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From the 11/12/2021 release of VAERS data:

Found 875,292 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 96 out of 8,753

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VAERS ID: 1858398 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046C21A / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (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: UNKNOWN
Current Illness: UNKNOWN
Preexisting Conditions: UNKNOWN
Allergies: NKDA
Diagnostic Lab Data: UNKNOWN
CDC Split Type:

Write-up: VACCINE ADMINISTERED WAS IN THE FRIDGE MORE THAN 30 DAYS AS RECOMMENDED BY THE MANUFACTURER.


VAERS ID: 1858787 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-10-25
Onset:2021-10-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30155BA / 1 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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: Albuterol inhaler,
Current Illness: Post covid respiratory issues
Preexisting Conditions: Sjogrens disease
Allergies: Penicillin , asprin ,contrast dye ,sulfur,steroids,gluten,dairy,
Diagnostic Lab Data:
CDC Split Type:

Write-up: 5 hours after vaccine was vomiting the next day at 12 I started having shortness of breath which lasted the rest of the day even using my inhaler it did not help


VAERS ID: 1860123 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-03-10
Onset:2021-10-26
   Days after vaccination:230
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 041L20A / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Feeling abnormal, Pyrexia, Skin warm
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: skin is really hot; felt really awful/bad; chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (skin is really hot), FEELING ABNORMAL (felt really awful/bad), CHILLS (chills) and PYREXIA (Fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 041L20A and 019B21A) for COVID-19 vaccination. No Medical history information reported. Concomitant products included SOTALOL for an unknown indication. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced SKIN WARM (skin is really hot), FEELING ABNORMAL (felt really awful/bad), CHILLS (chills) and PYREXIA (Fever). In October 2021, SKIN WARM (skin is really hot), FEELING ABNORMAL (felt really awful/bad), CHILLS (chills) and PYREXIA (Fever) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Treatment information was reported. It was reported that symptoms occurred 24 hours after the booster shot and lasted approximately 8 hours. Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Follow-up received on 01-NOV-2021 contains Significant information. Outcome of events updated.


VAERS ID: 1860124 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Minnesota  
Vaccinated:0000-00-00
Onset:2021-10-26
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

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

Write-up: she was not feeling well; Diarrhea/diarrhea up until yesterday and is unsure if she has it today; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea/diarrhea up until yesterday and is unsure if she has it today) and MALAISE (she was not feeling well,) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021 at 5:00 PM, the patient experienced DIARRHOEA (Diarrhea/diarrhea up until yesterday and is unsure if she has it today). On an unknown date, the patient experienced MALAISE (she was not feeling well,). At the time of the report, DIARRHOEA (Diarrhea/diarrhea up until yesterday and is unsure if she has it today) had not resolved and MALAISE (she was not feeling well,) outcome was unknown. Patient mentions that two weeks prior to the booster shot she took some antibiotics No Treatment Information were provided by the reporter Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Significant Follow up received contains Reporters address added, Mentioned about Booster dose, Event & Event Outcome updated


VAERS ID: 1860366 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-08-23
Onset:2021-10-26
   Days after vaccination:64
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 1 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, COVID-19, Drug ineffective, Heart rate increased, Nasopharyngitis, Oxygen saturation, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Infective pneumonia (broad), Dehydration (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: 2021; Test Name: Body temperature; Result Unstructured Data: Test Result:95 Fahrenheit; Comments: temperature today 95 degrees Fahrenheit,; Test Date: 2021; Test Name: Heart rate; Result Unstructured Data: Test Result:108; Comments: heart rate which was 70-81, is 108 today; Test Date: 2021; Test Name: oxygen level; Result Unstructured Data: Test Result:97-99 %; Comments: oxygen level 97-99%; Test Date: 2021; Test Name: Covid-19 test; Test Result: Negative ; Test Date: 20211025; Test Name: Covid-19 test; Test Result: Positive
CDC Split Type: USPFIZER INC202101488176

Write-up: heart rate which was 70-81, was 108 today; test results came back positive for COVID-19; test results came back positive for COVID-19; had a cold; This is a spontaneous report from a Pfizer Sponsored Program. A 51-year-old female patient received bnt162b2 (COMIRNATY), (Formulation: Solution for injection, Batch/Lot Number was EW0191, Expiration Date: 30Sep2021) as dose 1, single via an unspecified route of administration, administered in arm right on 23Aug2021 (age at vaccination 51 years) for covid-19 immunization. Patient was taking the vaccine to keep from being hospitalized. Patient medical history was not reported. The patient''s concomitant medications were not reported. On 25Oct2021, patient went to be tested for COVID-19 as she noticed her sense of taste and smell was gone. The patient also stated that she feels like today was the day the virus broke from my body because her heart rate which was 70-81, is 108 today. The patient also states that she has not had any headache, fever or body aches with this COVID-19 diagnosis. Patients ask a question that if it was recommended to get the second dose of the vaccine even if she did not receive it at 3 weeks patient also added that she was planning on getting it at 4 months after the first dose instead of the recommended 3 weeks after the first dose. On an unknown date patient also experience heart rate 108, temperature today 95 degrees Fahrenheit, oxygen level 97-99%. Patient had a cold and that convinced her to get her first dose of the Pfizer Covid 19 vaccine. The patient underwent lab test and procedure which included 95 Fahrenheit on an unknown date in 2021 temperature today 95 degrees Fahrenheit, heart rate increased: 108, heart rate which was 70-81, was 108 today, oxygen level 97-99%, sars-cov-2 test: negative, patient got tested for Covid on 25Oct2021, and got the positive result on 26Oct2021. The outcome of event all the events was not recovered but outcome of patient had a cold was unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1860379 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-03-01
Onset:2021-10-26
   Days after vaccination:239
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9261 / 2 RA / OT

Administered by: Work       Purchased by: ?
Symptoms: Computerised tomogram, Computerised tomogram thorax, Echocardiogram, Fibrin D dimer, Positron emission tomogram, Pulmonary embolism, SARS-CoV-2 test, Thrombosis, Ultrasound Doppler
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ASPIRIN [ACETYLSALICYLIC ACID]; FLUOXETINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: CT scan; Result Unstructured Data: Test Result:Unknown Results; Test Name: Chest CT; Result Unstructured Data: Test Result:Right upper lobe pulmonary nodule; Comments: Right upper lobe pulmonary nodule measuring 1 cm.; Test Date: 2021; Test Name: Cariac Echo; Result Unstructured Data: Test Result:Unknown Results; Test Date: 2021; Test Name: D Dimer; Result Unstructured Data: Test Result:Unknown Results; Test Date: 2021; Test Name: PET/CT or tissue sampling; Result Unstructured Data: Test Result:Unknown Results; Test Date: 20211025; Test Name: POC COVID-19 Molecular, Abbott ID NOW; Test Result: Negative ; Comments: Blood test; Test Date: 2021; Test Name: Venous Doppler Ultrasound; Result Unstructured Data: Test Result:Unknown Results
CDC Split Type: USPFIZER INC202101515053

Write-up: Occlusive thrombus; pulmonary emboli; This is a spontaneous report from a contactable pharmacist. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Right on 01Mar2021 (Batch/Lot Number: EL9261), vaccinated at age of 64 years old, as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); and fluoxetine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot No: EL1284) on 08Feb2021 05:00 PM via intramuscular on arm right for covid-19 immunisation, at age of 64 years old. The patient experienced occlusive thrombus, and pulmonary emboli both on 26Oct2021 11:00 with outcome of recovering. The patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included CT scan: unknown results on 2021, Chest CT: Right upper lobe pulmonary nodule measuring 1 cm on unspecified date, Cariac Echo: unknown results on 2021, D Dimer: unknown results on 2021, PET/CT or tissue sampling: unknown results on 2021, POC COVID-19 Molecular, Abbott ID NOW: negative on 25Oct2021, Venous Doppler Ultrasound: unknown results on 2021. Occlusive thrombus seen along the right common femoral vein, femoral vein, popliteal vein, and posterior tibial vein. Short segment occlusive thrombus seen along the distal left femoral vein. No focal fluid collections. Result: Acute on subacute pulmonary emboli (mild to moderate burden) as described. No right heart strain. Right upper lobe pulmonary nodule measuring 1 cm. Consider a non contrast. Chest CT at 3 months, a PET/CT, or tissue sampling. Acute on subacute mild to moderate burden pulmonary emboli characterized by right upper, middle, and lower segmental as well as left lower lobe segmental pulmonary emboli. No right heart strain. RIGHT VENTRICLE: No right ventricular strain. Patient exercised 4-5 days per week and took only two medications. He was healthy, did not have high blood pressure, renal issues, etc. The vaccine was responsible for this event. AE resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. Treatment was received for events. No covid prior vaccination. Covid tested post vaccination. Covid test post vaccination covid test type post vaccination=Blood test, covid test name post vaccination=POC COVID-19 Molecular, Abbott ID NOW, covid test date=25Oct2021, covid test result=Negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.; Sender''s Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Bell''s palsy and Facial paralysis cannot be completely excluded. The impact of this report on the benefit/risk profile of the product is evaluated as part of procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1860696 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-10-01
Onset:2021-10-26
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 301308A / 3 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: pravastatin, Advair, albuterol inhaler as needed, Allegra, Benadryl, levothyroxine, multivitamin and vitamin D
Current Illness: none
Preexisting Conditions: asthma, high cholesterol
Allergies: penicillin, sulfur, tetracycline
Diagnostic Lab Data:
CDC Split Type: vsafe

Write-up: The event that happened, I had a sensitivity and a pain that was like shingles. It was all the way around my core, my skin was extremely sensitive to touch and my left arm and wrist broke out in welts that same day. I went to Urgent Care the next day. The nurse at Urgent care gave me prednisone and by 24 hours later it started to improve.


