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From the 1/14/2022 release of VAERS data:

Found 1,031,637 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

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VAERS ID: 1918583 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Headache, Pain in extremity, SARS-CoV-2 test
SMQs:, 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: METFORMIN
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Headache; Shivers; Painful arm; Joint pain; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26238084) on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Shivers), PAIN IN EXTREMITY (Painful arm) and ARTHRALGIA (Joint pain) in a 61-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna Intramuscular Injection) (batch no. 3004675) for an unknown indication. No medical history was provided by the reporter. Concomitant products included METFORMIN from 01-Jan-2015 to an unknown date for Diabetes. On 22-Nov-2021, the patient received third dose of mRNA-1273 (COVID-19 Vaccine Moderna Intramuscular Injection) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant) and ARTHRALGIA (Joint pain) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), CHILLS (Shivers), PAIN IN EXTREMITY (Painful arm) and ARTHRALGIA (Joint pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna Intramuscular Injection) (Unknown) was unknown. No treatment information was provided. Patient mentioned that Symptoms from waking up morning after the vaccination, got worse during the day. Patient has 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 Company Comment: This is a regulatory authority case concerning a 61-year-old, male patient with no relevant medical history, who experienced the serious events of headache, chills, pain in extremity and arthralgia. The events headache, chills, pain in extremity and arthralgia occurred 1 day after the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 61-year-old, male patient with no relevant medical history, who experienced the serious events of headache, chills, pain in extremity and arthralgia. The events headache, chills, pain in extremity and arthralgia occurred 1 day after the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1918598 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

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

Write-up: Hours; Injection; Nausea; Vomiting; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26238864) on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Hours), INJECTION (Injection), NAUSEA (Nausea) and VOMITING (Vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Previously administered products included for Product used for unknown indication: DEPO-MEDRONE. Past adverse reactions to the above products included No adverse event with DEPO-MEDRONE. Concurrent medical conditions included Psoriatic arthritis. On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant) and VOMITING (Vomiting) (seriousness criterion medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (Hours) (seriousness criterion medically significant) and INJECTION (Injection) (seriousness criterion medically significant). At the time of the report, FEELING ABNORMAL (Hours), INJECTION (Injection), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. It was stated that patient experienced nausea from 10 hours after injection and vomiting 20 hours after injection. It was stated that patient had a steroid injection recently, but it was a one off for psoriatic arthritis. Company comments This regulatory authority case concerns a female patient with no reported relevant medical history, who experienced the unexpected serious events of nausea and vomiting. The events are unexpected as they are retained as serious per the source document Authority reporting. Nausea and vomiting occurred 1 day after the third dose (unknown dosage) of mRNA-1273. Regulatory authority reported the rechallenge as unknown, however, the outcome of the events is not recovered. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This regulatory authority case concerns a female patient with no reported relevant medical history, who experienced the unexpected serious events of nausea and vomiting. The events are unexpected as they are retained as serious per the source document Authority reporting. Nausea and vomiting occurred 1 day after the third dose (unknown dosage) of mRNA-1273. Regulatory authority reported the rechallenge as unknown, however, the outcome of the events is not recovered. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1918605 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLUCELVAX TETRA [INFLUENZA VACCINE INACT SAG 4V]
Current Illness:
Preexisting Conditions: Comments: No Medical History information was reported.
Allergies:
Diagnostic Lab Data: Test Date: 20210623; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fever chills; Headache dull; Appetite lost; Joint ache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26239588) on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever chills), HEADACHE (Headache dull), DECREASED APPETITE (Appetite lost) and ARTHRALGIA (Joint ache) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. Previously administered products included for Product used for unknown indication: AZ Covid vaccine in March 2021 and AZ Covid vaccine in May 2021. Past adverse reactions to the above products included No adverse event with AZ Covid vaccine and AZ Covid vaccine. Concomitant products included INFLUENZA VACCINE INACT SAG 4V (FLUCELVAX TETRA [INFLUENZA VACCINE INACT SAG 4V]) from 22-Nov-2021 to an unknown date for Flu vaccination. On 22-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced PYREXIA (Fever chills) (seriousness criterion medically significant), HEADACHE (Headache dull) (seriousness criterion medically significant), DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant) and ARTHRALGIA (Joint ache) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever chills) and HEADACHE (Headache dull) was resolving and DECREASED APPETITE (Appetite lost) and ARTHRALGIA (Joint ache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jun-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment medication was not provided by the reporter. Patient''s symptoms started about 3 am, approximately 24 hours after receiving both vaccines. She woke up to go to the bathroom, and felt ill from then on. She could not go to work on 23rd November, but stayed in bed all day. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Company Comment: This is a regulatory authority case concerning a female patient of an unknown age with no relevant medical history reported, who experienced serious, unexpected events of Pyrexia, Headache, Decreased appetite and Arthralgia. The events occurred approximately 1 day after the third dose of mRNA-1273 vaccine. Previously administered products included AZ Covid vaccine in March 2021 and AZ Covid vaccine in May 2021. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a female patient of an unknown age with no relevant medical history reported, who experienced serious, unexpected events of Pyrexia, Headache, Decreased appetite and Arthralgia. The events occurred approximately 1 day after the third dose of mRNA-1273 vaccine. Previously administered products included AZ Covid vaccine in March 2021 and AZ Covid vaccine in May 2021. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1918607 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Body temperature increased, Headache, Myalgia, Oropharyngeal pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Very faint; Sore throat; Headache; Headache fullness; Body temperature increased; Joint pain; Muscle pain; This case was received via RA (Reference number: GB-MHRA-ADR 26239894) on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Very faint), OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache), HEADACHE (Headache fullness), BODY TEMPERATURE INCREASED (Body temperature increased), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. No Medical History information was reported. On 22-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced HEADACHE (Headache fullness) (seriousness criterion disability), BODY TEMPERATURE INCREASED (Body temperature increased) (seriousness criterion disability), ARTHRALGIA (Joint pain) (seriousness criterion disability) and MYALGIA (Muscle pain) (seriousness criterion disability). On an unknown date, the patient experienced SYNCOPE (Very faint) (seriousness criteria disability and medically significant), OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion disability) and HEADACHE (Headache) (seriousness criterion disability). At the time of the report, SYNCOPE (Very faint), OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache), HEADACHE (Headache fullness), BODY TEMPERATURE INCREASED (Body temperature increased), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. 10 minutes after having the Moderna booster vaccine, patient felt very faint and hot. Had to lie down with the feet up, laid like that for approximately half an hour. One day post vaccination, patient have been very hot, had a sore throat and a headache. Patient''s joints and muscles were very sore that made walking difficult. Patient was taking paracetamol with little effect. Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Company Comment: This is a regulatory case concerning a female patient of an unknown age, with no relevant medical history of reported , who has experienced the serious unexpected events of SYNCOPE, OROPHARYNGEAL PAIN, HEADACHE, BODY TEMPERATURE INCREASED ARTHRALGIA on the same day after receiving the third dose of mRNA1273 vaccine. 10 minutes after having the mRNA-1273 booster vaccine, patient felt very faint and hot. Had to lie down with the feet up, laid like that for approximately half an hour. One day post vaccination, patient have been very hot, had a sore throat and a headache. Patient''s joints and muscles were very sore that made walking difficult The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per regulatory reporting; Sender''s Comments: This is a regulatory case concerning a female patient of an unknown age, with no relevant medical history of reported , who has experienced the serious unexpected events of SYNCOPE, OROPHARYNGEAL PAIN, HEADACHE, BODY TEMPERATURE INCREASED ARTHRALGIA on the same day after receiving the third dose of mRNA1273 vaccine. 10 minutes after having the mRNA-1273 booster vaccine, patient felt very faint and hot. Had to lie down with the feet up, laid like that for approximately half an hour. One day post vaccination, patient have been very hot, had a sore throat and a headache. Patient''s joints and muscles were very sore that made walking difficult The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per regulatory reporting


VAERS ID: 1918613 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Headache, Lip swelling, Neck pain, Paraesthesia, SARS-CoV-2 test, Swollen tongue, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: High cholesterol
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: lips started swelling; tingling of lips; neck pain; Lip swelling; Throat tightness; Headache; Tongue swelling non-specific; Chest pain; This case was received via RA (Reference number: GB-MHRA-ADR 26240080) on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LIP SWELLING (lips started swelling), PARAESTHESIA (tingling of lips), NECK PAIN (neck pain), LIP SWELLING (Lip swelling), THROAT TIGHTNESS (Throat tightness), HEADACHE (Headache), SWOLLEN TONGUE (Tongue swelling non-specific) and CHEST PAIN (Chest pain) in a 56-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for COVID-19 vaccination. The patient''s past medical history included High cholesterol. Previously administered products included for Product used for unknown indication: CITALOPRAM and LANSOPRAZOLE. Past adverse reactions to the above products included No adverse event with CITALOPRAM and LANSOPRAZOLE. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced LIP SWELLING (Lip swelling) (seriousness criterion hospitalization), THROAT TIGHTNESS (Throat tightness) (seriousness criterion hospitalization), HEADACHE (Headache) (seriousness criterion hospitalization), SWOLLEN TONGUE (Tongue swelling non-specific) (seriousness criterion hospitalization) and CHEST PAIN (Chest pain) (seriousness criterion hospitalization). On an unknown date, the patient experienced LIP SWELLING (lips started swelling) (seriousness criterion hospitalization), PARAESTHESIA (tingling of lips) (seriousness criterion hospitalization) and NECK PAIN (neck pain) (seriousness criterion hospitalization). At the time of the report, LIP SWELLING (lips started swelling), PARAESTHESIA (tingling of lips), NECK PAIN (neck pain), LIP SWELLING (Lip swelling), THROAT TIGHTNESS (Throat tightness), HEADACHE (Headache) and SWOLLEN TONGUE (Tongue swelling non-specific) was resolving and CHEST PAIN (Chest pain) had 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) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant drug information provided. The patient relevant history included HRT patches. Reporter stated that she had jab and then within a few minutes felt tingling of lips and tongue. Lips started swelling, she felt she could not get enough air into her through her mask. Called for help. Throat was getting tight and occasionally chest pain. Epipen adrenaline given. Ambulance called. Head and neck pain. Admittedly to a&e. The patient''s treatment included paracetamol, adrenaline steroids and anti-histamine for 3 days. Company Comment: This case concerns a 56-year-old, female patient with relevant medical history of high cholesterol, who experienced the unexpected events of lip swelling, paraesthesia, neck pain, throat tightness, headache, swollen tongue and chest pain. The events occurred the same day after the third dose of mRNA-1273. The rechallenge was unknown as was reported by Regulatory Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 56-year-old, female patient with relevant medical history of high cholesterol, who experienced the unexpected events of lip swelling, paraesthesia, neck pain, throat tightness, headache, swollen tongue and chest pain. The events occurred the same day after the third dose of mRNA-1273. The rechallenge was unknown as was reported by Regulatory Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1918623 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza like illness
SMQs:

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

Write-up: Flu like symptoms; This case was received via RA (Reference number: GB-MHRA-ADR 26240170) on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 54-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for COVID-19 vaccination. No Medical History information was reported. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion medically significant). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) was resolving. 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 regulatory case concerning a 54-year-old female patient with no relevant medical history reported who experienced the unexpected and serious event of influenza like illness. The event occurred the same day after a third dose of mRNA-1273 vaccine was administered. The rechallenge was not applicable since events happened after third dose and no further dose is expected. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 54-year-old female patient with no relevant medical history reported who experienced the unexpected and serious event of influenza like illness. The event occurred the same day after a third dose of mRNA-1273 vaccine was administered. The rechallenge was not applicable since events happened after third dose and no further dose is expected. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1918637 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pain, SARS-CoV-2 test, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (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: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Shaking; Pain dull; This case was received via RA (Reference number: GB-MHRA-ADR 26240974) on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of in a 68-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna Intramuscular Injection) for an unknown indication. No medical history was provided by the reporter. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 09-May-2021 to an unknown date for an unknown indication. On 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID-19 Vaccine Moderna Intramuscular Injection) (unknown route) 1 dosage form. 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 (COVID-19 Vaccine Moderna Intramuscular Injection) (Unknown) was unknown. Patient was unable to move injected arm without pain unable to sleep due to pain of arm also unable to stop shaking. Patient took 2 paracetamol 3.5 hours after the injection the arm was still very painful used 2 more paracetamol at 1 am Shaking started at about 12.30 ( midnight plus 30 mins) roughly 15 minutes after patient going to bed. Patient had 2 blankets a duvet a thick dressing gown and a sweatshirt on plus a fan heater - still shook for a while even with distraction of writing this still could not stop shaking and arm still very painful after the second paracetamol dose. Her first dose of vaccine was Astra Zeneca she was violently sick and had uncontrollable shaking - at one point thought she was severely ill, 2nd Dose was Astra Zeneca no reaction Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. Company Comment: This is a regulatory authority case concerning a 68-year-old, female patient with vaccine history of receiving another brand of Covid-19 vaccine (Covid-19 vaccine AstraZeneca) as primary doses, who experienced the unexpected serious events of shaking and pain. The event pain occurred the same day after the third dose of mRNA-1273 vaccine administration while the event pain occurred 1 day after the third dose of mRNA-1273 vaccine administration. The patient also experienced adverse event of shaking after her first dose of Covid-19 vaccine (Covid-19 vaccine AstraZeneca). The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 68-year-old, female patient with vaccine history of receiving another brand of Covid-19 vaccine (Covid-19 vaccine AstraZeneca) as primary doses, who experienced the unexpected serious events of shaking and pain. The event pain occurred the same day after the third dose of mRNA-1273 vaccine administration while the event pain occurred 1 day after the third dose of mRNA-1273 vaccine administration. The patient also experienced adverse event of shaking after her first dose of Covid-19 vaccine (Covid-19 vaccine AstraZeneca). The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1918638 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Morning sickness, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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: GABAPENTIN; INFLUENZA VIRUS.
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MORNING SICKNESS (Nausea gravidarum) and PYREXIA (Feverish) in a 58-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included GABAPENTIN for Low back pain, INFLUENZA VACCINE (INFLUENZA VIRUS) for an unknown indication. On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced MORNING SICKNESS (Nausea gravidarum) (seriousness criterion medically significant) and PYREXIA (Feverish) (seriousness criterion medically significant). At the time of the report, MORNING SICKNESS (Nausea gravidarum) and PYREXIA (Feverish) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication was reported.Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial.Company comment: This case concerns a 58-year-old, female patient with no medical history, who experienced the unexpected events of morning sickness and pyrexia. The events occurred approximately 2 days after the third dose of mRNA-1273. It was reported by the Regulatory Authority that the patient experienced nausea gravidarum, but no information regarding pregnancy was provided and considering the patient''s age the event seems unlikely. The rechallenge was not applicable as events occurred after third dose and no further dosing was reported or planned, based on information provided. The events were ongoing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. Sender''s Comments: This case concerns a 58-year-old, female patient with no medical history, who experienced the unexpected events of morning sickness and pyrexia. The events occurred approximately 2 days after the third dose of mRNA-1273. It was reported by the Regulatory Authority that the patient experienced nausea gravidarum, but no information regarding pregnancy was provided and considering the patient''s age the event seems unlikely. The rechallenge was not applicable as events occurred after third dose and no further dosing was reported or planned, based on information provided. The events were ongoing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1918641 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211109; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Leg cramps; This case was received via RA (Reference number: GB-MHRA-ADR 26241304) on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Leg cramps) in a 48-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for an unknown indication. Concurrent medical conditions included Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...). On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced MUSCLE SPASMS (Leg cramps) (seriousness criterion medically significant). At the time of the report, MUSCLE SPASMS (Leg cramps) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2021, 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. No relevant concomitant medications were reported. No treatment information was provided. Patient had severe cramp in left upper leg only. Patient was not enrolled in clinical trial Company Comment: This is a regulatory case concerning a 48 year-old male patient, with medical history of immunodeficiency, who has experienced the serious unexpected event of muscle spasm on the same day after receiving the third dose of mRNA1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per regulatory reporting; Sender''s Comments: This is a regulatory case concerning a 48 year-old male patient, with medical history of immunodeficiency, who has experienced the serious unexpected event of muscle spasm on the same dat after receiving the third dose of mRNA1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per regulatory reporting


VAERS ID: 1918642 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

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

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

Write-up: Pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26241318) on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Pain) in a 61-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. No Medical History information was reported. On 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced PAIN (Pain) (seriousness criterion medically significant). At the time of the report, PAIN (Pain) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No relevant concomitant medications reported. Patient had an ache around the injection site after dose 1 and thought that this booster dose was going to be the same and fade within a few hours. Instead, the pain went from being "uncomfortable" to sufficient to keep him awake all night and is still at that level now. Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. No treatment medications reported. Company Comment: This regulatory authority case concerns a 61 year-old, male patient with no relevant medical history, who experienced the serious (due to medically important condition) unexpected event of pain. The event occurred the same day after the booster dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event was reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 61 year-old, male patient with no relevant medical history, who experienced the serious (due to medically important condition) unexpected event of pain. The event occurred the same day after the booster dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event was reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1918649 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-23
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Ear pain, Fatigue, Headache, Nausea, Neuralgia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

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

Write-up: Neuralgia; Earache; Tiredness; Headache; Nausea; Dizziness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26242269) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NEURALGIA (Neuralgia), EAR PAIN (Earache), FATIGUE (Tiredness), HEADACHE (Headache), NAUSEA (Nausea) and DIZZINESS (Dizziness) in a 63-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. Concomitant products included ATORVASTATIN and CLOPIDOGREL for Stroke. In 2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced NEURALGIA (Neuralgia) (seriousness criterion medically significant), EAR PAIN (Earache) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). On 24-Nov-2021, HEADACHE (Headache), NAUSEA (Nausea) and DIZZINESS (Dizziness) had resolved. At the time of the report, NEURALGIA (Neuralgia), EAR PAIN (Earache) and FATIGUE (Tiredness) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The treatment information was not provided. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Company Comment: This is a regulatory authority case concerning a 63-year-old, female patient with use of concomitant products Clopidogrel and Atorvastatin, who experienced the unexpected serious events of Neuralgia, Ear pain, Fatigue, Headache, Nausea, Dizziness. The events occurred approximately on an unknown day after the third dose of mRNA 1273 Covid-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The use of concomitant medication Clopidogrel and Atorvastatin remains a confounder. The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 63-year-old, female patient with use of concomitant products Clopidogrel and Atorvastatin, who experienced the unexpected serious events of Neuralgia, Ear pain, Fatigue, Headache, Nausea, Dizziness. The events occurred approximately on an unknown day after the third dose of mRNA 1273 Covid-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The use of concomitant medication Clopidogrel and Atorvastatin remains a confounder. The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, is not affected by this report.


VAERS ID: 1918653 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions: Comments: The patient medical history was not provided
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Diarrhea; This case was received via RA (Reference number: GB-MHRA-ADR 26243541) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 68-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for an unknown indication. Co-suspect product included non-company product HEPATITIS A VACCINE for an unknown indication. The patient medical history was not provided. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started HEPATITIS A VACCINE (unknown route) at an unspecified dose. On 23-Nov-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant). On 23-Nov-2021, DIARRHOEA (Diarrhea) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had sudden onset stomach pain and acute diarrhea six hours after booster vaccine. Patient had not tested positive for COVID-19 since having the vaccine. Treatment information was not provided Company Comment : This is a regulatory authority case concerning a 68-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of Diarrhea. The events occurred approximately on the same day after the third dose of mRNA 1273 Covid-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 68-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of Diarrhea. The events occurred approximately on the same day after the third dose of mRNA 1273 Covid-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, is not affected by this report.


VAERS ID: 1918657 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-23
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: 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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; EZETIMIBE; FLUCELVAX TETRA [INFLUENZA VACCINE INACT SAG 4V]; THYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Inflammatory bowel disease (Moderna vaccine also caused flare up of IBS which have not suffered from foe some time. Took buscopan to help relieve symptoms.)
Allergies:
Diagnostic Lab Data: Test Date: 20211019; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Muscle ache; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26244832) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Muscle ache) in a 64-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Inflammatory bowel disease (Moderna vaccine also caused flare up of IBS which have not suffered from foe some time. Took buscopan to help relieve symptoms.). Previously administered products included for Product used for unknown indication: BUSCOPAN. Past adverse reactions to the above products included Inflammatory bowel disease with BUSCOPAN. Concomitant products included EZETIMIBE for Cholesterol, LEVOTHYROXINE SODIUM (THYROXINE) for Hypothyroidism, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 09-Mar-2021 to an unknown date and INFLUENZA VACCINE INACT SAG 4V (FLUCELVAX TETRA [INFLUENZA VACCINE INACT SAG 4V]) from 18-Oct-2021 to an unknown date for an unknown indication. On an unknown date, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced MYALGIA (Muscle ache) (seriousness criterion disability). At the time of the report, MYALGIA (Muscle ache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Oct-2021, SARS-CoV-2 test: negative (Negative) negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19. Severe muscle ache in lower back, hips and both legs. No treatment medication were provided. Company Comment : This is a regulatory authority case concerning a 64-year-old, female patient with use of concomitant medications levothyroxine and ezetimibe, who experienced the unexpected serious event of myalgia. The event occurred approximately on an unknown day after the unknown dose of mRNA 1273 Covid-19 Vaccine. The rechallenge was not applicable, as the event happened after the unknown dose. The use of concomitant medication use of concomitant medications levothyroxine and ezetimibe remains a confounder. The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 64-year-old, female patient with use of concomitant medications levothyroxine and ezetimibe, who experienced the unexpected serious event of myalgia. The event occurred approximately on an unknown day after the unknown dose of mRNA 1273 Covid-19 Vaccine. The rechallenge was not applicable, as the event happened after the unknown dose. The use of concomitant medication use of concomitant medications levothyroxine and ezetimibe remains a confounder. The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, is not affected by this report.


VAERS ID: 1918658 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bone pain, SARS-CoV-2 test, Vaccination site pain, Ventricular tachycardia
SMQs:, Torsade de pointes/QT prolongation (narrow), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Osteonecrosis (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211124; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Bone pain; Ventricular tachycardia; Vaccination site pain; This case was received via RA (Reference number: GB-MHRA-ADR 26244931) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BONE PAIN (Bone pain), VENTRICULAR TACHYCARDIA (Ventricular tachycardia) and VACCINATION SITE PAIN (Vaccination site pain) in a 53-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. Concomitant products included BISOPROLOL from 30-Sep-2020 to an unknown date for Ventricular tachycardia. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) (seriousness criteria medically significant and life threatening). On 24-Nov-2021, the patient experienced BONE PAIN (Bone pain) (seriousness criteria medically significant and life threatening) and VENTRICULAR TACHYCARDIA (Ventricular tachycardia) (seriousness criteria medically significant and life threatening). On 24-Nov-2021, VENTRICULAR TACHYCARDIA (Ventricular tachycardia) had resolved with sequelae. At the time of the report, BONE PAIN (Bone pain) was resolving and VACCINATION SITE PAIN (Vaccination site pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Nov-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was woke up with pain all over in bones at 3am and patient believed that her Ventricular tachycardia was set off by vaccine as a side effect. The patient underwent ECG and blood test. The patient was not enrolled in clinical trial. Treatment information was not provided by the reporter. This case concerns a 53-year-old female patient with a medical history of ventricular tachycardia, who experienced the unexpected events of bone pain, ventricular tachycardia, and vaccination site pain. The event vaccination site pain occurred on the same day after the third dose of mRNA � 1273 vaccine, while the two other events was experienced a day after. Events were reported as life threatening and medically significant but on the same day ventricular tachycardia resolved with sequelae. at the time of report vaccination site pain had resolved and bone pain was resolving. The rechallenge is unknown since no information about the first two doses were disclosed. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This case concerns a 53-year-old female patient with a medical history of ventricular tachycardia, who experienced the unexpected events of bone pain, ventricular tachycardia, and vaccination site pain. The event vaccination site pain occurred on the same day after the third dose of mRNA � 1273 vaccine, while the two other events was experienced a day after. Events were reported as life threatening and medically significant but on the same day ventricular tachycardia resolved with sequelae. at the time of report vaccination site pain had resolved and bone pain was resolving. The rechallenge is unknown since no information about the first two doses were disclosed. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1918660 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test, Vulvovaginal pain, Vulvovaginal pruritus, Vulvovaginal swelling
SMQs:, Angioedema (broad), Hypersensitivity (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CO-CODAMOL; COVID-19 VACCINE ASTRAZENECA; GABAPENTIN; INFLUENZA VIRUS; MIRENA; SERTRALINE
Current Illness:
Preexisting Conditions: Comments: No relevant medical history reported
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Result given Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Vulval swelling; Vulval itching; Vulval pain; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26245629) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VULVOVAGINAL SWELLING (Vulval swelling), VULVOVAGINAL PRURITUS (Vulval itching) and VULVOVAGINAL PAIN (Vulval pain) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No relevant medical history reported . Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) for Vaccination, CODEINE PHOSPHATE, PARACETAMOL (CO-CODAMOL), COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA), GABAPENTIN, LEVONORGESTREL (MIRENA) and SERTRALINE for an unknown indication. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced VULVOVAGINAL SWELLING (Vulval swelling) (seriousness criterion medically significant), VULVOVAGINAL PRURITUS (Vulval itching) (seriousness criterion medically significant) and VULVOVAGINAL PAIN (Vulval pain) (seriousness criterion medically significant). At the time of the report, VULVOVAGINAL SWELLING (Vulval swelling), VULVOVAGINAL PRURITUS (Vulval itching) and VULVOVAGINAL PAIN (Vulval pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Result given Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication information provided Company comment: This is a regulatory authority case concerning a female patient of unknown age with no relevant medical history, who experienced the unexpected serious events of Vulvovaginal swelling, Vulvovaginal pruritus, Vulvovaginal pain. The events occurred approximately on the same day after the third dose of mRNA 1273 Covid-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a female patient of unknown age with no relevant medical history, who experienced the unexpected serious events of Vulvovaginal swelling, Vulvovaginal pruritus, Vulvovaginal pain. The events occurred approximately on the same day after the third dose of mRNA 1273 Covid-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, is not affected by this report.


