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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 424 out of 8,010

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VAERS ID: 1757292 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Nebraska  
Vaccinated:2021-08-20
Onset:2021-08-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 1 RA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Anorectal discomfort, Heavy menstrual bleeding
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Nonw
Preexisting Conditions: Nonw
Allergies: Nonw
Diagnostic Lab Data: I went to see my GYN doctor, and had an annual women exam performed.
CDC Split Type:

Write-up: Lengthy and heavy menstrual period. Heavy days were generally 3, but I had about 10 days. I also experienced strong rectal pressure, while having such a strong menstrual period, which I had not experience before.


VAERS ID: 1757573 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: New York  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0182 / 1 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: Affect lability, Agitation, Anti-thyroid antibody, Anti-thyroid antibody positive, Basedow's disease, Blood thyroid stimulating hormone decreased, Goitre, Hypertension, Nausea, Restlessness, Tachycardia, Thyroid stimulating immunoglobulin, Thyroxine increased, Tri-iodothyronine, Ultrasound thyroid abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Akathisia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypertension (narrow), Optic nerve disorders (broad), Hypothyroidism (broad), Hyperthyroidism (narrow), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (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? Yes, 17 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Flexural Eczema
Allergies: NKA
Diagnostic Lab Data: 9/5/21 - THS <0.030 (Ref: 0.27 - 4.20 u[IU]/mL)). Free T4: 5.63 (Ref: 0.93 - 1.70 ng/dL), Triiodothyronine: 330.00 (Ref: 80.00 - 200.00 ng/dL), Free T3: 16.60 (Ref: 2.00 - 4.40 pg/mL). 9/7/21 - Serum Thyrotropin Receptor Antibody: 5.81 (Ref: 0.00 - 1.75 IU/L). 9/5/21 - Thyroid Stimulating Immunoglobulin: 5.25 (Ref: 0.00 - 0.55 IU/L). Thyroid Peroxidase Antibody: 79.8 (Ref: <9.0 IU/mL). Thyroglobulin Ab: <0.9 (Ref: <2.3 IU/mL). 9/6/21 - Thyroid Ultrasound revealed mildly enlarged, heterogenous, hypervascular right and left lobes of thyroid gland.
CDC Split Type:

Write-up: Patient started developing nausea & vomiting the same night of vaccine administration along with gradual progression of mood lability, agitation, restlessness, neck goiter. High blood pressure, tachycardia. All of which were difficult to control. She was diagnosed with Graves'' Disease and was treated with Propranolol 360 mg ER, Methimazole 30 mg BID.


VAERS ID: 1758881 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: New Jersey  
Vaccinated:1921-08-22
Onset:2021-08-23
   Days after vaccination:36526
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 059E21E / UNK RA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: vitamin c. ,centrum, vitamind d, rosuvastatin calcium,lisinopril, amlodipine besylate
Current Illness:
Preexisting Conditions: HBP, asthma, diabetes
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: high fever ( up to 103.4) lasting several days tiredness, pain


VAERS ID: 1759017 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-08-18
Onset:2021-08-23
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 3 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Abstains from alcohol, Ageusia, Areflexia, Blood glucose normal, Bordetella test negative, C-reactive protein increased, CSF culture negative, CSF glucose increased, CSF oligoclonal band absent, CSF protein increased, CSF white blood cell count negative, Computerised tomogram abdomen, Computerised tomogram head normal, Computerised tomogram thorax abnormal, Condition aggravated, Cryptococcus test, Facial pain, Facial paralysis, Facial paresis, Fatigue, Flow cytometry, Full blood count, Guillain-Barre syndrome, Hypertension, Hypoaesthesia, Hypoaesthesia oral, Hyporeflexia, Immunoglobulin therapy, Lumbar puncture, Magnetic resonance imaging head abnormal, Muscle fatigue, Muscle spasms, Muscular weakness, Musculoskeletal pain, Nausea, Non-tobacco user, Paraesthesia, Pulmonary function test normal, Pulmonary mass, Red blood cell sedimentation rate increased, SARS-CoV-2 test negative, Scan with contrast abnormal, Sensory loss, Speech disorder, Taste disorder, Vertigo, Vomiting, White blood cell count normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Dementia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Hypertension (narrow), Cardiomyopathy (broad), Demyelination (narrow), Hearing impairment (broad), Vestibular disorders (narrow), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Escitalopram, Bupropion, Omeprazole, Losartan, Amlodipine, Dolutegravir, Emtricitabine & Tenofovir Alafenamide, Glimepiride, Centrum Multi-Vitamin
Current Illness: None
Preexisting Conditions: Obstructive Sleep Apnea, Obesity, Major Depressive Disorder, Non-Insulin Dependent Diabetes Type II, Hypertension, HIV (long-term non-detectable), and Gastro-esophageal Reflux Disease
Allergies: None
Diagnostic Lab Data: SARS-CoV-2 panel (8/28) - negative CT Head w/o contrast (8/28) - No acute intracranial lesions CBC/Chemistry Panels (8/29) - C-Reactive Protein elevated at 1.05, Sedimentation Rate elevated at 39, Glucose - 180; WBC normal at 8; otherwise unremarkable Contrast Head MRI (8/31) - bilateral facial nerve enhancement; no intracranial abnormalities; mildly prominent cervical/axillary lymph nodes CT Chest/Abdomen/Pelvis with contrast (9/1) - a few nonspecific solid lung nodules <4mm Lumbar Puncture (9/1) - Clear CSF with WBC of 2 and elevated protein at 140.5; Glucose - 100; Negative for Lyme, Cryptococcus, flow cytometry, oligoclonal bands and culture
CDC Split Type:

Write-up: Five days after receiving a 3rd dose of Pfizer?s COVID vaccine, patient experienced painful bilateral musculoskeletal back spasms that progressively ascended from the lumbar to cervical region over the course of 4 days. Previously, he was in his usual state of health with no recent history of infection, rash, travel abroad, exposure to tick bites or trauma. Patient is a non-smoker and does not consume alcohol/illicit drugs. First Pfizer Vaccine Dose on 16 Feb 2021 and Second Pfizer Dose on 9 March 2021 with minimal side effects for 36 hours. By Day 4, various back regions began losing sensation in thoracic dermatomes, with onset of bilateral finger tip tingling (median nerve distribution - 1st thru 3rd digits), altered taste sensation, bilateral facial pain and bilateral dorsal foot and toe numbness. On Day 5, there was onset of prominent fatigue, oral/buccal numbness, complete loss of taste and rapidly progressive right facial paresis to paralysis within 12 hours. This prompted an ER visit, with a negative head CT. By Day 6, there was severe right facial paralysis with left facial paresis and loss of ability to hold water or food in mouth with impaired speech. Admitted to inpatient neurology on Day 7 of symptom onset (Day 11 after vaccine administration) with bilateral reduced patellar and absent ankle reflexes, lower extremity muscle weakness progression, episodic vertigo with nausea/vomiting and diffuse extremity/back paresthesia or numbness. On Day 8, there was bilateral complete loss of patellar and ankle reflexes and R $g L 4/5 proximal leg weakness. Preserved upper extremity reflexes and afebrile throughout hospitalization. Loss of pinprick to mid-calf bilaterally. Mastication fatigue without dysphagia. Pulmonary function assessments were within normal limits. No bladder or bowel involvement at any point. Lumbar puncture with albumin-cytological dissocation. Diagnosed with Acute Inflammatory Demyelinating Polyneuropathy (Guillain-Barre Syndrome) due to COVID vaccination. Treated with IVIG over a 5 day period with hypertension elevations. Symptom plateau half-way through treatment. Discharge home on hospital day #8 with ability to ambulate short-distance without assistive devices, but with easy muscular fatigue.


VAERS ID: 1759122 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-08-20
Onset:2021-08-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Myocarditis, Pneumonitis
SMQs:, Interstitial lung disease (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: you people are doing the wrong thing forcing people to get this shot. it almost killed me, now i have a cardiologist and im 41 and in great shape. you should be ashamed of yourselves. treating people like lab rats so you can make money. there are many more people like me that will never ever trust you guys again. if you have the antibodies you dont need the shot! you are all a bunch of scumbags to put it lightly
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 045B21A

Write-up: i will never ever get my 2nd shot. i had the same inflammation in my heart and lungs as i did when i had the virus. i told my doctor i have the antibodies but he told me to still get the shot. i am not happy with him, or you guys and our government forcing people to get this vaccine. you are going to kill people. and what for? money?? you guys are a joke along with this administration. treating people like lab rats for money and power. this isnt going to last much longer. my cardiologist has said alot of people like me, 41 and completely healthy are getting side effects. but nope, you guys and the media wont talk about it. you will get yours.


VAERS ID: 1759448 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: California  
Vaccinated:2021-03-30
Onset:2021-08-23
   Days after vaccination:146
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8734 / 2 LA / SYR

Administered by: Senior Living       Purchased by: ?
Symptoms: Anosmia, COVID-19, Chest discomfort, Fatigue, Oropharyngeal pain, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Taste and smell disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hydrochloride, inhaler
Current Illness: N/A
Preexisting Conditions: high blood pressure
Allergies: pollen, dust
Diagnostic Lab Data: Covid-19 test
CDC Split Type: vsafe

Write-up: My symptom started on August 23rd. I had loss of smell. I had fatigue and was tired. I had sore throat. I did not a fever. I went and got a Covid-19 test, came back positive. My symptom lasted for about 10 days. The fatigue was ongoing. It feels like someone is pulling on my chest.


VAERS ID: 1759581 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-03-31
Onset:2021-08-23
   Days after vaccination:145
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027B21A / 2 LA / SYR

Administered by: Other       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: Levothyroxine
Current Illness: None
Preexisting Conditions: Hypothyroidism due to Hashimoto''s disease, Ocular and facial rosacea
Allergies: None
Diagnostic Lab Data: COVID test 08/23/2021- positive
CDC Split Type: vsafe

Write-up: They do routine COVID tests at the school I work at and I tested positive for COVID on 08/23/2021. I did not have any symptoms. I had to quarantine. I did not need any treatment.


VAERS ID: 1762317 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-03-31
Onset:2021-08-23
   Days after vaccination:145
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805031 / N/A LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Diarrhoea, Headache, Malaise, Nausea, Pain in extremity, Pyrexia, SARS-CoV-2 test positive, Sinusitis
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Flu, have had a big knot at the injection site several years ago; now I take Benadryl before getting a flu shot. It was a one ti
Other Medications: No
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: Urgent care COVID test, positive result
CDC Split Type: vsafe

Write-up: Immediately after the vaccine, I had a sore arm and I don''t think I had a fever, but felt slight feverish the next day. I took ibuprofen. That was gone by Friday. COVID symptoms later: August 23, 2021 I had positive test for COVID, headache, fever, nauseous and very bad diarrhea. It mostly felt like a sinus infection with diarrhea. I had a cough but it wasn''t a bad cough. Mucinex and vitamins for treatment and Zyrtec and Claritin; low dose aspirin; zinc; Vit C; and I isolated and later I used cough syrup when I went back to work. I probably had those through August 30th. I went back to work on September 1st.


VAERS ID: 1764541 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-08-23
Onset:2021-08-23
   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 EL0140 / 2 LA / IM

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

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

Write-up: Tested Positive for Covid


VAERS ID: 1764573 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-06-24
Onset:2021-08-23
   Days after vaccination:60
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0162 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0171 / 2 LA / IM

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

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

Write-up: Tested Positive for Covid


VAERS ID: 1764615 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-02-04
Onset:2021-08-23
   Days after vaccination:200
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039K20A / 1 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030L20A / UNK - / -

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

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

Write-up: Tested Positive for Covid


VAERS ID: 1765294 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2020-12-23
Onset:2021-08-23
   Days after vaccination:243
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025J20A / 1 UN / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030120A / 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: 1765298 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-02-05
Onset:2021-08-23
   Days after vaccination:199
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013M20A / 1 UN / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 003A21A / 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: 1765900 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-01-29
Onset:2021-08-23
   Days after vaccination:206
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3592 / 3 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Swollen tongue
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Zoster vaccine 04/27/2011
Other Medications: Fosomax, Vitamin D3
Current Illness: Thalassemia
Preexisting Conditions: Thalassemia
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Tongue Swelling 8/23/2021 and 10/6/2021 lasting approximately 6 hours - 50 mg Benadryl administered


VAERS ID: 1766152 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-08-19
Onset:2021-08-23
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest X-ray, Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

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: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: Chest Xray September 10th, 2021
CDC Split Type:

Write-up: RML Pnuemonia


VAERS ID: 1766444 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-20
Onset:2021-08-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

Administered by: Pharmacy       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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lamotrigine Biotin Vitamin C Zinc
Current Illness: None
Preexisting Conditions: Epilepsy (2017 first seizure) Asthma (1980 first attack)
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Started menstruating 3 days after vaccine and haven?t stopped since (6+weeks).


