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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)

This is page 505 out of 10,317

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VAERS ID: 2033063 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-10-28
Onset:2021-11-21
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011F21A / 3 AR / SYR

Administered by: Other       Purchased by: ?
Symptoms: Chest X-ray, Computerised tomogram, Pneumonia bacterial
SMQs:, Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid 75 mcg; Allegra; Osteo Bi-Flex; Multivitamin; Fish oil; Turmeric
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Chest x-ray and CAT scan (lungs).
CDC Split Type:

Write-up: Bacterial pnemonia (both lungs).


VAERS ID: 2033272 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-10-16
Onset:2021-11-21
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / IM
FLU4: INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) / SEQIRUS, INC. - / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cerebrovascular accident, Computerised tomogram, Gastric disorder, Lumbar puncture, Magnetic resonance imaging, Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Nothing before vaccine was very healthy
Allergies: Latex
Diagnostic Lab Data: Mri CT Spinal tap
CDC Split Type:

Write-up: After receiving the vaccine I had a stoke since the stroke I had several visits to the hospital for stomach issues as well as being admitted for low platelet count


VAERS ID: 1907343 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Frequent bowel movements, Headache, Nausea, Palpitations, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), 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: Atorvastatin; Canagliflozin; Estradot; Gliclazide; Influenza Virus; Metformin; Starflower Oil [Borago Officinalis Oil]; Utrogestan
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: Palpitations; Headache; Nausea; Vomiting; Frequent bowel movements; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26232134) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting) and FREQUENT BOWEL MOVEMENTS (Frequent bowel movements) in a 48-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concomitant products included ATORVASTATIN for Cholesterol, CANAGLIFLOZIN, GLICLAZIDE and METFORMIN for Diabetes, INFLUENZA VACCINE (INFLUENZA VIRUS) from 20-Nov-2021 to an unknown date for Flu prevention, ESTRADIOL (ESTRADOT) for HRT, STARFLOWER OIL [BORAGO OFFICINALIS OIL] for Painful breasts, PROGESTERONE (UTROGESTAN) for an unknown indication. On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced PALPITATIONS (Palpitations) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant) and FREQUENT BOWEL MOVEMENTS (Frequent bowel movements) (seriousness criterion medically significant). At the time of the report, PALPITATIONS (Palpitations) and HEADACHE (Headache) had not resolved and NAUSEA (Nausea), VOMITING (Vomiting) and FREQUENT BOWEL MOVEMENTS (Frequent bowel movements) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was not breastfeeding. Paracetamol taken was reported. Patient was not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Company Comment: This case concerns a 48-year-old, female patient with relevant medical history of high cholesterol and diabetes and use of concomitant medication atorvastatin, canagliflozin, gliclazide and metformin, who experienced the unexpected events of palpitations, headache, nausea, vomiting and frequent bowel movements. The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was unknown as was reported by Regulatory Authority. The medical history of high cholesterol and diabetes and use of concomitant medication atorvastatin, canagliflozin, gliclazide and metformin 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 resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.; Sender''s Comments: This case concerns a 48-year-old, female patient with relevant medical history of high cholesterol and diabetes and use of concomitant medication atorvastatin, canagliflozin, gliclazide and metformin, who experienced the unexpected events of palpitations, headache, nausea, vomiting and frequent bowel movements. The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was unknown as was reported by Regulatory Authority. The medical history of high cholesterol and diabetes and use of concomitant medication atorvastatin, canagliflozin, gliclazide and metformin 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 resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.


VAERS ID: 1907344 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

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

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

Write-up: Joint ache; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26232174) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint ache) in a 56-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 2020 to 21-May-2021 for an unknown indication. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced ARTHRALGIA (Joint ache) (seriousness criterion medically significant). At the time of the report, ARTHRALGIA (Joint ache) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. other medication includes Paracetamol. Company comment- This is a regulatory case concerning a 56 years old, female patient with no clinical history who experienced the unexpected events of ARTHRALGIA The events occurred one day after 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 regulatory case concerning a 56 years old, female patient with no clinical history who experienced the unexpected events of ARTHRALGIA The events occurred one day after 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: 1908732 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLOPIDOGREL; COVID-19 MRNA VACCINE BNT162B2; SARS-COV-2 VACCINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bowel cancer; Transient ischemic attack
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Stomach pain; This case was received via RA (Reference number: GB-MHRA-ADR 26232416) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain) in a male patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. The patient''s past medical history included Bowel cancer in 2010 and Transient ischemic attack in 2012. Concomitant products included CLOPIDOGREL from 2012 to an unknown date, TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) and SARS-COV-2 VACCINE for an unknown indication. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) (seriousness criterion medically significant). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment medication was reported. It was reported that stomach pain followed by loose bowel movement. 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 53-year-old female patient, with medical history of bowel cancer and transient ischemic attack in 2012, who experienced the serious unexpected event of ABDOMINAL PAIN UPPER one dat after the third dose of mRNA-1273 vaccine. At the time of the report the event was resolving. Patient�s medical history of bowel cancer remains as a confounder for this event. 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 53-year-old female patient, with medical history of bowel cancer and transient ischemic attack in 2012, who experienced the serious unexpected event of ABDOMINAL PAIN UPPER one dat after the third dose of mRNA-1273 vaccine. At the time of the report the event was resolving. Patient�s medical history of bowel cancer remains as a confounder for this event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per regulatory reporting


VAERS ID: 1908747 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Dizziness postural, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS; COVID-19 VACCINE ASTRAZENECA; GABAPENTIN; ADRENALIN [EPINEPHRINE BITARTRATE]; AMITRIPTYLINE; EPIPEN; FROVATRIPTAN; METFORMIN; OMEPRAZOLE; PROPRANOLOL
Current Illness:
Preexisting Conditions: Comments: No other medical history was reported. Patient has not had symptoms associated with COVID-19 and Patient is not currently breastfeeding.
Allergies:
Diagnostic Lab Data: Test Date: 20210706; 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: Dizzy; Positional dizziness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26232702) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) and DIZZINESS POSTURAL (Positional dizziness) in a 37-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No other medical history was reported. Patient has not had symptoms associated with COVID-19 and Patient is not currently breastfeeding. Concomitant products included EPINEPHRINE BITARTRATE (ADRENALIN [EPINEPHRINE BITARTRATE]) from 21-Nov-2021 to 21-Nov-2021 for Anaphylactic reaction to vaccine, AMITRIPTYLINE, FROVATRIPTAN and PROPRANOLOL for Chronic migraine, EPINEPHRINE (EPIPEN) for Food allergy, GABAPENTIN for Functional neurological symptom disorder, METFORMIN and OMEPRAZOLE for Irritable bowel, INFLUENZA VACCINE (INFLUENZA VIRUS) from 21-Nov-2021 to an unknown date and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 30-Jun-2021 to an unknown date for Vaccination. On 21-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced DIZZINESS POSTURAL (Positional dizziness) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (Dizzy) (seriousness criterion medically significant). At the time of the report, DIZZINESS (Dizzy) had not resolved and DIZZINESS POSTURAL (Positional dizziness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jul-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. It was reported that patient had influenza vaccination and Moderna booster. Within a few minutes felt dizzy when sitting and standing. Symptom relieved by lying down. Patient has not tested positive for COVID-19 since having the vaccine and Patient is not enrolled in clinical trial. No treatment information was provided. Company''s comment: This is a regulatory case concerning a 37-year-old female patient, with no relevant medical history fir the causality assessment for the events reported, who experienced the serious unexpected events of of DIZZINESS and DIZZINESS POSTURAL. These events occurred on the same day after receiving the third dose of mRNA-1273 vaccine. Concomitant vaccination with influenza vaccine remains as a confounder/co-suspect for these events. It was stated in the report that the patient received epinephrine for anaphylactic reaction to the vaccine on the same date that mRNA-1273 and infuenza vaccine were given. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per regulatory reporting; Sender''s Comments: This is a regulatory case concerning a 37-year-old female patient, with no relevant medical history fir the causality assessment for the events reported, who experienced the serious unexpected events of of DIZZINESS and DIZZINESS POSTURAL. These events occurred on the same day after receiving the third dose of mRNA-1273 vaccine. Concomitant vaccination with influenza vaccine remains as a confounder/co-suspect for these events. It was stated in the report that the patient received epinephrine for anaphylactic reaction to the vaccine on the same date that mRNA-1273 and infuenza vaccine were given. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per regulatory reporting


VAERS ID: 1908748 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Headache, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS; OESTROGEN; UTROGESTAN
Current Illness:
Preexisting Conditions: Comments: No medical history were reported
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Vomiting; Diarrhea; Nausea; Tummy ache; Headache; Dizziness; This case was received via Regulatory Authority(Reference number: GB-MHRA-ADR 26232706) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), DIARRHOEA (Diarrhea), NAUSEA (Nausea), ABDOMINAL PAIN (Tummy ache), HEADACHE (Headache) and DIZZINESS (Dizziness) in a 57-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. No medical history were reported. Concomitant products included DIETHYLSTILBESTROL (OESTROGEN) from 18-Oct-2021 to an unknown date and PROGESTERONE (UTROGESTAN) from 18-Oct-2021 to an unknown date for Menopause, INFLUENZA VACCINE (INFLUENZA VIRUS) for an unknown indication. On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), ABDOMINAL PAIN (Tummy ache) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). At the time of the report, VOMITING (Vomiting), NAUSEA (Nausea) and HEADACHE (Headache) was resolving and DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Tummy ache) and DIZZINESS (Dizziness) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided by the reporter. Company Comment : This is a regulatory case concerning a 57-year-old female, with no relevant medical history reported , who experienced the serious unexpected events of VOMITING, DIARRHOEA, NAUSEA, ABDOMINAL PAIN, HEADACHE and DIZZINESS one day after receiving the third dose of mRNA1273 vaccine. At the time of the report the events had resolved. 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 57-year-old fe male, with no relevant medical history reported , who experienced the serious unexpected events of VOMITING, DIARRHOEA, NAUSEA, ABDOMINAL PAIN, HEADACHE and DIZZINESS one day after receiving the third dose of mRNA1273 vaccine. At the time of the report the events had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per regulatory reporting


VAERS ID: 1908924 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Heart rate, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension (Treated with medication since 2013 and well controlled.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Racing heart (tachycardia); Heart rate; This case was received via the RA (Reference number: GB-MHRA-ADR 26232711) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of TACHYCARDIA (Racing heart (tachycardia)) and HEART RATE (Heart rate) in a 65-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. The patient''s past medical history included Hypertension (Treated with medication since 2013 and well controlled.). On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced HEART RATE (Heart rate) (seriousness criterion medically significant). On an unknown date, the patient experienced TACHYCARDIA (Racing heart (tachycardia)) (seriousness criterion medically significant). On 21-Nov-2021, HEART RATE (Heart rate) had resolved. At the time of the report, TACHYCARDIA (Racing heart (tachycardia)) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. on 21/11/21 patient experienced fast heart rate from 10am to 11.30am. Heart rate was 135 and tested using a blood pressure monitor every 15 minutes. Felt light headed for the first 25 minutes. Blood pressure was not abnormal. Temperature was normal throughout. Contacted one company and after answering all questions was told to contact my GP within 24 hours and not to drink any alcohol or coffee. Since heart rate returned to normal I''ve felt well and able to carry out all normal activities. Company comment: This case concerns a 65-year-old, male patient with previous relevant medical history of hypertension, who experienced the unexpected serious event of tachycardia. Heart rate is also reported as an event in the case. On 18-Nov-2021, the patient received third dose (unknown dosage) of mRNA-1273; heart rate is reported with onset 3 days after vaccination. As per source document�s narrative, tachycardia, also occurred 3 days after vaccination date. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. Patient�s medical history of hypertension could be confounder based on a heart � related condition. 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 case concerns a 65-year-old, male patient with previous relevant medical history of hypertension, who experienced the unexpected serious event of tachycardia. Heart rate is also reported as an event in the case. On 18-Nov-2021, the patient received third dose (unknown dosage) of mRNA-1273; heart rate is reported with onset 3 days after vaccination. As per source document�s narrative, tachycardia, also occurred 3 days after vaccination date. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. Patient�s medical history of hypertension could be confounder based on a heart � related condition. 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: 1908926 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Palpitations, SARS-CoV-2 test
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (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: PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Palpitations; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26232760) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations) in a 74-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 29-Jan-2021 to 19-Nov-2021 for Routine vaccination. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced PALPITATIONS (Palpitations) (seriousness criterion medically significant). On 21-Nov-2021, PALPITATIONS (Palpitations) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2021, SARS-CoV-2 test: negative covid-19 test (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. It was reported that patient had missed heartbeats on day 2. On attending A&E the nurse said she was the 2nd person that day with those symptoms after Moderna vaccination. Patient had not tested positive for COVID-19 since having the vaccine Laboratory tests included: ECG done some hours later and it was OK. Treatment details not provided. Company Comment: This is a regulatory case concerning a 74-year-old fe male, with no relevant medical history reported , who experienced the serious unexpected event of PALPITATIONS 3 daysafter receiving the third dose of mRNA1273 vaccine. patient stated than an ECG was done with normal results. At the time of the report the events had resolved. 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 74-year-old fe male, with no relevant medical history reported , who experienced the serious unexpected event of PALPITATIONS 3 daysafter receiving the third dose of mRNA1273 vaccine. patient stated than an ECG was done with normal results. At the time of the report the events had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per regulatory reporting


VAERS ID: 1914105 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD220 / UNK - / IM

Administered by: School       Purchased by: ?
Symptoms: Tinnitus
SMQs:, Hearing impairment (narrow)

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: Metformin 500 mg 1 tablet three times a day for the past 5 years
Current Illness: Nil
Preexisting Conditions: Diabetes Mellitus for 5 years
Allergies: Nil
Diagnostic Lab Data: Nil
CDC Split Type:

Write-up: Tinnitus right year. Chirping noice heard in right year every 10-20 seconds


VAERS ID: 1914686 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Chills, Fatigue, Headache, Nausea, Neck pain, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: Medical History/Concurrent Conditions: COVID-19 pneumonia; Gallbladder removal; Hiatus hernia (took omeprazole)
Allergies:
Diagnostic Lab Data: Test Date: 20211111; 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: Headache; Neck pain; Nauseous; Fatigue; Shivering; Stomach ache; Pain in hip; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26234392) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NECK PAIN (Neck pain), NAUSEA (Nauseous), FATIGUE (Fatigue), CHILLS (Shivering), ABDOMINAL PAIN UPPER (Stomach ache) and ARTHRALGIA (Pain in hip) in a 49-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 COVID-19 pneumonia in December 2020, Hiatus hernia (took omeprazole) and Gallbladder removal in March 2021. Previously administered products included for Product used for unknown indication: OMEPRAZOLE. Past adverse reactions to the above products included No adverse event with OMEPRAZOLE. On 21-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), NECK PAIN (Neck pain) (seriousness criterion medically significant), NAUSEA (Nauseous) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (Stomach ache) (seriousness criterion medically significant) and ARTHRALGIA (Pain in hip) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), NECK PAIN (Neck pain), NAUSEA (Nauseous), FATIGUE (Fatigue), CHILLS (Shivering), ABDOMINAL PAIN UPPER (Stomach ache) and ARTHRALGIA (Pain in hip) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2021, 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. Te patient had the vaccination at 10.00, by 11.00 arm was painful and feeling dead and heavy. Throughout the day the other symptoms came on. Patient could not sleep last night eve though was so tired. The patient had taken paracetamol. No concomitant medication was reported. Company Comment: This case concerns a 49-year-old female patient, with medical history of Hiatus hernia and Gallbladder removal, who experienced the unexpected serious events of HEADACHE, NECK PAIN, NAUSEA, FATIGUE, CHILLS, ABDOMINAL PAIN UPPER and ARTHRALGIA. The events occurred on the same day of the administration of the third dose of mRNA-1273. The rechallenge was unknown. Patient�s medical history of Hiatus hernia and Gallbladder removal, remains as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 49-year-old female patient, with medical history of Hiatus hernia and Gallbladder removal, who experienced the unexpected serious events of HEADACHE, NECK PAIN, NAUSEA, FATIGUE, CHILLS, ABDOMINAL PAIN UPPER and ARTHRALGIA. The events occurred on the same day of the administration of the third dose of mRNA-1273. The rechallenge was unknown. Patient�s medical history of Hiatus hernia and Gallbladder removal, remains as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1915056 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE
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: Headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26232473) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 45-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna Intramuscular Injection) for an unknown indication. Concomitant products included BNT162B2 for Vaccination. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID-19 Vaccine Moderna Intramuscular Injection) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache) 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 Intramuscular Injection) (Unknown) was unknown. No treatment information was provided. Patient has not had symptoms associated with COVID-19. Patients entire upper arm is painful to touch, and pain extends through the shoulder and into his neck. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This is a regulatory case concerning a 45 year-old male patient, with no relevant medical history reported , who experienced the serious unexpected event of HEADACHE one 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 45 year-old male patient, with no relevant medical history reported , who experienced the serious unexpected event of HEADACHE one 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


VAERS ID: 1915058 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Disorientation, Hypoaesthesia, Nausea, Palpitations, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad), Sexual dysfunction (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: Heart disorder (Diagnosed with post COVID heart condition in June 2021); Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Thyroidectomy total (No thyroid tissue)
Allergies:
Diagnostic Lab Data: Test Date: 20211017; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: nausea; numbness; disorientation; palpitations; Fainting; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26232592) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting), NAUSEA (nausea), HYPOAESTHESIA (numbness), DISORIENTATION (disorientation) and PALPITATIONS (palpitations) in a 57-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 Thyroidectomy total (No thyroid tissue) in 2003. Concurrent medical conditions included Suspected COVID-19 since 17-Oct-2021 and Heart disorder (Diagnosed with post COVID heart condition in June 2021) since June 2021. On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced SYNCOPE (Fainting) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced NAUSEA (nausea) (seriousness criterion disability), HYPOAESTHESIA (numbness) (seriousness criterion disability), DISORIENTATION (disorientation) (seriousness criterion disability) and PALPITATIONS (palpitations) (seriousness criterion disability). On 21-Nov-2021, SYNCOPE (Fainting) was resolving. At the time of the report, NAUSEA (nausea), HYPOAESTHESIA (numbness), DISORIENTATION (disorientation) and PALPITATIONS (palpitations) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Oct-2021, SARS-CoV-2 test: yes (Positive) COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient experienced prickling of face and head, disorientation, palpitations, nausea, thumping heart No relevant concomitant and treatment medications were reported This case concerns a 57-year-old female, with reported medical history of Suspected COVID-19, Post covid heart condition and Thyroidectomy, who experience the serious unexpected events of Syncope, Nausea, Hypoaesthesia, Disorientation and Paliptations. The event Syncope occurred the same day of the administration of the 3rd dose of the mRNA-1273 vaccine and the events Nausea, Hypoaesthesia, Disorientation and Paliptations occurred on an unknown date. At the time of the report, the outcome for the event Syncope was Recovering/Resolving and for the events Nausea, Hypoaesthesia, Disorientation and Paliptations is Unknown. 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 Suspected COVID-19 and Post covid heart condition remains as a confounder for the events. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Based on medical judgment this event is relevant to the case.; Sender''s Comments: This case concerns a 57-year-old female, with reported medical history of Suspected COVID-19, Post covid heart condition and Thyroidectomy, who experience the serious unexpected events of Syncope, Nausea, Hypoaesthesia, Disorientation and Paliptations. The event Syncope occurred the same day of the administration of the 3rd dose of the mRNA-1273 vaccine and the events Nausea, Hypoaesthesia, Disorientation and Paliptations occurred on an unknown date. At the time of the report, the outcome for the event Syncope was Recovering/Resolving and for the events Nausea, Hypoaesthesia, Disorientation and Paliptations is Unknown. 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 Suspected COVID-19 and Post covid heart condition remains as a confounder for the events. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Based on medical judgment this event is relevant to the case.


