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From the 10/15/2021 release of VAERS data:

Found 800,916 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 191 out of 8,010

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VAERS ID: 1759778 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: bevacizumab; Calcium carbonate supplement; calciferol; magnesium glycinate; Baikalin; Emodin;
Current Illness: ovarian cancer
Preexisting Conditions: ovarian cancer; currently undergoing active treatment
Allergies: NKDA
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Rec''d COVID booster shot from community provider; now reporting diarrhea since booster shot given ~3 weeks ago


VAERS ID: 1761417 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-07-06
Onset:2021-09-14
   Days after vaccination:70
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0186 / 2 LA / SYR

Administered by: Private       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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin D, Antivert, ciprodex, mycostatin, robaxin, humira, indocin, sympicort, prilosec, yasmin, albuterol, proventil.
Current Illness: None
Preexisting Conditions: Asthma Preventative health care History of abnormal cervical Pap smear Myalgia Inflammatory spondylopathy of lumbar region Generalized articular hypermobility
Allergies: Guaifenesin-dm Cr Mucinex Guaifenesin Pseudoephedrine Base Hypertension
Diagnostic Lab Data: Positive PCR test on 09/18/2021
CDC Split Type:

Write-up: Patient tested positive for COVID on 09/18/2021. Symptoms started on 09/14/2021. She had congestion, runny nose, cough, left ear pain.


VAERS ID: 1761465 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0187 / 3 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Asthenopia
SMQs:, Corneal 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:
Current Illness:
Preexisting Conditions:
Allergies: sulfur, chemo, adhesive
Diagnostic Lab Data:
CDC Split Type:

Write-up: extremely heavy eyelids


VAERS ID: 1761586 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: New York  
Vaccinated:2021-09-07
Onset:2021-09-14
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808982 / 1 RA / IM

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: Synthroid, Nuvaring, phentermine, metformin, vitamin C, Zinc
Current Illness:
Preexisting Conditions: Hashimoto''s & PCOS
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Hair loss/thinning


VAERS ID: 1761601 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Erythema, Hypoaesthesia, Pain in extremity, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: vitamin D 2 Vitamin B12 fish oil tumeric
Current Illness: none
Preexisting Conditions: fibroids MTHFR mutation
Allergies: morphine pcn
Diagnostic Lab Data:
CDC Split Type:

Write-up: I did not personally give vaccine since administration of vaccine on 9/13/2021 pt has had pain in upper arm- but then subsequent- after normal immune redness and swelling pt has been experiencing numbness and weakness of upper arm from deltoid to elbow.


VAERS ID: 1761612 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: New York  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3592 / 1 RA / SYR

Administered by: Work       Purchased by: ?
Symptoms: Blood test normal, Chest X-ray normal, Chest pain, Electrocardiogram normal, Fatigue, Gait disturbance, Haemorrhoids, Headache, Menstruation irregular, Pain in extremity, SARS-CoV-2 test negative
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Fertility disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/a
Current Illness: None
Preexisting Conditions: None
Allergies: N/a
Diagnostic Lab Data: Test were done on 9/27/2021-9/28/2021
CDC Split Type:

Write-up: About forty five minutes after taking the first dose of the covid vaccine. I had a severe headache, I became very fatigue and had difficulty walking. I experienced hemorrhoids that shot to my anus unexpectedly. It lasted the entire day on and off. My arm was sore for a week and a half. I began having sharp chest pains which started Wednesday September 22nd, 2021 evening. The pains got worse on Friday. By Monday night 9/27/2021 I had to go to the Er to be sure it was not serious. The hospital diagnosed me with chest pain with unspecified type. Blood work was done, chest X-ray and ekg. They could not find the source of the problem. I was also tested for covid and it came back negative. I was prescribed Tylenol, alum-mag hydroxide-simeth and famotidine. I was discharged 9/28/2021. The chest pains was still there and subsided on Friday 10/1/2021. My menstrual cycle came two weeks after my period ended early September. I have been having pains in my lower part of my legs and off and on headaches since the first shot.


VAERS ID: 1761680 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: New York  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046CZ1A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Chills, Fatigue, Pruritus, 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: No
Preexisting Conditions: Asthma
Allergies: Peanut; Almond Allergies; and Environmental Sessional Allergies.
Diagnostic Lab Data: Observation for test.
CDC Split Type: vsafe

Write-up: 09/14/2021 evening felt fatigue (3 days), chills (1 day). Hives came on 09/22/2021 itchy, raised, ears, back, all over body from head, scalp, to toes and in between toes. Thursday 09/23/2021. Treated with Steroid injection at urgent care 09/23/2021 - AM then the allergist to received another treatment 09/23/2021 PM.


VAERS ID: 1761717 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       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: Vaccine error - Vaccine was administered past its beyond use date. The vaccine had been stored in the freezer beyond the time frame recommended by the manufacturer.


VAERS ID: 1761738 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       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: Vaccine error - Vaccine was administered past its beyond use date. The vaccine had been stored in the freezer beyond the time frame recommended by the manufacturer.


VAERS ID: 1761755 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Expired product administered, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccine error - Vaccine was administered past its beyond use date. The vaccine had been stored in the freezer beyond the time frame recommended by the manufacturer.


VAERS ID: 1761805 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-04-02
Onset:2021-09-14
   Days after vaccination:165
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8733 / 2 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Balance disorder, COVID-19, Cough, Dizziness, Dyspnoea, Fatigue, Headache, Nasopharyngitis, Nausea, Pain, Productive cough, Pyrexia, SARS-CoV-2 test positive, Vaccine breakthrough infection
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: vit D, inhaler albuterol & flovent
Current Illness:
Preexisting Conditions: asthma , pre diabetic only when I have had flare up asthma , overweight, fibromyalgia, arthritis, chronic fatigue, PTSD
Allergies: dust mite, pollen, cats , outdoor molds
Diagnostic Lab Data: Covid test positive
CDC Split Type: vsafe

Write-up: I was tired and achy at first, felt like flu. I was so cold, I could not get warm I felt nauseated, shortness of breath, I''m weak I feel unbalanced and dizzy. Low grade fevers, and I had some horrible coughing spasms. I cough up a lot of phlegm every morning. I''m still very fatigued. I came in on Friday I went in for infusion on antibodies. I still am experiencing symptoms of shortness of breath, headaches, and fatigue and cough.


VAERS ID: 1761948 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       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: Vaccine error - Vaccine was administered past its beyond use date. The vaccine had been stored in the freezer beyond the time frame recommended by the manufacturer.


VAERS ID: 1762131 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-04-11
Onset:2021-09-14
   Days after vaccination:156
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025B21A / 2 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: COVID-19, Injection site pain, Pain, SARS-CoV-2 test positive, Sinusitis
SMQs:, Extravasation events (injections, infusions and implants) (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Allopurinol ( 100mg 1xday ) Primidone ( 50mg 2 in evening ) Amlodipine ( 10mg 1xday ) Metoprolol ( 100mg 3xday ) Propranolol ( 40mg PRN ) Flovent HFA ( 110 mcg - daily ) Ventolin AFA (90mcg - PRN ) Areds 2 ( 2xday ) Aspirin Low Dose ( 81mg
Current Illness: NA
Preexisting Conditions: Asthma Premature Ventricular Contractions ? PVC Gout Arthritis Hypoglycemia Meniere?s Disease Macular Degeneration High BP Familiar Tremors
Allergies: Valium, Xanax, Gabapentin, Morphine, Vicodin Cough Medicine, Latex
Diagnostic Lab Data: COVID-19 Test Antibody Infusion
CDC Split Type: vsafe

Write-up: I had a sore arm at the site of the injection for less than 24 hours. I used Tylenol and ice packs and that resolved those issues. Five and half months later after receiving my 2nd dose of the vaccine I contracted COVID-19. I went to medical facility on that Thursday 9/16/21 thinking I just had a bad sinus infection. I was tested for COVID-19 and was prescribed antibiotics, steroids, and received a steroid shot to treat the sinus infection. The clinic called me that Saturday and advised to me that my COVID-19 Test came back positive and to continue taking the medication I was prescribed. I had the antibody infusion done on 9/20/21 at hospital. After I received the infusion, I still took the Tylenol twice a day to help with any aches or pains. I never ran a fever while having COVID-19.


VAERS ID: 1762358 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Muscle fatigue, Nerve injury, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Accidents and injuries (narrow), Arthritis (broad), Tendinopathies and ligament 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: Rifaxin
Current Illness: N/A
Preexisting Conditions: IBS/SIBO
Allergies: N/a
Diagnostic Lab Data: No tests, Prednisone for 10 days then sports or hand therapy.
CDC Split Type:

Write-up: Extreme fatigued arm,elbow and arm pain,ulnar nerve swelling ongoing problem since vaccine


VAERS ID: 1762724 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Iowa  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: Patient reported that she had a small bump just below the bend of her elbow following the first dose of covid. She states it is not red or hot to touch. She states it doesn''t her to press on it and that it has not changed her range of motion. She just can feel a bump and thought it could be related to the shot. It is visible to the eye compared to her other arm.


VAERS ID: 1762879 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: California  
Vaccinated:2021-09-07
Onset:2021-09-14
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

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

Write-up: Severe Continuous Tinnitus.


VAERS ID: 1764115 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Unknown  
Location: New York  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006C21A / UNK - / 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: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 14-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported No treatment medication were reported. The vaccine was administered after 4 days from time from first puncture. This case was linked to MOD-2021-332638 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up received contains no new information , but initial version the vaccine was administered after 4 days from time from first puncture was missed and added in inarrative


VAERS ID: 1764116 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Unknown  
Location: New York  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006C21A / UNK - / 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: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 29-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 14-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. No treatment medication was provided. The vaccine was administered after 4 days from time from first puncture. This case was linked to MOD-2021-332638 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up contains no new information , but the vaccine was administered after 4 days from time from first puncture was missed and added in narrative


VAERS ID: 1764174 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:2021-09-14
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / UNK - / -

Administered by: Other       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: MRNA 1273
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20211006533

Write-up: RECEIVED MODERNA AS A SECOND DOSE; This spontaneous report received from a health care professional concerned a 56 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A,expiry: 21-JUN-2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. Concomitant medications included mrna 1273 for prophylactic vaccination. On 14-SEP-2021, the patient experienced received moderna as a second dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received moderna as a second dose was not reported. This report was non-serious. This case, from the same reporter is linked to 20211006342.


