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From the 1/21/2022 release of VAERS data:

Found 1,049,249 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

This is page 104 out of 10,493

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VAERS ID: 2035552 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-09-13
Onset:2021-12-31
   Days after vaccination:109
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / IM

Administered by: Private       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: This patient was admitted to the Hospital on 12/31/2021 for COVID related symptoms. This is considered a breakthrough case.


VAERS ID: 2035584 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: New York  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 028K21A / 3 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Affective disorder, Anxiety, Dermatitis contact, Diarrhoea, Sensitive skin, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Psychosis and psychotic disorders (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations: Initial series of COVID vaccine, Dec 2020 & Jan 2021
Other Medications: Hydroxyzine (PRN) for anxiety. Prescribed after ''anxiety attacks'' that began after first COVID vaccine dose.
Current Illness: None, other than stated above.
Preexisting Conditions: None. Patient exercises regularly, has balanced diet, and healthy social habits.
Allergies: DKA.
Diagnostic Lab Data: None. Awaiting appointment from PCP.
CDC Split Type:

Write-up: Since 3rd COVID dose (booster) 2 weeks ago patient has had anxiety, mood disturbances, anxiety attacks, visual disturbances, frequent diarrhea, hypersensitive skin/contact dermatitis (treated with Prednisone). Patient is healthy and has no history of these episodes prior to COVID vaccine, which was administered Dec-Jan of 2020-2021.


VAERS ID: 2035680 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-12-19
Onset:2021-12-31
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Bell's palsy
SMQs:, Hearing impairment (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: Paxil prn ibuprofen, acetaminophen, epi pen
Current Illness: none
Preexisting Conditions: arthritis
Allergies: bee venom amoxicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: after booster shot, patient was diagnosed with Bell''s Palsy


VAERS ID: 2035748 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-06-16
Onset:2021-12-31
   Days after vaccination:198
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal X-ray, Acute kidney injury, Acute respiratory failure, Basal ganglia haemorrhage, Blood culture positive, Bronchial secretion retention, COVID-19, COVID-19 pneumonia, Cardiac arrest, Cerebral mass effect, Condition aggravated, Dialysis, Echocardiogram, Echocardiogram abnormal, Ejection fraction decreased, Enterobacter bacteraemia, Enterobacter test positive, Essential hypertension, Haemoglobin decreased, Hyperhidrosis, Hypervolaemia, Intensive care, Mechanical ventilation, Nausea, Normocytic anaemia, Pulseless electrical activity, Pyrexia, Renal impairment, Renal tubular necrosis, Respiratory failure, Respiratory rate increased, Resuscitation, SARS-CoV-2 test positive, Sepsis, Septic shock, Speech disorder, Sputum culture positive, Stress cardiomyopathy, Thrombocytopenia, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Other ischaemic heart disease (narrow), Renovascular disorders (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), 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, 15 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Encephalopathy PEG tube placement Craniotomy Midline shift of brain Basal ganglia hemorrhage Coma Acute respiratory failure Seizure
Allergies: LACTOSE
Diagnostic Lab Data: ASSESSMENT & PLAN: The patient is a 55 y.o. male with history of recent large non-traumatic L basal ganglia stroke (10/14-11/8) s/p emergent craniotomy and EVD placement, tracheostomy and PEG admitted from skilled nursing care facility LTACH with septic shock and acute on chronic hypoxic respiratory failure requiring ventilator support (preveously capped on trach), pressors and stress dose steroids. Found to have enterobacter bacteremia and COVID +. Hospital course c/b ATN from sepsis requiring HD with 2 episodes of PEA arrest 2/2 mucus plugging. # Acute on chronic respiratory failure, improved # Severe sepsis with shock, resolved # COVID-19 positive # Enterobacter bacteremia and PNA See summary above. BC from 12/31 and sputum 1/7 + for enterobacter, subsequent BC with NG. Received 10 course of meropenem, stress dose steroids and pressor support - now improved. Transferred out of ICU on 1/6. Unclear if COVID PNA contributing. Appears to have been continued on IV steroids and ABX longer than planned per notes so will discontinued on 1/11. - S/P IV ABX on x 10 days and S/P steroids x 12 days (discontinued 01/11) # PEA Arrest x2 due to mucous plugging # Pt removed tracheostomy tube PEA arrest on 1/7/2022 and 1/10/2022. ROSC followed brief CPR including epinephrine. S/p bronc by pulmonary on 1/10, right lung mucous plugs suctioned/removed. On 01/11, patient pulled out his tracheostomy tube, replaced at bedside with pulmonology. - continue restraints - continue PRN suctioning - continue robinul q6H - receiving humidified air by trach dome per RT - continue frequent suctioning and 3% NS nebs QID # AKI/ATN Patient had ATN from sepsis, renal function worsened with PEA/arrest, seen by nephrology, currently on dialysis, receiving MWF. -Nephrology following - HD per Nephrology - monitoring for renal recovery, will likely need to continue at discharge to LTACH # Normocytic anemia Hgb wavering around 7. Dips down during dialysis mornings, likely due to hypervolemia and improves $g7 afterwards. No signs or symptoms of bleed. - add on iron studies - if persistently < 7, will transfuse # Nausea and vomiting, resolved Episode of vomiting 1/12 and 1/13 after receiving AM meds through PEG. TF held; abdominal XR unrevealing. - continue to monitor; zofran PRN # Stress-induced cardiomyopathy Echo from 12/31 concerning for possible stress cardiomyopathy. Repeat TTE (1/7) with mildly improved EF 35 to 45% (versus 30 to 35%) - cardiology signed off - continue carvedilol, hydralazine and isosorbide dinitrate # Essential HTN -Continue carvedilol. Started on hydralazine + isosorbide dinitrate and d/c amlodipine at discharge. # Thrombocytopenia, resolved -Likely related to acute illness # History of basal ganglia hemorrhage -PTA Dilantin and Keppra resumed at renally adjusted doses #DVT prophylaxis: On Heparin sub Q #CODE STATUS: Full Discharge plan: Likely 1/15 if patient continues to be stable to LTACH if skilled nursing facility can accept admissions over the weekend.
CDC Split Type:

Write-up: The patient is a 55 y.o. male who presents to the emergency department via EMS for evaluation of septic shock. The patient arrives from skilled nursing care facility into Stabilization Room 3. The patient was admitted to skilled nursing care facility for a basal ganglia hemorrhage with shift and full code. Today the patient was noted to have a fever that spiked to 103 with increased respiratory rate and suspected septic shock. Per EMS, the patient was diaphoretic and vented upon arrival. Facility noted pressures in the 100''s, but EMS got a pressure of 68. The patient is typically nonverbal, but was noted to be decreased from baseline. He was started on Vancomycin and Zosyn before transfer.


VAERS ID: 2036067 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-05-20
Onset:2021-12-31
   Days after vaccination:225
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis, Computerised tomogram head abnormal, Magnetic resonance imaging
SMQs:, Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow)

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, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Fluoxetine SPIRACTIN Cryselle Fabior Foam Clindamycin
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: CT scan Cerebral venous sinus thrombosis MRI
CDC Split Type:

Write-up: Blood clots in the brain sinus veins


VAERS ID: 2036088 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 032H21A / 3 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Activated partial thromboplastin time normal, Alanine aminotransferase increased, Arthralgia, Aspartate aminotransferase increased, Blood fibrinogen normal, Burning sensation, C-reactive protein increased, Chest X-ray normal, Chest discomfort, Chest pain, Chills, Computerised tomogram thorax normal, Diarrhoea, Differential white blood cell count normal, Dyspnoea, Fatigue, Fibrin D dimer increased, Full blood count normal, Headache, Hepatitis A antibody, Hepatitis B test negative, Hepatitis C antibody negative, Hypoaesthesia, International normalised ratio normal, Metabolic function test, Night sweats, Pain, Pain in extremity, Paraesthesia, Petechiae, Prothrombin time normal, Rash, Red blood cell sedimentation rate normal, SARS-CoV-2 test negative, Troponin I normal, Urine analysis normal
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Waldenstrom Macroglobulinemia Malignant Lymphoplasmacytic Lymphoma (in remission)
Allergies: None
Diagnostic Lab Data: 1/10/22 - negative COVID-19 nasopharyngeal PCR swab 1/13/22 - mildly elevated D-dimer, f/u CT chest PE protocol negative. ALT 111, AST 77 (baseline 28/19 2 weeks prior). CRP 1.04. Otherwise normal labs including CBC w/diff, CMP, UA, troponin-I, ESR, aPTT, PT-INR, fibrinogen, Hep B sAg, HCV Ab, Hep A IgM. Chest x-ray WNL.
CDC Split Type:

Write-up: 12/31/21 thru 1/1/22 had body aches and headache, which resolved. Starting on 1/8/22 he began having shortness of breath, body aches, fatigue, chest pressure over sternum, constant headache, pain in left thorax and left medial/upper arm that moved around and described as a deep ache. As a result of these symptoms on 1/10/22 had a COVID-19 PCR test, which was negative. He also developed petechial rash on thighs and fingers that did not itch. His fingers and toes developed a tingling/numbness/burning sensation. He did not have any fever but he did have some chills and night sweats. No cough, sore throat, runny nose. Did have a single mildly loose stool, but no diarrhea, nausea, vomiting. No urinary symptoms. Left shoulder pain, hurts to raise arm. Chest pressure has been constant for past 6 days.


VAERS ID: 2037640 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-06-21
Onset:2021-12-31
   Days after vaccination:193
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6203 / 2 LA / -

Administered by: Work       Purchased by: ?
Symptoms: COVID-19, Cough, Nasal congestion, Oropharyngeal pain, Pyrexia, Rhinorrhoea, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), 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: Medical History/Concurrent Conditions: Cancer
Allergies:
Diagnostic Lab Data: Test Date: 20211231; Test Name: Nasal Swab; Test Result: Positive ; Comments: Covid test after post vaccination: Home kit.
CDC Split Type: USPFIZER INC202200018259

Write-up: Tested positive for covid; Tested positive for covid; congestion; fever; sore throat; occasional cough; running nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient. A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jun2021 (Lot number: EN6203) at the age of 46 years as DOSE 2, SINGLE and administered in arm left, administration date 21May2021 (Lot number: EL3247) as DOSE 1, SINGLE for covid-19 immunisation. Relevant medical history included: "Cancer" (unspecified if ongoing). The patient had no allergies. The patient had no other vaccines within 4 weeks. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31Dec2021, outcome "recovering" and all described as "Tested positive for covid"; NASAL CONGESTION (non-serious) with onset 31Dec2021, outcome "recovering", described as "congestion"; PYREXIA (non-serious) with onset 31Dec2021, outcome "recovering", described as "fever"; OROPHARYNGEAL PAIN (non-serious) with onset 31Dec2021, outcome "recovering", described as "sore throat"; COUGH (non-serious) with onset 31Dec2021, outcome "recovering", described as "occasional cough"; RHINORRHOEA (non-serious) with onset 31Dec2021, outcome "recovering", described as "running nose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) positive, notes: Covid test after post vaccination: Home kit. Therapeutic measures were not taken as a result of vaccination failure, covid-19, nasal congestion, pyrexia, oropharyngeal pain, cough, rhinorrhoea. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2037781 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: New York  
Vaccinated:2021-12-22
Onset:2021-12-31
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dermatitis, Erythema, Mechanical urticaria, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: None
Preexisting Conditions: N/A
Allergies: No known allergies
Diagnostic Lab Data: Dermatologist confirmed source of hives is internal and confirmed dermatographia. Advised of Moderna booster shot, but was unable to confirm that as cause. There were no changes to environment, diet, or household product use. Only change was getting COVID booster.
CDC Split Type:

Write-up: Approximately 10 days after shot, I experienced an intense itch on my scalp and the palm of my hands. Scratching resulted in new, raised hives with red, inflamed lines where I scratched. Made appointment with dermatologist after a week of increased hive symptoms with no improvement using over-the-counter antihistamines.


VAERS ID: 2037796 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Alabama  
Vaccinated:2021-12-27
Onset:2021-12-31
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3594 / 1 UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Condition aggravated, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Alive multivitamin, protein shakes, Mega-men''s multivitamin
Current Illness:
Preexisting Conditions: HTN, DM Type 2
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient had worsening of lower extremity edema 4-5 days after his vaccine administration.


VAERS ID: 2037821 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8727 / 1 AR / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0164 / 2 AR / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL3197 / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain upper, Angina pectoris, Dyspnoea, Flatulence, Heart rate abnormal, Heart rate increased, Palpitations
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Dehydration (broad)

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

Write-up: About 18-20 hours after receiving the booster (3rd shot in the series), I had an elevated heart rate between 120-130bpm which is abnormal for just waking up in bed. My resting heart rate will range from 55-75 bpm. Throughout the next two days I felt my heart pumping much harder and faster than ever before, almost feeling like my heart was aching/sore from abnormal activity. I had periods where I felt shortness of breath and some difficulty breathing (heavy breathing). Subsequently, I also experienced stomach pains plus abnormal passing of gas frequently. The stomach pains continue two weeks later and counting, though this may not be directly tied to the booster shot.


VAERS ID: 2037884 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Kansas  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 058H21A / 3 LA / IM

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

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

Write-up: Patient presented to the pharmacy to receive their Covid-19 Moderna booster vaccine, and communicated they had received their second dose on 8/13/21 on their consent form. At the time of their booster dose, it had been just over 4 months since they received their second dose. Staff didn''t communicate to the patient that they needed to wait until 6 months after their second dose to receive their booster dose, and the booster dose was administered. No known side effects have been observed.


VAERS ID: 2038207 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-05-12
Onset:2021-12-31
   Days after vaccination:233
Submitted: 0000-00-00
Entered: 2022-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017B21A / 1 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017B21A / 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: 2039107 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-01
Onset:2021-12-31
   Days after vaccination:274
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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: OCREVUS
Current Illness: Multiple sclerosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20224

Write-up: Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. Concurrent medical conditions included Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Dec-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) was resolving. Not Provided No treatment information was provided. Company Comment: This spontaneous case concerns a 31-year-old, female patient with relevant medical history of administration of Ocrevus (ocrelizumab), who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 1 month after administration of the third dose of the Moderna mRNA-1273 vaccine. No further details were provided. Treatment information was also not provided. However, the event was resolving at the time of the report. The medical history of administration of Ocrevus, which is an immunosuppressive drug used for the treatment of Multiple Sclerosis, remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This spontaneous case concerns a 31-year-old, female patient with relevant medical history of administration of Ocrevus (ocrelizumab), who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 1 month after administration of the third dose of the Moderna mRNA-1273 vaccine. No further details were provided. Treatment information was also not provided. However, the event was resolving at the time of the report. The medical history of administration of Ocrevus, which is an immunosuppressive drug used for the treatment of Multiple Sclerosis, remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2039503 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2021-12-17
Onset:2021-12-31
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19, Chest X-ray normal, Respiratory tract congestion, SARS-CoV-2 test negative, SARS-CoV-2 test positive, Sinus congestion
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: Metformin, Tamsulosin, Jardiance, Atorvastatin, Tylenol
Current Illness: None
Preexisting Conditions: Diabetes
Allergies: None
Diagnostic Lab Data: 2 Covid tests- one negative, one positive Chest x-rays- clear
CDC Split Type: vsafe

Write-up: I thought I was having a sinus infection. I had congestion in my head and chest. I took a Covid test the day before new years and it was negative. On new years, a friend of mine said some friends tested positive for Covid. Then, the Tuesday after new years I got tested again and it was positive. They also did a chest x-ray to see if I had pneumonia, but I did not. I am getting better but I still have some congestion.