VAERS ID: 1915064 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness: Chronic lung disease; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Preexisting Conditions: Medical History/Concurrent Conditions: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Nausea; Ache; Fatigue; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26233515) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), NAUSEA (Nausea) and PAIN (Ache) in a 26-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)). Concurrent medical conditions included Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...) and Chronic lung disease. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 05-Feb-2021 to 25-Apr-2021 for an unknown indication. On 21-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). On 22-Nov-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant) and PAIN (Ache) (seriousness criterion medically significant). At the time of the report, FATIGUE (Fatigue) outcome was unknown and NAUSEA (Nausea) and PAIN (Ache) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Chronic lung condition. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Treatment information was not provided Company Comment:This is a regulatory authority case concerning a 26-year-old, female patient with relevant concurrent medical condition of chronic lung disease and immunodeficiency with concurrent medication of steroid and vaccination history of receiving other brand of Covid-19 vaccine (Covid-19 AstraZeneca) for primary doses, who experienced the unexpected serious events of fatigue, nausea and pain. The event fatigue occurred the same day with the third dose of mRNA-1273 administration while the events nausea and pain occurred 1 day after the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The concurrent medical condition of chronic lung disease and immunodeficiency with concurrent medication of steroid and vaccination history of receiving other brand of Covid-19 vaccine remains confounders. 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 26-year-old, female patient with relevant concurrent medical condition of chronic lung disease and immunodeficiency with concurrent medication of steroid and vaccination history of receiving other brand of Covid-19 vaccine (Covid-19 AstraZeneca) for primary doses, who experienced the unexpected serious events of fatigue, nausea and pain. The event fatigue occurred the same day with the third dose of mRNA-1273 administration while the events nausea and pain occurred 1 day after the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The concurrent medical condition of chronic lung disease and immunodeficiency with concurrent medication of steroid and vaccination history of receiving other brand of Covid-19 vaccine remains confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1915065 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-02
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:
Current Illness:
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: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fever; Chills; Headache; This case was received via regulatory authority RA (Reference number: GB-MHRA-ADR 26233519) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 53-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 Suspected COVID-19 (Unsure when symptoms stopped) on 30-Mar-2020. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever) had not resolved and CHILLS (Chills) 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 concomitant products were reported. No treatment drugs were reported. Patient experienced fever, chills, headache, body ache all within 24 hours of vaccine. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. This case concerns a 53-year-old female patient, with no relevant medical history, who experienced the serious unexpected events of Pyrexia, Chills and Headache. The events occurred one day after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.; Sender''s Comments: This case concerns a 53-year-old female patient, with no relevant medical history, who experienced the serious unexpected events of Pyrexia, Chills and Headache. The events occurred one day after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.


VAERS ID: 1915073 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26233832) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in a 53-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. 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 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). On 22-Nov-2021, VOMITING (Vomiting) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment drug was provided by reporter. Patient felt fine for the first 24 hours after the vaccintion, then began to start feeling nauseous and from approximately 36 after the vaccination had bouts of vomiting until approximately 48 hours after the vaccination. Fingers crossed all is now well. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. Company Comment: This case concerns a 53-year-old male patient with no relevant medical history reported, who experienced the event of vomiting. A concomitant product in this case is the Covid-19 AstraZeneca vaccine. The events occurred approximately 1 day after the third dose with mRNA � 1273 vaccine. As per source document patient felt nauseous first. Vomiting was reported as medically significant but 1-day after the occurrence the event had resolved. 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 case concerns a 53-year-old male patient with no relevant medical history reported, who experienced the event of vomiting. A concomitant product in this case is the Covid-19 AstraZeneca vaccine. The events occurred approximately 1 day after the third dose with mRNA � 1273 vaccine. As per source document patient felt nauseous first. Vomiting was reported as medically significant but 1-day after the occurrence the event had resolved. 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: 1915081 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hypoaesthesia, Pain in extremity, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad), Sexual dysfunction (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: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: dead arm; Hand pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26233981) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This Regulatory Authority case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (dead arm) and PAIN IN EXTREMITY (Hand pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (Batch no. 3004675) for Corona virus infection. Previously administered products included for Product used for unknown indication: GLICLAZIDE, PREGABALIN, Thyroxine and Iron (tablet). Past adverse reactions to the above products included No adverse event with GLICLAZIDE, Iron, PREGABALIN and Thyroxine. On 20-Nov-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced PAIN IN EXTREMITY (Hand pain) (seriousness criterion disability). On an unknown date, the patient experienced HYPOAESTHESIA (dead arm) (seriousness criterion disability). At the time of the report, HYPOAESTHESIA (dead arm) outcome was unknown and PAIN IN EXTREMITY (Hand pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. No concomitant medication was reported by patient. No treatment medication was reported by patient. Patient reported that her arm was unusable without severe pain and experienced burning at tip of second finger. patient had no symptoms associated with Covid 19. Patient was not enrolled in clinical trial. Company comment: This case concerns a 62-years-old female patient, with no relevant medical history reported, who experienced the serious unexpected events of PAIN IN EXTREMITY and HYPOAESTHESIA. The events occurred on the following day of the dose of the mRNA-1273. The rechallenge is not applicable, as there is no information that states vaccination dose number and there is only one dose reported. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 62-years-old female patient, with no relevant medical history reported, who experienced the serious unexpected events of PAIN IN EXTREMITY and HYPOAESTHESIA. The events occurred on the following day of the dose of the mRNA-1273. The rechallenge is not applicable, as there is no information that states vaccination dose number and there is only one dose reported. The benefit-risk relationship of the mRNA-1273 is not affected by this report.


VAERS ID: 1915086 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Chills
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: Chronic kidney disease stage 3 (affecting lung volume)
Preexisting Conditions: Medical History/Concurrent Conditions: Scoliosis (affecting lung volume); Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Rigors; Body temperature; This case was received via RA (Reference number: GB-MHRA-ADR 26234146) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Rigors) and BODY TEMPERATURE (Body temperature) in a 54-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 21-Nov-2021 to 22-Nov-2021. Concurrent medical conditions included Scoliosis (affecting lung volume) and Chronic kidney disease stage 3 (affecting lung volume). On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced BODY TEMPERATURE (Body temperature) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (Rigors) (seriousness criterion medically significant). On 22-Nov-2021, BODY TEMPERATURE (Body temperature) was resolving. At the time of the report, CHILLS (Rigors) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Medical history included: Multiple long term conditions but none that affect immune system. No Concomitant medication details were provided. Patient''s temperature and rigors started at approx 18 hours after the vaccination. Treated with paracetamol. Patient was not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Company Comment: This case concerns a 54-year-old female patient with no relevant medical history, who experienced serious unexpected events of Body temperature and chills. According to the provided data from the source document, temperature and rigors started at approx 18 hours after the vaccination and the patient was treated with paracetamol. At the time of the report the events were resolving. It was stated that the patient had suspected COVID-19 at the time when the events occurred, however, it was also stated that the patient was not tested positive for COVID-19 since having the vaccine. 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 expected at the moment. 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 54-year-old female patient with no relevant medical history, who experienced serious unexpected events of Body temperature and chills. According to the provided data from the source document, temperature and rigors started at approx 18 hours after the vaccination and the patient was treated with paracetamol. At the time of the report the events were resolving. It was stated that the patient had suspected COVID-19 at the time when the events occurred, however, it was also stated that the patient was not tested positive for COVID-19 since having the vaccine. 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 expected at the moment. 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: 1915096 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Vomiting
SMQs:, Acute pancreatitis (broad), 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Vomiting; Dizziness; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26234433) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) and DIZZINESS (Dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 21-Nov-2021. On 21-Nov-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant). On 22-Nov-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). At the time of the report, VOMITING (Vomiting) and DIZZINESS (Dizziness) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Company Comment : This case concerns a female patient of an unknown age, with a history suspected COVID-19, who experienced the serious unexpected events of DIZZINESS and VOMITING. The event DIZZINESS occurred on the same day of the dose of mRNA-1273, and the event VOMITING occurred on the following day of the dose of the mRNA-1273. The rechallenge is not applicable, as there is no information that states vaccination dose number and there is only one dose reported. The 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 female patient of an unknown age, with a history suspected COVID-19, who experienced the serious unexpected events of DIZZINESS and VOMITING. The event DIZZINESS occurred on the same day of the dose of mRNA-1273, and the event VOMITING occurred on the following day of the dose of the mRNA-1273. The rechallenge is not applicable, as there is no information that states vaccination dose number and there is only one dose reported. The history of suspected COVID-19 remains a confounder. The benefit-risk relationship of the mRNA-1273 is not affected by this report.


VAERS ID: 1915097 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: High temperature; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26234554) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (High temperature) in a 61-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 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Nov-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant). At the time of the report, PYREXIA (High temperature) was resolving. 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 case concerns a 61-year-old, female patient with no relevant medical history reported, who experienced the unexpected serious event of pyrexia. The event occurred approximately one day after the booster dose of mRNA-1273 vaccine. The rechallenge was not applicable since the event happened after the booster dose and no information on additional dosing is expected. 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 61-year-old, female patient with no relevant medical history reported, who experienced the unexpected serious event of pyrexia. The event occurred approximately one day after the booster dose of mRNA-1273 vaccine. The rechallenge was not applicable since the event happened after the booster dose and no information on additional dosing is expected. 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: 1915100 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angioedema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Hives giant; Swelling arm; Skin warm; Itchy skin; Painful arm; This case was received via RA (Reference number: GB-MHRA-ADR 26234631) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Hives giant) in a 51-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced ANGIOEDEMA (Hives giant) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swelling arm), SKIN WARM (Skin warm), PRURITUS (Itchy skin) and PAIN IN EXTREMITY (Painful arm). At the time of the report, ANGIOEDEMA (Hives giant), PERIPHERAL SWELLING (Swelling arm), SKIN WARM (Skin warm), PRURITUS (Itchy skin) and PAIN IN EXTREMITY (Painful arm) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported by the reporter Treatment information was not provided Company comment- This case concerns a 51 year old female patient with no relevant medical history, who experienced the events of angioedema, peripheral swelling, skin warm, pruritus and pain in extremity. The events occurred approximately 2 days 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 51 year old female patient with no relevant medical history, who experienced the events of angioedema, peripheral swelling, skin warm, pruritus and pain in extremity. The events occurred approximately 2 days 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: 1915106 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, SARS-CoV-2 test, Somnolence
SMQs:, Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
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: sleepy; got home at 1pm; Excessive daytime sleepiness; This case was received (Reference number: GB-MHRA-ADR 26234848) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BACK PAIN (got home at 1pm) in a 50-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped). On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (got home at 1pm) (seriousness criterion medically significant). At the time of the report, BACK PAIN (got home at 1pm) 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 included COVID-19 MRNA VACCINE BIONTECH Treatment information was not provided. Patient had booster dose of vaccine at 6:30pm on saturday. Patient felt fine , went out delivering leaflets for two hours on next day Sunday 21st got home at 1pm, taken light lunch, slept four hours in the afternoon, slept fine that night, woke up at 7am as usual on Monday, felt tired slept again from 11am to 12:30pm, got up had a shower and lunch and gone back to bed again as tired and sleepy (3pm). Patient was not tested positive for COVID-19 since had the vaccine. Patient was not enrolled in clinical trial. Company comment:This is a regulatory authority case concerning a 50-year-old, male patient with concomitant Covid-19 vaccine of another brand (Covid-19 BioNTech), who experienced the unexpected serious events of somnolence (excessive daytime sleepiness), back pain and somnolence (sleepy). The event somnolence (excessive daytime sleepiness) occurred 1 day after the third dose of mRNA-1273 vaccine administration, the event somnolence (sleepy) exact occurrence unknown but stated that the event occurred after the third dose of mRNA-1273 vaccine administration while the event chronic back pain exact 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 50-year-old, male patient with concomitant Covid-19 vaccine of another brand (Covid-19 BioNTech), who experienced the unexpected serious events of somnolence (excessive daytime sleepiness), back pain and somnolence (sleepy). The event somnolence (excessive daytime sleepiness) occurred 1 day after the third dose of mRNA-1273 vaccine administration, the event somnolence (sleepy) exact occurrence unknown but stated that the event occurred after the third dose of mRNA-1273 vaccine administration while the event chronic back pain exact 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: 1915108 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

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

Write-up: sweaty; cold; headache; Feverish; Headache dull; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26235015) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweaty), NASOPHARYNGITIS (cold), HEADACHE (headache), PYREXIA (Feverish) and HEADACHE (Headache dull) in a 51-year-old female patient 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 27-May-2021 to an unknown date and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 05-Mar-2021 to an unknown date for COVID-19. On 21-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced PYREXIA (Feverish) (seriousness criterion medically significant) and HEADACHE (Headache dull) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERHIDROSIS (sweaty) (seriousness criterion medically significant), NASOPHARYNGITIS (cold) (seriousness criterion medically significant) and HEADACHE (headache) (seriousness criterion medically significant). At the time of the report, HYPERHIDROSIS (sweaty), NASOPHARYNGITIS (cold) and HEADACHE (headache) was resolving and PYREXIA (Feverish) and HEADACHE (Headache dull) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient felt really hot and sweaty for one minute and freezing the next after vaccination. Patient could not move her arm and had a really disturbed sleep. Headache was still ongoing and continued to feel really fatigued. Treatment included cold compress on arm and paracetamol. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment: This case concerns a 51-year-old female patient, with no medical history, who experienced the serious unexpected events of Hyperhidrosis, Nasopharyngitis, Headache, Pyrexia and Headache. The events of Pyrexia and Headache occurred the same day after the third dose of mRNA-1273 vaccine while the events of Hyperhidrosis, Nasopharyngitis, and Headache occurred after the third dose of mRNA-1273 vaccine. (The events start date not provided). The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.; Sender''s Comments: This case concerns a 51-year-old female patient, with no medical history, who experienced the serious unexpected events of Hyperhidrosis, Nasopharyngitis, Headache, Pyrexia and Headache. The events of Pyrexia and Headache occurred the same day after the third dose of mRNA-1273 vaccine while the events of Hyperhidrosis, Nasopharyngitis, and Headache occurred after the third dose of mRNA-1273 vaccine. (The events start date not provided). The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.


VAERS ID: 1915120 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004737 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Injection site warmth, 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: PFIZER BIONTECH COVID-19 VACCINE; PARACETAMOL; VOLTAROL [DICLOFENAC SODIUM]
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: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Generalised joint pains; Fever; Chills; Injection site warmth; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26235409) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (Generalised joint pains), PYREXIA (Fever), CHILLS (Chills) and INJECTION SITE WARMTH (Injection site warmth) in a 69-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna Intramuscular Injection) (batch no. 3004737) for an unknown indication. No medical history was provided by the reporter. Concomitant products included DICLOFENAC SODIUM (VOLTAROL [DICLOFENAC SODIUM]) from 10-Jan-1995 to an unknown date for Arthritis, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination, PARACETAMOL from 10-Mar-1993 to an unknown date for Osteoarthritis. On 21-Nov-2021, the patient received third dose of mRNA-1273 (COVID-19 Vaccine Moderna Intramuscular Injection) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced INJECTION SITE WARMTH (Injection site warmth) (seriousness criterion medically significant). On 22-Nov-2021, the patient experienced ARTHRALGIA (Generalised joint pains) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). At the time of the report, ARTHRALGIA (Generalised joint pains), PYREXIA (Fever), CHILLS (Chills) and INJECTION SITE WARMTH (Injection site warmth) 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 (COVID-19 Vaccine Moderna Intramuscular Injection) (Unknown) was unknown. 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. Treatment medication details not provided. Company Comment: This case concerns a 69 year old female patient with no relevant medical history, who experienced the serious unexpected events of injection site warmth, arthralgia, pyrexia and chills. The event injection site warmth occurred on the same day after the third dose of mRNA-1273 vaccine. The events arthralgia, pyrexia and chills occurred one 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 69 year old female patient with no relevant medical history, who experienced the serious unexpected events of injection site warmth, arthralgia, pyrexia and chills. The event injection site warmth occurred on the same day after the third dose of mRNA-1273 vaccine. The events arthralgia, pyrexia and chills occurred one 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: 1915122 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, 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: COVID-19 VACCINE ASTRAZENECA; RAMIPRIL
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data: Test Date: 20211025; 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; Chills; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26235475) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (High temperature) and CHILLS (Chills) in a 52-year-old female patient 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 COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) and RAMIPRIL for an unknown indication. On 21-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). At the time of the report, PYREXIA (High temperature) and CHILLS (Chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-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. Treatment information was not provided. Patient last menstrual period date was 25-OCT-2021. Patient has not had symptoms associated with COVID-19. Patient was not pregnant and not currently breastfeeding. 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 52-year-old, female patient with vaccination history of receiving another brand of Covid-19 vaccine as primary dose (Covid-19 vaccine AstraZeneca), who experienced the unexpected serious events of chills and pyrexia. The events chills and pyrexia occurred 1 day after the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The vaccination history of receiving another brand of Covid-19 vaccine as primary dose (Covid-19 vaccine AstraZeneca) remain confounder. 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 52-year-old, female patient with vaccination history of receiving another brand of Covid-19 vaccine as primary dose (Covid-19 vaccine AstraZeneca), who experienced the unexpected serious events of chills and pyrexia. The events chills and pyrexia occurred 1 day after the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The vaccination history of receiving another brand of Covid-19 vaccine as primary dose (Covid-19 vaccine AstraZeneca) remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1915123 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Pain, Peripheral swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Redness; Swelling arm; Ache; Throbbing pain; This case was received (Reference number: GB-MHRA-ADR 26235504) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PERIPHERAL SWELLING (Swelling arm), PAIN (Ache) and PAIN (Throbbing pain) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 19-Mar-2021 to 22-May-2021 for an unknown indication. On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced ERYTHEMA (Redness) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant), PAIN (Ache) (seriousness criterion medically significant) and PAIN (Throbbing pain) (seriousness criterion medically significant). At the time of the report, ERYTHEMA (Redness), PERIPHERAL SWELLING (Swelling arm), PAIN (Ache) and PAIN (Throbbing pain) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test Patient was not tested positive for COVID-19 since had the vaccine Patient was not enrolled in clinical trial Treatment medication were not reported Company Comment: This case concerns a female patient, unknown age, with no relevant medical history, who experienced the serious, unexpected events of erythema, pain and peripheral swelling. The events occurred 1 day after third dose of mRNA 1273 vaccine. The patient had AstraZeneca Covid-19 vaccine in March and May, and had mRNA 1273 as booster dose. Patient experienced swelling of arm, redness, ache and throbbing pain, no treatment information given, events have not resolved as of time of report. The rechallenge is not applicable as there is no additional dose expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a female patient, unknown age, with no relevant medical history, who experienced the serious, unexpected events of erythema, pain and peripheral swelling. The events occurred 1 day after third dose of mRNA 1273 vaccine. The patient had AstraZeneca Covid-19 vaccine in March and May, and had mRNA 1273 as booster dose. Patient experienced swelling of arm, redness, ache and throbbing pain, no treatment information given, events have not resolved as of time of report. The rechallenge is not applicable as there is no additional dose expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.


VAERS ID: 1915132 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Diarrhoea, Heavy menstrual bleeding, Illness, Nausea, Pyrexia, SARS-CoV-2 test, Sudden hearing loss
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow), 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: COVID-19 VACCINE ASTRAZENECA
Current Illness: Coeliac disease
Preexisting Conditions: Medical History/Concurrent Conditions: Gluten free diet (Adhere to very strict gluten free diet since.); Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: sudden; sickness; abdominal cramps; Heavy periods; Diarrhoea; Nausea; Fever; This case was received via RA (Reference number: GB-MHRA-ADR 26236189) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SUDDEN HEARING LOSS (sudden), ILLNESS (sickness), ABDOMINAL PAIN (abdominal cramps), HEAVY MENSTRUAL BLEEDING (Heavy periods), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and PYREXIA (Fever) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...) and Gluten free diet (Adhere to very strict gluten free diet since.). Concurrent medical conditions included Coeliac disease since 2016. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 19-May-2021 to an unknown date for an unknown indication. On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 22-Nov-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Heavy periods) (seriousness criterion medically significant), DIARRHOEA (Diarrhoea) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced SUDDEN HEARING LOSS (sudden) (seriousness criterion medically significant), ILLNESS (sickness) (seriousness criterion medically significant) and ABDOMINAL PAIN (abdominal cramps) (seriousness criterion medically significant). At the time of the report, SUDDEN HEARING LOSS (sudden), ILLNESS (sickness), ABDOMINAL PAIN (abdominal cramps), HEAVY MENSTRUAL BLEEDING (Heavy periods), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and PYREXIA (Fever) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. The patient experienced sudden, unexpected, heavy period. Nausea, feeling faint and urgent bowel movements within one hour. Waves of severe abdominal cramps since. The patient usually had light, non-painful periods and have never experienced anything like this before. A fewhours of feeling normal then sickness etc returned. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. Patient''s last menstrual period date was on 22-Nov-2021. Patient was not pregnant, Patient was not currently breastfeeding. Company Comment : This case concerns a 29-years-old female patient, with a history of Coeliac disease, who experienced the serious unexpected events of PYREXIA, HEAVY MENSTRUAL BLEEDING, NAUSEA, DIARRHOEA, SUDDEN HEARING LOSS, ILLNESS and ABDOMINAL PAIN. The event PYREXIA occurred on the following day of the third dose of the mRNA-1273, the events HEAVY MENSTRUAL BLEEDING, NAUSEA and DIARRHOEA occurred two days after the third dose of the mRNA-1273 the events SUDDEN HEARING LOSS, ILLNESS and ABDOMINAL PAIN occurred after an unknown time interval after the third dose of the mRNA-1273. The rechallenge is not applicable since no information about further dosing has been disclosed. The history of Coeliac disease and concomitant COVID-19 VACCINE ASTRAZENECA remain as confounders. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 29-years-old female patient, with a history of Coeliac disease, who experienced the serious unexpected events of PYREXIA, HEAVY MENSTRUAL BLEEDING, NAUSEA, DIARRHOEA, SUDDEN HEARING LOSS, ILLNESS and ABDOMINAL PAIN. The event PYREXIA occurred on the following day of the third dose of the mRNA-1273, the events HEAVY MENSTRUAL BLEEDING, NAUSEA and DIARRHOEA occurred two days after the third dose of the mRNA-1273 the events SUDDEN HEARING LOSS, ILLNESS and ABDOMINAL PAIN occurred after an unknown time interval after the third dose of the mRNA-1273. The rechallenge is not applicable since no information about further dosing has been disclosed. The history of Coeliac disease and concomitant COVID-19 VACCINE ASTRAZENECA remain as confounders. The benefit-risk relationship of the mRNA-1273 is not affected by this report.