VAERS ID: 1918664 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA FIRST DOSE / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Feeling abnormal, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef.))
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: Negative.
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: vomiting; very high fever; Feels bad; This case was received via Regulatory Authority on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VOMITING (vomiting), PYREXIA (very high fever) and FEELING ABNORMAL (Feels bad) in a 27-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. First dose) for an unknown indication. Concurrent medical conditions included Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef)). On 23-Nov-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced FEELING ABNORMAL (Feels bad) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced VOMITING (vomiting) (seriousness criteria disability and medically significant) and PYREXIA (very high fever) (seriousness criteria disability and medically significant). On 23-Nov-2021, FEELING ABNORMAL (Feels bad) had not resolved. At the time of the report, VOMITING (vomiting) and PYREXIA (very high fever) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Nov-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative.The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. It was verbally reported that, he can eat nothing.No Concomitant drugs were reported.No Treatment information were reported. Company comment: This case concerns a 27-year-old male patient with a medical history of immunodeficiency, who experienced the unexpected events of vomiting, pyrexia, and feeling abnormal. The events occurred on the same day after the first dose of mRNA � 1273 vaccine. Events were reported as disabling and medically significant and at the time of report has not resolved. As per source document patient also experienced not able to eat anything. The rechallenge is unknown since the events happened after the first dose and no information yet regarding the second dose is provided. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report. Sender''s Comments: This case concerns a 27-year-old male patient with a medical history of immunodeficiency, who experienced the unexpected events of vomiting, pyrexia, and feeling abnormal. The events occurred on the same day after the first dose of mRNA � 1273 vaccine. Events were reported as disabling and medically significant and at the time of report has not resolved. As per source document patient also experienced not able to eat anything. The rechallenge is unknown since the events happened after the first dose and no information yet regarding the second dose is provided. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1918665 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Muscular weakness, Pain, Rash erythematous, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Steroid therapy
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: No - Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 26247456) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS, RASH ERYTHEMATOUS, PAIN, and ASTHENIA in a 43-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. The patient''s past medical history included Steroid therapy. On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced RASH ERYTHEMATOUS (seriousness criterion medically significant), PAIN (seriousness criterion medically significant), and ASTHENIA (seriousness criterion medically significant). On an unknown date, the patient experienced MUSCULAR WEAKNESS (seriousness criterion medically significant). At the time of the report, MUSCULAR WEAKNESS, RASH ERYTHEMATOUS, and ASTHENIA had not resolved and PAIN was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) included on 21-Nov-2021, SARS-CoV-2 test No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) was unknown. Concomitant products were not provided. Treatment medication were not reported. The patient experienced significant pain and weakness in upper arm, hot red rash radiating from and around injection site. The patient had not tested positive for COVID-19 since having the vaccine. This is a regulatory case concerning a 43-year-old male patient with no relevant medical history reported who experienced the unexpected and serious events of muscular weakness, rash erythematous, pain and asthenia. The event muscular weakness occurred on an unknown day after a third dose of mRNA-1273 vaccine was administered and the rest of the events occurred the following day after vaccine was given. The rechallenge was not applicable since events happened after third dose. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1918666 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Diarrhoea, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (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: CLOPIDOGREL; LERCANIDIPINE; PRAVASTATIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210108; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Diarrhea; Feverish; Chest pain; Vomiting; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26247926) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Feverish), CHEST PAIN (Chest pain), VOMITING (Vomiting) and DIARRHOEA (Diarrhea) in a 55-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. Concomitant products included LERCANIDIPINE for Hypertension, CLOPIDOGREL for Stroke, PRAVASTATIN for an unknown indication. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced PYREXIA (Feverish) (seriousness criterion medically significant), CHEST PAIN (Chest pain) (seriousness criterion medically significant) and VOMITING (Vomiting) (seriousness criterion medically significant). On 25-Nov-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant). On 25-Nov-2021, VOMITING (Vomiting) and DIARRHOEA (Diarrhea) had resolved. At the time of the report, PYREXIA (Feverish) was resolving and CHEST PAIN (Chest pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-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 got started with fever and then vomiting , diarrhoea tight chest ,aching joints and tiredness. Concomitant medication was not provided Treatment information was not reported Company comment: This case concerns a 55-year-old female patient with a medical history of hypertension and stroke, who experienced the unexpected events of pyrexia, chest pain, vomiting and diarrhoea. The events pyrexia, chest pain and vomiting occurred on the same day after the third dose of mRNA � 1273 vaccine, while the diarrhoea was experienced 2-days later. As per source document patient also complained of arthralgia and fatigue. Events were reported as medically significant but at the time of report all the event had resolved except for pyrexia which was resolving. The rechallenge was unknown since no information about the first two doses were disclosed. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This case concerns a 55-year-old female patient with a medical history of hypertension and stroke, who experienced the unexpected events of pyrexia, chest pain, vomiting and diarrhoea. The events pyrexia, chest pain and vomiting occurred on the same day after the third dose of mRNA � 1273 vaccine, while the diarrhoea was experienced 2-days later. As per source document patient also complained of arthralgia and fatigue. Events were reported as medically significant but at the time of report all the event had resolved except for pyrexia which was resolving. The rechallenge was unknown since no information about the first two doses were disclosed. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1918845 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003659 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Eye irritation, Heart rate, Heart rate increased, Inappropriate schedule of product administration, Insomnia, Lacrimation increased, Loss of personal independence in daily activities, Paralysis, Pyrexia, Vaccination site discomfort, Vaccination site joint movement impairment
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Corneal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Lacrimal disorders (narrow), Arthritis (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VITAMIN C [ASCORBIC ACID]; ACICLOVIR; ZINC; VITAMIN D [VITAMIN D NOS]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: Heart rate; Result Unstructured Data: heart rate went up by 20 more than usual,; Test Date: 20211123; Test Name: fever; Result Unstructured Data: 38 degree fever (normally temperature is around 36)
CDC Split Type: HUMODERNATX, INC.MOD20213

Write-up: arm partly paralyzed; runny eyes- discharge, tears; insomnia; Vaccination Site Discomfort; couldn''t put shirt on; increased heart frequency / heart rate went up by 20 more than usual; Site of vaccine is sensitive can only extend left arm at 90 degrees, arm partly paralyzed; eye irritation; joint pain in shoulders / joint pain / right shoulder joint pain; 38 degree fever; Received 2 shots of AstraZeneca, last shot was 5.5 months ago; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (arm partly paralyzed) in a 63-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3003659) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included VITAMIN C [ASCORBIC ACID], ACICLOVIR, ZINC and VITAMIN D [VITAMIN D NOS] for an unknown indication. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced PARALYSIS (arm partly paralyzed) (seriousness criterion medically significant), LACRIMATION INCREASED (runny eyes- discharge, tears), INSOMNIA (insomnia), VACCINATION SITE DISCOMFORT (Vaccination Site Discomfort), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn''t put shirt on), HEART RATE INCREASED (increased heart frequency / heart rate went up by 20 more than usual), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Site of vaccine is sensitive can only extend left arm at 90 degrees, arm partly paralyzed), EYE IRRITATION (eye irritation), ARTHRALGIA (joint pain in shoulders / joint pain / right shoulder joint pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2 shots of AstraZeneca, last shot was 5.5 months ago). 23-Nov-2021, the patient experienced PYREXIA (38 degree fever). On 23-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2 shots of AstraZeneca, last shot was 5.5 months ago) had resolved. At the time of the report, PARALYSIS (arm partly paralyzed), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Site of vaccine is sensitive can only extend left arm at 90 degrees, arm partly paralyzed) and ARTHRALGIA (joint pain in shoulders / joint pain / right shoulder joint pain) had not resolved, LACRIMATION INCREASED (runny eyes- discharge, tears), INSOMNIA (insomnia), HEART RATE INCREASED (increased heart frequency / heart rate went up by 20 more than usual), EYE IRRITATION (eye irritation) and PYREXIA (38 degree fever) had resolved and VACCINATION SITE DISCOMFORT (Vaccination Site Discomfort) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn''t put shirt on) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Nov-2021, Heart rate: high (High) heart rate went up by 20 more than usual. On 23-Nov-2021, Pyrexia: high (High) 38 degree fever (normally temperature is around 36). symptoms came shortly after the vaccine. Received 2 shots of AstraZeneca, last shot was 5.5 months ago. Meds: naturopathic food supplement Company comment: This is a case of Inappropriate Schedule of Vaccination that concerns a 63-year-old female patient with no relevant medical history, who experienced the unexpected event of Paralysis. The event occurred 1 day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This is a case of Inappropriate Schedule of Vaccination that concerns a 63-year-old female patient with no relevant medical history, who experienced the unexpected event of Paralysis. The event occurred 1 day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1919776 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza like illness, Malaise
SMQs:

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

Write-up: genrally felt unwell for 36 hours; Flu-like aching; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26242388) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like aching) in a 62-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. On 22-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced INFLUENZA LIKE ILLNESS (Flu-like aching) (seriousness criterion medically significant). On 24-Nov-2021, INFLUENZA LIKE ILLNESS (Flu-like aching) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant product use was not provided. Patient had generally felt unwell for 36 hours, aching all over, feeling very cold and under the weather Patient had not tested positive for COVID-19 since having the vaccine Treatment information was not provided. Company comment: This is a regulatory authority case concerning a 62-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of influenza like illness and malaise. The event influenza like illness occurred 1 day after the third dose of mRNA-1273 vaccine administration while the event malaise occurrence unknown with respect to the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 62-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of influenza like illness and malaise. The event influenza like illness occurred 1 day after the third dose of mRNA-1273 vaccine administration while the event malaise occurrence unknown with respect to the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1919781 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Lymphadenopathy, Neck pain
SMQs:, 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Neck pain; Headache; Glands swollen; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26248187) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain), HEADACHE (Headache) and LYMPHADENOPATHY (Glands swollen) in a 61-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. No Medical History information was reported. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced LYMPHADENOPATHY (Glands swollen) (seriousness criterion medically significant). On an unknown date, the patient experienced NECK PAIN (Neck pain) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, NECK PAIN (Neck pain), HEADACHE (Headache) and LYMPHADENOPATHY (Glands swollen) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. On an unknown date, patient experienced Headache, Pain at vaccination site and at upper arm into neck. Patient felt very uncomfortable at night. Pain extended from underarm into side of chest. Treatment included extra Pain killers. Company Comment: This is a regulatory authority case concerning a 61-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Neck pain, Headache, Lymphadenopathy. The events occurred approximately on the same day after the third dose of mRNA 1273 Covid-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 61-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Neck pain, Headache, Lymphadenopathy. The events occurred approximately on the same day after the third dose of mRNA 1273 Covid-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, is not affected by this report.


VAERS ID: 1919784 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Headache, Neck pain, Rhinorrhoea, SARS-CoV-2 test
SMQs:, 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 Date: 20211119; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Joint ache; Headache; Armpit pain; Neck pain; Runny nose; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26249227) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain), RHINORRHOEA (Runny nose), ARTHRALGIA (Joint ache), HEADACHE (Headache) and AXILLARY PAIN (Armpit pain) in a 55-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for COVID-19 vaccination. No Medical History information was reported. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced NECK PAIN (Neck pain) (seriousness criterion medically significant), RHINORRHOEA (Runny nose) (seriousness criterion medically significant) and AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant). On 24-Nov-2021, the patient experienced ARTHRALGIA (Joint ache) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, NECK PAIN (Neck pain) and RHINORRHOEA (Runny nose) had not resolved, ARTHRALGIA (Joint ache) and HEADACHE (Headache) was resolving and AXILLARY PAIN (Armpit pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Nov-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 took Ibuprofen which helps but felt ill. Patient was not tested positive for COVID-19 since had the vaccine. Patient was not enrolled in clinical trial. Concomitant medication was not reported. Company Comment: This is a regulatory case concerning a 55-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Neck pain, Rhinorrhoea, Athrlagia, Headache, Axillary pain. The events occurred approximately on the same day after the third dose of mRNA 1273 Covid-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 55-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Neck pain, Rhinorrhoea, Athrlagia, Headache, Axillary pain. The events occurred approximately on the same day after the third dose of mRNA 1273 Covid-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, is not affected by this report.


VAERS ID: 1919786 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Palpitations, SARS-CoV-2 test, Tachycardia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 MRNA VACCINE BNT162B2; EVOREL; IBUPROFEN; UTROGESTAN
Current Illness: Asthma (Asthma but only use inhalers when ill. Started Hormone replacement therapy (HRT) on 29.10.21)
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: shaking; Palpitations; Tachycardia; This case was received via RA (Reference number: GB-MHRA-ADR 26251631) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of TREMOR (shaking), PALPITATIONS (Palpitations) and TACHYCARDIA (Tachycardia) in a 47-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 19-Mar-2020. Concurrent medical conditions included Asthma (Asthma but only use inhalers when ill. Started Hormone replacement therapy (HRT) on 29.10.21). Concomitant products included ESTRADIOL (EVOREL) from 29-Oct-2021 to an unknown date and PROGESTERONE (UTROGESTAN) from 12-Nov-2021 to 23-Nov-2021 for HRT, IBUPROFEN from 29-Oct-2021 to an unknown date for Pelvic pain, TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) from 13-Jan-2021 to an unknown date for Vaccination. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced PALPITATIONS (Palpitations) (seriousness criterion medically significant) and TACHYCARDIA (Tachycardia) (seriousness criterion medically significant). On an unknown date, the patient experienced TREMOR (shaking) (seriousness criterion medically significant). On 24-Nov-2021, TACHYCARDIA (Tachycardia) had resolved. At the time of the report, TREMOR (shaking) and PALPITATIONS (Palpitations) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was not pregnant and not breastfeeding. Patient had the Moderna booster about 1pm. By 6 PM the patient ached all over and had a few palpitations for a few seconds. By 10 PM, the patient was shaking uncontrollably, very cold, did not have a thermometer but temperature was very high. Every muscle hurt. The patient had taken paracetamol around 9 PM but it did not seem to do much. By midnight the pulse was 130 for around an hour. More palpitations. Eventually pulse dropped to about 90. Ended up in bed for 24 hours. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment information was not provided. This is a regulatory authority case concerning a 47-year-old, female patient with concurrent medical condition of Asthma and use of concomitant medications estradiol and progesterone, who experienced the unexpected serious events of Tremor, Palpitations, Tachycardia . The events occurred approximately on the same day after the third dose of mRNA 1273 Covid-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The concurrent medical condition of Asthma and use of concomitant medications estradiol and progesterone remains a confounder. The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 47-year-old, female patient with concurrent medical condition of Asthma and use of concomitant medications estradiol and progesterone, who experienced the unexpected serious events of Tremor, Palpitations, Tachycardia . The events occurred approximately on the same day after the third dose of mRNA 1273 Covid-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The concurrent medical condition of Asthma and use of concomitant medications estradiol and progesterone remains a confounder. The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, is not affected by this report.


VAERS ID: 1922339 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-11-23
   Days after vaccination:272
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Heart rate, Hypertension
SMQs:, Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad)

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

Write-up: Heart rate; Blood pressure high; Chest pain; This case was received via Regulatory Agency (Reference number: GB-MHRA-ADR 26243685) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEART RATE, HYPERTENSION and CHEST PAIN (Chest pain) in a 37-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. Concomitant products included LAMOTRIGINE from 01-Dec-2009 to an unknown date for Epilepsy. On 24-Feb-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 11-May-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced HEART RATE (Heart rate) (seriousness criteria hospitalization and medically significant), HYPERTENSION (Blood pressure high) (seriousness criteria hospitalization and medically significant) and CHEST PAIN (Chest pain) (seriousness criteria hospitalization and medically significant). At the time of the report, HEART RATE (Heart rate) and HYPERTENSION (Blood pressure high) was resolving and CHEST PAIN (Chest pain) had not resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications were provided by reporter. No treatment medications were provided. The patient''s laboratory tests include ECGs and Chest X-ray, however, the results were not provided. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Company comment: This regulatory case concerns a 37-year-old, male patient with relevant medical history of Lamotrigine intake for Epilepsy, who experienced the unexpected, serious events of chest pain, hypertension and heart rate. The events, which resulted in hospitalization, occurred 1 day after administration of the third dose of the Moderna mRNA-1273 vaccine. Electrocardiograms and Chest X-ray were done, however, the results were not provided. Treatment information was also not provided. However, the events hypertension and heart rate were resolving at the time of the report. The event chest pain had not resolved at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The medical history of Lamotrigine intake, which may cause the common side effect of chest pain, remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory case concerns a 37-year-old, male patient with relevant medical history of Lamotrigine intake for Epilepsy, who experienced the unexpected, serious events of chest pain, hypertension and heart rate. The events, which resulted in hospitalization, occurred 1 day after administration of the third dose of the Moderna mRNA-1273 vaccine. Electrocardiograms and Chest X-ray were done, however, the results were not provided. Treatment information was also not provided. However, the events hypertension and heart rate were resolving at the time of the report. The event chest pain had not resolved at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The medical history of Lamotrigine intake, which may cause the common side effect of chest pain, remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1922341 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Dizziness, Muscular weakness, Palpitations
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (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.MOD20213

Write-up: at 2120 left dinner but difficulty walking - legs weak but left leg weaker / heavier; palpitations; lightheadedness; woozy; Muscle weakness; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 26244198) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ASTHENIA (at 2120 left dinner but difficulty walking - legs weak but left leg weaker / heavier), PALPITATIONS (palpitations), DIZZINESS (lightheadedness), DIZZINESS (woozy) and MUSCULAR WEAKNESS (Muscle weakness) in a 58-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. No Medical History information was reported. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakness) (seriousness criterion medically significant). On an unknown date, the patient experienced ASTHENIA (at 2120 left dinner but difficulty walking - legs weak but left leg weaker / heavier) (seriousness criterion medically significant), PALPITATIONS (palpitations) (seriousness criterion medically significant), DIZZINESS (lightheadedness) (seriousness criterion medically significant) and DIZZINESS (woozy) (seriousness criterion medically significant). On 24-Nov-2021, MUSCULAR WEAKNESS (Muscle weakness) had resolved. At the time of the report, ASTHENIA (at 2120 left dinner but difficulty walking - legs weak but left leg weaker / heavier), PALPITATIONS (palpitations), DIZZINESS (lightheadedness) and DIZZINESS (woozy) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant drugs were reported. No treatment information was reported. Vaccine was administered at 1240. At 1900 felt muscle weakness in legs, had to prop myself upright. Some lightheadedness. Sat down for a dinner - OK but felt flu-ey. At 2120 left dinner but difficulty walking - legs weak but left leg weaker/heavier, pronounced limp. Caught a train home - felt better but at 11pm fell off a chair at home while trying to underdo show laces and found it difficult to get up. Phoned EMS - feeling woozy, tired, legs very heavy to lift (muscle weakness). No heart palpitations, no slurred words or vision, no rash or overly raised temperature, no facial drooping. Following morning muscle weakness gone but feeling Flu-ey. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Company comment: This is a regulatory case concerning a 58-year-old male patient with no medical history reported, who experienced the unexpected events of asthenia, palpitations, dizziness, and muscular weakness. The event muscular weakness occurred on the same day after the third dose of mRNA � 1273 vaccine, while the other events were experienced on an unknown date. Events were reported as medically significant but muscular weakness resolved after a day while the other events resolved at the time of report. The rechallenge is unknown since no information about the first two doses were disclosed. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 58-year-old male patient with no medical history reported, who experienced the unexpected events of asthenia, palpitations, dizziness, and muscular weakness. The event muscular weakness occurred on the same day after the third dose of mRNA � 1273 vaccine, while the other events were experienced on an unknown date. Events were reported as medically significant but muscular weakness resolved after a day while the other events resolved at the time of report. The rechallenge is unknown since no information about the first two doses were disclosed. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1922347 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dizziness postural, Dyspnoea, Eye pain, Fatigue, Headache, Injection site pain, Myalgia, Nausea, Oropharyngeal pain, Pyrexia, Rhinorrhoea, Thirst
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Comments: No Medical history reported
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Headache; Fever; Chills; Sore throat; Excessive thirst; Eye pain; Runny nose; Tiredness; Nausea; Shortness of breath; Muscle ache; Pain injection site; Dizzy on standing; This case was received via RA (Reference number: GB-MHRA-ADR 26245359) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), OROPHARYNGEAL PAIN (Sore throat), THIRST (Excessive thirst), DIZZINESS POSTURAL (Dizzy on standing), MYALGIA (Muscle ache), INJECTION SITE PAIN (Pain injection site), EYE PAIN (Eye pain), RHINORRHOEA (Runny nose), FATIGUE (Tiredness), NAUSEA (Nausea) and DYSPNOEA (Shortness of breath) in a 57-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for an unknown indication. No Medical history reported. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 09-Mar-2021 to 25-May-2021 for an unknown indication. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced DIZZINESS POSTURAL (Dizzy on standing) (seriousness criterion medically significant) and INJECTION SITE PAIN (Pain injection site) (seriousness criterion medically significant). On 24-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant), THIRST (Excessive thirst) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), EYE PAIN (Eye pain) (seriousness criterion medically significant), RHINORRHOEA (Runny nose) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and DYSPNOEA (Shortness of breath) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), OROPHARYNGEAL PAIN (Sore throat), THIRST (Excessive thirst), DIZZINESS POSTURAL (Dizzy on standing), MYALGIA (Muscle ache), INJECTION SITE PAIN (Pain injection site), EYE PAIN (Eye pain), RHINORRHOEA (Runny nose) and FATIGUE (Tiredness) had not resolved and NAUSEA (Nausea) and DYSPNOEA (Shortness of breath) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment drug has been provided. Company comment: This regulatory authority case concerns a 57-year-old, male patient with no reported relevant medical history, who experienced the unexpected serious events of headache, pyrexia, chills, oropharyngeal pain, thirst, dizziness postural, myalgia, injection site pain, eye pain, rhinorrhoea, fatigue, nausea, and dyspnoea. The events of chills, fatigue, headache, injection site pain, myalgia, nausea, pyrexia, are unexpected as they are retained as serious per the source document Authority reporting. The events occurred between one and two days after administration of one dose (unknown dosage) of mRNA-1273 vaccine, considered as third dose of her COVID-19 vaccine schedule. The patient received previously two doses of AstraZeneca COVID-19 vaccine. Regulatory authority reported the rechallenge as unknown, however, no additional dose was administrated. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events coding and seriousness captured per source document from Regulatory Authority reporting.; Sender''s Comments: This regulatory authority case concerns a 57-year-old, male patient with no reported relevant medical history, who experienced the unexpected serious events of headache, pyrexia, chills, oropharyngeal pain, thirst, dizziness postural, myalgia, injection site pain, eye pain, rhinorrhoea, fatigue, nausea, and dyspnoea. The events of chills, fatigue, headache, injection site pain, myalgia, nausea, pyrexia, are unexpected as they are retained as serious per the source document Authority reporting. The events occurred between one and two days after administration of one dose (unknown dosage) of mRNA-1273 vaccine, considered as third dose of her COVID-19 vaccine schedule. The patient received previously two doses of AstraZeneca COVID-19 vaccine. Regulatory authority reported the rechallenge as unknown, however, no additional dose was administrated. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events coding and seriousness captured per source document from Regulatory Authority reporting.