VAERS ID: 2039592 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-26
Onset:2021-12-31
   Days after vaccination:127
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / UNK LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, COVID-19, Hypophagia, Loss of personal independence in daily activities, Malaise, SARS-CoV-2 test positive
SMQs:, Dementia (broad), Guillain-Barre 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: Pt arrives via ems from home. His son (caregiver) has been sick with covid for two weeks and has been away from home. Since his son hasn''t been able to care for him the Patient states that he feels like he can no longer care for himself. Increasingly weak. This is a 87 yo male who presented to the ED with c/o of generalized weakness, decreased PO intake. He has a PMHx as listed. Apparently his son tested positive for COVID about 10-14 days ago, typically his son lives with him and cares for him but he has been staying elsewhere while he recovers. Since his son has been out he has not really been able to care for himself as well. Over the last 5 days has had progressive weakness, decreased PO intake, increased PO intake. Still in hospital on 01/17/2022 in COVID Stepdown unit.


VAERS ID: 2039656 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Hawaii  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 059HZ1A / 3 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Bone disorder, Bone pain, Bowel movement irregularity, Chills, Condition aggravated, Dyspepsia, Erythema, Fatigue, Feeding disorder, Feeling of body temperature change, Gait disturbance, Grip strength decreased, Headache, Hyperhidrosis, Inflammation, Pain, Pain in extremity, Pallor, Raynaud's phenomenon
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Arthritis (broad), Noninfectious diarrhoea (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), 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? No
Previous Vaccinations: 4/21/21, 37, Moderna injection, Very sore left arm, whole body sore, extreme fatigue 3/24/21, 37, Moderna injection, really sore
Other Medications: Q Max - Daily multi vitamin, Q Align - (cur cumin extract, Ginger Root extract, boswellia extract, papaya enzyme, black pepper extract), Q Biotics - pre and probiotics
Current Illness: no illness
Preexisting Conditions: Kidney stones, IBS, Acid Reflux, IT band syndrome from Hip surgery in June 2021, general inflammation, dizziness, fatigue, headaches, ocular migraines, glaucoma suspect (large veins in eyes, doc thinks I was born this way), Varicose veins in just the calves, may have Elhers Danlos Syndrome (I''m being referred to a geneticist from my PCP), Raynaulds
Allergies: Amoxicillin, cyndimicin, zithromicin, sulfa, and gluten intolerance
Diagnostic Lab Data: none were done
CDC Split Type:

Write-up: Splitting headaches, chills, all over body pain, extreme fatigue, sharp bone pains, couldn''t eat or have a bowel movement for 4 days, bad heartburn, inflammation, hard to hold anything (joints and bones in hands/feet were very sore), sweating, felt very hot at one point but my husband said my body was ice cold, complexion was super pale. All of this was in a course of 4 days. Now I am just really inflamed and having major joint pains, last Tuesday my femur felt like it was going to pop out of my right knee and was limping that evening. The following morning it was ok. I am going to PT twice a week. My physical therapist and my chiropractor think that my connective tissue disorder and the inflammation is causing me to still have issues with my joints and my Raynaulds. Last Friday (1/14/22) my raynaulds was really painful and red on the left hand''s pinky and ring finger. Its never painful and usually its white when it happens.


VAERS ID: 2039893 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-02-18
Onset:2021-12-31
   Days after vaccination:316
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Polymerase chain reaction
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? Yes, 17 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: APAP, metoprolol tartrate, mirtazapine
Current Illness: arthritis, hearing loss, cataract, HTN, osteoporosis, tremor
Preexisting Conditions: arthritis, hearing loss, cataract, HTN, osteoporosis, tremor
Allergies:
Diagnostic Lab Data: Cycle threshold: 11.5
CDC Split Type:

Write-up: COVID 19 infection requiring hospitalization


VAERS ID: 2040001 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: California  
Vaccinated:2021-10-06
Onset:2021-12-31
   Days after vaccination:86
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 058F21A / 3 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain, Biopsy, Chills, Headache, Incorrect dose administered, Nausea, Postmenopausal haemorrhage, Vaginal haemorrhage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (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: Estradiol Vaginal cream, Cyclobenzaprine 5mg Nexium 40mg, Azelastine Nasal Spray Flonase Nasal spray, Flovent Indapamide 1.25, Losartan 50mg morning-25mg evening Questran Powder, Magnesium Oxide tablet Xiidra eye drops, Diltiazem, Vitamin
Current Illness:
Preexisting Conditions: Hypertension, Rheumatoid Arthritis
Allergies: Keflex, Clindamycin, Flagel Seasonal Allergies
Diagnostic Lab Data: Dose 1: 042L20A, 01/22/2021 Dose 2: 042L20A, 02/20/2021 ER:12/31/2022 and 01/04/2022
CDC Split Type: vsafe

Write-up: I experienced abdominal pain and vaginal bleeding after receiving the third dose of my vaccine. I got a full dose of Moderna, for my third dose. The next day I felt like I was hit with a truck. I had chills, nausea and headache. I felt better 24 hours later. I had not not had any of those symptoms with the first two doses. It started on 2/31/2021 with the abdominal pain. I went to the ER and 1/4/2022 I started to gush Vaginal blood three days later and the pain improved. I went back to the ER because I was bleeding so much. It has been 20 years since my last Menstrual cycle. I have seen a Gynecologist and they are investigating. I am waiting on Biopsy results. I had to get an iron infusion after that. The bleeding slowed over a period of 10 days and now I am just spotting.


VAERS ID: 2040204 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-11-24
Onset:2021-12-31
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Polymerase chain reaction
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: albuterol, amlodipine, apixaban, atorvastatin, isosorbide mononitrate, losartan, metformin, metoprolol succinate, nitroglycerin, ondansetron, pantoprazole, prochlorperazine, tiotropium ACTIVE CHEMOTHERAPY
Current Illness: HTN, HLD, CHFpEF, COPD, Lung cancer, T2DM, CAD, Paroxysmal atrial fibrillation
Preexisting Conditions: Hx of prostate cancer, HTN, HLD, CHFpEF, COPD, Lung cancer, T2DM, CAD, Paroxysmal atrial fibrillation
Allergies:
Diagnostic Lab Data: Cycle threshold: 23.3
CDC Split Type:

Write-up: COVID-19 infection requiring hospitalization


VAERS ID: 2040456 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2020-12-23
Onset:2021-12-31
   Days after vaccination:373
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK5730 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0142 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Cough, Diarrhoea, Dysphonia, Fatigue, Headache, Hypogeusia, Hyposmia, Insomnia, Nausea, Oropharyngeal pain, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: 1-13-21 Pfizer/biotech Covid 19 vaccine
Other Medications: Imvexxy Actively Restasis
Current Illness: None
Preexisting Conditions: None
Allergies: Asa Pcn Nsaids
Diagnostic Lab Data: Covid test
CDC Split Type:

Write-up: Covid 12-31-2021 Sore throat, cough,congestion,headache,nausea,diarrhea,fever,fatigue,insomnia,diminished taste and smell, hoarseness


VAERS ID: 2040482 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-12-29
Onset:2021-12-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Muscle disorder, Muscle spasms, Muscle twitching
SMQs:, Rhabdomyolysis/myopathy (broad), Dyskinesia (broad), Dystonia (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: nicotinamide
Current Illness: none
Preexisting Conditions: none
Allergies: unknown
Diagnostic Lab Data: I have not yet seen a doctor. Is this something to be concerned about? Will the spasms go away? What is likely going wrong with my health due to this vaccine?
CDC Split Type:

Write-up: Two day after getting the J&J COVID shot I started having muscle spasms. First I had them in my right cheek, then the right side of my neck, then my arms, torso (sides), and legs. Within three days I was having muscle spasms all over my body. Some nights I would wake up due to these spasms. Some spasms were actually twitching muscles and others were a weird electric like buzz running through my muscles. As of today 1/17/22 (20 days after being vaccinated) I still have these muscle spasms. Now they are especially bad in my legs.


VAERS ID: 2040675 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7218 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Burning sensation, Gait disturbance, Headache, Influenza A virus test negative, Influenza B virus test, Lymphadenopathy, Migraine, Movement disorder, Myalgia, Pain, Pain in extremity, SARS-CoV-2 test negative, Sleep disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lexapro 30 mg once daily, Verapamil 180 mg once daily, prenatal once daily
Current Illness: None, possibly bronchitis
Preexisting Conditions: Chronic pain
Allergies: Ultram, bentyl, peppermint
Diagnostic Lab Data: Covid and Influenza A and B testing, both negative
CDC Split Type:

Write-up: I woke up on 12/31/2021 in so much pain I could barely walk or move. Every muscle and joint hurt, I walked like I was 90 years old. My lymph nodes swelled so much I ended up having headaches and migraines. I went to the chiropractor 3 times in less than a week for pain and headaches. My arm burned and hurt for at least two weeks.


VAERS ID: 2042016 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Maryland  
Vaccinated:0000-00-00
Onset:2021-12-31
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: 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: USMODERNATX, INC.MOD20224

Write-up: tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported. She was not hospitalized, she stayed at home. She was fully vaccinated and did not know manufacturer. Company Comment: This case concerns a female patient of an unknown age, with no medical history reported, who experienced the unexpected event of SARS-CoV-2 test positive. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a female patient of an unknown age, with no medical history reported, who experienced the unexpected event of SARS-CoV-2 test positive. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 2042402 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL3198 / 3 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Headache, Immunisation, Insomnia, Pain
SMQs:, Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RESTASIS
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: USPFIZER INC202200004555

Write-up: whole body aches; joint paint; headache; insomnia; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51 year-old female patient (not pregnant) received BNT162b2 (BNT162B2), administered in arm right, administration date 31Dec2021 13:00 (Lot number: FL3198) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: RESTASIS. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 23Feb2021, when the patient was 50 years old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 16Mar2021, when the patient was 50 years old, for COVID-19 immunization, reaction(s): "mild body ache", "joint pain", "fatigue". The following information was reported: IMMUNISATION (non-serious) with onset 31Dec2021 13:00, outcome "unknown", described as "booster"; PAIN (non-serious) with onset 01Jan2022 02:00, outcome "recovering", described as "whole body aches"; ARTHRALGIA (non-serious) with onset 01Jan2022 02:00, outcome "recovering", described as "joint paint"; HEADACHE (non-serious) with onset 01Jan2022 02:00, outcome "recovering", described as "headache"; INSOMNIA (non-serious) with onset 01Jan2022 02:00, outcome "recovering", described as "insomnia". Therapeutic measures were not taken as a result of pain, arthralgia, headache, insomnia. Additional Information: The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient was not diagnosed with Covid-19 prior to vaccination. The patient has not been tested for Covid-19 since the vaccination. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2042403 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 33130BA / 3 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Immunisation, Myalgia, Pyrexia, Vaccination site pain
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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202200004560

Write-up: Low grade fever; chills; muscle aches; soreness in arm of injection site; fatigue; headache; Dose number: 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 31Dec2021 09:00 (Lot number: 33130BA) at the age of 28 years as dose 3 (booster) , single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0170, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 01May2021, when the patient was 27 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0151, Location of injection: Arm Right), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 31Dec2021 09:00, outcome "unknown", described as "Dose number: 3"; PYREXIA (non-serious) with onset 31Dec2021 22:30, outcome "recovered", described as "Low grade fever"; CHILLS (non-serious) with onset 31Dec2021 22:30, outcome "recovered", described as "chills"; MYALGIA (non-serious) with onset 31Dec2021 22:30, outcome "recovered", described as "muscle aches"; VACCINATION SITE PAIN (non-serious) with onset 31Dec2021 22:30, outcome "recovered", described as "soreness in arm of injection site"; FATIGUE (non-serious) with onset 31Dec2021 22:30, outcome "recovered", described as "fatigue"; HEADACHE (non-serious) with onset 31Dec2021 22:30, outcome "recovered", described as "headache". Therapeutic measures were not taken as a result of pyrexia, chills, myalgia, vaccination site pain, fatigue, headache. Additional information The patient was diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2042996 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-04-12
Onset:2021-12-31
   Days after vaccination:263
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0162 / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory failure, Asthenia, Back pain, Blood albumin, COVID-19, COVID-19 pneumonia, Computerised tomogram head normal, Computerised tomogram thorax abnormal, Condition aggravated, Confusional state, Dementia, Dyspnoea, Fall, Hypoalbuminaemia, Hypotension, Laboratory test abnormal, Lung consolidation, Lung infiltration, Pleural effusion, Pneumonia bacterial, Pneumonia streptococcal, Procalcitonin increased, SARS-CoV-2 test positive, Sepsis, Toxic encephalopathy, Urinary tract infection
SMQs:, Liver related investigations, signs and symptoms (broad), Anaphylactic reaction (narrow), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 64-year-old female with a prior medical history of multiple sclerosis, generalized anxiety disorder, mild cognitive disorder secondary to MS
Allergies: Amoxicillin, Azithromycin, Norco [hydrocodone-acetaminophen], and Penicillins
Diagnostic Lab Data: COVID POSITIVE 12/31/2021
CDC Split Type:

Write-up: HOSPITAL COURSE: Briefly, this is a 64-year-old female with multiple sclerosis, who was admitted on 1/8/2022, for worsening confusion and weakness in setting of COVID and bacterial PNA. Treating acute encephalopathy secondary likely toxic/metabolic. For more detail, including PMH, PSH, PFH, Social Hx and further info please see admission H&P. Hospital course dictated by problem: Acute hypoxic respiratory failure due to bacterial PNA Sepsis due to pneumonia, resolved Right lower lobe bacterial streptococcus pneumonia COVID-19 pneumonia Was vaccinated 4/2021, but overdue for booster. COVID positive in clinic, estimated around 12/31. Was seen in clinic then as was having weakness with one fall at home Had COVID treated with monoclonal antibody 1/6/22. Despite this continued to have progressive weakness, confusion and then developed shortness of breath. 1/8 presented to ED with weakness and confusion hypoxia requiring supplemental O2 via NC at 6L. CTPE neg for PE.RLL consolidation. + PCT, Urine St pneumo agn +.Studies c/w bacterial PNA w/ elevated procal, imaging. Per ID felt respiratory issues were not related to COVID PNA, more so bacterial PNA and 2/2 PTA sedative meds (tramadol, etc).- Per ID: her CT shows a lobar infiltrate but not diffuse infiltrates c/w COVID Would stop Decadron and monitor, if she appears to have worsening component of viral PNA (hypoxia, etc) would resume - does not appear her PTA Zeposia is assoc w/ more severe COVID sxs (per ID), ok to cont per neurology Therefore decadron was discontinued. Respiratory status has been stable since stopping decadron. Abx: was on rocephin, doxycycline. Doxy d/c 1/9 as pneumococcal urine Ag positive. Patient was fully treated for her pneumonia with ceftriaxone, stopped at time of discharge. ID signed off. Patient was stable on room air at time of discharge. She was seen by PT who did clear her to return home. Follow-up with PCP in 2 weeks. Needs follow-up imaging within 4 to 6 weeks including to rule out infiltrates also evaluate pleural effusions. Patient understands if she has any recurrent infectious symptoms to return immediately. Discharge plan was discussed in detail with her husband via phone. Good questions were asked and all were answered. Bilateral pleural effusions, hypoalbuminemia CT w/ bilateral pleural effusions - this likely related to hypoalbuminemia - s/p Albumin 12.5 mg q30min x 2 doses as hypotensive, hypoalbuminemic and bilateral effusions. -Consider outpatient chest x-ray in 4 weeks Acute metabolic/toxic encephalopathy -resolved In setting of above. Mild dementia at baseline and w/ MS hx. Bacterial PNA and COVID causing encephalopathy. - Head CT negative for acute intracranial processAlso more susceptible given PTA sedative medications such as tramadol. Tramadol initially held to help. Tramadol was slowly resumed by 1/10 improving. Alert to person and place. Said year 2021 but redirected to recent new year and later recalled accurate year.1/11- sl confusion re earlier events . By day of discharge she appeared to be at her baseline mentation without any obvious confusion. Tramadol had been continued on a slightly lower dose. Advised to continue that at home. PCP can additionally eval Generalized weakness-diffuse generalized weakness likely secondary to COVID-19 with acute worsening also contributed by her baseline MS. PT OT consulted. PT cleared to go back to her home, her husband is able to give her 24/7 supports, although she remains a chronic high fall risk. Multiple sclerosis-chronic-has outpatient neurologist,home dose Zeposia and Baclofen Recently had battery of MRIs and per husband MS considered stable., She was maintained on PTA tramadol. Follow-up - needs to reSchedule w OP Neurologist (was supposed to be on 1/10) History of cognitive impairment secondary to MS Per husband at baseline alert to person, place and time.- Not on any meds. F/u Neurology History of generalized anxiety disorder, chronic benzodiazepine use-patient maintained on PTA Cymbalta Per husband she takes 2 mg of Valium usually every afternoon but little other than that. He asked about dosing and advised if wanted they could decrease to q. OD. She has a as needed Xanax prior to MRI as ordered but does not take that. Further management per psych vs primary care. History of chronic opiate use, chronic low back pain- reports she has chronic low back pain has been on tramadol for a long time, reported as she became more clear that her back pain was increased here, wants her past tramadol resumed, seems Encephalopathy contributing to confusion regarding her reported dose tells me she did not take it daily but just intermittent a few doses a day max when she needed it. Appears PTA she takes 100 a.m./50 p.m./150 PM. That is higher than I would recommend. At time of discharge she seemed to be stable with mild pain on the lower tramadol dose of- 50mg am, 50mg 2pm, 100mg available as prn at bedtime. I recommend continue that for now. charted hx of alc abuse. Recommend follow-up with TC pain clinic re other modalities Hx UTI: 2 weeks ago -$g rx antibiotics without improvement.


VAERS ID: 2043104 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-02-11
Onset:2021-12-31
   Days after vaccination:323
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 015M20A / UNK - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030A21A / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Fatigue, Pelvic pain, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 01/02/2022 SARS-CoV-2 (COVID-19) detected
CDC Split Type:

Write-up: 12/31/21 presents to ED for "worsening fatigue, SOB, and pelvic pain". PMHx of "atrial fibrillation, COPD, Essential hypertension"


VAERS ID: 2043265 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain upper, Biopsy endometrium, Blood follicle stimulating hormone, Blood test, Feeling cold, Headache, Heavy menstrual bleeding, Lymphadenopathy, Postmenopausal haemorrhage, Ultrasound uterus abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: vasotec 10 mg p.o. everyday
Current Illness: na
Preexisting Conditions: High blood pressure
Allergies: nka
Diagnostic Lab Data: 1. bloodwork fsh shown in menopause stage. 2. uterus ultrasound showm 6mm thicken of uterus, which is abnormal. 3. biospy result is pending, need follow up.
CDC Split Type:

Write-up: On 12/30/2021 3pm took covid 19 boost shot(Moderna) at facility, same night felt chill and headache, then left arm axillary and inguinal lymph notes swelling, stomach cramping, then next day noon had periods happen( post menopause for one year and half). prolong , heavy bleeding for 8 days. set appt to see my OB doctor. doctor suggusted to do the following percedure: 1. blood work for checking hormone level 2. ultrsound for abnormal finding 3. endometrial biopsy for further abnormal finding after ultrsound 4. office visit for check uterus size. uterus thicken than normal range per menopause patient.


VAERS ID: 2043462 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3592 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30255588 / 2 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 8757 / 3 LA / IM
UNK: VACCINE NOT SPECIFIED (OTHER) / UNKNOWN MANUFACTURER - / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Condition aggravated, Musculoskeletal discomfort, Oropharyngeal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: Pain throat and neck pressure.
Other Medications: Vitamin D2; Loratadine
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: I am waiting for exams.
CDC Split Type:

Write-up: I feel pain in my throat and pressure in my neck.


VAERS ID: 2043500 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-02-26
Onset:2021-12-31
   Days after vaccination:308
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 010M20A / 1 UN / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 043L20A / 2 UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre 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? Yes, 19 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: amlodipine apixaban Vitamin D3 famotidine ferrous sulfate hydrochlorothiazide latanoprost lisinopril pravastatin sennosides Tamsulosin timolol
Current Illness:
Preexisting Conditions: hypertension Diabetes chronic kidney disease dementia cervical cancer enlarged thyroid dyslipidemia
Allergies: No known allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was hospitalized with generalized weakness and "low grade fever."


VAERS ID: 2043552 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: New York  
Vaccinated:2021-10-25
Onset:2021-12-31
   Days after vaccination:67
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 071F21A / UNK LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Blood test, COVID-19, Chills, Ear pain, Feeding disorder, Headache, Hypersomnia, Lethargy, Nausea, SARS-CoV-2 antibody test, SARS-CoV-2 test negative, Taste disorder, Tremor, Vaccine breakthrough infection
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 1c Metoprolol succ ER 25mg O.D. Magnesium oxide.500 mgm OD 1c Levothyroxine 62.5 mcg O.D. Zinc 50 mgm OD vitamin D 5,000 U Monday- Friday. Hair formula 1 cap BID ASA 81mg OD.
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: I
CDC Split Type:

Write-up: 1st vaccine- 1/14/2021?.. 2nd dose 2/11/2021?. Booster dose. 10/25/2021 I had a breakthrough case from December 31, 2021 thru January 6, 2022 Symptoms: severe headache first night, severe stabbing pain in right ear for four days, lethargic and weak for first three days which I slept day and night. Chills, shaking uncontrollably fir one hour- no fever. Unable to eat due to sleeping and nausea, contacted my PA on day 3 1/2 and was ordered to take, ampicillin 850mgm BID for ten days and a round of steroids for 6 days. I lost 9 pounds in the first four days. My PA sent me to a tent testing site on day 5 and came back negative- I then took a take at home rapid test which also came back negative. When I was able to eat on day 5 my taste was ?weird? ?blueberries tasted like perfume, carrot soup tasted like liquid mashed potatoes but the spice ( ginger) burned my throat and I could not taste the ginger. I had no sore throat during the whole time. It took seven days for my food to taste normal. I went to see my PA on day 12 and because of my symptoms and two negative tests she had me get an IGG titer bloodwork for COVID antibodies?? she called is less than 24 hours to tell me I had had COVID. I had my two initial vaccines and my booster and I am very strict with masks and sanitizers


VAERS ID: 2045409 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: California  
Vaccinated:2021-12-17
Onset:2021-12-31
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 069H21A / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: Client reports numbness in both arms with onset of 1-2 weeks post vaccination, has not resolved since. Denies any other symptoms.


VAERS ID: 2045469 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 33036BD / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Limb injury, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-


VAERS ID: 2045484 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ1611 / UNK RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Joint injury, Limb injury, Pain, Paraesthesia, Product administration error
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Medication errors (narrow)

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

Write-up: Error: Shoulder joint injury (prolonged pain, tingling, etc.).


VAERS ID: 2045489 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Utah  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 003J21-2A / 1 LA / IM

Administered by: Pharmacy       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: Error: Patient Too Young for Vaccine Administered-


VAERS ID: 2045535 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: New York  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 028K21A / 3 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Reaction started day after injection and was more severe initially. Saw provider Dr due to scheduled appointment who characterized the red swolled arm as an adverse reaction. No treatment given at this time.


VAERS ID: 2045796 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: California  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 068H21A / 4 LA / IM

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

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

Write-up: Error: Booster Given Too Early-


VAERS ID: 2046167 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Maryland  
Vaccinated:2021-03-20
Onset:2021-12-31
   Days after vaccination:286
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 042B21A / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211231; Test Name: PCR Test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: USMODERNATX, INC.MOD20224

Write-up: COVID-19 Disease, 6 months after 2nd dose; Positive PCR ,6 months after 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19 Disease, 6 months after 2nd dose) and DRUG INEFFECTIVE (Positive PCR ,6 months after 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 042B21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Dec-2021, the patient experienced COVID-19 (COVID-19 Disease, 6 months after 2nd dose). 31-Dec-2021, the patient experienced DRUG INEFFECTIVE (Positive PCR ,6 months after 2nd dose). At the time of the report, COVID-19 (COVID-19 Disease, 6 months after 2nd dose) and DRUG INEFFECTIVE (Positive PCR ,6 months after 2nd dose) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. Company Comment: This case refers to a male patient of unspecified age with no known medical history who experienced the unexpected events of Drug ineffective and COVID-19 approximately 8 months after the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case refers to a male patient of unspecified age with no known medical history who experienced the unexpected events of Drug ineffective and COVID-19 approximately 8 months after the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2047382 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-05-10
Onset:2021-12-31
   Days after vaccination:235
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Pfizer 4/19/21 and 5/10/21. Positive on 1/18/22


VAERS ID: 2047398 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-12-06
Onset:2021-12-31
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 301308A / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3590 / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Apnoea, Aspiration, COVID-19, Chest X-ray abnormal, Overdose, Resuscitation, SARS-CoV-2 test positive, Unresponsive to stimuli, Vaccine breakthrough infection, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Drug abuse and dependence (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Medication errors (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Polysubstance abuse
Allergies: Keflex, PCN, Sulfadiazine
Diagnostic Lab Data: SARS CoV 2 PCR Covid19- Detected on 12/31/2021
CDC Split Type:

Write-up: Covid19 breakthrough. 1st vaccine received on 11/05/2021 while pt in jail. 40 y/o presents to ED with overdose. Roomates found pt unresponsive and performed CPR. Upon arrival, EMS found pt apneic with pulse and administered mult doses of Narcan on route to hospital. Pt vomited. Room air sat 76% and pt placed on 15 L NRB. CXR consistent with aspiration. Started on IV ABX.


VAERS ID: 2047509 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-12-13
Onset:2021-12-31
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 330308D / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Chest pain, Dyspnoea, Laboratory test, Sluggishness, Surgery
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: cynthyroid
Current Illness: no
Preexisting Conditions: no
Allergies: no
Diagnostic Lab Data: yes
CDC Split Type:

Write-up: Chest pains and difficulty breathing. It became worse and he became extremely weak and sluggish. By Jan 1st wife took him to the ER. On the next day he under went surgery.


VAERS ID: 2047739 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-12-27
Onset:2021-12-31
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Bell's palsy
SMQs:, Hearing impairment (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: bell''s palsy


VAERS ID: 2047749 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: West Virginia  
Vaccinated:2021-07-22
Onset:2021-12-31
   Days after vaccination:162
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blood creatinine abnormal, Blood urea abnormal, COVID-19 pneumonia, Urinary tract infection
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), 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, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient came to ED with abnormal labs (Scr and BUN) and was found to have a UTI and pneumonia due to Covid. Patient admitted to hospital.


VAERS ID: 2047915 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: New York  
Vaccinated:2021-12-29
Onset:2021-12-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 330258D / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fall, Muscle spasms
SMQs:, Dystonia (broad), Accidents and injuries (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: none
Allergies: none
Diagnostic Lab Data: Patient contacted PCP but has not been evaluated physically yet, PCP recommended holding off on second shot for now.
CDC Split Type:

Write-up: 2 days after patient received the vaccine she started having spasms which started in her hands. Since then she has continued to have spasm randomly throughout her body. She has not had spasm everyday but has had severe ones that have caused her to fall as part of them.


VAERS ID: 2048091 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3594 / 1 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Dizziness, Headache, Lip swelling, Pain
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: Sumatriptan
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Severe body aches, head aches, light headed, swollen lips


VAERS ID: 2050645 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-12-29
Onset:2021-12-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0810 / 3 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fatigue, Headache, Injection site pain, Paraesthesia, Tension headache
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None. Took 2 extra strength Tylenol after receiving vaccination.
Current Illness: Polyps in gall bladder.
Preexisting Conditions: Arthritis, left bundle branch blocking.
Allergies: None.
Diagnostic Lab Data:
CDC Split Type:

Write-up: 01/09/21 - 1st dose - Exhaustion. 01/30/21 - 2nd dose - Exhaustion, slight headache, soreness at injection site. possible TIA or complex migraine, was given Plavix (blood thinner) 12/29/21 - Booster - Wave of exhaustion, tingling sensation in face area, tightness in temple and back of the head area.


VAERS ID: 2050731 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Maryland  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram, Enzyme level test, Myocarditis, Pericarditis, Troponin increased
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: EKG, EChO, Blood pressure, Troponin- High enzyme levels- 5 days hospitalization Pericarditis/myocarditis
CDC Split Type:

Write-up: Severe chest pain and difficulty breathing. Pericarditis and myocarditis


VAERS ID: 2050802 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 033H21A / 3 RA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 004M20A / 2 RA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039K20-2A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Erythema, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Mechanical urticaria, Pain in extremity, Paraesthesia, Pruritus, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: prenatal vitamin
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: no test. Just by photos/exam.
CDC Split Type:

Write-up: Immediately after injection, I had tingling and aching in my right arm. The next morning, I woke up and had swelling, redness, pain, and warmth at the injection site. The swelling and redness lasted for a couple of days. The redness spread and then eventually resolved. shortly after that I developed achiness in my hands and fingers. That also resolved. About a 2 weeks after my vaccination, I developed hives on my torso and neck/scalp. The rash would disappear after a couple of minutes and then pop up in a new place. I have had it for about a week so far and I have photos documenting the rash. My PCP and I have discovered that I have dermatographia. Whenever I scratch or apply pressure to my body, it will become red and raised. I am taking daily Zyrtec and that seems to help with the itching, but the dermatographia is still present. I have no other history of allergic reactions, so our thought is that it is associated with my booster. I''d be happy to share photos of the rash. It''s very interesting. Definitely alarming, but hoping it will go away.