VAERS ID: 1766451 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-06-23
Onset:2021-08-23
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8736 / UNK - / SC

Administered by: Private       Purchased by: ?
Symptoms: Alanine aminotransferase increased, Anaemia, Antinuclear antibody increased, Aspartate aminotransferase increased, Autoimmune hepatitis, Biopsy bone marrow, Biopsy liver abnormal, Blood immunoglobulin G increased, Hepatic lymphocytic infiltration, Hepatitis, Hepatosplenomegaly, International normalised ratio increased, Magnetic resonance imaging, Pneumonia, Positron emission tomogram, Pyrexia, Ultrasound Doppler
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatitis, non-infectious (narrow), Liver-related coagulation and bleeding disturbances (narrow), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (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, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: Hopsital admissions, imaging with ultrasound, MRI, PET CT, liver and bone marrow biopsies.
CDC Split Type:

Write-up: Patient received Covid 19 vaccinations on 6/23/2021 and on 7/14/2021 without immediate complications. He developed fevers on 8/23 and was diagnosed with multifocal pneumonia, severe anemia, and hepatitis with elevated AST/ALT and INR on 8/30. Subsequent work-op including imaging with PET-CT , bone marrow biopsy, and liver biopsy revealed severe autoimmune hepatitis based on massive lymphoplasmocytic hepatic infiltration by histology, elevated serum IgG and ANA. He was treated with prednisone and rituximab. His condition is currently improving, The degree of liver infiltration with lymphocytes and severity of hepatosplenomegaly is atypical what I usually see in new diagnosis of autoimmune hepatitis.


VAERS ID: 1767218 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: California  
Vaccinated:2021-08-23
Onset:2021-08-23
   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 FC3183 / 3 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Immunisation, Off label use, Pain, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PRIVIGEN; LIPITOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchial asthma (Why was the patient taking Privigen (Verbatim): Bronchial Asthma and Bronciectasis); Bronchiectasis (Why was the patient taking Privigen (Verbatim): Bronchial Asthma and Bronciectasis)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101138885

Write-up: dull ache; had a rash 30 minutes into the infusion; got booster dose; got booster dose; This is spontaneous report from Pfizer. A contactable 78-year-old male consumer (patient) reported. A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FC3183), via an unspecified route of administration in right arm on 23Aug2021 (at the age of 78-year-old) as dose 3, single for COVID-19 immunisation at pharmacy. Medical history included bronchial Asthma (the patient taking Privigen) and bronciectasis (the patient taking Privigen). Concomitant medications included immunoglobulin human normal (PRIVIGEN) taken for asthma, bronchiectasis from an unknown date in Jan2019 to an unspecified stop date; atorvastatin calcium (LIPITOR) taken for respiratory therapy, start and stop date were not reported (been on it 10 to 15 years). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EG9261), via an unspecified route of administration in right arm on 25Jan2021 (at the age of 78-year-old) as dose 1, single for COVID-19 immunisation and experienced pain, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9809), via an unspecified route of administration in right arm on 17Feb2021 (at the age of 78-year-old) as dose 2, single for COVID-19 immunisation and experienced pain, He took a statins for respiratory therapy (There are no other medications would be relevant. No further details provided), He had been taking the IVIG for 2 years and had no problem. He asked if there was a certain timeframe recommended to wait between having the booster vaccine dose and getting an infusion of Privigen immunoglobulin. He reported that for over 2 years he had been getting Immunoglobulin infusions (10% Privigen, dose of 30 grams) a 4-hour infusion, every 28 days. 1 week ago, for antibodies for increasing your level of immune therapy, he received the Covid vaccine booster dose. He reported that during his last infusion, which he received 1 week after the booster dose, he experienced a reaction, stating, "when we get our blood tested my immunoglobulin is usually up and that''s good, but this time for the first time I had a rash 30 minutes into the infusion" and reported that the doctor had to stop the infusion early and told him that "we may be taking it too soon after getting the booster" and said "we should wait around 30 days and try again. He reported that he never had a reaction from the immunoglobulin and the only variable patient checked was getting the booster, the patient even checked that the bag they were infusing into my arm was the correct thing. He reported that now, he was perfectly fine "today" and plans to go back for another infusion 30 days from that Monday. He reported that he heard from his doctor and nurse that infusion patients or cancer patients should have a time lag between the shot and their next infusion or treatment. He reported that his doctor and nurse were not aware of any timeframe required in between the two products. Now calling to obtain more information. He then asked, "Who is the manufacturer of Privigen?" He reported that he received an infusion and took a picture of the product label but was not printed on there for him to know who the manufacturer was and if the booster dose was the same as both previous doses. He stated that even before they started the nurse said that she thought there was a time lag in between shot or booster or anything. When he had the first two in January and February there was a time that he went in for his IVIG and he had no reaction. It never even came up. It was not discussed, but for some reason the nurse said that before the procedure. The only new variable was the booster. As he understood, it was the same as the first two shots he had in January and February. He did not have a clue. Maybe it did not. He felt fine before the IVIG and felt fine now, and he had recovered nicely. The reaction occurred at the hospital in "PRIVACY". Rash was occurred on 30Aug2021 at 11:00. Once they stopped the treatment the rash was gone within 12 hours. Caller clarified that he would not define it as a rash. It was reddening of skin on face and chest. He has recovered 100 percent. It was 10% Privigen. Immunoglobuin was on the label. It says route for IV (intravenous). Dose was 30gram. It was prepared that morning when he showed up. He took a picture when they hung it to put it in the arm. The picture was what he was reading to provide product information. He did not see NDC, lot, and expiry on the picture he has. He started on an unknown date in Jan2019. He skipped the dose on the 30Aug2021 and will go 28 days out into September and he will go in a repeat the treatment. At that point they will see what the reaction was. The first two were given at the "PRIVACY". The third one was done at the "PRIVACY". No test was done. He waited 24 hours and it went away. It went away after stopping IVIG. The doctor and the nurses brought up the fact there may be a time lag that should occur from the time someone gets Moderna, Pfizer, or anything before doing this kind of thing including cancer treatments at infusion center. There was no prescribed time lag from when a person gets any of the shots until the next treatment. That was the unknown. He did not know if Moderna or Pfizer should came up with something to say wait such and such amount of time. After he had the next treatment, he will be happy the next day or whenever to call back and report any reaction or any difference going forward. He has been taking the IVIG (immunoglobulin) for 2 years and had no problem. The only variable was the booster shot. All three shots were given in right upper portion of arm. Over 24-hour period he had dull ache and it went away. That happened for all three shots. He needs to have his flu shot. Does Pfizer recommend waiting a certain period of time between the booster and the flu or shingles shot? The pharmacist and doctor asked to wait to one week. He knew that Pfizer was close to this because there are three or four other variants that will show up. This virus was not going away. We were going to be doing distancing and boosters forever. We would have to work as a team. The outcome of dull ache and had a rash 30 minutes into the infusion was reported as resolved on an unknown date. Follow-up (09Sep2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported in response to HCP telephonic follow-up activity that included: physician''s mailing address added. Follow-Up (17 Sep2021): Follow-up attempts are completed. No further information is expected.


VAERS ID: 1767539 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-01
Onset:2021-08-23
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Disease recurrence, Herpes virus infection
SMQs:, 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: CANNABIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Erythema multiforme; Herpes simplex
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101260347

Write-up: Herpes outbreak; Herpes outbreak; This is a spontaneous report from a contactable consumer or other non hcp. A 37-years-old female non-Pregnant patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 1 via an unspecified route of administration on Aug2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included herpes simplex, erythema multiforme. Concomitant medication(s) included cannabis (CANNABIS). The patient had Known allergies Tetracycline & erythromycin. Age at the time of Vaccination: 37 years. The patient was not pregnant at the time of vaccination The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. On 23Aug2021, 07:45 PM the patient experienced, After the first vaccine she had a Herpes Outbreak After the second vaccine, fainted within 2 minutes of receiving the shot & have had mental confusion ever since.1 week after the second shot, now had an outbreak of Erythema Multiformae, a secondary condition related to Herpes. Currently, the RA is investigating a connection between the Vaccines and activin Herpes and Erythema Multiformae outbreaks after Vaccines. The outcome of the events was not recovered. Therapeutic measures were taken Anti-Viral Medication as a result of herpes outbreak (disease recurrence), herpes outbreak (herpes virus infection). The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1768050 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-03-21
Onset:2021-08-23
   Days after vaccination:155
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19, Chest pain, Drop attacks, Dyspnoea, Feeling abnormal, Inhalation therapy, Memory impairment, SARS-CoV-2 test positive, Sinus disorder, X-ray
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Convulsions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Generalised convulsive seizures following immunisation (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lots of medication. Atenolol 25 mg daily, protonix 40 mg twice daily, singular once a day, lyrica 100 mg 3 times daily, zoloft 100 mg 2 tablets daily, hydroxyzine HCL 50n mg at bedtime, claritin 10 mg daily, baby aspirin once daily, requip
Current Illness: MRSA.
Preexisting Conditions: High blood pressure, GERD, restless legs, fibromyalgia, asthma, arthritis, seasonal allergies, PTSD, severe anxiety, depression, chronic migraines
Allergies: hydrocodone, sulfa drugs, emtrex,
Diagnostic Lab Data: Chest XRAY Covid Positive
CDC Split Type: vsafe

Write-up: I felt like I had a sinus infection, severe chest pain on left side of my chest, I went to ER doctor thought I had blood clot and they tested me for Covid and I had come back Covid Positive. I used my inhaler. I still get short of breath quickly and I still have a brain fog. I can''t remember certain things and I was dropping things and that getting better, and I''m still using my inhaler more then normal.


VAERS ID: 1768469 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-01-12
Onset:2021-08-23
   Days after vaccination:223
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9231 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Positive COVID-19 PCR test 8/23/21.
CDC Split Type:

Write-up: Fully vaccinated person became symptomatic for COVID-19 on 8/23/21 and tested positive on 8/23/21.


VAERS ID: 1771194 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-08-23
Onset:2021-08-23
   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 FD4884 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ageusia, Gastric disorder, Interchange of vaccine products, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Taste and smell disorders (narrow), Guillain-Barre syndrome (broad), Medication errors (broad)

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

Write-up: Systemic: Tingling (specify: facial area, extemities)-Medium, Error: Wrong Vaccine Formulation (ex. different manufact. initial and booster)-, Additional Details: no taste. stomach issue


VAERS ID: 1771417 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-02-04
Onset:2021-08-23
   Days after vaccination:200
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Chills, Cough, Diarrhoea, Headache, Malaise, Myalgia, Nasal congestion, Oropharyngeal pain, Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive, Throat irritation
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament 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? 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
CDC Split Type:

Write-up: C/O cough, chills, fever, sore or scratchy throat, headache, runny nose or congestion, myalgia, malaise, and diarrhea


VAERS ID: 1771718 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-02-03
Onset:2021-08-23
   Days after vaccination:201
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030L20A / 1 UN / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013M20A / 2 LA / IM

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

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

Write-up: Tested Positive for Covid


VAERS ID: 1771753 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-23
Onset:2021-08-23
   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 FC3182 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2588 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Lip swelling, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Facial swelling of lips and feeling faint. We called the pharmacy and they told us to use benadryl.