VAERS ID: 1860811 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-09-30
Onset:2021-10-26
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2589 / 2 RA / IM

Administered by: Work       Purchased by: ?
Symptoms: COVID-19, Nucleic acid test, SARS-CoV-2 test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 10/26 SARS/COV-2, NAAT, Positive
CDC Split Type:

Write-up: Breakthrough COVID


VAERS ID: 1860928 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 035C21A / 3 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Extra dose administered, Incorrect dose administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fosamax, Vitamin D
Current Illness: None
Preexisting Conditions: Osteoporosis, Vitamin D Deficiency, Bilateral Sensorineural hearing loss, prediabetes, atypical CP, allergic rhinitis
Allergies: NKDA, NKFA
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Received full dose of Moderna booster I/O half dose


VAERS ID: 1861027 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 088DZIA / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Brain scan normal, Electrocardiogram normal, Feeling cold, Headache, Hyperhidrosis, Migraine, Muscle spasms, Nausea, Swelling, Swelling face
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Calcium (1350mg, once a day) Women Multivitamin (once a day)
Current Illness: N/A
Preexisting Conditions: Osteoporosis
Allergies: N/A
Diagnostic Lab Data: Head Scan EKG
CDC Split Type: vsafe

Write-up: Went to receive Moderna booster shot on October 26, 2021 at 5:30PM, I started having reactions later that night at 11PM. I was getting up freezing to walk around due to nonstop cramping in my foot. The next day I woke up in the hallway and nauseous with swelling around my head and partially my face . My husband had to dry me off multiple times because I kept sweating profusely. I also had a consistent migraine and throbbing headache. I started taking Tylenol on that Wednesday night and Thursday morning. My eyes started turning black/blue by the weekend. I went to the hospital on October 31, 2021 after being recommend by family members. I received a head scan and EKG. Was told there was no internal bleeding and to take Advil which helped with the jabbing headache and swelling.


VAERS ID: 1861164 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30145BA / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test normal, Cardiovascular function test, Chest X-ray normal, Computerised tomogram normal, Dehydration, Dizziness, Electrocardiogram normal, Eyelid contusion, Fall, Head injury, Loss of consciousness, Syncope, Urine analysis normal
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (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: Tremfya, Xarelto, Nexium, losartan, multi-vitamin, fish oil capsule, calcium/magnesium,
Current Illness: none
Preexisting Conditions: GERD, hypertension (6 months), psoriasis, DVT behind left knee (14 years)
Allergies: none
Diagnostic Lab Data: see item #18
CDC Split Type:

Write-up: 11/05/2021, 8:30 AM, home. Unexplained syncope, resulting in loss of consciousness, a forward fall from a chair, hitting floor above left eye. Unconscious for about 60 seconds. 911 called. Paramedics arrived, completed ECG and functionality tests, recommended visit to ED. I had consumed 12 oz of water and 10 oz of black coffee, was about to eat breakfast when I felt faint and sat down. Hospital ED, 9:45 AM. Admitted to ER quickly. Tests: CT scan, chest x-ray, blood work, urinalysis, multiple ECGs. All tests negative. Syncope believed to be caused by dehydration. Follow-up, Monday, 11/08/2021, personal physician, completed examination, no adverse results, suggested dehydration as cause, recommended I take losartan at night rather than in the morning and to drink 2 liters of water a day. 11/11/2021. Feeling very good, bruising around eye is rapidly getting lighter and less noticeable. No adverse events sense 11/05. I''m not a doctor, but I don''t believe the vaccine had anything to do with my syncope.


VAERS ID: 1861329 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017F21A / 3 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood glucose fluctuation, Pyrexia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin, Atorvastatin, Losartan, Famotidine, Combivent, Tricor, Alendronate, Gabapentin, Lovaza, Meloxicam
Current Illness:
Preexisting Conditions: Diabetes, Hypercholesterolemia, Osteoporosis, Hypertension, Acid Reflux, Pain, Asthma
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient reported side effects to pharmacy staff on 11/10/2021. Patient reported a mild fever and fluctuations in blood sugars. Patient said she increased her blood sugar testing frequency to more closely monitor it but reported no other intervention.


VAERS ID: 1861385 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 035C21A / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Incorrect dose administered
SMQs:, Medication errors (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: ASA, Multivitamin, Vitamin D
Current Illness: Epigastric Abdominal Pain
Preexisting Conditions: HTN, Prediabetes, Gout, Testicular Cancer
Allergies: NKDA, NKFA
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Received full dose of Moderna booster instead of half dose


VAERS ID: 1861424 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 035C21A / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Incorrect dose administered
SMQs:, Medication errors (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: ASA
Current Illness: DM2, HLD
Preexisting Conditions: DM2, HLD, Reactive Airway, High Density Lipoprotein Deficiency
Allergies: NKDA, NKFA
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Received full dose of Moderna booster instead of half dose


VAERS ID: 1861452 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 035C21A / 3 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Incorrect dose administered
SMQs:, Medication errors (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: None
Current Illness: General Anxiety, Depression
Preexisting Conditions: Major Depression Disorder, Vitamin D Deficiency
Allergies: NKDA, NKFA
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Received full dose of Moderna booster instead of half dose


VAERS ID: 1861536 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-10-24
Onset:2021-10-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026D21A / 3 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Alopecia
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: Albuterol inhaler; amlodipine; fluocinonide; irbesartan; montelukast
Current Illness: None
Preexisting Conditions: Asthma; Hypertension; Borderline diabetic
Allergies: Brazil nuts; Baclofen; cefalexin; azithromycin; Minocin
Diagnostic Lab Data: None
CDC Split Type: vsafe

Write-up: I had a lot of my hair in my comb and in my brush falling out after the vaccination. I bought over the counter minoxidil that I''m putting on my scalp. And I also read that castor oil was good for balding. Another friend the same age and with the same manufacturer had the same problem. Appointment for dermatologist in the future.


VAERS ID: 1863712 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 076C21A / 2 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered, Vaccination site pain
SMQs:, Medication errors (narrow)

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

Write-up: received an expired vaccine; sore arm; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired vaccine) and VACCINATION SITE PAIN (sore arm) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired vaccine) and VACCINATION SITE PAIN (sore arm). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received an expired vaccine) had resolved. On 27-Oct-2021, VACCINATION SITE PAIN (sore arm) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications were reported. No Treatment information was reported.


VAERS ID: 1863713 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 076C21A / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered, Myalgia, Pain in extremity, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Sore arm; Body aches; fever; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MYALGIA (Body aches), PYREXIA (fever) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Flu (Route was Intramuscular and Injection site was Left deltoid and the lot number was 52772.) on 19-Oct-2021. Past adverse reactions to the above products included No adverse event with Flu. On 26-Oct-2021 at 1:08 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021 at 1:08 AM, the patient experienced PAIN IN EXTREMITY (Sore arm), MYALGIA (Body aches), PYREXIA (fever) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 27-Oct-2021, PAIN IN EXTREMITY (Sore arm), MYALGIA (Body aches), PYREXIA (fever) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. It was reported that no treatment was needed for the patient


VAERS ID: 1863716 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 076C21A / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. Concurrent medical conditions included Allergy to nuts. On 26-Oct-2021 at 11:08 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021 at 11:08 AM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Oct-2021 at 11:08 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. It was stated that, the patient never diagnosed with or tested positive for COVID-19. She did not have any acute illness at the time of vaccination and up to one month before. She also did not have any chronic or long-standing health conditions. She had not taken any prescription, over-the-counter medications, dietary supplement or herbal remedies at the time of vaccination. She did not experienced the similar event in the past and there was no other potential cause to the event. Patient did not receive any treatment for the event No concomitant medication reported.


VAERS ID: 1863834 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047B21A / 3 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: This spontaneous case reported by a healthcare professional, describes the occurrence of administered expired product (doses administered past the published expiry date) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 047B21A) for COVID-19 immunization. No medical history reported. On Oct 26, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 26, 2021, at 8:00 am, patient administered expired product (doses administered past the published expiry date). On Oct 26, 2021, at 8:00 am, administered expired product (doses administered past the published expiry date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.


VAERS ID: 1863835 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047B21A / 3 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: This spontaneous case reported by a healthcare professional, describes the occurrence of administered expired product (doses administered past the published expiry date) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 047B21A) for COVID-19 immunization. No medical history reported. On Oct 26, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 26, 2021, patient administered expired product (doses administered past the published expiry date). On Oct 26, 2021, administered expired product (doses administered past the published expiry date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Vaccine taken from freezer on Oct 26, 2021 at 8:00 am.


VAERS ID: 1863836 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047B21A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: Doses administered past the published expiry date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported No treatment medications were reported


VAERS ID: 1863838 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047B21A / 3 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: This spontaneous case reported by a healthcare professional, describes the occurrence of administered expired product (doses administered past the published expiry date) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 047B21A) for COVID-19 immunization. No medical history reported. On Oct 26, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 26, 2021, patient administered expired product (doses administered past the published expiry date). On Oct 26, 2021, administered expired product (doses administered past the published expiry date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. It was stated the vial was removed from freezer at 8 am, Oct 26, 2021. This case linked to MOD-2021-364617 (patient link).


VAERS ID: 1863839 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047B21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. it was reported that vaccine was removed from freezer at 8 am on 26-OCT-2021 No concomitant medication details was provided. No treatment medication details was provided.


VAERS ID: 1863940 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: California  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2589 / 3 RA / -
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain lower, Constipation, Haematochezia, Product use issue
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (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: Viibryd; Iron; Vitamin D [Vitamin D NOS]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diverticulosis.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101468177

Write-up: Blood present in stool at 5am; pain in lower abdomen; constipation; BNT162B2 on 26Oct2021, influenza vaccine on 26Oct2021; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 3 via unspecified route in right arm on 26Oct2021 14:00 (Lot Number: FF2589) single dose for covid-19 immunization at 44-year-old; influenza vaccine via unspecified route in Left Arm on 26Oct2021 unspecified dose for immunisation. Medical history included diverticulum. No known allergies, no covid prior vaccination. Concomitant medication included vilazodone hydrochloride (VIIBRYD); iron; vitamin D. No other vaccine in four weeks. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm for covid-19 immunisation, first dose on 28Mar2021 13:00 (lot number: ER2613) at 44-year-old, second dose on 16Apr2021 13:00 at 44-year-old; both had upset stomach and diarrhea. The patient experienced blood present in stool, pain in lower abdomen, constipation on 28Oct2021 05:00 with outcome of unknown. The third dose of vaccination was administered on 26Oct2021, patient woke up with pain in lower abdomen, constipation. Blood present in stool at 5am. The patient was keeping an eye on symptoms and would seek medical attention if it didn''t improve. Outcome of the other event was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1863967 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Immunisation, Interchange of vaccine products, Nausea, Off label use, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101484889

Write-up: nausea; body aches; headache/ nagging headache; fever; chills; very fatigued; booster dose of Pfizer COVID-19 vaccine. Initial two doses were Moderna; booster dose of Pfizer COVID-19 vaccine. Initial two doses were Moderna; booster dose; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: not reported) via intramuscular route of administration, administered in left deltoid on 26Oct2021 10:45 as DOSE 3 (BOOSTER), SINGLE for COVID- 19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included Moderna vaccine (MODERNA COVID-19 VACCINE, Lot number: not reported) via an unspecified route of administration on an unspecified date as dose 1, single and dose 2 single both for COVID- 19 immunization. Reporter stated on 27Oct2021 about noon started to feel very fatigued, 17:30 noticed fever and chills, 27Oct2021 19:00 headache began (headache/nagging headache), Fever and chills returned by 22:00, night was uncomfortable, on 26Oct2021 10:45 booster dose of Pfizer COVID-19 vaccine. Initial two doses were Moderna, booster dose, 28Oct2021 18:00 body aches started, and headache returned, Minor chills and nausea. Continued nagging headache. Body aches improved throughout day. Slept well that night. Event took place after use of product. Therapeutic measures were taken as a result of the events which included fever, chills, headache/ nagging headache included 400 mg Ibuprofen (Took more Ibuprofen at 12:30. 400 mg), 509 mg of Ibuprofen (By 21:40). Outcome of the events was recovered on 29Oct2021. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.