VAERS ID: 2051150 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: New York  
Vaccinated:2021-12-29
Onset:2021-12-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 032H21A / 3 AR / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Back pain, Condition aggravated, Musculoskeletal discomfort
SMQs:, Rhabdomyolysis/myopathy (broad), Retroperitoneal fibrosis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: flu shot once after I gave birth but never again. The discharging nurse after birth of second son talked me into a flu shot. I w
Other Medications: multi vitamin
Current Illness: nothing
Preexisting Conditions:
Allergies: Cipro and Sulfa
Diagnostic Lab Data:
CDC Split Type:

Write-up: My back started really bothering me to a point where it kept getting worse and now got a rx for PT. Lower back. I have had issues with my back in the past...when I run or from a weight lift injury so I haven''t run since 2019 and walk instead. I also do much lighter hand weights. I have been fine since 2019 but after covid booster my back started hurting more and more. I was fine with the first two shots . I did ask my dr if I was crazy connecting the two and she said no because she is seeing this more and more, My husband too has issue with his shoulder and was told that the shot does aggravate things that were issues in the past .. So my past issue from years ago is my back and not the covid booster aggravated my issue and I now have to pay $35 twice a week for PT to get better and to take away from my day. This is sucky and I thought you need to know.


VAERS ID: 2051539 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-12-27
Onset:2021-12-31
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral infarction, Cerebrovascular accident, Hemiparesis, Magnetic resonance imaging head abnormal
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Wellbutrin, calcium with vit D, atrovent nasal spray, birth control pills, MVI, maxalt, and sertraline
Current Illness: None
Preexisting Conditions: Depression
Allergies: cinnamon, garlic, sulfa
Diagnostic Lab Data: MRI brain: acute right MCA infarct
CDC Split Type:

Write-up: Acute right brain stroke with left sided weakness/hemiparesis


VAERS ID: 2051551 (history)  
Form: Version 2.0  
Age: 9.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-12-17
Onset:2021-12-31
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL0007 / 2 RA / IM

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

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

Write-up: Pfizer dose given at 14 day interval


VAERS ID: 2052183 (history)  
Form: Version 2.0  
Age: 10.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-12-17
Onset:2021-12-31
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL0007 / 2 RA / IM

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

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

Write-up: Dose given at 14 day interval


VAERS ID: 2052192 (history)  
Form: Version 2.0  
Age: 6.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL0007 / 1 LA / IM

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

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

Write-up: Pfizer dose given at 14 day interval


VAERS ID: 2052214 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-12-11
Onset:2021-12-31
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030H21B / 3 RA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: 2nd Moderna vaccine caused fatigue and fever for about 24 hours
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Dermatographia, I''ve been getting welts where I scratch, depending on body temperature. Happens more when I''m hot or take a bath/shower. Sometimes they appear even where I dont think I''ve scratched. Has been going on for 3 weeks now.


VAERS ID: 2052218 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-10-16
Onset:2021-12-31
   Days after vaccination:76
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8020 / 3 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Cough, Headache, Nasal congestion, Oropharyngeal pain, Respiratory symptom, SARS-CoV-2 test positive, Vaccine breakthrough infection
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? 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: Rapid Antigen Test 12/31/2021
CDC Split Type:

Write-up: Breakthrough COVID-19 positive via Rapid Antigen Test, with upper respiratory symptoms: cough sore throat headache nasal congestion.


VAERS ID: 2053697 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Arizona  
Vaccinated:0000-00-00
Onset:2021-12-31
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 204B21A / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210108; Test Name: COVID-19 PCR test; Result Unstructured Data: positive
CDC Split Type: USJNJFOC20220126030

Write-up: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age of unspecified race and ethnicity. Initial information was processed along with the additional information received on 14-JAN-2022. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose was not reported, (Dose number in series was 1) administered 1 in total to the left arm on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-JAN-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) positive. On 31-DEC-2021, the patient experienced his first symptom. On 04-JAN-2022, the patient had PCR test and on 08-JAN-2022 the results came for PCR test as positive which was a confirmed clinical vaccination failure, and confirmed covid-19 infection, patient denied receiving any booster dose. On 14-JAN-2022 patient only has little cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000211920.; Sender''s Comments: V0:20220126030-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 2053698 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Pennsylvania  
Vaccinated:2021-02-01
Onset:2021-12-31
   Days after vaccination:333
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Suspected COVID-19, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20220126472

Write-up: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a pharmacist concerned a patient of unspecified age, sex, race and ethnic origin. The patient''s height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, and batch number were not reported, expiry: unknown) dose was not reported, dose number in series was 1, 01 in total was administered on FEB-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 31-DEC-2021, the patient contracted coronavirus disease (COVID-19) (suspected COVID-19 infection) breakthrough infection roughly 2 weeks ago (end of December beginning of January) which resulted in suspected clinical vaccination failure (dose number in series was 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable The outcome of the suspected COVID-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). The case was associated with product quality complaint (PQC).; Sender''s Comments: V0 20220126472-COVID-19 VACCINE AD26.COV2.S- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.


VAERS ID: 1997532 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FM2952 / UNK LA / SC

Administered by: Private       Purchased by: ?
Symptoms: Exposure during pregnancy, Genital haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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: Euthyrox 50 mg daily use
Current Illness:
Preexisting Conditions: Hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Primigravida Pregnancy 19 + 1 week. Abundant genital bleeding, without previous trauma.


VAERS ID: 2012813 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-20
Onset:2021-12-31
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Test Date: 20211231; Test Name: COVID-19 virus test; Test Result: Positive.
CDC Split Type: IEPFIZER INC202200012958

Write-up: received Pfizer Booster vaccine; received Pfizer Booster vaccine; Tested positive for covid; Tested positive for covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a Representative. The reporter is the patient. A 42 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Dec2021 10:45 (Batch/Lot number: unknown) at the age of 42 years as dose 3 (booster), single, administration date 20Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date 30Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient''s concomitant medications were not reported. The following information was reported COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 31Dec2021, outcome unknown; IMMUNISATION (medically significant), OFF LABEL USE (medically significant), outcome unknown and all described as received Pfizer Booster vaccine. The patient underwent the following laboratory tests and procedures COVID-19 virus test on 31Dec2021 positive. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2016635 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-03
Onset:2021-12-31
   Days after vaccination:89
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Dyspnoea, Hypertension, Malaise
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood disorder; Breast cancer; COVID-19; Hashimoto''s disease (treated for 6 years); Hypertension; Spinal cord injury (4 years ago therapy: 130 injections and rehabilitation); Thyroid nodule; Traffic accident (4 years ago therapy: 130 injections and rehabilitation)
Allergies:
Diagnostic Lab Data: Test Date: 20211231; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:209/99 mmHg; Test Name: Body temperature; Result Unstructured Data: Test Result:to 40 Centigrade; Comments: 40 degrees Celsius
CDC Split Type: PLPFIZER INC202200006408

Write-up: the reporter went to the doctor because of difficult in breathing; the woman had the impression that she was dying; severe pressure surges - the highest was recorded on December 31, 2021 - 209/99 mmHg.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), administration date 03Oct2021 (Lot number: UNKNOWN) as dose 1, single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing); "Hashimoto''s disease" (unspecified if ongoing), notes: treated for 6 years; "thyroid nodules" (unspecified if ongoing); "breast cancer" (unspecified if ongoing); "spine injury after a car accident" (unspecified if ongoing), notes: 4 years ago, therapy: 130 injections and rehabilitation; "spine injury after a car accident" (unspecified if ongoing), notes: 4 years ago, therapy: 130 injections and rehabilitation; "blood problems" (unspecified if ongoing); "Covid-19", start date: 01May2021 (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Influenza virus vaccine, for Immunisation, reaction(s): "hemoptysis", "body temperature to 40 Celsius degrees for 3 weeks". The following information was reported: HYPERTENSION (life threatening) with onset 31Dec2021, outcome "unknown", described as "severe pressure surges - the highest was recorded on December 31, 2021 - 209/99 mmHg."; DYSPNOEA (non-serious) with onset 03Jan2022, outcome "unknown", described as "the reporter went to the doctor because of difficult in breathing"; MALAISE (non-serious) with onset 31Dec2021, outcome "unknown", described as "the woman had the impression that she was dying". It was explained that the patient has strong pressure surges - the highest was recorded on 31Dec2021 - 209/99 mmHg. That day the woman had the impression that she was dying. Spent the whole day in bed and taking 4 different antihypertensives. However, the drugs used had the opposite effect - blood pressure increased even more. She consulted the symptoms with a cardiologist and general practitioner. During the teleconsultation, she was advised not to take another dose of the vaccine as it was life-threatening for her. The woman did not take the second dose of Comirnaty scheduled for 23Oct2021. Today (03Jan2022) the reporter went to the doctor because of difficult in breathing. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (31Dec2021) 209/99 mmHg; body temperature: (unspecified date) to 40, notes: 40 degrees Celsius. Therapeutic measures were taken as a result of hypertension. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2022058 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Pleurisy
SMQs:, Systemic lupus erythematosus (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: Medical History/Concurrent Conditions: Peanut allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC202200005995

Write-up: Inflammation of the pleura for 48 hours, 24 hours after the last dose.; Immunisation; off label use; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 28 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 31Dec2021 09:15 (Batch/Lot number: unknown) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "nut allergy" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Moderna biotech spain (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 06:45 PM), administration date: 02Aug2021, for COVID-19 immunisation; Moderna biotech spain (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 31Dec2021 09:15, outcome "unknown", described as "Immunisation"; OFF LABEL USE (medically significant) with onset 31Dec2021 09:15, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Dec2021 09:15, outcome "unknown", described as "Interchange of vaccine products"; PLEURISY (medically significant) with onset 01Jan2022 08:00, outcome "recovering", described as "Inflammation of the pleura for 48 hours, 24 hours after the last dose.". The event "inflammation of the pleura for 48 hours, 24 hours after the last dose." was evaluated at the physician office visit. Therapeutic measures were taken as a result of pleurisy.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive no other medications within 2 weeks of vaccination. The patient had not diagnosed with COVID-19 prior to vaccination and post vaccination. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2023479 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Fever chills; Nausea; Headache; Generalised muscle aches; High temperature; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26419396) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever chills), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (Generalised muscle aches) and PYREXIA (High temperature) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced PYREXIA (Fever chills) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), MYALGIA (Generalised muscle aches) (seriousness criterion medically significant) and PYREXIA (High temperature) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever chills), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (Generalised muscle aches) and PYREXIA (High temperature) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-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. The concomitant medication was not reported. The treatment medication was not reported. Company comment: This is a regulatory case concerning a patient of unknown age and gender with no medical history reported who experienced the unexpected and serious events of pyrexia, nausea, headache and myalgia. The events occurred the following day a third dose of mRNA-1273 vaccine was administered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a patient of unknown age and gender with no medical history reported who experienced the unexpected and serious events of pyrexia, nausea, headache and myalgia. The events occurred the following day a third dose of mRNA-1273 vaccine was administered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023485 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FR907 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Choking, Dysphagia, Dysphonia, Immunisation, Interchange of vaccine products, Lip swelling, Musculoskeletal stiffness, Off label use, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000406

Write-up: Choking on food; Neck swollen; Neck stiff; Could not swallow it properly; Hoarse throat; Swollen lips; Patient received first and second dose of Non-Pfizer vaccine and booster dose of COMIRNATY; Patient received first and second dose of Non-Pfizer vaccine and booster dose of COMIRNATY; booster dose of COMIRNATY; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201011626434670-NHD89. Other Case identifier(s): GB-MHRA-ADR 26424193. A 43 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Lot number: FR907) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The last menstrual period date of the patient was 01Dec2021. The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient was not breastfeeding at the time of this report. Vaccination history included: Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 31Dec2021, outcome "unknown" and all described as "Patient received first and second dose of Non-Pfizer vaccine and booster dose of COMIRNATY"; IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "booster dose of COMIRNATY"; LIP SWELLING (non-serious) with onset 01Jan2022, outcome "recovering", described as "Swollen lips"; SWELLING (non-serious), outcome "unknown", described as "Neck swollen" and MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "Neck stiff", felt like swallowing golf balls. Neck had been less stiff after a long hot shower. The patient tried to eat lunch at 4pm and DYSPHAGIA (non-serious), outcome "unknown", described as "Could not swallow it properly"; Ended up CHOKING (medically significant), outcome "unknown", described as "Choking on food"; Left with DYSPHONIA (non-serious), outcome "unknown", described as "Hoarse throat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. The patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are needed. No further information is expected.


VAERS ID: 2026868 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-31
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XE395 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis, Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (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: KRJNJFOC20220110794

Write-up: This spontaneous report received from a health care professional by a Regulatory Authority (RA) concerned a 60-year-old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: XE395, and expiry: 30-APR-2023) dose was not reported, dose number in series was 1 with frequency time 1 total administered on 29-DEC-2021 for an unspecified indication. No concomitant medications were reported. On 31-DEC-2021, the patient experienced acute paralysis, and acute paralysis (facial paralysis) (dose number in series was 1). Outpatient treatment was administered. The action taken with covid-19 vaccine was not applicable. The outcome of the acute paralysis and acute paralysis (facial paralysis) was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20220110794-covid-19 vaccine acute paralysis and facial paralysis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 2029274 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202200007730

Write-up: hearing loss; tinnitus; This is a spontaneous report from a contactable physician. This is a report based on information received by Pfizer [Other Case identifier(s): US-BNTAG-1581 (BNTAG), license party for Comirnaty]. A female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: Unknown) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1, Single, Batch/Lot no.- Unknown), for COVID-19 Immunisation. The following information was reported: DEAFNESS (medically significant) with onset 31Dec2021, outcome "not recovered", described as "hearing loss"; TINNITUS (non-serious) with onset 31Dec2021, outcome "not recovered", described as "tinnitus". Bnt162b2 (COMIRNATY) is under agreement with Biontech. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender''s Comments: Based on current information available, the serious event Hearing loss mostly represented intercurrent condition in this patient, unrelated to Bnt162b2. Relevant medical history and concurrent disease are missing for a medically meaningful assessment.


VAERS ID: 2029518 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-12-31
   Days after vaccination:333
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 3 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 2 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Intermenstrual bleeding, 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: MIRENA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer; Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)); Radiotherapy (Breast Cancer (and radiotherapy) 5 years ago.); Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210722; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Vaginal bleeding; This case was received (Reference number: GB-MHRA-ADR 26424511) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (Vaginal bleeding) in a 47-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022A) for COVID-19 vaccination. Co-suspect products included non-company products COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination. The patient''s past medical history included Breast cancer in 2016, Suspected COVID-19 from 20-Jul-2021 to 27-Jul-2021, Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)) and Radiotherapy (Breast Cancer (and radiotherapy) 5 years ago.) in 2016. Concomitant products included LEVONORGESTREL (MIRENA) for an unknown indication. On 01-Feb-2021, the patient received first dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On 01-May-2021, the patient received second dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced INTERMENSTRUAL BLEEDING (Vaginal bleeding) (seriousness criterion medically significant). At the time of the report, INTERMENSTRUAL BLEEDING (Vaginal bleeding) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive COVID-19 test. The patient reported that due to Mirena coil she normally experienced very light or no bleeding at all instead of normal menstrual bleeding. A couple of weeks after the Moderna booster received patient started unexpected vaginal bleeding. Bleeding was still going on (today was the second day of bleeding). Something very similar, though a bit lighter, happened after patient received first dose of Covid Vaccine, that was AstraZeneca. Patient did not relate the report to possible blood clots or low platelet counts or possible inflammation of the heart (myocarditis or pericarditis). No treatment medication details was provided.; Sender''s Comments: This case concerns a patient, with medical history (Breast cancer, Suspected COVID-19, Neoplasm, leukemia or lymphoma, who experienced the serious unexpected event(s) of Intermenstrual bleeding. The event(s) started occurring approximately within 14 day(s) after the 3rd dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered NA. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report. The patient received 1st and 2nd doses of COVID-19 VACCINE ASTRAZENECA.