VAERS ID: 1764341 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-02-12
Onset:2021-09-14
   Days after vaccination:214
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM9810 / 2 - / IM

Administered by: Public       Purchased by: ?
Symptoms: COVID-19, Dyspnoea, Hypoxia, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 13 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: albuterol (PROAIR HFA) 108 (90 BASE) MCG/ACT HFA inhaler amoxicillin (AMOXIL) 250 MG capsule azelastine (ASTELIN) 137 MCG/SPRAY nasal spray benzonatate (TESSALON) 100 MG capsule Black Cohosh 160 MG capsule calcium polycarbophil (FIBERCON 62
Current Illness: None known
Preexisting Conditions: Pulmonary embolism (HCC) IBS (irritable bowel syndrome) Upper airway cough syndrome Vocal cord dysfunction Moderate persistent asthma without complication Daytime sleepiness OSA (obstructive sleep apnea) Non-seasonal allergic rhinitis due to other allergic trigger Gastroesophageal reflux disease without esophagitis History of asthma History of pulmonary embolus (PE) BMI 40.0-44.9, adult (HCC) Type 2 diabetes mellitus without complication, with long-term current use of insulin (HCC)
Allergies: Prednisone (vision changes)
Diagnostic Lab Data: Patient reported COVID-19 test positive on 9/14/21.
CDC Split Type:

Write-up: Patient presented to the emergency room on 9/17/2021 after testing positive for COVID-19 due to worsening of shortness of breath. She declined monoclonal antibodies at that time and was discharged home. She returned to the emergency department on 9/22/2021 due to worsening symptoms and hypoxia and was admitted for further management. She was treated with dexamethasone and supplemental oxygen. She was discharged home on 10/5/2021.


VAERS ID: 1765026 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: West Virginia  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8839 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Diarrhoea, Fatigue, Impaired work ability, Influenza virus test negative, Pruritus, Pyrexia, SARS-CoV-2 test negative, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Armour Thyroid 30 mg am Prozac 10 mg HS
Current Illness: none
Preexisting Conditions: Sleep disorder x25 years, Serotonin deficiency x 38 yrs
Allergies: Calamari
Diagnostic Lab Data: Went to an Urgent Care on the 25th of Sept. to be checked for covid and had a nasal respiratory panel for flu. Those tests were negative.
CDC Split Type:

Write-up: feeling fatigued, ran fever of 103-104 for 4 days, diarrhea x 2 weeks, in bed for 6 days, missed 2 days of work ,broke out in hives on day four that were over body mostly back and were itchy. Still have some occurring 22 days later.


VAERS ID: 1765088 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Diarrhoea, Feeling cold, Pain
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: ATORVASTATIN 10 MG BABY ASPIRIN 81 MG METFORMIN 850 MG NADOLOL 20 MG PANTOPRAZOLE 40 MG LOSARTAN 25 MG SUCRALTATE 1 GM
Preexisting Conditions: DIABETES LIVER CIRRHOSIS HEART ATTACK (09/2018) - INSERTED BARE METAL STENT
Allergies: NONE
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: COLD CHILS, BODY PAIN, DIARREAH


VAERS ID: 1765110 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-03-12
Onset:2021-09-14
   Days after vaccination:186
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 048A21A / 1 UN / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046B21A / 2 UN / SYR

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: COVID 19


VAERS ID: 1765124 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-03-12
Onset:2021-09-14
   Days after vaccination:186
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046B2119 / 1 UN / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046B2119 / 2 UN / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19
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: COVID 19


VAERS ID: 1765193 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Kentucky  
Vaccinated:0000-00-00
Onset:2021-09-14
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNKNOWN / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19
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: COVID 19 FHP OF CASE STATED SHE DOESNT HAVE CARD, OR KNOW EXACT VACC DATE


VAERS ID: 1765197 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-03-17
Onset:2021-09-14
   Days after vaccination:181
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / N/A UN / SYR

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: COVID 19


VAERS ID: 1765279 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-06-11
Onset:2021-09-14
   Days after vaccination:95
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0180 / 2 - / IM

Administered by: Pharmacy       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? 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: COVID POSTIVE


VAERS ID: 1765587 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-09-01
Onset:2021-09-14
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Menstrual disorder, Polymenorrhoea
SMQs:

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: Estrogen, testosterone, T4/T3, progesterone.
Current Illness:
Preexisting Conditions: Ovarian failure
Allergies: Latex
Diagnostic Lab Data:
CDC Split Type:

Write-up: Early menstrual cycle.


VAERS ID: 1765632 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: TINGLING AND NUMBNESS IN HANDS. HAS NOT GONE AWAY AS OF 10/6. ANY SHAKE TO HANDS MAKE IT FEELS WORSE


VAERS ID: 1766327 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Confusional state, Dizziness, Fatigue, Head discomfort, Headache, Nausea, Pain in extremity, Paraesthesia, Tinnitus, Vision blurred, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: Seasonal (pollen), fruits (peach, apple, cherry), nuts (walnut)
Diagnostic Lab Data:
CDC Split Type:

Write-up: First day after vaccine was normal symptoms (left arm soreness, tired, slight headache) Severe headache started day after vaccine. Nausea, pressure on head, dizziness, confusion, vomiting worse on days 2-3. Advil and ice packs were used starting day 2 but did not help. Headache and dizziness improved gradually over next few days. Once headache was better(by day 7), experienced ringing in ears, blurred vision, and right side (arm and leg) tingling sensation. Coming up on 4 weeks after first dose and still feel tingling sensation, ear ringing, and blurry vision.


VAERS ID: 1766894 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Unknown  
Location: New York  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006C21A / 2 - / 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: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 14-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant Medications details were provided. No Treatment Medications details were provided. The vaccine was administered after 4 days from time from first puncture. Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received contain no new significant information,but the event onset and therapy onset date added and vaccine was administered after 4 days from time from first puncture was missed and added in narrative


VAERS ID: 1766984 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-02-08
Onset:2021-09-14
   Days after vaccination:218
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Therapeutic response unexpected
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: METFORMIN; LEVOTHYROXINE; OLMESARTAN MEDOXOMIL
Current Illness: Blood pressure high; Diabetic; Thyroid disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: She received and the third gave her energy.; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (She received and the third gave her energy.) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 013L20A and 016M20A) for COVID-19 vaccination. Concurrent medical conditions included Diabetic, Blood pressure high and Thyroid disorder. Concomitant products included OLMESARTAN MEDOXOMIL for Blood pressure high, METFORMIN for Diabetes, LEVOTHYROXINE for Thyroid disorder. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (She received and the third gave her energy.). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (She received and the third gave her energy.) outcome was unknown. No treatment medication was reported. This case was linked to MOD-2021-335075 (Patient Link).


VAERS ID: 1767368 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal discomfort, Headache, Nausea, Oropharyngeal pain, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEXAPRO.
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: Rapid; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: USPFIZER INC202101216308

Write-up: Nausea; Upset stomach; Body aches; Fever; Sore throat; Head ache; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 14Sep2021 03:45 (at the age of 33-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient received no other vaccine in 4 weeks. The patient was not diagnosed with COVID-19 prior vaccination. On 14Sep2021 05:00 the patient experienced nausea, upset stomach, body aches, fever, sore throat, and head ache. The patient received no treatment for the events. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Rapid Nasal Swab): negative on 15Sep2021. The outcome of the events was reported as not resolved. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1767982 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-04-09
Onset:2021-09-14
   Days after vaccination:158
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 048A21A / 1 - / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046B21A / 2 - / IM

Administered by: Public       Purchased by: ?
Symptoms: Ageusia, Anosmia, COVID-19, Cough, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Taste and smell disorders (narrow), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (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:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: COVID 19 Antigen Positive on 9/16/21
CDC Split Type:

Write-up: Breakthrough case after Covid vaccination. Dose #1 03/12/2021, dose #2 04/09/2021 C/O loss of taste/smell, SOA, and cough


VAERS ID: 1768247 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-01-29
Onset:2021-09-14
   Days after vaccination:228
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025J20A / 1 - / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030L20A / 2 - / IM

Administered by: Public       Purchased by: ?
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Diarrhoea, Dyspnoea, Headache, Myalgia, Nasal congestion, SARS-CoV-2 test positive, Vaccine breakthrough infection
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Taste and smell disorders (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (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:
Current Illness:
Preexisting Conditions: Autoimmune disorder
Allergies:
Diagnostic Lab Data: SARS CoV + SARS CoV 2 Antigen Positive on 9/16/2021
CDC Split Type:

Write-up: Breakthrough case after Covid vaccination. Dose #1 12/23/2020 Dose #2 01/29/2021. C/O muscle aches, headache, loss of taste/smell, cough, SOA, diarrhea, and stuffy nose/ onset 09/14/2021


VAERS ID: 1768527 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fatigue, Pain, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Levoxyl Levothyronine Sertraline Omeprazole Vit D
Current Illness: NA
Preexisting Conditions: Hoshimotos hypothyroid
Allergies: Na
Diagnostic Lab Data:
CDC Split Type:

Write-up: 9/14/21 began sore arm, fatigue, body aches


VAERS ID: 1768573 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Expired product administered, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccine error - Vaccine was administered past its beyond use date. The vaccine had been stored in the freezer beyond the time frame recommended by the manufacturer.


VAERS ID: 1768577 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Expired product administered, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccine error - Vaccine was administered past its beyond use date. The vaccine had been stored in the freezer beyond the time frame recommended by the manufacturer.


VAERS ID: 1768633 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-04-08
Onset:2021-09-14
   Days after vaccination:159
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 - / IM

Administered by: Public       Purchased by: ?
Symptoms: COVID-19, Cough, Dyspnoea, Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive, Vaccine breakthrough infection
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: COPD
Allergies:
Diagnostic Lab Data: COVID 19 Antigen Positive 9/14/2021
CDC Split Type:

Write-up: Breakthrough case after Covid vaccination. Dose #1 4/8/2021. C/O fever, runny nose, SOA, cough/ onset 9/14/2021


VAERS ID: 1768778 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Eczema, Feeling of body temperature change, Malaise, Pain
SMQs:, Hypersensitivity (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: Went pale and unresponsive as a baby.
Other Medications: Multivitamin
Current Illness: None
Preexisting Conditions: None
Allergies: Pertussis vaccine
Diagnostic Lab Data:
CDC Split Type:

Write-up: After first shot, body aches, hot/cold flashes, feeling I?ll, eczema patches (6 dime size patches). After second shot I had roughly 15-20 more patches in addition to body aches, headache, and hot/cold flashes.


