provided. No relevant concomitant medications were 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: 1496440 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Decreased appetite, Fatigue, Myalgia, Periorbital swelling, Pyrexia, SARS-CoV-2 test, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 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: Puffy eyes; Appetite absent; Chills; Neck swelling; Fever; Generalised muscle aches; Tiredness; This regulatory authority case was reported by a consumer and describes the occurrence of SWELLING (Neck swelling), PERIORBITAL SWELLING (Puffy eyes), DECREASED APPETITE (Appetite absent), PYREXIA (Fever), MYALGIA (Generalised muscle aches), FATIGUE (Tiredness) and CHILLS (Chills) in a 33-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 17-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jul-2021, the patient experienced SWELLING (Neck swelling) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), MYALGIA (Generalised muscle aches) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 18-Jul-2021, the patient experienced PERIORBITAL SWELLING (Puffy eyes) (seriousness criterion medically significant), DECREASED APPETITE (Appetite absent) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). At the time of the report, SWELLING (Neck swelling) had not resolved and PERIORBITAL SWELLING (Puffy eyes), DECREASED APPETITE (Appetite absent), PYREXIA (Fever), MYALGIA (Generalised muscle aches), FATIGUE (Tiredness) and CHILLS (Chills) 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) (Intramuscular) was unknown. No treatment information was provided. No relevant concomitant medications were 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: 1497623 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300307 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anxiety, Depression, Headache, Hypersensitivity, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RAMIPRIL; VENTOLIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: COVID-19 virus test negative.
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Anxiety; Depression; Hypersensitivity; Fever; Headache; Muscle ache; This regulatory authority case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety), DEPRESSION (Depression), HYPERSENSITIVITY (Hypersensitivity), MYALGIA (Muscle ache), PYREXIA (Fever) and HEADACHE (Headache) in a 41-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 300307) for COVID-19 vaccination. The patient''s past medical history included Pregnancy. Concomitant products included SALBUTAMOL, SALBUTAMOL BASE, SALBUTAMOL SULPHATE, SALBUTAMOL SULPHATE MICRONISED (VENTOLIN) from 05-Jun-1988 to an unknown date for Asthma, RAMIPRIL from 05-May-2019 to an unknown date for Blood pH. On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant). On 18-Jul-2021, the patient experienced ANXIETY (Anxiety) (seriousness criterion medically significant), DEPRESSION (Depression) (seriousness criterion medically significant), HYPERSENSITIVITY (Hypersensitivity) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, ANXIETY (Anxiety), DEPRESSION (Depression), HYPERSENSITIVITY (Hypersensitivity), MYALGIA (Muscle ache) and HEADACHE (Headache) had not resolved and PYREXIA (Fever) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jul-2021, SARS-CoV-2 test: negative (Negative) COVID-19 virus test negative.. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was unknown. 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. In addition to this, the Authority report states that this male patient has a medical history of pregnancy. This event may be referring to patient''s history of being able to impregnate his female partner prior to vaccination, or there may be an error in capturing the event. However, since further information cannot be requested, this information is retained per Regulatory Authority report.


VAERS ID: 1497627 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Mental fatigue, Muscle fatigue, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Arthritis (broad), COVID-19 (broad)

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

Write-up: Mental fatigue; Muscle fatigue; Pain joint; This regulatory authority case was reported by a consumer and describes the occurrence of MENTAL FATIGUE (Mental fatigue), MUSCLE FATIGUE (Muscle fatigue) and ARTHRALGIA (Pain joint) in a 32-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced ARTHRALGIA (Pain joint). On 18-Jul-2021, the patient experienced MUSCLE FATIGUE (Muscle fatigue). On 19-Jul-2021, the patient experienced MENTAL FATIGUE (Mental fatigue). At the time of the report, MENTAL FATIGUE (Mental fatigue) and ARTHRALGIA (Pain joint) had not resolved and MUSCLE FATIGUE (Muscle 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. Concomitant product use was not provided by the reporter. Treatment information was unknown.; 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: 1497630 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-17
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Heavy menstrual bleeding, Hot flush, Menstruation irregular
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Vestibular disorders (broad), Fertility disorders (broad)

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

Write-up: feeling faint; Hot flushes; Heavy periods; Irregular periods; This regulatory authority case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Heavy periods), MENSTRUATION IRREGULAR (Irregular periods), DIZZINESS (feeling faint) and HOT FLUSH (Hot flushes) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concomitant products included LORATADINE from 30-Jun-2021 to an unknown date for Pollen allergy. On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Heavy periods) (seriousness criterion medically significant) and MENSTRUATION IRREGULAR (Irregular periods) (seriousness criterion medically significant). On 18-Jul-2021, the patient experienced HOT FLUSH (Hot flushes) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (feeling faint) (seriousness criterion medically significant). At the time of the report, HEAVY MENSTRUAL BLEEDING (Heavy periods), MENSTRUATION IRREGULAR (Irregular periods) and HOT FLUSH (Hot flushes) had not resolved and DIZZINESS (feeling faint) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Period arrived 6 days early. Very heavy and painful (like a teenager again), with hot flushes, headaches and feeling faint Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. No treatment medication information was mentioned by reporter. Company Comment: Very limited information regarding these events has been provided at this time and a causal relationship cannot be excluded; Sender''s Comments: Very limited information regarding these events has been provided at this time and a causal relationship cannot be excluded


VAERS ID: 1499757 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: Fever; Headache; Nausea; Chills; Muscle ache; This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea), CHILLS (Chills) and MYALGIA (Muscle ache) in a 41-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 17-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea), CHILLS (Chills) and MYALGIA (Muscle ache). On 18-Jul-2021, CHILLS (Chills) and MYALGIA (Muscle ache) had resolved. At the time of the report, PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) was resolving. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. No concomitant medication provided. Action taken was not applicable. No treatment information mentioned.; 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: 1499759 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Lethargy, Myalgia, Nausea, Pain in extremity, Peripheral swelling, Pruritus, Swelling face, Tremor, Wound complication
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), 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: TOPIRAMATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: dizzy; leg pain; itchy; lethargic; shaking; nauseated; Wound itching; Muscle pain; Swelling face; Swollen arm; Nausea; This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), PAIN IN EXTREMITY (leg pain), PRURITUS (itchy), LETHARGY (lethargic), TREMOR (shaking), SWELLING FACE (Swelling face), PERIPHERAL SWELLING (Swollen arm), WOUND COMPLICATION (Wound itching), NAUSEA (Nausea), MYALGIA (Muscle pain) and NAUSEA (nauseated) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 from 06-Apr-2020 to 16-Apr-2020. Concomitant products included TOPIRAMATE for an unknown indication. On 17-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) at an unspecified dose. On 17-Jul-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 18-Jul-2021, the patient experienced SWELLING FACE (Swelling face) (seriousness criterion medically significant) and MYALGIA (Muscle pain) (seriousness criterion medically significant). On 19-Jul-2021, the patient experienced WOUND COMPLICATION (Wound itching) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (dizzy) (seriousness criterion medically significant), PAIN IN EXTREMITY (leg pain) (seriousness criterion medically significant), PRURITUS (itchy) (seriousness criterion medically significant), LETHARGY (lethargic) (seriousness criterion medically significant), TREMOR (shaking) (seriousness criterion medically significant) and NAUSEA (nauseated) (seriousness criterion medically significant). On 19-Jul-2021, SWELLING FACE (Swelling face) and MYALGIA (Muscle pain) had resolved. At the time of the report, DIZZINESS (dizzy), PAIN IN EXTREMITY (leg pain), PRURITUS (itchy), LETHARGY (lethargic), TREMOR (shaking) and NAUSEA (nauseated) was resolving and PERIPHERAL SWELLING (Swollen arm), WOUND COMPLICATION (Wound itching) and NAUSEA (Nausea) had not resolved. No treatment information was given by reporter. Action taken with mRNA-1273 in response to the event was not applicable. Patient reported an hour after the vaccine she felt extremely hot, nauseated and dizzy and was visibly shaking, needing to sat down. She quickly became extremely lethargic.The following day she experienced extreme pain down the left side of her body (injected in left arm), hips, and leg muscles. At some points her legs became extremely unstable. Patient face was swollen. Not alarmingly so, but puffy. This has now disappeared. Her leg pain has returned later on the 19th, almost 48 hours later, but not to the same degree. She was experiencing waves of nausea. The injection site was hard, swolllen, red and itchy. 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: 1499764 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ejaculation failure, Fatigue, Headache, Migraine, Motion sickness, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), COVID-19 (broad), Sexual dysfunction (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Little; Headache; Swollen arm; Tired all the time; Migraine headache; Air sickness; This regulatory authority case was reported by a consumer and describes the occurrence of EJACULATION FAILURE (Little), MIGRAINE (Migraine headache), MOTION SICKNESS (Air sickness), PERIPHERAL SWELLING (Swollen arm), FATIGUE (Tired all the time) and HEADACHE (Headache) in a 41-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. On 17-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced MIGRAINE (Migraine headache) (seriousness criterion medically significant), MOTION SICKNESS (Air sickness) (seriousness criterion medically significant) and FATIGUE (Tired all the time) (seriousness criterion medically significant). On 19-Jul-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant). On an unknown date, the patient experienced EJACULATION FAILURE (Little) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). The patient was treated with PARACETAMOL for Headache, at an unspecified dose and frequency. On 19-Jul-2021, MIGRAINE (Migraine headache), MOTION SICKNESS (Air sickness) and FATIGUE (Tired all the time) had resolved. At the time of the report, EJACULATION FAILURE (Little) and HEADACHE (Headache) outcome was unknown and PERIPHERAL SWELLING (Swollen arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was given. The patient experienced painful arm and it was red and swollen arm around injection point. She had feeling of sickness without being sick, exhaustion, and a headache which she took paracetamol numbed it a little, but constant for 48 + hours (hrs). 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: 1499765 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Musculoskeletal stiffness, Peripheral swelling, Pyrexia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: Swelling of the underarm gland; Feeling very tired; Pain at the injection site; Stiffness; Joint aches; chills; headache; Fever; Based on the current case data, this case has been classified as invalid. This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling of the underarm gland), FATIGUE (Feeling very tired), VACCINATION SITE PAIN (Pain at the injection site), MUSCULOSKELETAL STIFFNESS (Stiffness), ARTHRALGIA (Joint aches), CHILLS (chills), PYREXIA (Fever) and HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. No Medical History information was reported. On 17-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling of the underarm gland) (seriousness criterion medically significant), FATIGUE (Feeling very tired) (seriousness criterion medically significant), VACCINATION SITE PAIN (Pain at the injection site) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (Stiffness) (seriousness criterion medically significant), ARTHRALGIA (Joint aches) (seriousness criterion medically significant), CHILLS (chills) (seriousness criterion medically significant) and HEADACHE (headache) (seriousness criterion medically significant). On 19-Jul-2021, PYREXIA (Fever) had resolved. At the time of the report, PERIPHERAL SWELLING (Swelling of the underarm gland), FATIGUE (Feeling very tired), VACCINATION SITE PAIN (Pain at the injection site), MUSCULOSKELETAL STIFFNESS (Stiffness), ARTHRALGIA (Joint aches), CHILLS (chills) and HEADACHE (headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) and mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Patient developed Swelling of the underarm gland, Feeling very tired, Pain at the injection site, Stiffness, Joint aches. Concomitant medication not reported. Treatment medication 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: 1499799 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Comments: Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: High temperature; Ache; Painful arm; Fatigue; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Ache), PAIN IN EXTREMITY (Painful arm), FATIGUE (Fatigue) and PYREXIA (High temperature) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Not known) for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding. The patient''s past medical history included Lactation decreased. On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 18-Jul-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant). On 18-Jul-2021, FATIGUE (Fatigue) had resolved. On 19-Jul-2021, PAIN (Ache) and PYREXIA (High temperature) had resolved. On 20-Jul-2021, PAIN IN EXTREMITY (Painful arm) was resolving. 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 medication were provided. No treatment information was provided by the reporter. 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: 1499845 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Lymphadenopathy, Pain in extremity, Peripheral swelling, Pruritus, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