VAERS ID: 1922348 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; CITALOPRAM; FOSTAIR
Current Illness: Lung disorder (Covid Nov-2020, last year and was left with lung damage and hence was still on steroid treatment.); Steroid therapy (Took regular steroid treatment (e.g. orally or rectally) via a pump.)
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fever; Shivers; High temperature; Headache; Fatigue; Feeling sick; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 26245394) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Shivers), PYREXIA (High temperature), HEADACHE (Headache), FATIGUE (Fatigue) and MALAISE (Feeling sick) in a 51-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. The patient''s past medical history included COVID-19 in November 2020 and Steroid therapy (Took regular steroid treatment (e.g. orally or rectally) via a pump.) since an unknown date. Previously administered products included for Product used for unknown indication: DEPO-MEDRONE. Past adverse reactions to the above products included No adverse event with DEPO-MEDRONE. Concurrent medical conditions included Lung disorder (Covid Nov-2020, last year and was left with lung damage and hence was still on steroid treatment.). Concomitant products included AMLODIPINE from 01-Jan-2017 to an unknown date, CITALOPRAM from 22-Dec-2020 to an unknown date and BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE (FOSTAIR) from 01-Sep-2021 to an unknown date for an unknown indication. On 22-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and MALAISE (Feeling sick) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever), CHILLS (Shivers), PYREXIA (High temperature), HEADACHE (Headache), FATIGUE (Fatigue) and MALAISE (Feeling sick) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient did not had symptoms associated with COVID-19 and not had a COVID-19 test. The patient was in hospital for three weeks in last Nov-2021 and on c pac machine. The patient took Paracetamol every 4 hours and drank water. Patient had not tested positive for COVID-19 since he had received the vaccine. Company comment: This case concerns a 51-year-old male, with reported history of COVID-19, who experienced the serious unexpected events of Pyrexia, Chills, Pyrexia, Headache, Fatigue and Malaise. The events occurred 1 day after the administration of the 3rd dose of the mRNA-1273 vaccine. At the time of the report, the outcome for the events was Not Recovered/Not Resolved. The rechallenge is not applicable since the events occurred after the 3rd dose of the of the mRNA-1273 vaccine and another dose will not be administered. The reported medical history of COVID-19 remains as a confounder for the events. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 51-year-old male, with reported history of COVID-19, who experienced the serious unexpected events of Pyrexia, Chills, Pyrexia, Headache, Fatigue and Malaise. The events occurred 1 day after the administration of the 3rd dose of the mRNA-1273 vaccine. At the time of the report, the outcome for the events was Not Recovered/Not Resolved. The rechallenge is not applicable since the events occurred after the 3rd dose of the of the mRNA-1273 vaccine and another dose will not be administered. The reported medical history of COVID-19 remains as a confounder for the events. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1922357 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Lymphadenopathy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: This case was received via RA (Reference number: GB-RA-ADR 26247467) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (fever), ARTHRALGIA (joint pain) and LYMPHADENOPATHY (Enlarged lymph nodes (excl infective) in a 50-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced LYMPHADENOPATHY (Enlarged lymph nodes (excl infective) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (fever) (seriousness criterion medically significant) and ARTHRALGIA (joint pain) (seriousness criterion medically significant). At the time of the report, PYREXIA (fever), ARTHRALGIA (joint pain) and LYMPHADENOPATHY (Enlarged lymph nodes (excl infective) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had lymph nodes in groin, it was really painful and enlarged and in arm pits both sides. He also experienced Fever, aches, rib cage painful and joint pain. Concomitant product use was not provided by reporter. Treatment information was not provided Company comment: This regulatory authority case concerns a 50-year-old, male patient with no reported relevant medical history, who experienced the unexpected serious events of pyrexia, arthralgia, and lymphadenopathy. The events are unexpected as they are retained as serious per the source document Authority reporting. The event lymphadenopathy occurred 1 day after the third dose (unknown dosage) of mRNA-1273. The date of onset of the events pyrexia and arthralgia was not reported. Regulatory authority reported the rechallenge as unknown, however, no additional dose was administrated, and the outcome of the events is not recovered. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This regulatory authority case concerns a 50-year-old, male patient with no reported relevant medical history, who experienced the unexpected serious events of pyrexia, arthralgia, and lymphadenopathy. The events are unexpected as they are retained as serious per the source document Authority reporting. The event lymphadenopathy occurred 1 day after the third dose (unknown dosage) of mRNA-1273. The date of onset of the events pyrexia and arthralgia was not reported. Regulatory authority reported the rechallenge as unknown, however, no additional dose was administrated, and the outcome of the events is not recovered. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1922365 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Myalgia, Night sweats, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: COVID-19 VACCINE ASTRAZENECA; GABAPENTIN; INFLUENZA VIRUS; LISINOPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Clinical trial participant; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Neuropathic pain; Suspected COVID-19 (Unsure when symptoms stopped); Comments: Taking Gabapentin for neuropathic pain possibly caused by Covid. Have had Atrial Fibrillation since 2013 and taking blood thinner Rivaroxoban to reduce associated risk. Not had a COVID-19 test
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075132111GBR009608

Write-up: night sweats; Vomiting; Muscle pain; Night sweat; This spontaneous report was received from (Agency number: GB-MHRA-WEBCOVID-202111251356440590-DXULL) on 26-NOV-2021 and refers to a 68-year-old male patient. The patient''s medical history included atrial fibrillation, neuralgia, suspected COVID-19, clinical trial participant and immunodeficiency. The patient''s concurrent conditions were not provided. Concomitant therapies included covid-19 vaccine nrvv ad (chadox1 ncov-19)(COVID-19 VACCINE ASTRAZENECA), gabapentin, influenza vaccine(INFLUENZA VIRUS) and lisinopril. On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated(HEPATITIS A VACCINE, INACTIVATED) and tozinameran (PFIZER BIONTECH COVID-19 VACCINE). On 23-NOV-2021 the patient experienced vomiting, night sweats and myalgia (medically significant). On an unknown date, the patient experienced another episode of night sweats. Reactions began with muscle tremors in arms and legs followed by severe vomiting, night sweats, pains in muscles and joints, and 24 hours later, numbness in the ends of the fingers. Some muscle pain and the numbness were continuing two days after receiving the booster vaccine. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of night sweats and myalgia was reported as not recovered/not resolved. The outcome of vomiting was reported as recovered/resolved. Action taken was not provided. The causality between adverse events and suspected vaccines was not provided. The agency considered the adverse events to be medically significant.


VAERS ID: 1922368 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Lymphadenopathy, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ehlers-Danlos syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Swollen lymph nodes; Fatigue; Chills; Nausea; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 26253706) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes), FATIGUE (Fatigue), CHILLS (Chills) and NAUSEA (Nausea) in a 54-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Not known) for an unknown indication. The patient''s past medical history included Ehlers-Danlos syndrome. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes), FATIGUE (Fatigue), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) and FATIGUE (Fatigue) had not resolved and CHILLS (Chills) and NAUSEA (Nausea) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication was provided. Company comment: This is a regulatory case concerning a 54-year-old female patient with a medical history of Ehlers-Danlos syndrome, who experienced the expected events of lymphadenopathy, chills, fatigue, and nausea. A concomitant product in this case is the Covid-19 vaccine AstraZeneca. The events occurred on the same day after the third dose of mRNA � 1273 vaccine. Events were reported as medically important and at the time of report chills and nausea was resolving while lymphadenopathy and fatigue had not. The rechallenge is unknown since the first two doses were of a different brand. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 54-year-old female patient with a medical history of Ehlers-Danlos syndrome, who experienced the expected events of lymphadenopathy, chills, fatigue, and nausea. A concomitant product in this case is the Covid-19 vaccine AstraZeneca. The events occurred on the same day after the third dose of mRNA � 1273 vaccine. Events were reported as medically important and at the time of report chills and nausea was resolving while lymphadenopathy and fatigue had not. The rechallenge is unknown since the first two doses were of a different brand. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1924133 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Haematemesis, Hiatus hernia, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness: COVID-19 vaccination
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075132112GBR001451

Write-up: vomiting; hiatus hernia; Vomiting blood; Information has been received from a Regulatory Agency (GB-MHRA-ADR 26276119) on 02-DEC-2021. This spontaneous report was received from a consumer concerning 61-years-old patient of unknown gender. Historical drug included lansoprazole for hiatus hernia; concomitant therapies included covid-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA). Patient was not enrolled in clinical trial and patient had not tested positive for COVID-19 since having the vaccine. On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (manufacturer unknown) for unknown indication (strength, dose, route of administration, anatomical location, lot number, and expiration date were not provided). On 23-NOV-2021, the patient was vaccinated with elasomeran (COVID-19 VACCINE MODERNA), dose 3b, lot number 3004732 (indication, strength, route of administration, anatomical location, and expiration date were not reported). On 23-NOV-2021 (reported as 12 hours after vaccine), the patient had a bad reflux, followed 3 hours later with volcanic brown vomiting and an upset hiatus hernia. The doctor said could have burst in blood vessel (haematemesis) due to strength of vomit and has advised stronger medication 2 x 30mg daily for a couple of weeks then 1x30mg daily until condition ease. The report did not relate to possible inflammation of the heart myocarditis or pericarditis. The outcome of vomiting and hiatus hernia was reported as not resolved and haematemesis was reported as resolving. The action taken, as well as the causal relationship between the event and the suspect vaccines were unknown. Rechallenge was reported as unknown. The Agency considered the events as medically significant events.


VAERS ID: 1926915 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Vomiting; Headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26242465) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for COVID-19 vaccination. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 19-Oct-2021 to an unknown date for Influenza. On 22-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 24-Nov-2021, VOMITING (Vomiting) and HEADACHE (Headache) had resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medication was reported. Treatment information was not provided by reporter. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial; Sender''s Comments: This case concerns a 61-year-old female patient with no medical history, who experienced the serious unexpected events of Vomiting and Headache. The events occurred 1 day after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report


VAERS ID: 1926921 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pain
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: PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Generalized aching; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26243250) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Generalized aching) in a 42-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 21-Jan-2021 to an unknown date for an unknown indication. On 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced PAIN (Generalized aching) (seriousness criterion medically significant). At the time of the report, PAIN (Generalized aching) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment medication was not provided by the reporter. It was reported severe generalised aching with pain from injection site and surrounding area. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient''s report was not relate to possible inflammation of the heart (myocarditis or pericarditis). This case concerns a 42 year-old, female patient with no relevant medical history, who experienced the serious (due to medically important condition) unexpected event of pain. The event occurred the same day after the booster dose of mRNA-1273 vaccine. The patient received two doses of COVID-19 mRNA BioNTech vaccine 8 months prior. The rechallenge was not applicable, as the event was reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 42 year-old, female patient with no relevant medical history, who experienced the serious (due to medically important condition) unexpected event of pain. The event occurred the same day after the booster dose of mRNA-1273 vaccine. The patient received two doses of COVID-19 mRNA BioNTech vaccine 8 months prior. The rechallenge was not applicable, as the event was reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1926925 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza, Influenza like illness, SARS-CoV-2 test
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE MRNA (BNT162B2)
Current Illness: Coeliac disease; Fibromyalgia; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: flu symptoms; Flu-like aching; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26243680) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA (flu symptoms) and INFLUENZA LIKE ILLNESS (Flu-like aching) in a 69-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...), Coeliac disease and Fibromyalgia. Concomitant products included COVID-19 VACCINE MRNA (BNT162B2) from 12-Feb-2021 to 05-May-2021 for an unknown indication. On 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like aching) (seriousness criterion disability). On an unknown date, the patient experienced INFLUENZA (flu symptoms) (seriousness criterion disability). At the time of the report, INFLUENZA (flu symptoms) and INFLUENZA LIKE ILLNESS (Flu-like aching) 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. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment information was provided. Patient had same reaction from all three vaccines. Every limb hurting badly for several weeks. Burning hands and feet, headaches. Basically bad flu symptoms without a cold or cough. Unable to get out of bed. This case concerns a 69 year old female patient with concurrent medical condition of immunodeficiency, who experienced the serious unexpected event of influenza and influenza like illness.The event occurred on the same day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial.; Sender''s Comments: This case concerns a 69 year old female patient with concurrent medical condition of immunodeficiency, who experienced the serious unexpected event of influenza and influenza like illness.The event occurred on the same day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1926928 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Illness, Lymph node pain, Myalgia, 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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Sickness; Muscle ache; High temperature; Lymph node pain; This case was received via RA (Reference number: GB-MHRA-ADR 26245406) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Lymph node pain), ILLNESS (Sickness), MYALGIA (Muscle ache) and PYREXIA (High temperature) in a 26-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. On 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced LYMPH NODE PAIN (Lymph node pain) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and PYREXIA (High temperature) (seriousness criterion medically significant). On 24-Nov-2021, the patient experienced ILLNESS (Sickness) (seriousness criterion medically significant). On 24-Nov-2021, MYALGIA (Muscle ache) and PYREXIA (High temperature) had resolved. At the time of the report, LYMPH NODE PAIN (Lymph node pain) had not resolved and ILLNESS (Sickness) outcome was unknown. 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 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medications were reported No treatment information was provided Company comment:This is a regulatory case concerning a 26-year-old, female patient with no reported medical history, who experienced the unexpected serious (medically significant) adverse events of lymph node pain, muscle ache, pyrexia and illness. The event started the same day after the vaccination with the booster dose of mRNA-1273 vaccine. The rechallenge was unknown since there''s no information about the first or second dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting the seriousness criteria.; Sender''s Comments: This is a regulatory case concerning a 26-year-old, female patient with no reported medical history, who experienced the unexpected serious (medically significant) adverse events of lymph node pain, muscle ache, pyrexia and illness. The event started the same day after the vaccination with the booster dose of mRNA-1273 vaccine. The rechallenge was unknown since there''s no information about the first or second dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting the seriousness criteria.


VAERS ID: 1926934 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Pain of skin, Pyrexia, SARS-CoV-2 test, Skin temperature, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Vomiting; Feverish; Skin tenderness; Skin temperature; Shivering; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26246470) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Feverish), PAIN OF SKIN (Skin tenderness), SKIN TEMPERATURE (Skin temperature), CHILLS (Shivering) and VOMITING (Vomiting) in a 45-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. The patient''s past medical history included Clinical trial participant. On 22-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced PYREXIA (Feverish) (seriousness criterion medically significant), PAIN OF SKIN (Skin tenderness) (seriousness criterion medically significant), SKIN TEMPERATURE (Skin temperature) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). On 24-Nov-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). At the time of the report, PYREXIA (Feverish), PAIN OF SKIN (Skin tenderness), SKIN TEMPERATURE (Skin temperature) and CHILLS (Shivering) had not resolved and VOMITING (Vomiting) 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 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19. Patient was a clinical trial participant, Study details: Zoe. No concomitant medications were reported. No treatment information was reported. This case concerns a 45 year old female patient with no relevant medical history, who experienced the serious unexpected events of pyrexia, pain of skin, skin temperature and chills. The events occurred 1 day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 45 year old female patient with no relevant medical history, who experienced the serious unexpected events of pyrexia, pain of skin, skin temperature and chills. The events occurred 1 day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1926936 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Allergic respiratory disease, Anaphylactic reaction, Bronchospasm, Chest discomfort, Dizziness, Headache, Hypersensitivity, Malaise, Nausea, Pruritus, SARS-CoV-2 test, Swelling of eyelid, Tachypnoea, Wheezing
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Asthma/bronchospasm (narrow), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; ESTRADIOL; PARACETAMOL
Current Illness: Hay fever
Preexisting Conditions: Medical History/Concurrent Conditions: Hysterectomy (Otherwise fit and well)
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: wheeze; 20 mins after vaccine ) got severe headache; lightheaded; itchy; eyelid swelling; wheezy; respiratory disease; generally unwell; chest tightness; allergy; tachypnoea; bronchospasm; nausea; anaphylactic reaction; Anaphylactic reaction to vaccine; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26247518) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a physician and describes the occurrence of WHEEZING (wheeze), HEADACHE (20 mins after vaccine ) got severe headache), DIZZINESS (lightheaded), PRURITUS (itchy), SWELLING OF EYELID (eyelid swelling), WHEEZING (wheezy), ALLERGIC RESPIRATORY DISEASE (respiratory disease), MALAISE (generally unwell), CHEST DISCOMFORT (chest tightness), HYPERSENSITIVITY (allergy), TACHYPNOEA (tachypnoea), BRONCHOSPASM (bronchospasm), NAUSEA (nausea), ANAPHYLACTIC REACTION (Anaphylactic reaction to vaccine) and ANAPHYLACTIC REACTION (anaphylactic reaction) in a 42-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. The patient''s past medical history included Hysterectomy (Otherwise fit and well). Concurrent medical conditions included Hay fever. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 04-Mar-2021 to an unknown date for COVID-19 vaccination, ESTRADIOL for Hormone replacement therapy, PARACETAMOL for Pain. On 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction to vaccine) (seriousness criteria medically significant and life threatening). On an unknown date, the patient experienced WHEEZING (wheeze) (seriousness criteria medically significant and life threatening), HEADACHE (20 mins after vaccine ) got severe headache) (seriousness criteria medically significant and life threatening), DIZZINESS (lightheaded) (seriousness criteria medically significant and life threatening), PRURITUS (itchy) (seriousness criteria medically significant and life threatening), SWELLING OF EYELID (eyelid swelling) (seriousness criteria medically significant and life threatening), WHEEZING (wheezy) (seriousness criteria medically significant and life threatening), ALLERGIC RESPIRATORY DISEASE (respiratory disease) (seriousness criteria medically significant and life threatening), MALAISE (generally unwell) (seriousness criteria medically significant and life threatening), CHEST DISCOMFORT (chest tightness) (seriousness criteria medically significant and life threatening), HYPERSENSITIVITY (allergy) (seriousness criteria medically significant and life threatening), TACHYPNOEA (tachypnoea) (seriousness criteria medically significant and life threatening), BRONCHOSPASM (bronchospasm) (seriousness criteria medically significant and life threatening), NAUSEA (nausea) (seriousness criteria medically significant and life threatening) and ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criteria medically significant and life threatening). On 24-Nov-2021, ANAPHYLACTIC REACTION (Anaphylactic reaction to vaccine) had resolved. At the time of the report, WHEEZING (wheeze), HEADACHE (20 mins after vaccine ) got severe headache), DIZZINESS (lightheaded), PRURITUS (itchy), SWELLING OF EYELID (eyelid swelling), WHEEZING (wheezy), ALLERGIC RESPIRATORY DISEASE (respiratory disease), MALAISE (generally unwell), CHEST DISCOMFORT (chest tightness), HYPERSENSITIVITY (allergy), TACHYPNOEA (tachypnoea), BRONCHOSPASM (bronchospasm), NAUSEA (nausea) and ANAPHYLACTIC REACTION (anaphylactic reaction) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Nov-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Patient has no previous allergic reactions and,patient was not currently breastfeeding. Patient had x2 covid AZ vaccines and felt generally unwell following these with headache, nausea and muscle pains. Patient had Moderna booster (eligible due to having child at home with respiratory disease.) Felt fine for initial 15 mins in the vaccine centre so left but on drive home (starting approx. 20 mins after vaccine) got severe headache, vomited, itchy red rash over IM injection site on left arm. Felt generally unwell and like been hit by a bus and started to feel wheezy with chest tightness, which she had never experienced before. This continued during the day. The patient tried to mobilise out of bed in the evening which worsened her respiratory symptoms (SOB, tightness, wheeze) and felt very lightheaded on standing. After speaking to 111 was advised to attend hospital. On arrival to emergency department (10 hours after symptom onset). Some facial and eyelid swelling but no airway swelling or obstruction. Sats 100 percent on RA but severe bronchospasm, tachypnoea, talking in 1/2 sentences, resp distress. Lightheaded and very itchy. Treated for anaphylactic reaction with IM adrenaline x 2 0.5mg, IVI, x 2 IV 500mcg adrenaline, hydrocortisone and chlorphenamine IV and salbutamol and ipratropium nebs and oxygen. Responded to treatment but admitted to HDU for monitoring. Following morning no further A/B/C symptoms but remained very itchy - treated with chlorphenamine. Mast cell tryptase samples taken - results awaited, discharged home after 24 hours monitoring with EpiPen and allergy clinic follow up. Patient has not tested positive for COVID-19 since having the vaccine and Patient was not enrolled in clinical trial. Company comment- This case concerns a 42-year-old female patient with a history of hay fever, who experienced the expected, serious (medically significant and life-threatening) event of anaphylactic reaction. The event started approximately 20 minutes after the booster dose of mRNA-1273. The rechallenge was not applicable since the patient received dose 1 and two of CHADOX1 NCOV-19 vaccine. The medical history of hay fever is a confounder. According to the Brighton Collaboration case definition, this report falls under level 2 of diagnostic certainty , since the patient has 1 major respiratory symptom (wheezing and severe bronchospasm with tachypnoea) and 1 minor skin symptom (pruritus), with rapid progression of signs and symptoms. The patient received treatment with adrenaline, hydrocortisone and clorphenamine, as well as salbutamol and ipratropium with positive results. Mast cell tryptase results are still pending. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 42-year-old female patient with a history of hay fever, who experienced the expected, serious (medically significant and life-threatening) event of anaphylactic reaction. The event started approximately 20 minutes after the booster dose of mRNA-1273. The rechallenge was not applicable since the patient received dose 1 and two of CHADOX1 NCOV-19 vaccine. The medical history of hay fever is a confounder. According to the Brighton Collaboration case definition, this report falls under level 2 of diagnostic certainty , since the patient has 1 major respiratory symptom (wheezing and severe bronchospasm with tachypnoea) and 1 minor skin symptom (pruritus), with rapid progression of signs and symptoms. The patient received treatment with adrenaline, hydrocortisone and clorphenamine, as well as salbutamol and ipratropium with positive results. Mast cell tryptase results are still pending. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1926946 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Fatigue, Headache, Lymphadenopathy, Oropharyngeal pain, SARS-CoV-2 test
SMQs:, 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: Clinical trial participant; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20211021; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Lymph nodes enlarged; Gland in neck; Sore throat; Armpit pain; Tiredness; Headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26256366) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph nodes enlarged), LYMPHADENOPATHY (Gland in neck), OROPHARYNGEAL PAIN (Sore throat), AXILLARY PAIN (Armpit pain), FATIGUE (Tiredness) and HEADACHE (Headache) in a 51-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 16-Oct-2021 and Clinical trial participant. On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes enlarged) (seriousness criterion medically significant), LYMPHADENOPATHY (Gland in neck) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant), AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, LYMPHADENOPATHY (Lymph nodes enlarged), LYMPHADENOPATHY (Gland in neck), OROPHARYNGEAL PAIN (Sore throat), AXILLARY PAIN (Armpit pain), FATIGUE (Tiredness) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Oct-2021, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown Route) was unknown. No treatment medication were provided. Concomitant medication was not reported. No meds and nothing relevant No health issues. Patient was not pregnant,Patient is not currently breastfeeding. Vaccination in left arm Neck gland on left swollen and lumpy Left Armpit painful Sore throat, tiredness, headache Patient has not tested positive for COVID-19 since having the vaccine Clinical trial participant Study details: Antibody testing. Re-challenge was reported as unknown. Company Comment: This case concerns a 51-year-old female patient, with a history of Suspected COVID-19, who experienced the unexpected, serious events of LYMPHADENOPATHY and OROPHARYNGEAL PAIN, and the expected serious events of LYMPHADENOPATHY, AXILLARY PAIN, FATIGUE and HEADACHE. The events occurred on the following day of the third dose of the mRNA-1273. The rechallenge is not applicable since no information about further dosing has been disclosed. The recent history of Suspected COVID-19 remains a confounder. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 51-year-old female patient, with a history of Suspected COVID-19, who experienced the unexpected, serious events of LYMPHADENOPATHY and OROPHARYNGEAL PAIN, and the expected serious events of LYMPHADENOPATHY, AXILLARY PAIN, FATIGUE and HEADACHE. The events occurred on the following day of the third dose of the mRNA-1273. The rechallenge is not applicable since no information about further dosing has been disclosed. The recent history of Suspected COVID-19 remains a confounder. The benefit-risk relationship of the mRNA-1273 is not affected by this report.