VAERS ID: 1915138 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Gingival pain, Lethargy, Maternal exposure during breast feeding, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gingival disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal exposures via breast milk (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
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: Maternal exposure during breast feeding; Sore gums; Lethargy; Aching joints; Fever; Leg pain; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26236669) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of GINGIVAL PAIN (Sore gums), LETHARGY (Lethargy), ARTHRALGIA (Aching joints), PYREXIA (Fever), PAIN IN EXTREMITY (Leg pain) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 35-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Breast feeding. On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced PAIN IN EXTREMITY (Leg pain) (seriousness criterion medically significant). On 22-Nov-2021, the patient experienced GINGIVAL PAIN (Sore gums) (seriousness criterion medically significant), LETHARGY (Lethargy) (seriousness criterion medically significant), ARTHRALGIA (Aching joints) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant). On 22-Nov-2021, PYREXIA (Fever) had resolved. At the time of the report, GINGIVAL PAIN (Sore gums) had not resolved, LETHARGY (Lethargy), ARTHRALGIA (Aching joints) and PAIN IN EXTREMITY (Leg pain) was resolving and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medications were reported. No concomitant medications were reported. It was reported bleeding & sore gums when previously no issues with gums. Patient had not tested positive for COVID-19 since having the vaccine and not enrolled in clinical trial. Company comment: This case concerns a 35-year-old, female patient with no reported relevant medical history, who experienced the unexpected serious events of gingival pain, lethargy, arthralgia, pain in extremity, and pyrexia. Maternal exposure during breast feeding is also reported in the case. The events of arthralgia and pyrexia are unexpected as they are retained as serious per the source document Authority reporting. The event pain in extremity occurred on the same day after the third dose (unknown dosage) of mRNA-1273. The events gingival pain, lethargy, arthralgia, and pyrexia occurred one day after vaccination date. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. 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 case concerns a 35-year-old, female patient with no reported relevant medical history, who experienced the unexpected serious events of gingival pain, lethargy, arthralgia, pain in extremity, and pyrexia. Maternal exposure during breast feeding is also reported in the case. The events of arthralgia and pyrexia are unexpected as they are retained as serious per the source document Authority reporting. The event pain in extremity occurred on the same day after the third dose (unknown dosage) of mRNA-1273. The events gingival pain, lethargy, arthralgia, and pyrexia occurred one day after vaccination date. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1915141 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNK / 3 - / -
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blood thromboplastin, Deep vein thrombosis, Fibrin D dimer, Platelet count, Prothrombin time, SARS-CoV-2 test, Ultrasound Doppler
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; RAMIPRIL
Current Illness: Nonsmoker
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Subdural haemorrhage; Swelling; Comments: Hypertension unsure if patient has had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: Thromboplastin Clotting Time; Result Unstructured Data: (Test Result:23.2,Unit:unknown,Normal Low:,Normal High:); Test Date: 20211123; Test Name: Fibrin D dimer; Result Unstructured Data: (Test Result:D-dimer was greater than 4000,Unit:unknown,Normal Low:,Normal High:); Test Date: 20211123; Test Name: Platelet count; Result Unstructured Data: (Test Result:no result,Unit:unknown,Normal Low:,Normal High:); Test Name: Prothrombin time; Result Unstructured Data: (Test Result:10.4,Unit:unknown,Normal Low:,Normal High:); Test Name: COVID-19 virus test; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:); Test Name: doppler ultrasound; Result Unstructured Data: (Test Result:partially occlusive thrombus extending from the mi,Unit:unknown,Normal Low:,Normal High:)
CDC Split Type: GBGLAXOSMITHKLINEGB202124

Write-up: This case was reported by a other health professional via regulatory authority and described the occurrence of dvt in a male patient who received Hepatitis A vaccine for prophylaxis. Co-suspect products included TOZINAMERAN (BIONTECH COVID-19 MRNA VACCINE) for prophylaxis. The patient''s past medical history included subdural haemorrhage. Previously administered products included HEPARIN and COVID-19 VACCINE ASTRAZENECA (on 02nd March 2021). Concurrent medical conditions included hypertension, swelling and non-smoker. Additional patient notes included Hypertension unsure if patient has had symptoms associated with COVID-19. Concomitant products included amlodipine and ramipril. On an unknown date, the patient received Hepatitis A vaccine (unknown). On 19th November 2021, the patient received the 3rd dose of BIONTECH COVID-19 MRNA VACCINE (unknown). On 21st November 2021, unknown after receiving Hepatitis A vaccine, the patient experienced deep vein thrombosis leg (serious criteria GSK medically significant). On an unknown date, unknown after receiving Hepatitis A vaccine, the patient experienced dvt (serious criteria GSK medically significant). On an unknown date, the outcome of the dvt was unknown and the outcome of the deep vein thrombosis leg was not recovered/not resolved. It was unknown if the reporter considered the dvt and deep vein thrombosis leg to be related to Hepatitis A vaccine. Additional details were provided as follows: The age at vaccination was unknown. On 21st November 2021, 2 days after receiving BIONTECH COVID-19 MRNA VACCINE, the patient experienced deep vein thrombosis leg. In November 2021, less than a week after receiving BIONTECH COVID-19 MRNA VACCINE, the patient experienced dvt. On an unknown date, patient''s covid 19 virus test was performed and result was reported as negative. On an unknown date, patient''s Activated Partial Thromboplastin Clotting Time and Prothrombin time were checked and result was reported as 23.2 and 10.4, respectively.. On 23rd November 2021, patient''s Fibrin D dimer was measured and result was reported as D-dimer was greater than 4000. On 23rd November 2021, the patient''s platelet count were measured and result was unknown. On an unknown date, patient''s doppler ultrasound results into a partially occlusive thrombus extending from the mid-portion of the right superficial femoral vein to popliteal vein. It was unknown if the reporter considered the dvt and deep vein thrombosis leg to be related to BIONTECH COVID-19 MRNA VACCINE. Initial information received from other health professional via regulatory authority on 24th November 2021: dvt and deep vein thrombosis leg. Case narrative : Patient was referred by his GP due to a 3 day history of atraumatic pain and swelling on the inner lateral aspect of his right thigh. His symptoms developed after having the COVID Booster (Pfizer) vaccine. His mother also developed a DVT post COVID Booster (Pfizer) vaccine. He has a D-dimer result of 7,970 and right leg doppler ultrasound revealed a partially occlusive thrombus extending from the mid-portion of the right superficial femoral vein to popliteal vein. He was commenced on Apixaban tablet. Patient has not tested positive for COVID-19 since having the vaccine Unsure if patient is enrolled in clinical trial Reaction Does your report relate to possible blood clots or low platelet counts If yes, we will ask you additional questions at the end of this report: "Yes" Suspect Reactions Please provide details of any relevant investigations or tests conducted: "Doppler Ultrasound right leg" Thromboembolic event / Thombocytopenia additional questions Please specify the details of the event: "Referred by his GP due to pain on th einner lateral aspect of right thigh 1 day post COVID Booster vaccine (Pfizer)." How was this diagnosed: "He had a doppler ultrasound of his right leg which showed a partially occlusive thrombus extending from the mid-portion of the right superficial femoral vein to popliteal vein" What was the date of diagnosis: "23/11/21", Was the platelet count less than 150 109/L: "No", What date was the platelet count measured: "23/11/21", What date was the D-dimer measured: "23/11/21", Were anti-PF4 antibodies identified: "Unknown" Is there any additional medical history, not already provided, that relates to previous venous or arterial thromboses: "Hypertension" Has the patient had any previous reactions to medications, especially heparin or anticoagulants: "NKDA" Does the patient have history of, or current, malignancy: "No", Does the patient have a history of, or concurrent, intracranial malignancy: "No", Does the patient have concurrent or recent intracranial infections: "No", Has the patient had recent surgical or medical interventions to the central nervous system (including lumbar puncture: "No", Has the patient had a recent trauma/head injury: "No", PT: "10.4" Activated Partial Thromboplastin Clotting Time (aPTT): "23.2"


VAERS ID: 1918511 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cold sweat, Dizziness, Hyperhidrosis, Immunisation, Palpitations, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (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:
Preexisting Conditions: Medical History/Concurrent Conditions: Gilbert''s syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101628972

Write-up: Booster; Heart pounding; Felt as she was going to faint; Hot and cold sweats; Hot and cold sweats; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority; report number is GB-MHRA-WEBCOVID-202111210403441360-JGEDM. Safety Report Unique Identifier GB-MHRA-ADR 26232103. A 59-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration, on 21Nov2021 (Lot Number: FH4751), at the age of 59-years-old, as 3rd single dose (booster), for COVID-19 immunisation. Medical history included Gilbert''s syndrome. Historical vaccine included first dose and second of BNT162B2 on unknown dates, for COVID-19 immunisation. The patient''s concomitant medications were not reported. The patient has not had symptoms associated with COVID-19, had not tested positive for COVID-19 since having the vaccine, was not enrolled in a clinical trial. The reported event was heart pounding on 21Nov2021 with outcome of recovering, serious due to disability. It was reported that the patient had to sit down during work that evening, she felt like she was going to faint, she had hot and cold sweats and her heart was nearly out her chest. A COVID-19 test was negative on 21Nov2021. The patient was recovering from heart pounding while the outcome feeling like going to faint and hot and cold sweats was not specified. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1918525 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-11-21
   Days after vaccination:275
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8713 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 MRNA VACCINE BNT162B2; FEXOFENADINE.
Current Illness: Asthma (Mild Asthma); Clinical trial participant; Hay fever (Allergies -hay fever and possibly dust?); Interstitial lung disease; Meniere''s disease (Not currently active other than isolated attacks (2-3 per yr)).
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MALAISE (Generally unwell), MYALGIA (Muscle pain), DIZZINESS (Dizziness), ARTHRALGIA (Pain joint), HEADACHE (Headache) and FATIGUE (Fatigue) in a 65-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. Co-suspect product included non-company product TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) for an unknown indication.Concurrent medical conditions included Interstitial lung disease, Hay fever (Allergies -hay fever and possibly dust?), Asthma (Mild Asthma), Clinical trial participant and Meniere''s disease (Not currently active other than isolated attacks (2-3 per yr)). Concomitant products included TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) from 05-May-2021 to an unknown date and FEXOFENADINE for an unknown indication. On 19-Feb-2021, the patient received first dose of TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) (unknown route) Dose 1. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant), ARTHRALGIA (Pain joint) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (Generally unwell) (seriousness criterion medically significant) and MYALGIA (Muscle pain) (seriousness criterion medically significant). On 22-Nov-2021, ARTHRALGIA (Pain joint) and HEADACHE (Headache) had resolved. At the time of the report, MALAISE (Generally unwell), MYALGIA (Muscle pain), DIZZINESS (Dizziness) and FATIGUE (Fatigue) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment information was not provided. Patient had pain at injection site followed by stiffness of arm. Following morning generally unwell and increasing joint and muscle pain, mild fatigue to begin with increasing to moderate ( stayed in bed for 24 hours) Mild dizziness from day 2 morning. Still ‘lightheaded'' day three with mild fatigue but other symptoms now resolved. Patient has not tested positive for COVID-19 since having the vaccine Patient was Clinical trial participant. Study details: COVID symptom study. Company comment- This case concerns a 65 year old female patient with no relevant medical history, who experienced the serious unexpected events of malaise, myalgia, dizziness, arthralgia, headache and fatigue. The events occurred approximately 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 65 year old female patient with no relevant medical history, who experienced the serious unexpected events of malaise, myalgia, dizziness, arthralgia, headache and fatigue. The events occurred approximately 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: 1918541 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   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: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Headache, Injection site pain, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), 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
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Diarrhoea; Stomach pain; Chills; Injection site pain; Headache; Fatigue; Generalised muscle aches; This case was received via RA (Reference number: GB-MHRA-ADR 26234824) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea), ABDOMINAL PAIN UPPER (Stomach pain), CHILLS (Chills), INJECTION SITE PAIN (Injection site pain), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (Generalised muscle aches) in a 54-year-old female patient 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) for COVID-19 vaccination. On 21-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and MYALGIA (Generalised muscle aches) (seriousness criterion medically significant). On 22-Nov-2021, the patient experienced DIARRHOEA (Diarrhoea) (seriousness criterion medically significant). At the time of the report, DIARRHOEA (Diarrhoea), ABDOMINAL PAIN UPPER (Stomach pain), CHILLS (Chills), INJECTION SITE PAIN (Injection site pain), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (Generalised muscle aches) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient had no symptoms of COVID-19 and had not tested positive for COVID-19 since having the vaccine No treatment information was provided by the reporter. Company comment- This case concerns a 54-year-old female patient, with no relevant medical history, who experienced the serious unexpected events of Diarrhoea, Abdominal pain upper, Chills, Injection site pain, Headache, Fatigue and Myalgia. The events of Abdominal pain upper, Chills, Injection site pain, Headache, Fatigue and Myalgia occurred the same day after the third dose of mRNA-1273 vaccine while the event of Diarrhoea occurred 1 day after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.; Sender''s Comments: This case concerns a 54-year-old female patient, with no relevant medical history, who experienced the serious unexpected events of Diarrhoea, Abdominal pain upper, Chills, Injection site pain, Headache, Fatigue and Myalgia. The events of Abdominal pain upper, Chills, Injection site pain, Headache, Fatigue and Myalgia occurred the same day after the third dose of mRNA-1273 vaccine while the event of Diarrhoea occurred 1 day after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.


VAERS ID: 1918552 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   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: Angioedema, Arthralgia, Chills, Headache, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), 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? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Frontal headache; Chills; Aching joints; Hives giant; This case was received via regulatory authority RA (Reference number: GB-MHRA-ADR 26236825) 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 (Frontal headache), CHILLS (Chills), ARTHRALGIA (Aching joints) and ANGIOEDEMA (Hives giant) in a 59-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 26-Sep-2021 to an unknown date 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 21-Nov-2021, the patient experienced HEADACHE (Frontal headache) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), ARTHRALGIA (Aching joints) (seriousness criterion medically significant) and ANGIOEDEMA (Hives giant) (seriousness criterion medically significant). On 21-Nov-2021, CHILLS (Chills) was resolving. On 22-Nov-2021, ARTHRALGIA (Aching joints) had resolved. At the time of the report, HEADACHE (Frontal headache) and ANGIOEDEMA (Hives giant) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No Treatment medications were provided. Company Comment: This is a regulatory authority case concerning a 59-year-old female patient with no relevant medical history reported, who experienced serious, unexpected events of Headache, Chills, Arthralgia and Angioedema. Headache, Chills and Arthralgia are unexpected as they are retained as serious per the source document Authority reporting. The events occurred approximately 1 day after the third dose of mRNA-1273 vaccine. 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 59-year-old female patient with no relevant medical history reported, who experienced serious, unexpected events of Headache, Chills, Arthralgia and Angioedema. Headache, Chills and Arthralgia are unexpected as they are retained as serious per the source document Authority reporting. The events occurred approximately 1 day after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1918558 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004632 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Confusional state, Headache, Lymphadenopathy, Lymphoedema, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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; METFORMIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Lymphedema; Glands swollen; Muscle pain; Confusion; Headache; Nausea; Fever; This regulatory authority case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (Lymphedema), LYMPHADENOPATHY (Glands swollen), MYALGIA (Muscle pain), PYREXIA (Fever), CONFUSIONAL STATE (Confusion), HEADACHE (Headache) and NAUSEA (Nausea) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004632) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 16-Mar-2020 to 22-Mar-2020. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 25-Feb-2021 to an unknown date for COVID-19 vaccination, METFORMIN from 20-Mar-2021 to an unknown date for Diabetes, INFLUENZA VACCINE (INFLUENZA VIRUS) from 11-Sep-2021 to an unknown date for Flu vaccination. On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 22-Nov-2021, the patient experienced LYMPHOEDEMA (Lymphedema) (seriousness criterion medically significant), LYMPHADENOPATHY (Glands swollen) (seriousness criterion medically significant), MYALGIA (Muscle pain) (seriousness criterion medically significant), CONFUSIONAL STATE (Confusion) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, LYMPHOEDEMA (Lymphedema), LYMPHADENOPATHY (Glands swollen), MYALGIA (Muscle pain) and PYREXIA (Fever) was resolving and CONFUSIONAL STATE (Confusion), HEADACHE (Headache) and NAUSEA (Nausea) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medication were not reported. Patient had not tested positive for COVID-19 since having the vaccine. Company Comment: This case concerns a 28-year-old, female patient with relevant medical history of suspected COVID-19, who experienced the unexpected events of lymphoedema, lymphadenopathy, myalgia, pyrexia, confusional state, headache and nausea. The events occurred 1 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, 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 28-year-old, female patient with relevant medical history of suspected COVID-19, who experienced the unexpected events of lymphoedema, lymphadenopathy, myalgia, pyrexia, confusional state, headache and nausea. The events occurred 1 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, however there was no information in the source document supporting that the events meet the criteria to be medically significant.


VAERS ID: 1918566 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   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: Dizziness, Nausea, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), 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: Comments: No medical history was provided by reporter.
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: Dizziness; Fever; Nausea; Ache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26237504) 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 66-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No medical history was provided by reporter. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 06-Feb-2021 to an unknown date and INFLUENZA VACCINE (INFLUENZA VIRUS) from 14-Oct-2021 to an unknown date for an unknown indication. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. 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 concomitant medication was reported. Treatment information was not provided by reporter. It was reported patient experienced came on very suddenly like hitting a brick wall. This is a regulatory authority case concerning a 66-year-old, female patient with vaccine history of receiving another brand of Covid-19 vaccine (Covid-19 vaccine AstraZeneca), who experienced the unexpected serious events of pyrexia, nausea, pain and dizziness. The events pyrexia, nausea, pain and dizziness 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 66-year-old, female patient with vaccine history of receiving another brand of Covid-19 vaccine (Covid-19 vaccine AstraZeneca), who experienced the unexpected serious events of pyrexia, nausea, pain and dizziness. The events pyrexia, nausea, pain and dizziness 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: 1918567 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   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: Fatigue, Migraine with aura, Nausea, Photopsia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Retinal disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; METOPROLOL
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: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: nauseous; vomiting; flashing lights; Nausea; Vomited; Migraine aura; Fatigue; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26237544) 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 NAUSEA (nauseous), VOMITING (vomiting), PHOTOPSIA (flashing lights), NAUSEA (Nausea), VOMITING (Vomited), MIGRAINE WITH AURA (Migraine aura) and FATIGUE (Fatigue) in a 37-year-old female patient 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 METOPROLOL from 01-Jun-2012 to an unknown date for Atrial fibrillation, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 01-Apr-2021 to an unknown date for an unknown indication. On 21-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), VOMITING (Vomited) (seriousness criterion medically significant), MIGRAINE WITH AURA (Migraine aura) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (nauseous) (seriousness criterion medically significant), VOMITING (vomiting) (seriousness criterion medically significant) and PHOTOPSIA (flashing lights) (seriousness criterion medically significant). On 21-Nov-2021, MIGRAINE WITH AURA (Migraine aura) had resolved. On 23-Nov-2021, VOMITING (Vomited) and FATIGUE (Fatigue) had resolved. At the time of the report, NAUSEA (nauseous), VOMITING (vomiting), PHOTOPSIA (flashing lights) and NAUSEA (Nausea) 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. Treatment medication were not reported. Patient last menstrual period date was 01-NOV-2021. Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding. Immediately after the vaccine patient started seeing flashing lights similar to migraine aura. She was also very nauseous. Later that evening she had extreme fatigue and vomiting. The following day she had nausea and fatigue. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. Company comment: This regulatory authority case concerns a 37-year-old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Nausea, Vomiting, Photopsia, Migraine with aura and Fatigue after mRNA- 1273 Moderna vaccine, third dose of the vaccination schedule (dosage unknown). The patient received previous vaccination with COVID-19 Vaccine AstraZeneca. The events occurred on the day after the dose of mRNA- 1273 vaccine. Immediately after vaccination the patient experienced photopsias, similar to migraine aura, and nausea. Later that evening she experienced fatigue and vomiting. Nausea, Fatigue and Vomiting are compatible with the known safety profile of the vaccine, but since they were reported with a serious outcome they are considered unexpected. The rechallenge is 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 regulatory authority case concerns a 37-year-old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Nausea, Vomiting, Photopsia, Migraine with aura and Fatigue after mRNA- 1273 Moderna vaccine, third dose of the vaccination schedule (dosage unknown). The patient received previous vaccination with COVID-19 Vaccine AstraZeneca. The events occurred on the day after the dose of mRNA- 1273 vaccine. Immediately after vaccination the patient experienced photopsias, similar to migraine aura, and nausea. Later that evening she experienced fatigue and vomiting. Nausea, Fatigue and Vomiting are compatible with the known safety profile of the vaccine, but since they were reported with a serious outcome they are considered unexpected. The rechallenge is 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: 1918568 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   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: Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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
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: Extremely swollen arm; Swollen arm; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26237482) 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 PERIPHERAL SWELLING (Extremely swollen arm) and PERIPHERAL SWELLING (Swollen arm) in a 52-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for COVID-19 vaccination. No medical history was provided. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 19-Mar-2021 to an unknown date for Vaccination. On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant). On an unknown date, the patient experienced PERIPHERAL SWELLING (Extremely swollen arm) (seriousness criterion medically significant). At the time of the report, PERIPHERAL SWELLING (Extremely swollen arm) and PERIPHERAL SWELLING (Swollen arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Company comment This regulatory authority case concerns a 52-year-old, female patient with no reported relevant medical history, who experienced the unexpected serious events of peripheral swelling (reported as "Extremely swollen arm" and "Swollen arm"). The event "swollen arm" occurred the day after the dose of mRNA-1273, considered as third dose of her COVID-19 vaccine schedule. The patient received previously AstraZeneca COVID-19 vaccine. 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 and coding assessed as per Regulatory Authority reporting.; Sender''s Comments: This regulatory authority case concerns a 52-year-old, female patient with no reported relevant medical history, who experienced the unexpected serious events of peripheral swelling (reported as "Extremely swollen arm" and "Swollen arm"). The event "swollen arm" occurred the day after the dose of mRNA-1273, considered as third dose of her COVID-19 vaccine schedule. The patient received previously AstraZeneca COVID-19 vaccine. 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 and coding assessed as per Regulatory Authority reporting.