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

Write-up: itchy; fever; Pain in arm; Leg pain; Swollen arm; Swollen lymph nodes; Chest pain; This regulatory authority case was reported by a consumer and describes the occurrence of PRURITUS (itchy), CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Leg pain), PERIPHERAL SWELLING (Swollen arm), LYMPHADENOPATHY (Swollen lymph nodes) and PYREXIA (fever) in a 34-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 17-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion medically significant). On 18-Jul-2021, the patient experienced PAIN IN EXTREMITY (Leg pain) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant) and LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant). 18-Jul-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On an unknown date, the patient experienced PRURITUS (itchy) (seriousness criterion medically significant) and PYREXIA (fever) (seriousness criterion medically significant). At the time of the report, PRURITUS (itchy), CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Leg pain), PYREXIA (fever) and PAIN IN EXTREMITY (Pain in arm) was resolving and PERIPHERAL SWELLING (Swollen arm) and LYMPHADENOPATHY (Swollen lymph nodes) had not resolved. It was noted that the patient felt ok after having the Covid vaccination but a few hours later it hurt on the left side when the she breathed in. A few hours after that, the patient''s arm started to swell, got hot and itchy. The next morning, the whole left side hurt and the only relief was to lay down on the left side. Deep breaths really hurt and the she started having a fever and felt really tired. The patient went for a scan of her breast after having pains and was told her lymph nodes are swollen too. Concomitant medications information not reported. Treatment information 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: 1500343 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-07-17
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Chills, Fatigue, Headache, Hyperpyrexia, Malaise
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: Body temperature; Result Unstructured Data: 40.5 Celcius
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of HYPERPYREXIA in a 57-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 17-Jul-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jul-2021, the patient experienced HYPERPYREXIA (seriousness criterion medically significant), MALAISE, HEADACHE, FATIGUE and CHILLS. At the time of the report, HYPERPYREXIA, MALAISE, HEADACHE, FATIGUE and CHILLS had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jul-2021, Body temperature: 40.5 c (High) Concomitant medications were not reported . Treatment information was not provided. Action taken with mRNA-1273 (COVID 19 Vaccine Moderna) was not applicable. 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: 1500417 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XE393 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Euphoric mood, Fatigue, Hallucination, Insomnia, Myalgia, Psychiatric symptom
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210741041

Write-up: HALLUCINATIONS; HAPPY STATE OF MIND; PSYCHOLOGICAL CHANGES, AS IF TAKING DRUGS; COULDN''T SLEEP; MUSCLE PAIN; TIREDNESS; This spontaneous report received from a patient concerned a 43 year old male of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE393, and expiry: unknown) dose was not reported, 1 total, administered at left arm on 17-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUL-2021, the patient experienced muscle pain, no fever, hallucinations, psychological changes, as if he was taking drugs, happy state of mind. Feeling really tired and could not sleep. All the symptoms resolved on the 18-JUL-2021 except for the tiredness that was ongoing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hallucinations, happy state of mind, psychological changes, as if taking drugs, couldn''t sleep, and muscle pain on 18-JUL-2021, and had not recovered from tiredness. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210741041-COVID-19 VACCINE AD26.COV2.S-HALLUCINATIONS. This event is considered unassessable. The event 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.


VAERS ID: 1504157 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Headache, Injection site rash, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (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 Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Dizziness; Joint pain; Injection site rash; Headache; Muscle ache; This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEADACHE (Headache), MYALGIA (Muscle ache), INJECTION SITE RASH (Injection site rash) and ARTHRALGIA (Joint pain) in a 48-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). On 18-Jul-2021, the patient experienced INJECTION SITE RASH (Injection site rash) (seriousness criterion medically significant). On 19-Jul-2021, the patient experienced ARTHRALGIA (Joint pain) (seriousness criterion medically significant). On 20-Jul-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant). At the time of the report, DIZZINESS (Dizziness), HEADACHE (Headache), MYALGIA (Muscle ache), INJECTION SITE RASH (Injection site rash) and ARTHRALGIA (Joint pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter. 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: 1504220 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-07-17
   Days after vaccination:65
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001659 / 1 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER FF3319 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac flutter, Chest pain, Chills, Fatigue, Interchange of vaccine products, Pain, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LYMECYCLINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acne; Lactation decreased; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: pain in chest; pain; shivers; fatigue; interchange of vaccine products; Heart fluttering; Heart pounding; This regulatory authority case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart fluttering) in a 21-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3001659) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product COVID-19 VACCINE MRNA (BNT162B2) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased, Acne and Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)). Concomitant products included LYMECYCLINE for Acne. On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient started COVID-19 VACCINE MRNA (BNT162B2) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant) and PALPITATIONS (Heart pounding). 17-Jul-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products). On an unknown date, the patient experienced CHEST PAIN (pain in chest), PAIN (pain), CHILLS (shivers) and FATIGUE (fatigue). On 17-Jul-2021, CARDIAC FLUTTER (Heart fluttering) and PALPITATIONS (Heart pounding) had resolved. At the time of the report, CHEST PAIN (pain in chest) had resolved, PAIN (pain), CHILLS (shivers) and FATIGUE (fatigue) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Patient was taking one tablet a day called Lymecycline for acne treatment. She had stopped taking it just before she had received the Pfizer vaccine. Patient received the Pfizer vaccine (2nd dose). In the evening she experienced the expected shivers, fatigue, and achiness. Then, she went to sleep and woke up in the middle of the night with pains in chest. It felt like a tiny knife was stabbing the heart and she couldn''t move. Every time she tried to move the stabbing pain either persisted or became worse. This lasted for about 10 minutes and then started to subside. The patient is reporting this because she never experienced heart pains and she not experiencing high-stress levels. No treatment information was provided. This is a case of Revaccination with different COVID-19 vaccine with adverse events. 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: This is a case of Revaccination with different COVID-19 vaccine with adverse events. 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: 1504653 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-06
Onset:2021-07-17
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNKNOWN / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Chills, Fatigue, Headache, Hyperpyrexia, Inappropriate schedule of product administration, Injection site induration, Injection site inflammation, Injection site pruritus, Injection site swelling, Injection site warmth, Malaise, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (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), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (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: 20210718; Test Name: Body temperature; Result Unstructured Data.
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of HYPERPYREXIA in a 32-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) .5 milliliter. On 17-Jul-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. On 17-Jul-2021, the patient experienced MALAISE. On 18-Jul-2021, the patient experienced HYPERPYREXIA (seriousness criterion medically significant), INJECTION SITE INFLAMMATION, INJECTION SITE WARMTH, INJECTION SITE INDURATION, INJECTION SITE PRURITUS, HEADACHE, NAUSEA, CHILLS, INJECTION SITE SWELLING, MYALGIA and FATIGUE. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (late second dose). At the time of the report, HYPERPYREXIA, INJECTION SITE INFLAMMATION, INJECTION SITE WARMTH, INJECTION SITE INDURATION, INJECTION SITE PRURITUS, HEADACHE, NAUSEA, CHILLS, INJECTION SITE SWELLING and MYALGIA had not resolved, MALAISE and FATIGUE was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (late second dose) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jul-2021, Body temperature: high (High). No treatment information was provided by the reporter No concomitant medication was provided by the reporter. Action taken with Moderna vaccine was not applicable. 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. Causality for the event Inappropriate schedule of vaccine administered is assessed as not applicable.; 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. Causality for the event Inappropriate schedule of vaccine administered is assessed as not applicable.