VAERS ID: 1926949 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Fatigue, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

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

Write-up: Diarrhea; Exhaustion; Vomiting; This case was received (Reference number: GB-MHRA-ADR 26256475) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), DIARRHOEA (Diarrhea) and FATIGUE (Exhaustion) in a 66-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant) and FATIGUE (Exhaustion) (seriousness criterion medically significant). On 24-Nov-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant). On 24-Nov-2021, VOMITING (Vomiting) had resolved. On 25-Nov-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, FATIGUE (Exhaustion) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product information was not provided. Treatment information was not provided. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Re-challenge was reported as unknown. This is a regulatory case concerning a 66 -year-old male patient with no medical history reported, who experienced the unexpected events of vomiting, diarrhoea, and fatigue. The events vomiting and fatigue occurred approximately 1 day after the third dose of mRNA � 1273 vaccine, while diarrhoea was experienced a day after. Events were reported as medically significant but events resolved or was resolving after two days upon start. The rechallenge is unknown since no information about the first two doses were disclosed. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 66 -year-old male patient with no medical history reported, who experienced the unexpected events of vomiting, diarrhoea, and fatigue. The events vomiting and fatigue occurred approximately 1 day after the third dose of mRNA � 1273 vaccine, while diarrhoea was experienced a day after. Events were reported as medically significant but events resolved or was resolving after two days upon start. The rechallenge is unknown since no information about the first two doses were disclosed. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1926955 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthritis allergic, Dermatitis allergic, Ehlers-Danlos syndrome, Rash
SMQs:, Anaphylactic reaction (broad), Congenital, familial and genetic disorders (narrow), Hypersensitivity (narrow), Arthritis (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: Ehlers-Danlos syndrome; Isolated ACTH deficiency; Mast cell activation syndrome; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)).
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: ehlers-danlos syndrome; rash; Allergic arthritis; Allergic rash; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26259196) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of EHLERS-DANLOS SYNDROME (ehlers-danlos syndrome), RASH (rash), ARTHRITIS ALLERGIC (Allergic arthritis) and DERMATITIS ALLERGIC (Allergic rash) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)) since an unknown date. Previously administered products included for Isolated ACTH deficiency: Hydrocortisone (subcutaneous pump that delivers 25mg hydrocortisone that is regularly increased to 50mg. I also have to inject 100mg when I go into crisis) since an unknown date. Past adverse reactions to the above products included No adverse event with Hydrocortisone. Concurrent medical conditions included Mast cell activation syndrome, Ehlers-Danlos syndrome and Isolated ACTH deficiency. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced ARTHRITIS ALLERGIC (Allergic arthritis) (seriousness criterion medically significant) and DERMATITIS ALLERGIC (Allergic rash) (seriousness criterion medically significant). On an unknown date, the patient experienced EHLERS-DANLOS SYNDROME (ehlers-danlos syndrome) (seriousness criterion medically significant) and RASH (rash) (seriousness criterion medically significant). At the time of the report, EHLERS-DANLOS SYNDROME (ehlers-danlos syndrome) and RASH (rash) had not resolved and ARTHRITIS ALLERGIC (Allergic arthritis) and DERMATITIS ALLERGIC (Allergic rash) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant and and treatment medications were not reported. The reporter did not provide causality assessment for the reported events. Patient has not tested positive for COVID-19 since having the vaccine. Company comment: This case concerns a 30-year-old female patient with relevant medical history of Mast cell activation syndrome, Ehlers-Danlos syndrome and ACTH deficiency who uses steroid therapy. The patient experienced serious unexpected events of Allergic arthritis and Dermatitis allergic which occurred during the same day when the patient received the third dose of the mRNA-1273 vaccine. In addition, Ehlers-Danlos syndrome and Rash were reported as an additional serious unexpected events by Regulatory Authority reporting, however, the exact start dates for these events were not provided. Reportedly, the patient had swelling of shoulder, knees and hip joints, as well as rash most of the way down the arm where she had received the vaccine. It was stated that the most of the swelling of joints and rash had gone. At the time of the report, the patient had an elevated rash at the injection site that was hot to the touch. Therefore, the outcome of the events Allergic arthritis and Dermatitis allergic was reported as resolving, while the outcome of the event of Ehlers-Danlos syndrome was reported as not resolved. The re-challenge and action taken with the suspect product were retained as unknown (in line with source document), however, can be assessed as not applicable as the events occurred following the third dose of the vaccine. The patient''s underlying medical history remains a confounder. The benefit-risk relationship of the MRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 30-year-old female patient with relevant medical history of Mast cell activation syndrome, Ehlers-Danlos syndrome and ACTH deficiency who uses steroid therapy. The patient experienced serious unexpected events of Allergic arthritis and Dermatitis allergic which occurred during the same day when the patient received the third dose of the mRNA-1273 vaccine. In addition, Ehlers-Danlos syndrome and Rash were reported as an additional serious unexpected events by Regulatory Authority reporting, however, the exact start dates for these events were not provided. Reportedly, the patient had swelling of shoulder, knees and hip joints, as well as rash most of the way down the arm where she had received the vaccine. It was stated that the most of the swelling of joints and rash had gone. At the time of the report, the patient had an elevated rash at the injection site that was hot to the touch. Therefore, the outcome of the events Allergic arthritis and Dermatitis allergic was reported as resolving, while the outcome of the event of Ehlers-Danlos syndrome was reported as not resolved. The re-challenge and action taken with the suspect product were retained as unknown (in line with source document), however, can be assessed as not applicable as the events occurred following the third dose of the vaccine. The patient''s underlying medical history remains a confounder. The benefit-risk relationship of the MRNA-1273 vaccine is not affected by this report.


VAERS ID: 1927543 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Feeling abnormal, Headache, Lethargy, Pain in extremity, SARS-CoV-2 test
SMQs:, Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN; CANDESARTAN; COVID-19 MRNA VACCINE BIONTECH; DULAGLUTIDE; FELODIPINE; FEXOFENADINE HYDROCHLORIDE; GLICLAZIDE; INFLUENZA VIRUS
Current Illness: Type 2 diabetes mellitus (poorly controlled)
Preexisting Conditions: Medical History/Concurrent Conditions: Thyroidectomy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: 12-18 hours after vax; lethargy; Painful arm; Aching joints; Headache; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 26245839) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (12-18 hours after vax), LETHARGY (lethargy), PAIN IN EXTREMITY (Painful arm), ARTHRALGIA (Aching joints) and HEADACHE (Headache) in a 52-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Thyroidectomy in 2017. Previously administered products included for Thyroidectomy: LEVOTHYROXINE. Concurrent medical conditions included Type 2 diabetes mellitus (poorly controlled). Concomitant products included ASPIRIN from 07-Nov-2021 to an unknown date for Anomaly heart, FEXOFENADINE HYDROCHLORIDE for Antihistamine therapy, CANDESARTAN and FELODIPINE for Blood pressure, DULAGLUTIDE and GLICLAZIDE for Diabetes, COVID-19 MRNA VACCINE BIONTECH from 10-Mar-2021 to an unknown date and INFLUENZA VACCINE (INFLUENZA VIRUS) from 30-Oct-2021 to an unknown date for Vaccination. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), ARTHRALGIA (Aching joints) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (12-18 hours after vax) (seriousness criterion medically significant) and LETHARGY (lethargy) (seriousness criterion medically significant). At the time of the report, FEELING ABNORMAL (12-18 hours after vax), LETHARGY (lethargy), PAIN IN EXTREMITY (Painful arm), ARTHRALGIA (Aching joints) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. It was reported that the patient had swelling and pain at injection site after 2-3 hours. 12-18 hours after vaccination joints aching, headache, general flu-like symptons, increased lethargy. The patient did not have symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient did not test positive for COVID-19 since having the vaccine. Treatment information was not reported Company Comment This case concerns a 52-year-old female patient, with medical history of Thyroidectomy and Type 2 diabetes mellitus (poorly controlled), who experienced the unexpected serious events of FEELING ABNORMAL, LETHARGY, PAIN IN EXTREMITY, ARTHRALGIA and HEADACHE. The events occurred on the same day of the administration of the third dose of mRNA-1273 vaccine. The rechallenge was unknown. Patient�s medical history of Thyroidectomy and Type 2 diabetes mellitus, remains as confounders. Patient received COVID-19 MRNA VACCINE BIONTECH as previous vaccination. Patient received influenza vaccine approximately 23 days before vaccination with mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 52-year-old female patient, with medical history of Thyroidectomy and Type 2 diabetes mellitus (poorly controlled), who experienced the unexpected serious events of FEELING ABNORMAL, LETHARGY, PAIN IN EXTREMITY, ARTHRALGIA and HEADACHE. The events occurred on the same day of the administration of the third dose of mRNA-1273 vaccine. The rechallenge was unknown. Patient�s medical history of Thyroidectomy and Type 2 diabetes mellitus, remains as confounders. Patient received COVID-19 MRNA VACCINE BIONTECH as previous vaccination. Patient received influenza vaccine approximately 23 days before vaccination with mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1927560 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046G21A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (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: PHMODERNATX, INC.MOD20214

Write-up: Fainting; Dizziness; Vomiting; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Dec-2021 and was forwarded to Moderna on 02-Dec-2021. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Dec-2021 and was forwarded to Moderna on 02-Dec-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Fainting) in a 17-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 046G21A) for an unknown indication. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Nov-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 23-Nov-2021 at 11:50 AM, the patient experienced DIZZINESS (Dizziness) and VOMITING (Vomiting). On 23-Nov-2021 at 12:35 PM, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant). On 23-Nov-2021 at 12:35 PM, DIZZINESS (Dizziness) and VOMITING (Vomiting) had resolved. On 23-Nov-2021 at 12:40 PM, SYNCOPE (Fainting) 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. No concomitant medication were reported. No treatment medication were reported. This case concerns a 17-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) with no relevant medical history who experienced the serious unexpected event of syncope approximately 12 hours after a dose of the vaccine. Rechallenge is not applicable, since no further dosing is expected. The benefit-risk relationship is not affected by this report; Sender''s Comments: This case concerns a 17-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) with no relevant medical history who experienced the serious unexpected event of syncope approximately 12 hours after a dose of the vaccine. Rechallenge is not applicable, since no further dosing is expected. The benefit-risk relationship is not affected by this report


VAERS ID: 1927564 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 007H21A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hypoaesthesia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Sexual dysfunction (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: PHMODERNATX, INC.MOD20214

Write-up: Fainting; NUMBNESS; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Dec-2021 and was forwarded to Moderna on 03-Dec-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Fainting) in a 19-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 007H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Nov-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 23-Nov-2021 at 5:40 PM, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant) and HYPOAESTHESIA (NUMBNESS). On 23-Nov-2021 at 6:20 PM, SYNCOPE (Fainting) and HYPOAESTHESIA (NUMBNESS) 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. No concomitant medication details was reported. No treatment medication details was reported. This case concerns a 19-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) with no relevant medical history who experienced the serious unexpected event of syncope same day as a dose of the vaccine. Rechallenge is not applicable, since no further dosing is expected. The benefit-risk relationship is not affected by this report; Sender''s Comments: This case concerns a 19-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) with no relevant medical history who experienced the serious unexpected event of syncope same day as a dose of the vaccine. Rechallenge is not applicable, since no further dosing is expected. The benefit-risk relationship is not affected by this report


VAERS ID: 1928226 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Dry mouth, Monoplegia, Pain in extremity, Taste disorder
SMQs:, Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tendinopathies and ligament disorders (broad), Dehydration (broad)

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

Write-up: Strange taste in mouth; Mouth dry; Low back pain; Back pain; Painful feet; Arm paralysis; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26242227) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DRY MOUTH (Mouth dry), BACK PAIN (Low back pain), BACK PAIN (Back pain), PAIN IN EXTREMITY (Painful feet), TASTE DISORDER (Strange taste in mouth) and MONOPLEGIA (Arm paralysis) in a 55-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 19-Jan-2020 to 26-Jan-2020. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 20-Mar-2021 to an unknown date for an unknown indication. On 22-Nov-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced MONOPLEGIA (Arm paralysis) (seriousness criterion medically significant). On 24-Nov-2021, the patient experienced DRY MOUTH (Mouth dry) (seriousness criterion medically significant), BACK PAIN (Low back pain) (seriousness criterion medically significant), BACK PAIN (Back pain) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Painful feet) (seriousness criterion medically significant). On an unknown date, the patient experienced TASTE DISORDER (Strange taste in mouth) (seriousness criterion medically significant). On 24-Nov-2021, MONOPLEGIA (Arm paralysis) was resolving. At the time of the report, DRY MOUTH (Mouth dry), BACK PAIN (Low back pain), BACK PAIN (Back pain) and PAIN IN EXTREMITY (Painful feet) had not resolved and TASTE DISORDER (Strange taste in mouth) outcome was unknown. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Company comment This case concerns a 55-year-old, female patient with relevant medical history of suspected COVID-19, who experienced the unexpected events of dry mouth, back pain, pain in extremity, taste disorder and monoplegia. The events occurred 1 and an unknown number of days after the first dose of mRNA-1273. The rechallenge was unknown since no information regarding the second dose was disclosed. The medical history of suspected COVID-19 remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events meet the criteria to be medically significant.; Sender''s Comments: This case concerns a 55-year-old, female patient with relevant medical history of suspected COVID-19, who experienced the unexpected events of dry mouth, back pain, pain in extremity, taste disorder and monoplegia. The events occurred 1 and an unknown number of days after the first dose of mRNA-1273. The rechallenge was unknown since no information regarding the second dose was disclosed. The medical history of suspected COVID-19 remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events meet the criteria to be medically significant.


VAERS ID: 1928240 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dyspnoea, Pyrexia, Rash, SARS-CoV-2 test, Sneezing
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: Difficulty breathing; Uncontrolled sneezing; Fever; Chills; Neck rash; This case was received via the Regulatory Authority (Reference number GB-MHRA-ADR 26243266) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSPNOEA, SNEEZING, RASH, PYREXIA, and CHILLS in a 58-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (COVID-19 VACCINE ASTRAZENECA) and COVID-19 VACCINE NRVV AD (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced RASH (seriousness criterion medically significant). On an unknown date, the patient experienced DYSPNOEA (seriousness criterion medically significant), SNEEZING (seriousness criterion medically significant), PYREXIA (seriousness criterion medically significant) and CHILLS (seriousness criterion medically significant). At the time of the report, DYSPNOEA, SNEEZING, PYREXIA, and CHILLS had resolved and RASH (Neck rash) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on an unknown date, SARS-CoV-2 test No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) was unknown. Treatment information was not provided. It was stated that patient was extremely ill. Patient experienced muscle ache, headache, feeling very sick, and last night a scarlet, angry red rash appeared over her face, neck, behind ears, and into hairline. Patient had difficulty breathing too. This case concerns a 58-year-old female subject, with no medical history reported, who experienced the unexpected and serious events of Dyspnoea, Sneezing, Rash, Pyrexia, and Chills. The event of Rash occurred 3 days after the third dose of mRNA-1273 vaccine. The events of Dyspnoea, Sneezing, Pyrexia, and Chills, occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge is not applicable, as no additional dosing will be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1928241 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

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

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

Write-up: rigours; headache; High temperature; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26243447) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (rigours), HEADACHE (headache) and PYREXIA (High temperature) in a 69-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for COVID-19 vaccination. Concomitant products included PILOCARPINE HYDROCHLORIDE (BOOTS PILOCARPINE) from 06-Jan-2012 to an unknown date for Glaucoma. On 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (rigours) (seriousness criterion medically significant) and HEADACHE (headache) (seriousness criterion medically significant). On 24-Nov-2021, PYREXIA (High temperature) was resolving. At the time of the report, CHILLS (rigours) and HEADACHE (headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19 Patient was experienced cold, rigours, high temperature, severe headache Patient is not enrolled in clinical trial No concomitant medications were provided by the reporter. Company Comment This case concerns a 69-year-old, male patient with no relevant medical history reported, who experienced the unexpected events of chills, headache and pyrexia. The events 1 day after the third dose of mRNA-1273. The rechallenge was unknown since no information regarding the first and second dose was disclosed and as was reported by regulatory Authority. The Benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events meet the criteria to be medically significant. No treatment information was provided by the reporter.; Sender''s Comments: This case concerns a 69-year-old, male patient with no relevant medical history reported, who experienced the unexpected events of chills, headache and pyrexia. The events 1 day after the third dose of mRNA-1273. The rechallenge was unknown since no information regarding the first and second dose was disclosed and as was reported by regulatory Authority. The Benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events meet the criteria to be medically significant.


VAERS ID: 1928242 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300473 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Burning sensation, Chills, Dizziness, Insomnia, Nausea, Pain in extremity, Peripheral coldness, Pyrexia, SARS-CoV-2 test, Sinus congestion, Sinus headache, Sleep disorder
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: shivering; burning sensation; cold feet; unable to sleep; sinuses became very stuffy; pains in ankle; Aching pain in hands, forearms, elbows; Insomnia; Sinus headache; Feverish; Joint pain; Foot pain; Nausea; Dizzy spells; Pain stomach; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26243902) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SINUS HEADACHE (Sinus headache), ARTHRALGIA (pains in ankle), PAIN IN EXTREMITY (Aching pain in hands, forearms, elbows), INSOMNIA (Insomnia), CHILLS (shivering), BURNING SENSATION (burning sensation), PERIPHERAL COLDNESS (cold feet), SLEEP DISORDER (unable to sleep), SINUS CONGESTION (sinuses became very stuffy), PYREXIA (Feverish), ARTHRALGIA (Joint pain), PAIN IN EXTREMITY (Foot pain), NAUSEA (Nausea), DIZZINESS (Dizzy spells) and ABDOMINAL PAIN UPPER (Pain stomach) in a 64-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 300473) for an unknown indication. No Medical History information was reported. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced SINUS HEADACHE (Sinus headache) (seriousness criterion medically significant), PAIN IN EXTREMITY (Aching pain in hands, forearms, elbows) (seriousness criterion medically significant), INSOMNIA (Insomnia) (seriousness criterion medically significant), PYREXIA (Feverish) (seriousness criterion medically significant), ARTHRALGIA (Joint pain) (seriousness criterion medically significant), PAIN IN EXTREMITY (Foot pain) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), DIZZINESS (Dizzy spells) (seriousness criterion medically significant) and ABDOMINAL PAIN UPPER (Pain stomach) (seriousness criterion medically significant). On an unknown date, the patient experienced ARTHRALGIA (pains in ankle) (seriousness criterion medically significant), CHILLS (shivering) (seriousness criterion medically significant), BURNING SENSATION (burning sensation) (seriousness criterion medically significant), PERIPHERAL COLDNESS (cold feet) (seriousness criterion medically significant), SLEEP DISORDER (unable to sleep) (seriousness criterion medically significant) and SINUS CONGESTION (sinuses became very stuffy) (seriousness criterion medically significant). At the time of the report, SINUS HEADACHE (Sinus headache), PAIN IN EXTREMITY (Aching pain in hands, forearms, elbows) and ARTHRALGIA (Joint pain) had not resolved, ARTHRALGIA (pains in ankle), CHILLS (shivering), BURNING SENSATION (burning sensation), PERIPHERAL COLDNESS (cold feet), SLEEP DISORDER (unable to sleep), SINUS CONGESTION (sinuses became very stuffy), PYREXIA (Feverish), PAIN IN EXTREMITY (Foot pain), NAUSEA (Nausea), DIZZINESS (Dizzy spells) and ABDOMINAL PAIN UPPER (Pain stomach) was resolving and INSOMNIA (Insomnia) 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. Concomitant product was not provided. Patient had no symptoms at all for first 8 hours (almost exactly) after vaccine given. Symptoms started with feeling of feverishness, shivering, very cold feet and hands. Followed quite rapidly by severe pains in ankle, knee, elbow, shoulder,hip joints, and head. Administered paracetamol to relive feverishness and pains but the effect was minimal. Went to bed early, started to experience extreme burning sensation in hands and feet. Hands were warm but feet still very cold despite burning sensation ( wore socks in bed to aid sleep but did not work). Sinuses became very stuffy, patient could not breathe through my nose and headache subsequently became more severe. Dizziness on getting up from bed and/or moving about, brain fog. Unable to sleep, could not find a position which was not painful and also absolutely wide awake all night. Not much resolution overnight, very dizzy and nauseous first thing in the morning. Took more paracetamol and began to feel that symptoms were subsiding about lunchtime. This reaction was far worse than the one I had to the initial Astra Zeneca vaccination, which did make to feel ill for a couple of days, but not nearly as painful or feverish as this. Company comment: This is a regulatory case concerning a 64 year-old, female patient with history of administration of COVID-19 Vaccine NRVV AD (CHADOX1 NCOV-19), who experienced the serious (due to medically important condition) unexpected, according CCDS, events of sinus headache, arthralgia (reported as joint pain and ankle pain), insomnia, chills, burning sensation, peripheral coldness, sleep disorder, sinus congestion, pyrexia, pain in extremity (reported as Aching pain in hands, forearms, elbows and Foot pain), nausea, dizziness and abdominal pain upper. The events Sinus headache, pyrexia, arthralgia (reported as joint pain), Pain in extremity (reported as Aching pain in hands, forearms, elbows and Foot pain), insomnia, nausea, Dizziness and Abd; Sender''s Comments: This is a regulatory case concerning a 64 year-old, female patient with history of administration of COVID-19 Vaccine NRVV AD (CHADOX1 NCOV-19), who experienced the serious (due to medically important condition) unexpected, according CCDS, events of sinus headache, arthralgia (reported as joint pain and ankle pain), insomnia, chills, burning sensation, peripheral coldness, sleep disorder, sinus congestion, pyrexia, pain in extremity (reported as Aching pain in hands, forearms, elbows and Foot pain), nausea, dizziness and abdominal pain upper. The events Sinus headache, pyrexia, arthralgia (reported as joint pain), Pain in extremity (reported as Aching pain in hands, forearms, elbows and Foot pain), insomnia, nausea, Dizziness and Abdominal pain upper occurred the same day after the booster dose of mRNA-1273 vaccine; the rest of the events occurred on an unknown date. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The patient received a dose of the COVID-19 Vaccine NRVV AD (CHADOX1 NCOV-19) on an unknown date and number of doses not provided, this remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1928245 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature increased, Dysgeusia, Headache, Lethargy, Lip swelling, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (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: SAYANA PRESS
Current Illness: Diverticular disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Lip swelling; After taste; Headache; Lethargy; Muscle ache; Nausea; Temperature elevation; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26245383) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LIP SWELLING (Lip swelling), DYSGEUSIA (After taste), HEADACHE (Headache), LETHARGY (Lethargy), MYALGIA (Muscle ache), NAUSEA (Nausea) and BODY TEMPERATURE INCREASED (Temperature elevation) in a 60-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for an unknown indication. Concurrent medical conditions included Diverticular disease. Concomitant products included MEDROXYPROGESTERONE ACETATE (SAYANA PRESS) for Localised muscle pain. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced LIP SWELLING (Lip swelling) (seriousness criterion medically significant), DYSGEUSIA (After taste) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), LETHARGY (Lethargy) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and BODY TEMPERATURE INCREASED (Temperature elevation) (seriousness criterion medically significant). On 23-Nov-2021, LIP SWELLING (Lip swelling) had resolved. At the time of the report, DYSGEUSIA (After taste), HEADACHE (Headache), LETHARGY (Lethargy), MYALGIA (Muscle ache), NAUSEA (Nausea) and BODY TEMPERATURE INCREASED (Temperature elevation) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medications was not reported Patient had lip swelling and tingling around mouth began 2 hours after the vaccine, the other symptoms began later in the day and overnight. She did not had a reaction like this to any previous vaccines of any kind. Her first two covid 19 vaccines were both Pfizer and all she had was a sore muscle at the injection site for approx 24 hours. The reactions to the Moderna had wiped her out today and she still had a very altered sense of taste, nausea and fatigue as well as the headache which had not really gone, despite taking paracetamol. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial Company comment: This is a regulatory case concerning a 60 year-old, female patient with concomitant medication of medroxyprogesterone acetate and prior administration of two doses of Pfizer Biontech COVID-19 vaccine (dates not provided), who experienced the serious (due to medically important condition) unexpected, according CCDS, events of Lip swelling, Dysgeusia, Headache, Lethargy, Myalgia, Nausea and Body temperature increased. The events occurred the same day after the booster dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The concomitant medication of medroxyprogesterone acetate and prior administration of two doses of Pfizer Biontech COVID-19 vaccine (dates not provided) remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 60 year-old, female patient with concomitant medication of medroxyprogesterone acetate and prior administration of two doses of Pfizer Biontech COVID-19 vaccine (dates not provided), who experienced the serious (due to medically important condition) unexpected, according CCDS, events of Lip swelling, Dysgeusia, Headache, Lethargy, Myalgia, Nausea and Body temperature increased. The events occurred the same day after the booster dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The concomitant medication of medroxyprogesterone acetate and prior administration of two doses of Pfizer Biontech COVID-19 vaccine (dates not provided) remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1928246 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (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
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Shaking; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26245411) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of TREMOR (Shaking) in a 52-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. On 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced TREMOR (Shaking) (seriousness criterion medically significant). On 24-Nov-2021, TREMOR (Shaking) had resolved. 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 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No Concomitant medications were reported. No Treatment medications were provided. Company Comment This case concerns a 52-year-old, male patient with no relevant medical history reported, who experienced the unexpected serious event of tremor. The event occurred approximately on the same day after the third dose of mRNA-1273 vaccine. The first dose administered was CHADOX1 NCOV-19 (COVID-19 VACCINE ASTRAZENECA) and the patient had similar symptoms, second dose type was not specified. The rechallenge was unknown as per reporter�s assessment. Previous vaccination with CHADOX1 NCOV-19 remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority�s report due to important medical event.; Sender''s Comments: This case concerns a 52-year-old, male patient with no relevant medical history reported, who experienced the unexpected serious event of tremor. The event occurred approximately on the same day after the third dose of mRNA-1273 vaccine. The first dose administered was CHADOX1 NCOV-19 (COVID-19 VACCINE ASTRAZENECA) and the patient had similar symptoms, second dose type was not specified. The rechallenge was unknown as per reporter�s assessment. Previous vaccination with CHADOX1 NCOV-19 remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority�s report due to important medical event.