VAERS ID: 2029519 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Headache; Migraine; This case was received via Regulatory authority This case was received via Regulatory authority. This regulatory authority case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine) and HEADACHE (Headache) in a 59-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced MIGRAINE (Migraine) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, MIGRAINE (Migraine) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative covid-19 test (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant Medication use information was not provided by reporter. After vaccination patient experienced intense migraine which lasted 12 hours. Patient was also weak with full headache and was still suffering. Patient was healthy. Treatment Medication use information was not provided by reporter. Patient did not relate the report to possible inflammation of the heart (myocarditis or pericarditis); Sender''s Comments: This is a regulatory case concerning a 59-year-old male patient with no medical history provided, who experienced the serious unexpected event of Migraine and expected event of Headache(seriousness criterion medically significant). These events occurred 2 days after the patient received the third dose of mRNA-1273 (Moderna CoviD-19 Vaccine). At the time of the report, both events had not resolved. The rechallenge was unknown since there''s no information about the first two doses. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2029530 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000029A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Myalgia, Pain, Paraesthesia, Tenderness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CERAZETTE; CITALOPRAM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: tenderness; Tenderness and pain underarm of the arm injected; Shivering; Muscle ache and pins and needles in the arm and hand injected only; Headache; Grmeral Muscle ache; This case was received (Reference number: GB-RA-ADR 26423870) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness), PAIN (Tenderness and pain underarm of the arm injected), CHILLS (Shivering), PARAESTHESIA (Muscle ache and pins and needles in the arm and hand injected only), HEADACHE (Headache) and MYALGIA (Grmeral Muscle ache) in a 42-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000029a) for an unknown indication. Concomitant products included CITALOPRAM from 01-Jan-2009 to an unknown date for Depression, DESOGESTREL (CERAZETTE) from 01-Jan-2019 to an unknown date for Irregular periods. On 30-Dec-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced TENDERNESS (tenderness) (seriousness criterion medically significant), PAIN (Tenderness and pain underarm of the arm injected) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant), PARAESTHESIA (Muscle ache and pins and needles in the arm and hand injected only) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and MYALGIA (Grmeral Muscle ache) (seriousness criterion medically significant). At the time of the report, TENDERNESS (tenderness), PAIN (Tenderness and pain underarm of the arm injected) and PARAESTHESIA (Muscle ache and pins and needles in the arm and hand injected only) had not resolved and CHILLS (Shivering), HEADACHE (Headache) and MYALGIA (Grmeral Muscle ache) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had no symptoms associated with COVID-19 Not had a COVID-19 test. Patient was not pregnant, patient was not currently breastfeeding. Treatment details were also not provided. Patient was not enrolled in clinical trial. Company comment: This case concerns a 42-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of tenderness, paraesthesia, and pain. The events occurred 1 day after the most recent dose of mRNA-1273. Information regarding clinical presentation, diagnostic tests and treatment provided has not been disclosed. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. Tenderness and pain were reported as experienced in the underarm of the vaccination arm. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 42-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of tenderness, paraesthesia, and pain. The events occurred 1 day after the most recent dose of mRNA-1273. Information regarding clinical presentation, diagnostic tests and treatment provided has not been disclosed. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. Tenderness and pain were reported as experienced in the underarm of the vaccination arm. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2029533 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000014A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Back pain, Discomfort, Dyspnoea, Fatigue, Gastrointestinal pain, Malaise, Nausea, Pain, Palpitations, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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: COVID-19 VACCINE ASTRAZENECA; COVID-19 VACCINE ASTRAZENECA
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Colectomy (I had to have a total colectomy and proctectomy as a result of UC.); Proctectomy (I had to have a total colectomy and proctectomy as a result of UC.); Ulcerative colitis (Not taking medication for ulcerative colitis but this is because I had to have a total colectomy and proctectomy as a result of UC); Comments: Not taking medication for ulcerative colitis but this is because I had to have a total colectomy and proctectomy as a result of UC. Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: unwell; chronic fatigue; high temperature; discomfort; Felt ill; Fever; Palpitation; Breathlessness; Pain in hip; Gut pain; Back pain; Nausea; Vomiting; Ache; Pain; This case was received (Reference number: GB-RA-ADR 26424738) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (chronic fatigue), PYREXIA (high temperature), DISCOMFORT (discomfort), MALAISE (Felt ill), MALAISE (unwell), PYREXIA (Fever), PALPITATIONS (Palpitation), DYSPNOEA (Breathlessness), ARTHRALGIA (Pain in hip), GASTROINTESTINAL PAIN (Gut pain), BACK PAIN (Back pain), NAUSEA (Nausea), VOMITING (Vomiting), PAIN (Ache) and PAIN (Pain) in a 44-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000014A) for an unknown indication. Not taking medication for ulcerative colitis but this is because I had to have a total colectomy and proctectomy as a result of UC. Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding. The patient''s past medical history included Ulcerative colitis (Not taking medication for ulcerative colitis but this is because I had to have a total colectomy and proctectomy as a result of UC), Proctectomy (I had to have a total colectomy and proctectomy as a result of UC.) and Colectomy (I had to have a total colectomy and proctectomy as a result of UC.). Concurrent medical conditions included Suspected COVID-19 since 09-Mar-2020. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 16-May-2021 to an unknown date and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for Vaccination. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced MALAISE (Felt ill) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), PALPITATIONS (Palpitation) (seriousness criterion medically significant), DYSPNOEA (Breathlessness) (seriousness criterion medically significant), ARTHRALGIA (Pain in hip) (seriousness criterion medically significant), GASTROINTESTINAL PAIN (Gut pain) (seriousness criterion medically significant), BACK PAIN (Back pain) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant), PAIN (Ache) (seriousness criterion medically significant) and PAIN (Pain) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (chronic fatigue) (seriousness criterion medically significant), PYREXIA (high temperature) (seriousness criterion medically significant), DISCOMFORT (discomfort) (seriousness criterion medically significant) and MALAISE (unwell) (seriousness criterion medically significant). On 01-Jan-2022, ARTHRALGIA (Pain in hip), GASTROINTESTINAL PAIN (Gut pain), BACK PAIN (Back pain), NAUSEA (Nausea), VOMITING (Vomiting), PAIN (Ache) and PAIN (Pain) had resolved. At the time of the report, FATIGUE (chronic fatigue), PYREXIA (high temperature), DISCOMFORT (discomfort), MALAISE (Felt ill) and MALAISE (unwell) had not resolved and PYREXIA (Fever), PALPITATIONS (Palpitation) and DYSPNOEA (Breathlessness) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. It was reported that Almost exactly 12 hours after having the booster patient awoke in agonising pain plus had very high temperature and felt seriously unwell. Paracetamol helped ease the pain for up to 3 hours but then patient would be in extreme discomfort again whilst waiting until patient could take more Paracetamol. Everything that sometimes hurt, such as my hip is sometimes uncomfortable, felt unbearably painful, causing writhing pain. patient still feel very unwell, however it is a lot better than it was Might be relevant that patient have long covid, having not recovered from being ill with covid 21 months ago. patient also have post covid chronic fatigue which patient suspect may impede recovery from this reaction. Note - patient had NO side effects of any kind from the AstraZeneca vaccine Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial; Sender''s Comments: This case concerns a 44-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Fatigue, Pyrexia, Discomfort, Malaise, Palpitations, Dyspnea, Arthralgia, Gastrointestinal Pain, Back Pain, Nausea, Vomiting, and Pain. The events occurred approximately 12 hours after the booster dose. The rechallenge was not applicable as events occurred after booster dose. The benefit-risk relationship of mRNA-1273 (Modrna covid-19 vaccine) is not affected by this report.


VAERS ID: 2029534 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005889 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Hypoaesthesia, Nausea, Pain, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20220102; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Numb arm morning after; Headache; Nausea; Ache; This case was received via RA (Reference number: GB-MHRA-ADR 26424907) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numb arm morning after), HEADACHE (Headache), NAUSEA (Nausea) and PAIN (Ache) in a 32-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005889) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and PAIN (Ache) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPOAESTHESIA (Numb arm morning after) (seriousness criterion medically significant). At the time of the report, HYPOAESTHESIA (Numb arm morning after), HEADACHE (Headache), NAUSEA (Nausea) and PAIN (Ache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2022, 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 information was not provided. List of concomitant medication were not given Patient had Numb arm morning after, with all listed side affects above, numb arm has improved but other side affects still present Patient was not enrolled in clinical trial; Sender''s Comments: This case concerns a patient, with medical history (not reported), who experienced the serious unexpected event(s) of hypoaesthesia, headache, nausea and pain. The event(s) started occurring approximately within 1 day(s) after the 1st dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered NA. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 2029580 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Nausea, Pain, Palpitations, Pyrexia, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (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: COVID-19 MRNA VACCINE BNT162B2
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210331; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: nauseous; Palpitation; Fever; Ache; Fainting; Headache; Nausea; Chills; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26424929) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (nauseous), PALPITATIONS (Palpitation), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea), CHILLS (Chills), PAIN (Ache) and SYNCOPE (Fainting) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) for an unknown indication. On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 01-Jan-2022, the patient experienced PALPITATIONS (Palpitation) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), PAIN (Ache) (seriousness criterion medically significant) and SYNCOPE (Fainting) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (nauseous) (seriousness criterion medically significant). On 01-Jan-2022, PALPITATIONS (Palpitation), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea), CHILLS (Chills), PAIN (Ache) and SYNCOPE (Fainting) had resolved. At the time of the report, NAUSEA (nauseous) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medications were reported. It was stated that the patient experienced headaches and felt nauseous 6 hours after having the vaccine. Patient woke in night (12 hours post vaccine) experienced fever, chills and palpitations and fainted. The fever, chills, headaches, body aches and nausea lasted for 12 hours. Patient had not tested positive for COVID-19 since having the vaccine Company Comment - This regulatory authority case concerns a 38 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of nausea, palpitations, pyrexia, headache, nausea, chills, pain and expected event of syncope. The events occurred between the same day and 1 day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 38 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of nausea, palpitations, pyrexia, headache, nausea, chills, pain and expected event of syncope. The event occurred on the same day and 1 day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030092 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: flu like symptoms; Fever chills; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26419891) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever chills) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced PYREXIA (Fever chills) (seriousness criterion disability). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) (seriousness criterion disability). At the time of the report, PYREXIA (Fever chills) had not resolved and INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported Patient had no symptoms associated with COVID-19. Patient completely floored with sever flu like symptoms. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment information was provided. Company comment This is a regulatory case concerning a 36-year-old patient of an unknown gender with no medical history reported, who experienced the serious unexpected, according to CCDS, events of PYREXIA and INFLUENZA LIKE ILLNESS. The event PYREXIA occurred the day after the third dose of mRNA-1273. INFLUENZA LIKE ILLNESS occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge was assessed as unknown according to SD. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This is a regulatory case concerning a 36-year-old patient of an unknown gender with no medical history reported, who experienced the serious unexpected, according to CCDS, events of PYREXIA and INFLUENZA LIKE ILLNESS. The event PYREXIA occurred the day after the third dose of mRNA-1273. INFLUENZA LIKE ILLNESS occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge was assessed as unknown according to SD. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2030103 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN5254 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Hyperhidrosis, Malaise, Presyncope
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000345

Write-up: Near fainting; Feeling sick; Sweating; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (MHRA). Regulatory number: GB-MHRA-WEBCOVID-202112310932341160-5V3AT (MHRA). Other Case identifier(s): GB-MHRA-ADR 26420365 (MHRA). A 41 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: Fn5254) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. Patient is not pregnant, patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The following information was reported: PRESYNCOPE (medically significant) with onset 31Dec2021, outcome "recovered" (31Dec2021), described as "Near fainting"; MALAISE (medically significant) with onset 31Dec2021, outcome "recovering", described as "Feeling sick" (end date was also reported as 31Dec2021); HYPERHIDROSIS (medically significant) with onset 31Dec2021, outcome "recovered" (31Dec2021), described as "Sweating"; HEADACHE (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Headache". The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.


VAERS ID: 2030115 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Headache; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 26420809) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 31-Dec-2021, HEADACHE (Headache) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment medication was reported. The patient developed hot cold, tired, headache, mucel ache. Patient has not had symptoms associated with COVID-19 and did not had an COVID-19 test. Patient was not enrolled in clinical trial. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). Company comment: This is a regulatory case concerning a 38-year-old, female patient with no medical history reported who experienced the unexpected serious event of Headache one day after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. As reported, the patient also developed hot cold, tired, and "mucel" ache, however these events were not coded by RA. The event terms, event seriousness, rechallenge and action taken with the suspect product were kept as per SD.; Sender''s Comments: This is a regulatory case concerning a 38-year-old, female patient with no medical history reported who experienced the unexpected serious event of Headache one day after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. As reported, the patient also developed hot cold, tired, and "mucel" ache, however these events were not coded by RA. The event terms, event seriousness, rechallenge and action taken with the suspect product were kept as per SD.