VAERS ID: 1504745 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: PTJNJFOC20210752311

Write-up: VASOVAGAL SYNDROME (SWEATING, LOSS OF CONSCIOUSNESS, PALLOR AND HYPOTENSION); This spontaneous report received from a pharmacist via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-V202107-3525] concerned a 27 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD974 expiry: UNKNOWN) 0.5 ml, 1 total, administered on 17-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 17-JUL-2021, the patient experienced vasovagal syndrome (sweating, loss of consciousness, pallor and hypotension). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vasovagal syndrome (sweating, loss of consciousness, pallor and hypotension). This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210752311-COVID-19 VACCINE AD26.COV2.S-VASOVAGAL SYNDROME (SWEATING, LOSS OF CONSCIOUSNESS, PALLOR AND HYPOTENSION). This event is considered unassessable. The event 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.


VAERS ID: 1505153 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0438 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Chills, Lethargy, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: COPFIZER INC202100916902

Write-up: swelling of the left armpit with a lot of pain; fever; lethargy; a lot of pain in the left armpit under the arm where the vaccine was applied; chills; This is a spontaneous report from a contactable pharmacist (Pfizer employee, reporting for himself as patient) received from a regulatory authority. A 28-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EX0438), dose 2 via an intramuscular route of administration, administered in arm left on 17Jul2021 at 10:00 (at the age of 28-year-old) as dose 2, single for covid-19 immunisation. vaccine was administered at a hospital. The patient medical history was not reported, relevant medical history was reported as none, known allergies reported as none and patient was not diagnosed with COVID-19 prior to vaccination. The patient concomitant medications were not reported, and patient has not received other vaccines four weeks prior to vaccination. The patient previously received first dose of bnt162b2 (BNT162B2, formulation: Solution for injection), vi an intramuscular route of administration, administered in Arm Left on 26Jun2021 at 09:00 (Batch/Lot Number: EW4109) as dose 1, single for covid-19 immunisation. On 17Jul2021 at 23:00, after the second dose of vaccination, the patient experienced chills, and on 18Jul2021 had fever, lethargy, and chills day after and at night on 18Jul2021 a lot of pain in the left armpit under the arm where the vaccine was applied. On 19Jul2021, the patient had swelling of the left armpit with a lot of pain, the pharmacist informed that he contacted the healthcare provider for a checkup, and at the time of reporting the medical staff had not arrived. The patient had not been tested for Covid-19 since vaccination. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. As treatment for events was reported as unknown. The outcome of the events was unknown at the time of this report. ; Sender''s Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events chills ,pyrexia, lethargy, axillary pain and swelling cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 1507129 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-17
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 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: ADHD (Mental and behavioral problems); Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100928507

Write-up: Bell''s palsy; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107201625538340-OXGVJ. Safety Report Unique Identifier GB-MHRA-ADR 25681651. A 31-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW3143) via an unspecified route of administration on 04Jul2021 as dose 1, single for COVID-19 immunization. Patient has not tested positive for COVID-19, since having the vaccine. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not currently breastfeeding. Patient medical history included asthma from an unknown date and unknown if ongoing, attention deficit hyperactivity disorder (mental and behavioral problems) from an unknown date and unknown if ongoing. The concomitant medications were not reported. On 17Jul2021, the patient experienced Bell''s palsy. This report did not relate to possible blood clots or low platelet counts. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected. ~


VAERS ID: 1507472 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-17
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002185 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abnormal behaviour, Altered state of consciousness, Headache, Pyrexia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug allergy (Pyrine drugs.)
Preexisting Conditions: Medical History/Concurrent Conditions: Convulsion; Malignant tongue cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP061876

Write-up: Suspected disturbed consciousness; Abnormal behaviour; Pyrexia; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of ALTERED STATE OF CONSCIOUSNESS (Suspected disturbed consciousness), ABNORMAL BEHAVIOUR (Abnormal behaviour), HEADACHE (Headache) and PYREXIA (Pyrexia) in a 51-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002185) for COVID-19 vaccination. The patient''s past medical history included Malignant tongue cancer and Convulsion. Concurrent medical conditions included Drug allergy (Pyrine drugs.). On 10-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 17-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced HEADACHE (Headache) (seriousness criterion hospitalization). On 18-Jul-2021, the patient experienced ALTERED STATE OF CONSCIOUSNESS (Suspected disturbed consciousness) (seriousness criteria hospitalization and medically significant), ABNORMAL BEHAVIOUR (Abnormal behaviour) (seriousness criterion hospitalization) and PYREXIA (Pyrexia) (seriousness criterion hospitalization). At the time of the report, ALTERED STATE OF CONSCIOUSNESS (Suspected disturbed consciousness), ABNORMAL BEHAVIOUR (Abnormal behaviour), HEADACHE (Headache) and PYREXIA (Pyrexia) outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ALTERED STATE OF CONSCIOUSNESS (Suspected disturbed consciousness), ABNORMAL BEHAVIOUR (Abnormal behaviour), HEADACHE (Headache) and PYREXIA (Pyrexia) to be possibly related. There was no concomitant medication reported. On 17-Jul-2021, headache developed. On 18-Jul-2021, the patient developed pyrexia .A family member of the patient complained that the patient had abnormal behaviors in his/her words and actions. The patient had disturbed consciousness and was raced to a hospital and hospitalized for treatment. There was no treatment medication reported. As per reporter,The cause was currently being examined if encephalitis or meningitis has been reported in the Moderna vaccine. 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.Limited information regarding these event s has been provided at this time. Further information has been requested; 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.Limited information regarding these event s has been provided at this time. Further information has been requested


VAERS ID: 1507486 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthma, Blood pressure measurement, Body temperature, Chest X-ray, Heart rate, Nausea, Oxygen saturation, Respiratory rate
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Autonomic nervous system imbalance (Autonomic imbalance); Bronchial asthma; Dermatitis atopic (Atopic dermatitis); Endometriosis of ovary (Right ovarian endometriosis)
Preexisting Conditions: Medical History/Concurrent Conditions: Asthmatic attack (Asthma attack within the past month)
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: Blood pressure; Result Unstructured Data: 130/91 mmHg at 11:45 am; Test Date: 20210717; Test Name: Blood pressure; Result Unstructured Data: 110/70mmHg at 11:50 am; Test Date: 20210717; Test Name: Blood pressure; Result Unstructured Data: 125/82mmHg at 12:00 pm; Test Date: 20210717; Test Name: Blood pressure; Result Unstructured Data: 112/72 mmHg at 12:15 pm; Test Date: 20210717; Test Name: Body temperature; Result Unstructured Data: 36.6 degree Celsius at 12:15 pm; Test Date: 20210717; Test Name: Chest xray; Result Unstructured Data: Normal; Test Date: 20210717; Test Name: Pulse; Result Unstructured Data: 95/ min at 11:45 am; Test Date: 20210717; Test Name: Pulse; Result Unstructured Data: 91/min at 11:50 am; Test Date: 20210717; Test Name: Pulse; Result Unstructured Data: 89/min at 12:00 pm; Test Date: 20210717; Test Name: Pulse; Result Unstructured Data: 87/min at 12:15 pm; Test Date: 20210717; Test Name: Spo2; Result Unstructured Data: 96 at 11:45 am; Test Date: 20210717; Test Name: Spo2; Result Unstructured Data: 99 at 11:50 am; Test Date: 20210717; Test Name: Spo2; Result Unstructured Data: 100 at 12:00 pm; Test Date: 20210717; Test Name: Spo2; Result Unstructured Data: 98 at 12:15 pm; Test Date: 20210717; Test Name: Respiratory rate; Test Result: Borderline ; Result Unstructured Data: 20/min at 11:45 am; Test Date: 20210717; Test Name: Respiratory rate; Result Unstructured Data: 18/min at 11:50 am; Test Date: 20210717; Test Name: Respiratory rate; Result Unstructured Data: 15/min at 12:15 pm
CDC Split Type: JPTAKEDA2021TJP061923