VAERS ID: 1928250 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 4589109670 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Chills, Dizziness, Dry throat, Dyspnoea, Eye pain, Feeling cold, Headache, Lethargy, Night sweats, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOPERAMIDE HYDROCHLORIDE
Current Illness:
Preexisting Conditions: Comments: No medical history information was reported.
Allergies:
Diagnostic Lab Data: Test Date: 20211001; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Shivering; Chilliness; Eye ache; Headache; Felt giddy; Lethargic; Night sweats; Feeling of total lack of energy; Dry throat; Laboured breathing; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26245811) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Shivering), FEELING COLD (Chilliness), EYE PAIN (Eye ache), HEADACHE (Headache), DIZZINESS (Felt giddy), LETHARGY (Lethargic), NIGHT SWEATS (Night sweats), ASTHENIA (Feeling of total lack of energy), DRY THROAT (Dry throat) and DYSPNOEA (Laboured breathing) in a 67-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 4589109670) for COVID-19 vaccination. No medical history information was reported. Concomitant products included LOPERAMIDE HYDROCHLORIDE for an unknown indication. On 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced FEELING COLD (Chilliness) (seriousness criterion medically significant), EYE PAIN (Eye ache) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), DIZZINESS (Felt giddy) (seriousness criterion medically significant), LETHARGY (Lethargic) (seriousness criterion medically significant), NIGHT SWEATS (Night sweats) (seriousness criterion medically significant), ASTHENIA (Feeling of total lack of energy) (seriousness criterion medically significant), DRY THROAT (Dry throat) (seriousness criterion medically significant) and DYSPNOEA (Laboured breathing) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (Shivering) (seriousness criterion medically significant). At the time of the report, CHILLS (Shivering), FEELING COLD (Chilliness), EYE PAIN (Eye ache), HEADACHE (Headache), DIZZINESS (Felt giddy), LETHARGY (Lethargic), NIGHT SWEATS (Night sweats) and ASTHENIA (Feeling of total lack of energy) had not resolved, DRY THROAT (Dry throat) was resolving and DYSPNOEA (Laboured breathing) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment information was not provided. The patient had no symptoms associated with COVID 19. The reporter stated that the patient never slept at all on 23 Nov and 24 Nov 2021. The patient experienced crushing head and eye ache, severe chill throughout the body, was shivering and went out of bed once to use the toilet. Another Lot number was also reported as LOT 3004675. The patient was not tested positive for COVID 19 since vaccine administration and was not enrolled in clinical trial. The report did not relate to possible inflammation of heart like myocarditis or pericarditis. Company comment: This regulatory case concerns a 67-year-old, male patient with no reported medical history, who experienced the unexpected, serious (IME) events of chills, feeling cold, eye pain, headache, dizziness, lethargy, night sweats, asthenia, dyspnoea and dry throat. The events occurred on the same day after third dose of mRNA-1273 vaccine. Regulatory authority captured the rechallenge as unknown, however no information about further dosing is disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.; Sender''s Comments: This regulatory case concerns a 67-year-old, male patient with no reported medical history, who experienced the unexpected, serious (IME) events of chills, feeling cold, eye pain, headache, dizziness, lethargy, night sweats, asthenia, dyspnoea and dry throat. The events occurred on the same day after third dose of mRNA-1273 vaccine. Regulatory authority captured the rechallenge as unknown, however no information about further dosing is disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.


VAERS ID: 1928268 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046G21A / UNK - / OT

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

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

Write-up: Unconscious; Nausea/Vomiting; Nausea/Vomiting; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Dec-2021 and was forwarded to Moderna on 02-Dec-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Unconscious), VOMITING (Nausea/Vomiting) and NAUSEA (Nausea/Vomiting) in a 68-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 046G21A) for an unknown indication. No Medical History information was reported. On 22-Nov-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 23-Nov-2021, the patient experienced LOSS OF CONSCIOUSNESS (Unconscious) (seriousness criteria hospitalization and medically significant), VOMITING (Nausea/Vomiting) (seriousness criterion hospitalization) and NAUSEA (Nausea/Vomiting) (seriousness criterion hospitalization). The patient was hospitalized on 23-Nov-2021 due to VOMITING. At the time of the report, LOSS OF CONSCIOUSNESS (Unconscious), VOMITING (Nausea/Vomiting) and NAUSEA (Nausea/Vomiting) was resolving. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. The concomitant history was not reported. The treatment history was not provided. This case concerns a 68-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) with no relevant medical history who experienced the serious unexpected event of loss of consciousness two days after a dose of the vaccine. Rechallenge is not applicable, since no further dosing is expected. The benefit-risk relationship is not affected by this report; Sender''s Comments: This case concerns a 68-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) with no relevant medical history who experienced the serious unexpected event of loss of consciousness two days after a dose of the vaccine. Rechallenge is not applicable, since no further dosing is expected. The benefit-risk relationship is not affected by this report


VAERS ID: 1929938 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-11-23
   Days after vaccination:175
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: CZPFIZER INC202101652229

Write-up: COVID-19 confirmed by positive COVID-19 test, mild symptoms of common cold; COVID-19 confirmed by positive COVID-19 test, mild symptoms of common cold; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient. A 53 year-old male patient received bnt162b2 (COMIRNATY), administration date 01Jun2021 (Lot number: Unknown) as dose 2, single and administration date 20Apr2021 (Lot number: Unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Nov2021, outcome "recovering" and all described as "COVID-19 confirmed by positive COVID-19 test, mild symptoms of common cold". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1930079 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XE389 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Injection site erythema, Vaccination site reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20211209302

Write-up: INJECTION SITE REDNESS; VACCINATION SITE REACTION; CHEST PAIN - CARDIAC; This spontaneous report received from a consumer via a Regulatory Authority [regulatory authority, DE-PEI-CADR2021205771] concerned a 48 year old female. The patient''s weight was 55 kilograms, and height was 168 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1)(suspension for injection, route of admin not reported, batch number: XE389 expiry: unknown) dose was not reported, 1 total, administered on 23-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-NOV-2021, the patient experienced chest pain - cardiac and vaccination site reaction. On 24-NOV-2021, the patient experienced injection site redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site redness on 25-NOV-2021, and had not recovered from chest pain - cardiac, and vaccination site reaction. This report was serious (Other Medically Important Condition).


VAERS ID: 1930288 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hunger, Influenza like illness
SMQs:, Hyperglycaemia/new onset diabetes mellitus (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.MOD20213

Write-up: Flu like symptoms and hunger; Flu like symptoms and hunger; This case was received via regulatory agency(Reference number: GB-MHRA-ADR 26243360) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms and hunger) and HUNGER (Flu like symptoms and hunger) in a 52-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for Booster. No Medical History information was reported. On 22-Nov-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Parenteral) 1 dosage form. On 23-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms and hunger) (seriousness criterion medically significant) and HUNGER (Flu like symptoms and hunger) (seriousness criterion medically significant). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms and hunger) and HUNGER (Flu like symptoms and hunger) was resolving. No concomitant medication reported. No treatment information was provided. Company Comment This case concerns a 52-year-old, male patient with no relevant medical history reported, who experienced the unexpected events of influenza like illness and hunger. The events occurred 1 day after an unknown number of doses of mRNA-1273. The rechallenge was not applicable since no information regarding the number of the doses was disclosed and as was reported by regulatory Authority. The Benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events meet the criteria to be medically significant.; Sender''s Comments: This case concerns a 52-year-old, male patient with no relevant medical history reported, who experienced the unexpected events of influenza like illness and hunger. The events occurred 1 day after an unknown number of doses of mRNA-1273. The rechallenge was not applicable since no information regarding the number of the doses was disclosed and as was reported by regulatory Authority. The Benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events meet the criteria to be medically significant.


VAERS ID: 1930443 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve replacement
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101654402

Write-up: Off label use; Interchange of vaccine products; Booster; Vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202111231100345490-GM6GH. Other Case identifier(s): GB-MHRA-ADR 26237743. A 40 year-old male patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Aortic valve replacement" (unspecified if ongoing). Concomitant medication(s) included: WARFARIN taken for aortic valve replacement. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 23Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "Booster"; VOMITING (medically significant) with onset 23Nov2021, outcome "recovering", described as "Vomiting". Clinical course: Patient had not symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1930556 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH F1C9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Fatigue, Hyperhidrosis, Immunisation, Interchange of vaccine products, Pain, Pain in extremity, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Back ache; Cholesterol; Diverticular disease; Drug-induced liver disease; Hernia; Hip resurfacing surgery; Hypothyroidism; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Kidney disorder; Liver disorder; Obesity; Osteoarthritis; Sleep apnea; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20211102; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101654462

Write-up: Vomiting; Pain chest; Tiredness; Painful arm; Heavy sweating; Interchange of vaccine products; Booster; pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111240422420320-VR90Y (RA). Other Case identifier(s): GB-MHRA-ADR 26241054 (RA). A 60 year-old female patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Lot number: F1c9413) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Drug-induced liver injury" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Hernia" (unspecified if ongoing); "Suspected COVID-19", start date: 23Nov2021 (ongoing); "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...; "Under active Thyroid" (unspecified if ongoing); "T2 Diabetic" (unspecified if ongoing); "Divcular disease" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "hips resurfaced" (unspecified if ongoing); "Kidney & liver disease" (unspecified if ongoing); "liver disease" (unspecified if ongoing); "Back ache" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 2, single, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (dose 1, single, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (disability, medically significant) with onset 23Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (disability, medically significant) with onset 23Nov2021, outcome "unknown", described as "Booster"; PAIN (disability, medically significant) with onset 2021, outcome "not recovered", described as "pain"; VOMITING (disability, medically significant) with onset 23Nov2021, outcome "not recovered", described as "Vomiting"; CHEST PAIN (disability, medically significant) with onset 23Nov2021, outcome "not recovered", described as "Pain chest"; FATIGUE (disability, medically significant) with onset 23Nov2021, outcome "not recovered", described as "Tiredness"; PAIN IN EXTREMITY (disability, medically significant) with onset 23Nov2021, outcome "not recovered", described as "Painful arm"; HYPERHIDROSIS (disability, medically significant) with onset 23Nov2021, outcome "recovering", described as "Heavy sweating". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Nov2021) negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of pain, chest pain, pain in extremity. Clinical coarse: Pain killers taken as Ambulance crew advised. Relevant medical history included hernia, under active thyroid, t2 diabetic, divcular disease, sleep apnea, cholesterol, osteoarthritis hips resurfaced, kidney & liver disease, obesity, back ache, mobility. Pain killers taken, ambulance crew advised. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Her report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1930557 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypotonia, Immunisation, Interchange of vaccine products, Limb discomfort, Monoplegia, Off label use, SARS-CoV-2 test, Thirst, Vaccination site pain
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Medication errors (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic anxiety; Multiple sclerosis
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Positive; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101654520

Write-up: woke at 3am weak; heavy limbs headache; Thirsty; very sore injection site; Leg paralysis; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202111240433526000-699MF (MHRA). Other Case identifier(s): GB-MHRA-ADR 26241035 (MHRA). Regulatory AuthorityA female patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 23Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "Booster"; HYPOTONIA (medically significant), outcome "not recovered", described as "woke at 3am weak"; LIMB DISCOMFORT (medically significant), outcome "not recovered", described as "heavy limbs headache"; MONOPLEGIA (medically significant) with onset 24Nov2021, outcome "not recovered", described as "Leg paralysis"; THIRST (medically significant), outcome "unknown", described as "Thirsty"; VACCINATION SITE PAIN (medically significant), outcome "unknown", described as "very sore injection site". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14Sep2021) positive, notes: Yes - Positive COVID-19 test. Therapeutic measures were taken as a result of hypotonia and included paracetamol. Clinical course: Patient did not have symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Reaction: This report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1930579 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-23
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hot flush, Migraine
SMQs:

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

Write-up: flashes; Migraine headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26248302) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine headache) and HOT FLUSH (flashes) in a 61-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. No Medical History information was reported. On 18-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced MIGRAINE (Migraine headache) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced HOT FLUSH (flashes) (seriousness criteria disability and medically significant). At the time of the report, MIGRAINE (Migraine headache) and HOT FLUSH (flashes) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medication details was provided. No treatment medication details was provided. The patient experienced Misty eye then black shape and spots with extra floaters than normal. Headache with flashes at right side of eye. Also black line instead of flashes.Still continuied with flashes or black line and headache also. She stated that Headache was not quite so bad today but still had flashes and black line. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment This case concerns a 61-year-old female patient with no reported relevant medical history, who experienced the unexpected serious events of MIGRAINE and HOT FLUSH. The events occurred on approximately 6 days after the administration of the third dose of mRNA- 1273 vaccine. The rechallenge was unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 61-year-old female patient with no reported relevant medical history, who experienced the unexpected serious events of MIGRAINE and HOT FLUSH. The events occurred on approximately 6 days after the administration of the third dose of mRNA- 1273 vaccine. The rechallenge was unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.


VAERS ID: 1930580 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Testicular pain
SMQs:, Sexual dysfunction (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: OMEPRAZOLE [OMEPRAZOLE SODIUM]
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Testicular pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26248342) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of TESTICULAR PAIN (Testicular pain) in a male patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. No medical history was provided by the reporter. Concomitant products included OMEPRAZOLE SODIUM (OMEPRAZOLE [OMEPRAZOLE SODIUM]) from 22-May-2020 to an unknown date for COVID-19 vaccination. On 22-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced TESTICULAR PAIN (Testicular pain) (seriousness criterion medically significant). On 24-Nov-2021, TESTICULAR PAIN (Testicular pain) had resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment medication details was reported. Patient was not enrolled in clinical trial. The patient has not had symptoms associated with COVID-19 and had not undergone a COVID-19 test. Company comment This case concerns a male patient of unknown age with no relevant medical history, who experienced the serious unexpected event of testicular pain. The event occurred the day after the third dose of mRNA-1273 and resolved in 1 day. The rechallenge is unknown, according to SD. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a male patient of unknown age with no relevant medical history, who experienced the serious unexpected event of testicular pain. The event occurred the day after the third dose of mRNA-1273 and resolved in 1 day. The rechallenge is unknown, according to SD. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1930583 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Injection site mass, Migraine, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: very red swollen arm; migraine; Injection site lump; Chronic migraine; Fever; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26248492) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very red swollen arm), MIGRAINE (migraine), PYREXIA (Fever), MIGRAINE (Chronic migraine) and INJECTION SITE MASS (Injection site lump) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. On 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 24-Nov-2021, the patient experienced MIGRAINE (Chronic migraine) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (very red swollen arm) (seriousness criterion medically significant), MIGRAINE (migraine) (seriousness criterion medically significant) and INJECTION SITE MASS (Injection site lump) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (very red swollen arm), MIGRAINE (migraine), PYREXIA (Fever), MIGRAINE (Chronic migraine) and INJECTION SITE MASS (Injection site lump) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medications reported by reporter. Patient has not tested positive for COVID-19 since having the vaccine. No treatment medications provided by the reporter. Patient experienced very red swollen arm, bad fever, migraine Company comment: This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected events of pyrexia, migraine, pain in extremity, and injection site mass. The event of pyrexia occurred on the same day, migraine one day after and the rest of events on unknown date after third dose of mRNA-1273. The rechallenge was not applicable as events occurred after third dose and no further dosing was reported or planned, based on information provided. However, the rechallenge was assessed as unknown by Regulatory Authority and it was retained as such. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a serious medical condition.; Sender''s Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected events of pyrexia, migraine, pain in extremity, and injection site mass. The event of pyrexia occurred on the same day, migraine one day after and the rest of events on unknown date after third dose of mRNA-1273. The rechallenge was not applicable as events occurred after third dose and no further dosing was reported or planned, based on information provided. However, the rechallenge was assessed as unknown by Regulatory Authority and it was retained as such. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a serious medical condition.


VAERS ID: 1930593 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, 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: COVID-19 VACCINE ASTRAZENECA; INFLUENZA VIRUS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: High temperature; Painful arm; Headache; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26248761) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (High temperature), PAIN IN EXTREMITY (Painful arm) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 03-Mar-2021 to an unknown date for COVID-19 vaccination, INFLUENZA VACCINE (INFLUENZA VIRUS) from 07-Oct-2021 to an unknown date for an unknown indication. On 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, PYREXIA (High temperature), PAIN IN EXTREMITY (Painful arm) and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment information was provided by the reporter. Company comment: This regulatory authority case concerns a 65-year-old female patient with no relevant medical history who experienced serious unexpected events of pyrexia, pain in extremity, headache. The events occurred within 24 hours from the third dose of the mRNA-1273 . The rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable. The regulatory authority assessed the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 65-year-old female patient with no relevant medical history who experienced serious unexpected events of pyrexia, pain in extremity, headache. The events occurred within 24 hours from the third dose of the mRNA-1273 . The rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable. The regulatory authority assessed the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1930594 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Heart rate increased, Nausea, Throat tightness, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CALCIUM; PFIZER BIONTECH COVID-19 VACCINE; IBUPROFEN; INFLUENZA VIRUS; THIAMINE; VITAMIN B12 NOS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fracture (4 fractured lumber vertebrae); Shoulder pain (broken shoulder)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Nausea; Heart rate increased; Throat tightness; Vomiting; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26248796) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), HEART RATE INCREASED (Heart rate increased), THROAT TIGHTNESS (Throat tightness) and VOMITING (Vomiting) in a 72-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for COVID-19 vaccination. The patient''s past medical history included Fracture (4 fractured lumber vertebrae) and Shoulder pain (broken shoulder). Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 08-Feb-2021 to an unknown date for COVID-19 vaccination, CALCIUM from 01-Nov-2020 to an unknown date for Calcium deficiency, INFLUENZA VACCINE (INFLUENZA VIRUS) from 09-Nov-2021 to an unknown date for Influenza immunisation, IBUPROFEN for Pain, THIAMINE from 01-Nov-2020 to an unknown date for Thiamine supplementation, VITAMIN B12 NOS from 01-Nov-2020 to an unknown date for Vitamin B12. On 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), HEART RATE INCREASED (Heart rate increased) (seriousness criterion medically significant), THROAT TIGHTNESS (Throat tightness) (seriousness criterion medically significant) and VOMITING (Vomiting) (seriousness criterion medically significant). On 24-Nov-2021, NAUSEA (Nausea), HEART RATE INCREASED (Heart rate increased), THROAT TIGHTNESS (Throat tightness) and VOMITING (Vomiting) had resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient had vaccine on the 23/11 about five minutes following the vaccine patient was sick. Patient then continued to vomit a few more times during the day and once in the night, has not been sick since. Patient also reports an increase in heart rate and tightness of the throat which started in the evening of the vaccine around 5pm and this continued through the following day (24/11). Patient is feeling better now, has not taken anything for these symptoms and did not seek medical advice. Company Comment: This case concerns a 72-year-old female subject, with no relevant medical history, who experienced the unexpected and serious events of Nausea, Heart rate increased, Throat tightness, and Vomiting. The events of Nausea and Vomiting are unexpected as they are retained as serious per the source document Authority reporting. The events occurred within the first day after the booster dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 72-year-old female subject, with no relevant medical history, who experienced the unexpected and serious events of Nausea, Heart rate increased, Throat tightness, and Vomiting. The events of Nausea and Vomiting are unexpected as they are retained as serious per the source document Authority reporting. The events occurred within the first day after the booster dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1930595 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Immobile, Lymphadenopathy, Myalgia, 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: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Headache; Muscle pain; Glands swollen; High temperature; Immobile; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26258310) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Muscle pain), LYMPHADENOPATHY (Glands swollen), PYREXIA (High temperature) and IMMOBILE (Immobile) in a 61-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. Previously administered products included for Product used for unknown indication: ATORVASTATIN CALCIUM. Past adverse reactions to the above products included No adverse event with ATORVASTATIN CALCIUM. Concurrent medical conditions included Suspected COVID-19 since 20-Mar-2020. On 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced IMMOBILE (Immobile) (seriousness criterion medically significant). On 24-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), MYALGIA (Muscle pain) (seriousness criterion medically significant), LYMPHADENOPATHY (Glands swollen) (seriousness criterion medically significant) and PYREXIA (High temperature) (seriousness criterion medically significant). On 25-Nov-2021, IMMOBILE (Immobile) had resolved. At the time of the report, HEADACHE (Headache), MYALGIA (Muscle pain), LYMPHADENOPATHY (Glands swollen) and PYREXIA (High temperature) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medications were reported. Treatment information was not provided. Patient was self administered ibuprofen and paracetamol and is still ongoing. Company Comment This case concerns a 61-year-old, male patient with relevant medical history of suspected COVID-19, who experienced the unexpected events of headache, myalgia, lymphadenopathy, pyrexia immobile. The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was unknown since no information regarding the first and second dose was disclosed and as was reported by regulatory Authority. The medical history of suspected COVID-19 remains a confounder. The Benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events meet the criteria to be medically significant. It was reported that the patient was coexisted with long term effects of covid or prior covid vaccine of continuous tinnitus and fatigue, fussy head/memory loss. Patient not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. It was reported that the events were not related to possible inflammation of the heart.; Sender''s Comments: This case concerns a 61-year-old, male patient with relevant medical history of suspected COVID-19, who experienced the unexpected events of headache, myalgia, lymphadenopathy, pyrexia immobile. The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was unknown since no information regarding the first and second dose was disclosed and as was reported by regulatory Authority. The medical history of suspected COVID-19 remains a confounder. The Benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events meet the criteria to be medically significant.


VAERS ID: 1930599 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Dry throat, Fatigue, Headache, Pruritus, Rash, SARS-CoV-2 test, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

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

Write-up: skin rash both arms not vaccination site; itch; Headache dull; Shivers; Skin rash; Dry throat; Tired all the time; Aching joints; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26249037) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (skin rash both arms not vaccination site), PRURITUS (itch), HEADACHE (Headache dull), CHILLS (Shivers), RASH (Skin rash), DRY THROAT (Dry throat), FATIGUE (Tired all the time) and ARTHRALGIA (Aching joints) in a 75-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. Concomitant products included ATORVASTATIN for Cholesterol. On 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced HEADACHE (Headache dull) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant), RASH (Skin rash) (seriousness criterion medically significant), DRY THROAT (Dry throat) (seriousness criterion medically significant), FATIGUE (Tired all the time) (seriousness criterion medically significant) and ARTHRALGIA (Aching joints) (seriousness criterion medically significant). On an unknown date, the patient experienced VACCINATION SITE PAIN (skin rash both arms not vaccination site) (seriousness criterion medically significant) and PRURITUS (itch) (seriousness criterion medically significant). On 25-Nov-2021, HEADACHE (Headache dull) had resolved. At the time of the report, VACCINATION SITE PAIN (skin rash both arms not vaccination site), PRURITUS (itch), CHILLS (Shivers), DRY THROAT (Dry throat) and ARTHRALGIA (Aching joints) was resolving and RASH (Skin rash) and FATIGUE (Tired all the time) 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. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Skin rash both arms not vaccination site, similar to hives itchy. Used e45 itch relief cream to relieve symptoms still persisting on 25. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Company comment: This is a regulatory case concerning a 75-year-old male patient with no relevant medical history, who experienced serious, unexpected events of vaccination site pain, pruritus, headache, chills, rash, dry throat, fatigue and arthralgia. The events occurred on the same day after the third dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 75-year-old male patient with no relevant medical history, who experienced serious, unexpected events of vaccination site pain, pruritus, headache, chills, rash, dry throat, fatigue and arthralgia. The events occurred on the same day after the third dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1930601 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Lymphadenopathy, Myalgia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: Joint pain; Chills; Glands swollen; Muscle ache; Vaccination site pain; Tiredness; This case was received via regulatory authority on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (Vaccination site pain), FATIGUE (Tiredness), CHILLS (Chills), LYMPHADENOPATHY (Glands swollen) and MYALGIA (Muscle ache) in a 64-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. On 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 24-Nov-2021, the patient experienced ARTHRALGIA (Joint pain) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), LYMPHADENOPATHY (Glands swollen) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). On 25-Nov-2021, CHILLS (Chills), LYMPHADENOPATHY (Glands swollen) and MYALGIA (Muscle ache) had resolved. At the time of the report, ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Tiredness) 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 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant product use was not provided. Patient experienced general feeling of being unwell for 24 hours after vaccine. Treatment medication included paracetamol. Company comment: This case concerns a 64-year-old female patient, with no medical history reported, who experienced the serious unexpected events of arthralgia, vaccination site pain, lymphadenopathy, myalgia, chills and fatigue after third dose of mRNA-1273. The events occurred within the first and second day after vaccination. The re-challenge is unknown since no information regarding first and second dose was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.; Sender''s Comments: This case concerns a 64-year-old female patient, with no medical history reported, who experienced the serious unexpected events of arthralgia, vaccination site pain, lymphadenopathy, myalgia, chills and fatigue after third dose of mRNA-1273. The events occurred within the first and second day after vaccination. The re-challenge is unknown since no information regarding first and second dose was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.