VAERS ID: 1918570 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   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: Illness, Pain, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211114; 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: Aching; Fainting; Sickness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26237700) 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 (Aching), ILLNESS (Sickness) and SYNCOPE (Fainting) in a 63-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 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced ILLNESS (Sickness) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (Aching) (seriousness criterion medically significant) and SYNCOPE (Fainting) (seriousness criterion medically significant). On 22-Nov-2021, ILLNESS (Sickness) had resolved. At the time of the report, PAIN (Aching) and SYNCOPE (Fainting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-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. Treatment information was not provided. Patient had not had any symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Company Comment: This case concerns a 63-year-old female patient with no relevant medical history provided who experienced serious unexpected events of Illness, Pain and Syncope. The event Illness occurred one day after the third dose of mRNA-1273. The precise temporal relationship for the events Pain and Syncope cannot be determined, having in mind that the start date of the reported events was not provided. The rechallenge was reported as unknown and was retained as such. Very limited information regarding clinical course of the events has been provided at this time. 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 63-year-old female patient with no relevant medical history provided who experienced serious unexpected events of Illness, Pain and Syncope. The event Illness occurred one day after the third dose of mRNA-1273. The precise temporal relationship for the events Pain and Syncope cannot be determined, having in mind that the start date of the reported events was not provided. The rechallenge was reported as unknown and was retained as such. Very limited information regarding clinical course of the events has been provided at this time. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1918581 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   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: Fatigue, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS
Current Illness: Asthma (asthma inhaler); Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: positive for COVID-19
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fatigue extreme; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26237921) 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 FATIGUE (Fatigue extreme) in a 57-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna Intramuscular Injection) for an unknown indication. The patient''s past medical history included Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)) since an unknown date. Concurrent medical conditions included Asthma (asthma inhaler). Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 12-Nov-2021 to an unknown date for Asthma. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID-19 Vaccine Moderna Intramuscular Injection) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced FATIGUE (Fatigue extreme) (seriousness criterion medically significant). At the time of the report, FATIGUE (Fatigue extreme) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: yes - positive covid-19 test (Positive) positive for COVID-19. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna Intramuscular Injection) (Unknown) was unknown. Treatment information was not provided Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. Company Comment: This case concerns a 57-year-old female patient, with no relevant medical history reported, who experienced the serious unexpected event of fatigue. The event 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 concomitant INFLUENZA VACCINE remains a confounder. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 57-year-old female patient, with no relevant medical history reported, who experienced the serious unexpected event of fatigue. The event 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 concomitant INFLUENZA VACCINE remains a confounder. The benefit-risk relationship of the mRNA-1273 is not affected by this report.


VAERS ID: 1918584 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-21
   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: Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: Swollen arm; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26238159) on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021. Based on the current case data, this case has been classified as invalid. This regulatory authority case was reported by a consumer and describes the occurrence of in a patient of an unknown age and gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. On 19-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. No concomitant drug was provided. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. No treatment drug was provided. Company comment This is a regulatory authority case concerning a patient of an unknown age and gender with no relevant medical history, who experienced the unexpected serious event of peripheral swelling (swollen arm). The event peripheral swelling (swollen arm) 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 patient of an unknown age and gender with no relevant medical history, who experienced the unexpected serious event of peripheral swelling (swollen arm). The event peripheral swelling (swollen arm) 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: 1918609 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   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: Confusional state, Fatigue, Headache, Myalgia, SARS-CoV-2 test, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; 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 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 CONFUSIONAL STATE (Confusion), FATIGUE (Tiredness), VOMITING (Vomiting), HEADACHE (Headache) and MYALGIA (Muscle ache) in a 44-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). On an unknown date, the patient experienced CONFUSIONAL STATE (Confusion) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 22-Nov-2021, VOMITING (Vomiting) had resolved. At the time of the report, CONFUSIONAL STATE (Confusion) and FATIGUE (Tiredness) had not resolved and HEADACHE (Headache) and MYALGIA (Muscle ache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-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. Treatment information was not provided.Concomitant medication were not given.Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient did not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Patient had hot and cold sweats, confusion and extreme tiredness. Other relevant investigations or tests reported as lateral flows taken daily.Company comment: This is a regulatory authority case concerning a 44-year-old, female patient with no relevant medical history, who experienced the unexpected events of Confusional state, Fatigue, vomiting, headache, Myalgia. The events occurred approximately 1 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 44-year-old, female patient with no relevant medical history, who experienced the unexpected events of Confusional state, Fatigue, vomiting, headache, Myalgia. The events occurred approximately 1 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: 1918611 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   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: Headache, Muscle spasms, Night sweats, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: muscle spasm; hot sweats; Vomiting; Headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26239973) 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 (muscle spasm), NIGHT SWEATS (hot sweats), VOMITING (Vomiting) and HEADACHE (Headache) in a 48-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced MUSCLE SPASMS (muscle spasm) (seriousness criterion medically significant) and NIGHT SWEATS (hot sweats) (seriousness criterion medically significant). On 22-Nov-2021, VOMITING (Vomiting) had resolved. At the time of the report, MUSCLE SPASMS (muscle spasm) and NIGHT SWEATS (hot sweats) had not resolved and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Nov-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient experienced Hot sweats, Aching muscles, Muscle spasm. The lab test COVID lateral flows was done. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. Company comment: This case concerns a 48-year-old male patient with no medical history, who experienced the serious unexpected events of Muscle spasm, Night sweats, Vomiting and Headache. The events of Muscle spasm, and Night sweats occurred on an unknown date after the third dose of mRNA-1273 vaccine while the events of Vomiting and Headache 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.; Sender''s Comments: This case concerns a 48-year-old male patient with no medical history, who experienced the serious unexpected events of Muscle spasm, Night sweats, Vomiting and Headache. The events of Muscle spasm, and Night sweats occurred on an unknown date after the third dose of mRNA-1273 vaccine while the events of Vomiting and Headache 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: 1918612 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   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: Abdominal pain upper, Malaise, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA.
Current Illness: Endometriosis; 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: Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Stomach pain; Feeling sick; 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 MALAISE (Feeling sick) and ABDOMINAL PAIN UPPER (Stomach pain) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication.Concurrent medical conditions included Endometriosis and 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 26-Feb-2021 to an unknown date. for an unknown indication. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, the patient experienced MALAISE (Feeling sick) (seriousness criterion medically significant). On 22-Nov-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) (seriousness criterion medically significant). At the time of the report, MALAISE (Feeling sick) and ABDOMINAL PAIN UPPER (Stomach pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) 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. Patient took COVID-19 VACCINE MODERNA dose 3b and 3c on 20 Nov 2021. Company comment: This case concerns a female patient of an unknown age with a relevant medical history of Endometriosis and Immunodeficiency, who experienced the serious unexpected events of Malaise and Upper abdominal pain. The events of Malaise occurred one day after the third dose of mRNA-1273 vaccine while the events of Abdominal pain occurred 2 days after the third dose of mRNA-1273 vaccine. The medical history of Endometriosis and Immunodeficiency are confounders. 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.; Sender''s Comments: This case concerns a female patient of an unknown age with a relevant medical history of Endometriosis and Immunodeficiency, who experienced the serious unexpected events of Malaise and Upper abdominal pain. The events of Malaise occurred one day after the third dose of mRNA-1273 vaccine while the events of Abdominal pain occurred 2 days after the third dose of mRNA-1273 vaccine. The medical history of Endometriosis and Immunodeficiency are confounders. 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: 1918614 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-21
   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: Amblyopia, Eye pain, Headache, SARS-CoV-2 test
SMQs:, Glaucoma (broad), Optic nerve 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: AMLODIPINE; INDAPAMIDE; INFLUENZA VIRUS; RAMIPRIL
Current Illness:
Preexisting Conditions: Comments: No medical history was reported.
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: Lazy eye; Eye pain; Headache; This case was received via regulatory (Reference number: GB-MHRA-ADR 26240125) 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 EYE PAIN (Eye pain), AMBLYOPIA (Lazy eye) and HEADACHE (Headache) in a 64-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No medical history was reported. Concomitant products included RAMIPRIL for Hypertension, AMLODIPINE, INDAPAMIDE and INFLUENZA VACCINE (INFLUENZA VIRUS) from 13-Oct-2021 to an unknown date 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 21-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 22-Nov-2021, the patient experienced EYE PAIN (Eye pain) (seriousness criterion medically significant). On 23-Nov-2021, the patient experienced AMBLYOPIA (Lazy eye) (seriousness criterion medically significant). At the time of the report, EYE PAIN (Eye pain) and AMBLYOPIA (Lazy eye) had not resolved and HEADACHE (Headache) 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. It was reported that Initial headache focused behind eyes, Discomfort felt like pressure behind eyes wanting to keep eyes closed or rub with hands, Following day left eye more comfortable but right eye uncomfortable and will not focus correctly. Patient has not had symptoms associated with COVID-19 and not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. Treatment medications included paracetamol and ibuprofen taken to try and ease symptoms. Company Comment: This case concerns a 64-year-old, male patient with no medical history, who experienced the unexpected events of headache, eye pain and amblyopia. The events occurred approximately from 2-4 days after the third dose of mRNA-1273. It was reported that patient had initial headache focused behind eyes, discomfort which felt like pressure behind eyes and on the following day left eye was more comfortable but right eye was uncomfortable and would not focus correctly. The rechallenge was not applicable as events occurred after third dose and no further dosing was reported or planned, based on information provided. 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 64-year-old, male patient with no medical history, who experienced the unexpected events of headache, eye pain and amblyopia. The events occurred approximately from 2-4 days after the third dose of mRNA-1273. It was reported that patient had initial headache focused behind eyes, discomfort which felt like pressure behind eyes and on the following day left eye was more comfortable but right eye was uncomfortable and would not focus correctly. The rechallenge was not applicable as events occurred after third dose and no further dosing was reported or planned, based on information provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1918617 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   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: Back pain, Pain
SMQs:, Retroperitoneal fibrosis (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: Back pain (Patient had occasional lower back pain which lasts for 1-2 weeks.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Pain; Acute back pain; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26240137) 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 BACK PAIN (Acute back pain) in a 69-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. The patient''s past medical history included Back pain (Patient had occasional lower back pain which lasts for 1-2 weeks.). On 21-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced BACK PAIN (Acute back pain) (seriousness criterion medically significant). At the time of the report, BACK PAIN (Acute back pain) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant medications were not reported. It was reported that the patient had similar lower back pain associated with mild trauma (bending quickly/twisting)previously. But she was started to experience severe acute lower back pain and sciatica just 90 minutes after receiving the vaccination. The pain was largely resolved within 48 hours and she also had flu-like symptoms for 48 hours. Patient reported that the back pain came on suddenly and certain that it was initiated through the vaccination and resolved unusually and quickly. She had no any other COVID-19 related symptoms or possible inflammation of the heart. Patient was not enrolled in clinical trial and not had an COVID-19 test also. Treatment information was not provided by the reporter. Company comment: This is a regulatory authority case concerning a 69-year-old, male patient with relevant medical history of lower back pain, who experienced the unexpected serious events of back pain and pain. The event back pain occurred 90 minutes after the third dose of mRNA-1273 vaccine and it was accompanied by sciatica while the event pain occurrence unknown with respect to the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The medical history of lower back pain and the patient''s age remains confounders. 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 69-year-old, male patient with relevant medical history of lower back pain, who experienced the unexpected serious events of back pain and pain. The event back pain occurred 90 minutes after the third dose of mRNA-1273 vaccine and it was accompanied by sciatica while the event pain occurrence unknown with respect to the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The medical history of lower back pain and the patient''s age remains confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1918622 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Lymphadenopathy, 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:
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 LYMPHADENOPATHY (Swollen lymph nodes) and PYREXIA (Fever) in a 31-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 20-Nov-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 22-Nov-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant). On 22-Nov-2021, PYREXIA (Fever) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant medications were not reported .Treatment information was not provided. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment: This case concerns a 31-year-old male patient, with no relevant medical history reported, who experienced the serious unexpected events of PYREXIA and LYMPHADENOPATHY. The event pyrexia occurred on the following day of the dose of the mRNA-1273, and the event lymphadenopathy occurred two days after the dose of mRNA-1273. The rechallenge was not applicable as there is no information that states vaccination dose number, there is only one dose reported. The benefit-risk relationship of the mRNA-1273 is not affected by this report. Sender''s Comments: This case concerns a 31-year-old male patient, with no relevant medical history reported, who experienced the serious unexpected events of PYREXIA and LYMPHADENOPATHY. The event pyrexia occurred on the following day of the dose of the mRNA-1273, and the event lymphadenopathy occurred two days after the dose of mRNA-1273. The rechallenge was not applicable as there is no information that states vaccination dose number, there is only one dose reported. The benefit-risk relationship of the mRNA-1273 is not affected by this report.


VAERS ID: 1918624 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   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 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal discomfort, Arthralgia, Headache, Muscle fatigue, Pyrexia, Rash
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Rash; Upset stomach; Aching joints; Headache; Muscle fatigue; Fever; This case was received via RA (Reference number: GB-MHRA-ADR 26240208) 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), MUSCLE FATIGUE (Muscle fatigue), PYREXIA (Fever), RASH (Rash), ARTHRALGIA (Aching joints) and ABDOMINAL DISCOMFORT (Upset stomach) in a 56-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 Suspected COVID-19 from 26-Mar-2020 to 10-Apr-2020 and Clinical trial participant. On 21-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), MUSCLE FATIGUE (Muscle fatigue) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and ARTHRALGIA (Aching joints) (seriousness criterion medically significant). On 22-Nov-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant) and ABDOMINAL DISCOMFORT (Upset stomach) (seriousness criterion medically significant). On 22-Nov-2021, HEADACHE (Headache) was resolving. At the time of the report, MUSCLE FATIGUE (Muscle fatigue), RASH (Rash), ARTHRALGIA (Aching joints) and ABDOMINAL DISCOMFORT (Upset stomach) had not resolved and PYREXIA (Fever) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown Route) was unknown. Concomitant medications were not provided. Patient has not tested positive for COVID-19 since having the vaccine. Patient was clinical trial participant and study details included screening tests January 2022. Treatment information was not provided. Company comment: This regulatory authority case concerns a 56-year-old female patient with no details on relevant medical history, who experienced the unexpected serious (medically significant) events of Muscle Fatigue, Abdominal discomfort, Headache, Rash and Arthralgia after mRNA- 1273 Moderna vaccine. The events Headache, Muscle fatigue, Pyrexia and Arthralgia occurred on they day after the third dose of mRNA- 1273 vaccine and Rash and Abdominal discomfort occurred approximately one day after the third dose. Headache, Pyrexia, Arthralgia and Rash 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. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 56-year-old female patient with no details on relevant medical history, who experienced the unexpected serious (medically significant) events of Muscle Fatigue, Abdominal discomfort, Headache, Rash and Arthralgia after mRNA- 1273 Moderna vaccine. The events Headache, Muscle fatigue, Pyrexia and Arthralgia occurred on they day after the third dose of mRNA- 1273 vaccine and Rash and Abdominal discomfort occurred approximately one day after the third dose. Headache, Pyrexia, Arthralgia and Rash 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. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report


VAERS ID: 1918647 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   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: Headache, Pain, 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:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding
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: High temperature; Ache; Headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26241845) 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 (High temperature) and PAIN (Ache) in a 44-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding. On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and PAIN (Ache) (seriousness criterion medically significant). On 22-Nov-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant). On 22-Nov-2021, HEADACHE (Headache) had resolved. At the time of the report, PYREXIA (High temperature) was resolving and PAIN (Ache) had not 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 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant information were provided No treatment information were provided. Company comment: This case concerns a 44-year-old, female patient with no relevant medical history reported, who experienced the events of headache, pyrexia and pain. The events headache and pain occurred on the same day after the third dose of mRNA � 1273 vaccine, while pyrexia was experienced a day after. Events were reported as medically significant but headache lasted only for a day and only pain had not resolve and pyrexia was resolving 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 case concerns a 44-year-old, female patient with no relevant medical history reported, who experienced the events of headache, pyrexia and pain. The events headache and pain occurred on the same day after the third dose of mRNA � 1273 vaccine, while pyrexia was experienced a day after. Events were reported as medically significant but headache lasted only for a day and only pain had not resolve and pyrexia was resolving 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: 1918652 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Headache, Heart rate increased, Myalgia, Nasopharyngitis, Pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (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 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Flu; Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211124; 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: headache; about 9 hrs after vaccine; aches all over body; cold symptoms; Head cold; Coughing; Head pain; Generalised muscle aches; Aching in limb; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26243384) 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), HEART RATE INCREASED (about 9 hrs after vaccine), PAIN IN EXTREMITY (Aching in limb), PAIN (aches all over body), MYALGIA (Generalised muscle aches), NASOPHARYNGITIS (cold symptoms), HEADACHE (Head pain), NASOPHARYNGITIS (Head cold) and COUGH (Coughing) in a 62-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for an unknown indication. Patient has not had symptoms associated with COVID-19. The patient''s past medical history included Flu. Previously administered products included for Flu: flu vaccine (Had flu jab about 6 weeks ago). Past adverse reactions to the above products included No adverse event with flu vaccine. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 24-May-2021 to an unknown date for an unknown indication. On 21-Nov-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) Dose 3b. On 21-Nov-2021, the patient experienced PAIN IN EXTREMITY (Aching in limb) (seriousness criterion medically significant) and MYALGIA (Generalised muscle aches) (seriousness criterion medically significant). On 22-Nov-2021, the patient experienced HEADACHE (Head pain) (seriousness criterion medically significant). On 23-Nov-2021, the patient experienced NASOPHARYNGITIS (Head cold) (seriousness criterion medically significant) and COUGH (Coughing) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criterion medically significant), HEART RATE INCREASED (about 9 hrs after vaccine) (seriousness criterion medically significant), PAIN (aches all over body) (seriousness criterion medically significant) and NASOPHARYNGITIS (cold symptoms) (seriousness criterion medically significant). At the time of the report, HEADACHE (headache), HEART RATE INCREASED (about 9 hrs after vaccine), PAIN IN EXTREMITY (Aching in limb), PAIN (aches all over body), MYALGIA (Generalised muscle aches) and NASOPHARYNGITIS (cold symptoms) was resolving and HEADACHE (Head pain), NASOPHARYNGITIS (Head cold) and COUGH (Coughing) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-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. The patient received paracetamol and ibuprofen for head cold symptoms and pain in head, but had no effect. The patient underwent 3 lateral flow tests which were all negative. The patient was not enrolled in clinical trial. Company Comment : This is a regulatory authority case concerning a 62-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Headache, Heart rate increased, Pain in extremity, Pain, Myalgia, Nasopharyngitis, Headache, Nasopharyngitis, Cough. The events occurred approximately on the same 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 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 62-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Headache, Heart rate increased, Pain in extremity, Pain, Myalgia, Nasopharyngitis, Headache, Nasopharyngitis, Cough. The events occurred approximately on the same 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 benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, is not affected by this report.