Write-up: Asthma symptoms (wheezing, coughing, difficulty breathing); Feeling queasy; This spontaneous case was reported by a physician and describes the occurrence of ASTHMA (Asthma symptoms (wheezing, coughing, difficulty breathing)) and NAUSEA (Feeling queasy) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Bronchial asthma since an unknown date, Autonomic nervous system imbalance (Autonomic imbalance) since an unknown date, Endometriosis of ovary (Right ovarian endometriosis) since an unknown date, Dermatitis atopic (Atopic dermatitis) since an unknown date and Asthmatic attack (Asthma attack within the past month). On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced ASTHMA (Asthma symptoms (wheezing, coughing, difficulty breathing)) (seriousness criterion hospitalization) and NAUSEA (Feeling queasy) (seriousness criterion hospitalization). The patient was treated with CHLORPHENIRAMINE MALEATE on 18-Jul-2021 for Adverse event, at an unspecified dose and frequency; CYSTEINE HYDROCHLORIDE, GLYCYRRHIZIC ACID, AMMONIUM SALT (MONOAMMONIUM GLYCYRRHIZINATE AND CYSTEINE AND SODIUM CHLORIDE) on 18-Jul-2021 for Adverse event, at an unspecified dose and frequency and METOCLOPRAMIDE HYDROCHLORIDE on 18-Jul-2021 for Adverse event, at an unspecified dose and frequency. On 17-Jul-2021, ASTHMA (Asthma symptoms (wheezing, coughing, difficulty breathing)) and NAUSEA (Feeling queasy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jul-2021, Blood pressure measurement: abnormal (abnormal) 130/91 mmHg at 11:45 am, normal (normal) 110/70mmHg at 11:50 am, abnormal (abnormal) 125/82mmHg at 12:00 pm and normal (normal) 112/72 mmHg at 12:15 pm. On 17-Jul-2021, Body temperature: normal (normal) 36.6 degree Celsius at 12:15 pm. On 17-Jul-2021, Chest X-ray: normal (normal) Normal. On 17-Jul-2021, Heart rate: normal (normal) 95/ min at 11:45 am, normal (normal) 91/min at 11:50 am, normal (normal) 89/min at 12:00 pm and normal (normal) 87/min at 12:15 pm. On 17-Jul-2021, Oxygen saturation: normal (normal) 96 at 11:45 am, normal (normal) 99 at 11:50 am, normal (normal) 100 at 12:00 pm and normal (normal) 98 at 12:15 pm. On 17-Jul-2021, Respiratory rate: borderline (Borderline) 20/min at 11:45 am, normal (normal) 18/min at 11:50 am and normal (normal) 15/min at 12:15 pm. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter considered ASTHMA (Asthma symptoms (wheezing, coughing, difficulty breathing)) and NAUSEA (Feeling queasy) to be possibly related. Concomitant medication information was not provided. On an unknown date, body temperature before vaccination: 36.8 degrees Celsius. 15 mins after receiving the vaccine, consumer started complaining from "difficulty breathing and feeling dizzy" and was placed on bed rest. At 12: 00 wheezing and cough developed, and the patient complained of difficulty breathing. At 12:20, there was no skin redness. Symptoms improved after administration of chlorpheniramine maleate, monoammonium glycyrrhizinate/glycine and L-cysteine hydrochloride, and metoclopramide hydrochloride. 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: 1507676 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: PTJNJFOC20210752252

Write-up: VASOVAGAL SYNDROME (SWEATING, LOSS OF CONSCIOUSNESS, PALLOR AND HYPOTENSION); This spontaneous report received from a pharmacist via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-V202107-3518] concerned a 37 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD974 expiry: UNKNOWN) 0.5 ml, 1 total administered on 17-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 17-JUL-2021, the patient experienced vasovagal syndrome (sweating, loss of consciousness, pallor and hypotension). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vasovagal syndrome (sweating, loss of consciousness, pallor and hypotension). This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210752252- Covid-19 vaccine ad26.cov2.s- Vasovagal syndrome (sweating, loss of consciousness, pallor and hypotension). 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: 1507677 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: PTJNJFOC20210752268

Write-up: VASOVAGAL SYNDROME (SWEATING,LOSS OF CONSCIOUSNESS,PALLOR AND HYPOTENSION); This spontaneous report received from a pharmacist via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-V202107-3523] concerned a 30 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD974 expiry: UNKNOWN) 0.5 ml, 1 total (duration of drug administration: 0 days) administered on 17-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 17-JUL-2021, the patient experienced vasovagal syndrome with sweating, loss of consciousness, pallor and hypotension. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vasovagal syndrome (sweating, loss of consciousness, pallor and hypotension). This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210752268-covid-19 vaccine ad26.cov2.s-vasovagal syndrome with sweating, loss of consciousness, pallor and hypotension. 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: 1509158 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: PTJNJFOC20210752677

Write-up: SYNCOPE/ VASO-VAGAL SYNDROME; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-B202107-3356] concerned a 57 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 and expiry: unknown) 0.5 ml, 1 total administered on 17-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 17-JUL-2021, the patient experienced syncope/ vaso-vagal syndrome. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope/ vaso-vagal syndrome on 17-JUL-2021. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0. 20210752677-covid-19 vaccine ad26.cov2.s- Syncope/ vaso-vagal syndrome. These events are 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: 1509159 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Presyncope
SMQs:, Anticholinergic syndrome (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: PTJNJFOC20210752659

Write-up: VASOVAGAL REACTION; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-B202107-3389] concerned a 31 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393) 0.5 ml, 1 total administered on 17-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 17-JUL-2021, the patient experienced vasovagal reaction, duration was 37 minutes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vasovagal reaction on 17-JUL-2021. This report was serious (Other Medically Important Condition).; Reporter''s Comments: Did Medication Error Occur? No; Sender''s Comments: 20210752659- covid-19 vaccine ad26.cov2. s- Vasovagal reaction. 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: 1509160 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Presyncope
SMQs:, Anticholinergic syndrome (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: PTJNJFOC20210752705

Write-up: VASOVAGAL REACTION; This spontaneous report received from a physician via a Regulatory Authority concerned a 29 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 expiry: UNKNOWN) .5 ml, one total administered on 17-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 17-JUL-2021, the patient experienced vasovagal reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vasovagal reaction on 17-JUL-2021. This report was serious (Other Medically Important Condition).; Reporter''s Comments: ; Sender''s Comments: V0:20210752705-Covid-19 vaccine ad26.cov2.s-Vasovagal reaction. 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: 1509340 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Epistaxis, Foaming at mouth, Road traffic accident, Seizure, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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: BRPFIZER INC202100917751

Write-up: he fainted in the car steering wheel; right after a seizure with the car in movement / he was still suffering the convulsions crises; we crashed our car into another car that was stopped; foaming mouth; bleeding nose; This is a spontaneous report from a contactable consumer or other non hcp from Pfizer medical information team. A male patient of an unspecified age received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: Not reported), dose 1 via an unspecified route of administration on 17Jul2021 as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient experienced fainted in the car steering, right after a seizure with the car in movement / he was still suffering the convulsions crises, we crashed our car into another car that was stopped, foaming mouth and bleeding nose on 17Jul2021. The patient was being treated with antibiotics and analgesics. Seriousness criteria for the reported events he fainted in the car steering and seizure. Patient wife stated that we left the house for her husband gets the vaccine Pfizer. It was going everything well on their day, they arrived at the vaccination point located in the city, then, patient went to the drive to receive the first dose of the Pfizer vaccine. He received the first dose, everything went as desired, but, when we were coming home. Patient was driving the car and in a matter of seconds he fainted in the car steering wheel. Patient wife was in his company and in the passenger seat, went through the biggest suffocation of her life, and right after a seizure with the car in movement, patient needed to act faster as he could, even so it was not enough, they crashed their car into another car that was stopped, Patient wife said thank god that at that moment there was no person in the street. Patient hit his face when car was collided. Patient wife leave here my report and Patient wife get it off one''s chest, we do not really know what caused such a strong reaction, but believe that this has to be passed on so that more people can know that they are not only diarrhea or fever the side effect of the vaccine, they could have lost their whole family. The outcome of the reported events was unknown.