VAERS ID: 1930603 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Influenza, Influenza like illness, Malaise, Rash, Rash erythematous, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AZATHIOPRINE; COVID-19 VACCINE ASTRAZENECA; FELODIPINE; INFLUENZA VIRUS
Current Illness: Autoimmune disorder (Currently being treated by Dental Hospital for an autoimmune disorder that is proving difficult to treat or identify specifically. Have had this condition since October 2016.); Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response)
Preexisting Conditions: Comments: Currently being treated by Dental Hospital for an autoimmune disorder that is proving difficult to treat or identify specifically. Have had this condition since October 2016. Due to this conditon I have taken high doses of Prednisolone (ie 40 to 60 mg on a tapering reduction) on a number of ocassions over the past five years. Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20200929; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: unwell; flu symptoms; rash; Red rash; Local swelling; Headache; Flu like symptoms; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26251623) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MALAISE (unwell), INFLUENZA (flu symptoms), RASH (rash), INFLUENZA LIKE ILLNESS (Flu like symptoms), RASH ERYTHEMATOUS (Red rash), SWELLING (Local swelling) and HEADACHE (Headache) in a 64-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. Currently being treated by Dental Hospital for an autoimmune disorder that is proving difficult to treat or identify specifically. Have had this condition since October 2016. Due to this conditon I have taken high doses of Prednisolone (ie 40 to 60 mg on a tapering reduction) on a number of ocassions over the past five years. Patient has not had symptoms associated with COVID-19. Previously administered products included for Autoimmune disorder: PREDNISOLONE (Took high doses of Prednisolone (ie 40 to 60 mg on a tapering reduction) on a number of occasions over the past five years.). Concurrent medical conditions included Autoimmune disorder (Currently being treated by Dental Hospital for an autoimmune disorder that is proving difficult to treat or identify specifically. Have had this condition since October 2016.) since October 2016 and Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response) since October 2016. Concomitant products included AZATHIOPRINE from 12-Oct-2021 to an unknown date for Autoimmune disorder, FELODIPINE from 24-Jan-2020 to an unknown date for Hypertension, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 06-Mar-2021 to an unknown date and INFLUENZA VACCINE (INFLUENZA VIRUS) from 25-Oct-2021 to an unknown date for an unknown indication. On 22-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion medically significant), SWELLING (Local swelling) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 25-Nov-2021, the patient experienced RASH ERYTHEMATOUS (Red rash) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (unwell) (seriousness criterion medically significant), INFLUENZA (flu symptoms) (seriousness criterion medically significant) and RASH (rash) (seriousness criterion medically significant). At the time of the report, MALAISE (unwell), INFLUENZA (flu symptoms), RASH (rash), INFLUENZA LIKE ILLNESS (Flu like symptoms) and HEADACHE (Headache) was resolving and RASH ERYTHEMATOUS (Red rash) and SWELLING (Local swelling) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Sep-2020, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. The patient felt well until lunchtime the day after the vaccination. Then started to shiver and was unwell with flu like symptoms. Her arm was very sore with swelling at site of vaccination. Flue like symptoms resolved three days later. Red rash at site of vaccination appeared on day three following vaccination. She also had rash which was hot to touch. The flu symptoms were treated with paracetamol and bed rest.one and a half days off work. The patient''s report was not related to possible inflammation of the heart (myocarditis or pericarditis). Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. CC. This regulatory authority case concerns a 64-year-old, female patient with no reported relevant medical history, who experienced the unexpected serious events of malaise, influenza, rash, influenza like illness, rash erythematous, swelling, and headache. The events of headache and rash are unexpected as they are retained as serious. The events influenza like illness, swelling and headache occurred one day after the dose of mRNA-1273. Rash erythematous occurred three days after vaccination. The date of onset of the events malaise, influenza and rash was not reported. The dose of mRNA-1273 is considered as third dose of her COVID-19 vaccine schedule. The patient received previously two doses of AstraZeneca COVID-19 vaccine. Regulatory authority reported the rechallenge as unknown, however, the outcome of the events is yet not recovered. Concomitant medication prednisolone could be potentially confounder for headache; and felodipine for rash erythematous. The patient previously received a dose of influenza vaccine, which could be a confounding factor, especially for the events malaise, influenza, and rash, which the onset date is not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events coding and seriousness captured per source document from Regulatory Authority reporting; Sender''s Comments: This regulatory authority case concerns a 64-year-old, female patient with no reported relevant medical history, who experienced the unexpected serious events of malaise, influenza, rash, influenza like illness, rash erythematous, swelling, and headache. The events of headache and rash are unexpected as they are retained as serious. The events influenza like illness, swelling and headache occurred one day after the dose of mRNA-1273. Rash erythematous occurred three days after vaccination. The date of onset of the events malaise, influenza and rash was not reported. The dose of mRNA-1273 is considered as third dose of her COVID-19 vaccine schedule. The patient received previously two doses of AstraZeneca COVID-19 vaccine. Regulatory authority reported the rechallenge as unknown, however, the outcome of the events is yet not recovered. Concomitant medication prednisolone could be potentially confounder for headache; and felodipine for rash erythematous. The patient previously received a dose of influenza vaccine, which could be a confounding factor, especially for the events malaise, influenza, and rash, which the onset date is not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events coding and seriousness captured per source document from Regulatory Authority reporting


VAERS ID: 1930605 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211030; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: COVID-19 virus test negative.
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: chills; rash; shivering; high temperature; Hand rash; Fever chills; Fever; Headache; Fatigue; This case was received via RA (Reference number: GB-MHRA-ADR 26251632) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (chills), RASH (rash), CHILLS (shivering), PYREXIA (high temperature), RASH (Hand rash), PYREXIA (Fever chills), PYREXIA (Fever), HEADACHE (Headache) and FATIGUE (Fatigue) in a 40-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: SERTRALINE (Currently taking Setraline 100mg daily). Past adverse reactions to the above products included Adverse event with SERTRALINE. On 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced PYREXIA (Fever chills) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 25-Nov-2021, the patient experienced RASH (Hand rash) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (chills) (seriousness criterion medically significant), RASH (rash) (seriousness criterion medically significant), CHILLS (shivering) (seriousness criterion medically significant) and PYREXIA (high temperature) (seriousness criterion medically significant). At the time of the report, CHILLS (chills), RASH (rash), CHILLS (shivering), PYREXIA (high temperature), PYREXIA (Fever chills), PYREXIA (Fever) and HEADACHE (Headache) was resolving and RASH (Hand rash) and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Oct-2021, SARS-CoV-2 test: negative (Negative) COVID-19 virus test negative.. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medication information was mentioned by reporter Patient reported that he experienced fatigue started in the afternoon on the day of the vaccine felt really tired Next day he could hardly get up and was really fatigued and had to sleep a lot. Overnight had onset of a high temperature fever and headache, chills and shivering. The rash came on him right hand started spreading around midday on the 25th November 2021. No treatment medication information was mentioned by reporter Company comment: This regulatory case concerns a 40-year-old male patient, with unknown medical history, who experienced the serious (medically significant) events of CHILLS (reported as chills and shivering), RASH (reported as rash and hand rash), PYREXIA (reported as high temperature, fever chills and fever), HEADACHE and FATIGUE. The events of headache, fatigue and pyrexia (fever chills and fever) occurred on the same day after receiving a third dose of mRNA-1273. The date of occurrence of other reported events is not provided. There is no information available on previous vaccination schedule. The rechallenge is captured as unknown as per the Regulatory Authority assessment. The benefit-risk relation of mRNA-1273 is not affected by this report. Event terms and seriousness were captured as per RA assessment.; Sender''s Comments: This regulatory case concerns a 40-year-old male patient, with unknown medical history, who experienced the serious (medically significant) events of CHILLS (reported as chills and shivering), RASH (reported as rash and hand rash), PYREXIA (reported as high temperature, fever chills and fever), HEADACHE and FATIGUE. The events of headache, fatigue and pyrexia (fever chills and fever) occurred on the same day after receiving a third dose of mRNA-1273. The date of occurrence of other reported events is not provided. There is no information available on previous vaccination schedule. The rechallenge is captured as unknown as per the Regulatory Authority assessment. The benefit-risk relation of mRNA-1273 is not affected by this report. Event terms and seriousness were captured as per RA assessment.


VAERS ID: 1930606 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-23
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; INFLUENZA VIRUS
Current Illness: Waldenstrom''s macroglobulinaemia (Waldenstrom''s macroglobulinaemia, on watch and wait.)
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Rash; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26252675) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RASH (Rash) in a 67-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. The patient''s past medical history included Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...). Concurrent medical conditions included Waldenstrom''s macroglobulinaemia (Waldenstrom''s macroglobulinaemia, on watch and wait.). Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 07-Feb-2021 to an unknown date for COVID-19 vaccination, INFLUENZA VACCINE (INFLUENZA VIRUS) for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant). At the time of the report, RASH (Rash) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment information was provided. 3rd dose of Covid after over days 4, 5 and 6 Patient was experience a blotchy red rash (which stings) between the top of my legs, in my armpits, sides of my chest, across my neck and shoulders. It appears to be spreading. Patient has not tested positive for COVID-19 since having the vaccine Company comment: This regulatory authority case concerns a 67-year-old male patient with a relevant medical history of Waldenstrom''s macroglobulinemia, who experienced the unexpected serious (medically significant) event of Rash after mRNA- 1273 Moderna vaccine, third dose of the vaccination schedule (dosage unknown). The patient had received initial schedule of vaccination with Pfizer BioNTech COVID-19 Vaccination approximately 9 months before. The event occurred approximately 4 days after the dose of mRNA- 1273 vaccine. Rash is consistent with the known safety profile of the vaccine, but since it was reported with a serious outcome it is considered unexpected. The rechallenge was reported as unknown, only one dose of mRNA- 1273 Moderna vaccine was administered. Underlying Waldenstrom''s macroglobulinemia might be a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report; Sender''s Comments: This regulatory authority case concerns a 67-year-old male patient with a relevant medical history of Waldenstrom''s macroglobulinemia, who experienced the unexpected serious (medically significant) event of Rash after mRNA- 1273 Moderna vaccine, third dose of the vaccination schedule (dosage unknown). The patient had received initial schedule of vaccination with Pfizer BioNTech COVID-19 Vaccination approximately 9 months before. The event occurred approximately 4 days after the dose of mRNA- 1273 vaccine. Rash is consistent with the known safety profile of the vaccine, but since it was reported with a serious outcome it is considered unexpected. The rechallenge was reported as unknown, only one dose of mRNA- 1273 Moderna vaccine was administered. Underlying Waldenstrom''s macroglobulinemia might be a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report


VAERS ID: 1930607 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Hallucination, Headache, Hyperhidrosis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Heavy sweating; Diarrhea; Fever; Headache; Hallucinating; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26252664) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache), HALLUCINATION (Hallucinating), HYPERHIDROSIS (Heavy sweating) and DIARRHOEA (Diarrhea) in a 58-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 23-Nov-2021 to an unknown date for an unknown indication. On 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and HALLUCINATION (Hallucinating) (seriousness criterion medically significant). On 24-Nov-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced HYPERHIDROSIS (Heavy sweating) (seriousness criterion medically significant) and DIARRHOEA (Diarrhea) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever), HEADACHE (Headache) and HYPERHIDROSIS (Heavy sweating) had not resolved and HALLUCINATION (Hallucinating) and DIARRHOEA (Diarrhea) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Company Comment. This case concerns a 58-year-old male subject, with no medical history reported, who experienced the unexpected and serious events of Pyrexia, Headache, Hallucination, Hyperhidrosis, and Diarrhoea. The events of Pyrexia and Headache are unexpected as they are retained as serious per the source document Authority reporting. The events occurred 1 day after the booster dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 58-year-old male subject, with no medical history reported, who experienced the unexpected and serious events of Pyrexia, Headache, Hallucination, Hyperhidrosis, and Diarrhoea. The events of Pyrexia and Headache are unexpected as they are retained as serious per the source document Authority reporting. The events occurred 1 day after the booster dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1930609 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Nausea, Pyrexia, Skin burning sensation
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; INFLUENZA VIRUS
Current Illness: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Preexisting Conditions: Medical History/Concurrent Conditions: Angiomyolipoma (Angiomyolipoma on left kidney.); Nephrectomy (Right kidney removed.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Burning skin; High temperature; Nausea; This case was (Reference number: GB-MHRA-ADR 26252699) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of in a 58-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. The patient''s past medical history included Angiomyolipoma (Angiomyolipoma on left kidney.) and Nephrectomy (Right kidney removed.). Concurrent medical conditions included Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...). Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 15-Mar-2021 to an unknown date for COVID-19 vaccination, INFLUENZA VACCINE (INFLUENZA VIRUS) from 01-Nov-2021 to an unknown date for Influenza immunisation. On 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient had high temperature, burning skin, dizzyness and vomiting. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment information was not provided. Company comment included This is a regulatory authority case concerning a 58-year-old, female patient with vaccination history of receiving another brand of Covid-19 vaccine (Covid-19 vaccine AstraZeneca) as previous doses, who experienced the unexpected serious events of pyrexia, skin burning sensation and nausea. The event nausea occurred 1 day after the third dose of mRNA-1273 vaccine administration while the events pyrexia and skin burning sensation occurrence unknown with respect to the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 58-year-old, female patient with vaccination history of receiving another brand of Covid-19 vaccine (Covid-19 vaccine AstraZeneca) as previous doses, who experienced the unexpected serious events of pyrexia, skin burning sensation and nausea. The event nausea occurred 1 day after the third dose of mRNA-1273 vaccine administration while the events pyrexia and skin burning sensation occurrence unknown with respect to the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1930615 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Diarrhoea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), 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? 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: 20211109; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: COVID-19 virus test was Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Diarrhoea; Abdominal pain; This case was received via regulatory authority on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea) and ABDOMINAL PAIN (Abdominal pain) in a 62-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. No Medical History information was reported. On 21-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant). On 24-Nov-2021, the patient experienced DIARRHOEA (Diarrhoea) (seriousness criterion medically significant). At the time of the report, DIARRHOEA (Diarrhoea) and ABDOMINAL PAIN (Abdominal pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2021, SARS-CoV-2 test: negative (Negative) COVID-19 virus test was Negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No Concomitant medication was provided. No Treatment medication was provided. Patient had not tested positive for COVID-19 since having the vaccine. Company comment: This case concerns a 62-year-old female patient, with no relevant medical history reported, who experienced the serious unexpected events of DIARRHOEA and ABDOMINAL PAIN. The event ABDOMINAL PAIN occurred two days after the third dose of the mRNA-1273 vaccine, the event DIARRHOEA occurred three days after the third dose of the mRNA-1273 vaccine. The rechallenge is not applicable since no information about further dosing has been disclosed. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 62-year-old female patient, with no relevant medical history reported, who experienced the serious unexpected events of DIARRHOEA and ABDOMINAL PAIN. The event ABDOMINAL PAIN occurred two days after the third dose of the mRNA-1273 vaccine, the event DIARRHOEA occurred three days after the third dose of the mRNA-1273 vaccine. The rechallenge is not applicable since no information about further dosing has been disclosed. The benefit-risk relationship of the mRNA-1273 is not affected by this report.


VAERS ID: 1930618 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 6181422501 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VACCINE INACT SAG 4V
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211008; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: GB-RA-ADR 26252954) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injection site pain, HEADACHE (Headache), ARTHRALGIA (Joint ache), FATIGUE (Tiredness) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 6181422501) for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19. Concomitant products included INFLUENZA VACCINE INACT SAG 4V from 18-Nov-2021 to an unknown date for Vaccination. On 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 24-Nov-2021, the patient experienced ARTHRALGIA (Joint ache) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, INJECTION SITE PAIN (Injection site pain) had not resolved, HEADACHE (Headache), ARTHRALGIA (Joint ache) and FATIGUE (Tiredness) was resolving and PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Oct-2021, SARS-CoV-2 test: no (Negative) COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment product was not provided by the reporter. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. Company Comment: This case concerns a male subject of unknown age, with no reported medical history, who experienced the unexpected and serious events of Injection site pain, Headache, Arthralgia, Fatigue, and Pyrexia. The events are unexpected as they are retained as serious per the source document Authority reporting. The events occurred within the first day after the booster dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a male subject of unknown age, with no reported medical history, who experienced the unexpected and serious events of Injection site pain, Headache, Arthralgia, Fatigue, and Pyrexia. The events are unexpected as they are retained as serious per the source document Authority reporting. The events occurred within the first day after the booster dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1930628 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Headache, Loss of consciousness, Paraesthesia, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (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: Blood pressure high; Chronic kidney disease stage 3; Immunodeficiency (Has an illness or condition, which reduces the immune response); Thyroid activity decreased (Under active thyroid)
Preexisting Conditions: Medical History/Concurrent Conditions: Anaesthesia (reaction to dental anaesthesia - same reaction.)
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: joint pain; unconscious; dizziness; Syncope; Generalized joint pain; Headache; Tingling feet/hands; This case was received via regulatory authority on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain), LOSS OF CONSCIOUSNESS (unconscious), DIZZINESS (dizziness), SYNCOPE (Syncope), PARAESTHESIA (Tingling feet/hands), ARTHRALGIA (Generalized joint pain) and HEADACHE (Headache) in a 51-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. The patient''s past medical history included Anaesthesia (reaction to dental anaesthesia - same reaction.). Concurrent medical conditions included Chronic kidney disease stage 3, Immunodeficiency (Has an illness or condition, which reduces the immune response), Thyroid activity decreased (Under active thyroid) and Blood pressure high. On 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced PARAESTHESIA (Tingling feet/hands) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 24-Nov-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant) and ARTHRALGIA (Generalized joint pain) (seriousness criterion medically significant). On an unknown date, the patient experienced ARTHRALGIA (joint pain) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (unconscious) (seriousness criterion medically significant) and DIZZINESS (dizziness) (seriousness criterion medically significant). On 24-Nov-2021, SYNCOPE (Syncope) had resolved. At the time of the report, ARTHRALGIA (joint pain), LOSS OF CONSCIOUSNESS (unconscious), DIZZINESS (dizziness) and PARAESTHESIA (Tingling feet/hands) had not resolved and ARTHRALGIA (Generalized joint pain) and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter. The patient had felt no effects until 2 A.M and was asleep for 8 hours. The patient woke up wanting to be sick, fell unconscious for about 6 minutes. The ambulance was called and since then, the patient had joint pain tingling in left arm and head ache with dizziness when standing up. Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Company comment: This regulatory authority case concerns a 51-year-old female patient with a relevant medical history of Hypothyroidism, Hypertension and Chronic kidney disease, who experienced the unexpected serious events of Syncope, Loss of consciousness, Dizziness, Paraesthesia, Arthralgia (reported as joint pain and generalized joint pain) and Headache after mRNA- 1273 Moderna vaccine. The events Paraesthesia and Headache occurred on the day after the third dose of mRNA- 1273 vaccine (dosage unknown) and Syncope and Arthralgia occurred approximately 1 day after the third dose. Loss of consciousness and Dizziness were reported on an unknown date after the third dose, but may be in connection with the event Syncope. It was reported that the patient woke up at 2AM with nausea and fell unconscious for about 6 minutes. Afterwards, arthralgia, vaccination site paraesthesia, headache and postural dizziness developed. Ambulance was called, but very limited information is available regarding clinical course. Arthralgia, Dizziness, Paraesthesia and Headache are consistent with the known safety profile of the vaccine, but since they were reported with a serious outcome they are considered unexpected. The rechallenge was reported as unknown, only information about the third dose was disclosed. Hypothyroidism, Hypertension and Chronic kidney disease might be confounders. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 51-year-old female patient with a relevant medical history of Hypothyroidism, Hypertension and Chronic kidney disease, who experienced the unexpected serious events of Syncope, Loss of consciousness, Dizziness, Paraesthesia, Arthralgia (reported as joint pain and generalized joint pain) and Headache after mRNA- 1273 Moderna vaccine. The events Paraesthesia and Headache occurred on the day after the third dose of mRNA- 1273 vaccine (dosage unknown) and Syncope and Arthralgia occurred approximately 1 day after the third dose. Loss of consciousness and Dizziness were reported on an unknown date after the third dose, but may be in connection with the event Syncope. It was reported that the patient woke up at 2AM with nausea and fell unconscious for about 6 minutes. Afterwards, arthralgia, vaccination site paraesthesia, headache and postural dizziness developed. Ambulance was called, but very limited information is available regarding clinical course. Arthralgia, Dizziness, Paraesthesia and Headache are consistent with the known safety profile of the vaccine, but since they were reported with a serious outcome they are considered unexpected. The rechallenge was reported as unknown, only information about the third dose was disclosed. Hypothyroidism, Hypertension and Chronic kidney disease might be confounders. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.


VAERS ID: 1930636 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA LOT 3004675 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Dizziness, Headache, Illness
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (No any other illness or condition other than immunodeficiency)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Abdominal pain; Sickness; Dizziness; Felt faint; Headache; This case was received via the regulatory authority (Reference number: GB-MHRA-ADR 26253522) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal pain), ILLNESS (Sickness), DIZZINESS (Dizziness), DIZZINESS (Felt faint) and HEADACHE (Headache) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. LOT 3004675) for an unknown indication. The patient''s past medical history included Immunodeficiency (No any other illness or condition other than immunodeficiency). On 23-Nov-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant), DIZZINESS (Felt faint) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 24-Nov-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant). 24-Nov-2021, the patient experienced ILLNESS (Sickness) (seriousness criterion medically significant). At the time of the report, ABDOMINAL PAIN (Abdominal pain) and ILLNESS (Sickness) had not resolved and DIZZINESS (Dizziness), DIZZINESS (Felt faint) and HEADACHE (Headache) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication information was provided. No treatment medication were provided. Company comment: This regulatory case concerns a 36-year-old, female patient with medical history of immunodeficiency, who experienced the unexpected, serious (IME) events of dizziness (reported as dizziness and felt faint), abdominal pain, headache and illness. The events dizziness and headache occurred on the same day after an unknown dose number of mRNA-1273 vaccine. The events abdominal pain and illness occurred one day after an unknown dose number of mRNA-1273 vaccine. Regulatory authority reported the rechallenge as unknown, however, no additional dose information was disclosed. The medical history of immunodeficiency remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.; Sender''s Comments: This regulatory case concerns a 36-year-old, female patient with medical history of immunodeficiency, who experienced the unexpected, serious (IME) events of dizziness (reported as dizziness and felt faint), abdominal pain, headache and illness. The events dizziness and headache occurred on the same day after an unknown dose number of mRNA-1273 vaccine. The events abdominal pain and illness occurred one day after an unknown dose number of mRNA-1273 vaccine. Regulatory authority reported the rechallenge as unknown, however, no additional dose information was disclosed. The medical history of immunodeficiency remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.