VAERS ID: 1918659 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   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, SARS-CoV-2 test, Scrotal pain, Tremor, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; BENDROFLUAZIDE; CANDESARTAN.
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19.
Allergies:
Diagnostic Lab Data: Test Date: 20211111; Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: Negative.
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: 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 SCROTAL PAIN (Times), FEELING ABNORMAL (Hours), TREMOR (Shaking) and VOMITING (Vomiting) in a 61-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Patient has not had symptoms associated with COVID-19. Concomitant products included ATORVASTATIN from 2009 to an unknown date, BENDROFLUMETHIAZIDE (BENDROFLUAZIDE) and CANDESARTAN for an unknown indication. On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). On an unknown date, the patient experienced SCROTAL PAIN (Times) (seriousness criterion medically significant), FEELING ABNORMAL (Hours) (seriousness criterion medically significant) and TREMOR (Shaking) (seriousness criterion medically significant). On 22-Nov-2021, VOMITING (Vomiting) had resolved. At the time of the report, SCROTAL PAIN (Times), FEELING ABNORMAL (Hours) and TREMOR (Shaking) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2021, SARS-CoV-2 test: negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No Treatment medication details were provided.Patient had vomiting for 12 hours (about 8 times), increased temperature, shaking. Patient was not tested positive for COVID-19 since having the vaccine was not enrolled in clinical trial.Company Comment: This case concerns a 61-year-old female patient, with a medical history of symptoms associated with Covid-19, who experienced the unexpected events of scrotal pain, feeling abnormal, tremor and vomiting. The event vomiting occurred approximately 1 day after the third dose of mRNA � 1273 vaccine, while the other events occurred on an unknown date. Events were reported as medically significant but vomiting only lasted for 12-hours (about 8 episodes) while the outcome of the other events were unknown. 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 61-year-old female patient, with a medical history of symptoms associated with Covid-19, who experienced the unexpected events of scrotal pain, feeling abnormal, tremor and vomiting. The event vomiting occurred approximately 1 day after the third dose of mRNA � 1273 vaccine, while the other events occurred on an unknown date. Events were reported as medically significant but vomiting only lasted for 12-hours (about 8 episodes) while the outcome of the other events were unknown. 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: 1919497 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   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: Lip swelling, Rash
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: lip swelling; Rash; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26239586) on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021. This regulatory authority case was reported by a physician and describes the occurrence of LIP SWELLING (lip swelling) and RASH (Rash) in a 74-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included SIMVASTATIN from 26-Sep-2012 to an unknown date for Cholesterol, RAMIPRIL from 14-Sep-2012 to an unknown date for Hypertension, ACETYLSALICYLIC ACID (ASPIRINE) from 14-Sep-2012 to an unknown date, BISOPROLOL from 21-Dec-2012 to an unknown date and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 03-Feb-2021 to an unknown date 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 21-Nov-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant). On an unknown date, the patient experienced LIP SWELLING (lip swelling) (seriousness criterion medically significant). At the time of the report, LIP SWELLING (lip swelling) and RASH (Rash) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medication was reported by patient. Patient reported concomitant medication as chlorphenamine 4mg TDS and prednisolone 20mg OD. Patient reported that he experienced full body rash and tongue, lip swelling on the same day after 12 hours of vaccination. Tongue and lip swelling required treatment so patient was put on chlorphenamine 4mg TDS and prednisolone 20mg OD, adrenaline was not needed. Discharge summery was not available to confirm. Company comment: This regulatory authority case concerns a 74-year-old, male patient with no reported relevant medical history, who experienced the unexpected serious events of lip swelling and rash (Full body rash: arms, legs, abdomen, back). The events occurred on the same day after the dose of mRNA-1273, considered as third dose of her COVID-19 vaccine schedule. The patient received previously an AstraZeneca COVID-19 vaccine. Regulatory authority reported the rechallenge as unknown, however, the outcome of the events is not recovered. The patient required treatment (chlorphenamine and prednisolone) in emergency department. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 74-year-old, male patient with no reported relevant medical history, who experienced the unexpected serious events of lip swelling and rash (Full body rash: arms, legs, abdomen, back). The events occurred on the same day after the dose of mRNA-1273, considered as third dose of her COVID-19 vaccine schedule. The patient received previously an AstraZeneca COVID-19 vaccine. Regulatory authority reported the rechallenge as unknown, however, the outcome of the events is not recovered. The patient required treatment (chlorphenamine and prednisolone) in emergency department. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1919771 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Pain in extremity, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Red rash; Headache; Chills; Painful arm; This case was received via Regulatory Authority(Reference number: GB-MHRA-ADR 26241805) 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 in a 56-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 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. No concomitant medications were provided Treatment medication included paracetamol Patient experienced Chills and fever 24 hours after vaccine, shaking and shivering, headache, nausea and general tiredness and this lasted around 36hrs. Patient also had Sore arm within 6 hours of vaccine which then became hot and painful with a large red patch below injection site. The main effects were eased by paracetamol, also the red mark on the arm is still visible on the 24th November (3days after vaccine) but the soreness has started to ease now. Patient felt all quite unpleasant as patient also experienced sore arm with AstraZeneca but not the other side effects and not the redness. Company Comment : This is a regulatory authority case concerning a 56-year-old, female patient with vaccine history of receiving another brand of Covid-19 vaccine (Covid-19 vaccine AstraZeneca) as previous dose, who experienced the unexpected, serious events of pain in extremity, chills, headache and erythematous rash. The event pain in extremity occurred the same day with the unknown dose number of mRNA-1273 vaccine administration while the events chills, headache and erythematous rash occurred 1 day after the unknown dose number 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 56-year-old, female patient with vaccine history of receiving another brand of Covid-19 vaccine (Covid-19 vaccine AstraZeneca) as previous dose, who experienced the unexpected, serious events of pain in extremity, chills, headache and erythematous rash. The event pain in extremity occurred the same day with the unknown dose number of mRNA-1273 vaccine administration while the events chills, headache and erythematous rash occurred 1 day after the unknown dose number 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: 1919780 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   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: Nausea
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: Nausea; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 26246113) 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 NAUSEA (Nausea) in a 64-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 28-Feb-2021 to 05-May-2021 for COVID-19. On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). On 22-Nov-2021, NAUSEA (Nausea) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was not tested positive for COVID-19 since had the vaccine Patient was not enrolled in clinical trial Treatment medications were not provided Company Comment : This is a regulatory case concerning a 64-year-old male patient with the Covid-19 AstraZeneca vaccine as a concomitant product, who experienced the expected event of nausea. The event occurred on the same day after the third dose of mRNA � 1273 vaccine. Nausea was reported to be medically significant in this case but the event resolved after a day. The rechallenge was 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 64-year-old male patient with the Covid-19 AstraZeneca vaccine as a concomitant product, who experienced the expected event of nausea. The event occurred on the same day after the third dose of mRNA � 1273 vaccine. Nausea was reported to be medically significant in this case but the event resolved after a day. The rechallenge was 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: 1922322 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   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: Infusion site pruritus, Lethargy, Malaise, Nausea, Peripheral swelling
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), 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: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hormone replacement therapy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: generally unwell; lethargic; Infusion site itching; Swelling of limb; Nausea; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 26237187) 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 INFUSION SITE PRURITUS (Infusion site itching), PERIPHERAL SWELLING (Swelling of limb), NAUSEA (Nausea), MALAISE (generally unwell) and LETHARGY (lethargic) in a 62-year-old patient of an unknown gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. The patient''s past medical history included Hormone replacement therapy. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced INFUSION SITE PRURITUS (Infusion site itching) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swelling of limb) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (generally unwell) (seriousness criterion medically significant) and LETHARGY (lethargic) (seriousness criterion medically significant). At the time of the report, INFUSION SITE PRURITUS (Infusion site itching), PERIPHERAL SWELLING (Swelling of limb) and NAUSEA (Nausea) had not resolved and MALAISE (generally unwell) and LETHARGY (lethargic) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment information was not provided Patient had been feeling lethargic and generally unwell since 21 November, when should patient started to feel better. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Company Comment: This case concerns a 62-year old subject of unknown gender, with a medical history of taking hormone replacement therapy and having previous vaccination with Astra Zeneca COVID-19 vaccine (unknown dose number, dosage, and date of administration), who experienced the serious (seriousness criterion=medically significant) unexpected events of Infusion site pruritus, Peripheral swelling, Nausea, Malaise (feeling generally unwell), and Lethargy. The events Malaise and Lethargy occurred unknown number of days after a booster dose of mRNA 1273 VACCINE while events Infusion site pruritus, Peripheral swelling, and Nausea occurred1 day after. No diagnostic tests done nor treatment medication given were mentioned. At the time of the report, outcome of the events Malaise and Lethargy was Recovering/Resolving while events Infusion site pruritus, Peripheral swelling, and Nausea were Not Recovered/Not Resolved. Rechallenge is not applicable as no additional dose is expected to be given. The patient''s age, medication with hormone replacement therapy, and previous vaccination with Astra Zeneca COVID-19 vaccine remain as confounders. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report.; Sender''s Comments: This case concerns a 62-year old subject of unknown gender, with a medical history of taking hormone replacement therapy and having previous vaccination with Astra Zeneca COVID-19 vaccine (unknown dose number, dosage, and date of administration), who experienced the serious (seriousness criterion=medically significant) unexpected events of Infusion site pruritus, Peripheral swelling, Nausea, Malaise (feeling generally unwell), and Lethargy. The events Malaise and Lethargy occurred unknown number of days after a booster dose of mRNA 1273 VACCINE while events Infusion site pruritus, Peripheral swelling, and Nausea occurred1 day after. No diagnostic tests done nor treatment medication given were mentioned. At the time of the report, outcome of the events Malaise and Lethargy was Recovering/Resolving while events Infusion site pruritus, Peripheral swelling, and Nausea were Not Recovered/Not Resolved. Rechallenge is not applicable as no additional dose is expected to be given. The patient''s age, medication with hormone replacement therapy, and previous vaccination with Astra Zeneca COVID-19 vaccine remain as confounders. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report.


VAERS ID: 1922330 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   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: Chest discomfort, Chest pain, Dyspnoea, Palpitations, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding.
Allergies:
Diagnostic Lab Data: Test Date: 20210927; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: shortness of breath; chest pain; Painful rash; Palpitations; Tight chest; This case was received (Reference number: GB-MHRA-ADR 26242283) 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 (shortness of breath), CHEST PAIN (chest pain), RASH (Painful rash), PALPITATIONS (Palpitations) and CHEST DISCOMFORT (Tight chest) in a 55-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) for Flu. On 21-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced RASH (Painful rash) (seriousness criterion medically significant), PALPITATIONS (Palpitations) (seriousness criterion medically significant) and CHEST DISCOMFORT (Tight chest) (seriousness criterion medically significant). On an unknown date, the patient experienced DYSPNOEA (shortness of breath) (seriousness criterion medically significant) and CHEST PAIN (chest pain) (seriousness criterion medically significant). On 23-Nov-2021, PALPITATIONS (Palpitations) had resolved, CHEST DISCOMFORT (Tight chest) was resolving. At the time of the report, DYSPNOEA (shortness of breath), CHEST PAIN (chest pain) and RASH (Painful rash) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Sep-2021, SARS-CoV-2 test: negative covid-19 test (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient was experiencing some inflammation around heart as patient had shortness of breath, chest pain and discomfort and if patient pressed on chest area it was tender. 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 55-year-old female patient with no relevant medical history, who experienced the serious unexpected events of Dyspnoea, Chest pain, Rash, Palpitation and Chest discomfort. The events of Dyspnoea and Chest pain occurred on an unknown date after the third dose of mRNA-1273 vaccine while the events of Rash, Palpitation and Chest discomfort occurred the same 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.; Sender''s Comments: This case concerns a 55-year-old female patient with no relevant medical history, who experienced the serious unexpected events of Dyspnoea, Chest pain, Rash, Palpitation and Chest discomfort. The events of Dyspnoea and Chest pain occurred on an unknown date after the third dose of mRNA-1273 vaccine while the events of Rash, Palpitation and Chest discomfort occurred the same 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: 1922333 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   Days after vaccination:1
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: Fatigue, Influenza
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

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

Write-up: Extreme fatigue; Flu symptoms; This case was received via RA (Reference number: GB-MHRA-ADR 26242660) 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 FATIGUE (Extreme fatigue) and INFLUENZA (Flu symptoms) in a 56-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE) for Dysfunction thyroid, INFLUENZA VACCINE (INFLUENZA VIRUS) from 25-Sep-2021 to an unknown date for an unknown indication. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Nov-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced INFLUENZA (Flu symptoms) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Extreme fatigue) (seriousness criterion medically significant). On 23-Nov-2021, INFLUENZA (Flu symptoms) had resolved. At the time of the report, FATIGUE (Extreme fatigue) outcome was unknown. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. It was reported that patient had absolutely no energy and struggled to get out of bed. Patient not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. No medical history information was reported. Treatment medication information was not provided by the reporter. Company comment This is a regulatory authority case concerning a 56-year-old, female patient with concomitant medication of Thyroxine, who experienced the unexpected serious events of influenza (flu symptoms) and fatigue (extreme fatigue). The event influenza (flu symptoms) occurred 1 day after the third dose of mRNA-1273 vaccine administration while the event fatigue (extreme fatigue) occurrence unknown with respect to the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The concomitant medication of Thyroxine remain confounder. 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 56-year-old, female patient with concomitant medication of Thyroxine, who experienced the unexpected serious events of influenza (flu symptoms) and fatigue (extreme fatigue). The event influenza (flu symptoms) occurred 1 day after the third dose of mRNA-1273 vaccine administration while the event fatigue (extreme fatigue) occurrence unknown with respect to the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The concomitant medication of Thyroxine remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1922345 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Medication errors (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: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pelvic pain
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101661801

Write-up: Glands swollen; Fever chills; 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 Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111241600420390-RB7HO. Other Case identifier(s): GB-MHRA-ADR 26244966. A 60 year-old female patient received bnt162b2 (COMIRNATY), administration date 21Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Pelvic pain" (unspecified if ongoing). The patient has not had symptoms associated with COVID-19. The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. Concomitant medication(s) included: PARACETAMOL taken for pelvic pain, start date: 21Nov2021, stop date: 23Nov2021. Vaccination history included: COVID-19 vaccine (Dose 1, Single, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; COVID-19 vaccine (Dose 2, Single, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 21Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 21Nov2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant) with onset 24Nov2021, outcome "not recovered", described as "Glands swollen"; PYREXIA (medically significant) with onset 22Nov2021, outcome "recovering" (however event stop date also reported as 24Nov2021), described as "Fever chills". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Nov2021) no - negative COVID-19 test. Clinical Course: The report did 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: 1922358 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-21
   Days after vaccination:6
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: Headache, SARS-CoV-2 test, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy))
Preexisting Conditions: Medical History/Concurrent Conditions: Radiotherapy (sessions ended in August); Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20200424; 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: Vaginal bleeding; Headache; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 26247493) 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 VAGINAL HAEMORRHAGE (Vaginal bleeding) and HEADACHE (Headache) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 14-Apr-2020 and Radiotherapy (sessions ended in August). Concurrent medical conditions included Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)). On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 22-Nov-2021, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding) (seriousness criterion medically significant). At the time of the report, VAGINAL HAEMORRHAGE (Vaginal bleeding) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2020, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. Patient reported heavy vaginal bleeding and severe cramps. Treatment medication was not provided. 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 32-year-old, female patient with previous relevant medical history of neoplasm with recent radiotherapy, who experienced the unexpected serious events of headache and vaginal haemorrhage. The event headache is unexpected as it is retained as serious per the source document Authority reporting. The events occurred between 6 and 7 days after the third dose of mRNA-1273. Regulatory authority reported the rechallenge as unknown, however, the outcome of the events is not recovered. Patient�s medical history of neoplasm with recent radiotherapy could be confounder. 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 32-year-old, female patient with previous relevant medical history of neoplasm with recent radiotherapy, who experienced the unexpected serious events of headache and vaginal haemorrhage. The event headache is unexpected as it is retained as serious per the source document Authority reporting. The events occurred between 6 and 7 days after the third dose of mRNA-1273. Regulatory authority reported the rechallenge as unknown, however, the outcome of the events is not recovered. Patient�s medical history of neoplasm with recent radiotherapy could be confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1922375 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK4913 / 3 - / -
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER UNK / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Influenza like illness, Myalgia, Neovascular age-related macular degeneration, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Retinal disorders (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: INFLUENZA VACCINE; FOSTAIR; LEMSIP MAX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)); Comments: Asthmatic but usually controlled. Patient has not had symptoms associated with COVID-19, Not had a COVID-19 test, Patient is not pregnant,Patient is not currently breast feeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBGLAXOSMITHKLINEGB202124

Write-up: soaking wet; i felt like i had flu; Cough; Fever; Generalised muscle aches; This case received by Regulatory Authority on 28th November 2021 This case was reported by a consumer via regulatory authority and described the occurrence of wet macular degeneration in a 44-year-old female patient who received DTPa-IPV (DTPa-IPV) for prophylaxis. Co-suspect products included TOZINAMERAN (BIONTECH COVID-19 MRNA VACCINE) (batch number FK4913, expiry date unknown) for prophylaxis. Previously administered products included COVID-19 VACCINE ASTRAZENECA (1st dose received on 22nd February 2021) and COVID-19 VACCINE ASTRAZENECA (2nd dose received on 11th May 2021). Concurrent medical conditions included asthma and steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)). Additional patient notes included Asthmatic but usually controlled. Patient has not had symptoms associated with COVID-19, Not had a COVID-19 test, Patient is not pregnant,Patient is not currently breast feeding. Concomitant products included INFLUENZA VACCINE, beclometasone dipropionate + formoterol fumarate (Fostair) and ascorbic acid + paracetamol + phenylephrine hydrochloride + sodium citrate (Lemsip Max). On an unknown date, the patient received DTPa-IPV (unknown). On 20th November 2021, the patient received the 3rd dose of BIONTECH COVID-19 MRNA VACCINE (unknown). On 21st November 2021, unknown after receiving DTPa-IPV, the patient experienced fever (serious criteria other: Serious as per reporter) and generalised muscle aches (serious criteria other: Serious as per reporter). On 24th November 2021, the patient experienced cough (serious criteria other: Serious as per reporter). On an unknown date, the patient experienced wet macular degeneration (serious criteria GSK medically significant and other: Serious as per reporter) and flu like symptoms (serious criteria other: Serious as per reporter). On 22nd November 2021, the outcome of the fever was recovered/resolved. On 23rd November 2021, the outcome of the generalised muscle aches was recovered/resolved. On an unknown date, the outcome of the wet macular degeneration and flu like symptoms were recovering/resolving and the outcome of the cough was not recovered/not resolved. It was unknown if the reporter considered the wet macular degeneration, flu like symptoms, fever, generalised muscle aches and cough to be related to DTPa-IPV. Additional details were reported as follows: The age at vaccination was unknown. The duration for the event fever was 1 day and for the event generalised muscle aches was 2 days. The time to onset for the events wet macular degeneration, flu like symptoms was less than a week and for the events fever, generalised muscle aches was 1 day and for the event cough was 4 days with respect to BIONTECH COVID-19 MRNA VACCINE. It was unknown if the reporter considered the wet macular degeneration, flu like symptoms, fever, generalised muscle aches and cough to be related to BIONTECH COVID-19 MRNA VACCINE. The concomitant vaccine doses of COVID-19 VACCINE ASTRAZENECA was captured as historical as per dates reported. Initial information received from consumer via regulatory authority on 28th November 2021: soaking wet, i felt like i had flu, Fever, Generalised muscle aches, Cough Case narrative : Got really cold about 20 hours after the vaccine booster. After about a further 8 hours i was soaking wet through. I felt like i had flu, my body hurt. I struggled to get out of bed. When the aches stopped coughing started. Patient has not tested positive for COVID-19 since having the vaccine, Patient is not enrolled in clinical trial Reaction, Does your report relate to possible inflammation of the heart (myocarditis or pericarditis) If yes, we will ask you some additional questions at the end of this report: "No"


VAERS ID: 1922461 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-11-21
   Days after vaccination:277
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, COVID-19, Confusional state, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: PCR; Test Result: Positive ; Comments: Nasal Swab
CDC Split Type: IEPFIZER INC202101691649

Write-up: Vaccination failure; COVID-19; muscle and joint aches; confusion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) via a Regulatory Authority. The reporter is the patient. A 30-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 17Feb2021 (Lot number: EK9788) at the age of 30 years as dose 2, single and intramuscular, administered in arm left, administration date 27Jan2021 (Lot number: EK9788) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine, had no known allergies, and had not been diagnosed with COVID prior to vaccination. The following information was reported: VACCINATION FAILURE (medically significant) with onset 21Nov2021, outcome "recovering", described as "Vaccination failure"; COVID-19 (medically significant) with onset 21Nov2021, outcome "recovering", described as "COVID-19"; ARTHRALGIA (non-serious) with onset 21Nov2021, outcome "recovering", described as "muscle and joint aches"; CONFUSIONAL STATE (non-serious) with onset 21Nov2021, outcome "recovering", described as "confusion". The patient reported developing many symptoms and had to take 5 days off work. The patient reported symptoms included blocked nose, headaches, muscle and joint aches, fever, chills, loss of smell, loss of taste, fatigue, and confusion. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Nov2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, arthralgia, confusional state.