VAERS ID: 1768885 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Unknown  
Location: Georgia  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       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: Vaccine error - Vaccine was administered past its beyond use date. The vaccine had been stored in the freezer beyond the time frame recommended by the manufacturer.


VAERS ID: 1768906 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2587 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Burning sensation, Chills, Dyspepsia, Dysstasia, Headache, Hyperhidrosis, Loss of bladder sensation, Magnetic resonance imaging head, Magnetic resonance imaging neck, Magnetic resonance imaging spinal, Nausea, Pallor, Pyrexia, Urine analysis, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: Chapstick
Diagnostic Lab Data: Blood work, MRI of Brain, neck and spine , Urinary panel (see medical records)
CDC Split Type:

Write-up: Headache Fever Chills /Sweating profusely Pale/Could not stand Nausea /Vomiting Burning in stomach/intestines Burning in legs Loss of bladder sensation


VAERS ID: 1771878 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-01-04
Onset:2021-09-14
   Days after vaccination:253
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EH9899 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1685 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Chills, Cough, Headache, Malaise, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Positive Covid-19 PCR test of unknown type.
CDC Split Type:

Write-up: C/O cough, chills, headache, runny nose, congestion, and malaise.


VAERS ID: 1772019 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: West Virginia  
Vaccinated:2021-03-25
Onset:2021-09-14
   Days after vaccination:173
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH N/A / 2 - / -

Administered by: Unknown       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? No
Hospitalized? Yes, 23 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient hospitalized with COVID symptoms after received the COVID-19 vaccines.


VAERS ID: 1772130 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-04-27
Onset:2021-09-14
   Days after vaccination:140
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0165 / 1 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Headache, Myalgia, Nasal congestion, Oropharyngeal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: to ER c/o sore throat, headache and nasal congestion x3 days. myalgias, cough


VAERS ID: 1772254 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

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

Write-up: hives soon after receiving vaccine


VAERS ID: 1772381 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-04-03
Onset:2021-09-14
   Days after vaccination:164
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8737 / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Condition aggravated, Dysphonia, Fatigue, Multiple sclerosis, Pain
SMQs:, Parkinson-like events (broad), Optic nerve disorders (broad), Demyelination (narrow), Immune-mediated/autoimmune disorders (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: Dose 1 Covid vaccine made me really tired. The next day, I started throwing up and could not hold anything down. I almost went t
Other Medications: Gabapentin; baclofen; clonazepam; methylphenidate
Current Illness: No
Preexisting Conditions: MS and Lyme disease
Allergies: Sulfa drugs
Diagnostic Lab Data: No
CDC Split Type: vsafe

Write-up: When I woke up, I had a relapse of MS with a new symptom. In addition to pain, fatigue...I had vocal issues called Dysphonia. As I increased dosage of my medications, the symptoms seem to disappear or improve. I wasn''t sure if the symptoms were vaccine related but wanted to report anyway.


VAERS ID: 1773535 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 0US1B21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Feeling of body temperature change, Headache, Tremor, Vaccination site anaesthesia, Vaccination site lymphadenopathy
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (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: USMODERNATX, INC.MOD20213

Write-up: Upon using left arm, left hand starts shaking; Constant numbness in the left arm & 2 fingers/ Degree of numbness goes up and down in the left arm & 2 fingers; Hands and feet get hot and cold; Headaches that will not stop; Swollen lymph node under the left arm; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Upon using left arm, left hand starts shaking), VACCINATION SITE ANAESTHESIA (Constant numbness in the left arm & 2 fingers/ Degree of numbness goes up and down in the left arm & 2 fingers), FEELING OF BODY TEMPERATURE CHANGE (Hands and feet get hot and cold), HEADACHE (Headaches that will not stop) and VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node under the left arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0US1B21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced TREMOR (Upon using left arm, left hand starts shaking), VACCINATION SITE ANAESTHESIA (Constant numbness in the left arm & 2 fingers/ Degree of numbness goes up and down in the left arm & 2 fingers), FEELING OF BODY TEMPERATURE CHANGE (Hands and feet get hot and cold), HEADACHE (Headaches that will not stop) and VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node under the left arm). At the time of the report, TREMOR (Upon using left arm, left hand starts shaking), VACCINATION SITE ANAESTHESIA (Constant numbness in the left arm & 2 fingers/ Degree of numbness goes up and down in the left arm & 2 fingers), FEELING OF BODY TEMPERATURE CHANGE (Hands and feet get hot and cold), HEADACHE (Headaches that will not stop) and VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node under the left arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant information was provided. No treatment information was provided.


VAERS ID: 1774919 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
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: Tingling and numbness going all down my injection arm down to my finger tips. Felt like a faint feeling of my arm being asleep. It started almost immediately after leaving the facility and lasted for 4 to 5 days before starting to go away.


VAERS ID: 1775274 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 301308A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Joint dislocation, Joint injury, Joint stiffness, Pain in extremity
SMQs:, Accidents and injuries (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
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: Pain in injection arm. Stiffness in both knees starting the night of the injection and lasting for more than one week. Led to injury in right knee after a run. Diagnosis was: internal derangement of right knee, with possible medial meniscus tear


VAERS ID: 1775493 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 050E21A / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Hyperhidrosis, Injection site pain, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (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: Multivitamins, omeprizole
Current Illness: None
Preexisting Conditions: None
Allergies: Codeine
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Headache, (the following symptoms were fairly intense) chills, sweats, pain at injection site, muscle aches, fatigue, shortness of breath, nausea


VAERS ID: 1775527 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Military       Purchased by: ?
Symptoms: C-reactive protein normal, Chest discomfort, Cough, Dyspnoea, Fibrin D dimer normal, Painful respiration, Pyrexia, Red blood cell sedimentation rate normal, Troponin normal
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: tylenol, tessalon, albuterol prn. advair bid
Current Illness: post covid sx (covid+ 2 june 21)
Preexisting Conditions: denies
Allergies: nkda
Diagnostic Lab Data: esr, d dimer, crp ,troponin all wnl
CDC Split Type:

Write-up: pt presented on 9/20/21 to clinic. covid + 2 June. some chest discomfort manifested after the vaccine mainly with deep inspiration feels like knives poking his chest thinks it is probably suprasternal but unsure. Worse with exertion relieved eventually with rest. Shortness of breath also worsened with the vaccine but back to baseline level it was at during his last appointment. When he gets into his car in the morning feels like it is hard to get a full breath. Had fevers for couple days but that was after a shot a week ago. None since. No loss of taste or smell. Dry cough persists since last appointment.. No relief with Flovent or albuterol.


VAERS ID: 1775668 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-04
Onset:2021-09-14
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Echocardiogram, Electrocardiogram, Laboratory test, Palpitations, Presyncope, Sleep disorder
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Women''s daily vitamin
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: My doctor sent a referral to a cardiologist who will be doing a full work up including EKG, echocardiogram, etc.
CDC Split Type:

Write-up: My symptoms started on 9/14/21. My heart rate was 125 bpm and I could not get it to come down with deep breathing. Since that day, I have experienced this frequently and to the point that it is waking me up at night and my heart is pounding out of my chest and I can''t calm it down. My head is aware of what is happening, but I can''t seem to calm my heart down. I have experienced heart palpitations almost every day since. It beats so hard it moves my hand when I place my hand over my heart. My normal heart rate has always been 60-70 bpm and now I check it multiple times a day and it is between 80-100 even when I am at rest. On 9/14, I almost felt like I was going to pass out because it was beating so hard. I thought it was anxiety, but after seeing my doctor about it and looking at the timeline, it was clear this all was happening due to the vaccine. I am still in the process of my treatment. I am waiting on a call from a cardiologist to get a full work up to make sure my heart is functioning properly. I have never experienced any of this before in my life until after the vaccine.


VAERS ID: 1776797 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-09-10
Onset:2021-09-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 301308A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cardiac flutter, Cardiac imaging procedure, Computerised tomogram thorax abnormal, Dyspnoea, Electrocardiogram, Palpitations, Pericardial effusion, Pneumonia, Pulmonary mass, X-ray
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tachyarrhythmia terms, nonspecific (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Plaquenil, Topiramate, Ibuprofen
Current Illness: Lupus, Neurocardiogenic Syncope, Tricuspid Regurgitation, Migraines, Possible MS
Preexisting Conditions: Lupus, Neurocardiogenic Syncope, Tricuspid Regurgitation, Migraines, Possible MS
Allergies: None
Diagnostic Lab Data: CT Scans of lungs and heart, x rays, ekgs
CDC Split Type:

Write-up: 5 days after receiving vaccine, I came down with Pneumonia and fluid around the heart. Since that day I have had heart palpitations as well as fluttering in my heart. I have had a daily heart rate going from 44 to 154. I have nodules on my lungs and have had breathing difficulty.


VAERS ID: 1776913 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-09-11
Onset:2021-09-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2588 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Condition aggravated, Thrombosis, Ultrasound scan abnormal, Varicophlebitis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Optimum Nutrition Whey Protein, Transparent Labs Pre-Workout
Current Illness:
Preexisting Conditions: Varicose Veins, Hyper-Active Airway
Allergies:
Diagnostic Lab Data: 09/17/2021- Ultrasounds performed on left and right lower extremities. Both locations confirmed to have "inflammation"
CDC Split Type:

Write-up: Blood clots developed in right calf varicose vein location within a few days of receiving 2nd Pfizer Covid-19 vaccination shot.


VAERS ID: 1779475 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Back pain, Chest pain, Electrocardiogram, Inflammation, Pain
SMQs:, Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? No
Hospitalized? No
Previous Vaccinations: Flu shot, I developed numbness and tingling of the right side of my face and the right side of my tongue swelled, which was the
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: Penicillin, Sulfa, Dilaudid, Amoxicillin
Diagnostic Lab Data: EKG- unchanged from previous.
CDC Split Type: vsafe

Write-up: I developed chest burning and chest pain midsternal. It was constant. Exercise did not affect it. Rest did not affect it. It was just constant. The pain would go through my back. That lasted for about 2 and a half weeks. I saw my doctor in between there and he diagnosed it as an inflammatory response. He started me in protonics. The chest pain was reproducible, like if you touched my chest you could reproduce it. He gave me a shot of Toradol and a shot of steroid. He did an EKG and the results were unchanged from previous. After the 2 weeks the chest burning went away. The pain became intermittent.