VAERS ID: 1863997 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: California  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2590 / 3 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Angina pectoris, Arthralgia, Blood test, Chest X-ray, Chest discomfort, Diarrhoea, Electrocardiogram, Fatigue, Headache, Immunisation, Limb discomfort, Myocardial infarction, Pain in extremity, SARS-CoV-2 test, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Myocardial infarction (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Other ischaemic heart disease (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ESTRADIOL; FENOFIBRATE; VALTREX; ROSUVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: High cholesterol
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:Unknown result; Comments: 2 blood test (Troponin-I); Test Name: Chest X-Ray; Result Unstructured Data: Test Result:Unknown result; Test Name: EKG; Result Unstructured Data: Test Result:Unknown result; Test Date: 20211031; Test Name: Covid-19 Aegis PCR; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: USPFIZER INC202101505847

Write-up: I vomited several times; exhaustion, experienced severe fatigue; pain in my arm, shoulder; discomfort in my arm and chest; discomfort in my arm and chest; pain in my heart; I thought I might be having a heart attack; I had a pretty bad headache; I had diarrhea and arm pain; I had diarrhea and arm pain; Booster; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: FF2590), via an unspecified route of administration, administered in arm left on 26Oct2021 16:45 as DOSE 3 (BOOSTER), SINGLE (at the age of 49-year-old) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included high cholesterol from an unknown date and unknown if ongoing. The patient previously took codeine and experienced known allergies: codeine. Concomitant medications included estradiol, fenofibrate, valaciclovir hydrochloride (VALTREX), rosuvastatin (ROSUVASTATIN), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included the patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: EN6205), via an unspecified route of administration, administered in arm left on 04Mar2021 15:30 as DOSE 1, SINGLE (at the age of 48-year-old), second dose BNT162B2 (BNT162B2, Solution for injection, Lot number: ER2613), via an unspecified route of administration, administered in arm left on 25Mar2021 15:30 as DOSE 2, SINGLE (at the age of 48-year-old), both doses for covid-19 immunisation. The patient had no other vaccine in four weeks. The patient not had covid prior vaccination. On 27Oct2021 (also reported as Wednesday), the patient had a pretty bad headache. On 27Oct2021, the patient had diarrhea and arm pain. On 28Oct2021, She woke up Thursday morning at 2:30 AM with pain in heart went to the ER because she thought she might be having a heart attack, discomfort in my arm and chest. The ER doctor stated that her heart was a muscle, and it was a reaction to the vaccine. He told me to take ibuprofen every 4-6 hours. On 29Oct2021, friday through Sunday, the patient continued to have diarrhea, exhaustion and pain in arm, shoulder and heart. On 31Oct2021, the patient had vomited several times early Sunday morning and experienced severe fatigue all day Sunday and Monday. I still have pain and felt moderately fatigued. She took a covid test on Sunday and it came back negative last night. The patient had a doctor appointment today to follow up regarding my heart issue. The adverse event was treated with Aleve. On an unspecified date, the patient underwent lab tests and procedures which included blood test: unknown result (2 blood test (Troponin-I)), chest x-ray and EKG: unknown result. On 31Oct2021, the patient had sars-cov-2 test: negative (nasal Swab). Therapeutic measures were taken as a result for all the events. Outcome of the events was not recovered.


VAERS ID: 1864159 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 076C21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered, Headache, Pain in extremity, SARS-CoV-2 test
SMQs:, Tendinopathies and ligament disorders (broad), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]; ADDERALL; PHENTERMINE
Current Illness: ADHD; Asthma; GERD
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210808; Test Name: COVID-19 test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: sore arm; Expired vaccine used; headache; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm), EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and HEADACHE (headache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Flu (Lot number:3NA4M , Route of administration is Intramuscular and first dose.) on 12-Oct-2021. Past adverse reactions to the above products included Adverse event with Flu. Concurrent medical conditions included Asthma since 2001, ADHD since 2011 and GERD since 2010. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for ADD, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]) for GERD, PHENTERMINE for Weight loss. On 26-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021, the patient experienced PAIN IN EXTREMITY (sore arm), EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and HEADACHE (headache). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. On 27-Oct-2021, PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.


VAERS ID: 1864160 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 076C21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad), Medication errors (narrow)

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

Write-up: Expired vaccine used; sore arm; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PAIN IN EXTREMITY (sore arm) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Oct-2021 at 3:39 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). 26-Oct-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. On 27-Oct-2021, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications was not reported. Treatment medications was not reported.


VAERS ID: 1864234 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047B21A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: Dose administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered past the published expiry date). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered past the published expiry date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant information was reported. No treatment information was reported.


VAERS ID: 1864445 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 076C21A / UNK RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. The patient''s past medical history included COVID-19 antibody test positive on 22-Jul-2021. On 26-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitants were reported. No treatment medication was reported.


VAERS ID: 1864485 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047B21A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: doses administered past the published expiry date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were provided No treatment medications were provided


VAERS ID: 1826154 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, COVID-19, Drug ineffective, SARS-CoV-2 test, Troponin
SMQs:, Lack of efficacy/effect (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myocardial infarction; Cerebral vascular lesion (Cerebral vascular accident); Hypercholesterolemia; Pacemaker insertion (cardiac); Renal failure
Allergies:
Diagnostic Lab Data: Test Date: 20211027; Test Name: PCR; Result Unstructured Data: Test Result:Positive; Test Date: 20211026; Test Name: Troponins; Result Unstructured Data: Test Result:Elevated; Comments: high troponin values were detected
CDC Split Type: ESPFIZER INC202101456024

Write-up: acute myocardial infarction; He has had a PCR for COVID-19 which came back positive.He was vaccinated with the two doses of Comirnaty in April 2021.; He has had a PCR for COVID-19 which came back positive.He was vaccinated with the two doses of Comirnaty in April 2021.; This is a spontaneous report from a contactable consumer or other non hcp (child of the patient). A 77-years-old male patient received third dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 26Oct2021 as dose 3 (booster), single for COVID-19 immunisation and the patient received the first dose of influenza vaccine via an unspecified route of administration on 26Oct2021 at 16:20 (Batch/Lot number was not reported) as dose 1, single for an unspecified indication. Medical history included Cerebral vascular accident, acute myocardial infarction from 2019 to an unknown date, ongoing diabetes mellitus, ongoing hypertension, renal failure, cardiac pacemaker insertion, hypercholesterolaemia. The patient''s concomitant medications were not reported. Patient previously received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: unknown), via an unspecified route of administration in April2021 as dose 1, single and received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: unknown), via an unspecified route of administration in April2021 as dose 2, single for COVID-19 immunisation. On 26Oct2021 at 19:30 patient experienced acute myocardial infarction. At 19:30, the patient presented chest pain and was transferred to the emergency room. In the emergency room high troponin values were detected and acute myocardial infarction was diagnosed. He was admitted in hospital for further evaluation. On 27Oct2021 he had a PCR for covid-19 which came back positive. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 27Oct2021 and troponin: elevated on 26Oct2021. The outcome of events was unknown. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.


VAERS ID: 1827903 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Public       Purchased by: ?
Symptoms: Blood glucose increased, Insulin therapy
SMQs:, Hyperglycaemia/new onset diabetes mellitus (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: Nova Rapid Insulin, Triseba Insulin
Current Illness: Root Canal on tooth day before shot.
Preexisting Conditions: Type 1 Diabetes
Allergies: No
Diagnostic Lab Data: Testing of blood sugars every 3 hours. Above 32.
CDC Split Type:

Write-up: Extremely High blood sugars. Not able to get under control with insulin.


VAERS ID: 1841692 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 3 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Blood pressure decreased, Dizziness, Headache, Immunisation, Interchange of vaccine products, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? Yes
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN [ACETYLSALICYLIC ACID]; BISOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Mitral regurgitation
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101464023

Write-up: caused collapse; drop n blood pressure; nausea; dizzy; pain in head and abdomen; pain in head and abdomen; Interchange of vaccine products; booster; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (COMIRNATY, lot number: FF8288), dose 3 via an unspecified route of administration, administered in Arm Right on 26Oct2021 13:00 as DOSE 3 (BOOSTER) (at the age of 70-years-old), SINGLE for COVID-19 immunization. Medical history included mitral regurgitation. Concomitant medications included acetylsalicylic acid (ASPIRIN), bisoprolol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced caused collapse, drop n blood pressure, nausea, dizzy, pain in head and abdomen, pain in head and abdomen, all on 27Oct2021 13:30; booster and interchange of vaccine products on 26Oct2021 13:00. Seriousness was reported as hospitalization, disability, life threatening, congenital anomaly. The patient''s hospitalization was prolonged as a result of the events. The events "caused collapse, drop n blood pressure, nausea, dizzy, pain in head and abdomen, pain in head and abdomen" resulted in: Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events "booster and interchange of vaccine products" was unknown, of the other events was recovering.