VAERS ID: 1930640 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Headache, Pain in extremity, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Arthritis (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: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Comments: No medical history was reported.
Allergies:
Diagnostic Lab Data: Test Date: 20210103; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Rash; Headache; Generalised joint pains; Painful arm; This case was received via the RA (Reference number: GB-MHRA-ADR 26253598) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RASH, PAIN IN EXTREMITY, HEADACHE and ARTHRALGIA in a 58-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. No medical history was reported. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 09-Mar-2021 to an unknown date for Vaccination. On 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 24-Nov-2021, the patient experienced ARTHRALGIA (seriousness criterion medically significant). On 25-Nov-2021, the patient experienced RASH (seriousness criterion medically significant) and HEADACHE (seriousness criterion medically significant). At the time of the report, RASH, PAIN IN EXTREMITY, HEADACHE and ARTHRALGIA had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2021, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Self cared at home, reaction severe enough to affect ability to work. No problems with any other vaccines she have ever had. She was a health care professional. No treatment information was reported. Company comment: This regulatory authority case concerns a 58-year-old female patient with no relevant medical history who experienced serious unexpected events of pain in extremity, arthralgia and rash. The events occurred approximately from within 24 hours to 2 days following the third dose of the mRNA-1273 . Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable. Rechallenge was assessed as unknown by the Regulatory authority. The benefit-risk relationship of mRNA-1273 is not affected by this report; Sender''s Comments: This regulatory authority case concerns a 58-year-old female patient with no relevant medical history who experienced serious unexpected events of pain in extremity, arthralgia and rash. The events occurred approximately from within 24 hours to 2 days following the third dose of the mRNA-1273 . Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable. Rechallenge was assessed as unknown by the Regulatory authority. The benefit-risk relationship of mRNA-1273 is not affected by this report


VAERS ID: 1930643 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004676 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Chills, Dizziness, Headache, Pain in extremity, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Type 2 diabetes mellitus (Type 2 diabetes)
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Allergies:
Diagnostic Lab Data: Test Date: 20210209; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: weakness; Vomiting; Dizziness; Headache; Shivering; Painful arm; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26253623) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), VOMITING (Vomiting), DIZZINESS (Dizziness), HEADACHE (Headache), CHILLS (Shivering) and PAIN IN EXTREMITY (Painful arm) in a 56-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004676) for an unknown indication. Concurrent medical conditions included Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...) and Type 2 diabetes mellitus (Type 2 diabetes). On 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 24-Nov-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). On an unknown date, the patient experienced ASTHENIA (weakness) (seriousness criterion medically significant). At the time of the report, ASTHENIA (weakness), VOMITING (Vomiting), DIZZINESS (Dizziness) and HEADACHE (Headache) was resolving, CHILLS (Shivering) had resolved and PAIN IN EXTREMITY (Painful arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, SARS-CoV-2 test: positive covid-19 test (Positive) Positive COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medications reported by reporter. Patient was received vaccine at 1645 23-Nov-2021 at splitting leisure centre Cardiff. Patient was experienced sore arm started straight away but other symptoms started overnight into 24th and still ongoing with a general feeling of weakness. Patient has not tested positive for COVID-19 since having the vaccine. No treatment medications provided by the reporter. Company comment: This case concerns a 56-year-old female patient, with medical history of diabetes type 2 and immunodeficiency who experienced the serious unexpected events of asthenia, vomiting, dizziness, headache, chills and pain in extremity after third dose of mRNA-1273. The events occurred within the first and second day after vaccination. The re-challenge is unknown since no information regarding dose 1 and 2 was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.; Sender''s Comments: This case concerns a 56-year-old female patient, with medical history of diabetes type 2 and immunodeficiency who experienced the serious unexpected events of asthenia, vomiting, dizziness, headache, chills and pain in extremity after third dose of mRNA-1273. The events occurred within the first and second day after vaccination. The re-challenge is unknown since no information regarding dose 1 and 2 was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.


VAERS ID: 1930645 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dehydration, SARS-CoV-2 test, Vertigo, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Dehydration (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia (Treated for aneamia in Aug 2021); Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20211012; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Vertigo; Vomiting; Dehydration; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26253650) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) in a 20-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. The patient''s past medical history included Anaemia (Treated for aneamia in Aug 2021) and Suspected COVID-19 (Unsure when symptoms stopped) on 12-Oct-2021. On 21-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced VERTIGO (Vertigo) (seriousness criterion medically significant). On 25-Nov-2021, VERTIGO (Vertigo) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Oct-2021, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Laboratory investigation included, patient performed ECG, Bloods, urine sample, BP, RR, HR with unknown results. There was no concomitant medication reported. There was no treatment medication reported. Additional event information included, patient experienced very unwell .and tests came back normal. Company comment: This is a regulatory authority case concerning a 20-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of vertigo, vomiting and dehydration. The events vertigo, vomiting and dehydration occurred 2 days after the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 20-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of vertigo, vomiting and dehydration. The events vertigo, vomiting and dehydration occurred 2 days after the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1930650 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMOXYCILLIN
Current Illness:
Preexisting Conditions: Comments: No medical history was reported.
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No-Negative COVID-19 Test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: swelling face; This case was receivedReference number: GB-MHRA-ADR 26253725) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling face) in a 27-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No medical history was reported. Concomitant products included AMOXYCILLIN from 05-Oct-2021 to 12-Oct-2021 for UTI. On 22-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced SWELLING FACE (swelling face) (seriousness criterion medically significant). On 24-Nov-2021, SWELLING FACE (swelling face) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Nov-2021, SARS-CoV-2 test: negative (Negative) No-Negative COVID-19 Test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment medication reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Company Comment This case concerns a 27-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of swelling face. The event occurred 1 day after the third dose of mRNA-1273. The rechallenge was unknown since no information regarding the first and second dose was disclosed and as was reported by regulatory Authority. The Benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the event meets the criteria to be medically significant.; Sender''s Comments: This case concerns a 27-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of swelling face. The event occurred 1 day after the third dose of mRNA-1273. The rechallenge was unknown since no information regarding the first and second dose was disclosed and as was reported by regulatory Authority. The Benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the event meets the criteria to be medically significant.


VAERS ID: 1930655 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse reaction, Chills, Headache, Nasopharyngitis, SARS-CoV-2 test, Skin discolouration, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (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: COVID-19 MRNA VACCINE BNT162B2
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chest infection (staph A chest infection March 2020); Hypothyroidism (Hypothyroidism from Hashimoto); Pneumonitis (Moderate covid pneumonitis)
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: significan not swelling; Cold; Less than 6 hours having had vaccine booster; Headache; Chills; Shivering; Adverse reaction; This case was received via RA (Reference number: GB-MHRA-ADR 26253784) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of ADVERSE REACTION (Adverse reaction), SKIN DISCOLOURATION (significan not swelling), NASOPHARYNGITIS (Cold), VOMITING (Less than 6 hours having had vaccine booster), HEADACHE (Headache), CHILLS (Chills) and CHILLS (Shivering) in a 27-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. The patient''s past medical history included Chest infection (staph A chest infection March 2020), Hypothyroidism (Hypothyroidism from Hashimoto) and Pneumonitis (Moderate covid pneumonitis). Previously administered products included for Product used for unknown indication: LEVOTHYROXINE (100mcg). Past adverse reactions to the above products included No adverse event with LEVOTHYROXINE. Concomitant products included TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) for an unknown indication. On 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced ADVERSE REACTION (Adverse reaction) (seriousness criterion medically significant). On an unknown date, the patient experienced SKIN DISCOLOURATION (significan not swelling) (seriousness criterion medically significant), NASOPHARYNGITIS (Cold) (seriousness criterion medically significant), VOMITING (Less than 6 hours having had vaccine booster) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). At the time of the report, ADVERSE REACTION (Adverse reaction) had not resolved and SKIN DISCOLOURATION (significan not swelling), NASOPHARYNGITIS (Cold), VOMITING (Less than 6 hours having had vaccine booster), HEADACHE (Headache), CHILLS (Chills) and CHILLS (Shivering) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Nov-2021, SARS-CoV-2 test: no (Negative) COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Treatment Medication use information was not provided by reporter. Patient was not currently breastfeeding. Less than 6 hours had vaccine booster, Patient were felt unwell, shivering, cold, achy and exhausted. Unable to regulate temperature, freezing and shivering which woke up in the night, rigouring and borderline hallucinating. Patient were Sent home from work following day with temperature of 38.5 and the shakes. Significant swelling, redness and tenderness to vaccine site. Sleeping a lot and headache was ongoing. Some alternating shivers chills and sweats still was going on over 30 hours since the vaccine dose. Patient was not tested positive for COVID-19 since the vaccine. Patient was not enrolled in clinical trial. Company Comment: This case concerns a 27-year-old female subject, with medical history of hypothyroidism and chest infection, who experienced the unexpected and serious events of Adverse reaction, Skin discolouration, Nasopharyngitis, Vomiting, Headache, and Chills. The events of Headache, Vomiting, and Chills, are unexpected as they are retained as serious per the source document Authority reporting. The event of Adverse reaction occurred the same day after the booster dose of mRNA-1273 vaccine. The events of Skin discolouration, Nasopharyngitis, Vomiting, Headache, and Chills, occurred on an unknown date after the booster dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in SD. The medical history remains confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 27-year-old female subject, with medical history of hypothyroidism and chest infection, who experienced the unexpected and serious events of Adverse reaction, Skin discolouration, Nasopharyngitis, Vomiting, Headache, and Chills. The events of Headache, Vomiting, and Chills, are unexpected as they are retained as serious per the source document Authority reporting. The event of Adverse reaction occurred the same day after the booster dose of mRNA-1273 vaccine. The events of Skin discolouration, Nasopharyngitis, Vomiting, Headache, and Chills, occurred on an unknown date after the booster dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in SD. The medical history remains confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1930658 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Eye swelling, Feeling hot, Headache, Hypoaesthesia, Hypotension, Pain, Palpitations, Rash, Vaginal haemorrhage, Vision blurred
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (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: GBMODERNATX, INC.MOD20213

Write-up: Spotting vaginal; Blurred vision; Palpitations; Low BP; Throbbing headache; Shooting pain; Feeling hot; Chest pain; Numbness in hand; Rash on face; Swollen eyes; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26253808) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Spotting vaginal), CHEST PAIN (Chest pain), HYPOAESTHESIA (Numbness in hand), RASH (Rash on face), EYE SWELLING (Swollen eyes), VISION BLURRED (Blurred vision), PALPITATIONS (Palpitations), HYPOTENSION (Low BP), HEADACHE (Throbbing headache), PAIN (Shooting pain) and FEELING HOT (Feeling hot) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. On 23-Nov-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness in hand) (seriousness criterion medically significant), RASH (Rash on face) (seriousness criterion medically significant), EYE SWELLING (Swollen eyes) (seriousness criterion medically significant), PALPITATIONS (Palpitations) (seriousness criterion medically significant), HYPOTENSION (Low BP) (seriousness criterion medically significant), HEADACHE (Throbbing headache) (seriousness criterion medically significant), PAIN (Shooting pain) (seriousness criterion medically significant) and FEELING HOT (Feeling hot) (seriousness criterion medically significant). On 24-Nov-2021, the patient experienced VISION BLURRED (Blurred vision) (seriousness criterion medically significant). On 25-Nov-2021, the patient experienced VAGINAL HAEMORRHAGE (Spotting vaginal) (seriousness criterion medically significant). On 24-Nov-2021, RASH (Rash on face), EYE SWELLING (Swollen eyes), PAIN (Shooting pain) and FEELING HOT (Feeling hot) had resolved. On 25-Nov-2021, VISION BLURRED (Blurred vision) had resolved, HEADACHE (Throbbing headache) was resolving. On 26-Nov-2021, HYPOTENSION (Low BP) had resolved. At the time of the report, VAGINAL HAEMORRHAGE (Spotting vaginal), CHEST PAIN (Chest pain), HYPOAESTHESIA (Numbness in hand) and PALPITATIONS (Palpitations) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medications were provided. No treatment information was provided. Patient mentioned that she tried to phone her doctor but had been not able to got through. She was sacred for the next one. She was a rough 12 hours before symptoms eased with some was still remaining. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in the clinical trail. Company Comment This case concerns female patient of unknown age with no relevant medical history reported, who experienced the unexpected serious events of rash, eye swelling, hypotension, vision blurred, headache, chest pain, hypoaesthesia and palpitations, during the next 24-48 hours after the first dose of mRNA-1273 vaccine. Vaginal haemorrhage occurred 3 days after vaccination (same dose). The rechallenge was not applicable since the events happened after the first dose and no information on additional dosing is available, additionally some of the events were still ongoing. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority�s report due to important medical event.; Sender''s Comments: This case concerns female patient of unknown age with no relevant medical history reported, who experienced the unexpected serious events of rash, eye swelling, hypotension, vision blurred, headache, chest pain, hypoaesthesia and palpitations, during the next 24-48 hours after the first dose of mRNA-1273 vaccine. Vaginal haemorrhage occurred 3 days after vaccination (same dose). The rechallenge was not applicable since the events happened after the first dose and no information on additional dosing is available, additionally some of the events were still ongoing. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority�s report due to important medical event.


VAERS ID: 1930662 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Headache, Nausea, Pain in extremity, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: HRT; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20211110; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Headache; Aching in limb; Nauseous; Feeling of total lack of energy; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26256070) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PAIN IN EXTREMITY (Aching in limb), NAUSEA (Nauseous) and ASTHENIA (Feeling of total lack of energy) in a 52-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped) and HRT. On 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced NAUSEA (Nauseous) (seriousness criterion medically significant) and ASTHENIA (Feeling of total lack of energy) (seriousness criterion medically significant). On 24-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Aching in limb) (seriousness criterion medically significant). On 25-Nov-2021, HEADACHE (Headache) was resolving. At the time of the report, PAIN IN EXTREMITY (Aching in limb), NAUSEA (Nauseous) and ASTHENIA (Feeling of total lack of energy) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Nov-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown Route) was unknown. Severe headache and aching of legs, nauseous with lack of energy. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No concomitant medications were provided. Treatment for the events were not provided. Company Comment: This case concerns a 52-year-old, female patient with relevant medical history of Suspected COVID-19 and HRT, who experienced the unexpected serious (medically significant) events of Nausea, Asthenia, Headache and Pain in extremity. The events occurred approximately 1 day after the third dose of mRNA-1273 Vaccine. At the time of report the outcome of the events was resolving for Headache, and Unresolved for Nausea, Asthenia and Pain in extremity. The rechallenge was unknown since no information about the events of the earlier dose was disclosed. The patient''s medical history of Suspected COVID-19 and HRT, remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 52-year-old, female patient with relevant medical history of Suspected COVID-19 and HRT, who experienced the unexpected serious (medically significant) events of Nausea, Asthenia, Headache and Pain in extremity. The events occurred approximately 1 day after the third dose of mRNA-1273 Vaccine. At the time of report the outcome of the events was resolving for Headache, and Unresolved for Nausea, Asthenia and Pain in extremity. The rechallenge was unknown since no information about the events of the earlier dose was disclosed. The patient''s medical history of Suspected COVID-19 and HRT, remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1930664 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Injection site erythema, Injection site pain, Night sweats, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: day 3 until now my arm has been getting redder and stiffer / more swollen; night sweats; Injection site redness; Fever; Injection site pain; Night sweat; This case was received via regulatory authority on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweat), INJECTION SITE PAIN (Injection site pain), INJECTION SITE ERYTHEMA (Injection site redness), NIGHT SWEATS (night sweats), PAIN IN EXTREMITY (day 3 until now my arm has been getting redder and stiffer / more swollen) and PYREXIA (Fever) in a 36-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. No Medical History information was reported. On 22-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced NIGHT SWEATS (Night sweat) (seriousness criterion medically significant), INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 24-Nov-2021, the patient experienced INJECTION SITE ERYTHEMA (Injection site redness) (seriousness criterion medically significant). On an unknown date, the patient experienced NIGHT SWEATS (night sweats) (seriousness criterion medically significant) and PAIN IN EXTREMITY (day 3 until now my arm has been getting redder and stiffer / more swollen) (seriousness criterion medically significant). At the time of the report, NIGHT SWEATS (Night sweat), INJECTION SITE PAIN (Injection site pain) and INJECTION SITE ERYTHEMA (Injection site redness) had not resolved and NIGHT SWEATS (night sweats), PAIN IN EXTREMITY (day 3 until now my arm has been getting redder and stiffer / more swollen) and PYREXIA (Fever) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medication reported. No treatment reported. 2days ago patient underwent negative lateral flow test. Patient felt fine on the day of the jab, fever came in overnight. Day 2 felt feverish all day with some arm pain near the injection site, that night and every night since patient had night sweats. Day 3 until now the arm have been getting redder and stiffer/more swollen, and today a large area was quite red and hot to the touch, and painful. Fever went away yesterday but felt unwell again today, unclear if it was a side effect or if patient had now picked up a bug, but fever had gone. Company comment. This regulatory authority case concerns a 36-year-old, female patient with no reported relevant medical history, who experienced the unexpected serious events of night sweats (reported twice), injection site pain, injection site erythema, pain in extremity, and pyrexia. The events of pyrexia, injection site pain, and injection site erythema, are unexpected as they are retained as serious per the source document Authority reporting. The events injection site pain, night sweats and pyrexia occurred one day after the third dose (unknown dosage) of mRNA-1273. Injection site erythema occurred two days after vaccination. The date of onset of the events night sweats, and pain in extremity was not reported. Regulatory authority reported the rechallenge as unknown, however, no information about additional dosing was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events coding, onset date, outcome and seriousness captured per source document from Regulatory Authority reporting.; Sender''s Comments: This regulatory authority case concerns a 36-year-old, female patient with no reported relevant medical history, who experienced the unexpected serious events of night sweats (reported twice), injection site pain, injection site erythema, pain in extremity, and pyrexia. The events of pyrexia, injection site pain, and injection site erythema, are unexpected as they are retained as serious per the source document Authority reporting. The events injection site pain, night sweats and pyrexia occurred one day after the third dose (unknown dosage) of mRNA-1273. Injection site erythema occurred two days after vaccination. The date of onset of the events night sweats, and pain in extremity was not reported. Regulatory authority reported the rechallenge as unknown, however, no information about additional dosing was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events coding, onset date, outcome and seriousness captured per source document from Regulatory Authority reporting.


VAERS ID: 1930666 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad)

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

Write-up: Light-headed; Pins and needles; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26256309) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Light-headed) and PARAESTHESIA (Pins and needles) in a 65-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. No Medical History information was reported. On 22-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced DIZZINESS (Light-headed) (seriousness criterion medically significant) and PARAESTHESIA (Pins and needles) (seriousness criterion medically significant). At the time of the report, DIZZINESS (Light-headed) and PARAESTHESIA (Pins and needles) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant product information was not provided. Treatment information was not provided. The patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Company comment: This case concerns a 65-year-old male patient with no relevant medical history reported, who experienced the serious unexpected events of dizziness and paraesthesia. The events occurred the day after the third dose of mRNA-1273. The rechallenge is unknown, according to SD. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 65-year-old male patient with no relevant medical history reported, who experienced the serious unexpected events of dizziness and paraesthesia. The events occurred the day after the third dose of mRNA-1273. The rechallenge is unknown, according to SD. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1930669 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Urinary tract inflammation
SMQs:

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

Write-up: Urinary tract inflammation; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26256323) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of URINARY TRACT INFLAMMATION (Urinary tract inflammation) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. On 22-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced URINARY TRACT INFLAMMATION (Urinary tract inflammation) (seriousness criterion disability). At the time of the report, URINARY TRACT INFLAMMATION (Urinary tract inflammation) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided by reporter. No treatment drug was provided by reporter. Patient is healthy with no underlying conditions. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial It was reported that the report was not related to possible blood clots or low platelet counts and possible myocarditis or pericarditis. Company Comment This case concerns a female patient of unknown age with no relevant medical history reported, who experienced the unexpected event of urinary tract inflammation. The event occurred 1 day after the third dose of mRNA-1273. The rechallenge was unknown since no information regarding the first and second dose was disclosed and as was reported by regulatory Authority. Benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the event resulted in a persistent or permanent incapacity; Sender''s Comments: This case concerns a female patient of unknown age with no relevant medical history reported, who experienced the unexpected event of urinary tract inflammation. The event occurred 1 day after the third dose of mRNA-1273. The rechallenge was unknown since no information regarding the first and second dose was disclosed and as was reported by regulatory Authority. Benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the event resulted in a persistent or permanent incapacity


VAERS ID: 1930693 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Feeling abnormal, Feeling hot, Headache, Malaise, Miliaria, Peripheral swelling, Rash erythematous, SARS-CoV-2 test, Somnolence
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211122; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: unwell; Swollen arm; Red rash; Heat rash; Fuzzy head; Feeling hot; Headache; Sleepiness; This case was received via Agency Regulatory Authority (Reference number: GB-MHRA-ADR 26258438) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MALAISE (unwell), PERIPHERAL SWELLING (Swollen arm), RASH ERYTHEMATOUS (Red rash), MILIARIA (Heat rash), FEELING ABNORMAL (Fuzzy head), FEELING HOT (Feeling hot), HEADACHE (Headache) and SOMNOLENCE (Sleepiness) in a 60-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. No Medical History information was reported. On 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced SOMNOLENCE (Sleepiness). On 24-Nov-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), RASH ERYTHEMATOUS (Red rash), MILIARIA (Heat rash), FEELING ABNORMAL (Fuzzy head), FEELING HOT (Feeling hot) and HEADACHE (Headache). On an unknown date, the patient experienced MALAISE (unwell). At the time of the report, MALAISE (unwell), PERIPHERAL SWELLING (Swollen arm), RASH ERYTHEMATOUS (Red rash), MILIARIA (Heat rash) and FEELING ABNORMAL (Fuzzy head) had not resolved and FEELING HOT (Feeling hot), HEADACHE (Headache) and SOMNOLENCE (Sleepiness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Nov-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medications were reported. No treatment drugs were reported. 3 days after vaccination, the patient had a hard surface (3 inches in diameter) that was red, very painful and hot to touch. The patient has been extremely unwell and in bed for 2 days. 3rd day the patient was not in bed. Company Comment: This case concerns a 60-year-old female patient with no relevant medical history, who experienced the unexpected events of Somnolence, Peripheral Swelling, Rash Erythematous, Miliaria, Feeling Abnormal, Feeling Hot, Malaise, and Headache. The events occurred 1 day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 60-year-old female patient with no relevant medical history, who experienced the unexpected events of Somnolence, Peripheral Swelling, Rash Erythematous, Miliaria, Feeling Abnormal, Feeling Hot, Malaise, and Headache. The events occurred 1 day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1930723 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-23
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Heart rate, Hyperhidrosis, Nightmare
SMQs:, Neuroleptic malignant syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; INFLUENZA VIRUS; Moderna CoviD-19 Vaccine
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: bad dreams; headache; sweating; Heart rate; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26261054) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NIGHTMARE (bad dreams), HEADACHE (headache), HYPERHIDROSIS (sweating) and HEART RATE (Heart rate) in a 56-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for COVID-19 vaccination. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA), INFLUENZA VACCINE (INFLUENZA VIRUS) and mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. In 2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced HEART RATE (Heart rate) (seriousness criteria medically significant and life threatening). On an unknown date, the patient experienced NIGHTMARE (bad dreams) (seriousness criteria medically significant and life threatening), HEADACHE (headache) (seriousness criteria medically significant and life threatening) and HYPERHIDROSIS (sweating) (seriousness criteria medically significant and life threatening). On 24-Nov-2021, HEART RATE (Heart rate) had resolved. At the time of the report, NIGHTMARE (bad dreams), HEADACHE (headache) and HYPERHIDROSIS (sweating) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient previously had Astra Zeneca which caused some side effects but nothing as severe as experienced with Moderna and caused severe reactions within 8 hours in a normally fit and healthy man with no known health problems and had racing heart, sweating, excruciating painful headache, aching all over, pain at injection site, bad dreams and feelings of dying when tried to slept, had paracetamol and recovered after few days Patient was not tested positive for COVID-19 since had the vaccine Patient was not enrolled in clinical trial. Company Comment: This RA case concerns a 56 year old male with no relevant medical history reported, with vaccination for Covid 19 using Covid 19 Vaccine Astra Zeneca ( as dose 1 and dose 2 ) , who experienced Serious ( Life threatening , medically significant ) , Unexpected events of hear rate on 23-Nov, 2021 and other Serious (life threatening , medically significant ), unexpected events of nightmare, headache and hyperhidrosis which occurred on an unknown date with the 3rd dose ( booster dose ) mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) , date of vaccination is unknown. The re-challenge for this case is not applicable since the events occurred after the 3rd dose and no additional doses will be given . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report..; Sender''s Comments: This RA case concerns a 56 year old male with no relevant medical history reported, with vaccination for Covid 19 using Covid 19 Vaccine Astra Zeneca ( as dose 1 and dose 2 ) , who experienced Serious ( Life threatening , medically significant ) , Unexpected events of hear rate on 23-Nov, 2021 and other Serious (life threatening , medically significant ), unexpected events of nightmare, headache and hyperhidrosis which occurred on an unknown date with the 3rd dose ( booster dose ) mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) , date of vaccination is unknown. The re-challenge for this case is not applicable since the events occurred after the 3rd dose and no additional doses will be given . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.