VAERS ID: 1779894 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-03-31
Onset:2021-09-14
   Days after vaccination:167
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8732 / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Back pain, COVID-19, Condition aggravated, SARS-CoV-2 test positive
SMQs:, Retroperitoneal fibrosis (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lisinopril; rosuvastatin; montelukast; prednisone; levofloxacin; Stiolto Respimat; Flovent; Travatan eye drops; coQ10; vitamin C; vitamin D; probiotic; multivitamin
Current Illness: N/A
Preexisting Conditions: Hypertension; COPD
Allergies: N/A
Diagnostic Lab Data: Antibodies
CDC Split Type: vsafe

Write-up: My family members had tested Positive for Covid-19 and so I went and got tested. I notified my Pulmonologist that I had tested Positive for Covid-19. I got an antibody treatment that evening. I recently had been treated for Pneumonia and my breathing was bad anyway, so I did not notice it getting worse. I quarantined and I did not notice that my symptoms were worse. My lower back pain was a little worse than normal. I ruptured a tendon in my right hand about a week after the antibody treatment.


VAERS ID: 1782279 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-02-25
Onset:2021-09-14
   Days after vaccination:201
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0145 / 1 UN / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9264 / 2 UN / SYR

Administered by: Public       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test
SMQs:, 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: Unknown
Current Illness: Unknown
Preexisting Conditions: Hypertension Cardiovascular Disease
Allergies: Unknown
Diagnostic Lab Data: Antigen test administered on 09/14/2021.
CDC Split Type:

Write-up: Patient Contracted COVID-19


VAERS ID: 1782305 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 042B21-2A / 1 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: No adverse event, Product administered to patient of inappropriate age
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: Moderna given to a child less than 18 years old. No adverse reaction reported.


VAERS ID: 1782451 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-02-10
Onset:2021-09-14
   Days after vaccination:216
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013L20A / UNK - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013M20A / UNK - / -

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? 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: COVID 19


VAERS ID: 1782542 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-04-03
Onset:2021-09-14
   Days after vaccination:164
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8734 / 2 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Body temperature increased, COVID-19, Chest pain, Cough, Respiratory tract congestion, SARS-CoV-2 test positive, Sneezing
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: high blood pressure medication 1xday
Current Illness: none
Preexisting Conditions: I only have a dry cough that I have had for years that is undiagnosed.
Allergies: none
Diagnostic Lab Data: Covid test- positive (9/14/2021)
CDC Split Type: vsafe

Write-up: I first felt unconformable Friday. I was coughing more, and I felt pain in my chest. I steamed that night and the pain went away. The steam consisted of breathing in warm air for half an hour. I had congestion, sneezing, and coughing. I took my temperature on Monday and it was 100 degrees. I called to make an appointment with my doctor. They made an appointment for Tuesday morning. I went to the appointment, and I had tested positive for covid. The night before I had steamed for half an hour and repeated that for every 6 hours. Later, that had drained my head. My temperature on Tuesday was 98 degrees. I went into isolation at that point. I am convinced that the steaming helped me feel better. I didn''t take any medication to help with covid. I only did the steaming, except for taking my normal blood pressure pill.


VAERS ID: 1782565 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 042B21-2A / 1 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Product administered to patient of inappropriate age
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: Moderna vaccine given to 13-year-old


VAERS ID: 1782637 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 20SA21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site hypoaesthesia, Injection site paraesthesia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

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

Write-up: Numbness, pins and needles, tingling, from injection sight to fingertips.


VAERS ID: 1782835 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-09-10
Onset:2021-09-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30130BN / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Contusion, Fatigue, Full blood count normal, Metabolic function test, Pain in extremity, Pruritus
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), 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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Xyzal, Yaz, Fish Oil Supplement, Vitamin C Supplement, Vitamin B Supplement
Current Illness: N/A
Preexisting Conditions: Asthma, Kidney Stones
Allergies: Wellbutrin
Diagnostic Lab Data: 9/17 CBC and CMP normal.
CDC Split Type:

Write-up: Thighs became very itchy overnight 9/14-9/15. The morning of 9/15 noted that most of thighs were bruised from the itching. The next few days legs were very sore, tender to touch and also have generalized fatigue. Took almost 2 weeks for the bruising to resolve.


VAERS ID: 1782920 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-09-12
Onset:2021-09-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 1 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Blood test normal, Chest pain, Headache, Herpes zoster, Neck pain, Scan normal
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (broad), Opportunistic infections (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: Woman?s multivitamin, vitamins c and d, probiotics
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: Heart scans did not show any damage (taken on 9/20/21), blood tests came back normal.
CDC Split Type:

Write-up: Chest pains beginning two days after the shot, then shingles following one month after, lots of headaches and neck pain from the initial vaccination date.


VAERS ID: 1785265 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 053E21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Eye swelling, Laboratory test, Leukopenia, Mouth swelling, Neutropenia, Swelling face, Swollen tongue
SMQs:, Anaphylactic reaction (narrow), Agranulocytosis (broad), Angioedema (narrow), Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: patient called pharmacy few days after injection. wanted to let us know to document she had eye swelling post vaccine. self treated with benadryl. didnt improve. called md got prednisone and started to get better. per labs had luekopenia and nuetropenia. md stated to still get 2nd shot. had history of angioedema before. recieved second shot on 10.13. will monitor


VAERS ID: 1787787 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test, Chest X-ray, Computerised tomogram head, Epistaxis, Headache, Hypertension
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Hypertension (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: Zero
Current Illness: Zero
Preexisting Conditions: Thalassemia Minor
Allergies: Small pox vax Penicillin Morphine
Diagnostic Lab Data: Blood work x2 have Toradol , no other test or blood work and sent me home. States , ?not allowed to file VEARS for Covid vaccine per Hospital policy?. 9/15/21 , IV fluids, Ibuprofen, blood work and sent home. Same comment,?Not allowed to report to VEARS per policy.? 10/07/2021 Blood work, CT Brain, Chest X Rays. Fluid Iv, Toradol, Zinc Oxide, muscle relaxers, and anti inflammatory all via iv. Still have headaches, bp still high. Considered high normal.
CDC Split Type:

Write-up: High bp Severe headache Nose bleeds Started with in 20 minutes of vaccine. High bp and headaches continue since vax. daily issue


VAERS ID: 1695238 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / -

Administered by: Private       Purchased by: ?
Symptoms: Heavy menstrual bleeding
SMQs:, Haemorrhage terms (excl laboratory terms) (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: No
Current Illness: No
Preexisting Conditions: No
Allergies: Allergy to strains of antibiotics (Keflex, Bactrum, Cechlor)
Diagnostic Lab Data:
CDC Split Type:

Write-up: Onset of heavy period, 2 weeks following previously light period, and light period the month prior,


VAERS ID: 1696712 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: The same severe adverse event confronted at first dose of vaccination .
Other Medications: Nothing was taken
Current Illness: I was in good health at times of vaccination.
Preexisting Conditions: Nothing was reported to date. Thank you
Allergies: I am not allergic. I found myself healthy.
Diagnostic Lab Data:
CDC Split Type:

Write-up: Left arm severe muscular pain, feels like swelling, after vaccination nausea, now feeling better, but the severe temperature at 10:00PM, then took Panadol tablet (single), now.


VAERS ID: 1701727 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Diarrhoea, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: No
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Nausea, stomach cramps & diaharrea. Slight fever


VAERS ID: 1709509 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-14
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain stem stroke, Coma scale, Computerised tomogram, Hypotension, Magnetic resonance imaging head, Pneumonia aspiration
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus; Hypertension; Parkinsonism
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: MRI brain; Result Unstructured Data: Brain stem stroke; Test Date: 20210914; Test Name: Glasgow coma scale; Result Unstructured Data: 11/15; Test Date: 20210914; Test Name: Computerised tomogram; Result Unstructured Data: Aspiration pneumonia
CDC Split Type: EGJNJFOC20210926801

Write-up: BRAIN STEM STROKE WITHIN 48 HOURS FROM THE VACCINATION DATE; ASPIRATION PNEUMONIA; HYPOTENSION; This spontaneous report received from a consumer via a company representative concerned an 80 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: diabetes mellitus (DM), hypertension (HTN), parkinsonism. and presented with acute DCL E4M5V2. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total, administered on 12-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-SEP-2021, the patient experienced brain stem stroke within 48 hours from the vaccination date, aspiration pneumonia and hypotension and was hospitalized. On 14-Sep-2021, Patient was admitted to Intensive Care Unit (ICU) and received anti-ischemic measures. Patient pan cultures were send and broad spectrum antibiotics were started. Patient developed severe bulbar symptoms, so he was intubated and provided mechanical ventilation (MV). He was started with levophed infusion for hypotension. Patient was still in in Intensive Care Unit (ICU) and mechanical ventilation and still under the treatment in hospital (ICU). Laboratory data included: MRI brain (NR: not provided) Brain stem stroke, Computerised tomogram (NR: not provided) Aspiration pneumonia, Glasgow coma scale (NR: not provided) 11/15 (units unspecified). Treatment medications (dates unspecified) included: norepinephrine bitartrate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from brain stem stroke within 48 hours from the vaccination date, aspiration pneumonia, and hypotension. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). .; Sender''s Comments: V0:20210926801-covid-19 vaccine ad26.cov2.s -Brain stem stroke within 48 hours from the vaccination date, Aspiration pneumonia, Hypotension. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1710561 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-14
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Apnoea, Chest pain, Dyspnoea, Influenza like illness
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Respiratory failure (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: PLJNJFOC20210930885

Write-up: APNEA; HEARTACHE; DIFFICULTIES WITH BREATHING; PAIN IN CHEST; FLU-LIKE SYMPTOMS/FEVER/CHILLS/SHE WAS COLD; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, 1 total, administered on 14-SEP-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-SEP-2021, the patient experienced flu-like symptoms/fever/chills/she was cold. On 16-SEP-2021, the patient experienced apnea, heartache, difficulties with breathing and pain in chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms/fever/chills/she was cold on 15-SEP-2021, and had not recovered from difficulties with breathing, apnea, pain in chest, and heartache. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210930885-COVID-19 VACCINE AD26.COV2.S-Apnea, Heartache. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.