VAERS ID: 1841833 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101453747

Write-up: Respiratory arrest; This is a spontaneous report from a contactable Physician received from a regulatory authority. Regulatory authority report number is v21130067. A 58-years-old male patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), dose 2 on 26Oct2021 (Batch/Lot number was not reported) at 58-year-old as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and the concomitant medications were not reported. It was unknown if there were any points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 26Oct2021 at around 02:00,Respiratory arrest occurred. On 26Oct2021 (the day of vaccination), the patient was admitted to the hospital. On an unspecified date, the outcome of the event was not provided. Events were assessed serious as hospitalization, medically significant, life threatening. The course of the event was as follows:On the day of admission to the psychiatric hospital, the patient was introduced and transformed to our hospital due to Respiratory arrest. The reporting physician classified the event as serious(hospitalization from 26Oct2021 and likely lead to disability) and assessed that the causality between the event and bnt162b2 as unassessable. Other possible cause of the event such as any other diseases was Drug-induced. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1842517 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004674 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Hypoaesthesia, Myalgia, Nausea, Pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (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: LORATADINE
Current Illness: Endometriosis; Fibromyalgia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Muscle pain; Immediate left arm; Stinging; Nausea; Chest pain; Numbness; This case was received via the regulatory authorityRA (Reference number: GB-MHRA-ADR 26123919) on 27-Oct-2021 and was forwarded to Moderna on 27-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), HYPOAESTHESIA (Numbness), MYALGIA (Muscle pain), PAIN IN EXTREMITY (Immediate left arm), PAIN (Stinging) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004674) for COVID-19 vaccination. Concurrent medical conditions included Endometriosis and Fibromyalgia. Concomitant products included LORATADINE for Allergy. On 26-Oct-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced MYALGIA (Muscle pain) (seriousness criterion medically significant), PAIN IN EXTREMITY (Immediate left arm) (seriousness criterion medically significant) and PAIN (Stinging) (seriousness criterion medically significant). At the time of the report, CHEST PAIN (Chest pain), HYPOAESTHESIA (Numbness), MYALGIA (Muscle pain), PAIN IN EXTREMITY (Immediate left arm), PAIN (Stinging) and NAUSEA (Nausea) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medications was not provided by the reporter. The patient administered vaccine to left arm . The Patient experienced Immediate left arm, wrist, hand, and ankle numbness. Then nausea 20 minutes after vaccine, followed by left sided chest muscle pain. arm numbness was residual, as was nausea and chest pain. The injection site was started stinging, 2 hours afterwards. The Patient does not have any inflammation of the heart (myocarditis or pericarditis). Company Comment: This case concerns a female patient with previous relevant medical history of fibromyalgia, who experienced the unexpected serious events of chest pain, hypoaesthesia, myalgia, pain in extremity, pain, and nausea. The events myalgia and nausea are unexpected as they are retained as serious per the source document Authority reporting. The events chest pain, hypoaesthesia, and nausea occurred on the same day after the dose of Spikevax. For myalgia, pain in extremity, and pain, the date of onset was not reported. The rechallenge was unknown as per RA reporting. The medical history of fibromyalgia could be confounder for pain. The benefit-risk relationship of Spikevax is not affected by this report. Events term, onset date, outcome and seriousness captured per RA from Regulatory Authority reporting.; Sender''s Comments: This case concerns a female patient with previous relevant medical history of fibromyalgia, who experienced the unexpected serious events of chest pain, hypoaesthesia, myalgia, pain in extremity, pain, and nausea. The events myalgia and nausea are unexpected as they are retained as serious per the source document Authority reporting. The events chest pain, hypoaesthesia, and nausea occurred on the same day after the dose of Spikevax. For myalgia, pain in extremity, and pain, the date of onset was not reported. The rechallenge was unknown as per RA reporting. The medical history of fibromyalgia could be confounder for pain. The benefit-risk relationship of Spikevax is not affected by this report. Events term, onset date, outcome and seriousness captured per RA from Regulatory Authority reporting.


VAERS ID: 1845204 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-09
Onset:2021-10-26
   Days after vaccination:78
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211026; Test Name: SARS-CoV-2 PCR Test; Test Result: Positive
CDC Split Type: TRPFIZER INC202101463089

Write-up: First dose on 17Jun2021, second dose on 09Aug2021; Patient has a positive PCR test after 2 doses of BNT162B2; Patient has a positive PCR test after 2 doses of BNT162B2; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Jun2021 (Batch/Lot number was not reported) and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 09Aug2021 (Batch/Lot number was not reported), both as single doses for COVID-19 immunisation (inappropriate schedule of vaccine administered). Relevant medical history and concomitant medications were not reported. On 26Oct2021, the patient had a positive PCR test after 2 doses of BNT162B2 (medically significant) with outcome of unknown. The lot number for BNT162B2 was not provided and will be requested during follow-up.


VAERS ID: 1845528 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Headache, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test, Syncope, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (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:
Current Illness: Sarcoidosis
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve replacement; Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Date: 20211026; 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: started 12 hours post vaccine; Fever; Headache; Aching joints; Sore throat; Tachycardia; Stomach pain; This case was received via RA (Reference number: GB-MHRA-ADR 26128179) on 28-Oct-2021 and was forwarded to Moderna on 28-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (started 12 hours post vaccine), PYREXIA (Fever), HEADACHE (Headache), ARTHRALGIA (Aching joints), OROPHARYNGEAL PAIN (Sore throat), TACHYCARDIA (Tachycardia) and ABDOMINAL PAIN UPPER (Stomach pain) in a 41-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Clinical trial participant and Aortic valve replacement. Concurrent medical conditions included Sarcoidosis. On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), ARTHRALGIA (Aching joints) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant), TACHYCARDIA (Tachycardia) (seriousness criterion medically significant) and ABDOMINAL PAIN UPPER (Stomach pain) (seriousness criterion medically significant). On an unknown date, the patient experienced SYNCOPE (started 12 hours post vaccine) (seriousness criterion medically significant). At the time of the report, SYNCOPE (started 12 hours post vaccine), TACHYCARDIA (Tachycardia) and ABDOMINAL PAIN UPPER (Stomach pain) was resolving and PYREXIA (Fever), HEADACHE (Headache), ARTHRALGIA (Aching joints) and OROPHARYNGEAL PAIN (Sore throat) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Oct-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided Treatment medication was not provided Company comment -This case concerns a 67-year-old, female patient with no relevant medical history, who experienced the unexpected events of Syncope, Pyrexia, Headache, Arthralgia, Oropharyngeal Pain, Tachycardia, and Abdominal Pain Upper. The events occurred approximately 1 day after the third dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown since no information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. Events of Pyrexia, Headache, Arthralgia, Oropharyngeal Pain, Tachycardia, and Abdominal Pain Upper seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events were serious.; Sender''s Comments: This case concerns a 67-year-old, female patient with no relevant medical history, who experienced the unexpected events of Syncope, Pyrexia, Headache, Arthralgia, Oropharyngeal Pain, Tachycardia, and Abdominal Pain Upper. The events occurred approximately 1 day after the third dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown since no information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. Events of Pyrexia, Headache, Arthralgia, Oropharyngeal Pain, Tachycardia, and Abdominal Pain Upper seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events were serious.


VAERS ID: 1845530 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004674 / 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? 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: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fever chills; Shivering; Headache fullness; This case was received via RA (Reference number: GB-MHRA-ADR 26128427) on 28-Oct-2021 and was forwarded to Moderna on 28-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever chills), CHILLS (Shivering) and HEADACHE (Headache fullness) in an 80-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004674) for COVID-19 vaccination. No Medical History information was reported. On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced PYREXIA (Fever chills) (seriousness criterion disability), CHILLS (Shivering) (seriousness criterion disability) and HEADACHE (Headache fullness) (seriousness criterion disability). At the time of the report, PYREXIA (Fever chills), CHILLS (Shivering) and HEADACHE (Headache fullness) 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. No concomitant products were reported. No treatment drugs were reported. It was reported that the report is not related to possible inflammation of the heart (myocarditis or pericarditis). Company Comment : This case concerns a 80-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of pyrexia, chills, and headache. The events occurred on the same day after the third dose of Moderna Covid-19 vaccine. The rechallenge is not applicable since no information about the other doses was disclosed The benefit-risk relationship of the vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity; Sender''s Comments: This case concerns a 80-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of pyrexia, chills, and headache. The events occurred on the same day after the third dose of Moderna Covid-19 vaccine. The rechallenge is not applicable since no information about the other doses was disclosed The benefit-risk relationship of the vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity


VAERS ID: 1845536 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-25
Onset:2021-10-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Heavy menstrual bleeding, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

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

Write-up: for heavy periods; Heavy periods; Tiredness; Headache; Nausea; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26132162) on 28-Oct-2021 and was forwarded to Moderna on 28-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (for heavy periods), HEAVY MENSTRUAL BLEEDING (Heavy periods), FATIGUE (Tiredness), HEADACHE (Headache) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 25-Oct-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). 26-Oct-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). On 27-Oct-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced HEAVY MENSTRUAL BLEEDING (Heavy periods) (seriousness criterion medically significant). On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (for heavy periods) (seriousness criterion medically significant). At the time of the report, HEAVY MENSTRUAL BLEEDING (for heavy periods) and FATIGUE (Tiredness) had not resolved and HEAVY MENSTRUAL BLEEDING (Heavy periods), HEADACHE (Headache) and NAUSEA (Nausea) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported. No treatment medication were reported. Company Comment: This case concerns a female patient with no relevant medical history, who experienced the unexpected serious events of heavy menstrual bleeding (reported as "for heavy periods" and "Heavy periods"), fatigue, headache, and nausea. The events of fatigue, headache, and nausea are unexpected as they are retained as serious per the source document Authority reporting. The events fatigue nausea, and headache occurred 1 day after the dose of Spikevax. The event heavy menstrual bleeding (reported as "Heavy periods") occurred 2 days after the dose of Spikevax. For the event heavy menstrual bleeding (reported as "for Heavy periods") the date of onset was not reported. The rechallenge was unknown as per RA reporting, although no dose number was reported. The benefit-risk relationship of Spikevax is not affected by this report. Events term, onset date, outcome and seriousness captured per RA from Regulatory Authority reporting.; Sender''s Comments: This case concerns a female patient with no relevant medical history, who experienced the unexpected serious events of heavy menstrual bleeding (reported as "for heavy periods" and "Heavy periods"), fatigue, headache, and nausea. The events of fatigue, headache, and nausea are unexpected as they are retained as serious per the source document Authority reporting. The events fatigue nausea, and headache occurred 1 day after the dose of Spikevax. The event heavy menstrual bleeding (reported as "Heavy periods") occurred 2 days after the dose of Spikevax. For the event heavy menstrual bleeding (reported as "for Heavy periods") the date of onset was not reported. The rechallenge was unknown as per RA reporting, although no dose number was reported. The benefit-risk relationship of Spikevax is not affected by this report. Events term, onset date, outcome and seriousness captured per RA from Regulatory Authority reporting.