VAERS ID: 1772192 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: California  
Vaccinated:2021-04-03
Onset:2021-08-23
   Days after vaccination:142
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / 1 LA / SYR

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

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: Over the counter medication, I took calcium and vitamin D supplements. 1200mg of calcium and 1 tablet of vitamin d supplement once a day
Current Illness: No
Preexisting Conditions: I have asthma since a child, and a fatty liver
Allergies: No
Diagnostic Lab Data: No
CDC Split Type: vsafe

Write-up: I felt under the weather, the evening after the vaccination. I was back to normal after 24 hours. I didn''t take anything and it was gone by the next day.


VAERS ID: 1772302 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-02-17
Onset:2021-08-23
   Days after vaccination:187
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9264 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ageusia, Anosmia, COVID-19, Chills, Cough, Dehydration, Diarrhoea, Dyspnoea, Exposure to SARS-CoV-2, Fatigue, Pneumonia, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive, Vaccine breakthrough infection
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (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? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Chronic lung disease (COPD), Diabetes
Allergies:
Diagnostic Lab Data: 08/29/2021 PCR+ COVID-19 test at Hospital
CDC Split Type:

Write-up: Breakthrough COVID-19 case with symptom onset 8/23/2021: Runny Nose/Congestion, Shortness of breath/difficulty breathing, Loss of smell or taste, Fatigue or tiredness, Chills, Cough. UI believes they were exposed during their trip from 8/19-8/23. Patient started to experience symptoms the night they returned from their trip. Patient reported symptom onset began with coughing spasms, congestion, fatigue and shortness of breath. Patient then developed severe diarrhea which led them to the ER. Patient was admitted to the hospital for dehydration, pneumonia and renal function observation. Patient was discharged after one week and reported symptoms have completely resolved. Hospitalized 8/29/2021-9/5/2021


VAERS ID: 1775401 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / SYR

Administered by: Private       Purchased by: ?
Symptoms: Muscular weakness, Polyneuropathy
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: polyneuropathy; muscle weakness


VAERS ID: 1775473 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Amenorrhoea
SMQs:, Fertility disorders (broad)

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

Write-up: Lost my period since the first shot


VAERS ID: 1776564 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-02-16
Onset:2021-08-23
   Days after vaccination:188
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026A21A / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure fluctuation, Blood test normal, Dyspnoea, Fatigue, Hot flush, Hyperhidrosis, Muscle spasms, Night sweats, Varicose vein
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (broad), Cardiomyopathy (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: Tamulosin, zinc 50 mg, vitamin B complex, vitamin D3, calcium, glucosomine
Current Illness: None
Preexisting Conditions: Lumbar and cervical surgeries
Allergies: Penicillin
Diagnostic Lab Data: Blood tests 10/05/21 to rule out thyroid, blood glycol or other metabolic causes. All tests are unremarkable. I can scan and email blood tests.
CDC Split Type:

Write-up: During late August I experienced shortness of breath, extreme night sweats, cramps in legs, the start of varicose veins (noted first in June 2021 by my primary care) fatigue, day sweats and hot flashes, and general fatigue, wide ranging blood pressure


VAERS ID: 1777602 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-08-20
Onset:2021-08-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Blood iron decreased, Blood test, Skin disorder
SMQs:

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: Armour thyroid, adderall, goodys powder
Current Illness: None
Preexisting Conditions: Post surgical Infection of the blood and spine 07/2020
Allergies: None
Diagnostic Lab Data: All I was told at the first draw, was bloodwork was normal. At second draw, I was told it was normal except stored iron was low.
CDC Split Type:

Write-up: If I scratch my arm blood pools under the skin of both forearms ? even now. Bloodwork is ?normal? except for low stored iron. Some random bruising Long term pain in the arm of the Injection site


VAERS ID: 1777613 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fatigue, Feeling abnormal, Headache
SMQs:, Dementia (broad)

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

Write-up: Patient developed massive unrelenting headache, extreme fatigue, and brain fog that lasted greater than 3 weeks


VAERS ID: 1777823 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-08-19
Onset:2021-08-23
   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 - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Breast mass, Breast pain, Heavy menstrual bleeding, Menstrual disorder
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Lipodystrophy (broad)

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

Write-up: Lump on left breast close to armpit. Lasted for 2 weeks with pain. Period started 2 weeks early..very unusual and has been heavier than usual.


VAERS ID: 1779512 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-01-27
Onset:2021-08-23
   Days after vaccination:208
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025J20A / UNK - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 12M20A / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Ear discomfort, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: fever, muscle aches, ear fullness


VAERS ID: 1779536 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 062E21A / 1 RA / -

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? 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: was supposed to get pfizer instead on moderna, not authorized for anyone under 18


VAERS ID: 1779550 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 062E21A / 1 LA / IM

Administered by: Private       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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Moderna vaccine given under the age of 18, no adverse reaction reported


VAERS ID: 1782404 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-02-10
Onset:2021-08-23
   Days after vaccination:194
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012L20A / 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: 1782509 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-16
Onset:2021-08-23
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: Hypoaesthesia, Muscle contractions involuntary, Muscle twitching, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Sildenafil 100mg daily as needed for erectile dysfunction Fenugreek unknown dose
Current Illness:
Preexisting Conditions:
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient has experienced approximately 2 months worsening bilateral lower extremity and bilateral upper extremity paresthesias and fasciculations. Patient states that he received the Johnson & Johnson vaccine first dose on 8/16/2021. He states that over the next week he developed numbness and tingling in his bilateral feet. He states that his symptoms progressively ascended to his bilateral thighs. He also reports numbness and tingling in his hands that have ascended to his proximal biceps bilaterally. He states that the muscle fasciculations are worse in his calves bilaterally and that he can see his muscles twitching. Denies any weakness to his lower extremities or upper extremities. Patient presented to hospital with these symptoms and a neurology consult has been obtained. No medication therapies have been used at this time.


VAERS ID: 1783795 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Oklahoma  
Vaccinated:2021-08-20
Onset:2021-08-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 041B21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Chest pain, Laboratory test, Neck pain, Neuralgia
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (broad)

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

Write-up: Chest pain (myocarditis) Leg nerve pain in both thighs and calf?s Hand and wrist weakness Neck pain


VAERS ID: 1784841 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-03-05
Onset:2021-08-23
   Days after vaccination:171
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6200 / 1 UN / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6200 / 2 UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Body temperature increased, COVID-19, Chest X-ray abnormal, Lung disorder, Mental status changes, Oxygen saturation decreased, SARS-CoV-2 test positive
SMQs:, Neuroleptic malignant syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Respiratory failure (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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: A male with PMH of ESRD ON PD, HTN, CHF and DM presented to the ED via EMS with complaints of generalized weakness and altered mental status. Pt is a poor historian and the history is taken mostly from review of chart and ED provider. Pt lives with his son who does the PD but he has COVID and is quarantined so pt''s last dialysis was 8/20/21. Pt tested positive for COVID today and only got the vaccine earlier this month. CXR shows patchy airspace disease in lungs.TMAX in ED 100.4, HR 112, RR 25. O2 sat on RA was 87%, 90% on 6L ans 98% on high flow NC. SBP has been i the 160s.


VAERS ID: 1785254 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / 1 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Tinnitus
Allergies: Nonw
Diagnostic Lab Data: None. But then no one can hear it but me.
CDC Split Type:

Write-up: Tinnitus became much worse within hours of shot. Has not subsided after over 6 weeks.


VAERS ID: 1785264 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 developed non-resolving tachycardia X2 days s/p vaccination and was given B/P medications as a result.


VAERS ID: 1624063 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF / UNK RA / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

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

Write-up: Strong Chest Pain, no treatment


VAERS ID: 1632275 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-23
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

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

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

Write-up: soar itchy arm in area of injection


VAERS ID: 1654857 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-23
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 29125BA / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Oxygen saturation, Oxygen saturation decreased, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210823; Test Name: low pulse oximetry; Result Unstructured Data: Test Result:low; Test Date: 202108; Test Name: low pulse oximetry; Result Unstructured Data: Test Result:normal
CDC Split Type: MXPFIZER INC202101098218

Write-up: respiratory distress; Low pulse oxymetry; This is a spontaneous report from a contactable consumer (patient). A 29-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: 29125BA) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced respiratory distress on 23Aug2021 and low pulse oxymetry on 23Aug2021. There has been no need to go to the hospital. The patient will do a molecular PCR test tomorrow. The outcome of the event respiratory distress was unknown while outcome of the event low pulse oxymetry was recovered on an unspecified date of Aug2021.


VAERS ID: 1655610 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7204 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Arthralgia, Blood test, Chest X-ray, Chest pain, Electrocardiogram, Heart rate, Palpitations, Supraventricular tachycardia
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210823; Test Name: Blood work; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210823; Test Name: Chest X-rays; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210823; Test Name: ECG; Result Unstructured Data: Test Result:Super ventricular tachycardia; Test Date: 20210823; Test Name: Heart rate; Result Unstructured Data: Test Result:220; Comments: bpm
CDC Split Type: CAPFIZER INC202101109550

Write-up: a sudden escalation in her heart rate/ super ventricular tachycardia; Heart palpitations; crushing chest pain; feelings of doom; bilateral pain in both shoulders; This is a spontaneous report received via COVAES from a contactable consumer (patient self). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 22Aug2021 13:15 (Lot Number: FD7204) (at the age of 59-year-old, not pregnant) as single dose for COVID-19 immunisation. No medical history. The patient''s concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Aug2021 at 13:30, the patient experienced a sudden escalation in her heart rate, very noticeable heart palpitations and crushing chest pain along with feelings of doom, and bilateral pain in both shoulders. The patient attended at a hospital emergency where it was noted her heart rate was 220 beats per minute. The patient was immediately given an ECG along with intravenous (IV) push Adenosine to reduce heart rate. The patient was monitored at the hospital for 12 hours to ensure her rate was ok. The patient received ongoing blood work and chest x-ray as assessment. She was discharged Tuesday morning with new medication Bisoprolol 2.5 mg and referral to a rapid Arrhythmia clinic for super ventricular tachycardia on 23Aug2021 at 13:30. The patient never had any issues with her heart rate and did not require medications to stabilize heart rate prior to the vaccine administration. The adverse events result in emergency room/department or urgent care. Outcome of the events was unknown. Seriousness assessed as life threatening and hospitalization.


VAERS ID: 1657517 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8162 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Depressed level of consciousness
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101098478

Write-up: Consciousness decreased; Blood pressure decreased; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 47-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 23Aug2021 19:15 (Batch/Lot Number: FE8162; Expiration Date: 30Nov2021) as single dose for covid-19 immunisation . Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies. The patient was not pregnant. The patient experienced consciousness decreased (life threatening) on 23Aug2021 19:15 with outcome of not recovered , blood pressure decreased (life threatening) on 23Aug2021 19:15 with outcome of not recovered. The patient was hospitalized because of the events. Therapeutic measures were taken as a result of the reported events including adrenaline injection. Since the vaccination, the patient has not been tested for COVID-19. Course of the event. 10 mins after the vaccination, the patient experienced Consciousness decreased, and Blood pressure decreased. Even 15 minutes after the Adrenaline injection, the patient did not get better, and was rushed to the PRIVACY Hospital. The reporter classified the events as serious (Hospitalized) and stated the events result in emergency room/department or urgent care and Life threatening illness (immediate risk of death from the event). Follow up information has been requested.; Sender''s Comments: Based on the available information and the close drug event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events depressed level of consciousness and blood pressure decreased cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1658056 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

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

Write-up: Vomiting; This case was received via RA (Reference number: GB-MHRA-ADR 25834248) on 23-Aug-2021 and was forwarded to Moderna on 23-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in an 18-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included DESOGESTREL (CERELLE) for an unknown indication. On 22-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). At the time of the report, VOMITING (Vomiting) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medication was not provided by the reporter. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1659341 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Private       Purchased by: ?
Symptoms: Feeling of body temperature change, Headache, Lethargy, Pain
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Flu
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Dr won?t report it just says common adverse reaction
CDC Split Type:

Write-up: Headaches for weeks, hot cold flushes no temp, aches, lethargic


VAERS ID: 1661932 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

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

Write-up: Exhaustion; Slight temperature; Headache dull; Loss of appetite; Flu-like aching; Shivers; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25838767) on 24-Aug-2021 and was forwarded to Moderna on 24-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like aching), CHILLS (Shivers), FATIGUE (Exhaustion), PYREXIA (Slight temperature) and HEADACHE (Headache dull) in a 20-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced CHILLS (Shivers) (seriousness criterion medically significant). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like aching) (seriousness criterion medically significant), FATIGUE (Exhaustion) (seriousness criterion medically significant), PYREXIA (Slight temperature) (seriousness criterion medically significant), HEADACHE (Headache dull) (seriousness criterion medically significant) and DECREASED APPETITE (Loss of appetite). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like aching), CHILLS (Shivers), FATIGUE (Exhaustion), PYREXIA (Slight temperature) and HEADACHE (Headache dull) had not resolved and DECREASED APPETITE (Loss of appetite) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by reporter No treatment medications provided by the reporter. Patient stated that she Cannot lift her arm and Complete loss of appetite Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1661937 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Fainting; started feeling light headed; This case was received via Regulatory Authority(Reference number: 25839344) on 24-Aug-2021 and was forwarded to Moderna on 24-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting) and DIZZINESS (started feeling light headed) in a 19-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suppressed lactation. On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant) and DIZZINESS (started feeling light headed) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Fainting) was resolving and DIZZINESS (started feeling light headed) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Woke up a couple hours after falling asleep for the toilet. When patient was washing my hands she started feeling light headed so went back to room and fainted as she walked in. No relevant concomitant medications were reported. No treatment information was provided. The patient has not tested positive for COVID-19 since having the vaccine. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Action taken with the suspect product and rechallnge results were captured to be in line with the information provided in the RA source document.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Action taken with the suspect product and rechallnge results were captured to be in line with the information provided in the RA source document.


VAERS ID: 1663608 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-08-23
   Days after vaccination:83
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood test normal, Cough, Dizziness, Dyspnoea, Electrocardiogram normal, Fatigue, Hyperhidrosis, Magnetic resonance imaging heart, Muscular weakness, Nausea, Pericarditis, Pleurisy
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Was on colchicine and ibuprofen to deal with the first round of pericarditis after taking my first vaccine earlier that spring.
Current Illness: Dealing with pericarditis from first vaccine. Colchicine helped the first time, and when I went for the second shot the CDC was called to confirm that it would be ok. They said to proceed and the first case of pericarditis was unrelated to my first shot because of the time between shot and symptoms. The second round of pericarditis was much worse and required hospitalization. I am in the hospital now, have been for a week.
Preexisting Conditions: Mild fatty liver disease.
Allergies: Fish/seafood
Diagnostic Lab Data: Over the last 2 weeks I''ve had various blood tests, ECG, electrocardiogram, and now a heart MRI. All tests showed everything is normal and ok, earlier tests did show inflammation in the pericardial sac. Still waiting for results of heart MRI
CDC Split Type:

Write-up: First shot had no side effects short term besides sore arm. I thought it was all good but then about a month and a half to 2 months later I had shortness of breath and it was causing bad pain in my chest to breathe. Can''t remember if I just went to family doctor or hospital but was diagnosed with pericarditis. Was prescribed colchicine and ibuprofen. Then got my second shot in June, medication had been working and I was told the pericarditis was too far away to be vaccine related and got the second shot. Approximately two months later, I got short of breath, severe chest pain much worse than before, muscle weakness and exhaustion. A cough later developed. I went to the hospital three times and was diagnosed with pericarditis. But then a week ago today, August 25 I got very nauseated. I ran to the bathroom but was so dizzy I had to sit on the floor and shut my eyes. I then began to sweat profusely and soaked my clothes in under 30 seconds and had huge puddles of sweat on the floor. I thought I was having a heart attack, was taken to hospital and have been here since. I''m on steroids to get the inflammation down and they appear to be working. Awaiting results for heart MRI


VAERS ID: 1664057 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal discomfort, Body temperature, Fatigue, Feeling of body temperature change, Headache, Hyperhidrosis, Insomnia, Maternal exposure during pregnancy, Pain, Ultrasound scan, Vaccination site pain, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy (14 weeks pregnant currently)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: abnormal; Test Name: Ultrasound scan; Result Unstructured Data: 12 weeks scan all fine at present
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Sweating; Ache; Upset stomach; Tiredness; Vaccination site pain; Feeling hot and cold; Difficulty sleeping; Vomited; Maternal exposure during pregnancy; Headache; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25841214) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), PAIN (Ache), ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Headache), VOMITING (Vomited), FATIGUE (Tiredness), VACCINATION SITE PAIN (Vaccination site pain), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), INSOMNIA (Difficulty sleeping) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Pregnancy (14 weeks pregnant currently). Concomitant products included FOLIC ACID from an unknown date to 20-Aug-2021 for Pregnant. On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Aug-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant). On 24-Aug-2021, the patient experienced VOMITING (Vomited) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERHIDROSIS (Sweating) (seriousness criterion medically significant), PAIN (Ache) (seriousness criterion medically significant), ABDOMINAL DISCOMFORT (Upset stomach) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant), VACCINATION SITE PAIN (Vaccination site pain) (seriousness criterion medically significant), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) (seriousness criterion medically significant) and INSOMNIA (Difficulty sleeping) (seriousness criterion medically significant). At the time of the report, HYPERHIDROSIS (Sweating), PAIN (Ache), ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Headache), FATIGUE (Tiredness), VACCINATION SITE PAIN (Vaccination site pain) and FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) had not resolved, VOMITING (Vomited) was resolving and INSOMNIA (Difficulty sleeping) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: abnormal (abnormal) abnormal. On an unknown date, Ultrasound scan: normal (normal) 12 weeks scan all fine at present. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was exposed to the medicine Second-trimester (13-28 weeks). Patient had body aching all over, injection site extremely painful and feels sore and bruised struggling to lift arm. Hot and cold with sweating. Upset stomach. Headaches and vomiting. Struggling to sleep first night. Still had symptoms at present 16 hours later. Patient had not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial.. Treatment medication was not reported. This is a case of maternal exposure during pregnancy with associated adverse events for this 30-year old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Follow up received additional events added.; Sender''s Comments: This is a case of maternal exposure during pregnancy with associated adverse events for this 30-year old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1664062 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Vaccination site pain, Vaccination site rash
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (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: CHLORPHENAMINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy NOS; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101105622

Write-up: Anaphylactic shock/ Throat started to tighten within 5 mins of vaccine and couldnt swallow; Pain injection site; Rash injection site; This is a spontaneous report from a contactable other hcp. This report is received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-APPCOVID-202108250750151150-IPIGV. Safety Report Unique Identifier GB-MHRA-ADR 25845294. A 39-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on 23Aug2021 (Batch/Lot number unknown), as dose 1, single (at the age of 39 years old) for COVID-19 immunisation. Medical history included Lactation decreased and Allergy NOS. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medication included chlorphenamine taken for Allergy NOS, start and stop date were not reported. The patient experienced anaphylactic shock, pain injection site and rash injection site on 23Aug2021. The clinical course included Throat started to tighten within 5 mins of vaccine and couldn''t swallow. Already taken 2 x Piroton tablets that day. The case was reported as serious due to medically significant and life threatening. The outcome of the event anaphylactic shock was recovered with sequelae, of the events pain injection site and rash injection site was not recovered. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1664383 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-08-23
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Nausea, Pain in extremity, Pruritus, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: nauseous; felt faint; itching; painful to lift arm; Dizzy spells; Nausea; This case was received via Regulatory authority (Reference number: GB-MHRA-ADR 25835281) on 24-Aug-2021 and was forwarded to Moderna on 24-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (nauseous), DIZZINESS (felt faint), PRURITUS (itching), DIZZINESS (Dizzy spells), NAUSEA (Nausea) and PAIN IN EXTREMITY (painful to lift arm) in a 25-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced DIZZINESS (Dizzy spells) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (nauseous) (seriousness criterion medically significant), DIZZINESS (felt faint) (seriousness criterion medically significant), PRURITUS (itching) (seriousness criterion medically significant) and PAIN IN EXTREMITY (painful to lift arm) (seriousness criterion medically significant). At the time of the report, NAUSEA (nauseous), DIZZINESS (felt faint), PRURITUS (itching), DIZZINESS (Dizzy spells) and NAUSEA (Nausea) had not resolved and PAIN IN EXTREMITY (painful to lift arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient usually in perfect health. 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. Patient was sat down and started swaying, felt faint and nauseous. Arms has been itching where injection was but stopped, was also painful to lift arm but seems ok now. No concomitant medication provided. No treatment information mentioned. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1664396 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Heart rate, Hyperhidrosis, Presyncope, Thrombosis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure measurement; Test Result: Inconclusive ; Result Unstructured Data: 112/77; Test Name: Pulse rate; Test Result: Inconclusive ; Result Unstructured Data: 62
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: blood clots; Sweaty; Pre-syncope; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25837207) on 24-Aug-2021 and was forwarded to Moderna on 24-Aug-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of THROMBOSIS (blood clots) in a 22-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) at an unspecified dose. On 23-Aug-2021, the patient experienced PRESYNCOPE (Pre-syncope). On an unknown date, the patient experienced THROMBOSIS (blood clots) (seriousness criterion medically significant) and HYPERHIDROSIS (Sweaty). On 23-Aug-2021, PRESYNCOPE (Pre-syncope) had resolved. At the time of the report, THROMBOSIS (blood clots) and HYPERHIDROSIS (Sweaty) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 112/77 (Inconclusive) 112/77. On an unknown date, Heart rate: 62 (Inconclusive) 62. 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. It was reported that approximately 10minutes post covid vaccination, patient complained of feeling lightheaded, sweaty and nauseous. He was taken to lay down and was given a drink of water. After approximately 10minutes symptoms resolved and discharged. The report did not relate to possible blood clots or low platelet count. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1664398 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dry eye, Fatigue, Headache, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness: Lactation decreased
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Fever; Headache; Tiredness; Muscle pain; Dry eyes; Chills; This case was received via Regulatory Authority MHRA (Reference number: GB-MHRA-ADR 25837532) on 24-Aug-2021 and was forwarded to Moderna on 24-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Tiredness), MYALGIA (Muscle pain), DRY EYE (Dry eyes) and CHILLS (Chills) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. Concurrent medical conditions included Lactation decreased and Lactation decreased. Concomitant products included PARACETAMOL for Pain. On 22-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant), MYALGIA (Muscle pain) (seriousness criterion medically significant), DRY EYE (Dry eyes) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Tiredness), MYALGIA (Muscle pain) and DRY EYE (Dry eyes) had not resolved and CHILLS (Chills) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided by reporter. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected.


VAERS ID: 1664408 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Maternal exposure during breast feeding, Pain, Pain in extremity
SMQs:, Neonatal exposures via breast milk (narrow), Tendinopathies and ligament disorders (broad)

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

Write-up: pain; Maternal exposure during breast feeding; Leg pain; This case was received via Regulatory authoirty(Reference number: GB-MHRA-ADR 25839066) on 24-Aug-2021 and was forwarded to Moderna on 24-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg pain), PAIN (pain) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 35-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Pregnancy and Cesarean section. Concurrent medical conditions included Breast feeding. Concomitant products included ENOXAPARIN SODIUM (CLEXANE) from 26-Apr-2021 to an unknown date for Cesarean section. On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced PAIN IN EXTREMITY (Leg pain) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (pain) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Leg pain) had not resolved, PAIN (pain) was resolving and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient reported that pain was identical to the menstruation sensation. Patient not had periods for over 12 months due to pregnancy. Patient was breastfeeding for almost 4 month old infant. It came on very suddenly and was very intense. The pain runs down the back of her left leg and up into buttock. Treatment information was not provided. Company comment This is a case of Maternal exposure during breastfeeding with associated AEs of pain in extremity and pain. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, use of concomitant medication enoxaparin sodium (Clexane) is a contributory factor to the events. Further information is not expected. This case was linked to MOD-2021-295652 (Parent-Child Link). See case MOD-2021-295652 for details regarding the child case.; Sender''s Comments: This is a case of Maternal exposure during breastfeeding with associated AEs of pain in extremity and pain. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, use of concomitant medication enoxaparin sodium (Clexane) is a contributory factor to the events. Further information is not expected.