VAERS ID: 1717079 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Inappropriate schedule of product administration, Oxygen saturation, Throat tightness, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Medication errors (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLINE; APIXABAN; CETIRIZINE; COLCHICINE; CYCLIZINE; DIAZEPAM; DIAZOXIDE; DOXAZOSIN; FOLIC ACID; FOSTAIR; FUROSEMIDE; HYDROXYCHLOROQUINE SULFATE; HYOSCINE BUTYLBROMIDE; LANSOPRAZOLE; ONDANSETRON; PREGABALIN; SALBUTAMOL; SENNA [SENNOS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adrenal insufficiency (Iatrogenic adrenal insufficiency); Asthma; Bronchiectasis; Chronic bronchitis; Hyperinsulinism; Hypertension; Lupus erythematosus systemic (Sustemic lupus erythematosus); Peripheral vascular disease; Polymyositis; Raynaud''s disease; Sjogren''s syndrome (Secondary Sjogren syndrome); Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)); Vena cava filter insertion (Inferior vena cava filter in situ)
Allergies:
Diagnostic Lab Data: Test Name: Saturations; Result Unstructured Data: Test Result:remained stable throughout; Comments: remained stable throughout but wheeze became significant
CDC Split Type: GBPFIZER INC202101211295

Write-up: throat tightness; bilateral wheeze; Anaphylaxis; DOSE 1: 29Jun2021; DOSE 2: 14Sep2021; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109141544357030-3MGN4, Safety Report Unique Identifier GB-MHRA-ADR 25939700. A female patient of an unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8222) via an unspecified route of administration on 14Sep2021, as a single dose for COVID-19 immunisation. Medical history included hyperinsulinism, bronchiectasis, peripheral vascular disease, asthma, chronic bronchitis, systemic lupus erythematosus, polymyositis, iatrogenic adrenal insufficiency, vena cava filter in situ (Inferior vena cava filter in situ), secondary Sjogren''s syndrome, hypertension and Raynaud''s disease, steroid therapy (Taking regular steroid treatment; example orally or rectally). The patient did not have symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN), apixaban (MANUFACTURER UNKNOWN), cetirizine (MANUFACTURER UNKNOWN), colchicine (MANUFACTURER UNKNOWN), cyclizine (MANUFACTURER UNKNOWN), diazepam (MANUFACTURER UNKNOWN), diazoxide (MANUFACTURER UNKNOWN), doxazosin (MANUFACTURER UNKNOWN), folic acid (MANUFACTURER UNKNOWN), beclometasone dipropionate/formoterol fumarate (FOSTAIR), furosemide (MANUFACTURER UNKNOWN), hydroxychloroquine sulfate (MANUFACTURER UNKNOWN), hyoscine butylbromide (MANUFACTURER UNKNOWN), lansoprazole (MANUFACTURER UNKNOWN), ondansetron (MANUFACTURER UNKNOWN), pregabalin (MANUFACTURER UNKNOWN), salbutamol (MANUFACTURER UNKNOWN), sennoside a+b (SENNA), verapamil (MANUFACTURER UNKNOWN) and morphine sulfate (ZOMORPH); all from an unknown date for an unspecified indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 29Jun2021, as a single dose for COVID-19 immunisation. On 14Sep2021, the patient experienced wheeze, anaphylaxis and throat tightness; all were reported as serious for being life-threatening and medically significant. The clinical course was reported as follows: 25 minutes following vaccination presented with sudden onset bilateral wheeze associated with throat tightness. Saturations remained stable throughout but wheeze became significant. Therapeutic measures were taken as a result of the events and included treatment with 3x adrenaline IM. The report was not related to possible blood clots or low platelet counts. The clinical outcome of the event throat tightness and wheeze was resolved on an unknown date in Sep2021; while that of the event anaphylaxis was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1720929 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-09-14
   Days after vaccination:113
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Polymerase chain reaction
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: Nasal swab; Test Result: Positive ; Comments: Nasal Swab (PCR)
CDC Split Type: GBPFIZER INC202101210721

Write-up: Contracted Covid19 (by positive PCR on 14Sep2021).; Contracted Covid19 (by positive PCR on 14Sep2021); This is a spontaneous report from a contactable consumer (patient). A 24-years-old male patient received bnt162b2 (COMIRNATY; formulation: solution for injection, Batch/Lot Number: ET1831), intramuscular, administered in left arm on 24May2021 as DOSE NUMBER UNKNOWN, SINGLE (at the age of 24-years-old) for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 14Sep2021, the patient contracted covid19 (by positive PCR on 14sep2021). The patient underwent lab tests and procedures which included Nasal swab: positive on 14Sep2021 (PCR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient''s event symptoms include headache, blocked nose, and loss of smell. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the event contracted covid19 (by positive PCR on 14sep2021).


VAERS ID: 1723495 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8845 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Diarrhoea, Electrocardiogram, Haematemesis, Heart rate, Tachycardia, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Dehydration (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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: blood exams; Result Unstructured Data: Test Result: unknown results; Test Date: 20210914; Test Name: electrocardiogram; Result Unstructured Data: Test Result: unknown results; Test Date: 20210914; Test Name: heart rate; Result Unstructured Data: Test Result:170
CDC Split Type: BRPFIZER INC202101226019

Write-up: last vomit came with blood; heart rate reached 170; vomiting; diarrhea; This is a spontaneous report from a contactable consumer (unspecified relationship with the patient) received through COVAES portal. A 12-year-old non-pregnant female patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in Arm Left on 11Sep2021 12:00 (Lot Number: FF8845) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. There was no other vaccines within 4 weeks prior to the COVID-19 vaccine. There were no concomitant medications. On 14Sep2021 12:00, she started having the following symptoms vomiting and diarrhea. On the period from noon until 09:00 PM, her last vomit came with blood, so ran to the emergency room. Arriving at the screening her heart rate reached 170, repeated twice and it gave 170, she was already admitted to the physician. The physician gave a medication to normalize the heartbeats And after a while he did an electrocardiogram and blood tests. The patient left the emergency room at 2:30 AM, the physician told to look urgently for a cardiologist. On the 15Sep2021, The patient paid for a private appointment with a cardiologist and was doing a load of exams. The events result in Hospitalization; Life threatening. Number of days Hospitalized: 1. Treatment received for the adverse event(s): electrocardiogram, blood exams and medication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was unknown.


VAERS ID: 1725853 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-09-14
   Days after vaccination:55
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Musculoskeletal stiffness, Nausea, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Medication errors (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: Vaccine administered greater than 35 day after 1st dose; Vomiting; Nausea; Stiffness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25942251) on 15-Sep-2021 and was forwarded to Moderna on 15-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), NAUSEA (Nausea) and MUSCULOSKELETAL STIFFNESS (Stiffness) in a 27-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and MUSCULOSKELETAL STIFFNESS (Stiffness) (seriousness criterion medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine administered greater than 35 day after 1st dose). At the time of the report, VOMITING (Vomiting) was resolving, NAUSEA (Nausea) and MUSCULOSKELETAL STIFFNESS (Stiffness) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine administered greater than 35 day after 1st dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment information was not provided. Company comment: This is a case of Inappropriate schedule of product administration for this 27year-old, male patient with no relevant medical history, who experienced the unexpected event of Vomiting, Nausea, and Musculoskeletal stiffness. The events occurred on the same day after the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The events of Vomiting and Nausea are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness is assessed as per Regulatory Authority reporting and retained for consistency with the RA report.; Sender''s Comments: This is a case of Inappropriate schedule of product administration for this 27year-old, male patient with no relevant medical history, who experienced the unexpected event of Vomiting, Nausea, and Musculoskeletal stiffness. The events occurred on the same day after the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The events of Vomiting and Nausea are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness is assessed as per Regulatory Authority reporting and retained for consistency with the RA report.


VAERS ID: 1725867 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-09-14
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004610 OR 3004 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Electrocardiogram, Heart rate, Heart rate increased, Platelet count, Platelet count increased, Pyrexia, Vaccination site rash
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: THACAPZOL
Current Illness: Thyrotoxicosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Heart looked good; Test Date: 20210914; Test Name: Pulse rate; Result Unstructured Data: High resting pulse at 160; Test Date: 20210914; Test Name: Thrombocyte count; Result Unstructured Data: Thrombocyte level and it was a bit high
CDC Split Type: SEMODERNATX, INC.MOD20213