VAERS ID: 1849764 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-23
Onset:2021-10-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005700 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 36.9 degree Celsius; Test Date: 20211026; Test Name: ECG; Result Unstructured Data: ST elevation.; Test Date: 20211026; Test Name: Troponin I; Result Unstructured Data: Increased.
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Myocarditis; Chest pain; This case was received via regulatory authority (Reference number: JP-TAKEDA-2021TJP112694) on 27-Oct-2021 and was forwarded to Moderna on 01-Nov-2021. This case, initially reported to the regulatory authority by a physician, was received via the regulatory authority (Ref, v21130050). Myocarditis was assessed as serious by the MAH. On an unknown date, the patient received the 1st dose of this vaccination. On an unknown date, body temperature before the vaccination 36.9 degrees Celsius. On 23-Oct-2021, at 17:25, the patient received the 2nd dose of this vaccination. On 26-Oct-2021, at 06:00, the patient had chest pain. At 08:00, the patient visited the hospital. ECG showed ST elevation and increased troponin I was observed. The patient was diagnosed with myocarditis. The outcome of chest pain and myocarditis was reported as unknown. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. This is a regulatory case concerning a 14-year-old, male patient with no relevant medical history reported , who experienced the serious expected and AESI event of myocarditis 3 days after receiving the second dose of Moderna COVID-19 vaccine. Time to onset for the first dose is unknown. ECG showed ST elevation and increased troponin I was observed. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Events seriousness assessed as per regulatory authority reporting.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This is a regulatory case concerning a 14-year-old, male patient with no relevant medical history reported , who experienced the serious expected and AESI event of myocarditis 3 days after receiving the second dose of Moderna COVID-19 vaccine. Time to onset for the first dose is unknown. ECG showed ST elevation and increased troponin I was observed. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Events seriousness assessed as per regulatory authority reporting.


VAERS ID: 1852599 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation, Malaise, Muscle spasms, Myalgia, Off label use
SMQs:, Rhabdomyolysis/myopathy (broad), Dystonia (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101467703

Write-up: General malaise; Frontal headache; Patient received Booster (dose 3) of Comirnaty; Patient received Booster (dose 3) of Comirnaty; Muscle ache; Leg cramps; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202110271650073920-7UWYM with Safety Report Unique Identifier of GB-MHRA-ADR 26130286. A 66-year-old male patient received third dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on 26Oct2021 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no symptoms associated with COVID-19 and did not have a COVID-19 test. The patient was not enrolled in a clinical trial. Concomitant medications were not reported. Patient previously received first and second dose of bnt162b2 on unspecified date, for COVID-19 immunisation. On 26Oct2021, the patient experienced muscle ache and leg cramps. On 27Oct2021, the patient experienced general malaise and frontal headache; all the events were reported as serious for being medically significant. The patient had not been tested positive for COVID-19 since having the vaccine. The patient''s report did not relate to possible inflammation of the heart (myocarditis or pericarditis). The clinical outcome of the event muscle ache was resolved with sequelae on an unknown date in Oct2021. The clinical outcome of the event leg cramps was recovering. The clinical outcome of events general malaise and frontal headache was not recovered at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1852604 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3712 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation, Interchange of vaccine products, Malaise, Off label use, Pain, Pain in extremity, SARS-CoV-2 test
SMQs:, 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: Triumeq
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: HIV positive (HIV-positive with symptoms or reduction in immune response, undetectable VL).
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101467735

Write-up: Headache; Feeling unwell; Arm pain; Off label use; third booster dose of BNT162b2; primary immunization series complete but unknown manufacturer (non-Pfizer); Dose 3; Pain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202110271847078740-81SSD, Safety Report Unique Identifier GB-MHRA-ADR 26130925. A 32-year-old male patient received third booster dose of BNT162b2 (COMIRNATY; Lot Number: FG3712) via an unspecified route of administration on 26Oct2021 (at the age of 32-year-old) as a single dose of COVID-19 immunisation. Medical history included HIV positive with symptoms or reduction in immune response and undetectable VL (viral load). Concomitant medication included lamivudine; abacavir sulfate; dolutegravir sodium (TRIUMEQ) for HIV positive. The patient had no symptoms associated with COVID-19. The patient was not enrolled in clinical trial. The historical vaccine included dose 1 and dose 2 COVID-19 Vaccine for COVID-19 immunisation, primary Immunization series complete but unknown manufacturer (non-Pfizer). On 26Oct2021, the patient experienced pain; on 27Oct2021, 1 day after vaccination, the patient experienced headache and feeling unwell. The events pain, headache and feeling unwell were reported as serious for being medically significant. The clinical course was reported as follows: arm pain worsened on 27Oct2021 since 26Oct2021 and had spread, headache (strong) and feeling unwell throughout both which had developed 16-24 hours after administration and were ongoing. It was reported that the report was not related to possible inflammation of the heart (myocarditis or pericarditis). On an unknown date, the patient underwent COVID-19 virus test and the result was negative. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the events arm pain, pain, headache and feeling unwell was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1852605 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Medication errors (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101467747

Write-up: Numbness in hand; The patient received Astrazeneca/The patient received dose 3 (booster) Comirnaty; Interchange of vaccine products; The patient received dose 3 (booster) comirnaty; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202110271925265140-PZFZI with Safety Report Unique Identifier of GB-MHRA-ADR 26131148. A 75-year-old male patient received third (booster) dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on 26Oct2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have symptoms associated with COVID-19 and was not enrolled in the clinical trial. The patient previously received COVID-19 VACCINE ASTRAZENECA (Lot number: UNKNOWN) on 09Oct2021, and covid-19 vaccine of unknown manufacturer on unspecified date, both as a single dose for COVID-19 immunisation. On 27Oct2021, the patient experienced numbness in the hand which was reported as serious for being medically significant. On an unknown date, the patient underwent a COVID-19 virus test and the result was negative. It was reported that this report does not relate to possible inflammation of the heart (myocarditis or pericarditis). The patient had not been tested positive for COVID-19, since having the vaccine. The clinical outcome of the event numbness in hand was not resolved at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1852607 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Discomfort, Exposure via breast milk
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal exposures via breast milk (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101467672

Write-up: breastfed baby has diarrhea; Discomfort; vaccine exposure via breast milk; This is a spontaneous report from a contactable consumer, the parent. This is a report received from the Regulatory Agency (RA). This is the first of 2 reports. Regulatory authority report number is GB-MHRA-WEBCOVID-202110272110476320-O0CM8 with Safety Report Unique Identifier GB-MHRA-ADR 26131598. A female baby of an unknown age received the BNT162b2 (COMIRNATY; solution for injection, Batch/Lot Number: not reported) via trans mammary route of administration via breast milk on 26Oct2021. Medical history and concomitant medications were not reported. On an unknown date in 2021, the patient experienced discomfort and on 27Oct2021, the patient experienced diarrhea; both the events were reported as serious for being medically significant. The clinical course was reported as follows as it was reported that the breastfed baby had diarrhea which was causing her discomfort. The clinical outcome of the events diarrhea was not recovered, and discomfort was unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101487667 Mother/child case


VAERS ID: 1852691 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-10-26
   Days after vaccination:149
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive; Comments: with the mutant strain of L452R.
CDC Split Type: HKPFIZER INC202101506611

Write-up: CONFIRMED CASE OF COVID-19; CONFIRMED CASE OF COVID-19; This is a spontaneous report from a non-contactable healthcare professional via The regulatory authority number: not applicable, based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS004396), license party for bnt162b2(COMIRNATY). A 37-year-old female patient started to receive two doses of Tozinameran (COMIRNATY) (lot number: unknown) on 09-May-2021 and 30-May-2021 respectively via unknown route at unspecified dosing frequency for COVID-19 immunization in. Medical history, concomitant medication(s) and past product were not reported. On 26-Oct-2021, the patient had symptoms. On 29-Oct-2021, the patient arrived flight. On an unknown date, the patient tested positive. The patient was confirmed as COVID-19 with the mutant strain of L452R. The adverse event Confirmed case of COVID-19 was considered as Important Medical Event. Outcome of the events was unknown. The Causality Assessments of the events COVID-19 and Vaccination failure was possible as per Primary reporter and per Company (BioNTech SE). No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1855121 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2832 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Chest discomfort, Dyspnoea, Hypoaesthesia oral, Pain in extremity, Pharyngeal hypoaesthesia
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101456398

Write-up: short-term heart arithmia; Numb tongue including numbness in the throat; Numb tongue including numbness in the throat; vibrations and tingling in the chest (in the middle); slight shortness of breath; pain in arm; This is a spontaneous report from a contactable consumer (patient). A 35-years-old non pregnant female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FF2832), via an unspecified route of administration, administered in Arm Left on 26Oct2021 (at the age 35 years) as DOSE 1, SINGLE for covid-19 immunisation in Public Health Clinic/Veterans Administration facility. No known allergies, medical history (No serious previous illness) and concomitant medications were reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 26Oct2021 15:30 the patient experienced short-term heart arrhythmia, numb tongue including numbness in the throat, vibrations and tingling in the chest (in the middle), slight shortness of breath, arm pain. No therapeutic measures were taken as a result of all the events. The clinical outcome of all the events was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1855258 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-10-26
   Days after vaccination:260
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20211026; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Nasal Swab
CDC Split Type: BEPFIZER INC202101503558

Write-up: headache; PCR test positive; PCR test positive; mild flu feeling for 24 hours; This is a spontaneous report received from a contactable consumer (Pfizer colleague), the patient. A 50-year-old adult male received COVID-19 immunization with the first dose of BNT162b2 (COMIRNATY, solution for injection; Lot EN0477 expiry information not provided) as a single dose via an unspecified route in the left arm on 18Jan2021 (at 50-years-old) and the second dose of BNT162b2 (COMIRNATY, solution for injection; Lot EK9788 expiry 31May2021) as a single dose via an unspecified route in the left arm on 08Feb2021 (at 50-years-old). The patient had no medical history. There were no concomitant medications or past drug history reported. On an unspecified date(s) the patient experienced mild flu feeling for twenty-four hours and headache. On 26Oct2021 the patient tested positive for COVID-19 with positive PCR test via nasal swab. There was no treatment received for mild flu feeling or headache. The outcome of the event PCR test positive was recovered on an unspecified date in 2021. The outcome of the event mild flu feeling was recovered on an unspecified date after twenty-four hours. The outcome of the headache was recovered on an unspecified date, Investigation results: The complaint for adverse event/LOE of PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EK9788. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. A Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. A Regulatory Authority process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.