VAERS ID: 1510822 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Cerebrovascular accident, Paralysis
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100929032

Write-up: bell ? s palsy; stroke; Palsy; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107201158379210-6URKQ. A female patient of an unspecified age received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation.The patient medical history was not reported.The patients concomitant medications were not reported. The patient experienced bells palsy on an unspecified date, stroke on an unspecified date , palsy on 17Jul2021. Patient had felt headaches and ear aches since my second jab then on 19th July suffered with what I thought was a stroke, was then diagnosed with Bells palsy at the hospital. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The events were assessed as serious. The outcome of events were reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1510938 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214003 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Atrial fibrillation
SMQs:, Supraventricular tachyarrhythmias (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: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Agitation; Fatigue
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: EPISODIO DI FIBRILLAZIONE ATRIALE SUBITO DOPO VACCINAZIONE; This regulatory authority case was reported by a physician and describes the occurrence of ATRIAL FIBRILLATION (EPISODIO DI FIBRILLAZIONE ATRIALE SUBITO DOPO VACCINAZIONE) in a 43-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 214003) for COVID-19 vaccination. The patient''s past medical history included Agitation and Fatigue. Concomitant products included PARACETAMOL for an unknown indication. On 17-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 17-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ATRIAL FIBRILLATION (EPISODIO DI FIBRILLAZIONE ATRIALE SUBITO DOPO VACCINAZIONE) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (EPISODIO DI FIBRILLAZIONE ATRIALE SUBITO DOPO VACCINAZIONE) had resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. On unknown date patient was tested for WBC cell count and no results were reported. Treatment information were not 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.; 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: 1511226 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002185 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal discomfort, Dysstasia, Feeling abnormal, Musculoskeletal discomfort, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Dementia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMLODIPINE BESILATE; ROSUVASTATIN CALCIUM; LEVOFLOXACIN HYDRATE
Current Illness: Dyslipidaemia; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Cellulitis; Tinea pedis; Comments: No medical history was provided.
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP062955

Write-up: Upper abdominal discomfort; Neck strange feeling; Nausea; not able to stand up; right neck discomfort; This regulatory authority case was reported by a pharmacist and describes the occurrence of ABDOMINAL DISCOMFORT (Upper abdominal discomfort), FEELING ABNORMAL (Neck strange feeling), NAUSEA (Nausea), DYSSTASIA (not able to stand up) and MUSCULOSKELETAL DISCOMFORT (right neck discomfort) in a 62-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002185) for COVID-19 vaccination. No medical history was provided. The patient''s past medical history included Cellulitis and Tinea pedis. Concurrent medical conditions included Hypertension and Dyslipidaemia. Concomitant products included AMLODIPINE BESILATE, ROSUVASTATIN CALCIUM and LEVOFLOXACIN (LEVOFLOXACIN HYDRATE) for an unknown indication. On 17-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced ABDOMINAL DISCOMFORT (Upper abdominal discomfort) (seriousness criterion hospitalization), FEELING ABNORMAL (Neck strange feeling) (seriousness criterion hospitalization), NAUSEA (Nausea) (seriousness criterion hospitalization), DYSSTASIA (not able to stand up) (seriousness criterion hospitalization) and MUSCULOSKELETAL DISCOMFORT (right neck discomfort) (seriousness criterion hospitalization). At the time of the report, ABDOMINAL DISCOMFORT (Upper abdominal discomfort), FEELING ABNORMAL (Neck strange feeling), NAUSEA (Nausea), DYSSTASIA (not able to stand up) and MUSCULOSKELETAL DISCOMFORT (right neck discomfort) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ABDOMINAL DISCOMFORT (Upper abdominal discomfort) and FEELING ABNORMAL (Neck strange feeling) to be possibly related. No further causality assessments were provided for NAUSEA (Nausea), DYSSTASIA (not able to stand up) and MUSCULOSKELETAL DISCOMFORT (right neck discomfort). No concomitant medication information was mentioned by reporter No treatment medication information was mentioned by reporter The patient had nausea and was not able to stand up 2 to 3 minutes after the vaccination and was transported to an emergency outpatient department. There were no apparent wheals and nerve, respiratory, gastrointestinal, or cardiovascular symptoms. After 3 hours of follow-up, symptoms improved, and the patient returned home. This case concerns a 62-year-old female hospitalized with serious unexpected events of abdominal discomfort, nausea, dysstasia, musculoskeletal discomfort and feeling abnormal. Event latency 2-3 minutes after first dose mRNA-1273. Events resolving. 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.; Sender''s Comments: This case concerns a 62-year-old female hospitalized with serious unexpected events of abdominal discomfort, nausea, dysstasia, musculoskeletal discomfort and feeling abnormal. Event latency 2-3 minutes after first dose mRNA-1273. Events resolving. 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: 1511340 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-07-17
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration, Pyrexia, Vaccination site infection, Vaccination site mass, Vaccination site swelling
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202100915958

Write-up: high fever; reduced general condition; vaccination site swelling; vaccination site infection; vaccination site lump; This is a spontaneous report from a Pfizer-sponsored program Pfizer Norway AS Facebook and Instagram. A male patient of an unspecified age received BNT162B2 (COMIRANTY; Solution for injection; Lot number: unknown), dose 1 via an unspecified route of administration on 18Jun2021 as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 19Jul2021, the patient experienced high fever and reduced general condition. Vaccination site infection, vaccination site lump and vaccination site swelling in 2021. On 16Jul2021, it was reported that, the Pfizer vaccine was well and groundbreaking. Patient had been to the doctor twice after dose 1 of Pfizer vaccine 18Jun2021. Injection site infection and antibiotics had not helped. Patient still felt the lump there. It was reported that no thanks for more from Pfizer, on 17Jul2021, same here - swelled up in the arm where the syringe was administered, been through 1 course of antibiotics without the lump getting better. It had been almost 1 month since the first dose of Pfizer. And after 2 doctor visits due to this, there was no word about that this could come from the vaccine. It gave less trust and dose 2 went to someone who wanted it. It was not me, on 21Jul2021, patient was strongly recommended to await with the second dose of the Pfizer vaccine today by a dermatologist. Those at the vaccination office agreed. Patient was admitted to medical ward from 19Jul2021 to 20Jul2021 with high fever and reduced general condition, doctor wrote that they suspect COVID-19 vaccine since infection started where Pfizer was administered. Patient received unspecified antibiotic treatment. The outcome of the events high fever and reduced general condition was unknown, and the rest of the events were not recovered. Information about batch/lot number will be requested.


VAERS ID: 1511376 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myoclonus, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210752673

Write-up: SYNCOPE; MYOCLONUS LEFT ARM; This spontaneous report received from a physician via a Regulatory Authority concerned a 31 year old male of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 expiry: unknown) 0.5 ml, 1 total, administered on 17-JUL-2021 for covid-19 immunization. No concomitant medications were reported. On 17-JUL-2021, the patient experienced syncope, myoclonus left arm and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope, and myoclonus left arm on 17-JUL-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210752673-COVID-19 VACCINE AD26.COV2.S-syncope, myoclonus left arm . These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.


VAERS ID: 1511377 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Hyperhidrosis, Hypotension, Pallor, Visual impairment
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210755662

Write-up: PALLOR; DIZZINESS; HYPOTENSION; SWEATING; ALTERED VISION; This spontaneous report received from a physician via a Regulatory Authority (EMEA EVHUMAN NLP, PT-INFARMED-B202107-3381) concerned a 29 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: XE393, expiry: UNKNOWN) .5 ml, 1 total administered on 17-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 17-JUL-2021, the patient experienced pallor, dizziness, hypotension, sweating, altered vision. The action taken with covid-19 vaccine was not applicable. The patient recovered from pallor, dizziness, hypotension, sweating, and altered vision on 17-JUL-2021. This report was serious (Other Medically Important Condition).; Reporter''s Comments: Other information- A young 28 years-old, who started with sweating, dizzines, altered vision, immediately after administration of the Jansen vaccine with fast resolution 5-10 min, AT 129/74, CF 50 bpm Sat ( aa ) 97 %, BMT 109 mg/dl, Dorsal decubitus, Tredelenburg maneuver, hydration. Recovery 20-30 min.; Sender''s Comments: V0-20210755662-Covid-19 vaccine ad26.cov2.s -Pallor, dizziness, hypotension, sweating, altered vision.. 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: 1511462 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Pain in extremity, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TRPFIZER INC202100920126

Write-up: fever; pain in her arm; numbness started and spread towards her body; This is a spontaneous report from a contactable consumer (patient) received. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 17Jul2021 at 13:30 (at an unspecified age) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 17Jul2021 at around 23:30 the patient experienced pain in her arm, fever, and numbness started and spread towards her body. Around 2:00 a.m. the symptoms peaked. She did not take it seriously because she thought her body could produce antibodies and it would last soon but she could tolerate until 4:00 a.m, then she went to hospital. They gave her body fluids, she felt well. The outcome of the events was unknown. No follow-up attempts are possible, information about batch/lot number cannot be obtained.