Write-up: High pulse, High resting pulse; large red eruption is right under the injection site ,size of around maybe 7-8 cm long; fever; thrombocyte level and it was a bit high; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT INCREASED (thrombocyte level and it was a bit high), HEART RATE INCREASED (High pulse, High resting pulse), VACCINATION SITE RASH (large red eruption is right under the injection site ,size of around maybe 7-8 cm long) and PYREXIA (fever) in a 16-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3005242 and 3004610 or 3004670) for COVID-19 vaccination. Concurrent medical conditions included Thyrotoxicosis. Concomitant products included THIAMAZOLE (THACAPZOL) for Thyrotoxicosis. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Sep-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced PLATELET COUNT INCREASED (thrombocyte level and it was a bit high). 14-Sep-2021, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced HEART RATE INCREASED (High pulse, High resting pulse) and VACCINATION SITE RASH (large red eruption is right under the injection site ,size of around maybe 7-8 cm long). On 15-Sep-2021, PYREXIA (fever) had resolved. At the time of the report, PLATELET COUNT INCREASED (thrombocyte level and it was a bit high) outcome was unknown, HEART RATE INCREASED (High pulse, High resting pulse) had not resolved and VACCINATION SITE RASH (large red eruption is right under the injection site ,size of around maybe 7-8 cm long) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, Heart rate: 160 (High) High resting pulse at 160. On 14-Sep-2021, Platelet count: increased (High) Thrombocyte level and it was a bit high. On an unknown date, Electrocardiogram: normal Heart looked good. As per the report patient had had the high pulse, maybe after receiving her first dose of Moderna vaccine or maybe not, the reporter was not sure also not sure if the high pulse was in relationship with the first dose. The large red eruption, had a size of around maybe 7-8 cm long which was irregular, which started right under the injection site and goes down 10 cm. As per the report doctor advised the reporter to call for emergency treatment due to that it could be myocarditis or something similar, since the vaccine can cause high pulse. No treatment were taken by the patient for symptoms. However the patient had visited the doctor. Company comment: This case concerns a 16 year old female with a medical history of Thyrotoxicosis who experienced the unlisted events of Heart rate increased and Platelet count increased and the listed events of Pyrexia and Vaccination site rash that began 1 day after Moderna COVID-19 vaccine. Re-challenge is not applicable for all events except for Heart rate increased as this was the second dose. The event Heart rate increased is reported as may having occurred after the first dose also so re-challenge may be positive for this. The medical history of Thyrotoxicosis and the possible positive re-challenge remain as confounders. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 16 year old female with a medical history of Thyrotoxicosis who experienced the unlisted events of Heart rate increased and Platelet count increased and the listed events of Pyrexia and Vaccination site rash that began 1 day after Moderna COVID-19 vaccine. Re-challenge is not applicable for all events except for Heart rate increased as this was the second dose. The event Heart rate increased is reported as may having occurred after the first dose also so re-challenge may be positive for this. The medical history of Thyrotoxicosis and the possible positive re-challenge remain as confounders. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1730851 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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: sore throat; chills; fever; Rash; This case was received via Regulatory Authority RA (Reference number: GB-MHRA-ADR 25955020) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), CHILLS (chills), PYREXIA (fever) and RASH (Rash) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) (seriousness criterion medically significant), CHILLS (chills) (seriousness criterion medically significant) and PYREXIA (fever) (seriousness criterion medically significant). At the time of the report, OROPHARYNGEAL PAIN (sore throat), CHILLS (chills) and PYREXIA (fever) outcome was unknown and RASH (Rash) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient reported that Inflammation and itchiness to both hands (red/hot rash) anti histamine taken. Concomitant products were not provided. Company Comment: This case concerns a 26-year-old, female patient with no relevant medical history, who experienced the unexpected events of Rash, Oropharyngeal pain, Chills and Pyrexia. The events occurred approximately on the same day after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The event was considered related to the study drug, per the reporter''s assessment was not provided. The benefit-risk relationship of Moderna Covid -19 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 26-year-old, female patient with no relevant medical history, who experienced the unexpected events of Rash, Oropharyngeal pain, Chills and Pyrexia. The events occurred approximately on the same day after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The event was considered related to the study drug, per the reporter''s assessment was not provided. The benefit-risk relationship of Moderna Covid -19 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: 1733103 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Chills, Cough, Nausea, Neck pain, Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: Chest pressure; Pain in neck; cough; Pain in body; Sore arm; Fever goes up and down; Chill; Shivering; Nausea; Chest pain; This case was received via regulatory authority RA (Reference number: GB-MHRA-ADR 25948859) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...). Concomitant products included LEVOTHYROXINE for Hypothyroidism. On 13-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion medically significant). On an unknown date, the patient experienced CHEST DISCOMFORT (Chest pressure), NECK PAIN (Pain in neck), COUGH (cough), PAIN (Pain in body), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever goes up and down), CHILLS (Chill), CHILLS (Shivering) and NAUSEA (Nausea). At the time of the report, CHEST PAIN (Chest pain) had not resolved and CHEST DISCOMFORT (Chest pressure), NECK PAIN (Pain in neck), COUGH (cough), PAIN (Pain in body), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever goes up and down), CHILLS (Chill), CHILLS (Shivering) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) COVID-19 virus test negative.. The report stated that the patient experienced fever that goes up and down, chill, shivering, chest pressure, pain in neck, cough, pain in body, nausea and sore arm. Treatment information was not provided. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. This case concerns a 33-year-old, female subject with no relevant medical history, who experienced the unexpected event of chest pain. The event occurred 1 day after the administration of the second dose of the Moderna COVID-19 Vaccine. The rechallenge was unknown since no information about the first dose was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was assessed as per Regulatory Authority reporting; however, there was no information in the source document supporting that the event is medically significant. Of note, there was no mention in the case narrative that the event ''chest pain'' occurred; however, the event was retained per Regulatory Authority report. Moreover, non-serious events were not captured by the Regulatory Authority but were mentioned in the case narrative.; Sender''s Comments: This case concerns a 33-year-old, female subject with no relevant medical history, who experienced the unexpected event of chest pain. The event occurred 1 day after the administration of the second dose of the Moderna COVID-19 Vaccine. The rechallenge was unknown since no information about the first dose was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was assessed as per Regulatory Authority reporting; however, there was no information in the source document supporting that the event is medically significant. Of note, there was no mention in the case narrative that the event ''chest pain'' occurred; however, the event was retained per Regulatory Authority report. Moreover, non-serious events were not captured by the Regulatory Authority but were mentioned in the case narrative.


VAERS ID: 1733113 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-14
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis, SARS-CoV-2 test
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chest pain
Allergies:
Diagnostic Lab Data: Test Date: 20210915; 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: Myocarditis; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 25952655) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of MYOCARDITIS (Myocarditis) in an 18-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Chest pain. In September 2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Sep-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. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported Patient had two day history of worsening SOB and chest pain. Attended ED and admitted for investigations. Patient underwent Cardiac Echo ,results were normal. MRI results were pending. No treatment information was provided. Company comment: This case concerns a 18-year-old, male subject with a history of chest pain and worsening of shortness of breath, who experienced the expected event of MYOCARDITIS. The event occurred after the second dose of Spikevax. The rechallenge was unknown as there''s no information available about the first dose. The event is consistent with the current understanding of the mechanism of action of the study medication. The current condition of chest pain and worsening of shortness of breath remain confounders.The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 18-year-old, male subject with a history of chest pain and worsening of shortness of breath, who experienced the expected event of MYOCARDITIS. The event occurred after the second dose of Spikevax. The rechallenge was unknown as there''s no information available about the first dose. The event is consistent with the current understanding of the mechanism of action of the study medication. The current condition of chest pain and worsening of shortness of breath remain confounders.The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1736091 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-14
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Expired product administered, Immunisation, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210942132

Write-up: EXPIRED VACCINE USED; REVACCINATION; VOMITED; FEVER; This spontaneous report received from a health care professional via a Regulatory Authority (EVHUMAN Vaccines, ES-AEMPS-1005473) on 15-SEP-2021 concerned an adult male of unspecified age, race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number was not reported) dose was not reported, 1 total administered on 14-SEP-2021 for covid-19 vaccination (Drug start and last period- 1days). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 14-SEP-2021, the patient experienced expired vaccine used, revaccination, vomited, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine used, revaccination, vomited and fever was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1736334 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Anxiety, Chest pain, Chills, Decreased appetite, Depression, Diarrhoea, Illness, Influenza, Influenza like illness, Pain in extremity, Pyrexia, Vertigo
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

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

Write-up: chills; diarrhea; fever; flu symptoms; Anxiety; Chest pain; Sickness; Stomach pain; Vertigo; Depression; Flu like symptoms; Appetite lost; Pain in arm; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25946431) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (chills), DIARRHOEA (diarrhea), PYREXIA (fever), INFLUENZA (flu symptoms), ANXIETY (Anxiety), CHEST PAIN (Chest pain), ILLNESS (Sickness), ABDOMINAL PAIN UPPER (Stomach pain), VERTIGO (Vertigo), DEPRESSION (Depression), INFLUENZA LIKE ILLNESS (Flu like symptoms), DECREASED APPETITE (Appetite lost) and PAIN IN EXTREMITY (Pain in arm) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion medically significant), ILLNESS (Sickness) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (Stomach pain) (seriousness criterion medically significant), VERTIGO (Vertigo) (seriousness criterion medically significant), DEPRESSION (Depression) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion medically significant), DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant). On 15-Sep-2021, the patient experienced ANXIETY (Anxiety) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (chills) (seriousness criterion medically significant), DIARRHOEA (diarrhea) (seriousness criterion medically significant), PYREXIA (fever) (seriousness criterion medically significant) and INFLUENZA (flu symptoms) (seriousness criterion medically significant). At the time of the report, CHILLS (chills), DIARRHOEA (diarrhea), PYREXIA (fever), INFLUENZA (flu symptoms), ANXIETY (Anxiety), CHEST PAIN (Chest pain), ILLNESS (Sickness) and ABDOMINAL PAIN UPPER (Stomach pain) had not resolved and VERTIGO (Vertigo), DEPRESSION (Depression), INFLUENZA LIKE ILLNESS (Flu like symptoms), DECREASED APPETITE (Appetite lost) and PAIN IN EXTREMITY (Pain in arm) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. Patient started with sore arm, 24 hours after injection began to get flu symptoms such as fever, chills and aches, a few hours later patient began to get moderate chest and stomach pain which has not yet resolved. Also with all this patient have had sickness and diarrhea, stomach pains. Treatment medication was not provided by the reporter. Company comment- This case concerns a 30-year-old, unknown gender patient with no relevant medical history, who experienced the unexpected events of, vertigo, chest pain and anxiety. The events occurred between 2 and 3 days after the first dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. The events were considered related to the product per the reporter''s assessment. The benefit-risk relationship of mRNA-1273 in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.; Sender''s Comments: This case concerns a 30-year-old, unknown gender patient with no relevant medical history, who experienced the unexpected events of, vertigo, chest pain and anxiety. The events occurred between 2 and 3 days after the first dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. The events were considered related to the product per the reporter''s assessment. The benefit-risk relationship of mRNA-1273 in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.


VAERS ID: 1738689 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004668 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210912; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: negative (No - Negative COVID-19 test)
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fever; Headache; Fatigue; Swollen glands; Painful arm; This case was received via United Kingdom MHRA (Reference number: ADR 25951324) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen glands), PAIN IN EXTREMITY (Painful arm), PYREXIA (Fever), HEADACHE (Headache) and FATIGUE (Fatigue) in a 22-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004668) for COVID-19 vaccination. No Medical History information was reported. On 14-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 15-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). At the time of the report, LYMPHADENOPATHY (Swollen glands), PAIN IN EXTREMITY (Painful arm), PYREXIA (Fever) and FATIGUE (Fatigue) was resolving and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2021, SARS-CoV-2 test: negative (Negative) negative (No - Negative COVID-19 test). The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The treatment history was not reported. The concomitant medications was not provided. Patient has not had symptoms associated with COVID-19. Patient was not pregnant and was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment: This case concerns a 22-year-old, female patient with no relevant medical history, who experienced the unexpected events of lymphadenopathy pain in extremity, pyrexia, headache and fatigue. The events occurred 1 to 2 days after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 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 22-year-old, female patient with no relevant medical history, who experienced the unexpected events of lymphadenopathy pain in extremity, pyrexia, headache and fatigue. The events occurred 1 to 2 days after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 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: 1738819 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myalgia, Oropharyngeal pain, Rhinorrhoea
SMQs:, Rhabdomyolysis/myopathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101211324

Write-up: Generalised muscle aches; Runny nose; Sore throat; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority report number GB-MHRA-WEBCOVID-202109141533280600-WFO2S, Safety Report Unique Identifier GB-MHRA-ADR 25939666. A 29-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number was not reported), via an unspecified route of administration on 13Sep2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no symptoms associated with COVID-19. Patient has not had COVID-19 test. Thus, the patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. On 14Sep2021, the patient experienced generalised muscle aches, runny nose, and sore throat; all were reported as serious for being medically significant. The clinical outcome of the events generalised muscle aches, runny nose, and sore throat was not resolved at the time of this report. No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.