VAERS ID: 1855270 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3530 / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Polyarthritis
SMQs:, Systemic lupus erythematosus (broad), Arthritis (narrow), Medication errors (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: SULFASALAZINA; ALPRAZOLAN; OMEPRAZOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Osteoarthropathy (seronegative controlled with Sulfasalazine, starting 3 years ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202101457584

Write-up: Arthritis (pain, heat and swelling) small joints and right knee; Product: COVID 19; Brand: AstraZenica; Batch/Lot number: 4120Z00. Dose number: 1; booster; Product: COVID 19; Brand: AstraZenica; Batch/Lot number: 4120Z00. Dose number: 1; This is a spontaneous report from a contactable physician (patient) received through Regulatory Authority portal. A 55-year-old male patient received the third dose of BNT162B2 (COMIRNATY) at 55-year-old, via an unspecified route of administration in arm left on 26Oct2021 14:00 (Batch/Lot Number: FG3530) at single dose (BOOSTER) for COVID-19 immunisation. Medical history included osteoarthropathy seronegative controlled with sulfasalazine, starting 3 years before. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sulfasalazina, alprazolam (ALPRAZOLAN), and omeprazole (OMEPRAZOL). No other vaccine in 4 weeks. The patient previously received the first dose of COVID-19 vaccine astrazeneca (ASTRAZENICA, Batch/Lot number: 4120Z00) at 54-year-old on 02Feb2021 and the second dose of COVID-19 vaccine astrazeneca (Batch/Lot number: 213VCD019W) at 54-year-old on 27Apr2021 for COVID-19 immunisation. Patient''s known allergies: Methotrexate and hydroxychloroquine. The patient experienced arthritis (pain, heat and swelling) small joints and right knee on 27Oct2021 07:00. This event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. No treatment received. Outcome of the event was resolving.; Sender''s Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1855272 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-26
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Biopsy, Blood test, Body temperature, Dermatitis, Epistaxis, Eye pain, HIV test, Hepatitis viral test, Hypersensitivity, Pyrexia, Swollen tongue
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Glaucoma (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Astigmatism
Allergies:
Diagnostic Lab Data: Test Date: 20211026; Test Name: biopsy; Result Unstructured Data: Test Result:prevascular dermatitis; Comments: prevascular dermatitis; Test Name: blood tests; Result Unstructured Data: Test Result:Normal; Test Name: Body temperature; Result Unstructured Data: Test Result:37.5 Centigrade; Test Name: hepatitis virus; Test Result: Negative ; Test Name: HIV; Test Result: Negative
CDC Split Type: BRPFIZER INC202101458307

Write-up: This is a spontaneous report from a contactable consumer (patient''s mother) from Pfizer medical information team. A 19 years old Male patient received 1st dose of BNT162B2 (COMIRNATY) on an unspecific date at single dose for covid-19 immunization. Medical history was astigmatism. Concomitant drug was not reported. Past drug was allergic to amoxicillin. The reporter who is the patient''s mother informs that her 19-year-old son had an allergic reaction to the vaccine. First thing: he had a fever up to 37.5 but it did not go any higher. He started to feel pain in the eyeball, but they thought it would be from the glasses, as the patient has astigmatism. They decided to take the patient to the hospital because of the pain and he had only two or three little spots on his body (there are pictures). This happened on Friday (she did not specify the date) and the doctor said it was nothing. From Friday to Saturday she took it to the service again because she did not think it was normal, because he started painting his belly and arms, a lot. In the service they said he was intoxicated, but as it was emergency care they did not know where the intoxication came from. They gave him an injection and told her to watch him. It looked like measles, skin reaction. He took fenergan. But the reaction got worse and worse (she informs that this was on Saturday but did not specify the date) and she took him to a different hospital. They suspected dengue, scabies, herpes, but the exams did not give anything. Everything normal. He had blood tests (25 tests) and had nothing. He tested for hepatitis, HIV (human immunideficiency virus) that came back negative. The doctor instructed to take him to the allergist. The allergist ordered a biopsy of the lesions he had on his skin. The result was prevascular dermatitis. That result came out yesterday (26Oct2021) (from the biopsy). She informs that the doctor said it was because of the vaccine, which was the only new drug he took. Informs that her child is healthy. She reports that today he is fine. She informs that he took 30 steroids (predisolone she bought and hyxizine prescribed by the doctor) and alexia 1 tablet. She informs that the doctor gave a letter to take the second dose with medication to take 24 hours before the vaccine. Informs that the patient is allergic to amoxicillin. He had a reaction when he was a baby and never took amoxicillin again. She informs that she and the patient are very insecure and afraid to take the second dose. Especially him, who because of the ''''psychologist'''' does not want to take the second dose. She informs that he did nothing for the SUS (unknown meaning), as the patient had a lot of neglect for the SUS. Everything they did to him was in private (biopsy, cream, all medicines are private). UBS (unknown meaning) did not provide assistance at all. She informs that the worst scene was when he started to bleed a lot from his nose, his tongue swelled up a lot. It was horrible. This was approximately 1 week after the vaccine or almost 10 days later. The doctor said in this episode ''''Lucky that he had already taken the fenergan and did not cover his throat and helped to pop everything out, otherwise it would be more serious''''. The reporter informs that she also took pfizer and felt nothing. She informs that she read that it is very unusual and he (the patient) was awarded. She informs that they say that the reaction time is fast (3 hours later), but his took a while to appear, it was not immediate. She informs that they said that he can take the second dose of astrazeneca, but that even so, the patient does not feel safe. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1855360 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-22
Onset:2021-10-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0810 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiovascular disorder, Erythema, Feeling hot, Gait inability, Hyperaesthesia, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gluten intolerance; Milk allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101456622

Write-up: sharp pain in her right foot on top/pain; couldn''t walk; discolored reddish; The foot had an area that very hot; sensitive to the touch; the circulation wasn''t normal; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 48-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in arm left on 22Oct2021 12:00 (Batch/Lot Number: FD0810) as dose 1, single at the age of 48-year-old for covid-19 immunisation. Medical history included known allergies: gluten and dairy. No other medical history. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. 4 days after injection (26Oct2021) patient was resting in bed at 1pm she started having a sharp pain in her right foot on top, the pain was so intense that she couldn''t touch nor she was able to put her foot down, she couldn''t walk she never experienced nothing like this. The foot had an area that was discolored reddish and very hot it felt like there was something stuck, that the circulation wasn''t normal. It was impossible to massage because too sensitive to the touch. She put ice but it was even worse. Then she took and Infrared sauna and soaked her foot in warm water with epson salts. Around 9pm she started feeling a bit better. This morning 27Oct2021 the foot was still sensitive to the touch but it''s much better. It was a scary experience. Adverse event on 26Oct2021 01:00 PM. No hospitalization prolonged. The outcome of event was recovering.


VAERS ID: 1856062 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0012 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101457446

Write-up: Fainting; Vomited; This is a spontaneous report from a contactable Other hcp. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110261305042470-LAOXH, safety report unique identifier is GB-MHRA-ADR 26122957. A 15-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 26Oct2021 (at the age of 15-years-old) (Lot Number: FK0012) as single dose for COVID-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. The patient experienced fainting, vomited on 26Oct2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1856075 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation, Off label use
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101457308

Write-up: Frontal headache; Off label use; Booster; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110261422579410-BT25Q, Safety Report Unique Identifier GB-MHRA-ADR 26123605. A female patient of an unspecified age received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on 26Oct2021 (Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had not symptoms associated with COVID-19 or had not a COVID-19 test. The patient experienced frontal headache on 26Oct2021 and off label use and booster on 26Oct2021. The outcome of event frontal headache was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1856169 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0114 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use
SMQs:, Medication errors (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: MGUS (Monoclonal gammopathy of undetermined significance)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101498210

Write-up: Swollen lymph nodes; off label use; Interchange of vaccine product; Booster; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Regulatory Authority. The Regulatory authority report number is GB-MHRA-WEBCOVID-202110291159482310-5Z9XT with Safety Report Unique Identifier of GB-MHRA-ADR 26139256. A 40-year-old female patient received third dose (booster) of BNT162b2 (COMIRNATY; Lot Number: FH0114) via an unspecified route of administration on 26Oct2021 as a single dose for COVID-19 immunisation. Medical history included monoclonal gammopathy of undetermined significance (MGUS). The patient had no symptoms associated with COVID-19 and not had a COVID-19 test. The patient was not pregnant and was not breastfeeding at the time of this report and was not enrolled in clinical trial. Concomitant medications were not reported. The patient previously received first dose of COVID-19 vaccine chadox1 ncov-19 (COVID-19 VACCINE ASTRAZENECA) for COVID-19 immunisation on 27Mar2021 and the second dose of COVID-19 vaccine chadox1 ncov-19 (COVID-19 VACCINE ASTRAZENECA) for COVID-19 immunisation on 27May2021. On 28Oct2021, the patient experienced swollen lymph nodes and reported as serious for being medically significant. The patient was not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event swollen lymph nodes was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1859510 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Vaccination site pain
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: RIGEVIDON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia; Heavy periods; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response)
Allergies:
Diagnostic Lab Data: Test Date: 20211025; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101468012

Write-up: Extreme muscle pain in the arm the vaccine was given to; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202110261950147820-RM3KG, Safety Report Unique Identifier GB-MHRA-ADR 26125132. A 13-year-old female patient received BNT162B2 (COMIRNATY, lot number unknown), via an unspecified route of administration in the arm on 26Oct2021 (at the age of 13 years old) as dose 1, single for COVID-19 immunisation. Medical history included anaemia and immunodeficiency (has an illness or condition, not listed above, which reduces the immune response) both from an unknown date and unknown if ongoing; then heavy periods. Patient has not had symptoms associated with COVID-19. Patient is not pregnant and is not currently breastfeeding. Patient''s last menstrual period date was 2021. Concomitant medication included ethinylestradiol, levonorgestrel (RIGEVIDON) taken for heavy periods from 18Apr2021. On 26Oct2021, the patient experienced extreme muscle pain in the arm the vaccine was given to, couldn''t apply any pressure or lift it without pain. The event was medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test was no - negative COVID-19 test on 25Oct2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1859515 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Feeling abnormal, Hypoaesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211020; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101467815