VAERS ID: 1664409 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-08-23
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pericarditis, SARS-CoV-2 test
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

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

Write-up: Pericarditis; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25839064) on 24-Aug-2021 and was forwarded to Moderna on 24-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PERICARDITIS (Pericarditis) in a 34-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. No medical history was reported. On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced PERICARDITIS (Pericarditis) (seriousness criteria hospitalization, medically significant and life threatening). At the time of the report, PERICARDITIS (Pericarditis) had not resolved. 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 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication details was reported. No treatment medication details was reported. Patient had pericarditis with extrasystoles. Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the event and excluding other etiology, a causal relationship cannot be excluded as patient had no significant history reported for medical condition or concomitant medication; Sender''s Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the event and excluding other etiology, a causal relationship cannot be excluded as patient had no significant history reported for medical condition or concomitant medication


VAERS ID: 1664411 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea, Heart rate, Heart rate increased, Maternal exposure during pregnancy, Palpitations, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypoglycaemia (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: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation
Allergies:
Diagnostic Lab Data: Test Date: 20210823; Test Name: Heart rate; Result Unstructured Data: Test Result:High
CDC Split Type: GBPFIZER INC202101105241

Write-up: exposed to the medicine Second-trimester; Shaking; Palpitations; Difficulty breathing; Tight chest; Heart rate high; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202108240801428900-0U2UK. Safety Report Unique Identifier GB-MHRA-ADR 25840056. A 34-years-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: FE8087, Expiration date: Unknown), via an unspecified route of administration on 22Aug2021 09:15 as DOSE 2, SINGLE for covid-19 immunization. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient medical history included vitamin supplementation from an unknown date and unknown if ongoing. The patient concomitant medication included folic acid (FOLIC ACID) taken for vitamin supplementation, start and stop date were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19, since having the vaccine. Patient was not enrolled in clinical trial. On 23Aug2021, the patient underwent lab tests and procedures which included heart rate: high. Palpitations started in afternoon after vaccine at 9.15. Sudden full body shakes, palpitations and difficulty breathing started at 12.45am that night, lasting approx 2 hours. Ambulance called but too busy to arrive. Cancelled when episode stopped. Third episode of palpitations in second night after vaccine, 12am -2am tight chest and mild shaking. 2 days after vaccine still tight chested. Patient was exposed to the medicine Second-trimester (13-28 weeks). On an unspecified date The patient experienced exposed to the medicine second-trimester. On 23Aug2021 00:45, the patient had experienced palpitations, difficulty breathing, shaking. On 23Aug2021, patient experienced heart rate high, tight chest. The events were considered as medical significant. The outcome of all events Palpitations, Heart rate high, Difficulty breathing, Tight chest, Shaking was not resolved. Outcome for other event was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1664413 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal discomfort, Abdominal pain upper, Pyrexia, SARS-CoV-2 test, Seizure
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: night; upset stomach; Stomachache; Fever; This case was received via regulatory authority(Reference number: GB-MHRA-ADR 25841126) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SEIZURE (night) in a 19-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Not known) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomachache) and PYREXIA (Fever). On an unknown date, the patient experienced SEIZURE (night) (seriousness criterion medically significant) and ABDOMINAL DISCOMFORT (upset stomach). On 24-Aug-2021, ABDOMINAL PAIN UPPER (Stomachache) and PYREXIA (Fever) had resolved. At the time of the report, SEIZURE (night) and ABDOMINAL DISCOMFORT (upset stomach) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided. Treatment information was not provided. Reporter stated that patient had Fever over night. By morning she was fine. Bit of an upset stomach as well. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Event Seizure was captured as Serious as per IME list. However, based on available information and medical criteria the event was assessed as Non-serious.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Event Seizure was captured as Serious as per IME list. However, based on available information and medical criteria the event was assessed as Non-serious.


VAERS ID: 1664414 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

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

Write-up: Fever; Headache; This case was received (Reference number: GB-MHRA-ADR 25841180) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. Based on the current case data, this case has been classified as invalid. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever) and HEADACHE (Headache) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient not had symptoms associated with COVID-19. Not had a COVID-19 test. Concomitant medication use information was not provided by reporter. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment medication use information was not provided by reporter. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1664415 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

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

Write-up: Chest aching; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 25841320) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest aching) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced CHEST PAIN (Chest aching) (seriousness criterion medically significant). At the time of the report, CHEST PAIN (Chest aching) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient not had symptoms associated with COVID-19. Not had a COVID-19 test. No concomitant medications were reported. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment information was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1664423 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), COVID-19 (broad)

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

Write-up: Breathlessness; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25850969) on 26-Aug-2021 and was forwarded to Moderna on 26-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSPNOEA (Breathlessness) in a 20-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced DYSPNOEA (Breathlessness) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (Breathlessness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1666437 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 2 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood creatine phosphokinase, Chest X-ray normal, Chest pain, Electrocardiogram normal, Fibrin D dimer increased, Full blood count
SMQs:, Haemorrhage laboratory terms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: Chronic Myelogenous Leukemia
Allergies:
Diagnostic Lab Data: His CBC and CPK were normal (08/24/2021) but his D-Dimer level was elevated at 1.63mg/L(collected on 08/24/2021 reported 3 days later. His EKG was normal (08/24/2021). Chest CT was negative for Pulmonary Embolism (08/27/2021'').
CDC Split Type:

Write-up: The next day after receiving the vaccine experienced chest pain, tightness when taking a deep breath. Was getting progressively worse. His vitals including oxygen levels were normal, no fever. There was no pain with palpation of the costosternal angle. His CBC and CPK were normal but his D-Dimer level was elevated at 1.63mg/L. His EKG was normal. Chest CT was negative for Pulmonary Embolism . He was initially treated with ASA 81mg PO QD and then switched to Eliquis 5mg PO BID


VAERS ID: 1667794 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-08-23
   Days after vaccination:82
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2243 / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DERCUTANE
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: pcr; Test Result: Positive ; Comments: Nasal Swab got the results on 26Aug2021 where they confirmed that patient had COVID
CDC Split Type: ESPFIZER INC202101120888

Write-up: COVID/COVID-19 PCR test positive/started on 23Aug2021 with symptoms; COVID/COVID-19 PCR test positive/started on 23Aug2021 with symptoms; This is a spontaneous report from a contactable pharmacist (the own patient and also a Pfizer employee) received through Regulatory Authority. A 40-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left at the age of 40-year-old on 02Jun2021 (Lot Number: EW2243) as single dose, dose 1 via an unspecified route of administration, administered in Arm Left on 12May2021 (Lot Number: ET3620) as single dose for COVID-19 immunisation. Medical history included none. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included isotretinoin (DERCUTANE) taken for an unspecified indication, start and stop date were not reported. Reported event was COVID. Patient started on 23Aug2021 with symptoms and on 24Aug2021 patient had patient''s PCR done. Patient got the results on 26Aug2021 where they confirmed that patient had COVID. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 24Aug2021 (Nasal Swab). The outcome of events was recovering.; Sender''s Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate


VAERS ID: 1668082 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Headache, Nausea, Pain in extremity, Pruritus, Pyrexia, Rash erythematous, Tremor
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: shaking; fever; Itching; Red rash; Headache; Feverish; Nauseous; Dizziness; Painful arm; This case was received via Regulatory Agency RA (Reference number: GB-MHRA-ADR 25855663) on 27-Aug-2021 and was forwarded to Moderna on 27-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PRURITUS (Itching), RASH ERYTHEMATOUS (Red rash), TREMOR (shaking), PYREXIA (fever), PAIN IN EXTREMITY (Painful arm), HEADACHE (Headache), PYREXIA (Feverish), NAUSEA (Nauseous) and DIZZINESS (Dizziness) in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Fever and Lactation decreased. Concomitant products included LEVOTHYROXINE for Hypothyroidism, IBUPROFEN and PARACETAMOL for an unknown indication. On 23-Aug-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 24-Aug-2021, the patient experienced PRURITUS (Itching) (seriousness criterion medically significant), RASH ERYTHEMATOUS (Red rash) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (Feverish) (seriousness criterion medically significant), NAUSEA (Nauseous) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). On an unknown date, the patient experienced TREMOR (shaking) (seriousness criterion medically significant) and PYREXIA (fever) (seriousness criterion medically significant). On 24-Aug-2021, PYREXIA (Feverish), NAUSEA (Nauseous) and DIZZINESS (Dizziness) had resolved. On 25-Aug-2021, HEADACHE (Headache) had resolved. On 26-Aug-2021, PAIN IN EXTREMITY (Painful arm) was resolving. At the time of the report, PRURITUS (Itching) and RASH ERYTHEMATOUS (Red rash) had not resolved and TREMOR (shaking) and PYREXIA (fever) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medication was not provided Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness of the events are based on the Regulatory Report received. As per medical judgement the events for this case are non-serious. As this a RA, reported events seriousness is kept as per RA assessment.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness of the events are based on the Regulatory Report received. As per medical judgement the events for this case are non-serious. As this a RA, reported events seriousness is kept as per RA assessment.


VAERS ID: 1668311 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Faint
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101101931

Write-up: Seizure; This is a spontaneous report from a contactable Pharmacist. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202108231427292130-ESI4K. Safety Report Unique Identifier GB-MHRA-ADR 25836922. A 22-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot# fe3380, via an unspecified route of administration on 23Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history included faint. Concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient experienced seizure on 23Aug2021. As soon as administered vaccine patient went still and then started fitting on the chair for few seconds. Patient had no memory of this happening and did not hurt himself. He had been known to faint before, but not fit. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of event was recovered on 23Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1668314 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Myocarditis, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: arm pain; shortness of breath; Myocarditis; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25839996) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. Based on the current case data, this case has been classified as invalid. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), DYSPNOEA (shortness of breath) and MYOCARDITIS (Myocarditis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain) (seriousness criterion medically significant) and DYSPNOEA (shortness of breath) (seriousness criterion medically significant). The patient was treated with PARACETAMOL at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm pain) and DYSPNOEA (shortness of breath) was resolving and MYOCARDITIS (Myocarditis) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient received vaccination at 4.15pm, no issues at first, slight arm pain and then patient took paracetamols, then napped around 6pm-10pm After which around 11-12pm Istarted feeling shortness of breath, pain around my heart, and it has been like that ever since, even with taking pain killers it did not go. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial No concomitant was provided. No treatment information was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected.


VAERS ID: 1668328 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

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

Write-up: injection; fever; Headache; Joint pain; Pain injection site; Fatigue; Fever chills; Sweating fever; This case was received via Regulatory Authority (Reference number: 25840866) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SWEATING FEVER (Sweating fever), INJECTION (injection), PYREXIA (fever), HEADACHE (Headache), ARTHRALGIA (Joint pain), INJECTION SITE PAIN (Pain injection site), FATIGUE (Fatigue) and PYREXIA (Fever chills) in a 43-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced SWEATING FEVER (Sweating fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), ARTHRALGIA (Joint pain) (seriousness criterion medically significant), INJECTION SITE PAIN (Pain injection site) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and PYREXIA (Fever chills) (seriousness criterion medically significant). On an unknown date, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced INJECTION (injection) (seriousness criterion medically significant) and PYREXIA (fever) (seriousness criterion medically significant). At the time of the report, SWEATING FEVER (Sweating fever) and PYREXIA (Fever chills) was resolving and INJECTION (injection), PYREXIA (fever), HEADACHE (Headache), ARTHRALGIA (Joint pain), INJECTION SITE PAIN (Pain injection site) and FATIGUE (Fatigue) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Patient had no symptoms associated with COVID-19. Not had a COVID-19 test. Fever started 12 hours after injection. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment information was not provided. Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1668329 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Lymph node pain, Nasopharyngitis, 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: Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: cold fever; Lymph node pain; This case was received via Regulatory Agency RA (Reference number: GB-MHRA-ADR 25840886) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Lymph node pain) and NASOPHARYNGITIS (cold fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. Concurrent medical conditions included Asthma. On 22-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced LYMPH NODE PAIN (Lymph node pain) (seriousness criterion medically significant). On an unknown date, the patient experienced NASOPHARYNGITIS (cold fever) (seriousness criterion medically significant). At the time of the report, LYMPH NODE PAIN (Lymph node pain) had not resolved and NASOPHARYNGITIS (cold fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications was not reported. Treatment history was not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Cold fever symptoms, painful bump under his armpits on the arm he got the vaccine. Very swollen bump size of tennis ball. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event Lymph node pain, a causal relationship cannot be excluded. Very limited information regarding the event Nasopharyngitis has been provided at this time. Further information regarding temporal association is necessary.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event Lymph node pain, a causal relationship cannot be excluded. Very limited information regarding the event Nasopharyngitis has been provided at this time. Further information regarding temporal association is necessary.