VAERS ID: 1930796 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-11-23
   Days after vaccination:175
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211122; Test Name: COVID by PCR; Test Result: Positive ; Comments: Nasal Swab
CDC Split Type: GBPFIZER INC202101693793

Write-up: After the vaccination the patient tested positive for COVID by PCR nasal swab on 23Nov2021. The patient had mild symptoms such as headache, sore throat, tiredness which started on 23Nov2021.; After the vaccination the patient tested positive for COVID by PCR nasal swab on 23Nov2021. The patient had mild symptoms such as headache, sore throat, tiredness which started on 23Nov2021.; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Jun2021 (Lot number: ER7812) at the age of 42 years as dose 2, single and intramuscular, administered in arm left, administration date 11May2021 (Lot number: ET1831) as dose 1, single for COVID-19 immunization. The patient was vaccinated in a workplace clinic. The patient''s relevant medical history and concomitant medications were not reported. Prior to the vaccination, the patient has not been diagnosed with COVID-19. The patient did not receive any other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Nov2021, outcome "recovering" and all described as "After the vaccination the patient tested positive for COVID by PCR nasal swab on 23Nov2021. The patient had mild symptoms such as headache, sore throat, tiredness which started on 23Nov2021.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Nov2021) positive, notes: Nasal Swab taken on 22Nov2021. Results were received on 23Nov2021. Therapeutic measures were not taken as a result of vaccination failure, covid-19. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1930888 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005884 / UNK - / IM
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS AFLBA632BA / UNK - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Back pain, Chest pain, Influenza like illness, Musculoskeletal chest pain
SMQs:, Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (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: EUTIROX;
Current Illness: Hypothyroidism
Preexisting Conditions: Medical History/Concurrent Conditions: Mite allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITGLAXOSMITHKLINEIT202124

Write-up: FLU SYMPTOMS, SEVERE JOINT PAIN IN THE LUMBAR AREA AND COST, INTERCOSTAL PAIN; FLU SYMPTOMS, SEVERE JOINT PAIN IN THE LUMBAR AREA AND COST, INTERCOSTAL PAIN; FLU SYMPTOMS, SEVERE JOINT PAIN IN THE LUMBAR AREA AND COST, INTERCOSTAL PAIN; FLU SYMPTOMS, SEVERE JOINT PAIN IN THE LUMBAR AREA AND COST, INTERCOSTAL PAIN; FLU SYMPTOMS, SEVERE JOINT PAIN IN THE LUMBAR AREA AND COST, INTERCOSTAL PAIN; This case was reported by a consumer via regulatory authority and described the occurrence of pain chest in a 55-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number AFLBA632BA, expiry date unknown) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Influenza Vaccine Quadrivalent Pre-Filled Syringe Device) injection syringe for prophylaxis and COVID-19 VACCINE MRNA (MRNA 1273) (SPIKEVAX) (batch number 3005884, expiry date unknown) for prophylaxis. Previously administered products included COMIRNATY (BIONTECH MANUFACTURING GMBH) (J07BX03) and COMIRNATY (BIONTECH MANUFACTURING GMBH) (J07BX03). Concurrent medical conditions included hypothyroidism and mite allergy. Concomitant products included levothyroxine sodium (Eutirox) and levothyroxine sodium (Eutirox). On 22nd November 2021, the patient received Fluarix Quadrivalent 2021-2022 season (intramuscular) .5 ml, Influenza Vaccine Quadrivalent Pre-Filled Syringe Device and SPIKEVAX (intramuscular) .25 ml. On 23rd November 2021, 1 days after receiving Fluarix Quadrivalent 2021-2022 season and Influenza Vaccine Quadrivalent Pre-Filled Syringe Device, the patient experienced pain chest (serious criteria other: Serious as per reporter), sore back (serious criteria other: Serious as per reporter), intercostal pain (serious criteria other: Serious as per reporter), flu like symptoms (serious criteria other: Serious as per reporter) and pain in joint (serious criteria other: Serious as per reporter). On 25th November 2021, the outcome of the pain chest, sore back, intercostal pain, flu like symptoms and pain in joint were recovered/resolved. It was unknown if the reporter considered the pain chest, sore back, intercostal pain, flu like symptoms and pain in joint to be related to Fluarix Quadrivalent 2021-2022 season and Influenza Vaccine Quadrivalent Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional information was provided as follows: On 23rd November 2021,1 day after receiving Spikevax, the patient experienced pain chest, sore back, intercostal pain, flu like symptoms and pain in joint. The duration of events was 2 days. It was unknown if the reporter considered the pain chest, sore back, intercostal pain, flu like symptoms and pain in joint.to be related to Spikevax. Initial information received from consumer via regulatory authority on 01st December 2021 FLU SYMPTOMS, SEVERE JOINT PAIN IN THE LUMBAR AREA AND COST, INTERCOSTAL PAIN


VAERS ID: 1930993 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-11-23
   Days after vaccination:146
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20211123; Test Name: COVID test; Result Unstructured Data: Test Result:result not reported
CDC Split Type: PLPFIZER INC202101646803

Write-up: tightness of the chest; asks if it is possible for him to contract Covid despite having been vaccinated twice; asks if it is possible for him to contract Covid despite having been vaccinated twice/no sense of smell and taste; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient. A male patient of an unspecified age (reported as 40, unit not reported) received bnt162b2 (COMIRNATY), via an unspecified route of administration, administration date 03Jun2021 (Batch/Lot number: unknown) as dose 1, single and via an unspecified route of administration, administration date 30Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 23Nov2021, outcome "unknown", described as "asks if it is possible for him to contract Covid despite having been vaccinated twice"; SUSPECTED COVID-19 (medically significant) with onset 23Nov2021, outcome "unknown", described as "asks if it is possible for him to contract Covid despite having been vaccinated twice/no sense of smell and taste"; CHEST DISCOMFORT (medically significant), outcome "unknown", described as "tightness of the chest". The patient said that apart from the lack of taste and smell, he also felt pressure in his chest. The patient has already consulted a doctor and went for a COVID test today. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Nov2021) result not reported. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1931023 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Malaise, Pain, SARS-CoV-2 test
SMQs:, 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.MOD20213

Write-up: unwell; Pain; This case was received via Agency Regulatory Authority(Reference number: GB-MHRA-ADR 26260008) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MALAISE (unwell) and PAIN (Pain) in a 47-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for COVID-19 vaccination. No Medical History information was reported. On 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced PAIN (Pain) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (unwell) (seriousness criterion medically significant). On 25-Nov-2021, PAIN (Pain) had resolved. At the time of the report, MALAISE (unwell) 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 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Text for relevant medical history and concurrent conditions include patient was fit and healthy, not had symptoms associated with COVID-19 and patient is not currently breastfeeding. Patient had no symptoms until 12 hrs later, arm went numb- like a dead arm, to a severe pain for 24 hours like contractions pain, everytime when patient moved the arm. Patient had given birth 5 times , so can do pain, but this was continuous contractions pain. Patient didn''t think it was going to stop. Patient stated that will never have another covid jab again based on this experience. Patient was not tested positive for COVID-19 since had the vaccine. Patient was not enrolled in clinical trial. Company comment: This case concerns a 47-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of malaise and pain. The events occurred the same day after the booster dose of mRNA-1273. The rechallenge was not applicable since information about previous doses has not been disclosed. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 47-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of malaise and pain. The events occurred the same day after the booster dose of mRNA-1273. The rechallenge was not applicable since information about previous doses has not been disclosed. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1931728 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Diarrhoea, Dizziness, Headache, Injection site rash, Nausea, Oropharyngeal pain
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)

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

Write-up: Nausea; Diarrhea; Shivering; Dizziness; Sore throat; Headache; Rash at site of injection; This case was received via regulatory authority on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache), NAUSEA (Nausea), DIARRHOEA (Diarrhea), CHILLS (Shivering), INJECTION SITE RASH (Rash at site of injection) and DIZZINESS (Dizziness) in a 59-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. Concomitant products included TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) from 27-Feb-2021 to an unknown date for an unknown indication. On 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced INJECTION SITE RASH (Rash at site of injection) (seriousness criterion medically significant). On 24-Nov-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 25-Nov-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and INJECTION SITE RASH (Rash at site of injection) had not resolved and HEADACHE (Headache), NAUSEA (Nausea), DIARRHOEA (Diarrhea), CHILLS (Shivering) and DIZZINESS (Dizziness) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Company comment: This case concerns a 59-year-old female patient with no relevant medical history provided, who experienced the following unexpected serious events: Injection site rash (occurred during the same day when the patient received the vaccine), Oropharyngeal pain and Headache (which occurred the day after vaccination), Nausea, Diarrhoea, Chills and Dizziness (which occurred two days after the vaccination). The events occurred following the vaccination with the third dose of the mRNA-1273 vaccine. At the time of the report Oropharyngeal pain and Injection site rash had not resolved, while the remaining events were resolving. No further information regarding the clinical course of the events was provided. The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such, however, it could have been considered as not applicable as the patient experienced the events following the third dose of the vaccine and no additional doses are planned. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 59-year-old female patient with no relevant medical history provided, who experienced the following unexpected serious events: Injection site rash (occurred during the same day when the patient received the vaccine), Oropharyngeal pain and Headache (which occurred the day after vaccination), Nausea, Diarrhoea, Chills and Dizziness (which occurred two days after the vaccination). The events occurred following the vaccination with the third dose of the mRNA-1273 vaccine. At the time of the report Oropharyngeal pain and Injection site rash had not resolved, while the remaining events were resolving. No further information regarding the clinical course of the events was provided. The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such, however, it could have been considered as not applicable as the patient experienced the events following the third dose of the vaccine and no additional doses are planned. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1931733 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Headache, Injection site pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Injection site pain; Headache; Feverish; Joint ache; This case was received via regulatory authority on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injection site pain), HEADACHE (Headache), PYREXIA (Feverish) and ARTHRALGIA (Joint ache) in a 42-year-old patient of an unknown gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 05-Mar-2021 to an unknown date for an unknown indication. On 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (Feverish) (seriousness criterion medically significant) and ARTHRALGIA (Joint ache) (seriousness criterion medically significant). On 24-Nov-2021, PYREXIA (Feverish) had resolved. On 25-Nov-2021, ARTHRALGIA (Joint ache) had resolved. On 26-Nov-2021, HEADACHE (Headache) had resolved. At the time of the report, INJECTION SITE PAIN (Injection site pain) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment medication information was mentioned by reporter. 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 Company comment. This regulatory authority case concerns a 42-year-old patient with no reported relevant medical history, who experienced the unexpected serious events of injection site pain, headache, pyrexia, and arthralgia. The events of are unexpected as they are retained as serious per the source document Authority reporting. The events occurred on the same day after the dose (unknown dosage) of mRNA-1273, considered as third dose of patient�s COVID-19 vaccine schedule. The patient received previously a dose of AstraZeneca COVID-19 vaccine. Regulatory authority reported the rechallenge as unknown, however, no additional dose was administrated. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting. Patient was not enrolled in clinical trial. Re-challenge was reported as unknown.; Sender''s Comments: This regulatory authority case concerns a 42-year-old patient with no reported relevant medical history, who experienced the unexpected serious events of injection site pain, headache, pyrexia, and arthralgia. The events of are unexpected as they are retained as serious per the source document Authority reporting. The events occurred on the same day after the dose (unknown dosage) of mRNA-1273, considered as third dose of patient�s COVID-19 vaccine schedule. The patient received previously a dose of AstraZeneca COVID-19 vaccine. Regulatory authority reported the rechallenge as unknown, however, no additional dose was administrated. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1931792 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Feeling of body temperature change, Headache, Lymph node pain, Pain, Pain in extremity, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: swollen lymph node; Head pain; Swollen arm; Armpit pain; General body pain; Feeling hot and cold; Painful arm; This case was received (Reference number: GB-MHRA-ADR 26257531) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), AXILLARY PAIN (Armpit pain), PAIN IN EXTREMITY (Painful arm), PAIN (General body pain), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), LYMPH NODE PAIN (swollen lymph node) and HEADACHE (Head pain) in a 45-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. Concomitant products included MIRTAZAPINE from 01-Jan-2013 to an unknown date for Depression, NORTRIPTYLINE from 01-Jan-2018 to an unknown date for Head pain, IBUPROFEN and PARACETAMOL for Pain. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 24-Nov-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant), PAIN (General body pain) (seriousness criterion medically significant), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) (seriousness criterion medically significant) and HEADACHE (Head pain) (seriousness criterion medically significant). On an unknown date, the patient experienced LYMPH NODE PAIN (swollen lymph node) (seriousness criterion medically significant). On 25-Nov-2021, HEADACHE (Head pain) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen arm), AXILLARY PAIN (Armpit pain) and PAIN IN EXTREMITY (Painful arm) had not resolved, PAIN (General body pain) and FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) was resolving and LYMPH NODE PAIN (swollen lymph node) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine Patient had all over body pain occurred following the injection this also happened on 2 previous Astra injections, was unable to get out of bed and rocking with the pain as tablets or finding comfi position did not help. Have seen the GP as swelling in armpit, she believes it is swollen lymph node and coarse of antibiotics has been given to help will review in a week. Company comment: This case concerns a 45-year-old female patient with medical history of general body pain with 2 previous AstraZeneca injections, who experienced the serious unexpected events peripheral swelling, axillary pain, pain in extremity, pain, feeling of body temperature change, lymph node pain and headache. The event pain in extremity occurred the same day after the third dose of mRNA-1273. The event lymph node pain occurred on an unknown date after the third dose of mRNA-1273. The rest of the events occurred the day after the third dose of mRNA-1273. The rechallenge is unknown, according to SD. The medical history of general body pain with 2 previous AstraZeneca injections remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 45-year-old female patient with medical history of general body pain with 2 previous AstraZeneca injections, who experienced the serious unexpected events peripheral swelling, axillary pain, pain in extremity, pain, feeling of body temperature change, lymph node pain and headache. The event pain in extremity occurred the same day after the third dose of mRNA-1273. The event lymph node pain occurred on an unknown date after the third dose of mRNA-1273. The rest of the events occurred the day after the third dose of mRNA-1273. The rechallenge is unknown, according to SD. The medical history of general body pain with 2 previous AstraZeneca injections remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1933219 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ4187 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dry throat, Ear pain, Headache, Illness, Malaise, Nausea, Oropharyngeal pain, Sweating fever
SMQs:, Acute pancreatitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202101661115

Write-up: patient got really sick; feeling dryness in throat; feel ill; pain in throat; fever/blouse wet due to the fever; pain in head; pain in ear; nausea; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team via Consumer Service. The reporter is the patient. A 36-year-old female patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Lot number: FJ4187) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (medically significant) with onset 23Nov2021, outcome "not recovered", described as "patient got really sick"; DRY THROAT (medically significant) with onset 23Nov2021, outcome "not recovered", described as "feeling dryness in throat"; MALAISE (medically significant) with onset 23Nov2021, outcome "not recovered", described as "feel ill"; OROPHARYNGEAL PAIN (medically significant) with onset 23Nov2021, outcome "not recovered", described as "pain in throat"; SWEATING FEVER (medically significant) with onset 23Nov2021, outcome "not recovered", described as "fever/blouse wet due to the fever"; HEADACHE (medically significant) with onset 23Nov2021, outcome "not recovered", described as "pain in head"; EAR PAIN (medically significant) with onset 23Nov2021, outcome "not recovered", described as "pain in ear"; NAUSEA (medically significant) with onset 23Nov2021, outcome "not recovered", described as "nausea". The events "patient got really sick", "feeling dryness in throat", "feel ill", "pain in throat", "fever/blouse wet due to the fever", "pain in head", "pain in ear" and "nausea" were evaluated at the physician office visit. Therapeutic measures were taken as a result of illness, dry throat, malaise, oropharyngeal pain, sweating fever, headache, ear pain, nausea. Clinical course: After making use of the product (on the same day), the patient started feeling dryness in throat, to feel ill, with pain in head, ear and throat. At night, the patient had a lot of fever and woke up the next day with the blouse wet due to the fever. The patient still had the symptoms and was worried. The patient informed that she had symptoms that she did not have before the use, and also had to look for a physician and do a treatment for the occurrence.


VAERS ID: 1934001 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL1939 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Immunisation, Interchange of vaccine products, Myocarditis, Off label use, Pericarditis, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), 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: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20211102; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101662083

Write-up: 3rd dose was administered, and the patient has previously received the full primary immunization series of an unknown manufacturer; 3rd dose was administered, and the patient has previously received the full primary immunization series of an unknown manufacturer; 3rd dose was administered, and the patient has previously received the full primary immunization series of an unknown manufacturer; Chest pain; Shortness of breath; Possible inflammation of the heart (myocarditis); Possible inflammation of the heart (pericarditis); This is a spontaneous report received from a contactable consumer from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111231413070010-RHPX9. Other Case identifier(s): GB-MHRA-ADR 26238941. A 61-year-old female patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Lot number: FL1939) at the age of 61-years-old as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Patient has not had symptoms associated with COVID-19. Concomitant medication(s) included: INFLUENZA VIRUS, administration date 09Nov2021. Vaccination history included: COVID-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization; COVID-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 23Nov2021, outcome "unknown" and all described as "3rd dose was administered, and the patient has previously received the full primary immunization series of an unknown manufacturer"; CHEST PAIN (medically significant) with onset 23Nov2021, outcome "recovering", described as "Chest pain"; DYSPNOEA (medically significant) with onset 23Nov2021, outcome "recovered" (23Nov2021), described as "Shortness of breath"; MYOCARDITIS (medically significant) with onset 2021, outcome "unknown", described as "Possible inflammation of the heart (myocarditis)"; PERICARDITIS (medically significant) with onset 2021, outcome "unknown", described as "Possible inflammation of the heart (pericarditis)". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Nov2021) no - negative COVID-19 test. Clinical course: The patient put yes above but she was not sure. She had no previous history of heart or chest pain. She had the booster this morning and 30 minutes or so after had sharp pain and restricted breathing for 10 minutes or so. She was monitoring the situation but so far although there was a slight residual feeling in her chest her breathing had returned to normal and she was fine. Patient was not enrolled in clinical trial. The report related to possible inflammation of the heart (myocarditis or pericarditis). Symptoms did not lead to a hospital stay. Diagnosis was not made by a medical professional. There had not been any other recent or ongoing illness that had not already mentioned. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1934010 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Adnexa uteri pain, Chills, Dizziness, Fatigue, Headache, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular 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: Endometriosis (Birth control every day, no days off for nearly 17 years, don''t have periods because endometriosis.); Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20200809; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101654378

Write-up: Ovarian pain; Headache; Fever; Chills; Exhaustion; Dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111231804530570-OAA0F. Other Case identifier(s): GB-MHRA-ADR 26240958. A 50 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 07Aug2020 (unspecified if ongoing), notes: Unsure when symptoms stopped; "endometriosis" (unspecified if ongoing), notes: Birth control every day, no days off for nearly 17 years, don''t have periods because endometriosis. The patient''s concomitant medications were not reported. The following information was reported: ADNEXA UTERI PAIN (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Ovarian pain"; HEADACHE (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Headache"; PYREXIA (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Fever"; CHILLS (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Chills"; FATIGUE (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Exhaustion"; DIZZINESS (medically significant) with onset 23Nov2021, outcome "recovering", described as "Dizzy". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Aug2020) yes - positive covid-19 test. Clinical course: Patient was not currently breastfeeding.1 pill daily levoestrogen fe every day 365 for 17 years. No period cycles allowed. Reporter stated got the shot around 12n and started feeling dizzy within an hour. Next came the headache, then fever and chills. Within 5 hours immense ovarian pain started. Report was not related to possible inflammation of the heart (myocarditis or pericarditis).Patient was not enrolled in clinical trial.Patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1934016 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lower respiratory tract infection, Pain, Rhinorrhoea
SMQs:, Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101654367

Write-up: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111232130169510-X7LP4. Other Case identifier(s): GB-MHRA-ADR 26240492. A female patient received bnt162b2 (COMIRNATY), administration date 21Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: LOWER RESPIRATORY TRACT INFECTION (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Chest cold"; PAIN (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Ache"; RHINORRHOEA (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Runny nose". Clinical course: Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1934021 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FIT0546 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Headache, Malaise, 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210624; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101654359

Write-up: stomach ache; Nausea; Headache; Stomachache; Vomited; Physically sick 5 times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111232218556420-TGLIM (RA). Other Case identifier(s): GB-MHRA-ADR 26240913 (RA). A 13 year-old male patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Lot number: FIT0546) at the age of 13 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 21Jun2021, stop date: 07Jul2021. The patient''s concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The following information was reported: ABDOMINAL PAIN UPPER (medically significant), outcome "not recovered", described as "stomach ache"; NAUSEA (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Nausea"; HEADACHE (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Headache"; ABDOMINAL PAIN UPPER (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Stomachache"; VOMITING (medically significant) with onset 23Nov2021, outcome "recovered" (23Nov2021), described as "Vomited"; MALAISE (medically significant) with onset 23Nov2021, outcome "unknown", described as "Physically sick 5 times". It was further reported that 30 mins after jab, Nausea, Headache, Stomach ache, Physically sick 5 times. Adverse reaction did not occur as a result of an exposure during pregnancy. No report was related to possible inflammation of the heart (myocarditis or pericarditis). The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (24Jun2021) positive, notes: Yes - Positive COVID-19 test. No follow-up attempts are Needed. No further information is expected.


VAERS ID: 1934029 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Dizziness, Dyspnoea, Eye irritation, Fatigue, Headache, Myalgia, Neck pain, Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test, Thermal burns of eye
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211122; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101662092

Write-up: This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111241006506100-MQY2V. Other Case identifier: GB-MHRA-ADR 26242532. A 21 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Batch/Lot number: unknown) at the age of 21 years as dose 1, single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient last menstrual period date was 04Nov2021. Patient had no symptoms associated with COVID-19 and was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The following information was reported: EYE IRRITATION (medically significant) with onset 2021, outcome "not recovered", described as "burning eyes"; FATIGUE (medically significant) with onset 2021, outcome "not recovered", described as "tiredness"; CHILLS (medically significant) with onset 2021, outcome "not recovered", described as "Chills right after"; HEADACHE (medically significant) with onset 23Nov2021, outcome "recovering", described as "Headache"; PYREXIA (medically significant) with onset 23Nov2021, outcome "recovering", described as "Fever all evening around 1hr later/Fever all night"; THERMAL BURNS OF EYE (medically significant) with onset 23Nov2021, outcome "recovering", described as "Eye burns"; ARTHRALGIA (medically significant) with onset 23Nov2021, outcome "recovering", described as "Shoulder soreness"; MYALGIA (medically significant) with onset 24Nov2021, outcome "recovering", described as "Muscle soreness"; DIZZINESS (medically significant) with onset 23Nov2021, outcome "recovering", described as "Dizzy"; DYSPNOEA (medically significant) with onset 23Nov2021, outcome "recovering", described as "Shortness of breath"; NECK PAIN (medically significant) with onset 24Nov2021, outcome "recovering", described as "Neck pain"; PAIN IN EXTREMITY (medically significant) with onset 2021, outcome "not recovered", described as "Extreme soreness in arm"; PAIN (medically significant) with onset 2021, outcome "not recovered", described as "Sore body".The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Nov2021) no - negative COVID-19 test. Therapeutic measures were taken as a result of pyrexia. Medicine didn''t help break the fever. Symptoms still ongoing (as reported). The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1934059 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Fatigue, Immunisation, Interchange of vaccine products, Off label use, Pain, Pain in extremity, Peripheral swelling, Vaccination site mass
SMQs:, Cardiac failure (broad), Angioedema (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: IBUPROFEN LYSINE; METFORMIN; PARACETAMOL; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Migraine; Mixed anxiety and depressive disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101674987

Write-up: Under left arm in armpit it is swollen and painful; Under left arm in armpit it is swollen and painful; Tiredness; weak; Ache/ Radiating down the arm and into the side of breast; off label use; Interchange of vaccine products; Booster; Sore lump on upper arm at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111261156125440-WJK6H. Other Case identifier(s): GB-MHRA-ADR 26256651. A 39 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 23Nov2021 (Lot number: FK9413) at the age of 39 years as dose 3 (booster) single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Mixed anxiety and depressive disorder" (unspecified if ongoing). The patient''s last menstrual period date was on 21Nov2021. Patient had no symptoms associated with COVID-19, had no COVID-19 test, was not enrolled in clinical trial and was not breastfeeding at the time of report. Concomitant medication(s) included: IBUPROFEN LYSINE taken for migraine; METFORMIN taken for diabetes mellitus; PARACETAMOL taken for migraine; SERTRALINE taken for mixed anxiety and depressive disorder. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE-1, Batch/lot number: not reported), administration date: 04Mar2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (DOSE-2; Batch/lot number: not reported), administration date: 21May2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 23Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "Booster"; VACCINATION SITE MASS (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Sore lump on upper arm at the injection site"; PERIPHERAL SWELLING (medically significant) with onset 24Nov2021, outcome "unknown", PAIN IN EXTREMITY (medically significant) with onset 24Nov2021, outcome "not recovered" and all described as "Under left arm in armpit it is swollen and painful"; FATIGUE (medically significant) with onset 24Nov2021, outcome "recovered" (25Nov2021), described as "Tiredness"; ASTHENIA (medically significant) with onset 24Nov2021, outcome "unknown", described as "weak"; PAIN (medically significant) with onset 24Nov2021, outcome "recovered" (25Nov2021), described as "Ache/ Radiating down the arm and into the side of breast". Patient had not tested positive for COVID-19 since having the vaccine. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). Clinical course included: the day after the vaccine almost exactly 24 hours later the patient started to feel tired, achy and weak. Under her left arm in her armpit it was swollen and painful. Radiating down her arm and into the side of breast. It was the same arm as the injection site. Patient also had a sore lump on upper arm it the injection site. No follow-up attempts are needed. No further information is expected.


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