Write-up: dizzy; Dizziness; Spaced out/spaced out and off my face; Numbness; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110270808500590-F3BPY. A 22-years-old non pregnant female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 26Oct2021 (at the age of 22 years). as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. Patient has not had symptoms associated with COVID-19. Patient last menstrual period date:06Jun2020. The patient experienced numbness on 26Oct2021, dizziness and spaced out/spaced out and off my face on 27Oct2021, dizzy on an unspecified date. The events were reported as medically significant. The patient felt very dizzy spaced out and off my face. The patient underwent lab tests and procedures which included SARS-Cov-2 test: negative on 20Oct2021 No - Negative COVID-19 test. the report does not relate to possible inflammation of the heart (myocarditis or pericarditis). Patient has not tested positive for COVID-19 since having the vaccine. Report does not relate to possible inflammation of the heart (myocarditis or pericarditis). At the time of report, the outcome of all the events was recovering other than dizzy which was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1859610 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use, Pain, Paraesthesia, Pyrexia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre 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:
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 INC202101467773

Write-up: Headache; Swollen lymph nodes; Generalised aching; Throbbing pain; Shivers; Fever; Off-label use; Interchange of vaccine products; Booster; Tingling in foot; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110280745013450-P8JNE, Safety Report Unique Identifier GB-MHRA-ADR 26133091. A 23-year-old non-pregnant female patient received booster dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 26Oct2021 (at the age of 23-years-old) as dose 3 (booster) single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. The patient was not pregnant at the time of vaccination. Patient was not currently breastfeeding. Patient last menstrual period date was 10Oct2021. Patient previously had COVID-19 Vaccine on an unspecified date for COVID-19 immunisation (Primary Immunization series complete but unknown manufacturer). On 26Oct2021, patient experienced generalised aching, throbbing pain, shivers, fever, tingling in foot, off-label use, interchange of vaccine products, booster. On 27Oct2021, patient experienced headache, swollen lymph nodes. The seriousness of events headache, swollen lymph nodes, generalised aching, throbbing pain, shivers and fever were considered as serious (medically significant). Headache, shivers, fever, aching in back of neck, left side of neck all the way down through arm pit, arm and down leg to foot. Tingling in foot and throbbing. Vaccine given in left arm. Swollen lymph nodes in left armpit. Paracetamol barely cut through the pain and wore off quickly. Off work. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: negative (No - Negative COVID-19 test). Therapeutic measures were taken as a result of event included treatment with Paracetamol. Report not related to possible inflammation of the heart (myocarditis or pericarditis). Outcome of event headache, fever was recovered on 28Oct2021, swollen lymph nodes was not recovered, generalised aching, throbbing pain was recovering, shivers was recovered on an unspecified date in 2021, tingling feet/hands was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected


VAERS ID: 1814234 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-10-23
Onset:2021-10-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abnormal dreams, Screaming
SMQs:, Hostility/aggression (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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Intense vivid dream resulting in thrashing around, yelling, screaming. Intensity of dream not typical. Woke up entire household


VAERS ID: 1814589 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-10-23
Onset:2021-10-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Extra dose administered, Fatigue, Pyrexia, Rash, Vaccine positive rechallenge
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Same reaction after second Moderna dose
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: Penicillin, Keflex, Azithromycin
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Rash on torso, fever, fatigue


VAERS ID: 1814644 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: South Dakota  
Vaccinated:2021-10-23
Onset:2021-10-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8841 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Axillary pain, Extra dose administered, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Medication errors (narrow)

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

Write-up: Booster shot. Vaccine administered to left deltoid. About 2 days later noticed swelling and soreness in axilla about size of baseball. No visible color change appreciated. No palpable lymph nodes appreciated.


VAERS ID: 1814663 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-10-23
Onset:2021-10-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 071F21A / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Axillary pain, Lymphadenopathy, Sleep disorder
SMQs:, 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: Multiple vitamins-minerals, Armour Thyroid 60mg, Atorvastain 10MG, cymbalta 90mg
Current Illness: none
Preexisting Conditions:
Allergies: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Swollen Lymph notes in left arm pit. Woke up during the night from the pain.


VAERS ID: 1814696 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-10-22
Onset:2021-10-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026D21A / UNK LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pruritus, Injection site swelling, Myalgia, Nausea, Pyrexia, Tenderness, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Low grade fever, chills, joint and muscle aches, headache, nausea, fatigue. Indurated swelling about 2-3? diameter near injection site like a medallion, noticing left axillary tender lymph nodes on 2nd day. Itching near injection site. Headache, nausea, Vomiting on 3rd day. Taking Tylenol and Advil for the symptomatic treatment


VAERS ID: 1814716 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: New York  
Vaccinated:2021-10-24
Onset:2021-10-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Dizziness, Palpitations, Retching
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: chills after 2nd dose for 1 day
Other Medications: 2 hours before vaccination - multi vitamin, B12. 4 hours after vaccination - 1 80 mg. aspirin, 1- 500 mg Ranolzine, 1 - Omega 3, 1-100 mg vitamin K., 10 PM - 1-5 mg melatonin, 1 -100 mg gabapentin, I - Trazodone 100 mg
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Chills, dizzy, heart pounding, dry heaves


VAERS ID: 1814734 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-10-25
Onset:2021-10-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2590 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product preparation issue
SMQs:, 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: irbesart/hctz 300/12.5
Current Illness: unknown
Preexisting Conditions: Hypertension
Allergies: NKA
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Patient was inadvertantly given 0.3ml of undiluted Pfizer vaccine. Patient was contacted immediately after this was discovered and notified of the error. He was told what adverse effects to watch for and what do if he experienced them. He was given my cell phone number to call if he had any further questions. I will plan on checking in with him later today and several times over the next few days/weeks.


VAERS ID: 1814765 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-10-25
Onset:2021-10-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 022C22A / 1 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Dizziness, Product administered to patient of inappropriate age
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Medication errors (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: None reported
Current Illness: None
Preexisting Conditions: None
Allergies: None reported
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Vaccine was given to 16 year old patient, briefly complained of dizziness, but resolved after observation.


VAERS ID: 1814792 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-10-22
Onset:2021-10-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 076C21A / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Lymphadenitis
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: PATIENT REPORTED INFLAMED LYMPH NODE


VAERS ID: 1814793 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-10-25
Onset:2021-10-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2590 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product preparation issue
SMQs:, 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: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was inadvertantly given 0.3 ml of undiluted Pfizer vaccine. Patient was called twice immediately after this was discovered to notify her of the error. She did not answer either call. A voicemail was left with instructions to call back ASAP with the store number and my cell phone number. I will continue to call the patient until she answers. I will tell her what adverse effects to watch for and what do if she experiences them. She will be given my cell phone number to call if she has any further questions. I will plan on checking in with her later today and several times over the next few days/weeks.


VAERS ID: 1814826 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: California  
Vaccinated:2021-10-24
Onset:2021-10-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 3203086 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ocular hyperaemia, Palpitations
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Glaucoma (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: palpitations, 56, 03/27/2021, Pfizer
Other Medications: aspirin 81 mg, CholestOff
Current Illness:
Preexisting Conditions: hepatitis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: palpitations, ranging from 88 to 95, started this morning when I got up at 6 a.m.; my eyes are blood shot; palpitations don''t go away


VAERS ID: 1814835 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-10-25
Onset:2021-10-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: Interchange of vaccine products
SMQs:, Medication errors (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: none
CDC Split Type:

Write-up: Patient requested the Moderna Booster. She had previously received the J&J as her first series. Instead of giving her the 1/2 dose Moderna booster, we gave her a 1/2 dose of J&J. I called CDC and they recommended to give the other 1/2 dose in the opposite arm. Patient tolerated both doses well.


VAERS ID: 1814842 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-10-22
Onset:2021-10-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 061E21A / 3 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Dysgeusia, Nausea, Parosmia
SMQs:, Acute pancreatitis (broad), Taste and smell disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Methocarbamol 750 mg Levothyroxine 75 mg Rosuvastatin 10mg Linsinopril 5 mg Calcium 600 mg Multi Vitamin Magnesium 400 mg Vitamin C 100 mg
Current Illness: Seasonal allergies
Preexisting Conditions: Arthritis Obesity
Allergies: Levaquin Mold Dust Pine Iodine wash Casein
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Metallic taste in mouth. Sense of smell changed. Nausea


VAERS ID: 1814965 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-10-22
Onset:2021-10-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Chest pain, Dizziness, Dyspnoea, Laboratory test, Palpitations
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Women?s multivitamin Vitamin D Tylenol Topical minoxidil/spironolactone gel Vaginal estrogen tablets
Current Illness: None
Preexisting Conditions: History of cardiac arrhythmia
Allergies: None
Diagnostic Lab Data: 10/25/21
CDC Split Type:

Write-up: MI Symptoms, heart racing/ pounding , chest pain, shortness of breath , lightheadedness. I?m currently being worked up in the hospital and they recommend that I complete this form.


VAERS ID: 1814989 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: California  
Vaccinated:2021-10-25
Onset:2021-10-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026C21A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Expired product administered, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: Patient was given Moderna vaccine and shortly after found out this lot (026C21A) is expired as of 10/24/21. Contacted Modera and they confirmed that the lot did expire. Patient did not experience and side effects at the time of this report. Awaiting on guidance from Moderna to see if dose needs to be repeated.


VAERS ID: 1814997 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-04-05
Onset:2021-10-25
   Days after vaccination:203
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808609 / 1 LA / IM

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

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

Write-up: hospitalization (non-ICU)


VAERS ID: 1815017 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-10-25
Onset:2021-10-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2593 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Hypoaesthesia oral, Paraesthesia oral, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: PATIENT RECEIVED VACCINE AT 9:04AM. AT 9:37AM PATIENT RETURNED TO THE COUNTER WITH A RED RASH ON NECK AND CHEST. PATIENT DENIED BREATHING DIFFICULTY AT THE TIME. PATIENT WAS GIVEN 50MG OF DIPHENHYDRAMINE AT 9:38AM. AT 9:44AM PATIENT STATED TONGUE FELT NUMB AND TINGLY AND WAS PROGRESSIVELY GETTING WORSE. PATIENT WAS TAKEN TO IMMUNIZATION AREA AND PHARMACIST ADMINISTERED 0.3MG EPINEPHRINE IM. PATIENT WAS SEATED AND GIVEN WATER. PATIENT WAS MONITORED FOR ANOTHER 20 MINUTES BEFORE SHE FELT SHE WAS FEELING BETTER.


VAERS ID: 1815031 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-10-25
Onset:2021-10-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8839 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dyspnoea, Nasal congestion
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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: none/unknown
Preexisting Conditions: none/unknown
Allergies: none/unknown
Diagnostic Lab Data: unknown
CDC Split Type:

Write-up: I gave the patient their second dose of pfizer vaccine around 945 am and received a call from the patient around 1145 am stating the patient had nasal congestion and shortness of breath. I advised the patient to seek the nearest emergency room.