VAERS ID: 1512133 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, CSF cell count, Computerised tomogram head, Electroencephalogram, Magnetic resonance imaging, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Test Result: Inconclusive ; Result Unstructured Data: Body temperature before the 1st dose of vaccine: 36.3 degrees Celsius; Test Date: 202107; Test Name: Head computerized tomogram (CT); Result Unstructured Data: no abnormalities.; Test Date: 202107; Test Name: Cerebrospinal fluid test,; Result Unstructured Data: no abnormalities.; Test Date: 20210719; Test Name: Electroencephalographic; Test Result: Inconclusive ; Result Unstructured Data: no apparent epileptic discharge; Test Date: 202107; Test Name: Magnetic resonance imaging (MRI); Result Unstructured Data: no abnormalities
CDC Split Type: JPTAKEDA2021TJP062962

Write-up: Acute symptomatic seizure (headache, vomiting, convulsive seizure, disturbed consciousness); This case was received via Takeda Pharmaceuticals (Reference number) on 20-Jul-2021 and was forwarded to Moderna on 28-Jul-2021. This regulatory authority case was reported by a physician and describes the occurrence of SEIZURE (Acute symptomatic seizure (headache, vomiting, convulsive seizure, disturbed consciousness)) in a 26-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 16-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 17-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced SEIZURE (Acute symptomatic seizure (headache, vomiting, convulsive seizure, disturbed consciousness)) (seriousness criteria hospitalization and medically significant). On 19-Jul-2021, SEIZURE (Acute symptomatic seizure (headache, vomiting, convulsive seizure, disturbed consciousness)) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, CSF cell count: no abnormalities (normal) no abnormalities.. In July 2021, Computerised tomogram head: no abnormalities (normal) no abnormalities.. In July 2021, Magnetic resonance imaging: no abnormalities (normal) no abnormalities. On 19-Jul-2021, Electroencephalogram: no apparent epileptic discharge (Inconclusive) no apparent epileptic discharge. On an unknown date, Body temperature: 36.3 (Inconclusive) Body temperature before the 1st dose of vaccine: 36.3 degrees Celsius. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered SEIZURE (Acute symptomatic seizure (headache, vomiting, convulsive seizure, disturbed consciousness)) to be possibly related. No concomitant product information was provided. On 16-Jul-2021, at 14:00, the patient received the 1st dose of this vaccine. On 17-Jul-2021, at 14:00, the patient had headache and vomiting and visited a hospital. The patient had convulsive seizure accompanied by disturbed consciousness during the visit. Symptoms of acute symptomatic seizure were observed. After visiting the hospital, cerebrospinal fluid test, head computerized tomogram (CT) and magnetic resonance imaging (MRI) showed no abnormalities. The patient was admitted to a hospital. On 19-Jul-2021, electroencephalographic examination showed no apparent epileptic discharge. The patient was discharged from the hospital. 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 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: 1512143 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Presyncope
SMQs:, Anticholinergic syndrome (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: PTJNJFOC20210755958

Write-up: VASOVAGAL REACTION; This spontaneous report received from a physician via a Regulatory Authority concerned a 38 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 expiry: UNKNOWN) .5 ml, frequency 1 total, administered on 17-JUL-2021 for covid-19 immunization. No concomitant medications were reported. On 17-JUL-2021, the patient experienced vasovagal reaction (duration 25 minutes). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vasovagal reaction on 17-JUL-2021. This report was serious (Other Medically Important Condition).; Reporter''s Comments: Did a medication error occur? -No; Sender''s Comments: V0: 20210755958-COVID-19 VACCINE AD26.COV2.S-Vasovagal Reaction. This event is considered unassessable. The event 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.


VAERS ID: 1513229 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100925646

Write-up: Anaphylactic reaction; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 587851. A 57-year-old female patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced anaphylactic reaction on 17Jul2021. 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: 1513803 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chest discomfort, Chest pain, Palpitations
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100923409

Write-up: Heart racing; Chest pain; Loss of energy; Tight chest; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107191252100590-NCX0V. Safety Report Unique Identifier GB-MHRA-ADR 25672620. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine, Solution for injection, Batch/Lot Number: FD8813, expiry date: not reported) dose 2 via an unspecified route of administration on 16Jul2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine, Solution for injection, Batch/Lot Number and expiry date: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On 17Jul2021, the patient experienced tight chest. On 18Jul2021, the patient experienced heart racing, chest pain, loss of energy. The events were reported as serious (disability). The outcome of the events was reported as not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1513837 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Inappropriate schedule of product administration, Night sweats, Off label use, Pain in extremity, Product use issue, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Medication errors (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: FERROUS SULFATE
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100956317

Write-up: Maternal exposure during breast feeding; Maternal exposure during breast feeding; High temperature; Chills/Shivers; Night sweat; Fatigue; Painful arm; Inappropriate schedule of vaccine administered; This is a solilcited report from the Regulatory Authority. This consumer reported information for both mother and fetus/baby. This is a maternal report. The consumer reported three reports. This is the second of three reports. The first report was received from the Regulatory Authority. Regulatory authority report number {GB-MHRA-YCVM-202105221131348610-EVFOO}, Safety Report Unique Identifier {GB-MHRA-ADR 25395065}. A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jul2021 (Batch/Lot Number: FA1027) as DOSE 2, SINGLE for COVID-19 vaccination. Medical history included ongoing breast feeding. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. The patient previous took first dose of BNT162B2 on 22May2021 at age of 26 years old for COVID-19 vaccination and experienced maternal exposure during pregnancy and painful arm. Concomitant medication included ferrous sulfate taken for caesarean section from 02Jun2021 to 15Jul2021. The patient experienced high temperature, chills and shivers, night sweat, fatigue and painful arm all on 17Jul2021, inappropriate schedule of vaccine administered on 17Jul2021, maternal exposure during breast feeding on an unspecified date. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 09Apr2021 (No - Negative COVID-19 test). Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of event high temperature, chills/shivers, and night sweat was recovered on 18Jul2021, outcome of events fatigue and painful arm was recovered on 19Jul2021. This is a serious report received with serious criteria other medically important condition from Regulatory Authority. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: "Based on the information in the case report a plausible temporal relationship, a possible causal relationship between the events Pyrexia, Chills , Night sweats, Fatigue, Pain in extremity and suspect drug BNT162B2 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. ,Linked Report(s) : GB-PFIZER INC-2021633497 Same patient and drug, different dose and events.;GB-PFIZER INC-202100956318 Mother-Baby case.


VAERS ID: 1514216 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Presyncope
SMQs:, Anticholinergic syndrome (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: PTJNJFOC20210752705

Write-up: LIPOTHYMIA, SWEATING, SKIN PALLOR, VASO-VAGAL REACTION; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-B202107-3393] concerned a 29 year old male with unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 expiry: UNKNOWN) 1 ml, one total administered on 17-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 17-JUL-2021, the patient experienced lipothymia, sweating, skin pallor, vaso-vagal reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lipothymia, sweating, skin pallor, vaso-vagal reaction on 17-JUL-2021. This report was serious (Other Medically Important Condition). Additional information was received from the reporter on 26-JUL-2021. The following information was updated and incorporated into the case narrative: RRT for event updated, unit dose changed from 0.5 ml to 1 ml .; Reporter''s Comments: Other information-Young 29-year-old that a few minutes after administration of the Janssen vaccine started with sweating, skin pallor, faint feeling/lipothymia, hypotension with recovery and, minutes 5-10, AT 105/66 CF 76 ACP without ltGlycemia 92 mg/dl, full recovered, dorsal decubitus and Tredelenburg maneuver; Sender''s Comments: V1 The follow up information in this version where RRT for event updated, unit dose changed from 0.5 ml to 1 ml. 20210752705-Covid-19 vaccine ad26.cov2.S- Lipothermia, sweating, skin pallor, vaso-vagal reaction. 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: 1514937 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bradycardia, Heart rate
SMQs:, Arrhythmia related investigations, signs and symptoms (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: 20210717; Test Name: Heart rate; Result Unstructured Data: Test Result:42 pulses instead of the usual 74; Comments: Sudden heart rate drop, 42 pulses instead of the usual 74
CDC Split Type: BEPFIZER INC202100919615