VAERS ID: 1668342 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

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

Write-up: Redness; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25841275) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 20-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced ERYTHEMA (Redness) (seriousness criterion medically significant). At the time of the report, ERYTHEMA (Redness) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant, Patient was not currently breastfeeding. Concomitant medication was not provided. Patient had patches of redness on the injected arm , starting in the shoulder down close to the elbow. Never had an allergic reaction in live. And patient skin tone was tanned so don''t get redness or bruise easily. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment medication was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1668343 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Burning sensation, Pruritus, Skin atrophy
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: thinning of skin; burning sensation; Itchy skin; This case was received via RA (Reference number: GB-MHRA-ADR 25841333) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PRURITUS (Itchy skin) in a 26-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 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced PRURITUS (Itchy skin) (seriousness criterion medically significant). On an unknown date, the patient experienced SKIN ATROPHY (thinning of skin) and BURNING SENSATION (burning sensation). At the time of the report, PRURITUS (Itchy skin) was resolving and SKIN ATROPHY (thinning of skin) and BURNING SENSATION (burning sensation) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event term pruritus, onset date and outcome captured per SD Authority reporting. Pruritus seriousness per overall case assessment by Authority. Non-serious events of skin atrophy and burning sensation added.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event term pruritus, onset date and outcome captured per SD Authority reporting. Pruritus seriousness per overall case assessment by Authority. Non-serious events of skin atrophy and burning sensation added.


VAERS ID: 1668346 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

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

Write-up: Shivering; Nausea; Tiredness; Ache; This case was received via Regulatory Agency RA (Reference number: ADR 25842666) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Ache), CHILLS (Shivering), NAUSEA (Nausea) and FATIGUE (Tiredness) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suppressed lactation. On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant). On 24-Aug-2021, the patient experienced CHILLS (Shivering) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). At the time of the report, PAIN (Ache), CHILLS (Shivering), NAUSEA (Nausea) and FATIGUE (Tiredness) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by reporter No treatment medications provided by the reporter. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events seriousness criteria was assessed as per regulatory authority report.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events seriousness criteria was assessed as per regulatory authority report.


VAERS ID: 1668350 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Emotional disorder, Headache, Influenza, Myalgia, Pyrexia, SARS-CoV-2 test, Swelling, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Fainting; Flu; Swelling; Emotional reaction; Fever; Chills; Headache; Muscle ache; Joint ache; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25843193) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting), INFLUENZA (Flu), SWELLING (Swelling), EMOTIONAL DISORDER (Emotional reaction), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Muscle ache) and ARTHRALGIA (Joint ache) in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced SYNCOPE (Fainting) (seriousness criteria disability and medically significant), INFLUENZA (Flu) (seriousness criterion disability), SWELLING (Swelling) (seriousness criterion disability), EMOTIONAL DISORDER (Emotional reaction) (seriousness criterion disability), PYREXIA (Fever) (seriousness criterion disability), CHILLS (Chills) (seriousness criterion disability), HEADACHE (Headache) (seriousness criterion disability), MYALGIA (Muscle ache) (seriousness criterion disability) and ARTHRALGIA (Joint ache) (seriousness criterion disability). At the time of the report, SYNCOPE (Fainting), INFLUENZA (Flu), SWELLING (Swelling), EMOTIONAL DISORDER (Emotional reaction), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Muscle ache) and ARTHRALGIA (Joint ache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Patient had no symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient experienced swelling in the armpits. Patient was 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 case concerns a 24-year-old female with serious unexpected events of syncope, influenza, swelling, emotional disorder, pyrexia, chills, headache, myalgia, and arthralgia. Event latency within 24 hours after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: This case concerns a 24-year-old female with serious unexpected events of syncope, influenza, swelling, emotional disorder, pyrexia, chills, headache, myalgia, and arthralgia. Event latency within 24 hours after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1668352 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210807; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Tiredness; Generalized aching; Headache; Shivers; High temperature; This case was received via regulatory authority (Reference number: 25843493) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), PAIN (Generalized aching), HEADACHE (Headache), CHILLS (Shivers) and PYREXIA (High temperature) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 22-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant), PAIN (Generalized aching) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant) and PYREXIA (High temperature) (seriousness criterion medically significant). On 23-Aug-2021, CHILLS (Shivers) had resolved. On 24-Aug-2021, PAIN (Generalized aching), HEADACHE (Headache) and PYREXIA (High temperature) had resolved. At the time of the report, FATIGUE (Tiredness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Aug-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Patient had no symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment information was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The action taken with the suspect product and rechallenge results were captured as per RA Source Document. Events seriousness was captured per overall case assessment by Authority.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The action taken with the suspect product and rechallenge results were captured as per RA Source Document. Events seriousness was captured per overall case assessment by Authority.


VAERS ID: 1668353 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Chills, Fatigue, Feeling cold, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: Feeling cold; Shivering; Fever; Chills; Nausea; Chest pain; Fatigue; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25843558) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), FEELING COLD (Feeling cold), PYREXIA (Fever), CHILLS (Shivering), FATIGUE (Fatigue), CHILLS (Chills) and NAUSEA (Nausea) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). On 24-Aug-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced FEELING COLD (Feeling cold) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). At the time of the report, CHEST PAIN (Chest pain), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) was resolving, FEELING COLD (Feeling cold) and CHILLS (Shivering) had resolved and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. The patient''s skin was very hot to touch but had chills and had to sleep in layers to stop shivering and feeling cold, then had pretty bad chest pain. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1668354 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Malaise, Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (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: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210722; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Shortness of breath; Ache; Painful arm; Feeling sick; Fever; This case was received via RA (Reference number: ADR 25843565) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), PAIN (Ache), PAIN IN EXTREMITY (Painful arm), MALAISE (Feeling sick) and PYREXIA (Fever) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased and Suspected COVID-19 from 20-Jul-2021 to 07-Aug-2021. On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), MALAISE (Feeling sick) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 24-Aug-2021, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (Shortness of breath) and PAIN (Ache) had not resolved and PAIN IN EXTREMITY (Painful arm), MALAISE (Feeling sick) and PYREXIA (Fever) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jul-2021, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1668359 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Hyperhidrosis, Lymphadenopathy, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: CETIRIZINE; PARACETAMOL
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by reporter
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Sweating; Glands swollen; Fever chills; Headache; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25843893) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), LYMPHADENOPATHY (Glands swollen), PYREXIA (Fever chills) and HEADACHE (Headache) in a 30-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No medical history was provided by reporter. Concomitant products included CETIRIZINE from 24-May-2021 to an unknown date for Allergy, PARACETAMOL from 08-Jun-2021 to 24-Aug-2021 for Headache and Ache. On 23-Aug-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced PYREXIA (Fever chills) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 24-Aug-2021, the patient experienced HYPERHIDROSIS (Sweating) (seriousness criterion medically significant) and LYMPHADENOPATHY (Glands swollen) (seriousness criterion medically significant). At the time of the report, HYPERHIDROSIS (Sweating), PYREXIA (Fever chills) and HEADACHE (Headache) was resolving and LYMPHADENOPATHY (Glands swollen) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jun-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medication was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time. MA thinks that the events in this RA case are non serious; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time. MA thinks that the events in this RA case are non serious


VAERS ID: 1668362 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Heart rate increased, Nausea, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Feverish; Heart rate increased; Nauseous; Generalised aching; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 25844383) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Feverish), HEART RATE INCREASED (Heart rate increased), NAUSEA (Nauseous) and PAIN (Generalised aching) in a 22-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced PYREXIA (Feverish) (seriousness criterion medically significant), HEART RATE INCREASED (Heart rate increased) (seriousness criterion medically significant), NAUSEA (Nauseous) (seriousness criterion medically significant) and PAIN (Generalised aching) (seriousness criterion medically significant). The patient was treated with PARACETAMOL for Adverse event, at a dose of 1 dosage form. On 24-Aug-2021, NAUSEA (Nauseous) had resolved. At the time of the report, PYREXIA (Feverish), HEART RATE INCREASED (Heart rate increased) and PAIN (Generalised aching) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events seriousness captured as per Regulatory Authority assessment in the Source Document.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events seriousness captured as per Regulatory Authority assessment in the Source Document.


VAERS ID: 1668371 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Headache; Fatigue; Fever chills; High temperature; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25846927) on 26-Aug-2021 and was forwarded to Moderna on 26-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever chills) and PYREXIA (High temperature) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant) and PYREXIA (High temperature) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache) and FATIGUE (Fatigue) was resolving and PYREXIA (Fever chills) and PYREXIA (High temperature) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported.Patient was not enrolled in clinical trial. No treatment information was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time. RA deems the events in this RA case as non serious.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time. RA deems the events in this RA case as non serious.


VAERS ID: 1668938 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0583 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy (details were unknown.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101091372

Write-up: urticaria; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. A 58-year-old male patient received second dose of BNT162b2 (COMIRNATY, Solution for injection), intramuscular, administered in arm left on 23Aug2021 at 16:30 (Batch/Lot Number: EY0583; Expiration Date: 31Oct2021) (at the age of 58-year-old) as single dose for COVID-19 immunisation. Medical history included some allergies, but details were unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient''s concomitant medications were not reported. On 02Aug2021, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0583, Expiration date 31Oct2021) intramuscular in the left arm for COVID-19 immunization. On 23Aug2021 at 16:30 (the day of vaccination), the patient received the second single dose of BNT162B2 (COMIRNATY). On 23Aug2021 at 17:00 (30 minutes after the vaccination), the patient experienced urticaria. The outcome of the event was recovering with treatment including intravenous corticosteroids. The reporter classified the event as non-serious. The reporter stated the event results in physician office visit. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Considering the product-event temporal relationship, a causal association between the reported ''urticaria'' and the administration of bnt162b2 cannot be completely excluded. Case will be reassessed once with additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1669725 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-08-23
   Days after vaccination:67
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Eye pain, Headache, Inappropriate schedule of product administration, Myalgia, Peripheral swelling, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Swollen arm; Headache; Chills; Fever; severely achy; Inappropriate schedule of vaccine administered; Eye ache; This case was received via Regulatory Agency (Reference number: GB-MHRA-ADR 25845844) on 26-Aug-2021 and was forwarded to Moderna on 26-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of EYE PAIN (Eye ache), PERIPHERAL SWELLING (Swollen arm), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) in a 23-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased and Lactation decreased. On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced EYE PAIN (Eye ache) (seriousness criterion medically significant). 23-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 24-Aug-2021, the patient experienced MYALGIA (severely achy). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 23-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, EYE PAIN (Eye ache), PERIPHERAL SWELLING (Swollen arm), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) was resolving and MYALGIA (severely achy) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. After first dose, symptoms cleared within 36 hours, after second dose, symptoms got worse after 24 hours and were ongoing. Treatment information was not provided. Company comment: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, with associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, with associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1669734 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Polymenorrhoea, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210822; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Frequent periods; Heavy periods; This case was received (Reference number: GB-MHRA-ADR 25846919) on 26-Aug-2021 and was forwarded to Moderna on 26-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of POLYMENORRHOEA (Frequent periods) and HEAVY MENSTRUAL BLEEDING (Heavy periods) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased and Lactation decreased. On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Heavy periods) (seriousness criterion medically significant). On 25-Aug-2021, the patient experienced POLYMENORRHOEA (Frequent periods) (seriousness criterion medically significant). At the time of the report, POLYMENORRHOEA (Frequent periods) and HEAVY MENSTRUAL BLEEDING (Heavy periods) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Aug-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Two days after vaccine came on heavy period. Her period was not due. She typically had regular periods. After last vaccine period lasted 5 weeks. Concomitant product use was not provided by reporter. Treatment information was not provided. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is not expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is not expected.