VAERS ID: 1815053 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: California  
Vaccinated:2021-10-25
Onset:2021-10-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026C21A / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Expired product administered, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: Patient was given Moderna vaccine and shortly after found out this lot (026C21A) is expired as of 10/24/21. Contacted Modera and they confirmed that the lot did expire. Patient did not experience and side effects at the time of this report. Awaiting on guidance from Moderna to see if dose needs to be repeated.


VAERS ID: 1815074 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: California  
Vaccinated:2021-10-25
Onset:2021-10-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026C21A / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Expired product administered, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: Patient was given Moderna vaccine and shortly after found out this lot (026C21A) is expired as of 10/24/21. Contacted Modera and they confirmed that the lot did expire. Patient did not experience any side effects at the time of this report. Awaiting on guidance from Moderna to see if dose needs to be repeated.


VAERS ID: 1815084 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-10-01
Onset:2021-10-25
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 UN / UN

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Nausea
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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies: NONE
Diagnostic Lab Data:
CDC Split Type:

Write-up: DIZZINESS AND NAUSEATED TREATMENT ONDANSETRON 4MG ODT 1 TID


VAERS ID: 1815127 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2021-10-25
Onset:2021-10-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1822811 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

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

Write-up: Burning at time of injection


VAERS ID: 1815131 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-09-10
Onset:2021-10-25
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / -

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

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

Write-up: Tested positive for COVID 10/25/21 after being fully vaccinated.


VAERS ID: 1815144 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Georgia  
Vaccinated:0000-00-00
Onset:2021-10-25
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039A21A / UNK LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Fall, Gait disturbance, Paralysis
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Accidents and injuries (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad)

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

Write-up: Paralyzed for about 12 hours. Fell out of bed to go to the bathroom. Could not even crawl to the toilet.


VAERS ID: 1815174 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: California  
Vaccinated:2021-10-25
Onset:2021-10-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0809 / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Inappropriate schedule of product administration
SMQs:, Medication errors (narrow)

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

Write-up: Patient made an appointment on website for his 2nd Pfizer vaccine. Arrived to pharmacy with school-appointed guardian and received his 2nd Pfizer dose. Insurance was not received and run until patient arrived at the pharmacy and rejected citing dose "too soon." Per CAIR registry, first dose was 10/18/21 only 7 days before the 2nd was given. Pfizer 2nd dose should be given 21 days after the first dose.


VAERS ID: 1815201 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: California  
Vaccinated:2021-10-25
Onset:2021-10-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 211A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: the vaccine was expired ,was over 6 hours and was left at room temperature


VAERS ID: 1815205 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-10-25
Onset:2021-10-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 014F21A / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Extra dose administered, Inappropriate schedule of product administration
SMQs:, Medication errors (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: Prenatal vitamins
Current Illness: NA
Preexisting Conditions: NA
Allergies: NA
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Covid booster given to early second dose give 5/21/21 and booster dose given 10/25/21


VAERS ID: 1815219 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: California  
Vaccinated:2021-10-25
Onset:2021-10-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 211A21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: expired vaccine was injected


VAERS ID: 1815225 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-02-26
Onset:2021-10-25
   Days after vaccination:241
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 014M20A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood gases, Brain natriuretic peptide, COVID-19, Chest X-ray, Cough, Dyspnoea, Full blood count, Metabolic function test, SARS-CoV-2 test positive, Troponin
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: acetaminophen 500mg q6hr prn for pain albuterol q4hr prn for cough ascorbic acid 500mg daily atorvastatin 10mg HS buspirone 15mg TID calcium carbonate 600mg daily cholecalciferol 1000IU daily Codeine-guaifenesin 5mL q6hr prn for cough and c
Current Illness: None documented
Preexisting Conditions: Hyperreactive airway disease, hypertension disorder, hyperlipidemia, peripheral neuropathy, type II diabetes, diverticular disease of large intestine, centriacinar emphysema, chronic diastolic heart failure, iron deficiency anemia, longstanding persistent atrial fibrillation, chronic obstructive lung disease, senile asthenia, chronic kidney disease stage 4, tinea corporis, history of malignant basal cell tumor of skin, myocardial infarction, Cardiomyopathy.
Allergies: ACE inhibitors - Cough Hyzaar - Hypokalemia
Diagnostic Lab Data: 10/25/2021: BMP, CCBC, Blood gas venous, BNP, Troponin Chest Xray
CDC Split Type:

Write-up: Patient contracted COVID after being fully vaccinated Shortness of breath and cough


VAERS ID: 1815248 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-10-24
Onset:2021-10-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Interchange of vaccine products
SMQs:, 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:

Write-up: Service member received Moderna for the first series of COVID-19 vaccination followed by Pfizer for the second series, administered at pharmacy.


VAERS ID: 1815257 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: New York  
Vaccinated:2021-10-25
Onset:2021-10-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939904 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Malaise, Pallor, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: UNKNOWN
Current Illness: NONE
Preexisting Conditions: UNKNOWN
Allergies: NO KNOWN ALLERGIES
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: PATIENT HAD AN APPOINTMENT FOR THE FIRST DOSE OF THE MODERNA VACCINE. THE VACCINE WAS ADMINISTERED INTO THE LEFT DELTOID, PATIENT WAS ADVISED TO SIT FOR 15 MINUTES TO MONITOR FOR ADVERSE EVENTS. PATIENT DID WAIT FOR A COUPLE OF MINUTES AND THEN LEFT THE PHARMACY. PATIENT RETURNED TO THE PHARMACY STATING THAT HE DID NOT FEEL GOOD. PATIENT WAS PALE AND SHAKING. PHARMACIST ASKED THE PATIENT IF HE HAD ANY DIFFICULTY BREATHING OR IF HE HAD ANY VISUAL DISTURBANCES, PATIENT SAID NO. PHARMACIST ALSO ASKED THE PATIENT IF HE HAD EATEN SINCE THE MORNING, PATIENT SAID NO. PHARMACIST QUICKLY GOT THE PATIENT A BOTTLE OF WATER AND A CHOCOLATE BAR. PATIENT DRANK THE WATER AND ATE THE CHOCOLATE. PHARMACIST STAYED WITH THE PATIENT TO MONITOR THE PATIENT, SOON THE PATIENT WAS NOT SO PALE ANYMORE. THE PHARMACIST AGAIN ASKED THE PATIENT IF HE WAS FEELING ANY BETTER, PATIENT SAID A LITTLE BIT. PHARMACIST CONTINUED TO MONITOR AND LET THE PATIENT KNOW IF HE FEELS DIZZY OR HAS ANY DIFFICULTY BREATHIING OR ANY VISUAL DISTURBANCES THE PHARMACIST WILL CALL AN AMBULANCE. THE PATIENT REQUESTED THE PHARMACIST CALL THE AMBULANCE. IMMEDIATELY THE PHARMACIST CALLED 911 AND ASKED FOR AN AMBULANCE. THE AMBULANCE ARRIVED AFTER A COUPLE OF MINUTES. THE EMT TOOK THE PATIENT WITH THEM, THE PATIENT WALKED OUT OF THE PHARMACY UNDER THE SUPERVISION OF THE EMT.


VAERS ID: 1815258 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-10-25
Onset:2021-10-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1855194 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Fall
SMQs:, Anticholinergic syndrome (broad), Accidents and injuries (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Not known
Current Illness: None
Preexisting Conditions: None
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient felt light headed and finally collapsed to the Ground.


VAERS ID: 1815266 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: California  
Vaccinated:2021-10-25
Onset:2021-10-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026C21A / 3 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: Patient received booster of Moderna on 10/25/21. According to moderna website specific lot number has an exp of of 10/24/21.


VAERS ID: 1815273 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: New York  
Vaccinated:2021-10-25
Onset:2021-10-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939904 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Malaise
SMQs:

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

Write-up: PATIENT RECEIVED VACCINE AND SOON AFTER DID NOT FEEL WELL. PATIENT REQUESTED AMBULANCE BE CALLED.


VAERS ID: 1815276 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: California  
Vaccinated:2021-10-25
Onset:2021-10-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026C21A / 3 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Extra dose administered
SMQs:, Medication errors (narrow)

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

Write-up: None stated.


VAERS ID: 1815281 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: California  
Vaccinated:2021-10-25
Onset:2021-10-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026C21A / 3 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Extra dose administered
SMQs:, Medication errors (narrow)

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

Write-up: None stated.


VAERS ID: 1815288 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: California  
Vaccinated:2021-10-25
Onset:2021-10-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026C21A / 3 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: Patient received booster of Moderna (025ml) on 10/25/21. According to modernatx website specific lot number has an exp of of 10/24/21.


VAERS ID: 1815294 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: California  
Vaccinated:2021-10-25
Onset:2021-10-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026C21A / 3 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: Patient received booster of Moderna (025ml) on 10/25/21. According to modernatx website specific lot number has an exp of of 10/24/21.


VAERS ID: 1815301 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-10-25
Onset:2021-10-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30125BA / UNK LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Product preparation issue
SMQs:, Medication errors (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: N/A
Current Illness: N/A
Preexisting Conditions: Epilepsy & Seizures
Allergies: Keppra & Lacosamide
Diagnostic Lab Data: N?A
CDC Split Type:

Write-up: Sterile water was used as the diluent with the Covid Vaccine (Phizer)instead of normal saline.


VAERS ID: 1815302 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: California  
Vaccinated:2021-10-25
Onset:2021-10-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026C21A / 3 - / IM

Administered by: Public       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Patient received booster of Moderna (025ml) on 10/25/21. According to modernatx website specific lot number has an exp of of 10/24/21.


VAERS ID: 1815309 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: California  
Vaccinated:2021-10-25
Onset:2021-10-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026C21A / 3 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Expired product administered, Extra dose administered
SMQs:, Medication errors (narrow)

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

Write-up: Patient received booster of Moderna (025ml) on 10/25/21. According to modernatx website specific lot number has an exp of of 10/24/21.


VAERS ID: 1815317 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-10-25
Onset:2021-10-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 076C21A / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: The patient received a third dose of Moderna only 4 months after receiving their second dose. The incident happened today and there were no adverse events reported while the patient was still in the pharmacy building. The patient was warned to contact their doctor and complete a VAERS report if any unusual symptoms arise after receiving the early dose.


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