Write-up: Bradycardia (sudden heart rate drop, 42 pulses instead of the usual 74); This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration, on 15Jul2021, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On 17Jul2021, the patient experienced bradycardia (sudden heart rate drop, 42 pulses instead of the usual 74). Clinical outcome of the adverse event was unknown at time of this report. The reporter wanted to know if a second injection (planned on 02Aug2021) would still be ok or if the same or worse heart problems would occur. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1516787 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-17
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: 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 INC202100908767

Write-up: Bleeding; Period pains; This is a spontaneous report from a contactable Consumer. This is a report received from the Regulatory Authority; report number GB-MHRA-WEBCOVID-202107170637155690-A5J4N, Safety Report Unique Identifier GB-MHRA-ADR 25667912. A 39-year-old female non pregnant patient received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Formulation: Solution for injection, Batch/lot number and expiry date: not reported) via an unspecified route of administration on 09Jul2021 as SINGLE DOSE for COVID-19 Immunisation. Medical history included suppressed lactation, suspected covid-19 from 17Jul2021 and ongoing. The patient was not currently breastfeeding. The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The patient previously received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Batch/lot number and expiry date: not reported) via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunization. The patient''s concomitant medications were not reported.On an unspecified date, the patient experienced bleeding. On 17Jul2021, the patient experienced period pains. The patient had very severe period cramps and bleeding.On an unspecified date, the patient underwent lab tests and procedures which included sars-cov-2 test: negative. The outcome of period pain was reported as resolved on 17Jul2021. The outcome of bleeding was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516788 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Investigation, Nausea, SARS-CoV-2 test, Vomiting
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: CHLORPHENAMINE MALEATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hives; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: flow tests; Test Result: Negative ; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100908774

Write-up: Vomiting; Nausea; This is a spontaneous report from a contactable consumer received from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107170643559750-1K4IF. Safety Report Unique Identifier GB-MHRA-ADR 25667917. A 24-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 15Jul2021, as a single dose for COVID-19 immunization. The patient''s medical history included lactation decreased and hives. The patient has not had symptoms associated with COVID-19. The patient was not pregnant and was not currently breastfeeding. The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. Concomitant medication included chlorphenamine maleate taken for urticaria from 07Jul2018 to an unspecified stop date. On 17Jul2021, the patient experienced vomiting and nausea. The patient underwent lab tests and procedures which included COVID-19 virus test: negative No - Negative COVID-19 test and flow test with negative result on an unspecified date. Outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516798 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Joint stiffness, Off label use, Product use issue
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909101

Write-up: ongoing breastfeeding, received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE); ongoing breastfeeding, received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE); Joint pain; Stiff joint; This is a spontaneous report from a contactable consumer. This is a report received from a regulatory authority. A 30-year-old female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jul2021 (Batch/Lot number was Not known) as dose 2, single for COVID-19 immunisation. Medical history included ongoing breast feeding. The patient''s concomitant medications were not reported. On 17Jul2021, the patient experienced joint pain and stiff joint. The case was assessed as serious (medically significant). The outcome of the events ''joint pain'' and ''stiff joint'' was recovered with sequelae. The clinical course was reported as follows: Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1516815 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, 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: SERTRALINE; LOSARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Blood pressure abnormal
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202100908763

Write-up: Blood stool; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202107170943059810-WO5HZ, Safety Report Unique Identifier GB-MHRA-ADR 25668251. A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: FE1510), via an unspecified route of administration on 16Jul2021 (at the age of 49-year-old), as a single dose for COVID-19 immunization. The patients medical history included anxiety and blood pressure abnormal (from an unknown date and unknown if ongoing). Historical vaccination included that the patient received COVID-19 VACCINE ASTRAZENECA, via an unspecified route of administration on 05Apr2021, as dose 1 for COVID-19 immunization. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Concomitant medication(s) included sertraline (SERTRALINE) taken for anxiety (from 10May2009 to an unspecified stop date); losartan (LOSARTAN) taken for blood pressure abnormal (from 07Nov2019 to an unspecified stop date). On 17Jul2021, the patient experienced blood stool. The patient stated that he found blood mucus on toilet paper after going to the loo. First time going to loo this morning 17Jul2021, after having the jab 16Jul2021. The clinical outcome for the event was not recovered. The patient underwent lab tests and procedures which included blood pressure measurement: unknown results on (unspecified date). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516824 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dizziness, Feeling cold, Feeling of body temperature change, Headache, Malaise, Nausea, Pain in extremity, Piloerection, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Headache; Malaise
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100908922

Write-up: Shivers; Goose bumps; Fever; Feeling hot and cold; Headache dull; Dizziness; General malaise; Nausea; Strong pain in arm where vaccine was administered.; shivering; headache; nauseous; feeling cold; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is -MHRA-WEBCOVID-202107171126004340-7PXZH. Safety Report Unique Identifier GB-MHRA-ADR 25668493. An unspecified age and gender patient received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Lot number Fd8813) via an unspecified route of administration, on 16Jul2021 at a 2nd single dose for COVID-19 immunization. The patient medical history included headache and malaise. The patient concomitant medications were not reported. Unsure sure if patient has had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. On unspecified date, patient experienced shivering, headache, nauseous, feeling cold, shivers, on 17Jul2021, patient experienced Goose bumps, fever, feeling hot and cold, headache dull, dizziness, general malaise, nausea. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on No-Negative COVID-19 test. Narrative case summary and additional information No medicines currently being taken. Will take Paracetamol for current headache and general malaise Unsure if patient has had symptoms associated with COVID-19. Woke up in the middle of the night after having the vaccine very hot but feeling cold and shivering, with goosebumps. Also a slight headache and nausea. Temperature resolved itself within a few hours but the goosebumps won''t go away despite not being / feeling cold. Mild headache still present as is slight dizziness and general malaise. Also still feeling slightly nauseous. Strong pain in arm where vaccine was administered. The outcome of the events fever, feeling hot and cold was recovered on 17July2021, outcome of the events shivers, nausea was recovering, and other outcome of the events was not recovered. No follow-up attempts are possible, No further information is expected.


VAERS ID: 1516826 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Malaise, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), 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: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210622; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100908926

Write-up: Headache; Muscle ache; Feeling sick; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107171136198030-IROWO, Safety Report Unique Identifier: GB-MHRA-ADR 25668495. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 16Jul2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included suspected covid-19 from 21Jun2021 to 10Jul2021. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. Since 17Jul2021, the patient experienced headache, muscle ache, feeling sick. The patient underwent lab tests and procedures which included COVID-19 virus test: Yes - Positive COVID-19 test on 22Jun2021. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of the events was not recovered. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1516827 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 1 - / -

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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100908849

Write-up: Fainting; This is a spontaneous report from a contactable physician received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107171136238300-AXUMN. Safety Report Unique Identifier GB-MHRA-ADR 25668571. A 23-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: fd5613), via an unspecified route of administration on 17Jul2021 (at the age of 23 years old) as first dose, single for covid-19 immunization. The patient medical history reported as none; no significant medical history. The patient''s concomitant medications were not reported. The patient has not had symptoms associated with covid-19 and not had a covid-19 test. The patient experienced fainting on 17Jul2021 with outcome of recovered on unspecified date in Jul2021. It was further reported that the patient fainted immediately after receiving vaccine. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1516836 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813-L774 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cold sweat, Dizziness, Electrocardiogram, Epistaxis, Hypotension, Metabolic function test, Pallor, Presyncope, Tinnitus
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clamminess (from aneasthetic meds post-surgery 10 years ago); Dizziness (from aneasthetic meds post-surgery 10 years ago); Ringing in ears (from aneasthetic meds post-surgery 10 years ago); Surgery.
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: standing BP; Result Unstructured Data: Test Result:82/55; Test Name: ECG; Result Unstructured Data: Test Result:Unknown result; Test Name: BM; Result Unstructured Data: Test Result:Unknown result
CDC Split Type: GBPFIZER INC202100908984

Write-up: dizziness; clamminess; Nosebleed; ringing in ears; blood pressure dropped to 82/55; clammy; pale; felt like he was going to collapse /Vasovagal reaction; This is a spontaneous report from a contactable other HCP received from the Regulatory Authority Regulatory Agency (RA). The regulatory authority report number: GB-MHRA-WEBCOVID-202107171226031600-Z8PD3, Safety Report Unique Identifier: GB-MHRA-ADR 25668601. A 27-year-old male patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 17Jul2021 (Lot Number: FD8813-L774) as single dose for COVID-19 immunisation. Patient was 27-year-old at the time of vaccination. Medical history included surgery. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient previously took aneasthetic meds (unspecified) post-surgery 10 years ago (2011) and experienced dizziness, clamminess and ringing in ears. The patient experienced dizziness and clamminess on an unspecified date; and ringing in ears 7 minutes post vaccine on 17Jul2021. Patient reports similar reaction to aneasthetic meds post-surgery 10 years ago. On 17Jul2021, the patient''s blood pressure dropped to 82/55 (standing BP) and was looking clammy, pale and felt like he was going to collapse on an unspecified date. 999 was called for further assessment. Patient recovered. It was reported to be likely a vasovagal episode. Patient was discharged. The patient also experienced nosebleed on an unspecified date. The events were considered non-serious. Other relevant investigations or tests conducted on an unspecified date included BM and ECG (unknown results). Patient has not tested positive for COVID-19 since having the vaccine. The report does not relate to possible blood clots or low platelet counts. The patient recovered from blood pressure dropped, clammy, pale and vasovagal reaction on an unspecified date in Jul2021 while outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516840 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100908864