VAERS ID: 1922804 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-11-21
   Days after vaccination:96
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

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

Write-up: Abdominal pain; This regulatory authority case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN (Abdominal pain) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. No Medical History information was reported. On 17-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant). At the time of the report, ABDOMINAL PAIN (Abdominal pain) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medication information provided. No relevant treatment medication information provided. After being vaccinated with COVID-19 vaccine , due to upper abdominal pain, he went to Emergency Department on 19-Sep-2021, and underwent balloon dilatation and stent placement through cardiac catheter on 21-Sep-2021. The diagnosis was coronary artery disease complicated with non-ST-segment ascending myocardial infarction. On 21-Sep-2021, the patient was admitted to ICU for treatment. On 23-Sep-2021, the patient was transferred to the general ward, and discharged from the hospital on 24-Sep-2021. Company comment: This is a regulatory authority case concerning a 61-year-old male patient with no relevant medical history reported, who experienced serious, unexpected event of Abdominal pain. The event occurred approximately 3 months after a dose of mRNA-1273 vaccine. It was reported that after being vaccinated with COVID-19 vaccine , due to upper abdominal pain, he went to Hospital Emergency Department on 19-Sep-2021. On 21-Sep-2021 patient underwent balloon dilatation and stent placement through cardiac catheter. The diagnosis was coronary artery disease complicated with non-ST-segment ascending myocardial infarction. He was discharged on 24-Sep-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 61-year-old male patient with no relevant medical history reported, who experienced serious, unexpected event of Abdominal pain. The event occurred approximately 3 months after a dose of mRNA-1273 vaccine. It was reported that after being vaccinated with COVID-19 vaccine , due to upper abdominal pain, he went to Hospital Emergency Department on 19-Sep-2021. On 21-Sep-2021 patient underwent balloon dilatation and stent placement through cardiac catheter. The diagnosis was coronary artery disease complicated with non-ST-segment ascending myocardial infarction. He was discharged on 24-Sep-2021. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1923808 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213D21A / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Echocardiogram abnormal, Epistaxis, Oedema peripheral, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies: NO
Diagnostic Lab Data: Left foot edema result of foot echo 11-25-2021
CDC Split Type:

Write-up: Swelling of the left leg, after the knee, bleeding from the nose, swelling of the foot.


VAERS ID: 1926487 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Crohn''s disease (take medicines for inflammatory bowel disease (crohn''s disease and ulcerative colitis)); Inflammatory bowel disease (take medicines for inflammatory bowel disease (crohn''s disease and ulcerative colitis)); Ulcerative colitis (take medicines for inflammatory bowel disease (crohn''s disease and ulcerative colitis))
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101637675

Write-up: Dizziness; Tiredness; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-APPCOVID-20211121194508. Other Case identifier(s): GB-MHRA-ADR 26232829. A 20-year-old male patient received bnt162b2 (COMIRNATY), administration date 21Nov2021 (Lot number: FH4751) at the age of 20 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "ulcerative colitis" (unknown if ongoing), notes: take medicines for inflammatory bowel disease (Crohn''s disease and ulcerative colitis); "Crohn''s disease" (unknown if ongoing), notes: take medicines for inflammatory bowel disease (Crohn''s disease and ulcerative colitis); "Inflammatory bowel disease" (unknown if ongoing), notes: take medicines for inflammatory bowel disease (Crohn''s disease and ulcerative colitis). Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The following information was reported: DIZZINESS (medically significant) with onset 21Nov2021, outcome "unknown", described as "Dizziness"; FATIGUE (medically significant) with onset 21Nov2021, outcome "unknown", described as "Tiredness". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (21Nov2021) negative, notes: No - Negative COVID-19 test. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1926559 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101637858

Write-up: Eye swelling; 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-202111210850471470-QXYF5 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26232240 (MHRA). A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid vaccine (Dose 1, Manufacturer unknown.), for COVID-19 immunization. Patient had not had symptoms associated with covid 19 and not had a covid 19 test. Patient had not tested positive for covid 19 since having the vaccine. Patient was not enrolled in clinical trial. The following information was reported: EYE SWELLING (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Eye swelling". Report not related to possible inflammation of the heart (myocarditis or pericarditis). The case was reported as serious by RA. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926575 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pH increased, Blood pressure measurement, Chills, Feeling of body temperature change, Headache, Heart rate, Hypertension, Immunisation, Interchange of vaccine products, Malaise, Myalgia, Off label use, Pain, Tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (My blood tends to clot in pregnancy); Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:100; Test Name: heart; Result Unstructured Data: Test Result:100
CDC Split Type: GBPFIZER INC202101637728

Write-up: Off label use; interchange of vaccine products; Booster; headache; aches and pains; shivers; muscle pain; Felt hot and cold but temperature by mouth stayed the same; Felt extremely unwell all night; readings were 100 for my heart and blood pressure; readings were 100 for my heart and blood pressure; Headache temporal; Blood pH high; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the regulatory authority Regulatory number: GB-MHRA-WEBCOVID-202111211031439890-12MEO (RA). Other Case identifier(s): GB-MHRA-ADR 26232346 (RA). A 52 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 21Nov2021 (Lot number: FK0596) at the age of 52 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Pregnancy" (unspecified if ongoing), notes: My blood tends to clot in pregnancy; "Suspected COVID-19", start date: 28Sep2021, stop date: 10Oct2021. 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 Immunisation; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunisation. Patient''s blood tends to clot in pregnancy, not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; HEADACHE (medically significant), outcome "not recovered", described as "headache"; PAIN (medically significant), outcome "not recovered", described as "aches and pains"; CHILLS (medically significant), outcome "not recovered", described as "shivers"; MYALGIA (medically significant), outcome "not recovered", described as "muscle pain"; HEADACHE (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Headache temporal"; BLOOD PH INCREASED (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Blood pH high"; FEELING OF BODY TEMPERATURE CHANGE (medically significant), outcome "unknown", described as "Felt hot and cold but temperature by mouth stayed the same"; MALAISE (medically significant), outcome "unknown", described as "Felt extremely unwell all night"; TACHYCARDIA (medically significant), HYPERTENSION (medically significant), outcome "unknown" and all described as "readings were 100 for my heart and blood pressure". The patient underwent the following laboratory tests and procedures: blood pressure measurement: 100; heart rate: 100. Clinical course: Aches and pains, shivers and readings were 100 for my heart and blood pressure. Felt extremely unwell all night. Felt hot and cold but temperature by mouth stayed the same. Headache, muscle pain. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1926623 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK05696 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Immunisation, Inability to crawl, Interchange of vaccine products, Musculoskeletal stiffness, Off label use, Pain in extremity, SARS-CoV-2 test
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Thyroid disorder (Take thyroxine due to thyroid been destroyed)
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101637890

Write-up: Very stiff and painful to move; 30 pm i can bearly move my left arm; Painful arm; pain across left shoulder blade and half way down left arm; 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). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111211502276040-ZKV01 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26232555 (MHRA). A 63 year-old female patient received bnt162b2 (COMIRNATY), administration date 21Nov2021 10:20 (Lot number: FK05696) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Thyroid disorder" (unspecified if ongoing), notes: Take thyroxine due to thyroid been destroyed. The patient''s concomitant medications were not reported. Past drug history included: Thyroxine, notes: Take thyroxine due to thyroid been destroyed. 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 21Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 21Nov2021, outcome "unknown", described as "Booster"; INABILITY TO CRAWL (medically significant) with onset 21Nov2021 14:30, outcome "unknown", described as "30 pm i can bearly move my left arm"; PAIN IN EXTREMITY (medically significant) with onset 21Nov2021 14:30, outcome "not recovered", described as "Painful arm"; ARTHRALGIA (medically significant) with onset 21Nov2021 14:30, outcome "unknown", described as "pain across left shoulder blade and half way down left arm"; MUSCULOSKELETAL STIFFNESS (medically significant), outcome "unknown", described as "Very stiff and painful to move". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) no - negative covid-19 test. Clinical course: Booster received at 10.20 on 21Nov2021 by 14.30, Patient can barely move her left arm, pain across left shoulder blade and halfway down left arm. Very stiff and painful to move. Patient not had symptoms associated with COVID-19. Since the vaccination, the patient was not tested positive for COVID-19. Patient was not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1926700 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Burning sensation, Hypoaesthesia, Pain, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101637631

Write-up: severe pain in both legs; legs also feel numb and burning; legs also feel numb and burning; Pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111212346364440-WRHLX Regulatory Authority. Other Case identifier(s): GB-MHRA-ADR 26233063 Regulatory Authority. A 24-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1.), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (medically significant), outcome "recovering", described as "severe pain in both legs"; PAIN (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Pain"; BURNING SENSATION (medically significant), HYPOAESTHESIA (medically significant), outcome "unknown" and all described as "legs also feel numb and burning". Clinical Course: Severe pain in both legs, full leg, like deep pain almost down to the bone yet whilst the pain is there my legs also feel numb and burning at the same time. Patient has not had symptoms associated with COVID-19. Patient was not pregnant, and not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial and the report does not relate to possible inflammation of the heart (myocarditis or pericarditis) and not had a COVID-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926706 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL1939 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dry mouth, Feeling cold, Immunisation, Influenza like illness, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalopathy/delirium (broad), Medication errors (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: RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...); Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy))
Allergies:
Diagnostic Lab Data: Test Date: 20200925; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101637667

Write-up: shivers; Feeling cold; Shaking; Dry mouth; like flu; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111220457227620-PXG6W (MHRA). Other case identifier: GB-MHRA-ADR 26233203 A 59 year-old male patient received bnt162b2 (COMIRNATY), administration date 21Nov2021 (Lot number: FL1939) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Immunodeficiency" (unspecified if ongoing), notes: Taking other treatments or medicines, not listed above, known to lower the immune response and i...; "Neoplasm" (unspecified if ongoing), notes: Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy). Concomitant medication included: RAMIPRIL taken for hypertension, start date: 10Nov2020. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1), administration date: 25Mar2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (DOSE 2), administration date: 03Jun2021, for COVID-19 immunisation.Patient has not had symptoms associated with COVID-19. The following information was reported: OFF LABEL USE (medically significant) with onset 21Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 21Nov2021, outcome "unknown", described as "Booster"; CHILLS (medically significant) with onset 22Nov2021, outcome "recovering", described as "shivers"; FEELING COLD (medically significant) with onset 22Nov2021, outcome "recovered" (22Nov2021), described as "Feeling cold"; TREMOR (medically significant) with onset 22Nov2021, outcome "recovered", described as "Shaking"; DRY MOUTH (medically significant) with onset 22Nov2021, outcome "recovered" (22Nov2021), described as "Dry mouth"; INFLUENZA LIKE ILLNESS (medically significant) with onset 22Nov2021, outcome "unknown", described as "like flu". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Sep2020) negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of chills, feeling cold, tremor, dry mouth, influenza like illness. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The reporter did not relate the event to possible inflammation of the heart (myocarditis or pericarditis). The course of the events was the patient woke up in the early hours of the morning shaking quite violently. It was like flu shivers but quite extreme and totally uncontrollable. The patient took paracetamol and codeine as directed on the box and returned to bed still shaking uncontrollably. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-MHRA-ADR 26233203 MHRA


VAERS ID: 1926726 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Immunisation, Peripheral swelling, SARS-CoV-2 test, Tenderness, Vaccination site swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101646486

Write-up: Booster; swelling around the injection point in my arm; arm/pit very tender; Swelling arm; Chest pain with radiation to left arm; This is a spontaneous report received from a contactable consumer (patient) from the regulatory authority (UK-MHRA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111220838056980-MCTCV. Other Case identifier: GB-MHRA-ADR 26233650. A 57-year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK0596) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacture unknown), for COVID-19 Immunization; Covid-19 vaccine (dose 2, manufacture unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; PERIPHERAL SWELLING (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Swelling arm"; CHEST PAIN (medically significant) with onset 21Nov2021, outcome "recovering", described as "Chest pain with radiation to left arm"; Vaccination site swelling (medically significant), outcome "unknown", described as "swelling around the injection point in my arm "; TENDERNESS (medically significant), outcome "unknown", described as "arm/pit very tender ". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: negative, notes: No - Negative COVID-19 test. Other clinical course: swelling around the injection point in her arm and additional swelling under arm/pit very tender with referred pain into her chest and down her arm to her hand. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Report is not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1926737 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Pain, 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: ALOGLIPTIN; AMLODIPINE; ATORVASTATIN; LEVOTHYROXINE; OMEPRAZOLE; RAMIPRIL; VENSIR
Current Illness: Anxiety; Blood pressure; Cholesterol; Gastroesophageal burn; Hypothyroidism
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210127; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101646145

Write-up: Booster; High temperature; aches and pains throughout my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111220939029930-NRH6S (RA). Other Case identifier(s): GB-MHRA-ADR 26233968 (RA). A 50 year-old male patient received bnt162b2 (COMIRNATY), administration date 21Nov2021 (Lot number: FK9413) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 25Jan2021 (not ongoing), notes: Unsure when symptoms stopped; "Hypothyroidism" (ongoing); "Blood pressure" (ongoing); "Cholesterol" (ongoing); "Gastroesophageal burn" (ongoing); "Anxiety" (ongoing). Concomitant medication(s) included: ALOGLIPTIN; AMLODIPINE taken for blood pressure measurement; ATORVASTATIN taken for blood cholesterol; LEVOTHYROXINE taken for hypothyroidism; OMEPRAZOLE taken for burn oesophageal; RAMIPRIL taken for blood pressure measurement; VENSIR taken for anxiety. Vaccination history included: Bnt162b2, administration date: 24Feb2021, for COVID-19 Immunisation; Bnt162b2, administration date: 12May2021, for COVID-19 Immunisation. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. 14 hours after receiving the booster vaccination on 21Nov2021, patient''s body temperating increased to 3 degrees above normal, causing many aches and pains throughout the body. This continued for 10 hours and was relieved by ibuprofen and paracetamol. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Jan2021) yes - positive covid-19 test. Outcome of events was recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1926738 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Erectile dysfunction, Feeling abnormal, Headache, Immunisation, Interchange of vaccine products, Nausea, Off label use, Psoriasis, Tinnitus
SMQs:, Acute pancreatitis (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow), Medication errors (broad), Immune-mediated/autoimmune disorders (narrow), Sexual dysfunction (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101646509

Write-up: Erectile dysfunction; Psoriasis aggravated; tinnitus/Tinnitus worsening; Headache/Headache getting worse; Chills; Nausea; fuzzy exploding feeling; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable consumer from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202111220943586330-TBAZW. Other Case identifier(s): GB-MHRA-ADR 26233917. A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 21Nov2021 (Lot number: FH4751) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete but unknown manufacturer, dose 1), for COVID-19 Immunisation; Covid-19 vaccine (Primary immunization series complete but unknown manufacturer, dose 2), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 21Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 21Nov2021, outcome "unknown", described as "Booster"; ERECTILE DYSFUNCTION (medically significant), outcome "unknown", described as "Erectile dysfunction"; PSORIASIS (non-serious), outcome "unknown", described as "Psoriasis aggravated"; TINNITUS (non-serious), outcome "unknown", described as "tinnitus/Tinnitus worsening"; HEADACHE (non-serious), outcome "not recovered", described as "Headache/Headache getting worse"; CHILLS (non-serious), outcome "recovered", described as "Chills"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "fuzzy exploding feeling". Patient has not had symptoms associated with COVID-19. The patient was not have a COVID-19 test. Patient is not enrolled in clinical trial. No follow up attempts are needed. No further information is expected.


VAERS ID: 1926757 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Chills, Dizziness, Feeling hot, Maternal exposure during pregnancy, Nausea, Palpitations, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211122; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101646186

Write-up: Fever; Chills; Nausea; aniexty; dizziness; Maternal exposure during pregnancy; Heart racing; feeling very hot; 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-202111221057444080-5BWXD. Other Case identifier(s): GB-MHRA-ADR 26234138. A 31 year-old female patient (pregnant) received bnt162b2 (COMIRNATY), administration date 21Nov2021 (Batch/Lot number: unknown) at the age of 31 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Date of last menstrual period: 01Jun2021. The patient was 24 weeks pregnant at the time of exposure to bnt162b2. The patient was 25 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 01Mar2022. Concomitant medication(s) included: FOLIC ACID taken for vitamin supplementation. The following information was reported: DIZZINESS (medically significant) with onset 21Nov2021, outcome "unknown", described as "dizziness"; MATERNAL EXPOSURE DURING PREGNANCY (medically significant) with onset 21Nov2021, outcome "unknown", described as "Maternal exposure during pregnancy"; PYREXIA (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Fever"; CHILLS (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Chills"; NAUSEA (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Nausea"; PALPITATIONS (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Heart racing"; FEELING HOT (medically significant) with onset 21Nov2021, outcome "unknown", described as "feeling very hot"; ANXIETY (medically significant) with onset 22Nov2021, outcome "unknown", described as "aniexty". Clinical course: Within the 15 minute wait after the vaccine on 21Nov2021, felt dizziness and feeling very hot. 22Nov2021- fever, chills, nauseous and anxiety. Heart racing. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient was exposed to the medicine Second-trimester (13-28 weeks). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Nov2021) negative, notes: No - Negative COVID-19 test. The report was not related to 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: 1926760 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling of body temperature change, Headache, Immunisation, Influenza like illness, Interchange of vaccine products, Nausea, Off label use, Pain, Pain in extremity
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101646500

Write-up: aching; hot then cold; Flu-like aching; Nausea; Headache; Off label use; Interchange of vaccine products; Booster; my arm was sore that afternoon; 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-202111221122471730-GCUPW. Other Case identifier(s): GB-MHRA-ADR 26234329. A 62 year-old female patient received bnt162b2 (COMIRNATY), administration date 21Nov2021 10:40 (Lot number: FH4751) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca, administration date: 28Feb2021, for COVID-19 Immunisation; Covid-19 vaccine (unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 21Nov2021 10:40, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Nov2021 10:40, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 21Nov2021 10:40, outcome "unknown", described as "Booster"; PAIN (medically significant), outcome "recovering", described as "aching"; PAIN IN EXTREMITY (medically significant) with onset 21Nov2021, outcome "recovering", described as "my arm was sore that afternoon"; INFLUENZA LIKE ILLNESS (medically significant) with onset 22Nov2021, outcome "recovering", described as "Flu-like aching"; NAUSEA (medically significant) with onset 22Nov2021, outcome "recovering", described as "Nausea"; HEADACHE (medically significant) with onset 22Nov2021, outcome "recovering", described as "Headache"; FEELING OF BODY TEMPERATURE CHANGE (medically significant), outcome "recovering", described as "hot then cold". Therapeutic measures were taken as a result of pain, pain in extremity, influenza like illness, nausea, headache, feeling of body temperature change. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. Had the injection at 10.40am. Her arm was sore that afternoon, but the main symptoms started in the night. Aching, hot then cold, headache and feeling nauseous. Took two paracetamol at 08.15 this morning which has helped, but still have some symptoms. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1926776 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Headache, Immunisation, Interchange of vaccine products, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101646496

Write-up: Headache NOS; Muscle ache; Stomach ache; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202111221245504700-BBIHC (MHRA). Other Case identifier(s): GB-MHRA-ADR 26234427 (MHRA). A 73 year-old patient received bnt162b2 (COMIRNATY), administration date 21Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and 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: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 21Nov2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Headache NOS"; MYALGIA (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Muscle ache"; ABDOMINAL PAIN UPPER (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Stomach ache". Symptoms started approx. 12h after vaccine given. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient did not report 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: 1926840 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye pain, Fatigue, Headache, Immunisation, Interchange of vaccine products, Nausea, Neck pain, Off label use, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Arthritis (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201224; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101646541

Write-up: Feverish; Nausea; Fatigue; Headache; Pain/ Ache; Neck pain; Sore eyes; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111221725404360-3XO58 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26235204 (MHRA). A 46 year-old female patient received bnt162b2 (COMIRNATY), administration date 21Nov2021 (Lot number: FK9413) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 23Dec2020, stop date: 04Feb2021. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, Dose 1), for covid-19 immunisation; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, Dose 2), for covid-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 21Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 21Nov2021, outcome "unknown", described as "Booster"; PYREXIA (medically significant), outcome "not recovered", described as "Feverish"; NAUSEA (medically significant), outcome "not recovered", described as "Nausea"; FATIGUE (medically significant), outcome "not recovered", described as "Fatigue"; HEADACHE (medically significant), outcome "not recovered", described as "Headache"; PAIN (medically significant), outcome "not recovered", described as "Pain/ Ache"; NECK PAIN (medically significant), outcome "not recovered", described as "Neck pain"; EYE PAIN (medically significant), outcome "not recovered", described as "Sore eyes". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (24Dec2020) positive. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. "Does your report relate to possible inflammation of the heart (myocarditis or pericarditis)? If yes, we will ask you some additional questions at the end of this report: No". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1926843 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Immunisation, Insomnia, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101646370