VAERS ID: 2030135 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005688 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Influenza like illness, Pain in extremity, SARS-CoV-2 test, Testicular pain
SMQs:, Tendinopathies and ligament disorders (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; PFIZER BIONTECH COVID-19 VACCINE
Current Illness: Asthma (Mild asthma diagnosed as child but not suffered and not had inhalers for years)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211231; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Flu like symptoms; Headache; Testicular pain; Painful arm; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26421573) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache), TESTICULAR PAIN (Testicular pain) and PAIN IN EXTREMITY (Painful arm) in a 34-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005688) for an unknown indication. Concurrent medical conditions included Asthma (Mild asthma diagnosed as child but not suffered and not had inhalers for years). Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 29-Jun-2021 to an unknown date and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for Vaccination. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), TESTICULAR PAIN (Testicular pain) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache), TESTICULAR PAIN (Testicular pain) and PAIN IN EXTREMITY (Painful arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was suffered little or no side effects with the first two jabs but this booster dose was wow. Patient was never felt anything like it Patient currently took Co codamol for the pain and discomfort and Patient was not even touching it. Patient had a ache as the muscles or joints in there body but just bizarre that it effects this area and causes such discomfort. Again hoping this will pass quickly as it makes sleeping or rest difficult. Patient was going to see how the next hours go and if things do not improve ,Patient may had to call 111, luckily had a partner home to help to patient otherwise Patient really struggle. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial Company comment: This Regulatory Authority case concerns a 34-year-old, male patient, with medical history of asthma, who experienced the unexpected, serious (Medically significant) events of Influenza like illness, headache, testicular pain and pain in extremity. The events occurred 1 day after he received a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. He reported he has never felt anything like this and he was taking Co codamol for the pain and discomfort. He cannot lift his arms, struggles to get out of the bath, standing up or walking is an effort and he was also experiencing headache and testicular pain. The patient received as first and second dose of his COVID-19 vaccination schedule two doses Biontech''s COVID-19 vaccine. Regulatory authority captured the rechallenge as unknown. The medical history of asthma remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This Regulatory Authority case concerns a 34-year-old, male patient, with medical history of asthma, who experienced the unexpected, serious (Medically significant) events of Influenza like illness, headache, testicular pain and pain in extremity. The events occurred 1 day after he received a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. He reported he has never felt anything like this and he was taking Co codamol for the pain and discomfort. He cannot lift his arms, struggles to get out of the bath, standing up or walking is an effort and he was also experiencing headache and testicular pain. The patient received as first and second dose of his COVID-19 vaccination schedule two doses Biontech''s COVID-19 vaccine. Regulatory authority captured the rechallenge as unknown. The medical history of asthma remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030148 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Back pain, Headache, Pain in extremity
SMQs:, Retroperitoneal fibrosis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Back ache; Headache; Painful arm; Joint pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26421957) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of BACK PAIN (Back ache), HEADACHE (Headache), PAIN IN EXTREMITY (Painful arm) and ARTHRALGIA (Joint pain) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced BACK PAIN (Back ache) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant) and ARTHRALGIA (Joint pain) (seriousness criterion medically significant). At the time of the report, BACK PAIN (Back ache), HEADACHE (Headache), PAIN IN EXTREMITY (Painful arm) and ARTHRALGIA (Joint pain) 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. 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: This is a regulatory case concerning a 34-year-old, female patient with no medical history reported, with an Interchange of vaccine products (two doses was with PFIZER BIONTECH COVID-19 VACCINE, before current vaccination) who experienced the serious unexpected , according CCDS, events of Back pain, Headache, Pain in extremity and Arthralgia. The events occurred approximately one day after the third dose of mRNA-1273 vaccine. The rechallenge was reported as unknown. No treatment was provided for reported events. The case was assessed as serious as per Regulatory Authority?s report due to important medical event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 34-year-old, female patient with no medical history reported, with an Interchange of vaccine products (two doses were with PFIZER BIONTECH COVID-19 VACCINE, before current vaccination) who experienced the serious unexpected , according CCDS, events of Back pain, Headache, Pain in extremity and Arthralgia. The events occurred approximately one day after the third dose of mRNA-1273 vaccine. The rechallenge was reported as unknown. No treatment was provided for reported events. The case was assessed as serious as per Regulatory Authority?s report due to important medical event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030163 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: 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:
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.MOD20224

Write-up: Fever; This case was received via regulatory authority on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever) 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. Patient felt cold after 4 hours of booster injection. Patient had previously 2 doses of BioNTech jab. The symptoms evolved in the following hours to joint pain and fever. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19 Company comment This is a regulatory case concerning a female patient of an unknown age with no medical history reported, who experienced the serious unexpected, according to CCDS, event of PYREXIA. The event occurred the same day after the third dose of mRNA-1273. The rechallenge was assessed as unknown according to SD. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This is a regulatory case concerning a female patient of an unknown age with no medical history reported, who experienced the serious unexpected, according to CCDS, event of PYREXIA. The event occurred the same day after the third dose of mRNA-1273. The rechallenge was assessed as unknown according to SD. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2030169 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Feeling cold, Pyrexia, SARS-CoV-2 test, Vomiting, Vomiting projectile
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; MESALAZINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
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.MOD20224

Write-up: vomiting; Feeling cold; Explosive diarrhea; Vomiting projectile; Fever; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26422997) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of FEELING COLD (Feeling cold), DIARRHOEA (Explosive diarrhea), VOMITING PROJECTILE (Vomiting projectile), PYREXIA (Fever) and VOMITING (vomiting) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)). Previously administered products included for Product used for unknown indication: Mesalazine (Taking oral mesalazine and mesalazine suppositories on a daily basis). Past adverse reactions to the above products included No adverse reaction with Mesalazine. Concomitant products included MESALAZINE for Ulcerative colitis, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced FEELING COLD (Feeling cold) (seriousness criterion medically significant), DIARRHOEA (Explosive diarrhea) (seriousness criterion medically significant), VOMITING PROJECTILE (Vomiting projectile) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced VOMITING (vomiting) (seriousness criterion medically significant). At the time of the report, FEELING COLD (Feeling cold), DIARRHOEA (Explosive diarrhea), VOMITING PROJECTILE (Vomiting projectile) and PYREXIA (Fever) had not resolved and VOMITING (vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. After vaccination patient felt feverish and cold and experienced watery, explosive diarrhea, went to bed within minutes suffered with projectile vomiting. Appeared to lose consciousness momentarily eyes rolled up and was unresponsive for like 15 seconds, after the first bout of vomiting. Was sitting up and communicating within minutes. Complained of not being able to breathe and needing fresh air. Vomited approximately 5 times after this. Patient was not had symptoms associated with COVID-19. Patient was not tested positive for COVID-19 since the vaccine. Patient was not enrolled in clinical trial. Treatment Medication use information was provided by reporter that includes took paracetamol with a glass of water. Company comment: This is a regulatory case concerning a male patient of an unknown age with medical history of ulcerative colitis treated with mesalazine and steroid therapy who experienced the unexpected serious events of Feeling cold, Diarrhoea, Vomiting projectile, Pyrexia and Vomiting on the same date after the third dose of COVID vaccine (mRNA-1273 Vaccine was the third dose). The event terms, event seriousness, rechallenge and action taken with the suspect product were kept as per SD. The patient''s medical history of ulcerative colitis remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a male patient of an unknown age with medical history of ulcerative colitis treated with mesalazine and steroid therapy who experienced the unexpected serious events of Feeling cold, Diarrhoea, Vomiting projectile, Pyrexia and Vomiting on the same date after the third dose of COVID vaccine (mRNA-1273 Vaccine was the third dose). The event terms, event seriousness, rechallenge and action taken with the suspect product were kept as per SD. The patient''s medical history of ulcerative colitis remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030176 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Migraine, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM; OMEPRAZOL [OMEPRAZOLE]
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.MOD20224

Write-up: SARS-CoV-2 infection; Vomiting; Migraine; This case was received via regulatory authority on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of COVID-19 (SARS-CoV-2 infection), VOMITING (Vomiting) and MIGRAINE (Migraine) in a 42-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included CITALOPRAM for Depression, OMEPRAZOL [OMEPRAZOLE] for Heartburn. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced COVID-19 (SARS-CoV-2 infection) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant) and MIGRAINE (Migraine) (seriousness criterion medically significant). At the time of the report, COVID-19 (SARS-CoV-2 infection) had not resolved and VOMITING (Vomiting) and MIGRAINE (Migraine) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The treatment medication was not reported. Patient has not had symptoms associated with COVID-19. It was reported that adverse reaction did not occur as a result of an exposure during pregnancy. This is a regulatory case concerning a 42-year-old female patient with a medical history of depression and heartburn, who experienced the events of Covid-19, vomiting and migraine. The events occurred approximately 1 day after the third dose of mRNA ? 1273 vaccine. Events were reported as medically significant and at the time of report migraine and vomiting was resolving but the event Covid-19 had not resolved. The rechallenge is unknown since no information about the first two doses were disclosed. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 42-year-old female patient with a medical history of depression and heartburn, who experienced the events of Covid-19, vomiting and migraine. The events occurred approximately 1 day after the third dose of mRNA ? 1273 vaccine. Events were reported as medically significant and at the time of report migraine and vomiting was resolving but the event Covid-19 had not resolved. The rechallenge is unknown since no information about the first two doses were disclosed. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 2030182 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-31
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, SARS-CoV-2 test
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Diarrhea; This case was received via the regulatory authority (Reference number: GB-MHRA-ADR 26423238) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...). On an unknown date, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant). At the time of the report, DIARRHOEA (Diarrhea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information not provided. Concomitant medication not provided. Patient had not tested positive for COVID-19 since having the vaccine. Company comment: This case concerns a 26-year-old female patient with no relevant medical history provided, who experienced serious unexpected event of Diarrhoea. The temporal relationship between the reported event and vaccine administration remains unknown since the date of administration of the mRNA-1273 vaccine (third dose) was not disclosed. At the time of this report, the event was still ongoing and no additional information regarding the clinical course of the events was provided. The rechallenge and action taken with the suspect product were reported as unknown as per RA and kept as such, however, could have been considered as not applicable as the patient experienced the events following the booster dose of the vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 26-year-old female patient with no relevant medical history provided, who experienced serious unexpected event of Diarrhoea. The temporal relationship between the reported event and vaccine administration remains unknown since the date of administration of the mRNA-1273 vaccine (third dose) was not disclosed. At the time of this report, the event was still ongoing and no additional information regarding the clinical course of the events was provided. The rechallenge and action taken with the suspect product were reported as unknown as per RA and kept as such, however, could have been considered as not applicable as the patient experienced the events following the booster dose of the vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2030183 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Maternal exposure during breast feeding, Nausea, Nervousness, Peripheral swelling, Pyrexia, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Neonatal exposures via breast milk (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Maternal exposure during breast feeding; Fever chills; Swollen arm; Nauseous; Shaky feelings; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26423259) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever chills), PERIPHERAL SWELLING (Swollen arm), NAUSEA (Nauseous), NERVOUSNESS (Shaky feelings) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Breast feeding. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced PYREXIA (Fever chills) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), NAUSEA (Nauseous) (seriousness criterion medically significant) and NERVOUSNESS (Shaky feelings) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever chills), PERIPHERAL SWELLING (Swollen arm), NAUSEA (Nauseous) and NERVOUSNESS (Shaky feelings) had not resolved and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: 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 treatment medication was reported. Company comment This is a regulatory case concerning a 38-year-old female patient currently Breast feeding with no other relevant medical history reported, who experienced the serious unexpected according to CCDS, events of Pyrexia, peripheral swelling, nausea, nervousness. Maternal exposure during breast feeding is considered as an additional event. The events occurred the day after the third dose of mRNA-1273. The rechallenge was assessed as unknown according to SD. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This is a regulatory case concerning a 38-year-old female patient currently Breast feeding with no other relevant medical history reported, who experienced the serious unexpected according to CCDS, events of Pyrexia, peripheral swelling, nausea, nervousness. Maternal exposure during breast feeding is considered as an additional event. The events occurred the day after the third dose of mRNA-1273. The rechallenge was assessed as unknown according to SD. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2030192 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Nausea, SARS-CoV-2 test, Urinary tract infection
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No- Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Urinary tract infection; Headache; Nausea; This case was received via Regulatory Authority(Reference number: GB-MHRA-ADR 26423419) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This Regulatory Authority case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection), HEADACHE (Headache) and NAUSEA (Nausea) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced URINARY TRACT INFECTION (Urinary tract infection) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 01-Jan-2022, NAUSEA (Nausea) had resolved. At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2021, SARS-CoV-2 test: negative (Negative) No- Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient not had symptoms associated with COVID-19. Patient was not pregnant, Patient was not currently breastfeeding. Patient last menstrual period date was 24-Dec-2021. About 12 hours after receiving my Moderna booster, patient started to develop a UTI, along with fatigue, nausea, chills, and a terrible headache. Patient got antibiotics for the UTI and that is starting to clear it up. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This case concerns a 36-year-old female patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of urinary tract infection, nausea and headache after the third dose of mRNA-1273. The events occurred the next day after vaccination. Event nausea recovered, headache recovering and urinary tract infection (after treatment with antibiotics) were recovering. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.; Sender''s Comments: This case concerns a 36-year-old female patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of urinary tract infection, nausea and headache after the third dose of mRNA-1273. The events occurred the next day after vaccination. Event nausea recovered, headache recovering and urinary tract infection (after treatment with antibiotics) were recovering. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.


VAERS ID: 2030194 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210102; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Fainting; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26423655) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 02-Jan-2021 to 10-Jan-2021. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for Vaccination. On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Fainting) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2021, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient reported that she experienced incident 11 hours after vaccine was given, gradually started to feel achy and unwell during the day and by 10:30 pm she was collapsed at home, and continue to feel achy. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment medication information was mentioned by reporter. Company Comment: This case concerns a 36-year-old female patient with no previous relevant medical history reported, who experienced the serious event of Syncope. The event occurred on the same day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). No treatment medication information was reported. Event seriousness assessed as per Regulatory Authority report and retained for consistency. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.; Sender''s Comments: This case concerns a 36-year-old female patient with no previous relevant medical history reported, who experienced the serious event of Syncope. The event occurred on the same day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). No treatment medication information was reported. Event seriousness assessed as per Regulatory Authority report and retained for consistency. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.


VAERS ID: 2030195 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Pain, Pain in extremity, SARS-CoV-2 test, Tinnitus
SMQs:, Retroperitoneal fibrosis (broad), Hearing impairment (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Type 2 diabetes mellitus (type 2 diabetic)
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.MOD20224