Write-up: numb arm; Pins and needles; This is a spontaneous report from a contactable consumer or other non hcp received from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authori-ty report number is GB-MHRA-WEBCOVID-202107171250398110-Safety Report Unique Identifier: GB-MHRA-ADR 25668675. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced numb arm, pins and needles on 17Jul2021. Patient was having heavy, numb arm and hand, with pins and needles in whole arm and hand of vaccinated side. Reduced feeling in hand and fingers. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No relevant investigations or tests were conducted. The outcome of event pins and needles was not recovered and outcome for event numb arm was unknow. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516858 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH BN FD8813 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhage, Menstruation irregular, Migraine, 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: Migraine
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100909282

Write-up: bleeding; migraine; Irregular menstrual cycle; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is-MHRA-WEBCOVID-202107171444120050-CZCPD, Safety Report Unique Identifier -MHRA-ADR 25668854. A 39-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jul2021 (Lot Number: BN FD8813) as single dose for COVID-19 immunization. Medical history included migraine. Patient had not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced bleeding on an unspecified date, irregular periods, irregular menstrual cycle on 17Jul2021, migraine on an unspecified date. Patient woke up this morning with migraine. The menstruation suddenly started late morning. The last menstruation patient had 2 weeks ago. Patient never had any irregular periods, always was perfectly on time. Bleeding was not strong, but was consistent. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 16Jul2021: No - Negative COVID-19 test. Outcome of irregular menstrual cycle was not recovered and the other events were recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516860 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Loss of personal independence in daily activities, Malaise, Menstruation irregular, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test, Urinary retention
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Fertility disorders (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: NEXPLANON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Birth control; Eczema; Environmental allergy; Fever (getting a fever with colds.); Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210615; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100909293

Write-up: unwell; i am unable to carry; unable to carry on with her daily activities; Fever; Generalised muscle aches; Nausea; Chills; Menstruation irregular; Headache; This is a spontaneous report from a contactable consumer. This is the first of 2 reports. The first report is a report received from the Regulatory Authority.The regulatory authority report number is GB-MHRA-WEBCOVID-202107171504239180-IPADL.Safety Report Unique Identifier GB-MHRA-ADR 25668869. A 25-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 16Jul2021 as single dose for Covid-19 immunisation. Medical history included lactation decreased, eczema and environmental allergies (dust/chemicals/scents/pollen/animals) and often had big immune responses such as getting a fever with colds, birth control. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Concomitant medication included etonogestrel (NEXPLANON) taken for birth control from 2013 to an unspecified stop date. Historical vaccine included the first dose of BNT162B2 for Covid-19 immunisation and experienced covid with symptoms, a change in her periods and an hour or two of chills. The patient experienced unwell on an unspecified date, she was unable to carry on an unspecified date, fever on 17Jul2021, generalised muscle aches on 17Jul2021, nausea on 17Jul2021, chills on 17Jul2021, menstruation irregular on 17Jul2021, headache on 17Jul2021. Today patient felt the same as she did when she covid symptoms were near their worst. She thought having already had covid had worsened her reaction as this is significantly worse than her first vaccine and she was unable to carry on with her daily activities. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 15Jun2021: Yes-Positive COVID-19 test. Case was reported as serious, other medically important condition. Outcome of events were not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : 202100920406 same patient but different dose,different event


VAERS ID: 1516865 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, SARS-CoV-2 test
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210712; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100908749

Write-up: Diarrhea; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202107171540553040-XZOBT, Safety Report Unique Identifier GB-MHRA-ADR 25668922. A 37-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number unknown), dose 2, single via an unspecified route of administration, on 16Jul2021 at a single dose for COVID-19 immunization. The patient medical history included suppressed lactation from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient did not COVID-19 test since having the vaccine. Patient is not enrolled in clinical trial. On 17Jul2021 patient experienced Diarrhea. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 12Jul2021 No - Negative COVID-19 test. The outcome of the event was recovered on 17Jul2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1516873 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909032

Write-up: Nosebleed; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107171721185800-JWBDO, Safety Report Unique Identifier is GB-MHRA-ADR 25669012. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 16Jul2021 at dose 2, single for COVID-19 immunization. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test, was not pregnant, and not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced nosebleed on 17Jul2021. The event was reported as serious per other medically important condition. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event was not recovered. No follow-up attempts are possible. information about lot/batch number cannot be obtained.


VAERS ID: 1516880 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Axillary pain
SMQs:, Arthritis (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: SYMBICORT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909149

Write-up: Armpit pain; Shoulder blade pain; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107171818368150-7FTXB. Safety Report Unique Identifier is GB-MHRA-ADR 25669114. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FD8813), via an unspecified route of administration on 16Jul2021 as dose 2, single for COVID-19 immunization. Medical history included lactation decreased and asthma. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test, was not pregnant and not currently breastfeeding. Concomitant medication included budesonide, formoterol fumarate (SYMBICORT) taken for asthma from 16Jul2021. The patient experienced armpit pain and shoulder blade pain on 17Jul2021. The events were reported as serious per other medically important condition. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516887 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac flutter, Chest discomfort, Chest pain
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909234

Write-up: Heart fluttering; Chest pain; Tight chest; This is a spontaneous report from a contactable consumer. This report is received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107171854495730-LEXK1. Safety Report Unique Identifier is GB-MHRA-ADR 25669163. A 25-year-old female patient (not pregnant during vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 16Jul2021 as dose 1, single for COVD-19 immunization. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patients concomitant medications were not reported. On 17Jul2021 the patient experienced heart fluttering, chest pain and tight chest. The outcome of all the events was reported as not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516890 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Lymphadenopathy, Mobility decreased, Pain, Renal function test, Renal impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Tumour lysis 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? 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: Asthma; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: Blood tests; Result Unstructured Data: Test Result:kidney function came back low; Comments: kidney function came back low; Test Name: Kidney fnction test; Result Unstructured Data: Test Result:kidney function came back low; Comments: kidney function came back low
CDC Split Type: GBPFIZER INC202100908965

Write-up: sore to the touch and hurt with sudden movements of the head; sore to the touch and hurt with sudden movements of the head; kidney function came back low; Swollen glands; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107172004456870-EHUVR, Safety Report Unique Identifier is GB-MHRA-ADR 25669231. A 29-year-old non pregnant and not currently breastfeeding female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiry date: unknown) via an unspecified route of administration on 17Jul2021 (at the age of 29 years) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included suppressed lactation and asthma. The patient concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiry date: unknown) via an unspecified route of administration on an unspecified date for COVID-19 immunization. Patient had the same reaction with first dose, the gland near my collar bone on the left side (the side where vaccine was administered) grew to the size of average malteaser and stayed for around 5 weeks, sore to the touch and hurt with sudden movements of the head. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient had no symptoms associated with COVID-19. Not had a COVID-19 test. On 17Jul2021, the patient experienced swollen glands. On an unspecified date, the patient was sore to the touch and hurt with sudden movements of the head and kidney function came back low. On an unspecified date, the patient underwent blood test and kidney test: kidney function came back low. The outcome of swollen glands was reported as not recovered. The outcome of the events kidney function came back low and sore to the touch and hurt with sudden movements of the head was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1516902 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909395

Write-up: palpitations; irregular heart beat; Exercise induced palpitation; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107172210038250-EEKVK. A 38-years-old male patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: FE1510), dose 2 via an unspecified route of administration on 17Jul2021 as DOSE 2, SINGLE for covid-19 immunisation.The patient medical history was not reported.The patient''s concomitant medications were not reported. The patient experienced palpitations on an unspecified date, exercise induced palpitation on 17Jul2021, irregular heart beat on an unspecified date.Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Doing sprint (running) repeats I noticed heart palpitations and an irregular heart beat for approximately 1.5 hours after exercise.Patient has not tested positive for COVID-19 since having the vaccine.Patient is not enrolled in clinical trial.The events were assessed as serious. The outcome of event for Exercise induced palpitation was recovered on 17Jul2021.Outcome of events was unknown on unknown date. No follow-up attempts are possible. No further information is expected.


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