Write-up: Unable to sleep; Abdominal pain lasted until 12 noon; 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 Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111221735350880-AF2Y8 (RA). Other Case identifier(s): GB-MHRA-ADR 26235263 (RA). A 51 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 21Nov2021 09:30 (Lot number: FK0596) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. Concomitant medication(s) included: INFLUENZA VIRUS taken for immunisation, administration date 27Oct2021. Vaccination history included: Covid-19 vaccine astrazeneca (dose 1), administration date: 16Mar2021, for covid-19 immunisation; Covid-19 vaccine astrazeneca (dose 2), administration date: 18May2021, for covid-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 21Nov2021 09:30, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Nov2021 09:30, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 21Nov2021 09:30, outcome "unknown", described as "Booster"; ABDOMINAL PAIN (medically significant) with onset 22Nov2021 12:45, outcome "recovering", described as "Abdominal pain lasted until 12 noon"; INSOMNIA (medically significant), outcome "unknown", described as "Unable to sleep". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Patient has not tested positive for COVID-19 since having the vaccine. LMP was 2019. This report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1926863 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use, SARS-CoV-2 test
SMQs:, Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210109; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101646636

Write-up: Patient received first and second dose of Non Pfizer vaccine and booster dose of COMIRNATY; Patient received first and second dose of Non Pfizer vaccine and booster dose of COMIRNATY; Patient received booster dose of comirnaty.; Enlarged lymph nodes (excl infective); 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-202111221848446840-CDLHV (RA). Other Case identifier(s): GB-MHRA-ADR 26235341 (RA). A 50 year-old patient received bnt162b2 (COMIRNATY), administration date 21Nov2021 (Lot number: FK9413) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 09Jan2021 (unspecified if ongoing). The patient did not have symptoms associated with COVID-19. The patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 21Nov2021, outcome "unknown" and all described as "Patient received first and second dose of Non Pfizer vaccine and booster dose of COMIRNATY"; IMMUNISATION (medically significant) with onset 21Nov2021, outcome "unknown", described as "Patient received booster dose of comirnaty."; LYMPHADENOPATHY (medically significant) with onset 21Nov2021, outcome "recovering", described as "Enlarged lymph nodes (excl infective)". The patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1926875 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Feeling cold, Feeling hot, Headache, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Arthritis (broad), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210206; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101646547

Write-up: headache; very hot; had pain in every joint; Shaking; feeling very cold; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report from a contactable consumer (patient). This is a report received from the regulatory authority (UK-MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202111222021249090-D0ZIF, Safety Report Unique Identifier GB-MHRA-ADR 26235468. A female patient received bnt162b2 (COMIRNATY), administration date 21Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 06Feb2021, stop date: 20Feb2021. 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 21Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 21Nov2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant), outcome "recovering", described as "headache"; TREMOR (medically significant) with onset 21Nov2021, outcome "recovering", described as "Shaking"; FEELING COLD (medically significant) with onset 21Nov2021, outcome "recovering", described as "feeling very cold"; FEELING HOT (medically significant), outcome "recovering", described as "very hot"; ARTHRALGIA (medically significant), outcome "recovering", described as "had pain in every joint". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Feb2021) yes - positive covid-19 test. Clinical course: 12 hours after having the booster, patient started to shake uncontrollably, feeling very cold. Blinding headache and very hot. Patient had pain in every joint. Patient has not tested positive for COVID-19 since having the vaccine. Patient is 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: 1926882 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Arthralgia, Asthenopia, Back pain, Bone pain, Chills, Drug ineffective, Dysarthria, Dysphonia, Feeling cold, Immunisation, Interchange of vaccine products, Malaise, Musculoskeletal chest pain, Neck pain, Nervousness, Off label use, Pain, Respiratory rate, Respiratory rate decreased, Skin burning sensation, Sluggishness, Suspected COVID-19
SMQs:, Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Corneal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Osteonecrosis (broad), Arthritis (broad), Respiratory failure (narrow), Medication errors (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211122; Test Name: Breathing rate; Result Unstructured Data: Test Result:slowed
CDC Split Type: GBPFIZER INC202101646194

Write-up: DRUG INEFFECTIVE; Suspected COVID-19; Pain bone; Aching joints; Sluggishness; Slurred speech; Back pain/ Upper back pain; Abdominal pain; Coldness; Breathing rate slowed; Neck pain; Rib pain; Chills; General malaise; Burning skin; Shaking inside; Voice disturbance, unspecified; Throbbing pain; Eyes heavy feeling of; off label use; Interchange of vaccine products; Booster; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202111222129046120-RWQGP, Safety Report Unique Identifier GB-MHRA-ADR 26235752. A 40 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 21Nov2021 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient not had a COVID-19 test. Patient is not currently breastfeeding. Patient last menstrual period was on 20Nov2021. The following information was reported: OFF LABEL USE (medically significant) with onset 21Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 21Nov2021, outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant) with onset 22Nov2021, outcome "not recovered", described as "DRUG INEFFECTIVE"; SUSPECTED COVID-19 (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Suspected COVID-19"; BONE PAIN (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Pain bone"; ARTHRALGIA (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Aching joints"; SLUGGISHNESS (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Sluggishness"; DYSARTHRIA (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Slurred speech"; BACK PAIN (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Back pain/ Upper back pain"; ABDOMINAL PAIN (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Abdominal pain"; FEELING COLD (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Coldness"; RESPIRATORY RATE DECREASED (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Breathing rate slowed"; NECK PAIN (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Neck pain"; MUSCULOSKELETAL CHEST PAIN (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Rib pain"; CHILLS (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Chills"; MALAISE (medically significant) with onset 22Nov2021, outcome "not recovered", described as "General malaise"; SKIN BURNING SENSATION (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Burning skin"; NERVOUSNESS (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Shaking inside"; DYSPHONIA (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Voice disturbance, unspecified"; PAIN (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Throbbing pain"; ASTHENOPIA (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Eyes heavy feeling of". The patient underwent the following laboratory tests and procedures: respiratory rate: (22Nov2021) slowed. Clinical course: Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Reporter did not consider the report relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be requested. No further information is expected.


VAERS ID: 1926891 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Immunisation, Myalgia, Nausea, SARS-CoV-2 test, Skin temperature
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 20211122; Test Name: SKIN TEMPERATURE; Result Unstructured Data: Test Result:unknown result
CDC Split Type: GBPFIZER INC202101646536

Write-up: Skin temperature; Nauseated; Tiredness; Muscle pain; Headache dull; booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111222220263530-6BOQ2 (Regulatory Authority). Other Case identifier(s): GB-MHRA-ADR 26235868 (Regulatory Authority). A 46-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 21Nov2021 (Batch/Lot number: unknown) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Date of last menstrual period: 15Nov2021. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunisation; Bnt162b2 (Dose 2), for COVID-19 Immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 21Nov2021, outcome "unknown", described as "booster"; SKIN TEMPERATURE (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Skin temperature"; HEADACHE (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Headache dull"; NAUSEA (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Nauseated"; FATIGUE (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Tiredness"; MYALGIA (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Muscle pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (unspecified date) no - negative covid-19 test; skin temperature: (22Nov2021) unknown result. Patient has not had symptoms associated with COVID-19, Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is 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: 1926930 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   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: Diabetes mellitus inadequate control, SARS-CoV-2 test
SMQs:, Hyperglycaemia/new onset diabetes mellitus (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: COVID-19 MRNA VACCINE BNT162B2
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Loss of control of diabetes; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26245641) 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 DIABETES MELLITUS INADEQUATE CONTROL (Loss of control of diabetes) in a 65-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Concomitant products included TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) from 26-Feb-2021 to an unknown date for an unknown indication. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced DIABETES MELLITUS INADEQUATE CONTROL (Loss of control of diabetes) (seriousness criterion medically significant). At the time of the report, DIABETES MELLITUS INADEQUATE CONTROL (Loss of control of diabetes) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patients glucose monitor was registered continued high glucose levels even though patient eating and exercising as normal. Patient had not tested positive for COVID-19 since having the vaccine. Patient not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. No medical history information was reported. Treatment medication information was not provided by the reporter. This case concerns a 65-year-old, female patient with relevant medical history of diabetes with glucose monitor, who experienced the unexpected event of diabetes mellitus inadequate control. The event occurred 1 day after the third dose of mRNA-1273. The rechallenge was unknown as was reported by regulatory Authority. The medical history of diabetes with glucose monitor 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 65-year-old, female patient with relevant medical history of diabetes with glucose monitor, who experienced the unexpected event of diabetes mellitus inadequate control. The event occurred 1 day after the third dose of mRNA-1273. The rechallenge was unknown as was reported by regulatory Authority. The medical history of diabetes with glucose monitor 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: 1926933 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-21
   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, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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

Write-up: Nausea; Chills; Vomiting; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26246459) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This case was received via Regulatory agency (Reference number: GB-MHRA-ADR 26246459) 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 NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills) in a 50-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concomitant products included DESOGESTREL and INFLUENZA VACCINE INACT SAG 3V (INFLUVAC) for an unknown indication. On 18-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). On 22-Nov-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). At the time of the report, NAUSEA (Nausea) was resolving and VOMITING (Vomiting) and CHILLS (Chills) had resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medication information was mentioned by reporter No treatment medication information was mentioned by reporter; Sender''s Comments: This case concerns a 50 year old female patient with no relevant medical history, who experienced the serious unexpected events of vomiting, nausea and chills. The events occurred approximately 3 days 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: 1926944 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   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
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Haemoptysis, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Infective pneumonia (broad), COVID-19 (broad)

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

Write-up: Coughing blood; This case was received via RA (Reference number: GB-MHRA-ADR 26256140) 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 HAEMOPTYSIS (Coughing blood) in a 55-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. Patient has not had symptoms associated with COVID-19. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 17-Feb-2021 to an unknown date and INFLUENZA VACCINE INACT SAG 3V (INFLUVAC) from 29-Oct-2021 to an unknown date for an unknown indication. On 21-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced HAEMOPTYSIS (Coughing blood) (seriousness criterion medically significant). At the time of the report, HAEMOPTYSIS (Coughing blood) 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 was not provided by the reporter. Treatment information was not provided. Chest X ray was done to patient but results were not given. This is a regulatory case concerning a 55-year-old male patient with the Covid-19 Pfizer Biontech vaccine and Influenza vaccine as concomitant products, who experienced the unexpected event of haemoptysis. The event occurred on the same day after the third dose of mRNA � 1273 vaccine. Haemoptysis was reported as medically significant but at the time of report event was resolving. The rechallenge was 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 55-year-old male patient with the Covid-19 Pfizer Biontech vaccine and Influenza vaccine as concomitant products, who experienced the unexpected event of haemoptysis. The event occurred on the same day after the third dose of mRNA � 1273 vaccine. Haemoptysis was reported as medically significant but at the time of report event was resolving. The rechallenge was 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: 1926945 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   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: Diarrhoea, SARS-CoV-2 test
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; EVOREL; IBUPROFEN; INFLUENZA VIRUS; UTROGESTAN
Current Illness:
Preexisting Conditions: Comments: The medical history was not provided by the reporter.
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: Diarrhea; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26256344) 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 DIARRHOEA (Diarrhea) in a 56-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. The medical history was not provided by the reporter. Concomitant products included ESTRADIOL (EVOREL) and PROGESTERONE (UTROGESTAN) for HRT, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 21-Mar-2021 to an unknown date, IBUPROFEN and INFLUENZA VACCINE (INFLUENZA VIRUS) for an unknown indication. On 21-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant). At the time of the report, DIARRHOEA (Diarrhea) 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. Patient experienced soft (not liquid) and very pale stools for the last five days and discomfort in lower bowels. A brief (twice in 10 mins) bout of very painful spasms in lower bowel area three days after booster which was enough to take breath away and need to sit down till it passed. Patient has not tested positive for COVID-19 since having the vaccine. No treatment medications were provided by the reporter. Company comment: This RA case concerns a 56 year old female with no reported medical history , who was vaccinated with Covid 19 Astra Zeneca ( for dose 1 and dose 2 ) and also with Infleunza vaccine , who experienced Serious ( Medically Significant) , unexpected event of Diarrhea which occurred at the same day after vaccination with the 3rd dose ( booster dose ) of mRNA-1273 vaccine ( Moderna Vaccine ) . The re-challenge for this case is not applicable since the events had not yet resolved and the event 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 female with no reported medical history , who was vaccinated with Covid 19 Astra Zeneca ( for dose 1 and dose 2 ) and also with Infleunza vaccine , who experienced Serious ( Medically Significant) , unexpected event of Diarrhea which occurred at the same day after vaccination with the 3rd dose ( booster dose ) of mRNA-1273 vaccine ( Moderna Vaccine ) . The re-challenge for this case is not applicable since the events had not yet resolved and the event 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: 1926948 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   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: Abdominal pain upper, Dizziness postural, Fatigue, Headache, 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: COVID-19 VACCINE ASTRAZENECA; PERINDOPRIL
Current Illness: Blood pressure high; Chronic kidney disease stage 3; Drug hypersensitivity (statins)
Preexisting Conditions: Comments: suffer with High blood pressure- CKD stage 3 and had a bad reaction to statins Unsure if patient has had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211124; 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: headache; Head pain; Exhaustion; Dizzy on standing; Nausea; Vomited; Stomach ache; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26256403) 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), HEADACHE (Head pain), FATIGUE (Exhaustion), DIZZINESS POSTURAL (Dizzy on standing), NAUSEA (Nausea), VOMITING (Vomited) and ABDOMINAL PAIN UPPER (Stomach ache) in a 60-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. suffer with High blood pressure- CKD stage 3 and had a bad reaction to statins Unsure if patient has had symptoms associated with COVID-19. Concurrent medical conditions included Blood pressure high, Chronic kidney disease stage 3 and Drug hypersensitivity (statins). Concomitant products included PERINDOPRIL from 14-Aug-2017 to an unknown date for Blood pressure, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 17-Feb-2021 to an unknown date for Vaccination. On 21-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache) (seriousness criterion medically significant). On 22-Nov-2021, the patient experienced HEADACHE (Head pain) (seriousness criterion medically significant), FATIGUE (Exhaustion) (seriousness criterion medically significant), DIZZINESS POSTURAL (Dizzy on standing) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and VOMITING (Vomited) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criterion medically significant). On 22-Nov-2021, ABDOMINAL PAIN UPPER (Stomach ache) had resolved. On 23-Nov-2021, VOMITING (Vomited) had resolved. At the time of the report, HEADACHE (headache), HEADACHE (Head pain), FATIGUE (Exhaustion) and DIZZINESS POSTURAL (Dizzy on standing) was resolving and NAUSEA (Nausea) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-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 information mentioned. The patient had negative PCR test and suffer with CKD stage 3. The patient felt very unwell on 22 Nov 21 and vomited. The patient felt slightly better on 23 Nov 2021. The patient felt very unwell 24 Nov 21, light headed , headache, exhausted Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. Company Comment : This RA case concerns a 60 year old female with relevant medical history of hypertension and CKD stage 3 , administered with Covid 19 Astra Zena Vaccine (as 1st and 2nd dose ) who experienced Serious ( Medically Significant ) , Unexpected event of upper abdominal pain which occurred the same day after vaccination with the 3rd dose ( booster dose ) of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . On the 2nd day after vaccination with the booster dose , she experienced Serious ( Medically Significant ) , unexpected event of vomiting . On the 3rd day post vaccination with the 3r dose , she experienced postural dizziness , headache and fatigue. Another Serious , unexpected event of headache occurred on an unknown date. SARS Cov - 2 test was done which yielded negative results. The re-challenge for this case is not applicable since the events occurred after the 3rd dose ( booster dose ) and no additional doses will be given. The medical illnesses reported above of CKD Stage 3 and hypertension can be considered confounders for this case (events mentioned may manifest secondary to these illnesses) . 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 60 year old female with relevant medical history of hypertension and CKD stage 3 , administered with Covid 19 Astra Zena Vaccine (as 1st and 2nd dose ) who experienced Serious ( Medically Significant ) , Unexpected event of upper abdominal pain which occurred the same day after vaccination with the 3rd dose ( booster dose ) of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . On the 2nd day after vaccination with the booster dose , she experienced Serious ( Medically Significant ) , unexpected event of vomiting . On the 3rd day post vaccination with the 3r dose , she experienced postural dizziness , headache and fatigue. Another Serious , unexpected event of headache occurred on an unknown date. SARS Cov - 2 test was done which yielded negative results. The re-challenge for this case is not applicable since the events occurred after the 3rd dose ( booster dose ) and no additional doses will be given. The medical illnesses reported above of CKD Stage 3 and hypertension can be considered confounders for this case (events mentioned may manifest secondary to these illnesses) . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.


VAERS ID: 1926972 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-21
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ear pain, Fatigue, Headache, Immunisation, Influenza, Interchange of vaccine products, Myocarditis, Off label use
SMQs:, Cardiomyopathy (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101697392