Write-up: back pain; pain in arms; Tinnitus; Shooting pain; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26423683) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), PAIN IN EXTREMITY (pain in arms), TINNITUS (Tinnitus) and PAIN (Shooting pain) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Previously administered products included for Product used for unknown indication: METFORMIN. Past adverse reactions to the above products included No adverse event with METFORMIN. Concurrent medical conditions included Type 2 diabetes mellitus (type 2 diabetic). On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced TINNITUS (Tinnitus) (seriousness criterion medically significant) and PAIN (Shooting pain) (seriousness criterion medically significant). On an unknown date, the patient experienced BACK PAIN (back pain) (seriousness criterion medically significant) and PAIN IN EXTREMITY (pain in arms) (seriousness criterion medically significant). At the time of the report, BACK PAIN (back pain) and PAIN IN EXTREMITY (pain in arms) outcome was unknown and TINNITUS (Tinnitus) and PAIN (Shooting pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. Treatment information was not provided by reporter. It was reported patient experienced shooting pains in arch of feet, Right eye drooped, cant sleep chest feels strange. Pain in arms was horrific and back pain etc. took 15 mins to fight the pain to get up to go to the toilet.Patient is not enrolled in clinical trial.Patient has not had symptoms associated with COVID-19. Company comment: This case concerns a 39-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of tinnitus and pain. The events occurred 1 day after the booster dose of mRNA-1273. The patient experienced pain in arch of his feet, as well as drooped right eye, strange feeling in chest, arm pain and back pain. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 39-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of tinnitus and pain. The events occurred 1 day after the booster dose of mRNA-1273. The patient experienced pain in arch of his feet, as well as drooped right eye, strange feeling in chest, arm pain and back pain. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2030198 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Myalgia, Nausea, Panic attack, SARS-CoV-2 test, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: nauseous; vomiting; Bilious vomiting; Panic attack; Pain stomach; Muscle pain; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26423736) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (nauseous), VOMITING (vomiting), VOMITING (Bilious vomiting), PANIC ATTACK (Panic attack), ABDOMINAL PAIN UPPER (Pain stomach) and MYALGIA (Muscle pain) in a 23-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced VOMITING (Bilious vomiting) (seriousness criterion disability), PANIC ATTACK (Panic attack) (seriousness criterion disability), ABDOMINAL PAIN UPPER (Pain stomach) (seriousness criterion disability) and MYALGIA (Muscle pain) (seriousness criterion disability). On an unknown date, the patient experienced NAUSEA (nauseous) (seriousness criterion disability) and VOMITING (vomiting) (seriousness criterion disability). On 01-Jan-2022, VOMITING (Bilious vomiting) and ABDOMINAL PAIN UPPER (Pain stomach) was resolving, PANIC ATTACK (Panic attack) had resolved. At the time of the report, NAUSEA (nauseous) and VOMITING (vomiting) was resolving and MYALGIA (Muscle pain) 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. The treatment information was not provided. No medical history ws provided by reporter. Approximately 6 hours after having the vaccine she began to feel nauseous and tired and her whole body ached. She also felt a tingling sensation in her legs, arms and stomach similar to what she experience when having a panic attack. Around 12 hours after having the vaccine she began vomiting violently and this continued for 4 hours until she was vomiting bile. The way she felt also triggered a panic attack. Company comment: This regulatory authority case concerns a 23-year-old female patient with no medical history reported, who experienced the unexpected serious (disability) events of Nausea, Vomiting, Panic attack, Abdominal pain and Myalgia after mRNA- 1273 vaccine, third dose of the vaccination schedule (reported as 3b dose). The patient had received initial schedule of vaccination with COVID-19 mRNA Vaccine BioNTech. The onset of the events occurred on the day after the 3b dose of mRNA- 1273 vaccine. Additionally, fatigue, paraesthesia in legs and arms and abdominal discomfort (reported as tingling sensation in stomach) were also described. The patient reported that the events were similar to panic attack?s symptoms. Nausea, Vomiting and Myalgia are consistent with the known safety profile of the vaccine, but since they were reported with a seriousness criteria they are considered unexpected. The seriousness criteria of Disability was assessed as per regulatory authority report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Patient had no symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial.; Sender''s Comments: This regulatory authority case concerns a 23-year-old female patient with no medical history reported, who experienced the unexpected serious (disability) events of Nausea, Vomiting, Panic attack, Abdominal pain and Myalgia after mRNA- 1273 vaccine, third dose of the vaccination schedule (reported as 3b dose). The patient had received initial schedule of vaccination with COVID-19 mRNA Vaccine BioNTech. The onset of the events occurred on the day after the 3b dose of mRNA- 1273 vaccine. Additionally, fatigue, paraesthesia in the legs and arms and abdominal discomfort (described as tingling sensation in stomach) were also described. The patient reported that the events were similar to panic attack?s symptoms. Nausea, Vomiting and Myalgia are consistent with the known safety profile of the vaccine, but since they were reported with a seriousness criteria they are considered unexpected. The seriousness criteria of Disability was assessed as per regulatory authority report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.


VAERS ID: 2030201 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
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.MOD20224

Write-up: Vomiting; Skin warm; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26423753) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) and SKIN WARM (Skin warm) in a 22-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced SKIN WARM (Skin warm) (seriousness criterion medically significant). On 01-Jan-2022, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). On 01-Jan-2022, SKIN WARM (Skin warm) had resolved. At the time of the report, VOMITING (Vomiting) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information not provided. Concomitant medication not provided. Company Comment: This is a regulatory case concerning a 22-year-old, male patient with no medical history reported, who experienced the unexpected serious events of vomiting and Skin warm. The events occurred approximately one day after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to important medical condition.; Sender''s Comments: This is a regulatory case concerning a 22-year-old, male patient with no medical history reported, who experienced the unexpected serious events of vomiting and Skin warm. The events occurred approximately one day after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to important medical condition.


VAERS ID: 2030207 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Erythema, Fatigue, Headache, Pain of skin, Pyrexia, Rash, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: tiredness; fever; headache; it hurts to touch; chills; Skin rash; Skin red; Swelling; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26423861) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (tiredness), PYREXIA (fever), HEADACHE (headache), PAIN OF SKIN (it hurts to touch), CHILLS (chills), RASH (Skin rash), ERYTHEMA (Skin red) and SWELLING (Swelling) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced RASH (Skin rash) (seriousness criterion medically significant), ERYTHEMA (Skin red) (seriousness criterion medically significant) and SWELLING (Swelling) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (tiredness) (seriousness criterion medically significant), PYREXIA (fever) (seriousness criterion medically significant), HEADACHE (headache) (seriousness criterion medically significant), PAIN OF SKIN (it hurts to touch) (seriousness criterion medically significant) and CHILLS (chills) (seriousness criterion medically significant). At the time of the report, FATIGUE (tiredness), PYREXIA (fever), HEADACHE (headache), PAIN OF SKIN (it hurts to touch), CHILLS (chills), RASH (Skin rash), ERYTHEMA (Skin red) and SWELLING (Swelling) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided by the reporter. Patient had not had symptoms associated with COVID-19. She had not had a COVID-19 test. Patient not tested positive for COVID-19 since had the vaccine. Patient was not pregnant. Patient was not breastfeeding. Patient had big swollen red patch that had appeared a couple cm below the vaccine administration place on the arm. It hurts to touch, seems proper hard and does not seem to be getting any better. All the common side effects were felt on top too (headache, fever, chills, unable to lift arm for a day, tiredness, full nose). Company comment: This is a regulatory case concerning a 30-year-old, female patient with no medical history reported who experienced the unexpected serious events of Fatigue, Pyrexia, Headache, Pain of skin, Chills, Rash, Erythema and Swelling. The events of Rash, Erythema and Swelling occurred one day after the third dose of mRNA-1273 vaccine, while the onset date of other events was not reported. The event terms, event seriousness, rechallenge and action taken with the suspect product were kept as per SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 30-year-old, female patient with no medical history reported who experienced the unexpected serious events of Fatigue, Pyrexia, Headache, Pain of skin, Chills, Rash, Erythema and Swelling. The events of Rash, Erythema and Swelling occurred one day after the third dose of mRNA-1273 vaccine, while the onset date of other events was not reported. The event terms, event seriousness, rechallenge and action taken with the suspect product were kept as per SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030222 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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.MOD20224

Write-up: Chest pain; Tight chest; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26423998) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain) and CHEST DISCOMFORT (Tight chest) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022A) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion medically significant) and CHEST DISCOMFORT (Tight chest) (seriousness criterion medically significant). On 01-Jan-2022, CHEST DISCOMFORT (Tight chest) had resolved. At the time of the report, CHEST PAIN (Chest pain) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. The patient had a really painful chest but not on the outside to touch, on the inside more on the left to middle side of the chest. The pain did not affect the breathing. But was like a pain that the patient have never had before. Concomitant and treatment medication was not provided. Company comment: This regulatory authority case concerns a 37-year-old female patient with no relevant medical history who experienced serious unexpected events of chest pain and chest discomfort, that occurred approximately 1 day after the 3rd dose of the mRNA-1273 . The rechallenge was not applicable due to occurrence after the 3rd dose. The regulatory authority assessed the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Seriousness as per regulatory authority.; Sender''s Comments: This regulatory authority case concerns a 37-year-old female patient with no relevant medical history who experienced serious unexpected events of chest pain and chest discomfort, that occurred approximately 1 day after the 3rd dose of the mRNA-1273 . The rechallenge was not applicable due to occurrence after the 3rd dose. The regulatory authority assessed the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Seriousness as per regulatory authority.


VAERS ID: 2030223 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Headache; High temperature; Ache; This case was received via RA (Reference number: GB-MHRA-ADR 26424030) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (High temperature) and PAIN (Ache) in a 48-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and PYREXIA (High temperature) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache) and PYREXIA (High temperature) outcome was unknown and PAIN (Ache) 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. No concomitant medications were provided. No treatment information was provided. Patient was healthy prior to booster but side effects appeared to be waning. Patient mentioned that he had all bone joints ache when moved and headache too, plus a high temperature forcing him to go to bed at 20:30 on NYE! Patient was not enrolled in clinical trial. Company comment: This is a regulatory case concerning a 48-year-old, male patient with no medical history who experienced the unexpected serious events of Headache, Pyrexia and Pain after the third dose of mRNA-1273 vaccine. The patient developed event of Pain one day after vaccine, while onset dates of events Headache and Pyrexia was not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The event term, event seriousness, rechallenge and action taken with the suspect product were kept as per RA.; Sender''s Comments: This is a regulatory case concerning a 48-year-old, male patient with no medical history who experienced the unexpected serious events of Headache, Pyrexia and Pain after the third dose of mRNA-1273 vaccine. The patient developed event of Pain one day after vaccine, while onset dates of events Headache and Pyrexia was not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The event term, event seriousness, rechallenge and action taken with the suspect product were kept as per RA.


VAERS ID: 2030237 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Injection site inflammation, Lymphadenopathy
SMQs:, Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Injection site inflammation; Swollen glands; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26424160) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen glands) and INJECTION SITE INFLAMMATION (Injection site inflammation) in a 55-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 21-Mar-2021 to an unknown date for an unknown indication. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant). On 01-Jan-2022, the patient experienced INJECTION SITE INFLAMMATION (Injection site inflammation) (seriousness criterion medically significant). At the time of the report, LYMPHADENOPATHY (Swollen glands) and INJECTION SITE INFLAMMATION (Injection site inflammation) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication were reported. It was stated that the patient had experienced the Injection site was hot and red, swollen. Company Comment This case concerns a 55-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of lymphadenopathy and injection site inflammation. The events occurred 2 days after the third dose of mRNA-1273. The rechallenge was unknown since no information regarding the first and second dose was disclosed and as was reported by regulatory Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events meet the criteria to be medically significant. No possible inflammation of the heart (myocarditis or pericarditis) was reported.; Sender''s Comments: This case concerns a 55-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of lymphadenopathy and injection site inflammation. The events occurred 2 days after the third dose of mRNA-1273. The rechallenge was unknown since no information regarding the first and second dose was disclosed and as was reported by regulatory Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events meet the criteria to be medically significant.


VAERS ID: 2030240 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Injection site pain, Palpitations, Peripheral swelling, SARS-CoV-2 test, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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.MOD20224

Write-up: Fatigue/unusual tiredness; Heart palpitations; Hives; Large arm swelling; Palpitations; Injection site pain; Headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26424195) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of URTICARIA (Hives), PERIPHERAL SWELLING (Large arm swelling), PALPITATIONS (Palpitations), INJECTION SITE PAIN (Injection site pain), HEADACHE (Headache), FATIGUE (Fatigue/unusual tiredness) and PALPITATIONS (Heart palpitations) in a 35-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced PERIPHERAL SWELLING (Large arm swelling) (seriousness criterion medically significant), PALPITATIONS (Palpitations) (seriousness criterion medically significant), INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 01-Jan-2022, the patient experienced URTICARIA (Hives) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant) and PALPITATIONS (Heart palpitations) (seriousness criterion medically significant). At the time of the report, URTICARIA (Hives), PALPITATIONS (Palpitations), INJECTION SITE PAIN (Injection site pain) and HEADACHE (Headache) had not resolved, PERIPHERAL SWELLING (Large arm swelling) was resolving and FATIGUE (Fatigue/unusual tiredness) and PALPITATIONS (Heart palpitations) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No Concomitant medications were reported. No Treatment information was reported. Patient was not tested positive for COVID-19 since vaccination. Patient was not enrolled in clinical trials The patient reported yes for a possible inflammation of the heart (myocarditis or pericarditis).The symptoms do not lead to a hospital stay and was not made a diagnosis by a medical professional. Company comment: This case concerns a 35-year-old female patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of urticaria, peripheral swelling, palpitations, injection site pain headache and fatigue after the third dose of mRNA-1273. The events started the same day after vaccination, except for urticaria that occurred the next day after third dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.; Sender''s Comments: This case concerns a 35-year-old female patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of urticaria, peripheral swelling, palpitations, injection site pain headache and fatigue after the third dose of mRNA-1273. The events started the same day after vaccination, except for urticaria that occurred the next day after third dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.


VAERS ID: 2030247 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000050A / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: HIV positive (HIV-positive with symptoms or reduction in immune response.Hiv UD but taking daily tablet .); Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211203; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Headache; Ache; Sickness; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 26424269) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PAIN (Ache) and ILLNESS (Sickness) in a 35-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000050A) for an unknown indication. Concurrent medical conditions included Suspected COVID-19 since 03-Dec-2021 and HIV positive (HIV-positive with symptoms or reduction in immune response.Hiv UD but taking daily tablet .). On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant) and ILLNESS (Sickness) (seriousness criterion medically significant). On 01-Jan-2022, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache) was resolving, PAIN (Ache) had not resolved and ILLNESS (Sickness) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Dec-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. Patient was General fit and well. No treatment information was provided. Company comment: This regulatory authority case concerns a 35-year-old male patient with a recent history of COVID-19, who experienced the unexpected serious (medically significant) events of Headache, Pain and Illness after mRNA- 1273 vaccine. The onset of the events occurred on the day after the third dose of mRNA- 1273 vaccine (reported as 3b dose). Information regarding the initial schedule of vaccination was not provided. Headache is consistent with the known safety profile of the vaccine, but since it was reported with a seriousness criteria it is considered unexpected. Very limited information is available regarding the clinical course of the events. The seriousness criteria of the events was assessed as per regulatory authority report. Recent COVID-19 infection (28 days before vaccination) might be a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Patient had not tested positive for covid-19 since the vaccine. patient was not enrolled in clinical trial.; Sender''s Comments: This regulatory authority case concerns a 35-year-old male patient with a recent history of COVID-19, who experienced the unexpected serious (medically significant) events of Headache, Pain and Illness after mRNA- 1273 vaccine. The onset of the events occurred on the day after the third dose of mRNA- 1273 vaccine (reported as 3b dose). Information regarding the initial schedule of vaccination was not provided. Headache is consistent with the known safety profile of the vaccine, but since it was reported with a seriousness criteria it is considered unexpected. Very limited information is available regarding the clinical course of the events. The seriousness criteria of the events was assessed as per regulatory authority report. Recent COVID-19 infection (28 days before vaccination) might be a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.