VAERS ID: 1738836 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202101211374

Write-up: Influenza; This is a spontaneous report from a contactable consumer or other non-health care professional received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109141920312770-MZBHZ, safety report unique identifier is GB-MHRA-ADR 25940794. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Sep2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date as dose 1, single for COVID-19 immunization. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 14Sep2021, the patient experienced influenza. On an unspecified date, the patient underwent covid-19 virus test which resulted negative. Outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1738845 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Hunger, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201106; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101211514

Write-up: Fever; Headache; Muscle pain; Hunger; Fatigue; This is a spontaneous report from a contactable Consumer received from the Regulatory Authority (MHRA). Regulatory authority report number [GB-MHRA-WEBCOVID-202109142035236650-OB3D0], Safety Report Unique Identifier [GB-MHRA-ADR 25941625]. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number, Expiry date was not reported), via an unspecified route of administration on 14Sep2021 (at the age of 41-year-old) as dose 2, single for COVID-19 immunization. Medical history included suspected COVID-19 from 01Nov2020 to 03Jan2021. Patient was not enrolled in clinical trial. The patient was not breastfeeding. The patient concomitant medications were not reported. Historical Vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number, Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient has not tested positive for COVID-19 since having the vaccine. On 14Sep2021, patient experienced fever, headache, muscle pain, hunger, fatigue. The patient underwent lab tests and procedures which included sars-cov-2 test was positive (yes - Positive COVID-19 test) on 06Nov2020. The outcome of the events fever, muscle pain and headache was recovering. The outcome of the events hunger and fatigue was not recovered. No follow-up attempts were possible; information about lot/batch number cannot be obtained. No further information was expected.


VAERS ID: 1738860 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymph node pain, SARS-CoV-2 test
SMQs:, 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 INC202101211387

Write-up: Lymph node pain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109142235472010-8VZLR Safety Report Unique Identifier GB-MHRA-ADR 25942192. A 32-year-old male patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FE3380), via an unspecified route of administration on 12Sep2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose for COVID-19 immunization. On 14Sep2021 the patient experienced lymph node pain. The event was assessed as medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date No - Negative COVID-19 test. outcome of event was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1738865 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
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 INC202101211530

Write-up: Painful periods; This is a spontaneous report from a contactable consumer received from the regulatory authority, The regulatory authority report number is GB-MHRA-WEBCOVID-202109150042342010-UTJN4, Safety Report Unique Identifier GB-MHRA-ADR 25942232. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FF2153) dose 2 via an unspecified route of administration on 11Sep2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported) vis an unspecified route of administration on an unknown date for COVID-19 Immunisation. On 14Sep2021, the patient experienced really painful periods, never felt pain like this before. The patient underwent lab tests and procedures which included COVID-19 virus test no-negative covid-19 test. The outcome of the event was not resolved. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1738872 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Nausea, Paraesthesia, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101217733

Write-up: dizzy spells; pins and needles; tummy churning; Fainting; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109150815362200-RRSWB, Safety Report Unique Identifier GB-MHRA-ADR 25944012. A female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 14Sep2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2, dose 1 on an unspecified date for COVID-19 immunisation. The patient experienced dizzy spells on an unspecified date, pins and needles on an unspecified date, fainting on 14Sep2021, tummy churning on an unspecified date. Dizzy spells, fainting, pins and needles throughout body, tummy churning. All events are medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 17Jul2021 Yes - Positive COVID-19 test. The outcome of the event fainting was recovering and unknown for other events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1738873 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Migraine, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202101217623

Write-up: Migraine; General body pain; Feverish; Dose 1: 09Jul2021; Dose 2: 14Sep2021; 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-202109150845324810-C1IP2, Safety Report Unique Identifier GB-MHRA-ADR 25944095. A 25-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 14Sep2021 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. On an unknown date, the patient underwent COVID-19 virus test and the result was negative. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 09Jul2021 as a single dose for COVID-19 immunisation. On 14Sep2021, the patient experienced migraine, general body pain and feverish; all reported as a serious for being medically significant. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event migraine, general body pain and feverish 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: 1738877 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Heart rate, Migraine, Nausea, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: Heart rate; Result Unstructured Data: elevated
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Tiredness; Headache; Fever; Migraine; Dizziness; Joint pain; Exhaustion; Pain; Nausea; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 25944326) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), HEADACHE (Headache), PYREXIA (Fever), MIGRAINE (Migraine), DIZZINESS (Dizziness), ARTHRALGIA (Joint pain), FATIGUE (Exhaustion), PAIN (Pain) and NAUSEA (Nausea) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. No Medical History information was reported. On 13-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), MIGRAINE (Migraine) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant), ARTHRALGIA (Joint pain) (seriousness criterion medically significant), FATIGUE (Exhaustion) (seriousness criterion medically significant), PAIN (Pain) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, FATIGUE (Tiredness) and HEADACHE (Headache) had not resolved, PYREXIA (Fever), MIGRAINE (Migraine), DIZZINESS (Dizziness), ARTHRALGIA (Joint pain), FATIGUE (Exhaustion) and PAIN (Pain) was resolving and NAUSEA (Nausea) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, Heart rate: elevated (High) elevated. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant product information were provided by the reporter. No treatment information was provided. Company Comment - This case concerns a 30-year-old, female patient with no relevant medical history, who experienced the unexpected events of pyrexia, migraine, dizziness, arthralgia, fatigue, pain, nausea, fatigue, and headache. The events occurred approximately 1 day after the second dose of Modena covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 30-year-old, female patient with no relevant medical history, who experienced the unexpected events of pyrexia, migraine, dizziness, arthralgia, fatigue, pain, nausea, fatigue, and headache. The events occurred approximately 1 day after the second dose of Modena covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1738894 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Headache, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Back pain; Headache; Nausea; Fever; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25945074) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 from 26-Dec-2019 to 03-Jan-2020. Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (OVRANETTE) for Contraception, SERTRALINE for Depression. On 14-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced BACK PAIN (Back pain) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 15-Sep-2021, PYREXIA (Fever) had resolved. At the time of the report, BACK PAIN (Back pain) and NAUSEA (Nausea) was resolving and HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medication were not reported. Patient had not tested positive for COVID-19 since having vaccine and was not enrolled in clinical trial. Company Comment: This case concerns a 30-year-old female with a medical history of depression, who experienced the unexpected events of back pain, headache, nausea and pyrexia on the same day after the second dose of mRNA-1273 (Moderna CoviD-19 Vaccine). The rechallenge was unknown as there''s no information available about the first dose. The benefit-risk relationship of mRNA-1273 (Moderna CoviD-19 Vaccine) is not affected by this report.; Sender''s Comments: This case concerns a 30-year-old female with a medical history of depression, who experienced the unexpected events of back pain, headache, nausea and pyrexia on the same day after the second dose of mRNA-1273 (Moderna CoviD-19 Vaccine). The rechallenge was unknown as there''s no information available about the first dose. The benefit-risk relationship of mRNA-1273 (Moderna CoviD-19 Vaccine) is not affected by this report.


VAERS ID: 1738971 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-09-14
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Heart racing; Painful arm; Headache; Fever; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 25955158) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart racing), PAIN IN EXTREMITY (Painful arm), HEADACHE (Headache) and PYREXIA (Fever) in a 40-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004222) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 14-Sep-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced PALPITATIONS (Heart racing) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 14-Sep-2021, PYREXIA (Fever) had resolved. On 16-Sep-2021, PAIN IN EXTREMITY (Painful arm) and HEADACHE (Headache) had resolved. At the time of the report, PALPITATIONS (Heart racing) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. The concomitant medications were not reported. The treatment information was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) , the reporter did not provide any causality assessments. Post vaccination patient not tested positive for COVID-19. Also patient was not enrolled in any clinical trials.It was reported that patient had no symptoms associated with COVID-19. Company Comment : This case concerns a 40-year-old male patient, with no relevant medical history provided, who experienced the unexpected events of PAIN IN EXTREMITY, HEADACHE, PYEXIA and PALPITATIONS. Inappropriate schedule of product administration was also considered an event having in mind that the second dose was administered two months following the first dose. The reported events of pain in extremity, headache, pyrexia and palpitations occurred on the same day than the second dose of COVID-19 Vaccine Moderna was administered. Except the event of palpitations which was resolving at the time of the report, the remaining events resolved. Rechallenge results and action taken with the suspect product were retained as per RA source document, although, the events developed after the second dose. The benefit-risk relation of COVID-19 Vaccine Moderna is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events met seriousness criteria.; Sender''s Comments: This case concerns a 40-year-old male patient, with no relevant medical history provided, who experienced the unexpected events of PAIN IN EXTREMITY, HEADACHE, PYEXIA and PALPITATIONS. Inappropriate schedule of product administration was also considered an event having in mind that the second dose was administered two months following the first dose. The reported events of pain in extremity, headache, pyrexia and palpitations occurred on the same day than the second dose of COVID-19 Vaccine Moderna was administered. Except the event of palpitations which was resolving at the time of the report, the remaining events resolved. Rechallenge results and action taken with the suspect product were retained as per RA source document, although, the events developed after the second dose. The benefit-risk relation of COVID-19 Vaccine Moderna is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events met seriousness criteria.