VAERS ID: 1669739 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Fatigue, Headache, Malaise, Pyrexia, Rash
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Unwell; Tightness in chest; Chest discomfort; Headache; Tiredness; Fever; Rash; This case was received via Agency (Reference number: GB-MHRA-ADR 25848923) on 26-Aug-2021 and was forwarded to Moderna on 26-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RASH (Rash), MALAISE (Unwell), CHEST DISCOMFORT (Tightness in chest), PYREXIA (Fever), CHEST DISCOMFORT (Chest discomfort), HEADACHE (Headache) and FATIGUE (Tiredness) in a 27-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Headache. On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 24-Aug-2021, the patient experienced CHEST DISCOMFORT (Chest discomfort) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (Unwell) (seriousness criterion medically significant) and CHEST DISCOMFORT (Tightness in chest) (seriousness criterion medically significant). On 24-Aug-2021, PYREXIA (Fever), CHEST DISCOMFORT (Chest discomfort) and HEADACHE (Headache) had resolved. On 25-Aug-2021, FATIGUE (Tiredness) had resolved. At the time of the report, RASH (Rash), MALAISE (Unwell) and CHEST DISCOMFORT (Tightness in chest) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant products were not provided. Treatment medication were not reported. Patient took the vaccination at mid-day and began to feel mildly unwell before going to bed. He woken up in the night with a fever and felt joints very stiff and achy, as struggled to sleep the rest of the night. On the morning patient had a headache and felt extremely tired all the day. But the fever and headache resolved by early afternoon with some paracetamol and ibuprofen. Later in the evening felt tightness in chest which remained for a number of hours but was resolved by the next day morning and haven''t returned. He noticed a red rash around the injection site around 5cm in diameter the day after the injection which was not yet resolved. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1669749 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Fatigue, Food intolerance, Injection site pain, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: Nausea; Armpit pain; Food intolerance; Fever; Tiredness; Injection site pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25851546) on 26-Aug-2021 and was forwarded to Moderna on 26-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Armpit pain), FOOD INTOLERANCE (Food intolerance), FATIGUE (Tiredness), INJECTION SITE PAIN (Injection site pain), NAUSEA (Nausea) and PYREXIA (Fever) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concomitant products included PARACETAMOL from 24-Aug-2021 to an unknown date for Fever. On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion disability) and INJECTION SITE PAIN (Injection site pain) (seriousness criterion disability). On 24-Aug-2021, the patient experienced FOOD INTOLERANCE (Food intolerance) (seriousness criterion disability) and PYREXIA (Fever) (seriousness criterion disability). On 25-Aug-2021, the patient experienced AXILLARY PAIN (Armpit pain) (seriousness criterion disability). On an unknown date, the patient experienced NAUSEA (Nausea) (seriousness criterion disability). On 26-Aug-2021, PYREXIA (Fever) was resolving. At the time of the report, AXILLARY PAIN (Armpit pain), FOOD INTOLERANCE (Food intolerance), FATIGUE (Tiredness) and INJECTION SITE PAIN (Injection site pain) had not resolved and NAUSEA (Nausea) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1671370 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Dizziness, Headache, Migraine, Nausea, Visual impairment
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (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: Multi vitamin, vitamin c and vitamin D.
Current Illness: None.
Preexisting Conditions: None.
Allergies: None.
Diagnostic Lab Data:
CDC Split Type:

Write-up: Symptoms started same day as vaccine with migraine followed by spotty vision and dizziness. On day 3 dizziness followed with nausea and headache from day 3-6. On day 7 headache went away but nauseous and dizziness/lightheaded continued. These symptoms are still on going to today''s date.


VAERS ID: 1671654 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal distension, Back pain, Body temperature, Chills, Dehydration, Disturbance in attention, Fatigue, Feeling hot, Injection site erythema, Malaise, Muscle spasms, Nasopharyngitis, Nausea, Pain in extremity, Peripheral swelling, Pyrexia, Swelling face, Vaccination site induration, Vomiting
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Every time whenever the patient got up to walk, temperature rose to the point that she had to lay down to stop her feeling of nauseous.
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: swollen abdomen; abdominal puffiness; back pain; cold; dehydration; unwell; cramps; nauseous; vomiting; tiredness; EXTREME HOT; SWOLLEN BICEPS; ARM PAIN; MUSCLE AT INJECTION SITE IS ALSO HARD; Fever; Chills; Physically unwell; Injection site redness; Poor concentration; Abdominal bloating; Low back pain; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 25852268) on 27-Aug-2021 and was forwarded to Moderna on 27-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DISTURBANCE IN ATTENTION (Poor concentration), ABDOMINAL DISTENSION (Abdominal bloating), BACK PAIN (Low back pain), ABDOMINAL DISTENSION (swollen abdomen), SWELLING FACE (abdominal puffiness), BACK PAIN (back pain), NASOPHARYNGITIS (cold), DEHYDRATION (dehydration), MALAISE (unwell), MUSCLE SPASMS (cramps), MALAISE (Physically unwell), INJECTION SITE ERYTHEMA (Injection site redness), NAUSEA (nauseous), VOMITING (vomiting), FATIGUE (tiredness), PYREXIA (Fever) and CHILLS (Chills) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. On 22-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced DISTURBANCE IN ATTENTION (Poor concentration) (seriousness criterion medically significant), ABDOMINAL DISTENSION (Abdominal bloating) (seriousness criterion medically significant), BACK PAIN (Low back pain) (seriousness criterion medically significant), MALAISE (Physically unwell) (seriousness criterion medically significant), INJECTION SITE ERYTHEMA (Injection site redness) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On an unknown date, the patient experienced ABDOMINAL DISTENSION (swollen abdomen) (seriousness criterion medically significant), SWELLING FACE (abdominal puffiness) (seriousness criterion medically significant), BACK PAIN (back pain) (seriousness criterion medically significant), DEHYDRATION (dehydration) (seriousness criterion medically significant), MALAISE (unwell) (seriousness criterion medically significant), MUSCLE SPASMS (cramps) (seriousness criterion medically significant), NAUSEA (nauseous) (seriousness criterion medically significant), VOMITING (vomiting) (seriousness criterion medically significant), FEELING HOT (EXTREME HOT), PERIPHERAL SWELLING (SWOLLEN BICEPS), PAIN IN EXTREMITY (ARM PAIN) and VACCINATION SITE INDURATION (MUSCLE AT INJECTION SITE IS ALSO HARD). an unknown date, the patient experienced NASOPHARYNGITIS (cold) (seriousness criterion medically significant). an unknown date, the patient experienced FATIGUE (tiredness) (seriousness criterion medically significant). On 23-Aug-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, DISTURBANCE IN ATTENTION (Poor concentration), ABDOMINAL DISTENSION (Abdominal bloating), BACK PAIN (Low back pain), INJECTION SITE ERYTHEMA (Injection site redness) and PAIN IN EXTREMITY (ARM PAIN) had not resolved, ABDOMINAL DISTENSION (swollen abdomen), SWELLING FACE (abdominal puffiness), BACK PAIN (back pain), NASOPHARYNGITIS (cold), DEHYDRATION (dehydration), MALAISE (unwell), MUSCLE SPASMS (cramps), MALAISE (Physically unwell), NAUSEA (nauseous), VOMITING (vomiting) and FATIGUE (tiredness) was resolving and FEELING HOT (EXTREME HOT), PERIPHERAL SWELLING (SWOLLEN BICEPS) and VACCINATION SITE INDURATION (MUSCLE AT INJECTION SITE IS ALSO HARD) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) Every time whenever the patient got up to walk, temperature rose to the point that she had to lay down to stop her feeling of nauseous.. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication of the patient was not reported. Started off tired within an hour of the injection. About 12 hours later extreme hot. The following day the patient had back pain in the same location as period cramps but much worsened and could not bend forward without feeling a jarring pain in low back. The patient had swollen bicep with redness and warm skin. The patient was unable to focus properly. Abdominal puffiness still ongoing as was arm pain, feeling of dehydration, inability to focus and tiredness. The muscle at the injection site was also hard. Back pain got worse in the afternoon as did the abdomen. Sibling of the patient was vaccinated on the same day of vaccination of the patient and reported similar at the same time also with continuous vomiting like morning sickness. No treatment information was provided by the reporter. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1671664 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Hangover, Impaired work ability, Injection site pain, Lethargy, Myalgia, Somnolence
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Arthritis (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: hangover; Slept from the morning through to evening; Took the day off work; Lethargy; Injection site pain; Muscle soreness; Joint ache; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25856008) on 27-Aug-2021 and was forwarded to Moderna on 27-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HANGOVER (hangover), LETHARGY (Lethargy), INJECTION SITE PAIN (Injection site pain), MYALGIA (Muscle soreness) and ARTHRALGIA (Joint ache) in a 30-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced LETHARGY (Lethargy) (seriousness criterion medically significant), INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant), MYALGIA (Muscle soreness) (seriousness criterion medically significant) and ARTHRALGIA (Joint ache) (seriousness criterion medically significant). On an unknown date, the patient experienced HANGOVER (hangover) (seriousness criterion medically significant), SOMNOLENCE (Slept from the morning through to evening) and IMPAIRED WORK ABILITY (Took the day off work). On 24-Aug-2021, LETHARGY (Lethargy), INJECTION SITE PAIN (Injection site pain), MYALGIA (Muscle soreness) and ARTHRALGIA (Joint ache) had resolved. At the time of the report, HANGOVER (hangover), SOMNOLENCE (Slept from the morning through to evening) and IMPAIRED WORK ABILITY (Took the day off work) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. There was no concomitant medication reported. There was no treatment medication reported. Reported information included, patient felt bad hangover without headache and he took day off work. Also he slept from morning through to evening which followed till night. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected.


VAERS ID: 1671667 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-23
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Hyperhidrosis, Injection site erythema, Lymphadenopathy, Pain, Pain in extremity, Pyrexia, Rash, SARS-CoV-2 test, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy; Comments: Not taking or on anything. Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210826; 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: arm pain; not around the injection; shivering; high temperature; exhaustion; Rash; Swollen glands; Shaking; Ache; Sweating; This case was received via Regulatory authority. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), TREMOR (Shaking), PAIN (Ache), HYPERHIDROSIS (Sweating), RASH (Rash), LYMPHADENOPATHY (Swollen glands), INJECTION SITE ERYTHEMA (not around the injection), CHILLS (shivering), PYREXIA (high temperature) and FATIGUE (exhaustion) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Not known) for COVID-19 vaccination. Not taking or on anything. Patient has not had symptoms associated with COVID-19. The patient''s past medical history included Pregnancy. In August 2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 2 dosage form. On 23-Aug-2021, the patient experienced TREMOR (Shaking) (seriousness criterion medically significant), PAIN (Ache) (seriousness criterion medically significant) and HYPERHIDROSIS (Sweating) (seriousness criterion medically significant). On 24-Aug-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant) and LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain) (seriousness criterion medically significant), INJECTION SITE ERYTHEMA (not around the injection) (seriousness criterion medically significant), CHILLS (shivering) (seriousness criterion medically significant), PYREXIA (high temperature) (seriousness criterion medically significant) and FATIGUE (exhaustion) (seriousness criterion medically significant). On 24-Aug-2021, TREMOR (Shaking) had resolved. On 25-Aug-2021, HYPERHIDROSIS (Sweating) had resolved. On 26-Aug-2021, PAIN (Ache) was resolving. At the time of the report, PAIN IN EXTREMITY (arm pain), INJECTION SITE ERYTHEMA (not around the injection), CHILLS (shivering), PYREXIA (high temperature) and FATIGUE (exhaustion) was resolving and RASH (Rash) and LYMPHADENOPATHY (Swollen glands) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Aug-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment was reported.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected.