VAERS ID: 2030249 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: itchy; Red rash; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26424288) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash) and PRURITUS (itchy) in a 42-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced RASH ERYTHEMATOUS (Red rash) (seriousness criterion medically significant). On an unknown date, the patient experienced PRURITUS (itchy) (seriousness criterion medically significant). At the time of the report, RASH ERYTHEMATOUS (Red rash) had not resolved and PRURITUS (itchy) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient last menstrual period date was reported as 15-Dec-2021. Patient has a red rash below the injection site. It was a little itchy to begin with but continues to be hot. Its 6cm wide by 3cm. Patient has no headache or temperature. Patient has not tested positive for COVID-19 since having the vaccine, Patient is not enrolled in clinical trial. Adverse reaction did not occur because of an exposure during pregnancy. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Company comment This is a regulatory case concerning a 42-year-old female patient with no medical history reported, who experienced the serious unexpected, events of rash erythematous and pruritus. The event rash erythematous occurred approximately 2 days after the third dose of mRNA-1273. The event pruritus occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge was assessed as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This is a regulatory case concerning a 42-year-old female patient with no medical history reported, who experienced the serious unexpected, events of rash erythematous and pruritus. The event rash erythematous occurred approximately 2 days after the third dose of mRNA-1273. The event pruritus occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge was assessed as unknown according to SD. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2030251 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Back pain, Chest discomfort, Headache, Incontinence, Monoplegia, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: Asthmatic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Incontinence; Paralysis leg; Joint pain; Fever; Vomiting; Headache; Back pain; Chest pressure; This case was received via Agency Regulatory Authority (Reference number: GB-MHRA-ADR 26424284) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of INCONTINENCE (Incontinence), MONOPLEGIA (Paralysis leg), ARTHRALGIA (Joint pain), PYREXIA (Fever), VOMITING (Vomiting), HEADACHE (Headache), BACK PAIN (Back pain) and CHEST DISCOMFORT (Chest pressure) in a 44-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Asthmatic. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced INCONTINENCE (Incontinence) (seriousness criterion medically significant), MONOPLEGIA (Paralysis leg) (seriousness criterion medically significant), ARTHRALGIA (Joint pain) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and CHEST DISCOMFORT (Chest pressure) (seriousness criterion medically significant). 31-Dec-2021, the patient experienced BACK PAIN (Back pain) (seriousness criterion medically significant). On 31-Dec-2021, VOMITING (Vomiting) had resolved. On 01-Jan-2022, MONOPLEGIA (Paralysis leg) and PYREXIA (Fever) had resolved, HEADACHE (Headache) was resolving. At the time of the report, INCONTINENCE (Incontinence), ARTHRALGIA (Joint pain), BACK PAIN (Back pain) and CHEST DISCOMFORT (Chest pressure) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No relevant medical history reported. No relevant concomitant medication information provided. No relevant treatment medication information provided Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Company Comment: This case concerns a 44-year-old female, with no relevant medical history reported in this case, who experienced the serious unexpected events of Incontinence, Monoplegia, Arthralgia, Pyrexia, Vomiting, Headache, Back Pain and Chest Discomfort. The events occurred approximately 2 days after the administration of the 3rd dose of mRNA-1273 vaccine and at the time of the report the outcome for the event was Recovering/Resolving for the events Incontinence, Arthralgia, Headache, Back Pain and Chest Discomfort; and Recovered/Resolved for the events Monoplegia, Pyrexia and Vomiting. The rechallenge could be considered not applicable since the events occurred after the 3rd dose and no additional dosing will be given. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 44-year-old female, with no relevant medical history reported in this case, who experienced the serious unexpected events of Incontinence, Monoplegia, Arthralgia, Pyrexia, Vomiting, Headache, Back Pain and Chest Discomfort. The events occurred approximately 2 days after the administration of the 3rd dose of mRNA-1273 vaccine and at the time of the report the outcome for the event was Recovering/Resolving for the events Incontinence, Arthralgia, Headache, Back Pain and Chest Discomfort; and Recovered/Resolved for the events Monoplegia, Pyrexia and Vomiting. The rechallenge could be considered not applicable since the events occurred after the 3rd dose and no additional dosing will be given. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030252 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Fainting; This case was received via the regulatory authority (Reference number: GB-MHRA-ADR 26424295) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting) in a 48-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant). On 31-Dec-2021, SYNCOPE (Fainting) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No relevant concomitant and treatment medications were reported Patient woke up the morning after the having the Moderna booster experienced nauseous and then very hot.she realized she was sweating alot and then passed out. she was unconscious for a couple of minutes before her husband found her on the floor and roused her. Patient still felt nauseous and hot so her husband opened the doors to cool her down and placed her legs higher than her head to help her come round. Once she had cooled down, her husband suggested she would be more comfortable in bed but I still felt nauseous and weak so couldn''t stand. Patient tried to crawl but felt sick so I lay on the kitchen floor resting for the next two hours falling in and out of sleep. After she woke up she didn''t feel sick anymore so walked slowly to bed where she slept for another two hours. By the afternoon she was fully recovered. Patient last menstrual period date was 10-DEC-2021 Patient has not had symptoms associated with COVID-19. Company comment: This case concerns a 48-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant) event of syncope. The event occurred the day after the booster dose of mRNA-1273. The patient reports that she woke up feeling nauseous, hot and with hyperhidrosis, after which she had a syncope episode. She was assisted by her husband for the next hours, still feeling nauseous and weak. On the same day, after resting and sleeping, the patient recovered spontaneously. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 48-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant) event of syncope. The event occurred the day after the booster dose of mRNA-1273. The patient reports that she woke up feeling nauseous, hot and with hyperhidrosis, after which she had a syncope episode. She was assisted by her husband for the next hours, still feeling nauseous and weak. On the same day, after resting and sleeping, the patient recovered spontaneously. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2030254 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-31
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 0000ZZA / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Maternal exposure during pregnancy, SARS-CoV-2 test, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Maternal exposure during pregnancy; Tachycardia; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26424309) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 42-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 0000ZZA) for an unknown indication. The patient''s past medical history included Pregnancy (Patient no longer pregnant at the time of reporting.). Previously administered products included for Blood pressure high: ENALAPRIL in 2004 and AMLODIPINE in 2004. Past adverse reactions to the above products included No adverse reaction with AMLODIPINE and ENALAPRIL. On 27-Dec-2021, the patient received third 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 31-Dec-2021, the patient experienced TACHYCARDIA (Tachycardia) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, TACHYCARDIA (Tachycardia) had not resolved and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Aug-2021, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Tachycardia, dizziness, headache, arm pain, chest pain. No concomitant and treatment medication were provided. Company comment: This case concerns a 42-year-old female patient with medical history of hypertensive medication, who experienced the unexpected, serious (medically significant) event of tachycardia. Additionally, the patient was pregnant at the time of vaccine exposure, though information regarding gestational age and obstetric history has not been provided. The event occurred 4 days after the booster dose of mRNA-1273. The report also mentions that the patient experienced dizziness, headache, arm pain and chest pain. Hypertensive medication and pregnancy could be a confounders for dizziness, tachycardia, and headache. The patient was no longer pregnant at the time of the report; however delivery outcome has not been provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 42-year-old female patient with medical history of hypertensive medication, who experienced the unexpected, serious (medically significant) event of tachycardia. Additionally, the patient was pregnant at the time of vaccine exposure, though information regarding gestational age and obstetric history has not been provided. The event occurred 4 days after the booster dose of mRNA-1273. The report also mentions that the patient experienced dizziness, headache, arm pain and chest pain. Hypertensive medication and pregnancy could be a confounders for dizziness, tachycardia, and headache. The patient was no longer pregnant at the time of the report; however delivery outcome has not been provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2030257 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Headache, Nausea, Pain in extremity, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Feverish; Nausea; Headache; Chest pain; Pain in arm; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26424320) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Feverish), CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Pain in arm) and NAUSEA (Nausea) in a 59-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), CHEST PAIN (Chest pain) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant). On 01-Jan-2022, the patient experienced PYREXIA (Feverish) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 31-Dec-2021, CHEST PAIN (Chest pain) had resolved. On 01-Jan-2022, PYREXIA (Feverish) had resolved. At the time of the report, HEADACHE (Headache) and NAUSEA (Nausea) was resolving and PAIN IN EXTREMITY (Pain in arm) 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 general fly like symptoms, hair follicles hurting also. No treatment information was provided. Company comment: This regulatory authority case concerns a 59-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) events of Headache, Pyrexia, Chest pain, Pain in arm and Nausea after mRNA- 1273 vaccine. The onset of the events Headache, Chest pain and Pain in arm occurred on the day after the third dose of mRNA- 1273 vaccine (reported as 3b dose) and Nausea and Pyrexia developed on the following day. Influenza-like symptoms and skin pain (reported as hair follicles hurting) were also reported. Very limited information is available regarding Chest pain other than it resolved after less than 1 day. Headache, Pyrexia, Nausea and Vaccination site pain are consistent with the known safety profile of the vaccine, but since they were reported with a seriousness criteria they are considered unexpected. The seriousness criteria of the events was assessed as per regulatory authority report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial.; Sender''s Comments: This regulatory authority case concerns a 59-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) events of Headache, Pyrexia, Chest pain, Pain in arm and Nausea after mRNA- 1273 vaccine. The onset of the events Headache, Chest pain and Pain in arm occurred on the day after the third dose of mRNA- 1273 vaccine (reported as 3b dose) and Nausea and Pyrexia developed on the following day. Influenza-like symptoms and skin pain (reported as hair follicles hurting) were also reported. Very limited information is available regarding Chest pain other than it resolved after less than 1 day. Headache, Pyrexia, Nausea and Vaccination site pain are consistent with the known safety profile of the vaccine, but since they were reported with a seriousness criteria they are considered unexpected. The seriousness criteria of the events was assessed as per regulatory authority report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.


VAERS ID: 2030258 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-31
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Dysmenorrhoea, Menstruation irregular, SARS-CoV-2 test, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (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: PFIZER BIONTECH COVID-19 VACCINE; PFIZER BIONTECH COVID-19 VACCINE
Current Illness: Asthma; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211227; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Menstrual cramp; Irregular menstrual cycle; SARS-CoV-2 infection; Vaginal bleeding; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26424318) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of COVID-19 (SARS-CoV-2 infection), VAGINAL HAEMORRHAGE (Vaginal bleeding), DYSMENORRHOEA (Menstrual cramp) and MENSTRUATION IRREGULAR (Irregular menstrual cycle) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. Concurrent medical conditions included Asthma and Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)). Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 29-May-2021 to an unknown date and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding) (seriousness criterion medically significant). On 01-Jan-2022, the patient experienced COVID-19 (SARS-CoV-2 infection) (seriousness criterion medically significant). On an unknown date, the patient experienced DYSMENORRHOEA (Menstrual cramp) (seriousness criterion medically significant) and MENSTRUATION IRREGULAR (Irregular menstrual cycle) (seriousness criterion medically significant). At the time of the report, COVID-19 (SARS-CoV-2 infection) and VAGINAL HAEMORRHAGE (Vaginal bleeding) had not resolved and DYSMENORRHOEA (Menstrual cramp) and MENSTRUATION IRREGULAR (Irregular menstrual cycle) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The patient''s last menstrual period was on 19-DEC-2021. Patient has not had symptoms associated with COVID-19. Patient had steroid as concomitant medication for asthma. Patient experienced pre menstrual cramping and vaginal bleeding which was usual before period, suspected period might be 15 days early after receiving Moderna vaccine. No treatment medications were reported. Company comment: This case concerns a 38-year-old female patient, with no relevant medical history, who experienced serious unexpected events of Vaginal Haemorrhage, COVID-19, Dysmenorrhoea and Menstruation irregular. The event of Vaginal haemorrhage occurred two days after the administration of the mRNA-1273 vaccine (as third dose) and as per case description, it was stated that the patient experienced premenstrual cramping and vaginal bleeding which was usual for the patient before the period, however, the period came 15 days earlier this time. The event of COVID-19 occurred four days after the patient had received the vaccine, however, SARS-CoV-2 test which was performed five days before the COVD-19 was negative. At the time of this report, the events of SARS-CoV-2 infection and Vaginal haemorrhage were still ongoing, while the outcome of the remaining two events was unknown. The rechallenge was reported as unknown as per SD and kept as such, however, it could have been considered as not applicable as the patient experienced the events following the third dose of the vaccine. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. The patient received Tozinameran COVID-19 vaccine prior to vaccination with the company product, therefore, Interchange of vaccine products should have been considered. Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2022: Follow up received with new events Irregular menstrual cycle, menstrual cramp added, Suspect drug action taken updated ,concomitant medication updated, seriousness criteria for the previously reported events are changed.; Sender''s Comments: This case concerns a 38-year-old female patient, with no relevant medical history, who experienced serious unexpected events of Vaginal Haemorrhage, COVID-19, Dysmenorrhoea and Menstruation irregular. The event of Vaginal haemorrhage occurred two days after the administration of the mRNA-1273 vaccine (as third dose) and as per case description, it was stated that the patient experienced premenstrual cramping and vaginal bleeding which was usual for the patient before the period, however, the period came 15 days earlier this time. The event of COVID-19 occurred four days after the patient had received the vaccine, however, SARS-CoV-2 test which was performed five days before the COVD-19 was negative. At the time of this report, the events of SARS-CoV-2 infection and Vaginal haemorrhage were still ongoing, while the outcome of the remaining two events was unknown. The rechallenge was reported as unknown as per SD and kept as such, however, it could have been considered as not applicable as the patient experienced the events following the third dose of the vaccine. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. The patient received Tozinameran COVID-19 vaccine prior to vaccination with the company product, therefore, Interchange of vaccine products should have been considered.


VAERS ID: 2030270 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Fatigue, Headache, 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: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20211129; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Tired all the time; Short of breath; Frequent headaches; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26424400) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Frequent headaches), FATIGUE (Tired all the time) and DYSPNOEA (Short of breath) in a 52-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped). On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced HEADACHE (Frequent headaches) (seriousness criterion medically significant) and DYSPNOEA (Short of breath) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Tired all the time) (seriousness criterion medically significant). On 31-Dec-2021, FATIGUE (Tired all the time) had not resolved. At the time of the report, HEADACHE (Frequent headaches) and DYSPNOEA (Short of breath) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Nov-2021, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment and concomitant medication information was not provided. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Report did not relate to possible inflammation of the heart (myocarditis or pericarditis). Company comment: This is a regulatory case concerning a 52-year-old, male patient with medical history of suspected COVID-19 and positive COVID-19 test (one month prior to events) who experienced the unexpected serious events of Headache, Fatigue and Dyspnoea on the same date after the third dose of mRNA-1273 vaccine. The patient''s medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The event seriousness, rechallenge and action taken with the suspect product were kept as per .; Sender''s Comments: This is a regulatory case concerning a 52-year-old, male patient with medical history of suspected COVID-19 and positive COVID-19 test (one month prior to events) who experienced the unexpected serious events of Headache, Fatigue and Dyspnoea on the same date after the third dose of mRNA-1273 vaccine. The patient''s medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The event seriousness, rechallenge and action taken with the suspect product were kept as per .


VAERS ID: 2030277 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Asthma (very mild); Depression; Fever (Reaction to 1st and 2nd doses (Pfizer) and booster (Moderna))
Allergies:
Diagnostic Lab Data: Test Date: 20220101; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Headache; This case was received via Regulatory Authority This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 24-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Fever (Reaction to 1st and 2nd doses (Pfizer) and booster (Moderna). Concurrent medical conditions included Depression, Anxiety and Asthma (very mild). On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2022, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient has not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient developed temple headache behind the eyes and forehead that was very photosensitive and worse standing up. Water and outdoor light exercise (walking) and ibuprofen helped but not stopping yet. Company comment: This is a regulatory case concerning a 24-year-old, male patient with medical history of depression, anxiety, asthma and previous reaction to COVID-19 vaccines (pyrexia) who experienced the unexpected serious event of Headache one day after the third dose of mRNA-1273 vaccine. As reported, COVID-19 test was negative. Patient''s medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The event term, event seriousness, rechallenge and action taken with the suspect product were kept as per RA.; Sender''s Comments: This is a regulatory case concerning a 24-year-old, male patient with medical history of depression, anxiety, asthma and previous reaction to COVID-19 vaccines (pyrexia) who experienced the unexpected serious event of Headache one day after the third dose of mRNA-1273 vaccine. As reported, COVID-19 test was negative. Patient''s medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The event term, event seriousness, rechallenge and action taken with the suspect product were kept as per RA.


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