VAERS ID: 1738978 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Eye irritation, Fatigue, Injection site pain, Injection site warmth, Lymphadenopathy, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Swollen lymph nodes; Redness; Fatigue; Muscle ache; High temperature; Burning eyes; Pain injection site; Injection site warmth; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 25958193) on 19-Sep-2021 and was forwarded to Moderna on 19-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes), MYALGIA (Muscle ache), PYREXIA (High temperature), EYE IRRITATION (Burning eyes), INJECTION SITE PAIN (Pain injection site), INJECTION SITE WARMTH (Injection site warmth), ERYTHEMA (Redness) and FATIGUE (Fatigue) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced INJECTION SITE PAIN (Pain injection site) (seriousness criterion medically significant) and INJECTION SITE WARMTH (Injection site warmth) (seriousness criterion medically significant). On 15-Sep-2021, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant), EYE IRRITATION (Burning eyes) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 16-Sep-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant) and ERYTHEMA (Redness) (seriousness criterion medically significant). On 16-Sep-2021, PYREXIA (High temperature) and EYE IRRITATION (Burning eyes) had resolved. On 17-Sep-2021, MYALGIA (Muscle ache) and FATIGUE (Fatigue) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes), INJECTION SITE PAIN (Pain injection site), INJECTION SITE WARMTH (Injection site warmth) and ERYTHEMA (Redness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter. Company comment: This case concerns a 30-year-old, female patient with no relevant medical history, who experienced the unexpected event of Lymphadenopathy, Myalgia, Pyrexia, Eye irritation, Injection site pain, Injection site warmth, Erythema and Fatigue. The events of Injection site Pain and warmth occurred on the same day after the second dose of mRNA-1273, Fatigue Myalgia, Pyrexia and Eye irritation occurred one day after the administration of the second dose and Lymphadenopathy and Erythema occurred two days after the administration of the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.; Sender''s Comments: This case concerns a 30-year-old, female patient with no relevant medical history, who experienced the unexpected event of Lymphadenopathy, Myalgia, Pyrexia, Eye irritation, Injection site pain, Injection site warmth, Erythema and Fatigue. The events of Injection site Pain and warmth occurred on the same day after the second dose of mRNA-1273, Fatigue Myalgia, Pyrexia and Eye irritation occurred one day after the administration of the second dose and Lymphadenopathy and Erythema occurred two days after the administration of the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.


VAERS ID: 1738985 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain lower, Blood urine present, Headache, Loss of consciousness, Myalgia, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: passed out; lower abdominal pain; headache; high temperature; Achy muscles; Blood in urine; unconscious; This case was received via Regulatory Authority RA (Reference number: GB-MHRA-ADR 25959792) on 19-Sep-2021 and was forwarded to Moderna on 19-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (unconscious), LOSS OF CONSCIOUSNESS (passed out), ABDOMINAL PAIN LOWER (lower abdominal pain), BLOOD URINE PRESENT (Blood in urine), HEADACHE (headache) and PYREXIA (high temperature) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced BLOOD URINE PRESENT (Blood in urine) (seriousness criterion medically significant). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (unconscious) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), ABDOMINAL PAIN LOWER (lower abdominal pain) (seriousness criterion medically significant), HEADACHE (headache) (seriousness criterion medically significant), PYREXIA (high temperature) (seriousness criterion medically significant) and MYALGIA (Achy muscles). At the time of the report, LOSS OF CONSCIOUSNESS (unconscious), LOSS OF CONSCIOUSNESS (passed out), ABDOMINAL PAIN LOWER (lower abdominal pain), HEADACHE (headache), PYREXIA (high temperature) and MYALGIA (Achy muscles) outcome was unknown and BLOOD URINE PRESENT (Blood in urine) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had a lot of blood in urine in the morning. Lower abdominal pain similar to a UTI. High temperature and headache. Achy muscles. Passed out in the afternoon after having the vaccine. Unconscious for approximately 2 minutes. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. This case concerns a 28 year-old, female patient with no previous relevant medical history who experienced the unexpected events of loss of consciousness, abdominal pain lower, blood urine present, headache and pyrexia. The events occurred on the same day of the second dose of COVID-19 Vaccine Moderna (mRNA-1273) and on unknown dates. The rechallenge was unknown since no information about the first dose was disclosed. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report. Events seriousness was assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events seemed to be serious by medical judgement and from a clinical or regulatory standpoint.; Sender''s Comments: This case concerns a 28 year-old, female patient with no previous relevant medical history who experienced the unexpected events of loss of consciousness, abdominal pain lower, blood urine present, headache and pyrexia. The events occurred on the same day of the second dose of COVID-19 Vaccine Moderna (mRNA-1273) and on unknown dates. The rechallenge was unknown since no information about the first dose was disclosed. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report. Events seriousness was assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events seemed to be serious by medical judgement and from a clinical or regulatory standpoint.


VAERS ID: 1739003 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

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

Write-up: fatigue; aches; Lip swelling; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 25962564) on 19-Sep-2021 and was forwarded to Moderna on 19-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), PAIN (aches) and LIP SWELLING (Lip swelling) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Gastritis chronic. Concomitant products included ESOMEPRAZOLE for Gastritis chronic. On 13-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced LIP SWELLING (Lip swelling) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (fatigue) (seriousness criterion medically significant) and PAIN (aches) (seriousness criterion medically significant). At the time of the report, FATIGUE (fatigue), PAIN (aches) and LIP SWELLING (Lip swelling) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had dermal fillers in lips 12 months prior to vaccine. she had zero side effects to first Moderna jab but 2nd absolutely floored her. Aches, pain, fatigue. However, the dramatic lip swelling was absolutely terrifying. lips are almost back to normal now. Company Comment: This case concerns a 39-year-old, female patient with relevant medical history of gastritis chronic, who experienced the unexpected events of pain, lip swelling and fatigue. The events occurred approximately 1 day after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 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 39-year-old, female patient with relevant medical history of gastritis chronic, who experienced the unexpected events of pain, lip swelling and fatigue. The events occurred approximately 1 day after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 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: 1740501 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005288 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Oropharyngeal discomfort
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)

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

Write-up: Discomfort in the throat; Possible of anaphylaxis; This case was received via Regulatory Authority (Reference number: JP-TAKEDA-2021TJP094999 ) on 15-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This case, initially reported to the Regulatory Authority by a (physician), was received via the regulatory authority (Ref, v21126807). The patient had a history of anaphylaxis caused by sting of yellow hornet (2020). On an unknown date, body temperature before the vaccination: 36.5 degrees Celsius. On 14-Sep-2021, at 10:07, the patient received the 1st dose of this vaccine. At 10:10, body temperature 128/78, pulse rate 82, and SPO2 97%. At 10:14, feeling of swollen throat developed. The patient had a discomfort in the throat. At 10:19, blood pressure 116/78, pulse rate 86, and SPO2 97%. At 10:37, blood pressure 125/58, pulse rate 88, and SPoO2 98%. Anaphylaxis was suspected because the symptoms were similar to bee stings and tended to worsen; thus, the patient transported to a hospital by ambulance. The outcome of discomfort in the throat and possible of anaphylaxis was 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.; 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 case concerns a 34-year-old, male patient with previous medical history of yellow hornet sting allergy, who experienced the expected event of anaphylactic reaction and unexpected event of oropharyngeal discomfort. The events occurred on the same day after the first dose of Moderna vaccine The rechallenge was not applicable since only information about the first dose was disclosed. The reporter assessed the events as possible. The medical history of allergy remains a confounder. The event anaphylactic reaction is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Moderna vaccine is not affected by this report.


VAERS ID: 1742501 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemoptysis, Haemorrhage, Inappropriate schedule of product administration, Pharyngeal erythema, SARS-CoV-2 test, Throat irritation
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Medication errors (narrow), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101217922

Write-up: bleeding; first dose 13Jul2021 and second dose 14Sep2021; spitting out blood; red raw throat; red raw throat; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109150757328910-YTJFM, Safety Report Unique Identifier GB-MHRA-ADR 25943928. A 39-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: FF2153), via an unspecified route of administration on 14Sep2021 as dose 2, single and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 13Jul2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. On 15Sep2021, the patient experienced bleeding and on an unspecified date in 2021, the patient experienced spitting out blood and red raw throat. The patient underwent lab tests which included SARS-Cov-2 test: negative on unknown date. The patient had not yet recovered from bleeding and outcome other events were unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1742503 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hallucination, Headache, Hyperhidrosis, Influenza, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101217736

Write-up: hallucinations; fever; sweating; vomiting; headache; Flu; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109150821552990-RQH40 and Safety Report Unique Identifier GB-MHRA-ADR 25944017. A 22-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solu-tion for injection, Batch/Lot Number: FF2153) via an unspecified route of administration on 14Sep2021 as DOSE 2, SINGLE (age at vaccination: 22-year-old) for covid-19 immunisation. The patient medical his-tory and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Historical vaccine received bnt162b2 (Batch/Lot Number not reported) via an unspecified route of administration on an unspecified date for covid-19 immunisation. On an unspecified date, the patient experienced fever, sweating, vomiting, headache and hallucinations. On 14Sep2021, patient experienced flu. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not en-rolled in clinical trial.The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on an unspecified date. The outcome of the events (fever, sweating, vomiting, headache, hallucinations) was unknown, event (Flu) was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1742564 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Breast pain, Musculoskeletal pain, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Lipodystrophy (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210912; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101217813

Write-up: Breast pain; Shoulder blade pain; Armpit pain; This is a spontaneous report from a contactable consumer received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109151907234920-MTJEK, Safety Report Unique Identifier GB-MHRA-ADR 25948000. A 37-year-old female patient received second dose of BNT162B2 (BNT162B2, Formulation: Solution for Injection, Batch/Lot Number: FF8222), via an unspecified route of administration on 13Sep2021 as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Previously, the patient received first dose of BNT162B2 via unspecified route of administration on an unknown date for COVID-19 immunisation. On 14Sep2021, the patient experienced Sore armpit and arm where injection was given and on 15Sep2021, patient experienced Pain down side of arm and breast on the side of the injection (sore breast and shoulder blade). The patient underwent lab tests and procedures which included sars-cov-2 test was negative on 12Sep2021 (No - Negative COVID-19 test). The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The patient has not had symptoms associated with COVID-19. The patient was not pregnant. The patient was not currently breastfeeding. The outcome of the events armpit pain and breast pain was not recovered, shoulder blade pain was recovering. No follow-up attempts are needed. No further information is expected.


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