Write-up: Earache; Flu symptoms; Headache; Fatigue; myocarditis; 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 Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111300041014830-SEM1N (RA). Other Case identifier(s): GB-MHRA-ADR 26267555 (RA). A 49 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. The patient was not currently breastfeeding. The patient was not enrolled in clinical trial. Vaccination history included: COVID-19 vaccine astrazeneca (Dose: 1, Single, Batch/Lot number: Unknown), for COVID-19 immunisation; COVID-19 vaccine astrazeneca (Dose: 2, Single, Batch/Lot number: Unknown), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (disability, medically significant) with onset 2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability, medically significant) with onset 2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (disability, medically significant) with onset 2021, outcome "unknown", described as "Booster"; EAR PAIN (disability, medically significant) with onset 21Nov2021, outcome "recovered" (25Nov2021), described as "Earache"; INFLUENZA (disability, medically significant) with onset 21Nov2021, outcome "recovering", described as "Flu symptoms"; MYOCARDITIS (disability, medically significant) with onset 2021, outcome "not recovered", described as "myocarditis"; HEADACHE (disability, medically significant) with onset 21Nov2021, outcome "recovered" (25Nov2021), described as "Headache"; FATIGUE (disability, medically significant) with onset 21Nov2021, outcome "recovering", described as "Fatigue". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1927546 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   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: Anxiety, Nightmare, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Bad dreams; Nightmares; Anxious mood; High temperature; This case was received via RA (Reference number: GB-MHRA-ADR 26246043) 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 (High temperature), NIGHTMARE (Bad dreams), NIGHTMARE (Nightmares) and ANXIETY (Anxious mood) in a 58-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. 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 21-Nov-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant). On 22-Nov-2021, the patient experienced NIGHTMARE (Bad dreams) (seriousness criterion medically significant), NIGHTMARE (Nightmares) (seriousness criterion medically significant) and ANXIETY (Anxious mood) (seriousness criterion medically significant). On 23-Nov-2021, PYREXIA (High temperature), NIGHTMARE (Bad dreams), NIGHTMARE (Nightmares) and ANXIETY (Anxious mood) had resolved. 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. 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 58-year-old female patient with no relevant medical history reported, who experienced serious, unexpected events of pyrexia, nightmare (reported as Bad dreams and Nightmares) and anxiety. The events occurred approximately 1 day after the third dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. 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 no relevant medical history reported, who experienced serious, unexpected events of pyrexia, nightmare (reported as Bad dreams and Nightmares) and anxiety. The events occurred approximately 1 day after the third dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1927547 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-21
   Days after vaccination:1
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: Arthralgia, Chills, Headache, Pain, 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL; INFLUENZA VIRUS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211111; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Aching joints; Chills; Aching in limb; Headache; Shooting pain; This case was received via Regulatory Authority-RA (Reference number: GB-MHRA-ADR 26246679) 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 ARTHRALGIA (Aching joints), CHILLS (Chills), PAIN IN EXTREMITY (Aching in limb), HEADACHE (Headache) and PAIN (Shooting pain) in a 65-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. Concomitant products included BISOPROLOL from 12-Dec-2011 to an unknown date for Heart rate, INFLUENZA VACCINE (INFLUENZA VIRUS) from 16-Oct-2021 to an unknown date for an unknown indication. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced ARTHRALGIA (Aching joints) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), PAIN IN EXTREMITY (Aching in limb) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and PAIN (Shooting pain) (seriousness criterion medically significant). On 22-Nov-2021, ARTHRALGIA (Aching joints), CHILLS (Chills), PAIN IN EXTREMITY (Aching in limb), HEADACHE (Headache) and PAIN (Shooting pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. It was reported that the day after the vaccine patient was very unwell and needed to stay in bed for 24 hours and she was in pain all over, aching knees, hips, finger joints. Patient also had pain in claves, shooting pain in thighs, aching abdomen, unable to get warm, lack of appetite and fatigue. Laboratory data was mentioned as on 22-Nov-2021 patient took lateral flo which was negative. No treatment medication was given. No treatment medication was given. Company Comment: This case concerns a 65-year-old female subject, with no medical history reported, who experienced the unexpected and serious events of Arthralgia, Chills, Pain in extremity, Headache, and Pain. The events of Arthralgia, Chills, and Headache, are unexpected as they are retained as serious per the source document Authority reporting. The events occurred 1 day 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.; Sender''s Comments: This case concerns a 65-year-old female subject, with no medical history reported, who experienced the unexpected and serious events of Arthralgia, Chills, Pain in extremity, Headache, and Pain. The events of Arthralgia, Chills, and Headache, are unexpected as they are retained as serious per the source document Authority reporting. The events occurred 1 day 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: 1928234 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   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: Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (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: Swelling; This case was received via RA (Reference number: GB-MHRA-ADR 26242527) 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 SWELLING (Swelling) 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 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 21-Nov-2021, the patient experienced SWELLING (Swelling) (seriousness criterion medically significant). At the time of the report, SWELLING (Swelling) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medication information provided. Patient started with painful injection site and swelling by the afternoon of 21-Nov-2021 and swelling to lower armpit breast side with discomfort to neck and fingers down vaccinated arm. Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial No treatment medication information provided. Company comment: This regulatory case concerns a 58-year-old, female patient with no reported medical history, who experienced the unexpected, serious (IME) events of swelling. The patient experienced pain at injection site and swelling by the afternoon of the same day after administration of third dose of mRNA-1273 vaccine. Swelling evolved to lower armpit breast side with discomfort to neck and fingers down vaccinated arm. 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 58-year-old, female patient with no reported medical history, who experienced the unexpected, serious (IME) events of swelling. The patient experienced pain at injection site and swelling by the afternoon of the same day after administration of third dose of mRNA-1273 vaccine. Swelling evolved to lower armpit breast side with discomfort to neck and fingers down vaccinated arm. 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: 1928236 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-21
   Days after vaccination:2
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: Chills, Chromaturia, Decreased appetite, Fatigue, Influenza like illness, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Flu
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: Flu like symptoms; Red urine; Tired all the time; Chills; Fever; Appetite lost; This case was received via the RA (Reference number: RA 26242185) 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 symptoms), DECREASED APPETITE (Appetite lost), CHROMATURIA (Red urine), FATIGUE (Tired all the time), CHILLS (Chills) and PYREXIA (Fever) in a 53-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 Flu. Previously administered products included for Product used for unknown indication: Flu Vaccine on 02-Nov-2021 and BEMFOLA. Past adverse reactions to the above products included No adverse effect with Flu Vaccine; and No adverse event with BEMFOLA. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant), FATIGUE (Tired all the time) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 23-Nov-2021, the patient experienced CHROMATURIA (Red urine) (seriousness criterion medically significant). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion medically significant). On 23-Nov-2021, CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), DECREASED APPETITE (Appetite lost) and CHROMATURIA (Red urine) had not resolved and FATIGUE (Tired all the time) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-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. Treatment information was not provided. Patient had some pain at the injection point on the first day of vaccination. Patient had flu like symptoms which began a few days later on the sunday while at work. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This regulatory authority case concerns a 53-year-old male patient with a history of previously administered Influenza Vaccine, who experienced the unexpected serious (medically significant) events of Influenza like illness, Decreased appetite, Chromaturia, Fatigue, Chills and Pyrexia after mRNA- 1273 Moderna vaccine. The events Decreased appetite, Fatigue, Chills and Pyrexia occurred approximately 2 days after the third dose of mRNA- 1273 vaccine, Influenza like illness occurred a few days after the third dose and Chromaturia occurred approximately 4 days after the third dose. Vaccination site pain was also reported on the first day after vaccination. SARS-CoV-2 test was negative. Very limited information is available regarding clinical course. The rechallenge was reported as unknown, only information about the third dose was disclosed. Recent Influenza vaccination 23 days before 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 53-year-old male patient with a history of previously administered Influenza Vaccine, who experienced the unexpected serious (medically significant) events of Influenza like illness, Decreased appetite, Chromaturia, Fatigue, Chills and Pyrexia after mRNA- 1273 Moderna vaccine. The events Decreased appetite, Fatigue, Chills and Pyrexia occurred approximately 2 days after the third dose of mRNA- 1273 vaccine, Influenza like illness occurred a few days after the third dose and Chromaturia occurred approximately 4 days after the third dose. Vaccination site pain was also reported on the first day after vaccination. SARS-CoV-2 test was negative. Very limited information is available regarding clinical course. The rechallenge was reported as unknown, only information about the third dose was disclosed. Recent Influenza vaccination 23 days before might be a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report


VAERS ID: 1930271 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0112 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101646267

Write-up: Shortness of breath; This is a spontaneous report received from a contactable reporter (Consumer) from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (RA). Regulatory number: GB-MHRA-APPCOVID-202111221348146080-CB7UO (RA). Other Case identifier: GB-MHRA-ADR 26234593 (RA). A 56 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FK0112) as dose 1, single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. The following information was reported: DYSPNOEA (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Shortness of breath". Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1930285 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-21
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 1 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101654442

Write-up: Major heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-EYC 00267194 (regulatory authority). Other Case identifier(s): GB-MHRA-ADR 26238342 (regulatory authority). A 53 year-old male patient received bnt162b2 (COMIRNATY), parenteral, administration date 15Nov2021 (Batch/Lot number: FH4751) 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: MYOCARDIAL INFARCTION (medically significant, life threatening) with onset 21Nov2021, outcome "unknown", described as "Major heart attack". Clinical course: Indication for bnt162b2 was reported as ill-defined disorder. The patient was taking PFIZER biontech for: Booster shot. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1930361 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   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: Chills, Facial paralysis, Feeling cold, Hypoaesthesia, Hypoaesthesia oral, Immunisation, Interchange of vaccine products, Nausea, Off label use, Pain, Pain in extremity, Pyrexia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to moulds; Hypersensitivity; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101646359

Write-up: Painful arm; Fever; Shivers; aches; feeling cold; nauseous; Numb tongue; Numb face on right side; Off-label use; Interchange of vaccine products; Booster; Facial palsy; 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-202111220929278060-BAI3K. Other Case identifier(s): GB-MHRA-ADR 26233881. A female patient received bnt162b2 (COMIRNATY), administration date 21Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hypersensitivity" (unknown if ongoing); "Immunodeficiency" (unknown if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...; "mould allergy" (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Fostair, notes: Take fostair inhaler for mould allergy. 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 21Nov2021, outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 21Nov2021, outcome "unknown", described as "Booster"; FACIAL PARALYSIS (medically significant) with onset 21Nov2021, outcome "recovered" (21Nov2021), described as "Facial palsy"; PAIN IN EXTREMITY (medically significant), outcome "not recovered", described as "Painful arm"; PYREXIA (medically significant), outcome "not recovered", described as "Fever"; HYPOAESTHESIA ORAL (medically significant) with onset 21Nov2021, outcome "unknown", described as "Numb tongue"; HYPOAESTHESIA (medically significant) with onset 21Nov2021, outcome "unknown", described as "Numb face on right side"; CHILLS (medically significant), outcome "unknown", described as "Shivers"; PAIN (medically significant), outcome "unknown", described as "aches"; FEELING COLD (medically significant), outcome "unknown", described as "feeling cold"; NAUSEA (medically significant), outcome "unknown", described as "nauseous". Therapeutic measures were taken as a result of facial paralysis, pain in extremity, pyrexia, hypoaesthesia oral, hypoaesthesia, chills, pain, feeling cold, nausea. Addition information: Numb tongue and face on right side 30 mins after vaccination for approx 10 mins. Vaccinations administered on right side. Approx 12 hours after vac - Shivers/ aches/ feeling cold/ nauseous. 18 hours after still feeling the same. Slight relief from paracetamol but not complete. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). Take fostair inhaler for mould allergy Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1930372 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   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: Abdominal pain upper, Arthralgia, Back pain, Body temperature, Chest pain, Chills, Decreased appetite, Diarrhoea, Fatigue, Feeling cold, Illness, Immunisation, Interchange of vaccine products, Malaise, Off label use, Pain, Pain in extremity, Palpitations, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), 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:
Preexisting Conditions: Medical History/Concurrent Conditions: Coeliac disease
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: Temperature; Result Unstructured Data: Test Result:high; Test Date: 20211121; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101646260

Write-up: haven''t felt like eating; ache everywhere (particularly my legs); tired; Diarrhea; Feeling sick; High temperature; Shivering/Shivers; Joint pain; Backache; Heart racing; Chest pain; tummy pains; so cold; being ill in night; Off label use; Interchange of vaccine products; Booster; ache/achey; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111221244548610-CBE6L. Other Case identifier(s): GB-MHRA-ADR 26234483. A 46-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 21Nov2021 11:00 (Batch/Lot number: unknown) at the age of 46 years, as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Coeliac disease" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. 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 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 (disability) with onset 21Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability) with onset 21Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (disability) with onset 21Nov2021, outcome "unknown", described as "Booster"; PAIN (disability) with onset 21Nov2021, outcome "recovering", described as "ache/achey"; DIARRHOEA (disability) with onset 21Nov2021 19:00, outcome "recovered" (22Nov2021), described as "Diarrhea"; MALAISE (disability) with onset 21Nov2021, outcome "not recovered", described as "Feeling sick"; PYREXIA (disability) with onset 21Nov2021, outcome "not recovered", described as "High temperature"; CHILLS (disability) with onset 21Nov2021, outcome "recovered" (22Nov2021), described as "Shivering/Shivers"; ARTHRALGIA (disability) with onset 21Nov2021, outcome "not recovered", described as "Joint pain"; BACK PAIN (disability) with onset 21Nov2021, outcome "not recovered", described as "Backache"; PALPITATIONS (disability) with onset 21Nov2021, outcome "recovered" (22Nov2021), described as "Heart racing"; CHEST PAIN (disability) with onset 21Nov2021, outcome "not recovered", described as "Chest pain"; ABDOMINAL PAIN UPPER (disability) with onset 21Nov2021, outcome "unknown", described as "tummy pains"; FEELING COLD (disability) with onset 21Nov2021, outcome "unknown", described as "so cold"; DECREASED APPETITE (disability) with onset 22Nov2021 13:00, outcome "unknown", described as "haven''t felt like eating"; PAIN IN EXTREMITY (disability) with onset 22Nov2021 13:00, outcome "unknown", described as "ache everywhere (particularly my legs)"; FATIGUE (disability) with onset 22Nov2021, outcome "unknown", described as "tired"; ILLNESS (disability) with onset 21Nov2021, outcome "unknown", described as "being ill in night". The patient underwent the following laboratory tests and procedures: Temperature: (21Nov2021) high; COVID-19 virus test: (21Nov2021) negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of pain with paracetamol. Clinical course: booster given at 11 am, started with diarrhoea at 7 pm. Felt achey, went to bed at 10 with paracetamol, woke at midnight (21Nov2021) feeling sick & tummy pains, shivers, so cold, heart racing, chest pain. Now next day (22Nov2021) at 1 pm, hadn''t felt like eating & ache everywhere particularly her back & legs. Also tired (22Nov2021) from being ill in night (21Nov2021). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Reaction - does your report relate to possible inflammation of the heart (myocarditis or pericarditis)? If yes, we will ask you some additional questions at the end of this report: "No". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1930403 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   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, Pruritus, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (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: 20211122; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101646317

Write-up: itching all over; Rash; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111222037104880-ZHFT5. Other Case identifier: GB-MHRA-ADR 26235535. A 43-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 21Nov2021 (at the age of 43-years-old) as Dose 3 (Booster), single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient is not pregnant nor currently breastfeeding. Historical vaccine included first dose & second dose of BNT162B2, on an unspecified dates for COVID-19 immunisation. The patient experienced itching all over on an unspecified date and rash on 22Nov2021. The events were considered medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 22Nov2021. The patient has not recovered from the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1930405 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   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 - / -
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Off label use, Pain in extremity, Product use issue
SMQs:, Tendinopathies and ligament disorders (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101646556

Write-up: Painful arm/under arm in left side to be very painful and tender; INFLUENZA VIRUS; INFLUENZA VIRUS; booster; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111222126561580-WTTBE. Other Case identifier(s): GB-MHRA-ADR 26235667. A 54 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 21Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VIRUS), administration date 21Nov2021 (Batch/Lot number: unknown) for immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2), administration date: 19May2021, for COVID-19 immunisation, reaction(s): "under arm in left side to be very painful and tender"; Bnt162b2 (Dose 1), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 21Nov2021, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Painful arm/under arm in left side to be very painful and tender"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 21Nov2021, outcome "unknown" and all described as "INFLUENZA VIRUS". Clinical course: Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not currently breastfeeding. "On 2nd covid vaccination and booster which was given alongside flu jab has caused my under arm in left side to be very painful and tender." Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report does not relate to possible inflammation of the heart. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1930421 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   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: Chills, Dizziness, Dizziness postural, Headache, Heart rate increased, Hyperventilation, Immunisation, Interchange of vaccine products, Malaise, Myalgia, Off label use, Pain, Pyrexia, SARS-CoV-2 test, Somnolence, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: SANDRENA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20201231; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101654430

Write-up: high temperature; fever; pain; headache; dizzy; muscle aches; feeling shivery; she lay dozing; Tried to get to the bathroom but fainted; Feeling sick; started to breath fast; Pulse rapid; Dizzy on standing; 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 United Kingdom Medicines and Healthcare products Regulatory Agency (UK-MHRA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111230825066580-WGM32 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26236927 (MHRA). A 62-year-old female patient received BNT162B2 (COMIRNATY, formulation: Solution for injection), administration date 21Nov2021 (Batch/Lot number: unknown) at the age of 62 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 29Dec2020 (unspecified if ongoing), notes: Unsure when symptoms stopped. Concomitant medication(s) included: SANDRENA taken for hormone replacement therapy, start date: 04Jul2009. Vaccination history included: COVID-19 vaccine Astrazeneca (DOSE 1), for COVID-19 immunisation, reaction(s): "feeling shivery", "Dizzy", "Dizzy on standing", "Headache", "Pulse rapid", "Feeling sick", "muscle ache", "Pain", "Fever", "High temperature"; COVID-19 vaccine Astrazeneca (DOSE 2), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 21Nov2021, outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 21Nov2021, outcome "unknown", described as "Booster"; PYREXIA (medically significant), outcome "recovering", described as "high temperature"; PYREXIA (medically significant), outcome "recovering", described as "fever"; PAIN (medically significant), outcome "recovering", described as "pain"; HEADACHE (medically significant), outcome "recovering", described as "headache"; DIZZINESS (medically significant), outcome "recovering", described as "dizzy"; MALAISE (medically significant) with onset 22Nov2021, outcome "recovered" (22Nov2021), described as "Feeling sick"; HYPERVENTILATION (medically significant) with onset 22Nov2021, outcome "recovered" (22Nov2021), described as "started to breath fast"; HEART RATE INCREASED (medically significant) with onset 22Nov2021, outcome "recovered" (22Nov2021), described as "Pulse rapid"; DIZZINESS POSTURAL (medically significant) with onset 22Nov2021, outcome "recovered" (22Nov2021), described as "Dizzy on standing"; MYALGIA (medically significant), outcome "unknown", described as "muscle aches"; CHILLS (medically significant), outcome "unknown", described as "feeling shivery"; SYNCOPE (medically significant) with onset 22Nov2021, outcome "recovering", described as "Tried to get to the bathroom but fainted"; SOMNOLENCE (medically significant) with onset 22Nov2021, outcome "recovering", described as "she lay dozing". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (31Dec2020) positive, notes: Yes - Positive COVID-19 test. Clinical course: Case narrative: Had her booster Monday afternoon 21Nov2021- Pfizer (her first two were AstraZ). No initial symptoms and played an easy game of tennis, followed by a couple of glasses of wine and pizza. It was only after midnight, in bed, that she started to get the same type of symptoms she had in January (when she had COVID) and after the first vaccination. She did not get any symptoms when she had the second dose. The symptoms last night were high temperature, muscle aches (any arthritis felt worse) and feeling shivery. However, she started to breath fast (hyperventilating) and my pulse was rapid and felt sick and dizzy. Tried to get to the bathroom but fainted. Her Hubby gave pain relief and she lay dozing for a while on the floor (did not feel able to get up). At some point this morning the fever broke and now in bed feeling a bit better. Still achy and she have a headache. 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: 1930427 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   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: Body temperature, Headache, Immunisation, Interchange of vaccine products, Lethargy, Pyrexia, SARS-CoV-2 test, Swelling, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Cauda equina syndrome; Depression; Insomnia; Migraine; Ovarian cyst; Recurrent pulmonary embolism
Allergies:
Diagnostic Lab Data: Test Date: 20211122; Test Name: temperature; Result Unstructured Data: Test Result:High; Test Date: 20211121; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101654187

Write-up: High temperature; Swollen of face feeling; Feeling swollen; Headache; Lethargy; patient received third (booster) dose of BNT162b2/previously received two doses of COVID-19 vaccine, at least one is non-Pfizer COVID-19 Vaccine; patient received third (booster) dose of BNT162b2/previously received two doses of COVID-19 vaccine, at least one is non-Pfizer COVID-19 Vaccine; patient received third (booster) dose of BNT162b2/previously received two doses of COVID-19 vaccine, at least one is non-Pfizer COVID-19 Vaccine; This is a spontaneous report received from a contactable reporter (Consumer) from the Agency Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111230912525640-XWODQ. Other Case identifier(s): GB-MHRA-ADR 26237150. A 44 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 21Nov2021 (Batch/Lot number: unknown) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Insomnia" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Cauda equina syndrome" (unspecified if ongoing); "Recurrent pulmonary embolism" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Ovarian cyst" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 2, SINGLELot Number: UNKNOWN;Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, SINGLELot Number: UNKNOWN;Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 21Nov2021, outcome "unknown" and all described as "patient received third (booster) dose of BNT162b2/previously received two doses of COVID-19 vaccine, at least one is non-Pfizer COVID-19 Vaccine"; PYREXIA (medically significant) with onset 22Nov2021, outcome "not recovered", described as "High temperature"; SWELLING FACE (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Swollen of face feeling"; SWELLING (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Feeling swollen"; HEADACHE (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Headache"; LETHARGY (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Lethargy". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Nov2021) no - negative covid-19 test. The patient had no symptoms associated with COVID-19 and was not enrolled in the clinical trial. The patient was not pregnant and was not breast feeding at the time of this report. The 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). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1930455 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   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 FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Epistaxis, Haemorrhage subcutaneous, Hyperaesthesia, Immunisation, Interchange of vaccine products, Muscular weakness, Off label use, Pain in extremity, Paraesthesia, SARS-CoV-2 test, Vaccination site mass, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210930; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101654438

Write-up: last; tender; touch; still; small; Pins and needles; Nose bleeds; Painful arm; Interchange of vaccine products; Booster; Off-label use; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111231206530440-XWWMZ. Other Case identifier(s): GB-MHRA-ADR 26238226. A 56-year-old female patient received bnt162b2 (COMIRNATY), administration date 21Nov2021 (Lot number: FK9413) at the age of 56 years as dose 3 (booster), single for covid-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 21Nov2021, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 21Nov2021, outcome "unknown", described as "Off-label use"; HAEMORRHAGE SUBCUTANEOUS (medically significant), outcome "not recovered", described as "last"; MUSCULAR WEAKNESS (non-serious), outcome "not recovered", described as "tender"; HYPERAESTHESIA (non-serious), outcome "not recovered", described as "touch"; VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "still"; VACCINATION SITE MASS (non-serious), outcome "not recovered", described as "small"; PARAESTHESIA (non-serious) with onset 22Nov2021, outcome "not recovered", described as "Pins and needles in feet"; EPISTAXIS (non-serious) with onset 22Nov2021, outcome "not recovered", described as "Nose bleeds"; PAIN IN EXTREMITY (non-serious) with onset 21Nov2021, outcome "not recovered", described as "Painful arm". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Sep2021) no - negative covid-19 test. Clinical Course: Patient had pin and needles in her feet. Nose bleeds didn''t last long and were small. Arm still tender to touch. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report was not related to possible inflammation of the heart (myocarditis or pericarditis).


VAERS ID: 1930461 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   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: Heart rate increased, Immunisation, Interchange of vaccine products, Malaise, Off label use, Pain, SARS-CoV-2 test, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Medication errors (broad), Dehydration (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: Medical History/Concurrent Conditions: Diverticular disease
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101654390

Write-up: Aches; feeling sick; fast heart rate; Tachycardia; 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 Agency. Regulatory number: GB-MHRA-WEBCOVID-202111231230147110-EZYEV. Other Case identifier(s): GB-MHRA-ADR 26238332. A 65 year-old female patient received bnt162b2 (COMIRNATY), administration date 21Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "CKD stage 3/4 Diverticular disease" (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 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 21Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Nov2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 21Nov2021, outcome "unknown", described as "Booster"; TACHYCARDIA (medically significant) with onset 22Nov2021, outcome "recovered" (23Nov2021), described as "Tachycardia"; PAIN (medically significant), outcome "unknown", described as "Aches"; MALAISE (medically significant), outcome "unknown", described as "feeling sick"; HEART RATE INCREASED (medically significant), outcome "unknown", described as "fast heart rate". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: Reporter reported patient experienced aches, no fever, fast heart rate feeling sick. 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. This report did not re-late 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.


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