VAERS ID: 1671686 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLENIL MODULITE; SALBUTAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)); Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210710; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101111442

Write-up: Nausea; Pain in arm; Dizzy spells; This is a solilcited report from the Vaccine Monitor program from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-YCVM-202108231304068880-G1Y1O, Safety Report Unique Identifier GB-MHRA-ADR 25846466. The 17-year-old (non-pregnant; LMP: 29Jul2021 as reported) female patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: FF3319) via an unspecified route of administration on 23Aug2021 as dose 1, single for covid-19 immunisation. The medical history included suspected covid-19 from 07Jul2021 to 14Jul2021 (not ongoing), steroid therapy. Taking regular steroid treatment (e.g. orally or rectally), asthma. The concomitant medication(s) included beclometasone dipropionate (clenil modulite) taken for asthma from 05Jun2017, salbutamol (salbutamol) taken for asthma from 12Mar2012. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. On 23Aug2021, the patient experienced nausea, pain in arm, dizzy spells. The reporter assessment of the causal relationship of the [nausea, pain in arm and dizzy spells] with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 10Jul2021 Yes - Positive COVID-19 test. The outcome of the event nausea and dizzy spells was recovered on 25Aug2021, pain in arm was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1671919 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004734 / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Flushing, Oropharyngeal discomfort, Oxygen saturation, Respiratory disorder
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Hypersensitivity (narrow), Respiratory failure (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: 20210823; Test Name: oxygen saturation; Result Unstructured Data: 92%; Test Date: 20210823; Test Name: oxygen saturation; Result Unstructured Data: 97% or higher in air; Test Date: 20210823; Test Name: blood pressure; Result Unstructured Data: remained at the level of 100s to 120s.
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Anaphylaxis; respiratory discomfort; strange sensation of pharynx; Flushed face; This case was received via Pharmaceuticals (Reference number: 2021TJP083109) on 24-Aug-2021 and was forwarded to Moderna on 03-Sep-2021. This case, initially reported to the Devices Agency (DA) by a physician, was received via the DA (Ref, v21124482). On an unknown date, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before the vaccination: 36.6 degrees Celsius. On 23-Aug-2021, at 13:39, the patient received the 2nd dose of this vaccine. At 13:41, respiratory discomfort and strange sensation of pharynx developed. Flushed face and decrease in SPO2 (92%) were also noted, and anaphylaxis was suspected. At 13:45, adrenaline 0.3 mL was administered. Peripheral route was secured, and saline 500 mL was administered. BP remained at the level of 100s to 120s, and SPO2 increased to 97% or higher in air. Although symptoms improved, the patient was raced to a hospital with referral. The outcome of anaphylaxis was reported as resolving. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Anaphylactic reaction developed after the vaccination. Symptoms improved after adrenaline was administered. The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1672092 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-23
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210904333

Write-up: Syncope; This spontaneous report received from a physician via Regulatory Authority (EVHUMAN Vaccines, PT-INFARMED-V202108-3080) on 01-SEP-2021 concerned a 19 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C19-02 expiry: UNKNOWN) 0.5 ml, 1 total, administered on 23-AUG-2021 for covid-19 immunisation. No concomitant medications were reported. On 23-AUG-2021, the patient experienced syncope. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope on 23-AUG-2021. This report was serious (Other Medically Important Condition).


VAERS ID: 1674441 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-23
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Gait inability, Headache, Muscular weakness, Seizure, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LEXAMIL; MARVELON; VITAFORCE
Current Illness: Abstains from alcohol; Non-smoker; Runny nose
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Comments: The patient mother had an allergy to mango and brother had an allergy to brufen .The patient did not have any illness at the time of vaccination. The patient did not received any herbal/traditional medicines. The patient did not have past history of similar event. The patient did not have adverse event after any previous vaccination. The patient did not have any pre-existing acute illness 30 days prior to vaccination. The patient did not have history of hospitalization in last 30 days, with cause. The patient did not have any pre-existing acute illness 30 days prior to vaccination. The patient had Soya infant formula as an infant.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAJNJFOC20210855918

Write-up: AFEBRILE SEIZURE; SYNCOPE; DIZZY; UNABLE TO WALK; LOWER LIMBS WEAKNESS; VOMITING; DULL HEADACHE; This spontaneous report received from a health care professional via a Regulatory authority concerned a 24-year-old female. The patient''s height, and weight were not reported. The patient''s past medical history included: covid-19, and concurrent conditions included: non-smoker, non-drinker, and runny nose, and other pre-existing medical conditions included the patient''s mother had an allergy to mango and brother had an allergy to brufen. The patient did not have any illness at the time of vaccination. The patient did not receive any herbal/traditional medicines. The patient was previously treated with Melodene (ethinylestradiol/gestodene), and Triadene (ethinylestradiol/gestodene). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE426 and expiry: Unknown) dose was not reported,1 total, administered on 23-Aug-2021 10:23, for prophylactic vaccination. Concomitant medications included ascorbic acid/betacarotene/tocopheryl acetate, desogestrel/ethinylestradiol, and escitalopram oxalate. On 23-Aug-2021 19:45, the patient experienced dull headache which started to worsen, became dizzy at 20:00. The patient rested her head on the back of the chair. The patient had no loss of bladder control. As per her family she experienced afebrile seizure for 10 second and was assisted to the floor with loss of consciousness for 10 second, vomited and was unable to walk because of lower limbs weakness and was transported via ambulance to Hospital and was hospitalized. The patient was hospitalized for unspecified days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dull headache, dizzy, afebrile seizure, vomiting, lower limbs weakness, syncope and unable to walk was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0:20210855918-Covid-19 vaccine ad26.cov2.s-Afebrile seizure, syncope, Dizzy , Unable to walk. 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). V0:20210855918-Covid-19 vaccine ad26.cov2.s-Lower limbs weakness, Vomiting , Dull headache. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1674450 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4421 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute pulmonary oedema, Dyspnoea, Feeling hot, Syncope, Thirst
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (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:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202101099946

Write-up: Severe shortness breath; Acute Pulmonary edema; Collapsed; Feeling hot; Thirsty; This is a spontaneous report from a contactable other HCP. A 53-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 23Aug2021 08:50 (Batch/Lot Number: FE4421; Expiration Date: 30Nov2021) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included diabetes mellitus on medication. The patient''s concomitant medications were not reported. The patient previous took first dose of BNT162B2 on an unspecified date for COVID-19 immunizaton. On 23Aug2021 at 08:58, the patient experienced severe shortness breath, acute pulmonary edema, collapsed, feeling hot and thirsty. The patient was hospitalized on 24Aug2021 due to severe shortness breath, acute pulmonary edema and collapsed. The event severe shortness breath was classified as life threatening. The outcome of events was recovering.; Sender''s Comments: Based on strong temporal relationship, a possible causal association between the event Dyspnoea, Acute pulmonary oedema , Syncope and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1675524 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-23
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Arrhythmia, Body temperature, Influenza, Oropharyngeal pain, Pyrexia, Rhinitis, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), 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: Test Name: fever; Result Unstructured Data: Test Result:37 Centigrade
CDC Split Type: BRPFIZER INC202101089674

Write-up: coryza in nose and throat; he had a 37 degrees fever; pain in his arm (at the vaccination site); he was worried; pain in his throat; He felt two episodes of arrhythmia (heart very accelerated as if he had run); today he started to present flu symptoms; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (COMIRNATY) on 12Aug2021 in arm at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient informed that he was vaccinated on 12Aug2021 and today he started to present flu symptoms (23Aug2021). He informed that his father and mother are coming off a flu. He informed coryza in nose and throat and he had a 37 degrees fever. He felt two episodes of arrhythmia (heart very accelerated as if he had run - he felt two episodes of arrhythmia on the ninth day after the vaccination and then no more). He also reported pain in his arm (at the vaccination site). He questioned if these reactions could be related to the vaccination. He informed that he has read that heart-related reactions could occur from 7 days after the vaccination and for this reason, he was worried. Patient questioned if he could take medications to treat this pain in his throat. Because it could be a virus. Medication such as azithromycin. The outcome of the events was unknown. The lot number for BNT162B2 was not provided and will be requested during follow up.


VAERS ID: 1676226 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-23
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pneumonia, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: FYBOGEL; MEBEVERINE HYDROCHLORIDE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Pulmonary embolism; Pneumonia; This case was received regulatory authority(Reference number: GB-MHRA-ADR 25855549) on 27-Aug-2021 and was forwarded to Moderna on 27-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) and PNEUMONIA (Pneumonia) in a 29-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 immunisation. Concomitant products included PLANTAGO OVATA (FYBOGEL) and MEBEVERINE HYDROCHLORIDE for Ill-defined disorder. On 03-Aug-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant) and PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) and PNEUMONIA (Pneumonia) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication details was reported. Company Comment: Very limited information regarding this event has been provided at this time. Further information is not expected.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information is not expected.


VAERS ID: 1676511 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Thrush
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: This case was received via MHRA on 29-Aug-2021 and was forwarded to Moderna on 29-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue) and DIZZINESS (Dizziness) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased and Thrush. Previously administered products included for an unreported indication: CANESTEN. Concomitant products included CITALOPRAM for Depression. On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). On 24-Aug-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache) had not resolved and FATIGUE (Fatigue) and DIZZINESS (Dizziness) 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. Treatment details were not provided. Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1676517 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-08-23
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: bleeding; Vaginal bleeding; This case was received via Regulatory Authority(Reference number: GB-MHRA-ADR 25864273) on 29-Aug-2021 and was forwarded to Moderna on 29-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HAEMORRHAGE (bleeding) and VAGINAL HAEMORRHAGE (Vaginal bleeding) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased and Lactation decreased. On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding) (seriousness criterion medically significant). On an unknown date, the patient experienced HAEMORRHAGE (bleeding) (seriousness criterion medically significant). At the time of the report, HAEMORRHAGE (bleeding) was resolving and VAGINAL HAEMORRHAGE (Vaginal bleeding) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. It was reported that this was her first period since having the COVID-19 vaccine and bleeding was extremely heavy and excessive lading 7 days. One week later, bleeding started again but not as heavy as first, but still heavy. Patient had not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Treatment information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness of the events are based on the Regulatory Report received. As per medical judgement the events for this case are non-serious. As this a RA, reported events seriousness is kept as per RA assessment.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness of the events are based on the Regulatory Report received. As per medical judgement the events for this case are non-serious. As this a RA, reported events seriousness is kept as per RA assessment.


VAERS ID: 1676540 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Headache, Maternal exposure during pregnancy, Pain
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (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: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: This case was initially received via on 24-Aug-2021. The most recent information was received on 31-Aug-2021 and was forwarded to Moderna on 31-Aug-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Pregnancy adverse effects details: Miscarriage) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included FOLIC ACID for Folic acid supplementation and Folic acid supplementation. On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. The patient''s last menstrual period was on 06-Jul-2021 and the estimated date of delivery was 12-Apr-2022. On 23-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), PAIN (Pain) and HEADACHE (Headache). On an unknown date, the patient experienced ABORTION SPONTANEOUS (Pregnancy adverse effects details: Miscarriage) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna CoviD-19 Vaccine) beginning around the seventh week of the pregnancy. The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 23-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, ABORTION SPONTANEOUS (Pregnancy adverse effects details: Miscarriage) outcome was unknown and PAIN (Pain) and HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information is not provided. Patient does think vaccination had an adverse effect on the pregnancy Company Comment: This is a case of product exposure during pregnancy with an associated adverse event of abortion spontaneous, headache and pain in the mother. Based on temporal association a causal relationship cannot be excluded Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Significant follow-up received on 31-Aug-2021- Pregnancy outcome Miscarriage Dose details were added; Sender''s Comments: This is a case of product exposure during pregnancy with an associated adverse event of abortion spontaneous, headache and pain in the mother. Based on temporal association a causal relationship cannot be excluded


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